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The Oximetry Module can be used with Philips Respironics BiPAP C Series (BiPAP AVAPS and BiPAP S/T) ventilators to measure functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate for adult and pediatric patients. The Oximetry module may be used in a hospital or home care environment.

The Philips Respironics BiPAP C-Series Ventilatory System (BiPAP AVAPS and BiPAP S/T) is intended to provide non-invasive ventilatory support to treat adult and pediatric (> 7 years of ages; > 18 kg) patients with Obstructive Sleep Apnea (OSA) and Respiratory Insufficiency. The Respironics BiPAP C-Series Ventilatory Support System may be used in the hospital or home.

The Respironics BiPAP C-Series (BiPAP AVAPS and BiPAP S/T) Ventilatory Support Devices when used with the Respironics Link Module Oximetry Interface Kit provides access to patient therapy information through the two-way transfer of data between patient devices and clinicians through the appropriate software including therapy efficacy and device settings as requested by the attending physician.

The Oximetry Interface Kit consists of the following components:

• Respironics Link Module
• SD Card and Mailer
• Masimo Oximetry Module and Sensor

When connected to the flow generator, the oximetry module records treatment and pulse oximetry data during therapy. The data is stored on a secure digital card. After treatment, the secure digital card containing the data can be removed from the device and sent to the clinician for review.

The Respironics BiPAP C-Series (BIPAP AVAPS and BiPAP S/T) devices, cleared under K092818, when used with the Respironics Oximetry Interface Kit are microprocessor controlled blower based positive pressure systems that interface with an with integrated heated humidifier, like the predicate cleared in K102465.

I am sorry, but the provided text does not contain the specific details about acceptance criteria, device performance tables, sample sizes, expert qualifications, or ground truth establishment relevant to the request. The document describes a 510(k) submission for a medical device (Respironics BiPAP Ventilator Series Oximetry Interface Kit) and focuses on administrative information, intended use, device description, non-clinical testing, and a statement of safety and effectiveness, mostly comparing it to predicate devices.

The "Test Execution Summary" section mentions several tests (Time Meters, Standard Regression Test, Pulse Oximetry User Interface, Pulse Oximetry Logging, Serial Port AutoBaud Detection, User Interface – Monitor Parameters Submenu) and states that "All tests have passed and requirements referenced in these tests have been verified," and "All tests were verified to meet the required acceptance criteria." However, it does not provide the specific numerical acceptance criteria or the reported device performance in a table format. It also does not delve into the methodology of studies with details like sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, or how ground truth was established for training sets, which are usually part of more comprehensive study reports rather than a 510(k) summary.

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The LNCS Sensors are indicated for the continuous nonitoring 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 hospital-type facilities, mobile, and home environments.

The LNCS Oximetry Sensors are to be reprocessed. They are fully compatible disposable sensors for use with Masimo SET and Masimo SET compatible pulse oximeter monitors. The LNCS Oximety Sensors are also compatible with Nellcor compatible pulse oximeter monitors. There is no change in the sensor design or performance. The only change is that the sensors are to be reprocessed and subjected to ethylene oxide (EO) sterilization, and are to be supplied as sterile sensors by Masimo.

The provided document is a 510(k) summary for the Masimo LNCS Oximetry Sensors. It focuses on the substantial equivalence of reprocessed and sterilized sensors to previously cleared sensors. Therefore, the information typically found in acceptance criteria and detailed study reports for new device performance (like specific accuracy metrics, sample sizes for test/training sets, expert qualifications, etc.) is not present in this summary.

Here's a breakdown of what can be extracted based on the request, and what cannot:

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

• Acceptance Criteria: Not explicitly stated in terms of specific performance metrics (e.g., accuracy, precision errors for SpO2). The primary acceptance criterion here is "substantial equivalence" to previously cleared predicate devices. This means the reprocessed sensors must perform at least as well as the original, non-reprocessed sensors.
• Reported Device Performance: The document only states: "The results of the performance data demonstrate that the LNCS Oximetery Sensors, after reprocessed and sterilized are as safe and effective as the legally marketed predicate devices." No specific numerical performance values (e.g., SpO2 accuracy, pulse rate accuracy) are provided in this summary.

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 for Test Set: Not specified.
• Data Provenance: The testing was "in-house and laboratory validation testing." No information on country of origin or whether it was retrospective or prospective is provided.

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)

• Number of Experts: Not applicable/not specified. For oximetry sensors, ground truth typically comes from a reference device (e.g., CO-oximeter for SpO2) rather than expert consensus on images.
• Qualifications of Experts: Not applicable/not specified.

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

• Adjudication Method: Not applicable/not specified. Oximetry sensor performance is typically evaluated against reference instruments, not expert adjudication in the way image analysis algorithms are.

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. This device is an oximetry sensor, not an AI-powered diagnostic tool requiring human reader studies.

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

• Standalone Performance: Not applicable in the context of an "algorithm only" device, as this is a physical sensor. The "performance data" mentioned would be for the sensor itself.

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

• Type of Ground Truth: Not explicitly stated in this summary. For oximetry devices, ground truth for SpO2 accuracy is typically established using a reference CO-oximeter with arterial blood samples. The document refers to "in-house and laboratory validation testing," which would imply such rigorous reference methods.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device is a sensor, not an AI/ML algorithm that requires a training set.

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

• Ground Truth for Training Set: Not applicable.

Summary of available information as per request:

This 510(k) summary is for a device modification (reprocessing and sterilization) of an existing device type, not a new technology introduction. Therefore, the focus is on demonstrating that the reprocessing and sterilization do not negatively impact the established performance and safety of the device, rather than establishing original performance criteria from scratch. Detailed performance metrics and study designs, if required, would typically be found in the full 510(k) submission, not necessarily in the public summary.

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

The devices are reprocessed Low Noise Cabled Sensors (LNCS)® Series - Adult, Pediatric, and Infant SpO2 adhesive sensors. The sensors are disposable devices used for continuous noninvasive arterial oxygen saturation and pulse rate monitoring.

The provided document states that the Reprocessed Pulse Oximeter Sensors have identical indications for use, technological characteristics, design, materials, and intended use as the predicate devices. Therefore, the acceptance criteria are implicitly that the reprocessed devices perform as "originally intended" by the manufacturer of the predicate devices. The study conducted to prove this involved bench and laboratory testing.

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: Not explicitly stated. The document refers to "bench and laboratory testing" and "each individual Pulse Oximeter Sensor is tested," suggesting that a robust testing protocol was followed but does not provide specific numbers for the test set.
• Data Provenance: Not explicitly stated. The document does not mention the country of origin of data or whether it was retrospective or prospective. It describes general testing conducted by the applicant, Ascent Healthcare Solutions.

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

• Number of Experts: Not applicable. The "ground truth" here is the performance specifications of the original, new device. The testing conducted by Ascent Healthcare Solutions was to verify that the reprocessed devices meet these pre-defined specifications through direct measurement and physical/chemical analysis, not through expert interpretation of clinical data on the reprocessed devices themselves.
• Qualifications of Experts: Not applicable, for the reasons above.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The testing described is objective, physical, and chemical in nature, designed to confirm that the reprocessed devices meet established performance parameters. There is no subjective interpretation requiring an adjudication process.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The device is a reprocessed medical device, and the evaluation focused on its functional equivalence to the original device through bench and laboratory testing.

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

• Standalone Performance: Not applicable. This device is a physical medical sensor, not an algorithm. The performance evaluation is of the sensor itself.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the reprocessed sensors is the performance specifications and characteristics of the original, new predicate devices (Masimo LNCS and SPO2.COM Sensors). The objective was to demonstrate that the reprocessed devices continue to meet these original manufacturer specifications after reprocessing.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not an AI/ML algorithm that requires a "training set." The device is a reprocessed physical medical device.

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this type of device.

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The T-105 Series Vital Signs Monitor is intended to monitor a single patient's vital signs in the hospital, acute care settings, outpatient surgery, healthcare practitioner facilities or in an environment where patient care is provided by qualified healthcare personnel who will determine when use of this device is indicated, based upon their professional assessment of the patient's medical condition. The patient populations include adult, pediatric and neonatal. The device is capable of monitoring:

• . Pulse rate (via oximetry data)
• . Non-invasive pressure (systolic, diastolic and mean oscillometric (NIBP)
• . Temperature
• . Blood Oxygen Saturation (SpO2 via finger oximeter)
  This device is intended for use by qualified healthcare personnel trained in its use.

The Omron HBP T-105 Series is a modification of the Colin Press-Mate PM-2100 and is intended to monitor a single patient's vital signs. The device is capable of monitoring:

• . Pulse rate (via oximetry data):
• Non-invasive pressure (systolic, diastolic and mean oscillometric (NIBP); .
• . Temperature; and
• . Blood Oxygen Saturation (SpO2 via finger oximeter)

The provided document is a 510(k) premarket notification for the Omron HBP T-105 Series Vital Signs monitor. This type of submission relies on demonstrating substantial equivalence to pre-existing legally marketed predicate devices, rather than presenting a full de novo study with detailed acceptance criteria and performance data as might be found in a clinical trial report for a novel AI device.

Therefore, the requested information, particularly regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies (especially for AI systems), is largely not present in this document. The document focuses on demonstrating that the new device's specifications are similar to or the same as those of the predicate devices.

However, I can extract what is available and highlight what is missing based on your request.

Acceptance Criteria and Reported Device Performance

The "Acceptance Criteria" here are implicitly the specifications of the predicate devices, as the new device claims "same as predicate device" for most performance metrics. The "Reported Device Performance" is also stated in relation to these predicate device specifications.

Missing Information from the Document:

1. Sample sizes used for the test set and the data provenance: This information is not provided. A 510(k) submission for a vital signs monitor often relies on performance data collected during design verification and validation, but detailed sample sizes and population demographics are not routinely included in the public summary. Given the device is a technical modification of existing technology, the "testing" would likely involve demonstrating compliance with recognized standards (e.g., ISO 81060-1 for NIBP, ISO 80601-2-61 for Pulse Oximetry) rather than a novel clinical study for equivalence, and the results are summarized as "same as predicate."

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided. For device performance, the "ground truth" would be established by reference measurement devices or established clinical protocols, not by expert consensus on, for example, image interpretation.

3. Adjudication method for the test set: Not applicable/not provided. Adjudication is typically relevant for subjective assessments, which is not the primary mode of evaluation for a vital signs monitor.

4. 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 a vital signs monitor, not an AI-powered diagnostic imaging system. There are no "human readers" or "AI assistance" in the context of interpretation of complex medical cases.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable in the context of AI. The device's algorithms (e.g., for oscillometric NIBP, SpO2) operate intrinsically. Performance is assessed against reference standards.

6. The type of ground truth used: For vital signs monitors, the ground truth is typically established using independent, highly accurate reference measurement equipment/methods. For example, for NIBP, this might involve simultaneous intra-arterial pressure measurements, or non-invasive methods validated against such standards. For SpO2, it might involve co-oximetry measurements from arterial blood samples. This document does not detail the specific ground truth methods employed in its validation studies, but it is implied that standard validation procedures were followed for each parameter.

7. The sample size for the training set: Not applicable. This device does not employ machine learning/AI in a way that requires a distinct "training set" in the context of general-purpose vital signs monitoring. Its algorithms are based on established physiological principles.

8. How the ground truth for the training set was established: Not applicable, as no AI training set is described.

Summary of Study that Proves the Device Meets Acceptance Criteria

The document states that the Omron HBP T-105 Series is a modification of the Colin Press-Mate PM-2100. The primary method for proving the device meets acceptance criteria in a 510(k) submission like this is demonstrating substantial equivalence to a previously cleared predicate device.

The "study" in this context is not a standalone clinical trial in the sense of a drug or novel AI device, but rather a series of verification and validation (V&V) tests to confirm that the modified device performs according to its specifications and is at least as safe and effective as the predicate.

The provided table itself serves as the core of this proof, by showing that:

• Many key specifications (measurement method, patient target, accuracy of pressure indicator, accuracy of pulse rate for NIBP, SpO2 measurement method and accuracy for Nellcor, temperature measurement method and accuracy) are "same as predicate device."
• Where changes exist (e.g., power source, display, operating/storage conditions, dimensions, weight, BP module, SpO2 module, addition of Masimo sensors, use of an Omron algorithm for quick BP measurement), these changes are either presented as minor design updates (e.g., battery type, display technology) or by referencing other legally marketed predicate devices for the specific component/feature (e.g., Omron HEM907 for Air Control Valve/Applicable Cuff, Omron HEM-757 for Quick BP algorithm, Nellcor N-595 and Masimo RAD-5 with their respective sensors for SpO2).

The conclusion of the FDA (as shown in pages 4-6) is that the device is "substantially equivalent" to the predicate devices, which signifies that the manufacturer successfully demonstrated that the changes do not raise new questions of safety or effectiveness and that the performance meets acceptable standards, usually through bench testing, engineering analysis, and potentially limited clinical testing if deemed necessary for specific changes (though not detailed here).

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