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The Healgen® Accurate Oral Fluid Drug Test COT is a lateral flow chromatographic immunoassay for the qualitative detection of COT in oral fluid at the cut-off concentration 30 ng/mL.

This assay provides only a preliminary result. An alternative laboratory test must be used to confirm the results provided by this drug test. Gas chromatography/mass spectrometry (GC/MS) is the preferred method confirmation test.

The Healgen® Accurate Oral Fluid Drug Test is a competitive binding lateral flow immunochromatographic assay for the qualitative and simultaneous detection of Marijuana (THC) and Cotinine in human oral fluid at the cutoff concentrations listed below and their metabolites.

This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography mass spectrometry (GC/MS) and liquid chromatography mass spectrometry (LC/MS) are the preferred confirmatory methods.

The Healgen® Accurate Oral Fluid Drug Test COT is immunochromatographic assay that uses a lateral flow system for the qualitative detection of cotinine in human oral fluid. The Healeen® Accurate Oral Fluid Drug Test immunochromatographic assay for the qualitative and simultaneous detection of Marijuana (THC) and Cotinine in human oral fluid. The tests are the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.

This document describes the performance characteristics and studies for the Healgen® Accurate Oral Fluid Drug Test and Healgen® Accurate Oral Fluid Drug Test COT, which are qualitative immunoassays for detecting Cotinine (COT) and Marijuana (THC) in oral fluid.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in the document. However, the "Precision-Reproducibility-Cut-Off" studies implicitly define the expected performance around the cut-off values. The "Comparison Studies" and "Layuser Studies" then demonstrate the agreement of the device with a gold standard (LC/MS/MS).

2. Sample Sizes Used for the Test Set and Data Provenance

• Precision-Reproducibility-Cut-Off (Analytical Performance):

  • For each of the 9 concentration levels and 3 device lots: 50 samples (2 runs per day for 25 days).
  • Total samples = 9 concentrations * 50 samples/concentration * 3 lots = 1350 samples for COT, and 1350 samples for THC.
  • Data Provenance: Samples were "spiked" with cotinine or marijuana in negative oral fluid samples, indicating a controlled laboratory setting. The origin (country/retrospective/prospective) is not specified, but the nature of spiking implies prospective sample preparation for the study.

• Method Comparison Studies (Expert Operator):

  • COT: 427 samples
  • THC: 126 samples
  • Data Provenance: Oral fluid samples. The data provenance (e.g., country of origin, retrospective or prospective collection) is not specified.

• Layuser Studies:

  • COT: 362 samples
  • Data Provenance: Oral fluid samples. The data provenance is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Ground Truth Establishment: The ground truth for all performance studies (Precision, Method Comparison, Layuser) was established by LC/MS/MS (Liquid Chromatography/Mass Spectrometry/Mass Spectrometry), which is stated as the "preferred method confirmation test."
• Qualifications of Experts: This implies that the ground truth was not established by human experts interpreting images or subjective data, but by highly accurate analytical laboratory equipment and the qualified personnel operating it. The document does not specify the number or qualifications of the lab personnel who performed the LC/MS/MS analysis, as GC/MS and LC/MS/MS are considered an objective gold standard in drug testing.

4. Adjudication Method for the Test Set

• LC/MS/MS serves as the objective ground truth, providing quantitative results against which the device's qualitative results are compared. Therefore, an "adjudication method" in the sense of reconciling disagreements between human readers is not applicable here. Any discrepancies between the device result and LC/MS/MS are reported as "discordant results."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

• This is not an AI-assisted diagnostic device, but a rapid diagnostic test (lateral flow immunoassay). Therefore, an MRMC comparative effectiveness study involving human readers with and without AI assistance is not applicable.
• The "Layuser Studies" evaluate the performance of the device in the hands of untrained users, essentially assessing human performance with the device instructions. It shows that layusers can achieve comparable results to expert operators for COT detection.

6. If a Standalone (i.e., algorithm-only without human-in-the-loop performance) Was Done

• This question is not applicable as the device is a lateral flow immunoassay kit, not an algorithm. Its "standalone" performance is inherently demonstrated by the results it produces directly from the oral fluid sample, without further human-in-the-loop interpretation beyond reading the visual lines on the strip. The "Precision-Reproducibility-Cut-Off" and "Method Comparison Studies" characterize this inherent device performance.

7. The Type of Ground Truth Used

• The ground truth used was analytical confirmation by LC/MS/MS. This is an objective, quantitative laboratory method considered the gold standard for drug detection and quantification in biological samples.

8. The Sample Size for the Training Set

• The document describes performance studies, but it does not mention a "training set" in the context of machine learning. This is a traditional immunoassay device, which does not employ machine learning algorithms that require separate training and test sets. The studies described are for analytical and clinical validation of the device's performance.

9. How the Ground Truth for the Training Set Was Established

• As there is no mention of a "training set" for a machine learning model, this question is not applicable.

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The Psychemedics Microplate EIA For Cotinine in Hair is an in vitro diagnostic device for the qualitative detection of cotinine in human head and body hair as an aid in the detection of cotinine after use or exposure to tobacco products. The assay is intended for a single site and uses a cutoff calibrator of 200 pg cotinine/mg hair. This device is intended exclusively for Psychemedics use only and is not intended for sale to anyone.

The Psychemedics Microplate EIA For Cotinine in Hair provides only a preliminary analytical test result. A more specific alternate chemical method must be used to obtain a confirmed analytical result. Liquid Chromatography/Mass spectrometry/Mass spectrometry (LC/MS/MS) is the confirmatory method used by Psychemedics Corporation. The LC/ MS/MS analysis uses a cutoff, after extensive washing of 100 pg cotinine/mg hair with presence of hydroxycotinine at or above 10 pg/mg hair.

The Psychemedics Microplate EIA For Cotinine in Hair consists of two parts; a pre-analytical hair treatment procedure (to convert the solid matrix of hair to a measurable liquid matrix) and the screening assay, the Psychemedics Microplate EIA for Cotinine. The screening portion of the test system consists of (1) microplate wells coated with cotinine conjugated to bovine serum albumin (BSA), polyclonal rabbit anti-cotinine, goat antirabbit secondary antibody conjugated to HRP (horseradish peroxidase), substrate [3, 3', 5, 5' tetramethylbenzidine (TMB)], HCl to acidify (and stop the reaction), and wash buffer for washing the plates. Absorbance in the wells is read with a microplate reader.

Liquid Chromatography/Mass spectrometry/Mass spectrometry (LC/MS/MS) is the confirmatory method used by Psychemedics Corporation. The LC/MS/MS analysis uses a cutoff, after extensive washing of the hair, of 100 pg cotinine/mg hair with presence of hydroxycotinine at or above 10 pg/mg hair.

Here's a structured summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance for Psychemedics Microplate EIA for Cotinine in Hair (K192517)

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device and provides performance data rather than explicitly stating pre-defined "acceptance criteria" as pass/fail thresholds for specific metrics. However, based on the performance testing results, we can infer the implied acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance:

• Comparison Study (EIA vs. LC/MS/MS): A total of 82 samples were utilized.
  • Data Provenance: The document states "Samples were identified for inclusion in the study by screening with a screening assay for cotinine in serum (K974234)." It doesn't explicitly state the country of origin or if they were retrospectively or prospectively collected human hair samples, but implies they are human hair samples.
• Precision Studies (EIA): Not explicitly stated as "test set," but 10 samples were used for intra-assay and 50 samples for inter-assay precision at various levels around the cutoff. These were "negative hair spiked with previously LC/MS/MS-validated calibrator and control spiking solutions."
• Cosmetic Treatments: Sets of 5 cotinine-negative and 6 cotinine-positive samples (total of 11) were used.
• Environmental Contamination: 7 hair samples were exposed to smoke for this specific test.
• LC/MS/MS Recovery from Hair: 5 authentic samples.
• LC/MS/MS Precision, Linearity, LLOQ/LOD: These studies involved spiked samples rather than a separate "test set" of authentic patient samples, with varying numbers of replicates (e.g., 5 analyses, 5 samples for 5 days).
• Sample Stability during Shipping and Storage: 6 samples for shipping stability and another 6 samples for storage stability.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Experts:

The primary "ground truth" for the comparison study and for confirming the EIA results is the Liquid Chromatography/Mass Spectrometry/Mass Spectrometry (LC/MS/MS) method. This is a laboratory-based analytical method, not directly dependent on expert human interpretation of images or clinical signs. The document does not mention human experts establishing ground truth for the test set.

4. Adjudication Method for the Test Set:

Not applicable, as the ground truth is established by the LC/MS/MS analytical method, which is a quantitative measurement, not subject to human adjudication in the traditional sense of multiple readers interpreting a case. The LC/MS/MS confirms positive cotinine levels above a certain cutoff (100 pg cotinine/mg hair with presence of hydroxycotinine at or above 10 pg/mg hair).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. The device is an in vitro diagnostic assay, not an imaging device or AI algorithm requiring human interpretation. The comparison is between the new EIA screening method and the confirmatory LC/MS/MS method.

6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done:

Yes, a standalone study of the device (Psychemedics Microplate EIA for Cotinine in Hair) was performed in comparison to the LC/MS/MS confirmatory method, which serves as the "gold standard" ground truth. The EIA itself operates independently without direct human intervention in the interpretation of its results (beyond reading the microplate reader output). The final confirmed analytical result is obtained by LC/MS/MS.

7. The Type of Ground Truth Used:

The ground truth used is an alternative chemical method, specifically Liquid Chromatography/Mass Spectrometry/Mass Spectrometry (LC/MS/MS), which is considered a highly specific and sensitive analytical technique for cotinine detection. This is a form of laboratory/analytical ground truth. The LC/MS/MS analysis uses a cutoff of 100 pg cotinine/mg hair (after extensive washing) with the presence of hydroxycotinine at or above 10 pg/mg hair.

8. The Sample Size for the Training Set:

The document does not explicitly mention a "training set" in the context of machine learning. The device is a traditional enzyme immunoassay (EIA). The performance studies involve validation of the assay's characteristics (precision, linearity, cross-reactivity, etc.) using spiked samples, negative controls, and a limited number of authentic samples for comparison studies. There isn't a "training set" in the sense of data used to train an AI model.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no specific "training set" for an AI model. The calibrators and control materials for the EIA and LC/MS/MS are prepared using drug stocks from commercial vendors with certificates of analysis, and their concentrations are confirmed by LC/MS/MS.

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The Masimo Rad-97 and Accessories can communicate with network systems for supplemental remote viewing and alarming (e.g., at a central station, the Masimo Rad-97 and Accessories are indicated to provide the continuous non-invasive monitoring data obtained from the Masimo Rad-97 and Accessories for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) to multiparameter devices for the display on those devices.

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of carboxyhemoglobin saturation (SpCO) of adult, pediatric, and infant patients during no motion conditions in hospitals and hospital-type facilities. The Masimo Rad-97 and Accessories are not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms.

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of methemoglobin saturation (SpMet) of adult, pediatal patients during no motion conditions in hospitals and hospital-type facilities.

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of total hemoglobin concentration (SpHb) of adult and pediatic patients during no motion conditions in hospital-type facilities.

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of respiratory rate (RRa) for adult, pediatric, and neonatal patients during no motion conditions in hospitals, hospital-type facilities, home environments, and transport within healthcare facilities.

The optional Nomoline Capnography product family is intended to other medical backboard devices for monitoring of breath rate and CO2. The Nomoline Capnography product family is intended to a patient breathing circuit for monitoring of inspired gases during anesthesia, recovery and respiratory care. The environment is the operating suite, intensive care unit and patient population is adult, pediativ and infant patients.

The optional non-invasive blood pressure (NIBP) module is indicated for the noninvasive measurement of arterial blood pressure in hospitals, hospital-type facilities, mobile, and home environments. The NIBP module is designed to measure blood pressure for patient population described in the following table:

The subject device, Masimo Rad-97 System and Accessories (Rad-97 product family), features a touchscreen display that continuously displays numeric values for the measured monitoring parameters. The Rad-97 product family can be operated on AC power or internal rechargeable battery.

The subject device (Rad-97 product family) is substantially the same as the predicate (Rad-97 product family) cleared under K180046, and has the same indications for use. The Rad-97 comprises of the same measurement technologies as cleared in the predicate, which includes the Masimo rainbow SET technology, capnography technology, and noninvasive blood pressure (NIBP) technology. These technologies enable the Rad-97 product family to provide noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), Perfusion Index (Pi), Pleth Variability Index (PVi), carboxyhemoglobin (SpCO), methemoglobin (SpMet), total hemoglobin (SpHb), oxygen content (SpOC), acoustic respiration rate (RRa), and/or optional capnography parameters or optional noninvasive blood pressure (NIBP) parameters.

The subject of this submission is the update to the SpO2 performance specification for the RD SET Disposable sensors for the neonate population to match that of the cleared 1.5% Arms for adults (K180046).

The document describes a 510(k) premarket notification for the "Masimo Rad-97 and Accessories" with a focus on an update to the SpO2 performance specification for the neonate population. The primary goal of the submission is to demonstrate that the device, specifically the RD SET Disposable sensors, maintains its performance for neonates consistent with previously cleared specifications for adults.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a table format with a pass/fail. Instead, it refers to the "SpO2 performance specification" which the device is being updated to match, implying this as the target. The key performance metric cited is ARMS (Accuracy Root Mean Square).

The acceptance criteria for SpO2 accuracy are implicitly set by the previously cleared performance for adults, which is 1.5% ARMS. The submission aims to align the neonate performance with this.

Reported Device Performance:

While the aggregated data shows an ARMS of 3.185%, the document states, "The analysis of the clinical data further supported the safe form, fit, and function of the RD SET Disposable Sensor on neonates. The Arms performance was calculated for reference purposes." And "The results of the clinical testing supported the subject device did not raise any different questions of safety and effectiveness as compared to the predicate device." This suggests that the clinical data, despite not strictly meeting the 1.5% ARMS in all ranges for neonates in the initial and aggregated studies, was deemed sufficient to support substantial equivalence due to the nature of the submission (labeling update, not a new device or significant modification) and the "reference purposes" of the ARMS calculation in this context. The core assertion is that the same device is being used, and the form, fit, and function for neonates are supported.

2. Sample size used for the test set and the data provenance

• Initial Study: 19 neonatal subjects.
• Aggregated Study: 42 neonatal subjects (including 22 pre-term neonates). This aggregation combines data from the initial study with data from "prior studies."
• Data Provenance: The studies collected "convenience blood samples from an arterial line" in a "clinical environment." The document specifies that the aggregated data was from "3 different sites." The country of origin is not explicitly stated, but given the FDA submission, it's typically assumed to be conducted in the US or under comparable ethical/clinical standards acceptable to the FDA. The data is prospective clinical data collected for the purpose of verifying the device's performance on neonates.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The ground truth for SpO2 measurements was established using a reference co-oximeter from arterial blood samples. This is a direct, objective measurement, not one established by human expert consensus or interpretation. Therefore, the concept of "number of experts" or their "qualifications" for establishing ground truth as typically applied to image-based AI studies (e.g., radiologists interpreting images) is not applicable here. The accuracy of the co-oximeter itself would be the relevant qualification.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Since the ground truth is established by a reference co-oximeter on arterial blood samples, there is no adjudication method involving human experts for the test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This device is a physiological monitor (pulse oximeter), not an AI-assisted diagnostic imaging tool that would typically involve human readers interpreting AI outputs. The "AI" aspect is not explicitly mentioned or studied in the context of human reader improvement.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device itself provides the SpO2 measurements. The study assesses the accuracy of these measurements against a reference standard. While the device (Masimo Rad-97 with RD SET Disposable sensors) operates without human intervention in generating the SpO2 reading, the study framework is not typically referred to as a "standalone" or "algorithm only" study in the context of AI regulatory submissions. It's a performance validation study for a medical device. The "algorithm" here is the signal processing within the oximeter. The ARMS metric specifically reflects this standalone device accuracy.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth used was objective reference measurements of SaO2 (arterial oxygen saturation) from arterial blood samples analyzed by a reference co-oximeter.

8. The sample size for the training set

The document does not mention a training set in the context of model development or machine learning. This submission is for a medical device (pulse oximeter) that relies on established physiological principles and signal processing, not a de novo AI/ML algorithm that requires distinct training and test sets in the typical sense. The device's underlying algorithms were presumably developed and validated in prior clearances (K180046). This submission is an update to the labeling for a specific patient population (neonates) using an existing sensor, justifying it with clinical performance data on that population.

9. How the ground truth for the training set was established

As there is no mention of a training set for an AI/ML model, this question is not applicable based on the provided document. The device's core technology and its existing cleared performance for adults underpin the rationale for extending the performance specifications to neonates.

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The LZI Cotinine II Enzyme Immunoassay is intended for the quantitative determination of cotinine in human urine at the cutoff value of 200 ng/mL when calibrated against cotinine. The assay is intended as an aid in the detection of cotinine after use or exposure to tobacco products. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.

The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as gas or liquid chromatography/mass spectrometry (GC/MS or LC/MS) or (2) permitting laboratories to establish quality control procedures.

The assay provides only a preliminary analytical result. A more specific alternative chemical method (e.g., gas or liquid chromatography and mass spectrometry) must be used in order to obtain a confirmed analytical result. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.

The LZI Cotinine II Enzyme Immunoassay is a homogeneous enzyme immunoassay with readyto-use liguid reagents. The assay is based on competition between drug in the sample and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for a fixed amount of antibody in the reagent. Enzyme activity decreases upon binding to the antibody, and the drug concentration in the sample is measured in terms of enzyme activity. In the absence of drug in the sample, cotinine-labeled G6PDH conjugate is bound to antibody, and the enzyme activity is inhibited. On the other hand, when free drug is present in the sample, antibody would bind to free drug; the unbound cotinine-labeled G6PDH then exhibits its maximal enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that can be measured spectrophotometrically at 340 nm.

The LZI Cotinine II Enzyme Immunoassay is a kit comprised of two reagents, an R1 and R2 which are bottled separately but sold together within the kit.

The R1 solution contains mouse monoclonal anti-cotinine antibody, glucose-6-phosphate (G6P) nicotinamide adenine dinucleotide (NAD), stabilizers, and sodium azide (0.09 %) as a preservative. The R2 solution contains glucose-6-phosphate dehydrogenase (G6PDH) labeled with cotinine in buffer with sodium azide (0.09 %) as a preservative.

The provided text describes the LZI Cotinine II Enzyme Immunoassay, its intended use, and performance characteristics, but it does not describe a study that directly establishes acceptance criteria and directly proves the device meets specific acceptance criteria in a structured manner you requested.

The document is a 510(k) Summary of Safety and Effectiveness, which typically outlines the device's characteristics and demonstrates substantial equivalence to a predicate device. It includes performance data such as precision, linearity, and method comparison (accuracy) with clinical samples, which implicitly serve to show the device is safe and effective for its stated intended use. However, explicit acceptance criteria values that the device must meet are not directly listed in a table format with corresponding proof of meeting them.

I will extract the closest information available to address your request, making inferences where necessary based on the context of common performance expectations for such devices.

Here's a breakdown of the information as requested, largely derived from the "Method Comparison - Clinical Samples" and "Precision" sections.

Acceptance Criteria and Device Performance for LZI Cotinine II Enzyme Immunoassay

Note: The document does not explicitly state "acceptance criteria" in a definitive table format with corresponding proof. Instead, it presents performance study results that are implicitly considered acceptable for demonstrating substantial equivalence. The "Reported Device Performance" below is directly from the study results. The "Acceptance Criteria" are inferred based on the observed performance and typical expectations for diagnostic assays.

1. Table of Acceptance Criteria and Reported Device Performance

• 1 sample (128.6 ng/mL LC/MS) was positive by EIA but was between 50% below cutoff and cutoff concentration (100-199.9 ng/mL). The report states it was "discrepant" but the EIA result (positive) aligns with the stated LC/MS value being within the range where a positive result starts to become more likely if it's "near cutoff positive". However, interpreting that specific discrepancy is complex without a clear cut-off definition of "positive" for LC/MS in the table.
• 1 sample (204.2 ng/mL LC/MS) was negative by EIA but was between cutoff and 50% above cutoff concentration (200-299.9 ng/mL). The report states it was "discrepant". | The accuracy study uses LC/MS as the gold standard. The reported percentages reflect agreement for positive and negative results with respect to the 200 ng/mL cut-off. The discrepancies highlight inherent variability near the cutoff. |
  | Accuracy (Qualitative) | High overall agreement with LC/MS, similar to semi-quantitative.| Overall Agreement: ~96.4% for positive, ~98.7% for negative.
  Discrepant Samples:
• 1 sample (128.6 ng/mL LC/MS) was positive by EIA (146.6 mAU) with a qualitative cutoff rate of 126.4 mAU. This sample was LC/MS positive but between 100-199.9 ng/mL, the EIA result was positive.
• 1 sample (204.2 ng/mL LC/MS) was negative by EIA (93.8 mAU) with a qualitative cutoff rate of 126.4 mAU. This sample was LC/MS positive (204.2 ng/mL) but the EIA result was negative. | Similar to semi-quantitative accuracy, with concordance defined by the qualitative response based on mAU compared to a cutoff rate. |
  | Precision (Qualitative) | At 200 ng/mL cutoff, some variability is expected. For concentrations significantly above or below the cutoff, 100% agreement with expected result (positive/negative) is expected. | At 200 ng/mL:
• Within Run (N=22): 10 Neg/12 Pos
• Total Precision (N=88): 51 Neg/37 Pos
  At 250-400 ng/mL: 100% Positive
  At 0-150 ng/mL: 100% Negative | This indicates that at the exact cutoff concentration (200 ng/mL), there is expected variability in classification. This is typical for assays and is why results near the cutoff require careful interpretation and often confirmatory testing. |
  | Precision (Semi-Quantitative)| Same as qualitative. At 200 ng/mL cutoff, some variability is expected. For concentrations significantly above or below the cutoff, 100% agreement with expected result (positive/negative) is expected. | At 200 ng/mL:
• Within Run (N=22): 14 Neg/8 Pos
• Total Precision (N=88): 55 Neg/33 Pos
  At 250-400 ng/mL: 100% Positive
  At 0-150 ng/mL: 100% Negative | The semi-quantitative precision results also show variability at the 200 ng/mL cutoff, with 100% agreement for samples sufficiently above or below the cutoff. This confirms the device's ability to consistently classify samples away from the decision point. |
  | Linearity | Percent recovery between 85% and 115% of expected values across the assay's linear range. | Range 100 ng/mL to 1000 ng/mL: Recovery ranging from 97.9% to 110.8%.
  At 20 ng/mL: 167.5% recovery.
  At 0 ng/mL: N/A (reported 19.3 ng/mL determined). | The device demonstrated good linearity within the critical range for its intended use (100-1000 ng/mL). The higher recovery at 20 ng/mL suggests reduced accuracy at very low concentrations, which is generally not a concern given the 200 ng/mL cutoff. |
  | Cross-reactivity | Minimal or no significant cross-reactivity with common substances, particularly structurally unrelated compounds, at physiologically relevant concentrations or concentrations higher than expected. | Cotinine-related compounds: Some cross-reactivity with compounds like (-) Norcotinine (20.00%) and (R, S)-Norcotinine (23.53%).
  Structurally Unrelated Pharmacological Compounds: "ND" (Not Detected) at high concentrations (e.g., 100,000 ng/mL) for most tested drugs. Negative results for 0 ng/mL cotinine spiked with these compounds, and correct positive/negative results for cotinine controls. | The device largely demonstrates specificity against a wide panel of common drugs and related substances, indicating minimal interference for its intended purpose. Some expected cross-reactivity with specific cotinine metabolites is noted. |
  | Endogenous Interference | No significant interference from common endogenous substances at relevant concentrations. | No significant undesired cross-reactants or endogenous substance interference was observed except for Boric Acid (1000 ng/mL) and Citric Acid (pH 3) (800 ng/mL) which showed interference at ±25% of cutoff and also at ±50% of cutoff. | Most endogenous substances showed no interference. Boric acid and citric acid showed interference, which is important for laboratories to be aware of when testing samples that might contain these substances. |
  | Specific Gravity Interference | No interference observed across the tested range. | No interference was observed in samples ranging from 1.005 to 1.028 specific gravity when spiked with cotinine at control concentrations. | This indicates the device is robust to variations in urine specific gravity, which is a common factor in urine drug testing. |
  | pH Interference | No major interference observed across the tested pH range. | No major interference between pH 3 to pH 11. | This demonstrates the device's robustness across a wide physiological pH range for urine, an important aspect for clinical utility. |

2. Sample Size Used for the Test Set and Data Provenance

• Accuracy (Method Comparison - Clinical Samples):

  • Sample Size: 104 unaltered clinical samples.
  • Data Provenance: Samples were collected by Lin-Zhi International, Inc. (LZI). The country of origin is not specified, but LZI is based in Santa Clara, CA, USA. The samples are indicated to be "clinical samples," implying they were prospectively collected from human subjects for diagnostic purposes. They are referred to as "unaltered," suggesting they were tested as received without intentional modification. The study is retrospective in the sense that these samples were then tested against a new assay.

• Precision:

  • Sample Size: For each cotinine concentration, 22 determinations were made within a run, and a total of 88 determinations were made across multiple runs (2 runs/day for 22 days).
  • Data Provenance: Samples were prepared by spiking a cotinine standard into a "pool of negative human urine." This indicates a controlled laboratory setting (likely in-house at LZI) rather than clinical samples, and thus not tied to a specific country of origin from patients.

• Linearity, Cross-reactivity, Endogenous Interference, Specific Gravity, pH Interference: These studies used spiked samples prepared in a laboratory setting (e.g., "drug free-urine pool," "pool of negative human urine"). The sample sizes for each condition are detailed in the tables (e.g., "10 replicates" for linearity, "replicates" for others).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• For the Accuracy (Method Comparison - Clinical Samples): The ground truth was established by LC/MS (Liquid Chromatography/Mass Spectrometry). This is an analytical laboratory method, not typically performed by "experts" in the sense of clinicians or radiologists. The result from the LC/MS machine is the ground truth. Therefore, the concept of "number of experts" and their "qualifications" is not applicable here as the ground truth is an objective chemical measurement.

4. Adjudication Method for the Test Set

• For the accuracy study, the "ground truth" was established by LC/MS, which is a definitive analytical method. Therefore, no human adjudication method (like 2+1, 3+1 consensus) was used or required for determining the confirmed cotinine concentration. The comparison was directly between the LZI Cotinine II Enzyme Immunoassay results and the LC/MS results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typical for imaging devices where human readers interpret images, sometimes with and without AI assistance, to assess AI's impact on human performance. The LZI Cotinine II Enzyme Immunoassay is an in-vitro diagnostic (IVD) device (a laboratory test), not an imaging device that would involve human readers for interpretation in this manner.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Yes, the performance studies described are essentially standalone evaluations of the LZI Cotinine II Enzyme Immunoassay. The accuracy, precision, linearity, and interference studies assess the analytical performance of the device itself (the "algorithm" in a broad sense, referring to the assay's methodology and reagents) against established reference methods or known concentrations, without requiring human intervention for interpretation beyond operating the automated clinical analyzer and analyzing the data. The results (e.g., ng/mL concentrations or positive/negative classifications) are generated directly by the assay on the automated analyzer.

7. The Type of Ground Truth Used

• Primary Ground Truth for Clinical Accuracy: LC/MS (Liquid Chromatography/Mass Spectrometry) for cotinine concentrations. This is a highly specific and sensitive analytical technique, often considered the gold standard for drug confirmation testing.
• Ground Truth for Other Studies (Precision, Linearity, Cross-reactivity, etc.): Known concentrations of cotinine or other substances (spiked samples) in negative human urine pools.

8. The Sample Size for the Training Set

• The document describes performance studies for device validation. It does not provide information about a "training set" in the context of an AI/machine learning model. This device is an enzyme immunoassay, a chemical assay, not an AI-based diagnostic algorithm that typically undergoes a separate training phase with a large dataset. The "training" for such an assay would be its initial development and optimization, not a dataset-driven training process in the AI sense.

9. How the Ground Truth for the Training Set Was Established

• As explained in point 8, the concept of a "training set" for an AI/machine learning model is not applicable to this enzyme immunoassay device. Therefore, how its ground truth was established is not relevant here. The development of the assay's chemical reagents and methodology would have involved internal validation and optimization, but not a "training set" in the context of AI.

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The Masimo Rad-97 and Accessories can communicate with network systems for supplemental remote viewing and alarming (e.g., at a central station). In addition, the Masimo Rad-97 and Accessories are indicated to provide the continuous non-invasive monitoring data obtained from the Masimo Rad-97 and Accessories for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) to multiparameter devices for the display on those devices.

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of carboxyhemoglobin saturation (SpCO) of adult, pediatric, and infant patients during no motion conditions in hospital-type facilities. The Masimo Rad-97 and Accessories are not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms.

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of methemoglobin saturation (SpMet) of adult, pediatric, and neonatal pation conditions in hospitals and hospitals and hospital-type facilities.

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of total hemoglobin concentration (SpHb) of adult and pediatric patients during no motion conditions in hospital-type facilities.

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of respiratory rate (RRa) for adult, pediatric, and neonatal patients during no motion conditions in hospitals, hospital-type facilities, home environments, and transport within healthcare facilities.

The optional Nomoline Capnography product family is intended to other medical backboard devices for monitoring of breath rate and CO2. The Nomoline Capnography product family is intended to a patient breathing circuit for monitoring of inspired gases during anesthesia, recovery and respiratory care. The environment is the operating suite, intensive care unit and patient population is adult, pediatric and infant patients.

The optional non-invasive blood pressure (NIBP) module is indicated for the noninvasive measurement of arterial blood pressure in hospitals, hospital-type facilities, mobile, and home environments. The NIBP module is designed to measure blood pressure for patient population described in the following table:

Patient Population Approximate Age Range Newborn (neonate) Birth to 1 month of age Infant 1 month to 2 years of age Child 2 to 12 years of age Adolescent 12-21 years of age Adult 21 years of age and older

The optional Masimo Centroid O2 is intended for the non-invasive continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR).

The optional Masimo Centroid O2 is indicated for the continuous monitoring of functional arterial oxygen saturation of hemoglobin (SpO2) and pulse rate (PR) for use with adult, pediatric and neonatal patients during both no motion and motion conditions and for patients who are well or poorly perfused in hospital-type facilities and home environments.

Devices with Masimo technology are only to be used with Masimo sensors and cables.

The subject device, Masimo Rad-97 System and Accessories (Rad-97 product family), features a touchscreen display that continuously displays numeric values for the measured monitoring parameters. The Rad-97 product family can be operated on AC power or internal rechargeable battery.

The subject device (Rad-97 product family) is substantially the same as the predicate (Rad-97 product family) cleared under K180046, and has the same indications for use. The Rad-97 comprises of the same measurement technologies as cleared in the predicate, which includes the Masimo rainbow SET technology, capnography technology, and noninvasive blood pressure (NIBP) technology. These technologies enable the Rad-97 product family to provide noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), Perfusion Index (Pi), Pleth Variability Index (PVi), carboxyhemoglobin (SpCO), methemoglobin (SpMet), total hemoglobin (SpHb), oxygen content (SpOC), acoustic respiration rate (RRa), and/or optional capnography parameters or optional noninvasive blood pressure (NIBP) parameters.

The subject of this submission, is the inclusion of Masimo Centroid 02 sensor to be used with the Rad-97 and similar devices that utilize Masimo SET technology.

The Centroid O2 is a family of wearable, battery operated, sensors that support Masimo SET technology. The Centroid O2 uses wireless communication to a host device (e.g., Rad-97, Radical-7) in order to support the continuous monitoring of Masimo SET parameters (SpO2 and PR). Centroid O2, similar to the previously cleared RD SET sensors (K180046), are intended for the noninvasive continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR).

The Centroid O2 consists of both disposable and reusable components. The disposable components include the sensor and wrist strap: the reusable component contains the hardware to transfer the measured data wirelessly. Centroid 02 uses a battery as a power source for the sensor and to enable measurement data to be transferred wirelessly to a host device (e.g. Rad-97, Radical-7).

The provided text describes the Masimo Rad-97 and Accessories device and the study conducted to ensure its accuracy. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are presented as "Accuracy (ARMS)*" for SpO2, with the reported performance values reflecting the device's accuracy within those ranges.

*ARMs accuracy is a statistical calculation of the difference between device measurements and reference measurements. Approximately two-thirds of the device measurements fell within +/- ARMs of the reference measurements in a controlled study.

The clinical study explicitly reports on "SpO2 No Motion Accuracy" with an Adjusted RMS of 1.3, which corresponds to an ARMs value of 2% during no-motion conditions. For "SpO2 Motion Accuracy," the Adjusted RMS is 2.2, corresponding to an ARMs value of 3% during motion conditions. These reported values directly align with the acceptance criteria for SpO2 for adults/pediatrics/infants during no motion and for all patient populations during motion.

2. Sample Size Used for the Test Set and the Data Provenance

The document states, "a clinical study was performed... on healthy adult volunteers." However, the exact sample size (number of healthy adult volunteers) used for the test set is not explicitly mentioned in the provided text.

The data provenance is prospective, as it was a "clinical study" performed specifically "to establish the accuracy (ARMs) of the Centroid O2 sensors." The country of origin of the data is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

The document states that the comparison was made "in comparison to blood measurements from a laboratory CO-Oximeter." This implies that the ground truth for SpO2 measurements was established using a laboratory CO-Oximeter, which is a highly accurate reference method. It does not involve human experts in establishing the ground truth directly for SpO2 measurements in this context. The reliance is on the accuracy of the laboratory instrument.

4. Adjudication Method for the Test Set

Since the ground truth for SpO2 measurements was based on a laboratory CO-Oximeter, there was no human adjudication method (e.g., 2+1, 3+1) used for establishing the ground truth for the test set. The CO-Oximeter serves as the objective reference standard.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no mention of a Multi Reader Multi Case (MRMC) comparative effectiveness study in the provided text. The device is a patient monitor, and the study focuses on the accuracy of the device's measurements (SpO2, PR, etc.) compared to a reference standard, not on human interpretation or the impact of AI on human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, a standalone study was done. The clinical study described "evaluate[d] the sensor's performance for no motion and motion conditions, in the range of 70% to 100% SaO2, in comparison to blood measurements from a laboratory CO-Oximeter." This is a direct assessment of the device's (and its underlying algorithm's) performance without human intervention in the measurement process itself.

7. The Type of Ground Truth Used

The type of ground truth used for the clinical study was laboratory-measured SaO2 (functional oxygen saturation of arterial hemoglobin) from a CO-Oximeter. This is an objective physiological measurement from a reference device.

8. The Sample Size for the Training Set

The provided text does not mention the sample size for the training set. The clinical study described is for validation/testing, not for training. The document states that the Masimo Rad-97 and Accessories (Centroid O2) uses "Masimo SET technology," which is an established technology, implying that the underlying algorithms would have been developed and potentially trained on prior datasets, but details of such training sets are not included here.

9. How the Ground Truth for the Training Set Was Established

Since the document does not provide information on a training set, it does not describe how the ground truth for a training set was established. The clinical study focuses on evaluating the Centroid O2 sensor's performance against a reference (laboratory CO-Oximeter) during no-motion and motion conditions.

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The Masimo Rad-97 and Accessories are indicated for hospital-type facilities, mobile, and home environments.

The Masimo Rad-97 and Accessories can communicate with network systems for supplemental remote viewing and alarming (e.g., at a central station).

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Rad-97 and Accessories are indicated for use with adult, pediatic, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused. In addition, the Masimo Rad-97 and Accessories are indicated to provide the continuous non-invasive monitoring data obtained from the Masimo Rad-97 and Accessories for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) to multi-parameter devices for the display on those devices.

The Masimo Rad-97 and Accessories are not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms.

The optional Nomoline Capnography product family is intended to other medical backboard devices for monitoring of breath rate and CO2. The Nomoline Capnography product family is intended to a patient breathing circuit for monitoring of inspired gases during anesthesia, recovery and respiratory care. The environment is the operating suite, intensive care unit and patient population is adult, pediatric and infant patients.

The optional non-invasive blood pressure (NIBP) module is indicated for the noninvasive measurement of arterial blood pressure. The NIBP module is designed to measure blood pressure for patient population described in the following table:

The subject device, Masimo Rad-97 System and Accessories (Rad-97) product family, features a touchscreen display that continuously displays numeric values for the measured monitoring parameters. The Rad-97 product family can be operated on AC power or internally rechargeable battery.

The Rad-97 product family comprises the same measurement technologies as cleared in the predicate, Root (with connected external Radical-7 and capnography (ISA) and internal NIBP modules), which includes the Masimo Rainbow SET technology, capnography technology and noninvasive blood pressure (NIBP) technology. These technologies enable the Rad-97 product family to provide noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), Perfusion Index (PI), Pleth Variability Index (PVI), carboxyhemoglobin (SpCO), methemoglobin (SpMet), total hemoglobin (SpHb), oxygen content (SpOC), acoustic respiration rate (RRa) and/or optional capnography parameters or optional noninvasive blood pressure (NIBP) parameters.

The Rad-97 product family is available with different measurement parameter configurations, ranging from a fully loaded configuration to a simplified configuration with pulse oximetry parameters only. In a fully loaded configuration, the Rad-97 model includes all parameters provided by the Masimo Rainbow SET technology including SpO2, PR, PI, PVI, SpCO, SpMet, SpHb, SpOC and RRa. Additionally, this fully loaded version can be optionally available with either NIBP or capnography technology.

The Rad-9 model, an instrument model within the Rad-97 product family, is an embodiment with a simplified configuration. The Rad-9 model includes the Masimo SET technology (a subset of Masimo Rainbow SET technology), which provides pulse oximetry parameters of SpO2, PR, PI and PVI. The Rad-9 model can be optionally available with NIBP technology.

Same as the predicate, the Rad-97 product family includes inout/output interfaces for connection to external devices. Furthermore, same as the predicate, the Rad-97 product family can communicate through wired/wireless connection with networked systems such as Patient SafetyNet (K071047) and/or hospital electronic medical/health record (EMR) systems.

The RD SET Disposable Sensors, listed with other cleared accessories in Section 11.7, are the same as the currently marketed product. The only change is the added labeling information regarding the sensors' performance in terms of limits of agreement (LOA) as defined by Bland-Altman.

Here's an analysis of the provided text to extract the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The reported performance for "Upper 95% LOA" (3.15%) indicates that the device did not meet the specified acceptance criterion of "= -3%".

The document also lists other accuracy specifications for various parameters, but it does not explicitly state an "acceptance criteria" alongside them in the same format as the LOA for SpO2. These are presented as general "Accuracy (ARMS)" specifications.

Accuracy (ARMS) Specifications (not explicitly presented as acceptance criteria vs. performance in the provided text, but rather device specifications):

• ARMS defined as a statistical calculation of the difference between device measurements fell within +/- ARMs of the reference measurements in a controlled study.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated as a number. The study was conducted on "healthy adult volunteers."
• Data Provenance: Retrospective or Prospective is not explicitly stated, but clinical studies are generally prospective. The data is from "healthy adult volunteers," implying a clinical study setting. Country of origin is not specified, but the Masimo Corporation is based in Irvine, CA, USA, suggesting the study likely took place in the USA or under its regulations.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This information is not provided in the text. The ground truth for SpO2 was established by "blood measurements from a laboratory CO-Oximeter," which is an instrument, not human experts.

4. Adjudication Method for the Test Set

• Not applicable. The ground truth was established by an instrument (laboratory CO-Oximeter) comparing directly to the device measurements; there was no human adjudication process involved for establishing the ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. This type of study typically involves human readers interpreting cases with and without AI assistance. This document describes the performance of a medical device (oximeter) and its various physiological monitoring capabilities, not an AI-powered diagnostic imaging tool that would typically undergo MRMC studies.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

• Yes, a standalone performance study was done. The clinical study described "evaluate the sensor's performance for no motion condition, in the range of 70% to 100% in comparison to blood measurements from a laboratory CO-Oximeter." This evaluates the device directly against a reference standard, which is a standalone performance assessment.

7. Type of Ground Truth Used

• The ground truth used for SpO2 was instrumental measurement / reference standard. Specifically, it was "blood measurements from a laboratory CO-Oximeter."

8. Sample Size for the Training Set

• This information is not provided in the text. The document describes a clinical study for validating the device's accuracy, not for training a new algorithm. The device incorporates "Masimo Rainbow SET technology," which is a pre-existing technology, and the study is for the performance of the integrated product and its sensors.

9. How the Ground Truth for the Training Set Was Established

• This information is not provided in the text, as no specific training set or new algorithm development is detailed. The technology itself (Masimo Rainbow SET) is described as utilizing principles of spectrophotometry and photoplethysmography, implying established scientific principles rather than a continuously trained machine learning model.

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The Masimo Root Monitoring System and Accessories are indicated for use by healthcare professionals for the monitoring of multiple physiological parameters in healthcare environments.

The Masimo Root Monitoring System and Accessories can transmit data for supplemental remote viewing and alarming (e.g., at a central station).

The optional Masimo Radical-7 Pulse CO-Oximeter and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Radical-7 Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments. In addition, the Masimo Radical-7 Pulse CO-Oximeter and accessories are indicated to provide the continuous non-invasive monitoring data obtained from the Masimo Radical-7 Pulse CO-Oximeter and accessories of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate to multi-parameter devices for the display of those devices.

The optional Masimo Radius-7 Wearable Pulse CO-Oximeter and Accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Radius-7 Wearable Pulse CO-Oximeter and accessories are indicated for use with adult and pediatric patients during both no motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.

The optional ISA product family consists of three types of sidestream gas analyzers (ISA CO2, ISA AX+ and ISA OR+), intended to be connected to other medical backboard devices for monitoring of breath rate and the following breathing gases:

ISA CO2: CO2

ISA AX+: CO2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane

ISA OR+: CO2, O2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane

ISA CO2, ISA AX+ and ISA OR+ are intended to be connected to a patient breathing circuit for monitoring of inspired/expired gases during anesthesia, recovery and respiratory care. The intended environment is the operating suite, intensive care unit and patient room. ISA CO2 is also intended to be used in road ambulances. The intended patient population is adult, pediatric and infant patients.

The optional SEDLine Sedation Monitor is indicated for use in the operating room (OR), intensive care unit (ICU), and clinical research laboratory. It is intended to monitor the state of the brain by real-time data acquisition and processing of EEG signals. The system includes the Patient State Index (PSI), a proprietary computed EEG variable that is related to the effect of anesthetic agents.

The Root Monitoring System (Root) is a multifunctional device that monitors vital signs of patients from neonates to adults. Parameters monitored by Root include non-invasive functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), respiratory rate (RRa), inspired/expired gases during anesthesia, recovery and respiratory care, state of the brain by real-time data acquisition and processing of EEG signals, and Patient State Index (PSI) which is an EEG variable that is related to the effect of anesthetic agents.

Root is intended to be used with the previously FDA cleared measurement technologies for the modules of:

• . Masimo Radical-7 Pulse CO-Oximeter (Radical-7 module), with cleared technologies of SpO2, pulse rate, SpCO, SpMet, SpHb and RRa monitoring per K110028.
• Masimo Radius-7 Pulse Oximeter (Radius-7 module), with cleared technologies of ● SpO2, pulse rate, SpCO, SpMet, SpHb and RRa monitoring per K110028.
• . ISA-Infrared Sidestream Gas Analyzer (ISA module), with cleared technologies of breathing gases and respiratory rate monitoring per K103604.
• Sedline Sedation Monitor with Frontal PSI and SEDTrace EEG Electrode Set ● (Sedline module), with cleared technologies of EEG and PSI monitoring per K051874.

Root is intended to be used as an alternative user interface to facilitate access control and monitoring device functions and to connect system networks such as the Patient SafetyNet (K071047).

Root displays patient monitoring information from the connected modules. Visual alarms are shown on the Root display and audible alarms are generated through the Root internal speaker. When the module is disconnected from Root, the monitoring information from the module is no longer displayed on Root.

Data from connected modules, including patient monitoring data, can be communicated to network systems. Root also functions as a pass-through means for communicating information between connected devices and network systems.

The predicate device, Masimo Root Monitoring System (Root) was cleared in K142394, is the same as the subject device, Masimo Root Monitoring System (Root). Both the predicate and subject devices include the option to connect the Masimo Radius-7 Pulse Oximeter (Radius-7) module. The main difference is that the Radius-7 in the subject device now provides the same measurement functionality as the Radical-7 module.

The Masimo Root Monitoring System and Accessories is a multifunctional device designed for monitoring multiple physiological parameters in healthcare environments.

Here's an analysis of its acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes performance in terms of compliance with various standards and successful completion of verification and validation activities. It doesn't list specific quantitative acceptance criteria for each physiological parameter (e.g., accuracy ranges for SpO2, pulse rate, etc.) for the Root system itself, as these are attributed to the individual modules (Radical-7, Radius-7, ISA, Sedline). The Root system primarily acts as an interface and data aggregator.

2. Sample Size Used for the Test Set and Data Provenance:

The document is for a 510(k) premarket notification, which often relies on non-clinical testing and substantial equivalence to a predicate device rather than extensive clinical trials for the primary monitor system itself.

The document indicates that for the Root Monitoring System and the modified Radius-7 Module, "thoroughly tested through verification and validation" was performed. This suggests a series of engineering and performance tests on the device hardware and software.

• Sample Size: Not explicitly stated in numerical terms within the provided text. The testing appears to be primarily laboratory-based and engineering verification rather than a patient-based test set.
• Data Provenance: The nature of the tests (electrical, mechanical, software, etc.) implies that the data was generated internally by Masimo Corporation during product development and validation phases. No information about country of origin of data or whether it was retrospective or prospective is given, as it is non-clinical.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:

This information is typically relevant for clinical studies or studies involving human judgment (e.g., image interpretation). Since the testing described is non-clinical (electrical safety, software verification, mechanical, etc.), the concept of "experts establishing ground truth for a test set" in the context of clinical outcomes or diagnostic accuracy doesn't directly apply.

Instead, the "ground truth" for these engineering and performance tests would be established by:

• Engineering specifications and design documents.
• Applicable voluntary standards (e.g., IEC, ISO, Mil-Std).
• FDA guidances (e.g., Human Factors, Wireless, Software).

The "experts" would be the engineering and quality assurance teams responsible for designing, conducting, and evaluating these tests against established requirements and standards. Their qualifications would involve expertise in relevant engineering disciplines, regulatory compliance, and quality assurance.

4. Adjudication Method for the Test Set:

Adjudication methods (like 2+1, 3+1) are typically used in clinical trials or studies where human interpretation or endpoint determination is subjective and requires consensus. As the described testing is non-clinical, an adjudication method for a test set in this sense is not directly applicable.

The verification and validation processes would involve:

• Test protocols defining clear pass/fail criteria.
• Independent review of test results.
• Conformity assessment against standards.

Any discrepancies or failures would likely be resolved through engineering review, root cause analysis, and retesting, rather than an adjudication panel.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical testing was done." The Masimo Root system functions as an interface and aggregator for other FDA-cleared modules; its primary mode of submission is through substantial equivalence based on non-clinical tests and its role not altering the intended use of the connected modules.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

The concept of "standalone" performance, often used for AI algorithms, isn't directly applicable here in the same way. The Masimo Root Monitoring System is a hardware device with software that integrates and displays data from other cleared modules. Its "performance" is in correctly displaying data, processing alarms, and interacting with devices and networks.

• The non-clinical performance testing described (electrical, EMC, software, etc.) essentially assesses the system's "standalone" functional performance relative to its design specifications and applicable standards, without human intervention in the data generation process, but with a human-in-the-loop for monitoring.
• However, if "standalone" refers to an algorithm making a diagnostic decision without human input, then no such study was done because this device is a monitoring system and not a diagnostic AI algorithm.

7. Type of Ground Truth Used:

For the non-clinical tests specified:

• Engineering specifications and design requirements: For software verification, functional testing, mechanical characteristics, and interface performance.
• Compliance with harmonized standards: For electrical safety (IEC60601-1), EMC (IEC-60601-1-2), alarm systems (IEC-60601-1-8), biocompatibility (ISO-10993).
• Compliance with FDA Guidances: For Usability (Human Factors) and Wireless performance.
• Predicate Device Equivalence: The foundation of the 510(k) submission is demonstrating substantial equivalence to a legally marketed predicate device (K142394 Masimo Root Monitoring System). The performance of the predicate device serves as an implicit "ground truth" for overall device function and safety. The modifications to the Radius-7 module were then tested to ensure they achieved the same performance as the Radical-7 module's existing cleared functionalities.

8. Sample Size for the Training Set:

This question is related to machine learning models. The Masimo Root Monitoring System is described as a medical device for monitoring and data integration, not as a device utilizing a machine learning algorithm that requires a "training set." Therefore, this information is not applicable and not provided in the document.

9. How the Ground Truth for the Training Set Was Established:

As there is no indication of a machine learning algorithm or a "training set" in the context of this device, this question is not applicable. The device's foundational components (Radical-7, Radius-7, ISA, Sedline modules) are previously cleared technologies with their own established ground truths for their respective physiological measurements, which the Root system then displays and manages.

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The Diagnostic Station DS20 is a 12-lead EGG device used for the recording, analysis and evaluation of ECG waveforms. Recordings made with the DS20 can be used as a diagnostic aid for heart function and heart conditions.

The DS20 also measures the following patient vital information to further assessment: pulmonary lung function (spirometry), blood pressure, functional oxygen saturation of arterial hemoglobin (SpO2), carboxyhemoglobin saturation (SpCO), respiration, temperature, and weight.

The DS20 is intended for data collection only. It is not intended for continuous momitoring use and does not provide an alarm function.

The DS20 is indicated for use in hospital and clinic settings, on adult and pediatric patients.

The Diagnostic Station DS20 is a 12-lead EGG (Electrocardiograph) device used for the recording, analysis and evaluation of ECG waveforms. It also measures the following patient vital information to further aid in patient assessment: pulmonary lung function (spirometry), blood pressure, functional oxygen saturation of arterial hemoglobin (SpO>), carboxyhemoglobin saturation (SpCO), respiration, temperature and weight. It also supports a 5-lead ECG measurement of heart rate when 12-lead ECG analysis is not needed.

The DS20 does not provide a patient monitoring capability with alarm annunciation.

The DS20 has a color display. It accepts user input via a touch panel, barcode scanner or keyboard. It can generate a variety of reports that can be viewed on the display or printed on a strip chart recorder or laser printer.

The DS20 is mains- or battery-powered and uses sensors that come in contact with the patient.

The DS20 is intended to function in the patient vicinity alongside other medical devices. It can operate as a stand-alone device or can be connected to the SCHILLER SEMA3 Data Management System via Ethernet (land-line or WiFi) in order to store reports and retrieve work orders for a given patient.

This document describes the Diagnostic Station DS20, a medical device for recording and analyzing ECG waveforms, along with other vital signs. The provided text outlines the device's indications for use and performance data, but it does not contain specific acceptance criteria, detailed study designs for clinical performance, or a comparative effectiveness study with human readers.

Based on the provided text, here's a breakdown of the information requested, with "N/A" indicating information not explicitly found:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on compliance with established regulatory standards for electrical safety, essential performance, and electromagnetic compatibility (EMC), as well as software verification and validation. It does not provide numerical acceptance criteria for specific diagnostic performance metrics (e.g., sensitivity, specificity for ECG interpretation) nor does it report those metrics.

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size for Test Set: N/A (The document primarily details compliance with regulatory standards through successful testing, not a specific clinical test set for diagnostic performance.)
• Data Provenance (e.g., country of origin, retrospective/prospective): N/A (Clinical study data for performance evaluation is not detailed in this submission summary.)

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• N/A (The document does not describe a test set with expert-established ground truth for diagnostic performance.)

4. Adjudication Method for the Test Set

• N/A (No specific test set or adjudication method is described.)

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was it done? No. The document does not mention any MRMC comparative effectiveness study or any studies involving human readers, with or without AI assistance.
• Effect size of human reader improvement: N/A (Not applicable as no such study was performed/reported.)

6. Standalone (Algorithm Only) Performance Study

• The Diagnostic Station DS20 is described as a device that records, analyzes, and evaluates ECG waveforms and measures vital information. It supports a 5-lead ECG measurement of heart rate. The document mentions "analysis and evaluation of ECG waveforms" which implies an algorithmic component. However, it does not describe a standalone performance study comparing its algorithmic output against ground truth for specific diagnostic accuracy metrics (e.g., automated ECG interpretation accuracy). The performance data section focuses on general safety, performance, and software standards compliance rather than diagnostic performance of its analytical features.

7. Type of Ground Truth Used

• N/A (For the aspects related to diagnostic performance of ECG interpretation or vital signs analysis, specific ground truth methods are not detailed. The "successful testing" refers to compliance with performance standards rather than clinical accuracy against a gold standard.)

8. Sample Size for the Training Set

• N/A (The document does not provide information about a training set for any algorithmic components within the device.)

9. How the Ground Truth for the Training Set Was Established

• N/A (No training set is mentioned in the provided text.)

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The Masimo Root Monitoring System is indicated for use by healthcare professionals for the monitoring of multiple physiological parameters in healthcare environments. The Root Monitoring System, when used with the optional ISA module, is not intended to be used in road ambulances.

The Masimo Root Monitoring System can communicate with network systems for supplemental remote viewing and alarming (e.g., at a central station).

The optional Masimo Radical-7 Pulse CO-Oximeter and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Radical-7 Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments. In addition, the Masimo Radical-7 Pulse CO-Oximeter and accessories are indicated to provide the continuous non-invasive monitoring data obtained from the Masimo Radical-7 Pulse CO-Oximeter and accessories of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate to multi-parameter devices for the display of those devices.

The optional Masimo Radius-7 Wearable Pulse Oximeter and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and/or respiratory rate (RRa). The Masimo Radius-7 Wearable Pulse Oximeter and accessories are indicated for use with adult, and pediatric patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, and hospital-type facilities.

The optional ISA product family consists of three types of sidestream gas analyzers (ISA CO2, ISA AX+ and ISA OR+), intended to be connected to other medical backboard devices for monitoring of breath rate and the following breathing gases:

ISA CO2: CO2

ISA AX+: CO2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane

ISA OR+: CO2, O2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane

ISA CO2, ISA AX+ and ISA OR+ are intended to be connected to a patient breathing circuit for monitoring of inspired/expired gases during anesthesia, recovery and respiratory care. The intended environment is the operating suite, intensive care unit and patient room. ISA CO2 is also intended to be used in road ambulances. The intended patient population is adult, pediatric and infant patients.

The optional SEDLine Sedation Monitor is indicated for use in the operating room (OR), intensive care unit (ICU), and clinical research laboratory. It is intended to monitor the state of the brain by real-time data acquisition and processing of EEG signals. The system includes the Patient State Index (PSI), a proprietary computed EEG variable that is related to the effect of anesthetic agents.

The optional temperature module is indicated to measure temperature (oral, adult axillary, pediatric axillary, and rectal) of adult and pediatric patients. The device is intended to be used by clinicians and medically qualified personnel. It is available for sale only upon the order of a physician or licensed health care provider.

The optional non-invasive blood pressure (NIBP) module is indicated for the noninvasive measurement of arterial blood pressure in healthcare environments. The NIBP module is designed to measure blood pressure for patient population described in the following table:

The Root Monitoring System (Root) is a multifunctional device that monitors vital signs of patients from neonates to adults. Parameters monitored by Root include non-invasive functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), respiratory rate (RRa), inspired/expired gases during anesthesia, recovery and respiratory care, state of the brain by real-time data acquisition and processing of EEG signals, temperature, non-invasive blood pressure (NIBP) and Patient State Index (PSI) which is an EEG variable that is related to the effect of anesthetic agents.

Root displays patient monitoring information from the connected modules. Visual alarms are shown on the Root display and audible alarms are generated through the Root internal speaker. The user accesses the connected modules' monitoring functions, using the Root display. When the module is disconnected from Root, the monitoring information from the module is no longer displayed on Root.

Data from connected modules, including patient monitoring data, can be communicated to network systems. Root also functions as a pass-through means for communicating information between connected devices and network systems.

The subject device is the same as the primary predicate (K142394). The main difference is that the subject device has been modified to integrate internal modules for temperature and NIBP measurement technologies.

The provided text describes a 510(k) premarket notification for the Masimo Root Vital Signs Monitoring System and Accessories. It outlines the device's intended use, technological characteristics, and a comparison to predicate devices, focusing on the integration of new internal temperature and non-invasive blood pressure (NIBP) modules.

However, the document states:
"Clinical Testing: Not applicable. Clinical performance testing was not performed with the subject device, Root, to support substantial equivalence."

This means that the submission does not include a study proving the device meets specific acceptance criteria based on clinical performance. Instead, the substantial equivalence determination for this particular submission is based on non-clinical testing (bench testing, alarm testing, usability testing, software verification) and the fact that the new internal modules utilize previously cleared measurement technologies from predicate devices.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets the acceptance criteria in the clinical sense, as such a study was explicitly stated as "Not applicable" and "not performed" in this regulatory filing.

I can, however, extract related information that was used for the substantial equivalence determination:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria with corresponding performance data from clinical studies. The performance is assessed based on the fact that existing, cleared technologies are integrated.

2. Sample size used for the test set and the data provenance

No clinical test set was used for performance assessment of the new integrated modules. The acceptance for these modules is based on their prior clearance as standalone devices or integrated into other predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable, as no clinical test set requiring expert ground truth establishment was conducted.

4. Adjudication method for the test set

Not applicable, as no clinical test set requiring adjudication was conducted.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No MRMC study was performed. The submission explicitly states "Clinical performance testing was not performed."

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This concept typically applies to AI/algorithm performance. While the device integrates various measurement technologies (which could be considered "standalone" in their function), the document does not detail specific algorithm-only performance studies for the integrated components in the context of this 510(k) submission for the Root system itself. Instead, it relies on the previous clearance of the individual measurement technologies.

7. The type of ground truth used

For the integrated temperature and NIBP modules, the "ground truth" for their performance was established during the original 510(k) clearances of the predicate devices they are derived from (K101680 for temperature, K090989 for NIBP). The current submission relies on the established equivalence of these previously cleared technologies.

8. The sample size for the training set

Not applicable, as this submission does not describe the development or training of new algorithms that would require a training set. It concerns the integration of existing, cleared technologies.

9. How the ground truth for the training set was established

Not applicable, for the same reason as above.

Summary of what the document does state regarding the basis for approval:

The FDA's decision for substantial equivalence is based on:

• Non-clinical testing: Bench testing, alarm testing (IEC60601-1-8), usability testing (per FDA Human Factors and Usability Draft Guidance), and software verification (per FDA Software Guidance). These tests focused on the system's functionality and safety, not the clinical accuracy of the physiological parameters, which are handled by the integrated, previously cleared modules.
• The fact that the device integrates previously FDA-cleared measurement technologies for the modules (Radical-7, Radius-7, ISA, Sedline, and the newly integrated internal temperature and NIBP modules). The specific regulatory clearances cited for these modules are:
  • Masimo Radical-7 Pulse CO-Oximeter: K110028
  • Masimo Radius-7 Pulse Oximeter: K110028
  • ISA Module: K103604
  • SEDLine Sedation Monitor: K051874
  • Internal temperature module (from Welch Allyn Spot Ultra Vital Signs/Welch Allyn Spot Vital Signs LXi): K101680
  • Internal non-invasive blood pressure (NIBP) module (from Zoll R Series): K090989
• The argument that the differences between the subject device and the predicates (mainly the integration of internal temperature and NIBP modules) are not critical to intended use and do not affect the safety and effectiveness of the device when used as labeled, because these are existing, cleared technologies.

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The Masimo Root Monitoring System is indicated for use by healthcare professionals for the monitoring of multiple physiological parameters in healthcare environments.

The Masimo Root Monitoring System can transmit data for supplemental remote viewing and alarming (e.g., at a central station).

The optional Masimo Radical-7 Pulse CO-Oximeter and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Radical-7 Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments. In addition, the Masimo Radical-7 Pulse CO-Oximeter and accessories are indicated to provide the continuous non-invasive monitoring data obtained from the Masimo Radical-7 Pulse CO-Oximeter and accessories of functional oxygen saturation of arterial hemoglobin (SpO-) and pulse rate to multi-parameter devices for the display of those devices.

The optional Masimo Radius-7 Wearable Pulse Oximeter and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and/or respiratory rate (RRa). The Masimo Radius-7 Wearable Pulse Oximeter and accessories are indicated for use with adult and pediatric patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.

The optional ISA product family consists of three types of sidestream gas analyzers (ISA CO2, ISA AX+ and ISA OR+), intended to be connected to other medical backboard devices for monitoring of breath rate and the following breathing gases:

ISA CO2: CO2

ISA AX+: CO2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane

ISA OR+: CO2, O2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane

ISA CO2. ISA AX+ and ISA OR+ are intended to be connected to a patient breathing circuit for monitoring of inspired/expired gases during anesthesia, recovery and respiratory care. The intended environment is the operating suite, intensive care unit and patient room. ISA CO2 is also intended to be used in road ambulances. The intended patient population is adult, pediatric and infant patients.

The optional SEDLine Sedation Monitor is indicated for use in the operating room (OR). intensive care unit (ICU), and clinical research laboratory. It is intended to monitor the state of the brain by real-time data acquisition and processing of EEG signals. The system includes the Patient State Index (PSI), a proprietary computed EEG variable that is related to the effect of anesthetic agents.

The Root Monitoring System (Root) is a multifunctional device that monitors vital signs of patients from neonates to adults. Parameters monitored by Root include non-invasive functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), respiratory rate (RRa), inspired/expired gases during anesthesia, recovery and respiratory care, state of the brain by real-time data acquisition and processing of EEG signals, and Patient State Index (PSI) which is an EEG variable that is related to the effect of anesthetic agents.

Root displays patient monitoring information from the connected modules. Visual alarms are shown on the Root display and audible alarms are generated through the Root internal speaker. When the module is disconnected from Root, the monitoring information from the module is no longer displayed on Root.

Data from connected modules, including patient monitoring data, can be communicated to network systems. Root also functions as a pass-through means for communicating information between connected devices and network systems.

The provided document describes the Masimo Root Monitoring System and its accessories. The submission is for a device modification and new indications for use, specifically the addition of the Masimo Radius-7 Pulse Oximeter module. The document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K140188).

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present "acceptance criteria" in a typical quantitative format (e.g., target specificity, sensitivity, or quantifiable error rates for a diagnostic device). Instead, the performance is evaluated through various verification and validation tests against established standards and the functionality of the predicate device. The acceptance criterion for each test appears to be "Pass," indicating successful completion and meeting predefined internal requirements.

2. Sample Size for the Test Set and Data Provenance

The document does not specify a quantitative "sample size" in terms of patients or cases for most of the tests. The tests are described as functional verification and usability studies.

• For "Display validation of Radius-7 module" and "Display validation of Root and Radical-7, ISA, and Sedline modules": The document mentions "Clinicians (users)" participated in usability tests. The exact number of clinicians is not provided.
• For all other verification tests: "Test personnel" conducted the tests. No specific number is provided.
• Data Provenance: The studies appear to be internal, non-clinical (laboratory/in-house) verification and validation tests, not involving real-world patient data collection from a specific country or in a retrospective/prospective manner.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This section is not applicable in the traditional sense for this type of device submission. The "ground truth" for these functional and usability tests is established by adherence to engineering specifications, regulatory standards (like IEC 60601-1-8), and successful operation as designed.

• Usability testing: Involved "Clinicians (users)," implying healthcare professionals as experts for evaluating usability. Specific qualifications (e.g., years of experience, specialty) are not detailed.
• For other verification tests, "Test personnel" are likely engineers or technicians qualified to conduct technical evaluations.

4. Adjudication Method for the Test Set

No formal adjudication method like "2+1" or "3+1" is described. The acceptance criterion for all tests is simply "Pass," meaning the device either successfully performed the function or met the standard, or it did not. This implies a binary outcome based on whether the test objectives and endpoints were met, likely determined by the test personnel or clinicians involved.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done or mentioned. This type of study is typically performed for diagnostic devices where human readers interpret patient data (e.g., images) with and without AI assistance to measure improvement in diagnostic accuracy. The Masimo Root Monitoring System is a monitoring system and user interface, not a diagnostic imaging AI algorithm.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop) Performance

The device itself is a "monitoring system and accessories" that functions as a user interface and communication hub for previously cleared modules. Its primary function is to display data, generate alarms, and connect to networks. Therefore, "standalone" performance in the context of an algorithm's diagnostic accuracy without human involvement is not a relevant metric for this device. The performance evaluated here is the functionality and safety of the monitoring system itself, especially its new integration with the Radius-7 module.

7. Type of Ground Truth Used

The "ground truth" is based on:

• Engineering specifications and design requirements: For successful display, connectivity, and communication functions.
• Regulatory standards: Such as IEC 60601-1-8 for alarm compliance, IEC 60601-1 and IEC 60601-1-2 for electrical safety and EMC, ISO-10993 for biocompatibility, and FDA guidances for Usability, Wireless, and Software.
• Functionality of previously cleared predicate devices/modules: The Root system primarily integrates and acts as a user interface for these existing, cleared technologies.

8. Sample Size for the Training Set

The document does not describe any machine learning or AI components that would require a "training set" in the conventional sense. The device's functionality is based on established hardware and software integration, not data-driven model training.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned or implied for machine learning, this question is not applicable.

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