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The Reprocessed RD SET pulse oximeter sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult, pediatric, and infant patients during non-motions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.

In a clinical setting, a pulse oximeter sensor measures the oxygen saturation of arterial blood (SpO2). A pulse oximeter sensor is composed of a light emitting diode (LED) and a sensor that are placed on opposite sides of a patient's finger or foot. The LED contains a red light and an infrared light that are differentially absorbed by oxygenated and deoxygenated hemoglobin. Based on the relative absorption of the two wavelengths that is determined by the sensor, the POX determines the relative amount of oxygenated and deoxygenated hemoglobin, which is calculated as SpO2. In order to make the SpO2 calculation independent of skin color, finger size, etc., the pulse oximeter sensor uses only the time varying light absorption component generated by the patient's pulse. The sensor also uses the period of pulsation to measure patient pulse rate. The pulse oximeter can estimate the amount of oxygen in the blood without having to draw a blood sample.

The primary components of an oxygen transducer, or Pulse Oximeter (POX) Sensor, are lightemitting diodes (red and infrared LED) and a photo sensor. These components (with their wiring system) are embedded within a taping system designed for wrapping the POX Sensor around a patient's finger, foot, or hand so that the LED and photo sensor are directly opposite to each other. As the lights are emitted and received across a vascular bed, the rates of absorption at the two wavelengths vary depending upon the ratios of oxygenated and deoxygenated hemoglobin within the blood.

As part of the reprocessing manufacturing process, we collect used devices from hospitals, replace required components, clean the devices and test the functional performance of the devices to ensure they meet or exceed requlatory requirements and the expectations of our customers.

The provided text describes the 510(k) summary for reprocessed pulse oximeter sensors. It outlines the device, its intended use, comparison to predicate devices, and testing performed to demonstrate substantial equivalence.

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

Acceptance Criteria and Reported Device Performance

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The sensor is indicated for single patient use for continuous noninvasive arterial oxygen saturation and pulse rate monitoring.

In a clinical setting, a pulse oximeter sensor measures the oxygen saturation of arterial blood (SpO2). A pulse oximeter sensor is composed of a light emitting diode (LED) and a sensor that are placed on opposite sides of a patient's finger or foot. The LED contains a red light and an infrared light that are differentially absorbed by oxygenated and deoxygenated hemoglobin. Based on the relative absorption of the two wavelengths that is determined by the sensor, the POX determines the relative amount of oxygenated and deoxygenated hemoglobin, which is calculated as SpO2. In order to make the SpO2 calculation independent of skin color, finger size, etc., the pulse oximeter sensor uses only the time varying light absorption component generated by the patient's pulse. The sensor also uses the period of pulsation to measure patient pulse rate. The pulse oximeter can estimate the amount of oxygen in the blood without having to draw a blood sample.

The primary components of an oxygen transducer, or Pulse Oximeter (POX) Sensor, are light-emitting diodes (red and infrared LED) and a photo sensor. These components (with their wiring system) are embedded within a taping system designed for wrapping the POX Sensor around a patient's finger, foot, or hand so that the LED and photo sensor are directly opposite to each other. As the lights are emitted and received across a vascular bed, the rates of absorption at the two wavelengths vary depending upon the ratios of oxygenated and deoxygenated hemoglobin within the blood.

The proposed devices of this submission do not differ from the predicate device. The only difference is that the proposed devices will be exposed to vaporized hydrogen peroxide for sterilization instead of ethylene oxide.

This document describes the validation of a reprocessed pulse oximeter sensor. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size for Test Set: The document does not explicitly state the number of healthy adult volunteers involved in the clinical validation testing.
• Data Provenance: The clinical validation testing was performed by Stryker Sustainability Solutions. The country of origin of the data is not specified but is presumably where the company operates or sponsored the study. The study was prospective as it involved clinical validation testing on healthy adult volunteers.

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

The document does not mention the use of experts to establish a ground truth for the test set. The clinical validation focused on direct measurement of SpO2 and pulse rate.

4. Adjudication Method for the Test Set:

Not applicable, as no external adjudication method is described for defining the ground truth in the clinical validation. The SpO2 and pulse rate measurements are direct physiological measurements.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is more relevant for diagnostic imaging devices where human interpretation is a key component. The pulse oximeter sensor provides direct physiological measurements.

6. Standalone (Algorithm Only) Performance Study:

Yes, a standalone performance study was done through:

• Non-clinical bench simulation testing: This involved using a stand-in device for SpO2 sensor verification. These tests (continuity and sensitivity) assess the device's functional performance independently.
• Clinical validation testing: This directly assessed the device's ability to measure SpO2 and pulse rate on healthy adult volunteers, which represents the algorithm's performance in a real-world scenario without human interpretation.

7. Type of Ground Truth Used:

• Clinical Validation: The ground truth for SpO2 measurements in the clinical validation would typically be established by a co-oximeter or other reference method for arterial oxygen saturation, though this is not explicitly detailed in the provided text. The output of the device itself (SpO2 and pulse rate) is a direct measure against implied physiological norms or a gold standard measuring device.
• Bench Testing: The ground truth for continuity and sensitivity testing is based on engineered specifications and the expected electrical and optical behavior of the sensor.

8. Sample Size for the Training Set:

This information is not provided in the document. The device is a reprocessed sensor, and the validation focuses on verifying the performance of the reprocessed device against its original specifications and predicate devices. It doesn't describe an AI/ML algorithm development process that typically involves a training set.

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

This information is not provided as the document does not detail an AI/ML algorithm requiring a training set. The validation is for a reprocessed medical device.

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The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor Model MAXNAR is indicated for single patient use when continuous non-invasive arterial oxygen saturation and pulse rate monitoring is required for adult patients as indicated in the sensor directions for use. This device is for prescription use only.

The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor, model MAXNAR is designed for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate in conjunction with a Nellcor Pulse Oximeter. The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor, model MAXNAR, is intended for prescription use with adult patients in hospitals, hospital-type facilities, and intra-hospital transport. The proposed device is not provided sterile

The provided document describes a 510(k) premarket notification for a reprocessed medical device, the Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor, Model MAXNAR. This is not an AI/ML device, but a reprocessed physical sensor. Therefore, many of the typical acceptance criteria and study components for an AI/ML device (like an algorithm's performance, human reader improvement, expert consensus for ground truth on images, training sets, etc.) are not applicable here.

Instead, the study focuses on demonstrating substantial equivalence to an existing predicate device by showing that the reprocessed sensor meets performance specifications and safety standards similar to a new device. The "ground truth" here is the actual arterial oxygen saturation measured by a co-oximeter, and the "device performance" refers to the accuracy of the SpO2 sensor against this gold standard.

Here's an attempt to extract and reframe the information based on the prompt's requirements, noting where AI/ML specific criteria do not apply:

Device: Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor, Model MAXNAR
Device Type: Reprocessed pulse oximeter sensor (physical hardware, not an AI/ML algorithm)

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for this device, as a pulse oximeter, is its accuracy in measuring SpO2. This is evaluated against an established standard (ISO 80601-2-61:2011).

Note: "Arms" refers to the "Accuracy Root Mean Square" deviation, which is a statistical measure of accuracy for pulse oximeters.

Study Details

1. Sample Size and Data Provenance:

   • Test Set Sample Size: 10 healthy adult volunteer subjects.
   • Data Provenance: The study was conducted in a laboratory setting on healthy volunteers. The exact country of origin is not specified, but the context implies it's within the US, given the FDA submission. It was a prospective clinical trial.
   • Subject Demographics: Ages 25 to 36 years; weight 105 - 220 lb.; height 60 – 72 in.; BMI of 20.0 – 33.4.

2. Number of Experts Used to Establish Ground Truth and Qualifications:

   • Not applicable in the typical AI/ML sense where human experts label images.
   • The ground truth for SpO2 was established invasively using a co-oximeter (arterial blood gas analysis), which is the gold standard for measuring arterial oxygen saturation. This does not involve human expert interpretation of images. The study followed "ISO 80601-2-61:2011 Procedure for invasive laboratory testing on healthy volunteers applicable sections."

3. Adjudication Method for the Test Set:

   • Not applicable. This study is a direct comparison of the device reading against an objective, invasive gold standard (co-oximetry), not an interpretation that requires adjudication by multiple experts.

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

   • No. An MRMC study is relevant for AI/ML systems that assist human interpretation of medical images. This device is a sensor that directly measures a physiological parameter. The study focuses on the sensor's accuracy, not its impact on human reader performance.

5. Standalone (Algorithm Only) Performance:

   • Yes, but framed differently. This is a hardware device, not an algorithm. The "standalone performance" is the accuracy of the reprocessed sensor itself (Model MAXNAR) in measuring SpO2 and pulse rate against the co-oximeter standard, without further human interpretation other than reading the display. The reported performance of 2% SpO2 accuracy is this standalone performance.

6. Type of Ground Truth Used:

   • Outcomes Data/Physiological Measurement (Invasive Gold Standard): Arterial oxygen saturation (SpO2) measurements obtained via co-oximetry on arterial blood samples from healthy volunteers. This is considered the true physiological value.

7. Sample Size for the Training Set:

   • Not applicable. This isn't an AI/ML algorithm that requires a training set. The "training" for a reprocessed device involves the manufacturing and reprocessing procedures themselves, ensuring they meet the original equipment manufacturer's specifications and performance.

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

   • Not applicable. As above, no training set in the AI/ML context. The closest analogy would be the validation of the reprocessing methods to ensure the sensor performs "as new." This involves non-clinical tests (biocompatibility, disinfection, shelf life, electrical, tissue heating, pulse rate accuracy, active element assessment, adhesive peel, environmental testing, visual inspection, cleaning efficacy) to establish that the reprocessed device meets specifications. The clinical study mentioned verifies the final performance.

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The Medline ReNewal Reprocessed Masimo LNCS Adult and Pediatric SpO2 Adhesive Sensors are indicated for single patient use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult and pediatric patients during no motion conditions, and for patients who are well perfused in hospitals and hospital-type facilities.

Medline ReNewal Reprocessed Masimo LNCS Adult and Pediatric SpO2 Adhesive Sensors, models LNCS Adtx, LNCS Pdtx, LNCS Adtx-3, and LNCS Pdtx-3 are designed for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate in conjunction with instruments containing Masimo SET oximetry or licensed to use LNCS sensors. The Medline ReNewal Reprocessed Masimo LNCS sensor models LNCS Adtx, LNCS Pdtx, LNCS Adtx-3, and LNCS Pdtx-3 are intended for prescription use with adult and pediatric patients in hospitals, hospital-type facilities, and intra-hospital transport. The proposed device is not provided sterile.

The provided text describes a 510(k) summary for the Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors. This document is a premarket notification to the FDA, demonstrating that the reprocessed device is substantially equivalent to legally marketed predicate devices.

The study described is a clinical trial conducted to evaluate the SpO2 accuracy of the reprocessed sensors, specifically focusing on the acceptance criteria for SpO2 accuracy.

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

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

• Sample Size: 10 healthy adult volunteer subjects.
• Data Provenance: The study was conducted from May 9 to May 10, 2018. The location of the study (e.g., country of origin) is not explicitly stated but is implied to be within the jurisdiction of the U.S. FDA, given it's part of a 510(k) submission. The study involved prospective data collection as it was a clinical trial performed specifically to evaluate the device.

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

The document does not specify the number or qualifications of experts (e.g., medical professionals, technicians) used to establish the ground truth for SpO2 measurements. The ground truth for SpO2 accuracy in pulse oximetry studies typically relies on co-oximetry measurements from arterial blood samples. While the study followed ISO standards that dictate such procedures, the explicit mention of experts establishing ground truth is absent.

4. Adjudication method for the test set

The document does not describe an adjudication method. For a study evaluating SpO2 accuracy against a reference method (like co-oximetry), adjudication in the sense of multiple expert reviews of a single interpretation is not typically applicable. The comparison is between the device's measurement and the objective reference measurement.

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 study solely focused on the accuracy of the device itself (standalone performance) in measuring SpO2 in comparison to a reference method, not on how human readers (if this were an AI diagnostic tool) might improve with AI assistance.

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

Yes, a standalone study was done. The clinical trial specifically evaluated the SpO2 accuracy of the proposed devices (the reprocessed sensors) themselves. The performance assessed was the sensor's ability to accurately measure SpO2, which is an inherent function of the device's technology.

7. The type of ground truth used

The ground truth used for SpO2 accuracy in this type of study is typically invasive laboratory testing on healthy volunteers where arterial blood samples are taken and analyzed by a co-oximeter. This is implied by the reference to "ISO 80601-2-61:2011 Procedure for invasive laboratory testing on healthy volunteers applicable sections" in the "Performance Testing Clinical Tests" section. This forms an objective, physiological ground truth.

8. The sample size for the training set

The document describes a clinical trial for performance evaluation, not the training of an AI algorithm. Therefore, there is no mention of a training set sample size. The device is a reprocessed medical sensor, not an AI model that requires a training dataset.

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

As the device is a reprocessed sensor and not an AI algorithm, there is no training set or associated ground truth establishment for a training phase. The clinical study tested the device's performance directly against established physiological measurements.

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OxiMax Adult: continuous non-invasive arterial oxygen saturation and pulse rate monitoring of patients > 30 kg.

OxiMax Pediatric: continuous non-invasive arterial oxygen saturation and pulse rate monitoring of patients 10 - 50 kg.

OxiMax Infant: continuous non-invasive arterial oxygen saturation and pulse rate monitoring of patients between 3 kg and 20 kg.

OxiMax Neonate: continuous non-invasive arterial oxygen saturation and pulse rate monitoring of patients foot if 40 kg.

The ReNy Medical Reprocessed OxiMax Sensors are accessory devices to an oximeter monitoring system. The oxisensor is designed as a transducer for the transmission of electrical signals from the oximeter to the patient and the return of patient modified signals back to the oximeter for analysis and display of patient information. The sensor contains three optical components; two light emitting diodes (LEDs) serve as light sources and one photodiode acting as a light detector LED and sensor are contained in a laminated envelope provided with an adhesive bandage for attachment a patient. A sensor package is attached to a cable terminated in a multi-pin connector that plugs into the oximeter.

The provided text describes a 510(k) summary for ReNu Medical's Reprocessed OxiMax Sensors, which are oximetry sensors. The submission focuses on demonstrating substantial equivalence to predicate devices, particularly regarding safety and effectiveness.

Here's an analysis of the provided text in relation to your questions, focusing on what is explicitly stated:

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

The document does not explicitly provide a table of acceptance criteria with corresponding device performance metrics in numerical form. It broadly states that:

• "Reprocessed OxiMax Sensors were tested to demonstrate functional characteristics by bench testing and in vivo clinical studies."
• "Bench testing was performed to determine pulse rate accuracy using an OxiTest 7 simulator. Varying environmental conditions and physical tests were performed for temperature and humidity."
• "Clinical studies in vivo were performed on both Adult and Neonate subjects to demonstrate accuracy of SpO2 in the reprocessed sensors."

While it mentions "pulse rate accuracy" and "accuracy of SpO2," it does not specify what the acceptance thresholds for these accuracies were, nor does it provide the measured performance values for the reprocessed sensors.

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

• Sample size: The document states "Clinical studies in vivo were performed on both Adult and Neonate subjects," but it does not provide specific sample sizes for these subject groups.
• Data provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given they are "in vivo clinical studies," they were likely prospective.

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)

This information is not provided in the document. The studies mentioned are clinical, implying direct measurement rather than expert interpretation of data. For oximetry sensors, "ground truth" for SpO2 accuracy would typically come from a co-oximetry blood gas analyzer, not expert consensus on images or other subjective data.

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

This is not applicable to the type of device and study described. Oximetry sensor accuracy is typically determined by comparing the device's readings to a reference standard (e.g., co-oximetry), not through human adjudication of ambiguous cases.

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

• MRMC study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic imaging devices where human interpretation is a key component. The ReNu Medical device is an oximetry sensor, a physiological measurement device, not an AI diagnostic tool that assists human readers.
• Effect size of human reader improvement: Therefore, this information is not applicable and not provided.

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

• Standalone performance: Yes, the described "bench testing" and "in vivo clinical studies" focus on the performance of the reprocessed sensors themselves, indicating a standalone assessment of the device's accuracy. This is not an "algorithm only" performance as the device is hardware, but it evaluates the device's output independently.
• Without human-in-the-loop: The accuracy measurements (pulse rate and SpO2) are direct device outputs, not dependent on human interpretation in the sense of a human-in-the-loop system for AI.

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

The document does not explicitly state the specific ground truth method, but for oximetry sensors, the established scientific method for "accuracy of SpO2" in clinical studies involves:

• Inducing a range of oxygen saturations in subjects.
• Simultaneously measuring arterial oxygen saturation using a co-oximeter (a laboratory device that directly measures different hemoglobin species from arterial blood samples).
• Comparing the sensor's readings to the co-oximeter's readings. This is the accepted "gold standard" for blood oxygen saturation measurement.

For "pulse rate accuracy," the ground truth would typically be derived from an ECG monitor.

8. The sample size for the training set

This information is not applicable as the device is a reprocessed medical sensor, not an AI/ML algorithm that requires a training set. The "reprocessing" involves cleaning, testing, and sometimes replacing components, but it does not involve machine learning model training.

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

This information is not applicable for the same reason as point 8.

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The M-LNCS Sensors are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate (measured by an SpO₂ sensor) for use with adult, pediatric, infant, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.

The Reprocessed M-LNCS Sensors are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult, pediatric, infant, 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.

The M-LNCS and Reprocessed M-LNCS Oximetry Sensors are fully compatible disposable sensors for use with instruments which include or compatible with the following technologies:

• · Masimo SET technology
• · Masimo Rainbow SET technology
• · Nellcor technology

The M-LNCS series has been validated with Masimo SET Oximetry Technology and on Nellcor's N-200 Pulse Oximeter. The saturation accuracy of the Neonate and Preterm sensors were validated on adult volunteers and 1% was added to account for properties of fetal hemoglobin.

Here's an analysis of the provided text regarding the acceptance criteria and study data for the Masimo M-LNCS Oximetry Sensors:

Important Note: The provided document is a 510(k) summary, which often summarizes the results of studies rather than detailing the full study methodology. As such, some specific details like exact sample sizes for each test, data provenance in terms of country of origin for all tests, specific ground truth establishment for all parameters, and multi-reader multi-case study details are not fully elaborated in this summary.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are presented as the accuracy specifications for SpO2 and pulse rate under different conditions (no motion, motion, low perfusion) and for different patient populations (adult/pediatric/infant, neonatal). The study's reported performance is implied by the statement that the sensors "met all design specifications" and "are as safe and effective as the legally marketed predicate devices." Therefore, the reported performance aligns with the specified accuracy ranges.

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

The document states that the saturation accuracy of the Neonate and Preterm sensors were validated on adult volunteers. However, it does not specify the sample size for this validation or for other tests. The provenance is implied to be human subject testing for some aspects (adult volunteers) but no geographical location is specified. The studies are non-clinical, implying they were prospective tests conducted specifically for this submission.

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

The document does not mention the use of "experts" to establish ground truth in the context of radiologists or similar medical specialists. For oximetry, ground truth is typically established by reference devices or methods (e.g., co-oximetry for SpO2, ECG for pulse rate).

4. Adjudication Method for the Test Set

Not applicable. Adjudication is typically used for subjective diagnoses or interpretations by multiple readers. For oximetry accuracy, the comparison is to a definitive reference standard, not expert consensus requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or subjective interpretation tasks where the performance of human readers, with and without AI assistance, is evaluated. Oximetry sensor evaluation focuses on the accuracy of the device itself against physiological parameters.

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

Yes, the testing described appears to be standalone performance of the device. The "performance testing including bench accuracy testing" and the validation on "adult volunteers" for saturation accuracy are tests of the device's ability to measure physiological parameters independently.

7. The Type of Ground Truth Used

For saturation accuracy, the ground truth for neonatal/preterm sensors was established by validation on adult volunteers, where a "1% was added to account for properties of fetal hemoglobin." This implies that the ground truth for SpO2 was likely established using a reference co-oximeter on the adult volunteers. For pulse rate, the ground truth would typically be from an ECG or similar gold standard. The other tests, such as "bench accuracy testing," would use simulated physiological signals or phantoms.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI. Oximetry sensors traditionally rely on algorithms based on physiological principles and empirical data, not typically large-scale machine learning training sets in the modern sense. The validation studies mentioned would be more akin to "test sets" for verifying the device's performance against established criteria.

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

As no explicit training set for an AI algorithm is mentioned, the method for establishing ground truth for a training set is not applicable based on the provided text. The device's underlying technology (Masimo SET, Masimo Rainbow SET, Nellcor technology) already incorporates established algorithms for signal processing and SpO2/pulse rate calculation.

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The reprocessed pulse oximeter sensors are indicated for use for continuous noninvasive arterial oxygen saturation (SpO2) and pulse rate monitoring.

SterilMed's reprocessed pulse oximeter sensors consist of a sensor, integrated sensor cable, and a sensor plug which connects to the Pulse Oximeter. These devices feature a sensor that uses an optical means to determine the light absorption of functional arterial hemoglobin. The sensor contains three optical components: two light emitting diodes (LED's) that serve as light sources, and one photodiode, that acts as a light receiver. The oximeter sensor is positioned so that the LED's and photodiode oppose one another across the tissue. The sensor is connected via cable to a pulse oximeter, which provides continuous noninvasive, self-calibrated measurements of both oxygen saturation of functional hemoglobin and pulse rate.

The provided text describes a 510(k) summary for SterilMed, Inc.'s Reprocessed Pulse Oximeter Sensors. It details functional and safety testing, non-clinical tests, and clinical studies conducted to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Although specific numerical acceptance criteria (e.g., +/- 2% accuracy) are not explicitly stated in the document for SpO2 and pulse rate accuracy, the document indicates that the reprocessed sensors demonstrated "appropriate functional characteristics" and "SpO2 accuracy" in both bench and in vivo clinical validations.

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

The document mentions "in vivo clinical studies were conducted on both adult volunteers and neonatal subjects" but does not specify the sample size for these clinical studies. It also does not explicitly state the country of origin or whether the data was retrospective or prospective. However, given the nature of a 510(k) submission for a reprocessed medical device, clinical studies are typically prospective to demonstrate the safety and efficacy of the reprocessed version.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth in the clinical studies. For pulse oximetry, the ground truth for SpO2 and pulse rate is typically established through a co-oximeter analyzing arterial blood samples for SpO2, and an ECG or manual pulse check for pulse rate. Expertise would be required for proper blood gas analysis and clinical assessment, but the document does not elaborate on this.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method for the test set in the clinical studies.

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

No. This type of study is typically relevant for interpretative diagnostic devices (e.g., imaging devices) where human readers interpret output. Pulse oximeters provide direct quantitative measurements, so an MRMC study is not applicable.

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

Yes, in the context of a pulse oximeter sensor, its performance is inherently "standalone" in how it acquires and transmits raw physiological data (light absorption). The "algorithm" here refers to the internal processing within the oximeter (which is not part of this 510(k) submission) to convert light absorption into SpO2 and pulse rate. The tests described (SpO2 and pulse rate accuracy using a simulated tester, and in vivo clinical studies) are evaluations of the sensor's ability to accurately provide these measurements.

7. The Type of Ground Truth Used

The ground truth for the clinical studies would have been established using reference standard methods for measuring SpO2 and pulse rate. For SpO2, this typically involves arterial blood gas analysis (co-oximetry). For pulse rate, this could be from electrocardiography (ECG) or other accurate physiological monitoring. The document states "in vivo clinical studies were conducted... to demonstrate SpO2 accuracy," implying comparison against such a reference.

8. The Sample Size for the Training Set

The document does not mention a training set in the context of device performance evaluation. For a reprocessed pulse oximeter sensor, there isn't typically a "training set" in the machine learning sense. The "training" here refers to the development and validation of the reprocessing protocol itself, and the document discusses "process validation testing" for sterilization and "validation of functional performance" for the reprocessed devices. However, no specific sample size for this developmental "training" is provided.

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

Given that a "training set" in the machine learning sense is not applicable, the concept of establishing ground truth for it is also not applicable here. Instead, the ground truth for validating the reprocessing process is established by demonstrating that the reprocessed sensors meet the same functional and safety requirements as new devices. This is achieved through the various non-clinical tests (sterilization, bioburden, packaging, shelf life) and the functional bench testing and clinical studies mentioned.

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The MRC Reprocessed Pulse Oximeter sensors are used as a noninvasive method to provide continuous SpO2 monitoring and pulse rate monitoring. These devices are intended for prescription use.

The Midwestern Reprocessing Center reprocessed pulse oximeter sensors are non-invasive sensors used to provide continuous SpO2 monitoring and pulse rate. The sensors contain a dual wavelength light emitting diode (LED), and an optical photodiode sensor which are housed in a pad which attaches to the patient using adhesive material. The LED emits red and infrared light in alternate pulses, governed by the Oximeter instrument. The photodiode sensor responds to the light and generates a current that is interpreted by the Oximeter instrument. The Oximeter instrument interprets the different amounts of each light type (red and infrared) from the output of the photodiode and interprets the information and displays a reading. The sensor operates without any type of tissue penetration, electrical contact, or heat transfer to the patient. The sensors use optical means to determine the light absorption of functional arterial hemoglobin. The sensor is indicated for use as a non-invasive method to provide continuous SpO2 monitoring and pulse rate.

{
  "acceptance_criteria_and_performance_table": null,
  "study_summary": {
    "sample_size_test_set": null,
    "data_provenance": null,
    "number_of_experts_ground_truth_test_set": null,
    "qualifications_experts_ground_truth_test_set": null,
    "adjudication_method_test_set": null,
    "mrmc_comparative_effectiveness_study": false,
    "effect_size_human_readers_mrmc": null,
    "standalone_performance_study": true,
    "type_of_ground_truth": "clinical testing and non-clinical functional testing (such as performance/functional testing, cleaning validation, and biocompatibility testing)",
    "sample_size_training_set": null,
    "ground_truth_establishment_training_set": null
  },
  "additional_notes": "The provided text indicates that 'Clinical Testing demonstrated that the reprocessed devices used with its compatible pulse oximeter perform as intended and are safe and effective' and 'Based on the assessment of clinical testing, non-clinical functional testing, cleaning validation, and biocompatibility testing performed, Midwestern Reprocessing Center concludes that the Midwestern Reprocessing Center reprocessed pulse Oximeter sensors are substantially equivalent to their predicate devices'. However, no specific acceptance criteria or quantitative performance metrics are provided to be presented in a table. The document focuses on demonstrating substantial equivalence through various tests rather than specific performance against numerical acceptance criteria. Therefore, a table of acceptance criteria and reported device performance cannot be generated from the given text."
}

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The reprocessed pulse oximeter sensors are indicated for use for continuous noninvasive arterial oxygen saturation (SpO2) and pulse rate monitoring.

SterilMed's reprocessed Masimo LNCS® Pulse Oximeter Sensors consist of a sensor, integrated sensor cable, and the sensor plug which connects to the Pulse Oximeter. The reprocessed Masimo LNOP® Pulse Oximeter Sensors consist of a sensor (two LED's and a photodiode), connector extension and connector, but do not feature an integrated cable. Both configurations have a sensor that uses an optical means to determine the light absorption of functional arterial hemoglobin. The sensor contains three optical components: two light emitting diodes (LED's) that serve as light sources, and one photodiode, that acts as a light receiver. The oximeter sensor is positioned so that the LED's and photodiode oppose one another across the tissue. The sensor is connected via cable to a pulse oximeter, which provides continuous noninvasive, self-calibrated measurements of both oxygen saturation of functional hemoglobin and pulse rate.

Note: Only the pulse oximeter sensor is the subject of this submission, the oximeter and any other related equipment are not included in the scope of this submission.

This document, K092368, is a 510(k) premarket notification for reprocessed pulse oximeter sensors by SterilMed, Inc. It aims to demonstrate substantial equivalence to predicate devices (Masimo LNCS® and LNOP® pulse oximeter sensors).

Given the nature of this submission (reprocessed medical devices) and the available information, the "device" in the context of your request refers to the reprocessed pulse oximeter sensors. The study described is primarily focused on demonstrating that the reprocessed sensors perform equivalently to new, predicate sensors.

Here's a breakdown based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list quantitative acceptance criteria in a table format with corresponding reported performance metrics for specific clinical parameters (e.g., SpO2 accuracy, pulse rate accuracy). Instead, it describes a more general approach to ensuring functional equivalence.

The document states: "Representative samples of reprocessed pulse oximeter sensors were tested to demonstrate appropriate functional characteristics by utilizing the necessary bench testing and an in vivo clinical validation."

And further: "The reprocessed pulse oximeter sensors are substantially equivalent to the Masimo pulse oximeter sensors. This conclusion is based upon the devices' similarities in functional design (principles of operation), materials, indications for use and methods of construction."

While not a direct table of specific numerical acceptance criteria, the implicit acceptance criterion is that the reprocessed sensors demonstrate functional characteristics equivalent to the predicate devices. The study and testing performed aimed to confirm this.

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

• Sample Size for the Test Set: The document states "Representative samples of reprocessed pulse oximeter sensors were tested..." but does not specify the exact sample size used for the in vivo clinical validation.
• Data Provenance: The document does not specify the country of origin of the data. It's a submission to the FDA in the United States, implying the study was likely conducted to support US regulatory requirements, but the specific location of the clinical validation is not stated. The data is prospective in nature, as it describes a clinical validation study conducted to support the submission.

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

The document does not mention the use of experts to establish ground truth in the context of interpreting the in vivo clinical validation results, nor does it specify the number or qualifications of clinicians involved in the study itself. For pulse oximetry, "ground truth" for SpO2 is typically established through co-oximetry of arterial blood samples, rather than expert interpretation of images or other subjective data. Similarly, pulse rate ground truth would be from a reference ECG or direct physiological measurement.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method as typically understood for studies involving expert consensus (e.g., 2+1, 3+1). This type of adjudication is usually relevant for subjective interpretations (like medical imaging), which is not the primary focus of validating a pulse oximeter sensor. For objective measurements like SpO2 and pulse rate, the comparison would be between the device's readings and a gold standard measurement technique.

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. MRMC studies are typically used for diagnostic devices that rely on human interpretation of information (e.g., radiologists reading images). The validation for a pulse oximeter sensor focuses on its objective measurement accuracy against a reference standard, not on how human readers interpret its output or how it assists human decision-making. Therefore, there is no mention of an effect size for human readers improving with or without AI assistance.

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

Yes, the in vivo clinical validation described is essentially a standalone performance assessment. The study investigates the performance of the reprocessed sensors themselves, measuring their capability to accurately determine SpO2 and pulse rate. While a human would be monitoring the oximeter, the "performance" being evaluated is that of the sensor (the device), not a human's interpretation of its output in a clinical scenario or an AI algorithm's contribution to that interpretation. The reprocessed sensor itself is the "algorithm only" device being tested in this context.

7. The Type of Ground Truth Used

For pulse oximeter sensors, the most common "gold standard" or ground truth for oxygen saturation (SpO2) in clinical validation is:

• Co-oximetry of arterial blood samples. This involves drawing arterial blood and analyzing it with a co-oximeter to precisely measure the arterial oxygen saturation (SaO2). The SpO2 readings from the pulse oximeter are then compared to these SaO2 values.
• For pulse rate, the ground truth would typically be derived from a simultaneously measured electrocardiogram (ECG) or another highly accurate physiological monitor.

The document states "an in vivo clinical validation" but does not explicitly detail the specific gold standard or ground truth methods used (e.g., co-oximetry). However, based on standard practices for pulse oximeter validation, these are the expected ground truth methodologies.

8. The Sample Size for the Training Set

The document does not mention or describe a "training set." This is expected because the reprocessed pulse oximeter sensors are not an AI/machine learning device that requires a training phase. Their function is based on established optical principles, and the validation aims to confirm that the reprocessing does not compromise these principles or the sensor's performance.

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

As no training set is mentioned or applicable to this type of device, this question is not relevant to the information provided in the document.

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