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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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The device is intended to measure, amplify, and record physiological signals acquired from a patient for archival in a sleep study. The physiological signals 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 device 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 device is intended for use on both adults and children only under the direction of a physician or qualified sleep technician.

The device or any accessory, does not include alarms, and is not intended to be used as a critical component of an alarm system.

The device or any accessory, is not to be used alone as an apnea monitor or as a component in an apnea monitoring system.

The device or any accessory, is not to be used alone as a life support device or as a critical component of a life support system.

The Polysmith Sleep System, Model NTI6600 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 a breakdown of the acceptance criteria and study details for the Polysmith Sleep System, Model NTI6600, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" as separate performance thresholds the device must meet. Instead, it presents the "Automated Analysis Agreement" as the device's performance, which is then compared against "Average Human Scoring Agreement." Assuming the implied acceptance is substantial equivalence to human performance for these metrics, the table is structured as follows:

In the "Additional Sleep Staging Analysis," which seems to be a more detailed analysis, the total agreement for automated scoring against consensus human scoring is:

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

• Sample Size (Automated Analysis): 8,053 recorded epochs, of which 7,606 were scored.
• Sample Size (Additional Sleep Staging Analysis): 20 sleep studies.
• Data Provenance: The studies were chosen at random from existing sleep studies of acceptable signal quality from accredited labs. For the automated analysis, studies were chosen at random from a sleep lab independent of Neurotronics. The document does not specify the country of origin, but given the FDA submission, it's likely US-based or compliant with US standards. The data is retrospective.

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

• Automated Analysis: Two expert scorers from different organizations. Each is a registered sleep clinician with at least 5 years' experience scoring sleep records.
• Additional Sleep Staging Analysis: Three independent scorers. Each is a registered sleep specialist with at least five years' experience in the field. Each had some prior experience using Polysmith to manually score studies.

4. Adjudication Method for the Test Set

• Automated Analysis: The document states "The human scoring was completed by two expert scorers." It then calculates "Average Human Scoring Agreement," implying an average of their individual scores or comparison. It doesn't explicitly describe an adjudication process for disagreements between the two human scorers to establish a single ground truth for direct comparison with the automated analysis. Instead, it compares the automated system's performance against this average human agreement, and also compares the two human scorers' agreement with each other.
• Additional Sleep Staging Analysis: This section explicitly used a majority method (2/3 majority-rule) to establish the "true sleep staging (consensus)." Epochs where there was no agreement among the human scorers were discarded (non-consensus).

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

• No, a direct MRMC comparative effectiveness study "with AI vs without AI assistance" was not explicitly described in the context of improving human reader performance. The study focused on the standalone performance of the automated analysis system compared to human scoring. While humans scored the data, the goal was to assess the device's accuracy relative to human experts, not to measure the improvement in human performance aided by the device.

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

• Yes, a standalone performance analysis was conducted. The "Automated Analysis Agreement" and the "Results" section for "Additional Sleep Staging Analysis" directly report the performance of the algorithm itself against human expert assessments (either average or consensus). The scorers for the "Additional Sleep Staging Analysis" were explicitly provided with a version of Polysmith that "did not have any automated analysis capability," emphasizing that the human scoring served purely as ground truth.

7. The Type of Ground Truth Used

• Expert Consensus / Expert Scoring: For both analyses, the ground truth was established by human expert scorers. In the "Automated Analysis," it's based on two expert scorings. In the "Additional Sleep Staging Analysis," it's based on a 2/3 majority rule consensus of three expert scorers.

8. The Sample Size for the Training Set

• Not provided. The document states, "The studies used for this testing were not used to train the algorithm," but it does not specify the size or characteristics of the training set used for the algorithm's development.

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

• Not provided. The document focuses solely on the ground truth for the test sets and explicitly states the test sets were not used for training. Information on how the training data's ground truth was established is absent.

Ask a specific question about this device

The device 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.

This device, or any accessory, is not to be used alone as an apnea monitor or as a component in an apnea monitoring system.

This device, or any accessory, is not to be used alone as a life support device or as a critical component of a life support system.

This device is intended for use on both adults and children only under the direction of a physician or qualified sleep technician.

The device is intended to amplify and record physiologic potentials used for Polysomnography (PSG) or Sleep Studies. The bio-potentials are transferred to Polysmith polysomnography software running on a personal computer. Qualified practitioners use the information to score Polysomnograms and diagnose Sleep Disorders. The device is intended for use on both adults and children only under the direction of a physician or qualified sleep technician.

This 510(k) summary for the Polysmith Sleep System (K062943) focuses on its substantial equivalence to predicate devices based on technological characteristics, safety, and performance standards, rather than clinical performance acceptance criteria based on a specific study. Therefore, much of the requested information regarding performance metrics, sample sizes, expert involvement, and ground truth types is not present in the provided document.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide specific quantitative acceptance criteria related to a device's diagnostic performance (e.g., sensitivity, specificity for detecting sleep disorders) or a study reporting such performance. Instead, the "acceptance criteria" are implied through compliance with various safety and industrial standards.

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

The document does not describe a clinical test set with a specific sample size. The testing described focuses on device safety, electrical performance, and compliance with standards, rather than a clinical validation study involving patient data.

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

Not applicable, as no clinical test set requiring expert-established ground truth is described.

4. Adjudication method for the test set

Not applicable, for the same reason as above.

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

Not applicable. This device is described as an amplifier and recorder of physiological signals for use in Polysomnography (PSG) by a qualified sleep clinician to aid in diagnosis. It is not an AI-driven diagnostic tool intended to supercede or augment human reading in the way an MRMC study would evaluate. It is a data acquisition device.

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

Not applicable. The device itself is not an algorithm performing diagnosis. It's a data capture system. Its "performance" is in accurately acquiring and conditioning physiological signals, not in interpreting them. That interpretation is explicitly stated to be done by a "qualified sleep clinician."

7. The type of ground truth used

For the safety and performance testing described, the "ground truth" would be the established requirements and limits set by the various industrial standards (e.g., maximum leakage current, electromagnetic interference limits, stress test resilience, accurate signal amplification).

8. The sample size for the training set

Not applicable. This document describes a medical device for data acquisition, not a machine learning model that requires a training set of data.

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

Not applicable, for the same reason as above.

Summary of the Study Proving the Device Meets Acceptance Criteria:

The provided 510(k) summary does not detail a single "study" in the sense of a clinical performance trial. Instead, it describes a comprehensive set of engineering, safety, and quality assurance activities that collectively demonstrate the device's adherence to its specifications and relevant regulatory standards.

The "study" comprises:

• Voluntary Compliance with Industrial Standards: The device underwent testing to ensure compliance with a range of international and national standards for medical electrical equipment (e.g., UL 60601-1, EN 60601-1-4, IEC 60601-2-26, CAN/CSA 22.2 No 601.1 M90, CISPR 11). These standards cover aspects like electrical safety, electromagnetic compatibility, and specific requirements for EEG/PSG devices.
• Quality System Compliance: The manufacturer's adherence to 21 CFR Part 820 (Quality System Regulation) and CAN/CSA-ISO13485:2003 (Medical Devices Quality Management Systems) ensures that the device was designed, manufactured, and tested under a robust quality management framework.
• Verification and Validation Activities: The device was "verified and validated according to the product specifications." This included:
  • Environmental and mechanical stress testing.
  • Electromagnetic immunity and emissions testing.
  • Medical device safety testing.
  • Software verification and validation according to its functionality.

The overall conclusion is that "The test results confirm that the device is in accordance with its specifications," thereby meeting the implicit acceptance criteria set by these standards and internal product requirements for a device intended to measure, amplify, and record physiological signals for Polysomnography. The device's substantial equivalence to predicates was based on similar indications for use, intended use, and technological characteristics, as well as adherence to these safety and performance standards.

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