Somnolyzer 24X7 is intended to be used for analysis (automatic scoring and manual rescoring), display, redisplay (retrieve), summarize, reports generation and networking of data received from monitoring devices typically used to evaluate sleep and respiratory related sleep disorders.

This device is to be used under the supervision of a physician.

Device Description

Somnolyzer 24X7 is a software system for automatic analysis of sleep, respiratory and movement information recorded during sleep studies. It processes information recorded during sleep by electrodes and sensors attached to the body. It generates reports that include quantitative sleep, breathing and motion parameters, used to evaluate sleep and respiratory-related disorders.

AI/ML Overview

The provided text is a 510(k) summary for the Somnolyzer® 24X7. While it states that "Clinical performance testing was conducted" and mentions "Performance Data," it does not provide specific details regarding acceptance criteria, the study design, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot populate the table or answer most of your detailed questions based solely on the provided text. The document focuses on the regulatory submission, intended use, and substantial equivalence to a predicate device, rather than a detailed report of the device's performance study.

Here's what I can extract and what is missing:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified in the provided text	Not specified in the provided text

Study Details (Based on available information)

1. Sample size used for the test set and the data provenance:
* Test Set Sample Size: Not specified.
* Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Number of Experts: Not specified.
* Qualifications of Experts: Not specified.

3. Adjudication method for the test set:
* Not specified.

4. 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 specified. The document states the device is an "aid for the diagnosis" and "automatic scoring and manual rescoring," implying human oversight, but doesn't detail a comparative effectiveness study with and without AI assistance for human readers.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* The device performs "automatic analysis of sleep, respiratory and movement information" and "automatic scoring," implying standalone algorithmic function. However, the document also states it's an "aid" and allows "manual rescoring," and is to be "used under the supervision of a physician." A dedicated "standalone performance" study result or methodology is not detailed.

6. The type of ground truth used:
* Not specified. (e.g., expert consensus, pathology, outcomes data, etc.)

7. The sample size for the training set:
* Not specified.

8. How the ground truth for the training set was established:
* Not specified.

Conclusion:
The provided 510(k) summary indicates that clinical performance testing was conducted for the Somnolyzer® 24X7, but it does not include the detailed results, acceptance criteria, or specifics of the study methodology required to answer the questions comprehensively. Such details are typically found in the full 510(k) submission, particularly in performance data sections that are often proprietary and not fully disclosed in the public summary.

Summary

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K083620

6 2009 MAR

510 (k) SUMMARY

The Siesta Group Somnolyzer® 24X7

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared:

Applicant:

The Siesta Group North America, Inc. 5475 Airport Terminal Road Salisbury, MD 21804 Telephone: (443) 944-8189 Facsimile: (443) 944-8191

Contact Person:

Zvi Ladin, PhD. Principal Boston MedTech Advisors, Inc. 990 Washington Street Suite #204 Dedham, MA 02026 Telephone: (781) 407 0900 x104 Facsimile: (781) 407 0901 Email: zladin@bmtadvisors.com

Date Prepared:

December 4, 2008

Name of Device and Name/Address of Sponsor

Trade/Proprietary Name: Somnolyzer® 24X7 Common Name: Sleep Analysis System

Classification Name:	Ventilatory Effort Recorder
Classification Panel:	Anesthesiology and Respiratory Devices Branch
C.F.R. Section:	21 C.F.R. § 868.2375

Manufacturing Facility:

The Siesta Group, GmbH Schlosshoferstrasse 11/3 Vienna 1210 Austria

Predicate Devices

Morpheus TM 1, Automated Sleep Study Scoring and Data System by Widemed, Ltd. cleared under 510(k) #K022506.

The Siesta Group - Somnolyzer 24x7 510(k) Submission Section 6 - 510 (k) Summary

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© 2008 The Siesta Group

Intended Use / Indications for Use

Somnolyzer 24X7 is a computer program (software) intended for use as an aid for the diagnosis of sleep and respiratory disorders.

This device is to be used under the supervision of a physician.

Technological Characteristics

Performance Data

Clinical performance testing was conducted.

Substantial Equivalence

Somnolyzer 24X7 has the same intended use and indications for use, principles of operation and performance characteristics as the predicate device and is therefore substantially equivalent to the predicate device.

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Image /page/2/Picture/2 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

& 2009 MAR

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

The Siesta Group North America Incorporated C/o Zvi Ladin, Ph.D Principal Boston MedTech Advisors, Incorporated 990 Washington Street, Suite 204 Dedham, Massachusetts 02026

Re: K083620

Trade/Device Name: Somnolyzer® 24X7 Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: December 5, 2009 Received: December 8, 2009

Dear Dr. Ladin:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Dr. Ladin

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Suite Y. Michaels, M.D.

Ginette Y. Michaud. M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name:

Somnolyzer® 24X7

Indications For Use:

Somnolyzer 24X7 is a computer program (software) intended for use as an aid for the diagnosis of sleep and respiratory disorders.

Somnolyzer 24X7 is intended to be used for analysis (automatic scoring and manual re-scoring), display, redisplay (retrieve), summarize, reports generation and networking of data received from monitoring devices typically used to evaluate sleep and respiratory related sleep disorders.

This device is to be used under the supervision of a physician.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Cunne

ﻧ ﺍﻟﺮﺍﺋﺮ . ﺍﻟﻘﺮﺁﻥ Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

Page 1 of

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).