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

Oximeter sensors are used with compatible pulse oximeters to noninvasively continually monitor oxygen saturation and pulse rate. The primary components of the sensors are light-emitting diodes (red and infrared LED) and a photosensor. These components are embedded within a taping system to wrap the sensor around a patient's finger, foot or hand so that the LED and photosensor are directly opposite each other. As light is emitted and received across the vascular bed, the rates of absorption at the two wavelengths vary depending upon the ratios of oxygenated and deoxygenated hemoglobin within the blood. The pulse oximeter detects the changes in absorption and utilizes an algorithm to calculate the corresponding pulse rate (beats/minute) and percent arterial oxygen saturation.
Vanguard receives previously used pulse oximeter sensors from healthcare facilities; cleans, reworks, (replaces the tape [all patient-contacting materials]), inspects, tests, repackages and sterilizes the devices; and returns them to a healthcare facility.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

The provided text does not specify numerical acceptance criteria for performance (e.g., accuracy, precision). Instead, it states that the testing "demonstrates that the reprocessed devices perform as intended and are safe and effective." The performance is implicitly demonstrated by showing that the reprocessed sensors are "essentially identical to the original equipment manufacturer (OEM) devices" and that "No changes are made to the electro-optical components; the reprocessed sensors possess equivalent technological characteristics."

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

The document does not explicitly state the sample size used for performance testing of the reprocessed pulse oximeter sensors, nor does it specify the data provenance (e.g., country of origin, retrospective or prospective). It broadly mentions "cleaning, sterilization, and packaging validations, and performance and biocompatibility testing."

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

This information is not provided in the document. The type of device (reprocessed pulse oximeter sensors) typically relies on measurable physical parameters rather than expert interpretation for performance evaluation.

4. Adjudication method for the test set

This information is not provided. Given the nature of pulse oximetry performance testing, adjudication methods typically seen in image or data interpretation studies (like 2+1 or 3+1 for consensus) would not be applicable.

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 is not mentioned. This type of study is typically relevant for interpretative devices (e.g., AI in radiology), not for a device like a reprocessed pulse oximeter sensor, which directly measures physiological parameters. This device does not involve AI or human interpretation in its core function.

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

This concept is not directly applicable. A pulse oximeter sensor is a hardware device for measurement. While it contains an algorithm to calculate pulse rate and SpO2 from collected data, the "standalone" performance here refers to the device's ability to accurately measure these parameters. The evaluation confirms that the reprocessed device functions equivalently to the original device, which inherently means its embedded algorithm (unchanged) performs as expected. The study likely involved comparing readings from the reprocessed sensor against a reference standard, not assessing an algorithm in isolation from the hardware.

7. The type of ground truth used

The document does not explicitly state the type of ground truth used for specific performance metrics. However, for pulse oximetry, the ground truth would typically be established by a reference method for arterial oxygen saturation and pulse rate, such as co-oximetry for SaO2 and ECG for heart rate, or tightly controlled hypoxic studies. The phrase "performance testing" implies comparison to such established standards.

8. The sample size for the training set

This information is not applicable and not provided. As a reprocessed hardware device with an existing, unchanged algorithm, there is no "training set" in the context of machine learning or AI algorithm development.

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

This information is not applicable and not provided for the same reasons as point 8.

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Reprocessed Pulse Oximeter Sensors are intended for use when continuous external monitoring of arterial oxygen saturation and pulse rate are required.

The reprocessed pulse oximeter sensor is an electro-optical 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 non-invasive, self-calibrated measurements of both oxygen saturation of functional hemoglobin and pulse rate. Please note that this submission only pertains to the sensor. It does not pertain to the pulse oximeter or connecting cable.

The provided document is a 510(k) summary for SterilMed's reprocessed pulse oximeter sensors. It outlines the device's description, intended use, and claims of substantial equivalence to predicate devices. However, the document does not contain the detailed study information required to answer your specific questions regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies.

Therefore, I cannot provide a complete answer with the requested details from the text. The document states that "Representative samples of reprocessed sensors underwent bench testing and a clinical study to verify functional characteristics," but it does not elaborate on these studies' methodologies, results, or specific acceptance criteria met.

Here's a breakdown of what can be extracted and what is missing:

What can be inferred from the document:

• Device Name: SterilMed Reprocessed Nellcor Pulse Oximeter Oxisensor II Sensor N-25 and N-25LF
• Intended Use: "Reprocessed Pulse Oximeter Sensors are intended for use when continuous external monitoring of arterial oxygen saturation and pulse rate are required."
• Predicate Device: Nellcor Oxisensors™ (compatible with Nellcor N-200 pulse oximeter, K863784).
• Study Types Mentioned: Bench testing and a clinical study were performed to verify functional characteristics. Process validation testing was done for cleaning, sterilization, and packaging. Manufacturing includes visual and functional testing.
• Conclusion: The reprocessed sensors are "substantially equivalent" to predicate devices based on functional design, materials, indications for use, and construction methods.

What is missing from the document and therefore cannot be provided:

1. A table of acceptance criteria and the reported device performance: The document states that testing was done to "verify functional characteristics which are substantially equivalent to the predicate devices'," but it provides no specific performance metrics or thresholds for acceptance.
2. Sample size used for the test set and the data provenance: No details about the number of devices or subjects in the clinical study or bench testing are given, nor is the origin of the data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided. Given the nature of pulse oximetry, the "ground truth" for oxygen saturation would typically come from arterial blood gas analysis, not expert consensus on images.
4. Adjudication method for the test set: Not mentioned.
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: This is not applicable to a reprocessed pulse oximeter sensor, which is a hardware device for direct measurement, not an AI interpretation tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not applicable as it's not an AI algorithm. Its performance is inherent to the device itself.
7. The type of ground truth used: While not explicitly stated, for a pulse oximeter, the ground truth for oxygen saturation would typically be obtained through methods like arterial blood gas analysis.
8. The sample size for the training set: Not applicable and not mentioned, as this is a device reprocessing submission rather than an AI/machine learning model.
9. How the ground truth for the training set was established: Not applicable and not mentioned.

In summary, the provided text confirms that studies were conducted to demonstrate substantial equivalence, but it lacks the granular details requested regarding acceptance criteria, specific performance results, and study methodologies.

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

Oximeter sensors are used with compatible pulse oximeters to noninvasively continually monitor oxygen saturation and pulse rate. The primary components of the sensors are light-emitting diodes (red and infrared LED) and a photosensor. These components are embedded within a taping system to wrap the sensor around a patient's finger, foot or hand so that the LED and photosensor are directly opposite each other. As light is emitted and received across the vascular bed, the rates of absorption at the two wavelengths vary depending upon the ratios of oxygenated and deoxygenated hemoglobin within the blood. The pulse oximeter detects the changes in absorption and utilizes an algorithm to calculate the corresponding pulse rate (beats/minute) and percent arterial oxygen saturation.

Vanguard receives previously used oximeter sensors from healthcare facilities; cleans, reworks, (replaces the tape [all patient-contacting materials]), inspects, tests, repackages and sterilizes the devices; and returns them to the healthcare facility.

The provided text is a 510(k) summary for Vanguard Reprocessed Pulse Oximeter Sensors. While it asserts that the reprocessed devices perform as intended and are safe and effective, it does not contain detailed acceptance criteria or a study write-up with specific performance metrics, sample sizes, or ground truth establishment methods typically found in a clinical study report.

The document is a regulatory submission for substantial equivalence based on the technological characteristics and functional testing compared to a predicate device. It indicates that "Sterilization validations, and functional/performance and biocompatibility testing demonstrates that the reprocessed devices perform as intended and are safe and effective." However, it does not elaborate on the specific methodologies or results of these tests in a way that would allow for the construction of the requested table and detailed description.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance: The document does not provide specific numerical acceptance criteria or performance metrics for the reprocessed pulse oximeter sensors beyond the general statement that they perform as intended and are safe and effective.
• Sample sized used for the test set and the data provenance: No sample sizes for testing are mentioned.
• Number of experts used to establish the ground truth...: Not applicable as no clinical study with ground truth establishment is described.
• Adjudication method: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device is a physical sensor, not an algorithm, so this is not applicable in the way it's framed for AI/algorithm performance.
• The type of ground truth used: Not applicable.
• The sample size for the training set: Not applicable as it's not an AI/ML device requiring a training set.
• How the ground truth for the training set was established: Not applicable.

The "Test Data" section merely states: "Sterilization validations, and functional/performance and biocompatibility testing demonstrates that the reprocessed devices perform as intended and are safe and effective." This is a high-level summary and does not provide the granular information needed to describe acceptance criteria or a study that proves the device meets those criteria.

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