Search Results

The non-invasive Masimo O3 Regional Oximeter System and accessories are indicated for use as an adjunct monitor of regional hemoglobin oxygen saturation of blood (rSO2) in the tissue under the sensor in patients in healthcare environments. The O3 Regional Oximeter is only to be used with Masimo O3 sensors. The use of any other sensor is not supported or recommended by Masimo and could give erroneous results.

When used with the O3 Adult Sensor, the O3 Regional Oximeter is indicated for measuring absolute and trending regional hemoglobin oxygen saturation of blood (rSO2) in adults ≥ 40kg.

When used with the O3 Pediatric Sensor, the O3 Regional Oximeter is indicated for measuring absolute and trending regional hemoglobin oxygen saturation of blood (rSO2) on cerebral sites and trending rSO2 on non-cerebral sites in pediatrics ≥ 5 kg and

The Masimo O3 Regional Oximeter is a noninvasive regional oximeter designed to continuously measure and monitor regional hemoglobin oxygen saturation (rSO2) in the tissue under the sensor. The Masimo O3 Regional Oximeter consists of the O3 Module, O3 Sensors (e.g., O3 Adult, O3 Pediatric, O3 Infant/Neonatal sensors), and a Host/Backboard Device (e.g., Root).

The Masimo O3 Regional Oximeter System provides the following measurements and calculated features:

• Regional Oxygenation (rSO2): Regional tissue oxygenation level in the deep tissue local to the sensor site.
• Delta Baseline (Δbase): Calculation of the relative difference in rSO2 with respect to baseline rSO2.
• Area Under the Limit (AUL index): Index that quantifies the duration (amount of time) the patient stays below rSO2 low alarm limit and depth (refers to the gap between the patient's rSO2 level and the rSO2 low alarm limit) of patient's stay below the user defined rSO2 low alarm limit (LAL).
• Delta SpO2 (ΔSpO2): Calculation of the difference between SpO2 and rSO2. The source of SpO2 is from peripheral SpO2 measurement (using pulse oximeter).
• Delta HHb (ΔHHb): Index associated with the relative change in deoxygenated hemoglobin.
• Delta O2Hb (ΔO2Hb): Index associated with the relative change in the oxygenated hemoglobin.
• Delta cHb (ΔcHb): Calculation of the sum of the Delta HHb and Delta O2Hb, and is an index, associated with the change in the total (oxygenated and deoxygenated) hemoglobin.

The provided FDA 510(k) clearance letter and summary for the Masimo O3 Regional Oximeter (K243324) states that the submission is for an expansion of indications for existing "delta features" (ΔO2Hb, ΔHHb, ΔcHb) of the device. This means the core rSO2 measurement accuracy was not re-evaluated, as it was previously cleared under the predicate (K214072) and no changes were made to the device's fundamental operation.

Therefore, the acceptance criteria and study detailed below focus specifically on the expansion of trending ability of the delta features to new patient populations (pediatric and neonates) and non-cerebral sites.

Acceptance Criteria and Device Performance for Masimo O3 Regional Oximeter (K243324)

Based on the provided document, the acceptance criteria and study focus on confirming the trending ability of the delta features (ΔO2Hb, ΔHHb, ΔcHb) for expanded indications. The document does not specify quantitative acceptance criteria (e.g., a specific correlation coefficient or accuracy range) for these delta features, unlike the rSO2 accuracy (ARMS) specifications which are quantitative. Instead, it speaks of "strong correlation" and "equivalent performance."

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for the Test Set

• Non-cerebral trending study: Data from 25 subjects.
• Pediatric/Neonatal trending study: Data from 29 subjects.
• Data Provenance: The document does not explicitly state the country of origin or whether the studies were retrospective or prospective. Clinical studies for 510(k) submissions are typically prospective, but this is not confirmed here.

3. Number of Experts and Qualifications for Ground Truth

• The document describes studies for "trending ability" of physiological parameters (hemoglobin changes). For such physiological measurements, the ground truth is typically established by direct physiological measurement or well-established reference methods, not by expert panel review of images or clinical assessments. Therefore, the concept of "experts establishing ground truth" in the manner of diagnostic imaging studies (e.g., radiologists) is not applicable here. The ground truth would be the actual physiological changes occurring in the subjects, measured by a gold standard method (though not explicitly detailed in the summary).

4. Adjudication Method for the Test Set

• Given that the studies are evaluating the trending ability of physiological measurements against an assumed physiological ground truth (not expert interpretations), an "adjudication method" in the sense of reconciling multiple expert opinions (e.g., 2+1, 3+1) is not applicable.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools where human readers interpret medical images or data with and without AI assistance to measure improvement in reader performance. The Masimo O3 Regional Oximeter is a physiological monitoring device that provides direct measurements, and the current submission is about expanding the trending indications of those measurements, not assisting human interpretation of complex medical cases.

6. Standalone (Algorithm Only) Performance

• Yes, implicitly. The studies described evaluate the device's ability to trend delta features. This is a direct measurement of the device's algorithm performance in a clinical setting against physiological changes. The device itself produces these measurements, so the performance reported is inherently "algorithm only" in terms of its output, even though it's measured on human subjects.

7. Type of Ground Truth Used

• The ground truth for studies of physiological monitoring devices like oximeters is typically actual physiological values measured concurrently by a highly accurate or gold-standard reference method. For regional oximetry and hemoglobin changes, this might involve induced changes in oxygenation/perfusion and simultaneous measurement with a more invasive or laboratory-based technique, though the summary does not detail the specific reference method used for these "delta features" studies. It is implied to be a quantitative, objective physiological ground truth, not based on expert consensus, pathology, or outcomes data in the traditional sense of diagnostic imaging.

8. Sample Size for the Training Set

• The document does not provide information on the training set sample size. This submission is for an expanded indication based on clinical study data, not a new algorithm development submission where training data sets are typically detailed. It is assumed the algorithms for the delta features were trained/developed prior to the predicate device clearance (K214072) or during earlier development cycles, and the current submission is about validating their performance for new uses.

9. How Ground Truth for Training Set was Established

• The document does not provide information on how the ground truth for any potential training set was established. As this submission pertains to an expanded indication for existing features, the focus is on clinical validation of those features in new contexts rather than the de novo development process.

Ask a specific question about this device

The Lap.Ox™ Laparoscopic Tissue Oximeter is intended to estimate the percent oxygen saturation (StO2) in a volume of tissue, including bowel tissue, during laparoscopy.

The Lap.Ox™ Laparoscopic Tissue Oximeter is indicated for use in monitoring patients during circulatory or perfusion assessment during laparoscopy.

The Lap.Ox™ Laparoscopic Tissue Oximeter is intended to be used by physicians, surgeons, nurses, or other skilled users in a medical environment.

The Lap.Ox™ Laparoscopic Tissue Oximeter should only be used on adult patients.

The proposed Lap.Ox™ Laparoscopic Tissue Oximeter ("Lap.Ox" or "Device") is a cordless, battery-powered device that estimates the percent oxygen saturation (StO2) in a volume of tissue, including bowel tissue. The device includes two components:

• a Reusable Main Unit that shows a digital readout of percent oxygen saturation (StO2) when the system is in contact with tissue (also denoted as "main unit" or "durable"); and
• a Disposable Kit that contains two AA batteries and a sterile single-use disposable consisting of sources, detectors, a laparoscopic tube, and a sheath that is placed around the Reusable Main Unit (denoted as "Disposable").

The Device uses spatially-resolved optical measurements at three wavelengths. The Device displays the StO2 estimate on the built-in screen. The Device is constructed from biocompatible materials that can tolerate bodily fluids. The basic principle of operation of the Lap.Ox Laparoscopic Tissue Oximeter is spectrophotometric oximetry which entails utilizing red and near-infrared light to measure the color of blood and determine an oxygen saturation value.

The provided FDA 510(k) clearance letter for the Lap.Ox™ Laparoscopic Tissue Oximeter details aspects of its regulatory review, including its intended use, technological characteristics, and a summary of performance testing. However, the document does not provide specific acceptance criteria or detailed results of a study proving the device meets those criteria, particularly in the context of clinical performance or accuracy of StO2 measurements with numerical values.

The letter broadly states that "The verification and validation studies demonstrated that Lap.Ox performs as intended" and "ViOptix conducted a clinical study... The results demonstrated that the performance of the Lap.Ox Laparoscopic Tissue Oximeter, on human subjects, is comparable to the predicate device."

Without the actual study report or more detailed submission information, it's impossible to explicitly fill out the table and answer all questions with specific numerical values for device performance and study details.

Based on the provided text, here is what can be inferred and what information is missing:

Acceptance Criteria and Device Performance (Inferred/Missing)

Given the device is an oximeter, typical acceptance criteria would involve accuracy and precision compared to a reference method (e.g., arterial blood gas analysis, or the predicate device's measured values). However, these specific criteria and the measured performance are not detailed in the provided text.

Ask a specific question about this device

Cerebral Autoregulation Index (CAI) Algorithm is an informational index intended to represent a surrogate measurement of whether cerebral autoregulation is likely intact or is likely impaired as expressed by the level of coherence or lack thereof between Mean Arterial Pressure (MAP) and the Absolute Levels of Blood Oxygenation Saturation (StO2) in patient's cerebral tissue. MAP is acquired by the HemoSphere pressure cable and StO2 is acquired by the ForeSight oximeter cable. CAI is intended for use in patients over 18 years of age receiving advanced hemodynamic monitoring. CAI is not indicated to be used for treatment of any disease or condition and no therapeutic decisions should be made based solely on the Cerebral Autoregulation Index (CAI) Algorithm.

The Cerebral Adaptive Index (CAI) Algorithm is being renamed to Cerebral Autoregulation Index (CAI) Algorithm. The originally cleared Cerebral Adaptive Index is in effect an index of cerebral autoregulation, and the renaming results in a labeling change. The evidence to support the proposed labeling change for the Cerebral Autoregulation Index algorithm demonstrates the capability of CAI to represent a surrogate measurement of whether cerebral autoregulation is likely intact or is likely impaired, as expressed by the level of coherence or lack thereof between MAP (as a surrogate of cerebral perfusion pressure) and cerebral StO2 (as a surrogate of cerebral blood flow) of the patient.

The Cerebral Autoregulation Index (CAI) Algorithm is a derived parameter that quantifies the dynamic relationship between two existing hemodynamic parameters, Mean Arterial Pressure (MAP) and the Absolute Levels of Blood Oxygenation Saturation (StO2) in the cerebral tissue. CAI is intended to represent a surrogate measurement of whether cerebral autoregulation is likely intact or is likely impaired as expressed by the level of coherence between MAP and cerebral StO2. The output will be represented as an index value in a trend plot.

MAP is acquired from the HemoSphere Pressure Cable (initially cleared in K180881 on November 16, 2018). StO2 used for computing CAI is acquired from the ForeSight Oximeter Cable (cleared in K201446 on October 1, 2020).

CAI will be continuously displayed at 20-second rate. The parameter will not have any alarm ranges and will be represented as a number with a range between 0 to 100. A high CAI value (CAI ≥45) means that MAP and StO2 have a greater coherence and informs the clinician that alterations in MAP may result in concomitant changes in cerebral oxygen saturation because cerebral autoregulation is likely impaired. Whereas a low CAI value (CAI

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

Device Name: Cerebral Autoregulation Index (CAI) Algorithm

The document describes a 510(k) submission for a name change (and re-clarification of its meaning) of an existing device (Cerebral Adaptive Index (CAI) Algorithm) to Cerebral Autoregulation Index (CAI) Algorithm. The core algorithm and its function remain the same. The performance data presented appears to be the original validation data for the algorithm, supporting the claim that the renamed device retains its safety and effectiveness.

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Test Set Sample Size: 50 subjects.
   • Data Provenance: Retrospectively obtained from 3 clinical sites:
     • Northwestern University, Chicago, USA
     • UC Davis, Sacramento, USA
     • Amsterdam UMC, Amsterdam, The Netherlands
   • Patient Characteristics: Adult surgical patients (cardiac and general surgery) over 18 years of age.

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

   • The document does not specify the number of experts used to establish the ground truth or their qualifications. The ground truth was established algorithmically based on physiological measurements.

3. Adjudication Method:

   • Not applicable/Not mentioned. The ground truth was established via a polynomial fit of CBFV-MAP data to determine LLA and ULA, and then a rule-based classification (Intact or Impaired) was applied. There's no indication of human adjudication of this ground truth.

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

   • No MRMC study was done, as this algorithm is not intended for human interpretation or direct assistance in a diagnostic image reading scenario. Its output is an index value representing a physiological state.

5. Standalone Performance:

   • Yes, a standalone performance evaluation was conducted. The study assessed the algorithm's ability to discriminate between "Intact" and "Impaired" cerebral autoregulation conditions based on its calculated CAI value, against a ground truth derived from physiological measurements (CBFV-MAP).

6. Type of Ground Truth Used:

   • Physiological Ground Truth: The ground truth for cerebral autoregulation status (Intact vs. Impaired) was established using a polynomial fit of Cerebral Blood Flow Velocity (CBFV) and Mean Arterial Pressure (MAP) data. Specifically, LLA (Lower Limit of Autoregulation) and ULA (Upper Limit of Autoregulation) were determined from this data, and an autoregulation status was assigned based on MAP's relationship to these limits:
     • Impaired: MAP ≤ LLA or MAP ≥ ULA
     • Intact: LLA

Ask a specific question about this device

The noninvasive ODI-Tech, when used with the DRS handpiece, is intended for use as an adjunct monitor of local hemoglobin oxygen saturation of blood in the skin beneath the sensor on the hand. It is intended as an adjunct for assessing local perfusion in individuals at risk of reduced-flow or no-flow ischemic states. The device is indicated for use on intact skin only.

The clinical value of trend data has not been demonstrated in disease states.

The ODI-Tech device should not be used as the sole basis for diagnosis or therapy.

In patients with darkly pigmented skin, measurements should be interpreted with can interfere with the reflected light signal and reduce the quality of measurements.

Not Found

While the provided FDA 510(k) clearance letter acknowledges the substantial equivalence of the ODI-Tech device and its intended use, it does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets those criteria.

The 510(k) clearance is based on the device being substantially equivalent to a predicate device, meaning it performs as well as or better than a legally marketed device. However, the clearance letter itself does not include the specifics of the performance study. To answer your questions comprehensively, information from the actual 510(k) submission, specifically the sections detailing performance data and clinical studies, would be required.

Therefore, I cannot provide a detailed answer to your request based solely on the provided text. The text only confirms the device's clearance and its intended use, but not the specifics of its performance testing.

To answer your request, I would need access to the actual 510(k) summary or the full submission document for K241393, which typically includes detailed performance data and study methodologies.

Ask a specific question about this device

SnapshotNIR (KD205) is intended for use by healthcare professionals as a non-invasive tissue oxygenation measurement system that reports an approximate value of:

• oxygen saturation (St02),
• relative oxyhemogoblin level (Hb02), and
• relative deoxyhemoglobin (Hb) level
  in superficial tissue. SnapshotNIR (KD205) displays two-dimensional color-coded images of tissue oxygenation of the scanned surface and reports multispectral tissue oxygenation measurements for selected tissue regions.

SnapshotNIR (KD205) is indicated for use to determine oxygenation levels in superficial tissues.

SnapshotNIR (KD205) is a medical device that operates like a camera. The SnapshotNIR device is completely non-contact, capturing images from 12 inches away from the patient or other imaging field-ofviews. The device uses six near-infrared wavelengths of light and white light emitting diodes (LEDs) to produce a resultant tissue oxygenation image and a colour-based "RGB" or clinical image, respectfully, that can be viewed on the touchscreen display.

SnapshotNIR is based on multispectral imaging technology and performs spectral analysis at each pixel to determine the approximate values of tissue oxygen saturation (StO2), oxyhemoglobin levels (HbO2), and deoxyhemoglobin levels (Hb) in superficial tissues and displays a two-dimensional, color-coded image of the tissue oxygen saturation (StO2).

SnapshotNIR consists of:

• · SnapshotNIR
• · Recharger
• · User Guide
• · Quick Start Guide
• · Sterile Drape (Optional)

The intended use and user interaction remained the same in the new model (KD205). The user will notice that the modified device no longer requires the user to take a calibration image prior to image capture. SnapshotNIR now uses an embedded computer module and a touchscreen LCD. Additional minor form factor changes were made on the new model (KD205) to accommodate the hardware change. With respect to the software used by SnapshotNIR, the predicate and new model (KD205) operate similarly.

This document, K240601, is a 510(k) Premarket Notification from the FDA regarding the Kent Imaging SnapshotNIR model KD205. It's a clearance letter, not a study report or a detailed technical submission. Therefore, it does not contain the information requested regarding acceptance criteria and performance studies in the level of detail typically found in a clinical study report or a more comprehensive technical submission to the FDA.

Specifically, the document states:

• "Nonclinical engineering-based tests (e.g., IEC 60601-1-2, etc) among other performance bench tests support conclusions that the KD205 device is safe for use with a low risk of adverse events occurring during the intended use scenarios."
• "These tests and findings are analogous to those conducted on the predicate KD204 SnapshotNIR device and demonstrate that the KD205 device is similarly safe, and effective compared to a current legally marketed device."
• "In a sub-analysis of the pre-clinical dataset, the KD205 device demonstrated no significant differences (derived via 2-way ANOVA models) in STO2 across the ischemia-reperfusion test when comparing cohorts of low versus high tissue scattering effects."

While it mentions "pre-clinical dataset" and "tests and findings," it does not provide any specific acceptance criteria, reported performance values, sample sizes, provenance of data, expert qualifications, or details about MRMC studies, standalone performance studies, or ground truth establishment. The purpose of this 510(k) summary is to establish substantial equivalence to a predicate device, not to detail the full performance study results.

Therefore, I cannot populate the requested table or answer most of the questions based solely on the provided text. The document focuses on the conclusion of substantial equivalence rather than the raw data and detailed methodology of the performance studies conducted.

Ask a specific question about this device

The OxiplexTS200 tissue oximeter is intended to non-invasively estimate the percent oxygen saturation (StO2) in a volume of tissue. It is indicated for monitoring patients during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation. The device can be used for monitoring in Medical Clinics, laboratories and outpatient facilities.

The OxiplexTS200 should not be used as the sole basis for diagnosis or therapy. The value of these measurements in disease states has not been demonstrated.

The ISS Medical non-invasive tissue oximeter. OxiplexTS200. is intended for use as an adjunct monitor of regional oxy- and deoxy-hemoglobin concentration, and of hemoglobin oxygen saturation of blood in tissues during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation.

The OxiplexTS200 is a device for use in spot-checking as well as continuous monitoring of patients in healthcare facilities. It is not intended for home use or to be used for "out of hospital" transport.

The OxiplexTS200 is an instrument system and includes the following components:

• OxiplexTS200 Unit with two sensors and phantom block ●
• Power cable ●
• Accessories (straps for sensors; strap for phantom block; dark cloth) ●
• ISS flash memory
• Operation Manual
• Analoq Input module with USB cable (optional)
• . Analog Output module with USB cable (optional)

The OxiplexTS200 uses near-Infrared Spectroscopy (NIRS), a noninvasive diagnostic tool, to offer features for the assessment and monitoring of oxygenation in tissues such as brain and muscle. Near-infrared light (in the wavelength range 700-900 nm) can penetrate several centimeters into numerous body tissues. NIRS enables continuous real time measurements of changes in the hemoglobin oxygenation state, thus providing information on tissue oxygenation and hemodynamics.

The ISS Medical OxiplexTS200 is a tissue oximeter that non-invasively estimates percent oxygen saturation (StO2) in tissue. Its performance testing compared it to the ViOptix ODISsey Tissue Oximeter model OXY-2.

1. Acceptance Criteria and Reported Device Performance

Note about accuracy: The provided tables show the stated accuracy of the predicate device (ViOptix ODISsey) and the OxiplexTS200, which are presented as similar. The study's finding of "essentially identical sensitive, reliable and accurate measurements of StO2" suggests that the OxiplexTS200 meets or performs comparably to the predicate's accuracy levels over a relevant range.

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

• Sample Size (Clinical Test Set): 25 human subjects
• Data Provenance (Clinical Test Set): Data was collected through comparison measurements acquired in the Biomedical Optics Research Laboratory at the Department of Neonatology at University Hospital Zürich in Zürich, Switzerland. This indicates prospective data collection from human subjects.
• Sample Size (Bench Test Set): Not explicitly stated as a number of "samples", but the test involved a phantom containing human blood diluted in an optically scattering medium "at three levels; from physiological levels to increasingly higher concentrations."

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

There is no mention of experts being used to establish a ground truth for the test set. The comparison was made between the OxiplexTS200 and a legally marketed predicate device (ViOptix ODISsey Tissue Oximeter model OXY-2). The predicate device's measurements serve as the reference for comparison. The study was conducted in a research laboratory directed by a Professor in Neonatology, indicating scientific oversight.

4. Adjudication Method for the Test Set

No adjudication method is described. The study compared the StO2 readings of the OxiplexTS200 directly against those of the predicate device.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This device is an oximeter, not an AI-powered diagnostic tool requiring human interpretation.

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

Yes, a standalone performance assessment was conducted for the OxiplexTS200 by comparing its readings to a predicate device. The device's output (StO2 measurements) was directly compared, as it functions as an automated measurement device.

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

The ground truth for the clinical study was established by comparing the OxiplexTS200's StO2 readings against those obtained simultaneously from the legally marketed predicate device, the ViOptix ODISsey Tissue Oximeter model OXY-2. For the bench testing, a phantom with simulated physiological properties and known (controlled) StO2 levels was used, where the predicate device's readings served as the reference.

8. The sample size for the training set

The document does not provide information about a "training set" characteristic of machine learning models. The OxiplexTS200 is a hardware device utilizing Near-Infrared Spectroscopy (NIRS) principles, not a software algorithm that undergoes a training phase with a dataset in the conventional sense.

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

As there is no mention of a "training set" in the context of machine learning, this information is not applicable. The device's operation is based on established NIRS principles and optical parameters, which are inherent to its design and calibration, rather than on a trained dataset.

Ask a specific question about this device

The Intra. Ox™ 2.0 Handheld Tissue Oximeter is intended to non-invasively estimate the percent oxygen saturation (StO2) in a volume of tissue, including bowel tissue.

The Intra. Ox™ 2.0 Handheld Tissue Oximeter is indicated for use in monitoring patients during circulatory or perfusion examinations.

The Intra. Ox™ 2.0 Handheld Tissue Oximeter is intended to be used by physicians, surgeons, nurses, or other skilled users in a medical environment.

The Intra.Ox™ 2.0 Handheld Tissue Oximeter should only be used on adult patients.

The ViOptix Intra.Ox" 2.0 Handheld Tissue Oximeter (device) is a sterile, cordless, battery-powered device that non-invasively estimates the percent oxygen saturation (StO2) in a volume of tissue. The device includes three components and an accessory: · Main Unit: a re-usable module consists of light sources, detectors, and processing electronics to convert measurements of reflected light into an estimate of StO2;

• Sheath: a single-use, sterile Sheath placed around the Main Unit during device use (provide in the Disposable Kit); and · Battery Pack: a single-use battery (provided in the Disposable Kit) that is paired with the Main Unit to provide power.

The device uses spatially resolved optical measurements. The device performs measurements on the patient by direct physical contact to the patient's tissue and displays the StO2 estimate on the Intra.Ox 2.0 Handheld Tissue Oximeter is a single-use disposable constructed from biocompatible materials that and other liquids such as disinfectants and marking materials. The device shares the same technological characteristics as the predicate device (K221010), including principle of operation, StO2 measured parameters, accuracy and range, energy delivered and power source.

The provided text does not contain detailed information regarding the acceptance criteria of a device for regulatory approval or a specific study proving it meets these criteria with the level of detail requested in the prompt.

The document is an FDA 510(k) clearance letter for the ViOptix Intra.OxTM 2.0 Handheld Tissue Oximeter. It states that the device is substantially equivalent to a previously marketed predicate device (K221010). The information provided is primarily about the regulatory basis for clearance, the device's intended use, and a high-level summary of studies performed.

Here's an analysis of what information is available and what is missing based on your specific questions:

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

• Missing. The document does not specify quantitative acceptance criteria (e.g., accuracy, precision targets) for the device's performance, nor does it present a table of reported device performance against such criteria. It generally states that the device "responds appropriately" and "provides clinically relevant information."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• The document mentions an "animal study" and "human clinical data from published scientific literature (Gonzalez-Jacobo et al.)".
• Sample Size: The exact sample sizes for both the animal study and the human clinical data are not provided.
• Data Provenance:
  • Animal study: No details on country of origin or whether it was retrospective/prospective.
  • Human clinical data (Gonzalez-Jacobo et al.): No details on country of origin or whether it was retrospective/prospective from the provided text. It merely states it included "multiple surgical" settings.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Missing. The document does not specify how ground truth was established, nor does it mention the number or qualifications of experts involved in any ground truth determination.

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

• Missing. No information on adjudication methods is present.

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

• Not applicable / Missing. This device is an oximeter, not an AI-assisted diagnostic imaging device that requires human readers to interpret results. Therefore, an MRMC study related to human readers improving with AI assistance is not relevant to this type of device. The document mentions the device provides "comparable information to the existing standard of care" but doesn't quantify improvement in human performance with the device.

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

• The Intra.Ox™ 2.0 Handheld Tissue Oximeter is a standalone device that measures StO2. Its performance as a measurement device is inherent. The studies mentioned (animal and human clinical data) would assess the device's ability to accurately measure oxygen saturation. So, in essence, the "standalone performance" of the device is what these studies would have evaluated.
• Stated from text: "The animal study demonstrates that the Intra.Ox™ 2.0 Handheld Tissue Oximeter responds appropriately to the presence of transient ischemia induced by arterial occlusion" and the human study "demonstrates that the Intra.Ox™ 2.0 Handheld Tissue Oximeter provides clinically relevant information regarding bowel ischemia". This describes its standalone performance.

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

• For the animal study: The ground truth was likely induced "transient ischemia induced by arterial occlusion" which is a physiological challenge.
• For the human study: The "existing standard of care" is mentioned, implying that the device's measurements were compared against established clinical methods for assessing bowel ischemia. The specific nature of this "standard of care" (e.g., pathology, clinical observation, other monitoring devices) is not detailed.

8. The sample size for the training set

• Not applicable / Missing. This is not an AI/ML device that typically has a separate "training set" in the common understanding of machine learning. It's a measurement device. It was likely "calibrated" or developed using internal data, but the document doesn't provide details on sample sizes for such development or calibration processes.

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

• Not applicable / Missing. See point 8.

In summary: The provided document is a regulatory clearance letter, not a detailed clinical study report. It confirms the device's substantial equivalence based on summaries of testing, but it does not contain the granular detail on acceptance criteria, sample sizes, expert involvement, or ground truth establishment that you are requesting. Such details would typically be found in the full 510(k) submission, specifically the non-clinical and clinical test reports, which are not part of this public clearance letter.

Ask a specific question about this device

The Edwards Algorithm for Measurement of Blood Hemoglobin is indicated for continuously monitoring changes to hemoglobin concentration in the circulating blood of adults ≥ 40 kg receiving advanced hemodynamic monitoring using HemoSphere ForeSight Oximeter Cable and non-invasive ForeSight sensors (large) in cerebral locations.

The Edwards Algorithm for Measurement of Blood Hemoglobin is intended for use as an adjunct monitor of relative and total hemoglobin concentration of blood in individuals at risk for reduced-flow or no-flow ischemic states in surgical and ICU settings.

The Edwards Algorithm for Measurement of Blood Hemoglobin is intended for continuously and non-invasively monitoring the relative and total hemoglobin values in the blood of patients requiring advanced hemodynamic monitoring in a critical care environment. The outputs of the algorithm include the relative changes in total hemoglobin in blood ( $\Delta$ tHb) and total hemoglobin in blood (tHb) parameters and are derived from the relative change in concentration of total tissue hemoglobin ( $\Delta$ ctHb parameter) measured by the ForeSight Oximeter Cable on the HemoSphere Advanced Monitoring Platform (K213682, cleared June 22, 2022).

The subject algorithm provides relative blood hemoglobin ( $\Delta$ tHb; measured in g/dL of blood) values continuously as a change over time from 0 g/dL. It can also be calibrated using an optional input of reference blood hemoglobin measurements such as ones obtained in vitro from a blood gas analyzer. When calibrated, it provides the value of total blood hemoglobin (tHb).

Additionally, the algorithm also provides three secondary output flags:
o DoNotCalibrate Flag: This flag is intended to indicate when a calibration should not be performed.
o Recalibrate Flag: This flag is intended to indicate when a new calibration is recommended.
o Unstable Flag: This flag is intended to indicate when the input signal ( $\Delta$ ctHb) is unstable.

The provided text describes the Edwards Algorithm for Measurement of Blood Hemoglobin, an algorithm intended for continuously monitoring changes to hemoglobin concentration. Here's a breakdown of the acceptance criteria and the study proving its performance:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "The results demonstrated that the subject device subject device met the acceptance criteria of 1g/dL with a bias close to 0 and precision less than 1g/dL". While it mentions meeting the criteria, the exact numerical values for bias and precision are not explicitly provided in the text beyond "close to 0" and "less than 1g/dL". The 1g/dL criteria appears to be for RMSE/ARMS.

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

• Sample Size: 83 patients
• Data Provenance:
  • Country of Origin: Data was collected from 5 sites across the US and EU.
    • Amsterdam, The Netherlands (European Union) - 27 patients (32.53%)
    • Santander, Spain (European Union) - 8 patients (9.64%)
    • Greenville, North Carolina, USA - 18 patients (21.69%)
    • Sacramento, California, USA - 11 patients (13.25%)
    • Chicago, Illinois, USA - 19 patients (22.89%)
  • Retrospective or Prospective: Retrospective analyses were performed on data already collected, independent of the device development.

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

The document does not explicitly state the number of experts used or their specific qualifications for establishing the ground truth. However, it indicates that the device's performance was compared against a "laboratory co-oximeter," which implies a gold standard measurement method rather than expert consensus on images.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by laboratory co-oximeter measurements, not through expert adjudication of human interpretations.

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

No, an MRMC comparative effectiveness study was not done. The study focused on the algorithm's direct performance against a laboratory co-oximeter. The text states, "No clinical trial was performed in support of the subject 510(k) submission."

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

Yes, a standalone performance study was done. The performance data was assessed by comparing the device's output to laboratory co-oximeter measurements, without human interaction with the algorithm's output during the measurement process. The algorithm's outputs are numerical values for hemoglobin concentration.

7. The Type of Ground Truth Used

The ground truth used was laboratory co-oximeter measurements of total hemoglobin values in blood. This is considered a highly accurate and objective reference method for hemoglobin quantification.

8. The Sample Size for the Training Set

The document does not provide information regarding the sample size used for the training set. The descriptions provided are solely for the retrospective analysis performed for validation (the test set).

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

The document does not provide information regarding how the ground truth for the training set was established, as details about the training phase are not included in the provided text.

Ask a specific question about this device

Cerebral Adaptive Index (CAI) Algorithm is an informational index to help assess the level of coherence or lack thereof between Mean Arterial Pressure (MAP) and the Absolute Levels of Blood Oxygenation (StO2) in patient's cerebral tissue. MAP is acquired by the HemoSphere Pressure Cable and StO2 is acquired by the ForeSight Oximeter Cable.

CAI is intended for use in patients over 18 years of age receiving advanced hemodynamic monitoring.

CAI is not indicated to be used for treatment of any disease or condition and no therapeutic decisions should be made based solely on the Cerebral Adaptive Index (CAI) Algorithm.

Cerebral Adaptive Index (CAI) Algorithm is a derived parameter that quantifies the dynamic relationship between two existing hemodynamic parameters, Mean Arterial Pressure (MAP) and the Absolute Levels of Blood Oxygenation Saturation (StO2) in the cerebral tissue. CAI is intended to show the level of coherence between MAP and cerebral StO2. The output will be represented as an index value and a trended graph.

MAP is acquired from the HemoSphere Pressure Cable (initially cleared in K180881 on November 16, 2018). StO2 used for computing CAI is acquired from the ForeSight Oximeter Cable (cleared in K201446 on October 1, 2020).

The CAI parameter can enhance clinician's understanding of the underlying hemodynamic changes behind cerebral desaturation events. It helps the clinician recognize/ identify possible causes of, for example, decrease in StO2 and clinical events related to StO2 decrease (e.g., hypotension as opposed to inadequate oxygen content).

CAI will be continuously displayed at 20-second rate. The parameter will not have any alarm ranges and will only be represented as a number with a range between 0 to 100. A high CAI value (CAI ≥45) means that MAP and StO2 have a greater coherence and informs the clinician that alterations in MAP may result in concomitant changes in cerebral oxygen saturation Whereas a low CAI value (CAI

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

Acceptance Criteria and Device Performance Study for Cerebral Adaptive Index (CAI) Algorithm

The Cerebral Adaptive Index (CAI) Algorithm is an informational index designed to assess the coherence between Mean Arterial Pressure (MAP) and Absolute Levels of Blood Oxygenation (StO2) in cerebral tissue.

1. Acceptance Criteria and Reported Device Performance

The performance goals for the CAI algorithm were established using a CAI threshold of 45.

Conclusion: The device met all pre-defined acceptance criteria for sensitivity, specificity, and ROC AUC at the specified CAI threshold of 45.

2. Sample Size and Data Provenance for Test Set

• Sample Size: 145 subjects aged 18 or older.
• Data Provenance: Retrospectively obtained from four different clinical sites within the US:
  • Northwestern University, Chicago
  • UC Davis, Sacramento
  • University of Minnesota, Minneapolis
  • Stanford University, Stanford
• Patient Characteristics: Adult surgical patients (cardiac surgery, general surgery, and surgical ICU) whose StO2 (via Foresight Sensors) and MAP (via Flotrac Sensors) were being monitored. Patients were randomly selected.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number of experts or their qualifications used to establish the ground truth.

4. Adjudication Method for Test Set

The document does not explicitly state an adjudication method. The ground truth was based on the Pearson's Correlation Coefficient (Corr) between MAP and StO2 from the clinical data.

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

An MRMC comparative effectiveness study was not mentioned in the provided text. The study focused on the standalone performance of the algorithm.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance study was conducted. The reported sensitivity, specificity, and ROC AUC values are for the CAI Algorithm operating without human intervention, based on the retrospective clinical data.

7. Type of Ground Truth Used

The ground truth was established by classifying the relationship between MAP and StO2 using the Pearson's Correlation Coefficient (Corr) from the utilized time-series clinical data.

• Weak/Moderate MAP-StO2 association: 0

Ask a specific question about this device

The non-invasive Masimo O3® Regional Oximeter System and accessories are indicated for use as an adjunct monitor of regional hemoglobin oxygen saturation of blood (rSO2) in the tissue under the sensors in patients in healthcare environments. The O3® Regional Oximeter is only to be used with Masimo O3 sensors. The use of any other sensor is not supported or recommended by Masimo and could give erroneous results.

When used with the O3 Adult Sensor, the O3® Regional Oximeter is indicated for measuring absolute and trending regional hemoglobin oxygen saturation of blood (rSO2) in adults ≥ 40kg.

When used with the O3 Pediatric Sensor, the O3® Regional Oximeter is indicated for measuring absolute and trending regional hemoglobin oxygen saturation of blood (rSO2) on cerebral sites and trending rSO2 on non-cerebral sites in pediatrics ≥ 5 kg and

The Masimo O3 Regional Oximeter is a noninvasive regional oximeter designed to continuously measure and monitor regional hemoglobin oxygen saturation (rSO2) in the tissue under the sensor. The Masimo O3 Regional Oximeter consists of the following components: 03 Module, 03 Sensors (e.g. O3 Adult, O3 Pediatric, and O3 Infant/Neonatal Sensors), and a display monitor (e.g. Root).

The O3 Regional Oximeter System provides the following key measurements and calculated features:

• Regional Oxygenation (rSO2): Regional tissue oxygenation level in the deep tissue local to the sensor site.
• Delta Baseline (Abase): Calculation of the relative difference in rSO2 with respect to baseline rSO2.
• Area Under the Limit (AUL index): Index that quantifies the duration (amount of time) the patient stays below rSO2 low alarm limit and depth (refers to the gap between the patient's rSO2 level and the rSO2 low alarm limit) of patient's stay below the user defined rSO2 low alarm limit (LAL).
• Delta SpO2 (4SpO2): Calculation of the difference between SpO2 and rSO2. The source of SpO2 is from peripheral SpO2 measurement (using pulse oximeter).
• Delta HHb (1HHb): Index associated with the change in deoxygenated hemoglobin.
• Delta O2Hb (ΔO2Hb): Index associated with the change in the oxygenated.
• Delta cHb (AcHb): Calculation of the sum of the Delta HHb and Delta O2Hb, and is an index, associated with the change in the total (oxygenated and deoxygenated) hemoglobin.

The document describes the Masimo O3 Regional Oximeter System and its update to include adjunct monitoring of absolute rSO2 in non-cerebral sites, specifically for adults. The performance data presented focuses on the accuracy (ARMS) of the Oximeter.

Here's an analysis 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 provides the acceptance criteria in terms of accuracy (ARMS) specifications for different measurements and patient populations. It implicitly states that the clinical study data supports these specifications.

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

• Sample Size for the Test Set: 25 subjects.
• Data Provenance: The document does not explicitly state the country of origin. It indicates the study was conducted clinically with "a controlled desaturation protocol," which implies a prospective study design.

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 rSO2 readings were compared against "tissue oxygen saturation (SvO2) computed using a combination of arterial and venous blood samples." This indicates that the ground truth was established through direct physiological measurement rather than expert interpretation of images or other data. Therefore, the concept of "experts" to establish ground truth in the traditional sense of, e.g., radiologists interpreting images, does not directly apply here.

4. Adjudication method for the test set

Not applicable. The ground truth was established through physiological measurements (arterial and venous blood samples), not through human adjudication of interpretations.

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

Not applicable. This device is an oximeter, a physiological monitoring device, not an AI-powered diagnostic imaging tool that would typically involve human readers. The study focuses on the device's accuracy in measuring rSO2.

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

Yes, the clinical testing described in the document is a standalone performance study. The Masimo O3 Regional Oximeter's rSO2 readings were recorded and directly compared to the physiological ground truth (SvO2 computed from blood samples). There is no mention of a human-in-the-loop component in evaluating the device's accuracy.

7. The type of ground truth used

The ground truth used was outcomes data directly related to physiological measurement: tissue oxygen saturation (SvO2) computed using a combination of arterial and venous blood samples.

8. The sample size for the training set

The document does not specify a separate "training set" or its size. This type of device relies on established biophysics and calibration rather than a machine learning model that requires a distinct training phase with annotated data. The clinical study described served as a validation (test) set for the device's performance against a gold standard.

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

As no distinct training set for a machine learning model is described, this question is not applicable. The device's underlying principle relies on multi-distance diffusion spectroscopy, which is a physical measurement technique. Calibration and validation would have been performed during the device's development using known physiological states. The clinical study served as the final validation of its performance in a clinical setting against a direct physiological measure.

Ask a specific question about this device