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The ACCUSOM device is indicated for use in the diagnostic evaluation of adults with possible sleep apnea. The ACCUSOM can score obstructive apneas, which includes mixed apneas. The ACCUSOM device is intended for use in the home and clinic setting.

The ACCUSOM device is a battery and line powered ventilatory effort recorder. The ACCUSOM device is indicated for use in the diagnostic evaluation of adults with possible sleep apnea. The ACCUSOM can score obstructive apneas, which includes mixed apneas. The ACCUSOM device is intended for use in the home and clinic setting. As with the predicate Silent Night V device, the ACCUSOM is supplied to patients only upon physician order for use in Home Sleep Testing. The ACCUSOM device is positioned on the patient's arm. The sensors are positioned on the patient's body and connect into the ACCUSOM device. The ACCUSOM contains identical functions and the same algorithm as the predicate Silent Night V device (K000253). The indications for use of the ACCUSOM are identical to the Silent Night V (K000253). The ACCUSOM device provides physiological measurements that are identical to the predicate Silent Night V device including: Arterial oxygen saturation level (SpO2)) (Sampled every 5 (+/- 0.2 . seconds)), Pulse Rate (Sampled every 5 (+/- 0.2 seconds)), Respiration effort signal (Sampled every 100 (+/- 0.5 mseconds)), Airflow waveform corrected for ambient room noise (Sampled at 5.2083 kHz, . accurate to 100ppm over the operating temperature range). Throughout a typical sleep study, sleep disordered breathing information and statistics are stored into the ACCUSOM memory. The stored information includes time and duration of apneas and hypopneas, blood oxygen saturation levels, pulse rate, respiratory effort level, sound intensity level, epoch numbers, and paused time intervals. The new ACCUSOM device can retain three 8.5-hour sleep studies. Existing software retrieves, scores, displays and prints the collected data on a personal computer platform. A summary report and event log can be provided to the physician to view the sleep data. The ACCUSOM is a battery-powered device with cables that attach to a nasal sensor, to a respiratory effort sensor, and to a blood oxygen saturation sensor (SpO2). The ACCUSOM contains visual and audible sensor status indicators for the patient's convenience. At the end of each night of testing, the sensors are removed and the ACCUSOM is plugged into a wall outlet to recharge and to upload the previous night's data using the cellular network to NovaSom, Inc. for report preparation. If the cellular network is insufficient in the patient's residence, the ACCUSOM data will be downloaded using the traditional RS232 cable connection upon receipt at NovaSom, Inc.

The provided document is a 510(k) summary for the ACCUSOM Ventilatory Effort Recorder, which is a device for diagnosing sleep apnea. It is a submission for a new device claiming substantial equivalence to a predicate device (Silent Night V, K000253).

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for the ACCUSOM device's performance, nor does it provide a direct table of reported performance against such criteria.

Instead, the submission states that the ACCUSOM device is substantially equivalent to the predicate Silent Night V. The core argument for this equivalence is that the ACCUSOM contains identical functions and the same algorithm as the predicate device.

Therefore, the "acceptance criteria" appear to be implicit: the ACCUSOM must perform at least as well as the predicate device, the Silent Night V. The "reported device performance" for the ACCUSOM is not presented as new performance data but rather as being equivalent to the Silent Night V due to the identical algorithm.

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

• Test Set Sample Size: Not applicable/Not stated for the ACCUSOM device. The document explicitly states: "Because the new ACCUSOM device utilizes the same algorithm as the predicate Silent Night V device, no additional clinical testing has been performed." The clinical studies referenced are for the predicate device, Silent Night V (K000253), found on pages 251-275 of that submission. This document does not provide details about the sample size of those predicate studies.
• Data Provenance: Not stated for the ACCUSOM as no new clinical studies were performed. For the predicate, while clinical studies are mentioned, their details (country of origin, retrospective/prospective) are not included in this document.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable/Not stated for the ACCUSOM device. As no new clinical testing was performed for the ACCUSOM, no experts were used to establish ground truth specifically for this device.
• Qualifications of Experts: Not stated. Any expert information would have been associated with the predicate device's original studies, which are not detailed here.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/Not stated for the ACCUSOM device. Since no new clinical testing was performed for the ACCUSOM itself, no adjudication method was used for its test set.

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

• MRMC Study: No. The document does not mention any MRMC study. The focus is on the device's inherent ability to score obstructive apneas, not on how human readers interact with or are assisted by the device.

6. Standalone Performance Study (Algorithm Only)

• Standalone Performance Study: Yes, implicitly. The claim that the ACCUSOM "contains identical functions and the same algorithm as the predicate Silent Night V device" means that the algorithm's performance is considered to be the same as the predicate. The predicate device's clearance (K000253) would have involved assessing its algorithm's standalone performance in scoring sleep apnea events. This document, however, does not provide performance metrics for the algorithm itself (e.g., sensitivity, specificity, accuracy).

7. Type of Ground Truth Used

• Type of Ground Truth: Not explicitly stated in this document. For diagnosis of sleep apnea, ground truth is typically established by Polysomnography (PSG) scored by a sleep expert. Given the device's function, it is highly likely that the predicate device's clinical studies used expert-scored PSG as the ground truth, but this document does not confirm it.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable/Not stated. The document states the ACCUSOM uses the "same algorithm" as the predicate device. Therefore, any "training" of the algorithm would have occurred for the predicate. This document does not provide information on the training set for the predicate's algorithm.

9. How Ground Truth for the Training Set was Established

• Ground Truth Establishment for Training Set: Not applicable/Not stated. As mentioned above, no new algorithm training occurred for the ACCUSOM, and details for the predicate's algorithm development are not provided here.

In summary:

The core of this 510(k) submission for the ACCUSOM device relies on its substantial equivalence to a previously cleared predicate device (Silent Night V). The argument for equivalence is based on the ACCUSOM having the identical algorithm and functions as the predicate. Consequently, no new clinical studies, performance criteria, or ground truth establishment processes were undertaken for the ACCUSOM device itself, as its performance is assumed to be equivalent to the predicate. The document points to the predicate's 510(k) submission for any clinical study details.

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