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AcuPebble Ox200 is a wearable device intended for use in the recording, analysis, displaying, exporting, and storage of biophysical parameters to aid in the evaluation of adult patients with, or with suspected, obstructive sleep apnea (OSA). The device is primarily intended for home setting use (although can also be used in healthcare settings) under the direction of a Healthcare Professional (HCP).

AcuPebble Ox200 is prescribed by a Health Care Professional for the patient to use in the home as a 'home sleep apnea test' (HSAT). AcuPebble Ox200 comprises: 1- A small microphones/accelerometer sensor, identical to the one in the previously cleared devices AcuPebble SA100 (K210480) and AcuPebble Ox100 (K222950) that is worn on the front of the neck around the suprasternal notch area (the "AcuPebble SA100 sensor"), and attaches with a single use biocompatible adhesive tape (same one as for "AcuPebble SA100" and "AcuPebble Ox100)); 2- Another PPG/accelerometer sensor ("AcuPebble_oximetry sensor") worn either on the finger or on the forehead; 2- A mobile device app (the "AcuPebble Ox200 app") that guides the patient through the steps of the test, collects the data from the sensors, and uploads them in the cloud ; 3- A cloud-based software that analyses the collected signals as in the previously cleared devices; 4- A web app user interface for healthcare professionals where they can set up a study and see the results, including different physiological channel traces and OSA diagnostic parameters, as in the previously cleared devices.

The differences between AcuPebble Ox200 and the previously cleared device (K222950) are:

• A new sensor for sensing the PPG signal and extraction of the SpO2 and pulse rate channel from. This new sensor can be placed either on the finger or the forehead.
• The addition of new parameters extracted from the acoustic neck sensor including position, respiratory efforts and respiratory rate channels.

The OSA diagnostic indexes are still extracted from the signals measured with the identical sensor as in the predicate (neck sensor only), and with the same algorithms, remain unchanged with respect to the predicate device (K222950) and hence have not been separately tested in this device.

Here's a summary of the acceptance criteria and the studies that prove the device meets those criteria, based on the provided text:

AcuPebble Ox200 Acceptance Criteria and Performance Study Summary

1. Table of Acceptance Criteria and Reported Device Performance

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AcuPebble Ox100 is a wearable device intended for use in the recording, analysis, displaying, exporting, and storage of biophysical parameters to aid in the evaluation of adult patients with, or with suspected, obstructive sleep apnea (OSA). The device is primarily intended for home settings use (although can also be used in healthcare settings) under the direction of a Healthcare Professional (HCP).

AcuPebble Ox100 is prescribed by a Health Care Professional for the patient to use in the home as a 'home sleep apnea test' (HSAT). AcuPebble Ox100 comprises: 1- A small physiological sensing device, identical to the previously cleared device AcuPebble SA100 (K210480) that is worn on the front of the neck around the suprasternal notch area (the "AcuPebble SA100 sensor"), and attaches with a single use biocompatible adhesive tape (same one as for "AcuPebble SA100" too); 2- Another physiological wireless sensing device ("AcuPebble finger oximetry sensor") worn on the finger; 3- A mobile device app (the "AcuPebble Ox100 app") that guides the patient through the steps of the test, collects the data from the sensor (continuously in the case of the "AcuPebble SA100 sensor", and at the end of the test in the case of the "AcuPebble finger oximetry sensor"), and uploads them in the cloud ; 4- A cloud-based software that analyses the signals from the "AcuPebble SA100 sensor" (already cleared as part of K210480); 5- A web app user interface for healthcare professionals where they can set up a study and see the results, including different physiological channel traces and OSA diagnostic parameters. Outputs of the device relevant to its intended use are further described in the comparison table below.

The provided text describes the AcuPebble Ox100 device and its substantial equivalence to a predicate device (AcuPebble SA100, K210480) based on various performance data and testing. However, it does not contain a detailed study specifically proving that the device meets defined acceptance criteria for its effectiveness in aiding the evaluation of Obstructive Sleep Apnea (OSA).

The information provided primarily focuses on:

• Comparison to Predicate and Reference Devices: Highlighting similarities in indications for use, regulation, target population, environment of use, and certain performance metrics previously claimed for the predicate or a reference device (NightOwl, K191031).
• Compliance with Recognized Consensus Standards: For biocompatibility, electrical safety (EMC), home healthcare safety, risk management, and software development.
• High-level performance metrics: AHI, ODI, Diagnostic LR+, LR-, Sensitivity, Specificity, and Pulse rate/SpO2 performance, which appear to be inherited or similar to the predicate/reference device claims rather than outcomes of a new primary study for AcuPebble Ox100's specific combination of sensors.

Information NOT explicitly available in the provided text:

• A dedicated table of acceptance criteria for AcuPebble Ox100 with its own reported performance to demonstrate compliance.
• Detailed information about a specific clinical study conducted for AcuPebble Ox100 to prove its diagnostic performance. The diagnostic metrics listed (Sensitivity, Specificity, etc.) are presented as "Same" compared to the predicate, implying these are existing claims rather than results from a new study specific to Ox100 to justify a de novo clearance.
• Sample sizes for a test set specifically for demonstrating the performance of AcuPebble Ox100 in diagnosing OSA.
• Data provenance (country of origin, retrospective/prospective) for a study validating AcuPebble Ox100's diagnostic capabilities.
• Number of experts, their qualifications, or adjudication methods for establishing ground truth of a test set for AcuPebble Ox100's diagnostic performance.
• Whether a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done for AcuPebble Ox100, or any effect size of AI assistance.
• The type of ground truth used for a study validating AcuPebble Ox100's diagnostic capabilities.
• Sample size and ground truth establishment for the training set of AcuPebble Ox100's diagnostic algorithm.

Based on the provided text, here's what can be extracted, and what is missing or implied:

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

The document doesn't explicitly present a standalone table of "acceptance criteria" for the AcuPebble Ox100 followed by "reported device performance" from a new study of this specific device. Instead, it compares the AcuPebble Ox100's characteristics and performance to its predicate (AcuPebble SA100) and a reference device (NightOwl) in a tabular format. The performance metrics listed are presented as "Same" to the predicate, implying that these are the established performance levels from the predicate device that the AcuPebble Ox100 is deemed to meet by being substantially equivalent.

Here's a reconstruction of the relevant performance metrics mentioned, noting that these are largely presented as being "Same" as the predicate:

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

• Not specified for a new effectiveness study of AcuPebble Ox100. The performance metrics (Diagnostic LR+, LR-, Sensitivity, Specificity) are stated to be the "Same" as the predicate device (AcuPebble SA100). Therefore, any sample size and data provenance would refer to the previous clearance of K210480. This information is not provided in the document for K210480.
• For the SpO2 performance, compliance with ISO 80601-2-61 is stated. Such compliance typically requires specific testing against a reference oximeter in a clinical setting with a certain number of subjects across defined SpO2 ranges, but the specific sample size, country of origin, or retrospective/prospective nature of this verification for AcuPebble Ox100 is not detailed.

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

• Not specified for a new effectiveness study of AcuPebble Ox100. This information would be relevant for the diagnostic performance metrics, which are stated to be "Same" as the predicate. Details for the predicate (K210480) are not in this document.

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

• Not specified for a new effectiveness study of AcuPebble Ox100. This would relate to the diagnostic performance metrics, which are stated to be "Same" as the predicate. Details for the predicate (K210480) are not in this document.

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 such study is mentioned or described for AcuPebble Ox100. The device is intended to aid in evaluation, but no comparative effectiveness study with human readers (with vs. without AI assistance) is detailed.

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

• The diagnostic performance metrics listed (Sensitivity, Specificity, LR+, LR-) usually reflect standalone algorithm performance against a gold standard. However, these are listed as "Same" to the predicate device (AcuPebble SA100). The document does not provide details of a new standalone study for AcuPebble Ox100 itself to derive these numbers. The "cloud-based software that analyses the signals" and "web app user interface for healthcare professionals" suggest an algorithmic analysis component.

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

• Not specified for a new effectiveness study of AcuPebble Ox100. For diagnostic assessments of OSA, polysomnography (PSG) scored by experts according to AASM guidelines is the typical gold standard/ground truth. However, the document does not confirm this for a specific study validating AcuPebble Ox100's performance.

8. The sample size for the training set:

• Not specified. The document refers to "A cloud-based software that analyses the signals" but does not provide details on its training set or how it was developed for AcuPebble Ox100.

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

• Not specified.

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AcuPebble SA100 is indicated to sense, record, and interpret a patient's physiological signals (including respiratory pattern) during sleep for the purpose of prescreening patients for obstructive sleep apnea (OSA) syndrome. The designed for use in home-screening of adults with suspected possible sleep breathing disorders (although it can also be used in clinic). Results are used to assist the healthcare professional's in the patient's evaluation.

The system is not intended as a substitute for full polysomnography when additional parameters such as sleep stages, limb movements, or EEG activity are required.

AcuPebble SA100 comprises a sensor that is worn on the front of the neck around the suprasternal notch area (the "AcuPebble SA100 sensor"), a mobile device app that guides the patient through the steps of the test, collects the data from the sensor, and uploads them in the "AcuPebble SA100 app"), and a cloud-based analysis software (the "AcuPebble SA100 algorithms". The "AcuPebble SA100 Sensor" consists of a small biocompatible enclosure with very low power sensors and electronics inside. It is attached to the front of the neck (somewhere between the Adam's apple and the suprasternal notch area) by single-use biocompatible adhesive tape. The sensor measures physiological body sounds. The data sensed is streamed via a Bluetooth link to the "AcuPebble SA100 app" on a smart device (mobile phone/tablet). The data can be uploaded into the cloud where it is analyzed, any time after the sleep study test is finished at the tap of a button in the app. AcuPebble SA100 signal processing algorithms produce a number of OSA diagnostic traces and parameters. These can be accessed by the Health Care Professional through a healthcare professional portal, which can be accessed from any computer or smart device with an Internet connection.

AcuPebble SA100 is not intended to be used with patients with pacemakers or other implantable devices, or with patients with known or suspected arrhythmias. This device has not been validated in patients with congestive heart failure or patients with neuromuscular disorders. Patients with significant cardiopulmonary or neurological disorders need to be excluded from using the device.

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

Device Name: AcuPebble SA100
Intended Use: To sense, record, and interpret a patient's physiological signals (including respiratory pattern) during sleep for the purpose of prescreening patients for obstructive sleep apnea (OSA) syndrome. Designed for home-screening of adults with suspected possible sleep breathing disorders to assist healthcare professionals in patient evaluation. Not a substitute for full polysomnography.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined "acceptance criteria" with numerical thresholds for diagnostic accuracy (PPV, NPV, LR+, LR-). Instead, it presents the results of the clinical validation study for several diagnostic indices (AHI3, AHI4, ODI3, ODI4) and heart rate accuracy. The implicit acceptance is that these values demonstrate substantial equivalence to the predicate device.

Implicit Acceptance Criteria (Performance Benchmarks from Predicate/Context): Not explicitly stated with numerical targets in the provided text. The submission focuses on demonstrating substantial equivalence to the predicate (Drowzle, K173974) and reference devices (NightOwl, K191031; Sleep Strip II, K112822). The reported values in the table are the result of meeting the substantial equivalence standard, rather than being against pre-set numerical acceptance criteria.

Reported Device Performance:

Heart Rate Accuracy:

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

• Sample Size for Test Set: 150 consecutive evaluation patients.
• Data Provenance: Not specified in terms of country of origin. The study was a "Clinical Investigation," conducted in accordance with ISO 14155:2011 and 21 CFR 812.28(a)(1) (GCP for clinical investigations). This implies a prospective study design for data collection, as it refers to "consecutive evaluation patients."

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

• The document does not specify the number or qualifications of experts used to establish the ground truth. It states that the ground truth for diagnostic accuracy was based on "the AASM for airflow reductions and desaturations" and "established thresholds, for OSA (i.e. 5, 15 and 30)". For heart rate, the ground truth was the "PPG signal of the polygraphy system." This implies that the ground truth was derived from a gold-standard PSG (Polysomnography) system, rather than expert interpretation of the device's output alone.

4. Adjudication Method for the Test Set

• The document does not mention any specific adjudication method (e.g., 2+1, 3+1, none) for the test set. Ground truth appears to be derived from the gold standard PSG, rather than expert review of the device's output.

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

• No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not described. The clinical validation focuses on the device's accuracy compared to a polysomnography system, not on assisting human readers.

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

• Yes, the clinical validation study appears to be a standalone performance evaluation. The device (AcuPebble SA100) generates diagnostic indices (AHI, ODI) and heart rate output, and these are compared directly against a polygraphy system, which serves as the ground truth. The role of a human healthcare professional is described as using the results to "assist" in patient evaluation, implying the device provides direct outputs.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for OSA diagnostic indices (AHI, ODI) was established using definitions from the "AASM" (American Academy of Sleep Medicine) for airflow reductions and desaturation criteria (3% and 4%). This indicates comparison against polysomnography (PSG), which is the gold standard for sleep apnea diagnosis. For heart rate, the ground truth was "the heart rate obtained from the PPG signal of the polygraphy system," further confirming PSG as the reference.

8. The Sample Size for the Training Set

• The document does not specify the sample size used for the training set. The clinical validation section only refers to the "150 consecutive evaluation patients" used for the accuracy validation clinical study (i.e., the test set).

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

• The document does not specify how the ground truth for the training set was established, as the training set details are not provided.

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