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The Polysmith Sleep System, Model NT17593 is intended to measure, amplify, and record physiological signals acquired from a patient for archival in a sleep study. The physiological signals are recorded and conditioned for analysis and display. The data may be analyzed in real-time or offline on dedicated polysomnography software running on a personal computer by a qualified sleep clinician to aid in the diagnosis of Sleep Disorders.

The Polysmith Sleep System, Model NT17593 is intended for use by healthcare professionals within a hospital, laboratory, clinic, or nursing home; or outside of a medical facility under direct supervision of a medical professional.

The Polysmith Sleep System, Model NTT7593 is intended for use on both adults and children only under the direction of a physician or qualified sleep technician.

The Polysmith Sleep System, Model NTT7593 includes automatic detection of some arrhythmias (including some potentially life threatening arrhythmias), however detection of an arrhythmia may be performed with 30 seconds or more delay, and is based on a single ECG lead only.

The Polysmith Sleep System, Model NTI7593, or any accessory, is not intended for the life monitoring of high risk patients, does not include or trigger alarms, and is not intended to be used alone as, or a critical component of,

• an alarm or alarm system:
• · an apnea monitor or apnea monitoring system; or
• · a life monitor or life monitoring system.

The Polysmith Sleep System, Model NT17593 is intended to amplify and record physiologic potentials used for Polysomnography (PSG) or Sleep Studies. The device consists of a compatible amplifier, head box, PC, patient sensors, and may include optional external devices, USB DC Box, and audio/video input devices.

Compatible amplifiers may use commercially available sensors and electrodes, an internal SpO2 module, and internal pressure transducers to collect, digitize, and send physiological signals to the host PC.

The Polysmith software may record from video, speaker and microphone equipment. The Polysmith software may also record auxiliary signals from compatible amplifiers or USB DC Box which allow for data inputs from compatible sources.

Polysmith records and displays the data for online or offline review. Qualified practitioners use the information to score polysomnograms and diagnose Sleep Disorders.

Here's an analysis of the acceptance criteria and study as described in the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

(Note: The document states the new device is "comparable" to the BSM-9100A, which includes the "same algorithm." It does not explicitly list the acceptance criteria values for the BSM-9100A, but rather assumes that comparable performance to a device with a more critical intended use is sufficient.)

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

• Sample Size: Not explicitly stated as a number of patients or recordings. The document refers to the use of standard databases:
  • MIT: The Massachusetts Institute of Technology–Beth Israel Hospital Arrhythmia Database
  • AHA: The American Heart Association Database for Evaluation of Ventricular Arrhythmia Detectors
  • NST: The Noise Stress Test Database
• Data Provenance: The databases (MIT, AHA, NST) are widely recognized cardiological datasets. The document does not specify their country of origin for this particular study, nor whether the data was retrospective or prospective. Given they are established historical databases, they are inherently retrospective.

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

• Not explicitly stated in the provided text. The databases (MIT, AHA, NST) are widely recognized and have ground truths established by clinical experts during their creation. However, the document does not detail how this specific study confirmed ground truth for its testing or the number/qualifications of experts involved in the original ground truth creation of these databases.

4. Adjudication method for the test set:

• Not explicitly stated. Given the use of established databases, the ground truth annotations within these databases would have been created through expert consensus or established protocols, but the specific adjudication method for this particular study is not detailed.

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 with and without AI assistance was not conducted or described. The study focuses solely on the standalone performance of the algorithm against reference databases.

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

• Yes, a standalone algorithm-only performance evaluation was conducted. The tables provided show the "Polysmith Sleep System, NTI7593 (NEW)" performance metrics (Sensitivity, Predictivity, FPR) directly against the reference databases, without any mention of human-in-the-loop interaction. The document states: "The arrhythmia analysis results are to be reviewed by a qualified clinician and are not to serve as results for direct diagnosis or treatment of arrhythmia conditions. The arrhythmia analysis function is only to provide indicators for further investigation," which further reinforces its standalone, assistive role.

7. The type of ground truth used:

• The ground truth used is based on expert consensus annotations embedded within the standard, publicly available databases:
  • MIT: The Massachusetts Institute of Technology–Beth Beth Israel Hospital Arrhythmia Database
  • AHA: The American Heart Association Database for Evaluation of Ventricular Arrhythmia Detectors
  • NST: The Noise Stress Test Database

8. The sample size for the training set:

• Not explicitly stated. The document indicates that the "newly integrated algorithm is the same algorithm implemented in the reference device, BSM-9100A (K082785)," implying this algorithm was likely trained or developed previously, possibly using portions of these or other similar databases. However, the training set size specific to this submission for the Polysmith device is not provided.

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

• Not explicitly stated for this submission. Since the algorithm is adopted from the BSM-9100A, the ground truth for its original training would have been established during the development of that device or the algorithm itself, likely through expert annotation of ECG recordings, similar to how the ground truth for the testing databases was established. The document doesn't provide details on the development of this algorithm's ground truth.

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