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The Sunrise Air is a non-invasive home care aid in the evaluation of obstructive sleep apnea (OSA) in patients 18 years and older with suspicions of sleep breathing disorders.

The Sunrise Air consists of the Sunrise software (v1.28.00), which analyzes data from one of three compatible sensors (Sunrise sensor 1, Sunrise sensor 2, or Sunrise Air) placed on the patient's chin. Sunrise sensor 1 was approved through DEN210015, while Sunrise sensor 2 was cleared through K222262. The current version of the Sunrise device introduces a new sensor, Sunrise Air. The Sunrise device is intended to detect respiratory events, identify sleep stages and position, and generate key sleep parameters—such as the apnea-hypopnea index ("Sunrise AHI") and positional states classifications. The collected data is compiled into a report for further interpretation by a healthcare provider.

The provided FDA 510(k) clearance letter for the Sunrise Air device primarily focuses on demonstrating substantial equivalence to a predicate device, rather than detailing a comprehensive clinical study to prove the device meets specific acceptance criteria for its claimed indications.

The document highlights bench testing for technical equivalence, but lacks the detailed clinical study information typically provided for direct performance claims against established ground truth. Specifically, it states that "No modifications have been made to the Sunrise algorithm used to generate sleep parameters," and that a "validation study of SpO₂ and pulse rate accuracy for the subject device was conducted using raw PPG data acquired during the clinical validation for the Sunrise sensor 2 (K222262)." This suggests reliance on prior clearances for core algorithm performance and a specific re-validation for only the PPG data processing change.

Therefore, many of the requested details about acceptance criteria, clinical study design, and ground truth establishment for the overall device performance (e.g., AHI calculation, OSA evaluation) are not explicitly present in this summary.

Given the information in the provided document, here's what can be extracted and inferred:

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

Based on the information provided, the "acceptance criteria" are implied by the comparisons to the predicate and reference devices, and some specific performance metrics are given for SpO2 and pulse rate. The primary acceptance criterion for the device's main function (evaluation of OSA via AHI) is that "No modifications have been made to the Sunrise algorithm used to generate sleep parameters," implying continued equivalence to the predicate's performance.

Study that Proves the Device Meets Acceptance Criteria:

The document describes a combination of bench testing and reliance on prior clinical validation for specific components. There isn't a single, new "study" designed to prove the overall device meets a set of clinical acceptance criteria for OSA evaluation, but rather, individual tests to establish equivalence of components or re-validate specific algorithm changes.

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

• Overall Device (for AHI/OSA evaluation): Not explicitly stated for a new study. The document states that "No modifications have been made to the Sunrise algorithm used to generate sleep parameters." This implies reliance on the clinical validation data from the predicate device (Sunrise K222262). The original K222262 submission would contain this information.
• SpO₂ and Pulse Rate Accuracy:
  • Sample Size: Not explicitly stated. The study was conducted using "raw PPG data acquired during the clinical validation for the Sunrise sensor 2 (K222262)." The sample size for that original clinical validation would be the relevant number.
  • Data Provenance: Retrospective, as it used data from a previous clinical validation study (for Sunrise sensor 2, cleared under K222262). The country/region of origin of this data is not specified in this document.

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

• Overall Device (for AHI/OSA evaluation): Not specified in this document, as the core algorithm relies on prior validation. For the original K222262 clearance, ground truth would typically be established by a consensus of sleep experts (e.g., board-certified sleep physicians or registered polysomnographic technologists (RPSGTs)).
• SpO₂ and Pulse Rate: Ground truth for these parameters is typically established through a co-oximeter or arterial blood gas analysis, not necessarily by "experts" in the human sense, but by a gold-standard measurement device.

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

• Not specified within this 510(k) summary for any new studies. For the original clinical validation of the AHI algorithm, an adjudication method (such as independent scoring by multiple qualified technologists/physicians with consensus or a tie-breaker) would typically be employed for the polysomnography (PSG) ground truth.

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

• No, an MRMC comparative effectiveness study involving human readers and AI assistance is not described in this document. The device is for "aiding in the evaluation" and generates parameters; it is not presented as an AI-assisted diagnostic tool for human interpretation improvement in this summary.

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

• Yes, the device's capability to "detect respiratory events, identify sleep stages and position, and generate key sleep parameters" and a "Sunrise AHI" implies a standalone algorithmic performance in generating these outputs from the sensor data. The statement "No modifications have been made to the Sunrise algorithm used to generate sleep parameters" means that the standalone performance of the algorithm itself is considered validated based on its prior clearance. The SpO₂ and pulse rate accuracy also represent standalone algorithm performance.

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

• Overall Device (for AHI/OSA evaluation): Not explicitly stated, but for sleep apnea diagnostic devices, the ground truth is overwhelmingly polysomnography (PSG) scored by qualified experts (e.g., according to AASM guidelines). This would have been the ground truth for the predicate device's (K222262) clearance.
• SpO₂ and Pulse Rate: The ground truth for SpO₂ accuracy is typically established using a reference pulse oximeter or co-oximeter (invasive arterial blood gas analysis may be used for a subset of the data if required for the specific accuracy claims and range). For pulse rate, a simultaneous ECG or the reference oximeter's heart rate measurement.

8. The sample size for the training set:

• Not specified in this document. As the core algorithm is unchanged from the predicate, its training data would have been part of the K222262 submission.
• The document mentions "cloud-based algorithm (Sunrise PPG algorithm)" as a change for PPG data processing, but it does not specify the training set size for this particular component, only that its validation was done on existing test data.

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

• Not specified in this document, as the core algorithm leverages prior clearance. For the predicate device, ground truth for training data would have broadly been established in the same manner as the test set: expert-scored polysomnography (PSG) data. However, the specific details (e.g., single expert vs. consensus) are not provided here.

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ABPMpro Ambulatory Blood Pressure Recorder is a Non-Invasive oscillometric and ECG device intended to acquire Ambulatory non-invasive Blood Pressure signals and 3 Channel ECG signals from the upper body surfaces. Cardiac rhythm is acquired via 3 Channel ECG signals. Additional physiological signals like plethysmogram, body position and activity are also measured. The Recorder is intended for adults and children who are over the age of 12 years. ABPMpro Software allows transfer of Blood Pressure-, ECG- and data from additional signals from the Recorder to a Windows-based PC-based computer program via USB cable for the purpose of creating reports and printouts. The Software does not perform diagnostics. Physicians carry out diagnostics evaluations of this data. The system is only for measurement, recording and display. It makes no diagnosis.

The ABPMpro is a portable device for recording physiological signals. The ABPMpro is used as a long-term blood pressure as well as a long-term ECG device. The ABPMpro is a portable device worn on the upper arm by means of a cuff and used as an oscillometric 24h ambulatory blood pressure recorder. The ABPMpro consists of the following hardware: ABPMpro recorder with integrated accelerometer and position sensor; Brachial blood pressure cuff (3 sizes available); Optional: 3-channel ECG sensor; Optional: Plethysmogram-sensor (LED). Following the completion of the patient recording session, the device, cuff and electrodes are removed from the patient. The ABPMPro is connected to the PC using the USB cable. With the downloaded ABPMpro Analyzer Software open on the PC, the user can download the recorded data. The user can select the patient data and begin analysis. The device is intended for prescription use.

The provided text details the 510(k) premarket notification for the SOMNOmedics GmbH ABPMpro device. It outlines the device's intended use and presents a summary of performance testing and substantial equivalence comparison to predicate devices.

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

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

The document doesn't explicitly present a table of "acceptance criteria" with quantitative targets alongside the device's performance. Instead, it states that performance testing was conducted to confirm "compliance to device specifications" and that recorded signals "comply with the performance criteria set forth by SOMNOmedics that includes the minimum performance specification recommended by the applicable standards."

The key standards referenced for performance are:

• IEC 80601-2-30: for automated non-invasive sphygmomanometers (blood pressure).
• IEC 60601-2-47: for ambulatory electrocardiographic systems (ECG).

The reported device performance based on the clinical study related to blood pressure measurement against a recognized standard (ISO 81060-2:2018) is the most direct evidence provided for meeting performance criteria:

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

The clinical testing data provenance is described as an "open, prospective, clinical validation study."

• General validation study (for blood pressure at rest): N = 90
  • Age: 12-76 years (Mean age 39.7 ± 15.1)
  • Gender: 47 male (52%), 43 female (48%)
• Ambulatory validation study (for blood pressure under dynamic exercise): N = 36
  • Age: 22-65 years (Mean age 40.9 ± 11.0)
  • Gender: 20 male (56%), 16 female (44%)

The country of origin for the data is not explicitly stated, but the sponsor is "SOMNOmedics GmbH Am Sonnenstuhl 63 Randersacker, Germany D-97236", which suggests the study may have been conducted in Germany or a location adhering to European standards. The study received "Ethics Committee approval" and was conducted "in accordance with good clinical practice (GCP) as described in 21 CFR 812.28(a)(1)," which are US regulations. This suggests a study potentially designed for US regulatory submission, but the exact location is not provided.

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

For the blood pressure measurements, the ground truth was established by:

• Two observers provided simultaneous auscultatory reference BP measurements using a dual-head teaching stethoscope.
• Qualifications of experts: Not explicitly stated beyond "two observers." It's implied they are trained to accurately use the reference sphygmomanometer and stethoscope for auscultatory measurements.

4. Adjudication method for the test set

The method for establishing reference blood pressure was the "same arm sequential method" described in the Universal Standard (ISO 81060-2:2018). The involvement of "two observers" taking "simultaneous auscultatory reference BP measurements" suggests a form of consensus or comparison between them to establish the reference, as per the standard's requirements for validating automated sphygmomanometers. However, a specific adjudication method (e.g., 2+1, 3+1, averaging, arbitration) for discrepancies between the two observers is not explicitly described. The standard itself outlines how such measurements are to be handled.

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

No MRMC comparative effectiveness study was mentioned. The device, ABPMpro, does not appear to be an AI-assisted diagnostic tool; rather, it is a data acquisition and display device. The software "does not perform diagnostics. Physicians carry out diagnostics evaluations of this data. The system is only for measurement, recording and display. It makes no diagnosis." Therefore, a human-in-the-loop or AI assistance study involving human readers would not be applicable or expected for this device's stated function.

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

The primary performance evaluation for the blood pressure measurement was the "accuracy" against the reference standard (ISO 81060-2:2018), which is a standalone performance assessment of the device's ability to accurately measure BP. For ECG, the compliance to IEC 60601-2-47 further indicates a standalone performance assessment of its signal acquisition capabilities.

7. The type of ground truth used

The ground truth for blood pressure measurements was established using:

• Expert Consensus/Reference Measurement: Simultaneous auscultatory reference BP measurements taken by two trained observers (using a calibrated standard aneroid sphygmomanometer and a dual-head teaching stethoscope). This aligns with the "expert consensus" category for reference standard measurements in clinical studies of measurement devices.
• Standardized Method: The "same arm sequential method" described in the ISO 81060-2:2018 Universal Standard.

8. The sample size for the training set

The document does not specify a training set or its sample size. This is typical for medical devices that are not "machine learning/AI" devices requiring a distinct training and test split for an algorithm. The "ABPMpro" is presented as a measurement and recording device, not one with a diagnostic AI algorithm that learns from data.

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

As no training set is mentioned (see point 8), this information is not applicable.

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The Sunrise device is a non-invasive home care aid in the evaluation of obstructive sleep apnea (OSA) in patients 18 years and older with suspicions of sleep breathing disorders.

The Sunrise device is a cloud-based software device that analyzes data from a sensor (Sunrise sensor 1 or Sunrise sensor 2) placed on the patient's chin. The device detects respiratory events, identifies sleep stages and position. The device generates sleep parameters, e.g. apnea hypopnea index "Sunrise AHI", and position discrete states. Data collected by the device is integrated in a report for further interpretation by the healthcare provider.

The provided text details the performance data for the Sunrise device to support its substantial equivalence determination. However, it does not explicitly state "acceptance criteria" in a表格 format as requested. Instead, it describes performance metrics (e.g., median measurement bias and LOA, sensitivity, specificity, global accuracy, and RMS values) for various parameters against pre-determined thresholds of clinical acceptability or against a gold standard (PSG).

Based on the provided information, I will infer the acceptance criteria from the reported performance, as these are the values the device did achieve and were deemed sufficient for substantial equivalence.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

As explicit acceptance criteria thresholds are not stated, the "Acceptance Criteria" column will reflect the reported performance that was deemed acceptable for substantial equivalence. The "Reported Device Performance" will reiterate these values.

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

• Clinical Study 1: 289 patients, retrospective, comparative, open study. Performed in Belgium.
• Clinical Study 2: 31 patients, retrospective, comparative, open study. Performed in France.
• Clinical Study 3: 10 patients, retrospective, comparative, open study. Performed in Belgium.
• Clinical Study 4 (SpO2 & Pulse Rate): Not explicitly stated, but validated in accordance with ISO 80601-2-61:2019 and FDA guidance. This is typically a controlled bench study with a human subject population, but the document does not break down the sample size for this specific validation.
• Thermistor Validation: Not explicitly stated (the text mentions "a validation study was conducted").

All mentioned clinical studies are described as retrospective, comparative, and open studies.

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

The document does not specify the number or qualifications of experts used to establish the ground truth (PSG data). It only refers to "the gold-standard PSG" as the comparison. In typical PSG studies, the PSG data is scored by trained sleep technologists and sometimes reviewed by a sleep physician, but this detail is not provided.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method for the test set. The ground truth is stated to be "the gold-standard PSG."

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

No MRMC study comparing human readers with and without AI assistance is mentioned. The studies focus on the performance of the device (algorithm) itself against PSG.

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

Yes, the clinical studies describe the performance of the "algorithm" and the "device" against PSG, indicating a standalone (algorithm only) evaluation. The text states: "The algorithm was used to analyze sensor data and evaluate the performance of the device compared to PSG."

7. The Type of Ground Truth Used

The primary ground truth used for OSA parameters (TST, AHI, ORDI, OSA severity) and position discrete states was Polysomnography (PSG), referred to as the "gold-standard PSG." For SpO2 and pulse rate accuracy, the ground truth was established in accordance with ISO 80601-2-61:2019 and relevant FDA guidance, which typically involves comparison against a reference oximeter or validated measurement system. For the thermistor, it was compared to an "oronasal thermal airflow sensor used in PSG."

8. The Sample Size for the Training Set

The document does not explicitly state the sample size for the training set. The clinical studies mentioned (n=289, n=31, n=10) are described as performance evaluation studies for the device, not necessarily for training. It states the "Sunrise algorithm... has been updated," implying a development process that would include training, but the specifics of the training dataset are not provided.

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

The document does not provide information on how the ground truth for any potential training set was established. It focuses solely on the performance evaluation of the device against the "gold-standard PSG" for its validation studies.

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