This device is intended for use in a sleep laboratory for the acqusition, display, storage, and analysis of polysomnography data obtained from a polygraph with IRIG compatible outputs. It's purpose is to assist a qualified sleep practitioner in the diagnosis of sleep disorders in patients 13 years of age and older. To use the analysis capabilities, there must be at least two EEG channels, two rapid eye movement channels (electroocculograms), a chin EMG (electromyogram) channel, a leg EMG channel, an airflow channel, two respiratory effort channels, and an oxygen desaturation channel. This device is to be used only under the direction of a physician or qualified sleep technician.

Device Description

POLYSMITH is a polysomnography data acquisition, analysis, display, and storage system, which accepts polysomnography data and allows the operator to view the data on the computer monitor. The device also automatically analyzes the data to determine the sleep stage for each thirty-second epoch and to detect apneas and hypopneas. The hardware consists of a personal computer with an enclosed analog-todigital converter and a connector block for conveniently connecting the input data leads. The device is designed to input data from a polygraph that has IRIG-compatible outputs. To use all analysis capabilities, there should be at least two EEG channels, two rapid eye movement channels (electro-occulograms), a chin EMG (electromyogram), a leg EMG, an ECG, airflow, two respiratory effort channels and an oxygen saturation channel. The software, which is running under the NT operating system, will display all of the acquired data on the computer screen for reviewing and operator editing. The automated analysis feature, designed tor subjects 13 years of age and older, generates multiple reports, including a sleep stage summary, describing the sleep data.

AI/ML Overview

The POLYSMITH study evaluated the device's performance by comparing it to a predicate device, the Oxford SAC system, and also to human scoring.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state numerical acceptance criteria (e.g., a specific percentage agreement or correlation coefficient that the device needed to achieve to be deemed acceptable). Instead, the assessment is framed around demonstrating "substantial equivalence" to a predicate device and comparison to human scoring. Therefore, the "reported device performance" is the finding of substantial equivalence based on these comparisons.

Acceptance Criteria (Implied)	Reported Device Performance
Substantial equivalence to predicate device (Oxford SAC system) for polysomnography data analysis	The device performance was compared with that of the predicate device, the Oxford SAC system, by analyzing six all-night sleep records. While no specific metrics are given, the FDA's 510(k) clearance indicates that this comparison supported a finding of substantial equivalence.
Agreement with human scoring for sleep staging, apnea, and hypopnea detection	The device performance was compared to human scoring using two all-night sleep recordings from patients with severe sleep apnea. Again, no specific metrics are given for "agreement" but the overall clearance implies acceptable performance relative to human scoring.

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

Test Set for Predicate Device Comparison:
- Sample Size: Six all-night sleep records.
- Data Provenance: Recorded to optical disk at the Henry Ford Sleep Diagnostic Center (HFSDC) in Detroit, Michigan. The text states these were "all-night sleep records," implying retrospective data.
Test Set for Human Scoring Comparison:
- Sample Size: Two all-night sleep recordings.
- Data Provenance: From the Henry Ford Sleep Diagnostic Center (HFSDC), of patients with severe sleep apnea. These were "all-night sleep recordings," implying retrospective data.

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

The document does not specify the exact number of human experts who scored the two all-night sleep recordings used for comparison. It simply states "human scoring." It also does not provide specific qualifications (e.g., "radiologist with 10 years of experience"). However, for polysomnography data, it is generally understood that such scoring would be performed by qualified sleep technicians or physicians specializing in sleep medicine.

4. Adjudication Method for the Test Set

The document does not detail any specific adjudication method (e.g., 2+1, 3+1, none) for the human scoring used as ground truth. It refers to "human scoring" as a singular entity.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The comparison was against human scoring, but the framework for an MRMC study with multiple readers and analysis of improvement with AI assistance is not present in the provided text.

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

Yes, the studies described represent standalone performance of the POLYSMITH device. The comparisons were made directly between the device's output and either a predicate device's output or human scoring, without human-in-the-loop interaction for the POLYSMITH during these evaluations. The device's function is to "automatically analyzes the data to determine the sleep stage for each thirty-second epoch and to detect apneas and hypopneas."

7. The Type of Ground Truth Used

For the predicate device comparison: The predicate device's (Oxford SAC system) analysis results served as a form of reference or "ground truth" for demonstrating substantial equivalence.
For the human scoring comparison: "Human scoring" served as the ground truth. This is a form of expert consensus/opinion, where human experts (presumably qualified sleep professionals) interpret the raw polysomnography data to determine sleep stages and detect events.

8. The Sample Size for the Training Set

The document does not provide any information about the sample size used for the training set. It focuses solely on the performance evaluation using test data.

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

The document does not provide any information on how the ground truth for any potential training set was established.

Summary

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411005

Nov 1 2 1997

2. 510 (K) Summary

Applicant: Neurotronics Incorporated 20825 NE 132nd Ave. Route 1 Box 543 Waldo, FL 32694

Contact person: Jack R. Smith, Ph.D. 352-468-1006 Fax: 352-468-1006 e-mail: smith@neurotronics.com

Device Name: POLYSMITH

SUBSTANTIAL EQUIVALENCE

This new system, the POLYSMITH, is essentially equivalent, with the same intended use, to the Microtronics SAC system. same individual (Dr. Jack R. Smith) designed both The On October 6, 1986, the FDA notified Microtronics systems. K862527A) that their sleep-analyzing computer was (Re: determined to be substantially equivalent to devices in interstate commerce prior to May 28, 1976. Software for the processing of heart rate and respiration signals was subsequently added (FDA Ref. K863124). Microtronics was subsequently sold to Oxford Medical Instruments, and the Microtronics system is now known as the Oxford SAC system.

Device Description

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Intended Use

The device is intended for use in a sleep laboratory for the acquisition, display, storage, and analysis of polysomnography data from a polygraph with IRIG compatible outputs. The analysis features of the system are designed for subjects 13 years of age and older.

Warning:

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The POLYSMITH software derives a description of a night's sleep from raw polysomnography data presented to the system. It is possible for the summary data to be incorrect for reasons including bad or missing polysomnography data, power failure, inaccurate calibration, and clinical data, to which the system has not been exposed. The POLYSMITH maintains all of the raw data. All summary data should be verified by examining the raw data on the computer monitor. The data can be viewed with the same resolution as a 10mm/sec. polygraph recording by viewing the data in the 10-second screen display mode. Since some of the sleep-staging criteria are based on specified amplitude levels, the EEG and EOG signals must be calibrated for accurate sleep It is recommended that a signal with known staging. waveform characteristics, such as a calibration signal, be included at the beginning or end of the recording as verification that the calibration was done.

Assessment of Performance Data

The device performance was compared with that of a predicate device, the Oxford SAC system. The system performance was evaluated by analyzing six all-night sleep records recorded to optical disk at the Henry Ford Sleep Diagnostic Center (HFSDC) in Detroit, Michigan and comparing the results obtained with the predicate device. In addition, the device performance was compared to human scoring, using two allnight sleep recordings, from the HFSDC, of patients with severe sleep apnea. Each recording contains two EEG channels (central and occipital), two eye channels, a chin EMG channel, a leg EMG channel, an airflow channel, and one respiratory effort channel.

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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized human figure with three overlapping profiles, representing the department's focus on people and health. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure. The logo is simple and recognizable, conveying the department's mission and purpose.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 2 1997

Jack R. Smith, Ph.D. Neurotronics Incorporated 4609 NW 6th Street, B-5 Gainesville, Florida 32609

Re : K971803 Polysmith Regulatory Class: II (two) Product Code: 73 MNR Dated: August 18, 1997 Received: August 20, 1997

Dear Dr. Smith:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Jack R. Smith, Ph.D.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1_of_ 1

510(k) Number (if known): K971803

Device Name: Polysmith

Indications For Use:

This device is intended for use in a sleep laboratory for the acqusition, display, storage, and analysis of polysomnography data obtained from a polygraph with IRIG compatible outputs. It's purpose is to assist a qualified sleep practitioner in the diagnosis of sleep disorders in patients 1.3 years of age and older. To use the analysis capabilities, there must be at least two EEG channels, two rapid eye movement channels (electroocculograms), a chin EMG (electromyogram) channel, a leg EMG channel, an airflow channel, two respiratory effort channels, and an oxygen desaturation channel. This device is to be used only under the direction of a physician or qualified sleep technician.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Adol A. Ciark.

(Division Sign-Off) (Division Sign-Olt)
Division of Cardiovascular, Respiratory, Division ological Devices

510(k) Number _

Prescription Use_V (Par 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 868.2375 Breathing frequency monitor.

(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).