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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

2. Sample Sizes and Data Provenance

• SpO2 and Pulse Rate: 12 subjects with varying skin tone. The study was performed by an independent testing lab. (Country of origin not specified, but the device manufacturer is UK-based.) Data appears to be prospective clinical validation.
• Respiratory Rate:
  • Study 1: 31 healthy subjects. Conducted under laboratory conditions. (Country of origin not specified, but the device manufacturer is UK-based.) Data appears to be prospective clinical validation.
  • Study 2: 150 patients referred for OSA diagnosis. Conducted during natural sleep. Royal Free London Hospital NHS Foundation Trust (UK). Data appears to be prospective clinical validation, with a trial registration number (NCT03544086).
• Respiratory Effort: 150 patients referred for OSA diagnosis. Conducted during natural sleep. Royal Free London Hospital NHS Foundation Trust (UK). Data appears to be prospective clinical validation, with a trial registration number (NCT03544086).
• Body Position Detection:
  • Study 1: 17 volunteers. Conducted under laboratory conditions. (Country of origin not specified, but the device manufacturer is UK-based.) Data appears to be prospective clinical validation.
  • Study 2: 60 patients referred for OSA diagnosis. Conducted during natural sleep. Virgen Macarena Hospital, Spain. Data appears to be prospective clinical validation, with a trial registration number (NCT04028011).

3. Number of Experts and Qualifications for Ground Truth (Test Set)

• Respiratory Effort: "manual scoring by two clinicians". Qualifications of the clinicians are not explicitly stated (e.g., specific specialties or years of experience), but they are described as "clinicians." For the automatic scoring comparison, an FDA-cleared device (Embla RemLogic, K162140) served as a reference.
• Other parameters (SpO2, Pulse Rate, Respiratory Rate, Body Position): The ground truth relied on established reference devices and standards (e.g., functional simulator, capnography, RIP bands, ISO 80601-2-61:2017), rather than expert consensus on individual cases for the test set. For OSA diagnostic indexes, the performance is inherited from the predicate device, so the ground truth setup for that specific parameter is not detailed for AcuPebble Ox200 in this document.

4. Adjudication Method (Test Set)

• Respiratory Effort: Manual scoring was done by "two clinicians," and the agreement between them or a further adjudication process (e.g., 2+1) is not specified beyond "the agreement in distinguishing." However, a primary comparison for superiority was made against an FDA-cleared device's automatic scoring (Embla RemLogic).
• For other parameters, adjudication is not applicable as ground truth was established by reference devices/standards.

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

No MRMC comparative effectiveness study is explicitly mentioned as having been performed to assess how much human readers improve with or without AI assistance for this device. The evaluations focus on the standalone performance of the device's outputs.

6. Standalone Performance (Algorithm Only)

Yes, standalone performance was done for several new parameters:

• SpO2 and Pulse Rate Output: Validated as per ISO 80601-2-61:2017 using an independent testing lab.
• Respiratory Rate: Validated in two studies against capnography and respiratory inductance plethysmography (RIP) bands.
• Respiratory Effort Detection: Validated against RIP bands and compared to automatic scoring of an FDA-cleared device.
• Body Position Detection: Validated in laboratory conditions and during natural sleep.
• The OSA diagnostic indexes (AHI) are explicitly stated to be "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." Their performance is inherited from the predicate.

7. Type of Ground Truth Used (Test Set)

The ground truth varied by parameter:

• SpO2 and Pulse Rate: Reference pulse oximetry and functional simulator, following ISO 80601-2-61:2017 standards for accuracy assessment.
• Respiratory Rate: Capnography (K150272) in a lab setting, and chest and abdomen respiratory effort bands of Embletta MPR Sleep Data Recording System (K122516) during natural sleep.
• Respiratory Effort: Manual scoring by two clinicians based on RIP bands (Respiratory Inductance Plethysmography) and automatic scoring from the FDA-cleared device Embla RemLogic (K162140).
• Body Position Detection: Presumed to be observational ground truth established by study personnel in lab, and potentially manually annotated based on video/observation in natural sleep studies, or potentially using other reference accelerometers. The document does not specify the exact method for ground truth for body posture.

8. Sample Size for the Training Set

The document does not explicitly state the sample size used for the training set for any of the algorithms. It focuses on the validation studies.

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

As the training set information is not provided, the method for establishing its ground truth is also not detailed in this document. The document primarily describes the validation of the device's performance against established clinical standards and reference devices.

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