RespiEvents™ is a software package running on a personal computer that is intended to provide analysis of breathing patterns from RespiTrace technology, aid in identifying and classifying apneas, displaying heart rate changes from electrocardiographic waveforms, logging values from pulse oximetry, and displaying signals from physiologic recording devices such as a body position sensor and impedance pneumograph, in the wake and sleeping states as well as activities of daily living.

Device Description

RespiEvents™ is a software analysis program running on a personal computer. RespiEvents™ presents waveforms collected from RespiTrace™ technology-based RespiEvelts "prosents wavelorm" and RespiTrace PT™ and is intended to provide analysis of:

Breathing patterns from Respitrace™ technology, ● ·
Aid in identifying and classifying apneas, .
Displaying heart rate changes from electrocardiographic waveforms, .
Logging values from pulse oximetry, and .
Displaying signals from physiologic recording devices .
The purpose of RespiEvents™ software is to capture full fidelity Respitrace™ data on a continuous basis, and to provide playback and analysis of the captured data.
The system presents the information from physiologic recording devices such as a body position sensor and impedance pneumograph, in the wake and sleeping states. The system does not present alarms, alarm functions, or alarm management.

AI/ML Overview

The provided document (K012020) describes a Special 510(k) Submission for the RespiEvents™ software, Version 5.2. This submission focuses on modifications to a previously cleared device (RespiEvents™ software, Version 4.2, K001369). The document does not overtly present specific acceptance criteria or a detailed study proving the device meets them in the format usually expected for rigorous performance evaluation.

Instead, the submission emphasizes that the modifications did not change the intended use or the fundamental scientific technology of the device. It relies on nonclinical tests to demonstrate that the new software performs equivalently to the predicate device and that all functions comply with user requirements, safety standards, and performance specifications.

Therefore, many of the requested details about acceptance criteria, clinical studies, sample sizes, ground truth establishment, and expert involvement are not explicitly available in this summary document. The document primarily focuses on verifying the functionality and safety of the software modifications.

Here's an attempt to answer based on the provided text, with significant caveats for missing information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a formal table of acceptance criteria with specific quantitative performance metrics. Instead, the "acceptance criteria" are implied to be that the updated software functions as intended, is in compliance with user requirements, safety standards, and performance specifications, and performs substantially equivalently to the predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Functional Compliance: All functions operate according to user requirements.	The new software has undergone complete verification and validation test scenarios to show that all functions are in compliance with the user requirements. This involved the use of simulated input signals, manual operations, and recordings of actual physiological waveforms. (Specific test results or metrics are not provided.)
Safety Compliance: Adherence to safety standards.	The new software has undergone complete verification and validation test scenarios to show that all functions are in compliance with safety standards. ... When used in accordance with the directions for use, by qualified personnel, RespiEvents™ software, version 5.2, is safe and effective, as indicated, for its intended use. (Specific safety standards or test results are not provided.)
Performance Specification Compliance: Meets defined performance specifications.	The new software has undergone complete verification and validation test scenarios to show that all functions are in compliance with performance specifications. (Specific performance specifications or test results are not provided.)
Substantial Equivalence: Performance is equivalent to the predicate device (RespiEvents™ software, Version 4.2).	The testing of the RespiEvents™ software, version 5.2 demonstrates the performance is substantially equivalent to the predicate device. (This is a summary conclusion; specific comparative data or metrics are not presented.) The modifications were primarily to operate on a different OS (Windows 95/98) and improve the user interface; "No modifications were made to the core software, algorithms, or fundamental scientific technology." This suggests the assumed performance is identical to the predicate.

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

Sample Size: Not explicitly stated. The document mentions "simulated input signals, manual operations and recordings of actual physiological waveforms" but does not give a number of cases or data points used in the nonclinical tests.
Data Provenance: The document does not specify the country of origin for any "actual physiological waveforms" used, nor does it explicitly state if the data was retrospective or prospective. Given the nature of a software update for an existing device, it's likely they used existing or simulated data relevant to the predicate device's use.

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

This information is not provided in the document. The testing described is "verification and validation scenarios." For software that processes physiological signals, "ground truth" might refer to known characteristics of simulated signals or expert interpretations of physiological waveforms. However, the document does not elaborate on how ground truth was established for these nonclinical tests or if any external experts were involved.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the description of "verification and validation scenarios" for a software update, it's more likely that the testing involved comparing software output against expected results or direct observation of functionality, rather than an expert adjudication process typically seen in clinical studies validating diagnostic accuracy.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done (or at least, not reported in this summary). The document explicitly discusses "nonclinical tests" and focuses on substantial equivalence to the predicate device. It does not describe any studies involving human readers or evaluating the improvement with AI assistance (as this is a software update for signal processing, not an AI diagnostic tool in the modern sense).

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

Yes, implicitly. The "nonclinical tests" described, including the use of "simulated input signals" and analysis of "recordings of actual physiological waveforms," represent a form of standalone testing of the software's performance. The software's function is to analyze and present information; its performance in these tasks would be evaluated directly without human interpretation as part of a human-in-the-loop workflow being measured. The focus is on the software's ability to correctly process and display data.

7. The Type of Ground Truth Used

Implicitly, known values for simulated signals and/or established interpretations for actual physiological waveforms. The document mentions "simulated input signals" and "recordings of actual physiological waveforms." For simulated signals, the ground truth would be the known parameters of the simulated data. For actual physiological waveforms, the ground truth would likely be established through established medical guidelines, prior expert interpretation, or consensus derived from the predicate device's accepted performance. No pathology or outcomes data is mentioned.

8. The Sample Size for the Training Set

Not applicable / Not provided. This is a software update for an existing analytical tool, not a new machine learning algorithm that requires a "training set" in the conventional sense. The "core software, algorithms, or fundamental scientific technology" were explicitly not modified. Therefore, there isn't a "training set" for this specific submission. The original predicate device would have been developed based on scientific principles and potentially empirical data, but that's not described here.

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

Not applicable / Not provided. As there is no "training set" for this specific submission due to it being a software update without core algorithm changes, this question is not relevant to the information provided.

Summary

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K012020

Image /page/0/Picture/1 description: The image shows the logo for Non-Invasive Monitoring Systems Inc. The logo features the company name in two lines, with the acronym "Nims" in a bold, stylized font above the full name. The word "Nims" is set against a black background.

Special 510(k) Submission

510(k) Summary APPENDIX G

AUG 2 1 2001

510(k) Summary For Non-Invasive Monitoring Systems, Inc. RespiEvents™ software, Version 5.2

June 24, 2001 DATE THIS SUMMARY WAS PREPARED:

SUBMITTER'S NAME AND ADDRESS:

Non-Invasive Monitoring Systems, Inc. 1840 West Avenue Miami Beach, Florida 33139

CONTACT PERSON:

Allan F. Brack, Chief Executive Officer Telephone: (305) 534-3694 Facsimile: (305) 534-9368

DEVICE NAME:

Proprietary or Trade Name: RespiEvents™ software, Version 5.2 Event data processing software for a PC Common Name: Programmable Diagnostic Computer Classification Name:

PREDICATE DEVICE:

The legally marketed device to which equivalence is claimed is:

RespiEvents™ software, Version 4.2, K001369, cleared on July 26, 2000.

74 DQK * Product Code:
870.1425 * CFR Section:

DEVICE DESCRIPTION:

1840 West Avenue, Miami Beach, FL 33139, USA Tel: 1 305 534 3694 - Fax: 1 305 534 9368 http://www.nims-inc.com - nims@respitrace.com

Non-Invasive Monitoring Systems, Inc. RespiEvents™ v5.2

June 2001 APPENDIX G, page G01

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Breathing patterns from Respitrace™ technology, ● ·
Aid in identifying and classifying apneas, .
Displaying heart rate changes from electrocardiographic waveforms, .
Logging values from pulse oximetry, and .
Displaying signals from physiologic recording devices .

The purpose of RespiEvents™ software is to capture full fidelity Respitrace™ data on a continuous basis, and to provide playback and analysis of the captured data.

The system presents the information from physiologic recording devices such as a body position sensor and impedance pneumograph, in the wake and sleeping states. The system does not present alarms, alarm functions, or alarm management.

INTENDED USE:

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:

This submission is for modifications to the RespiEvents™ software, version 4.2 that was cleared for marketing under Premarket Notification K001369. The RespiEvents™ software, version 5.2 is a modification to the predicate device which does not change the intended use or the fundamental scientific technology.

The RespiEvents™ software has been modified to operate on PC running Microsoft Windows 95 or 98 and presents the user with an ergonomically acceptable typical Windows User Interface. The software also has several re-named traces for greater user clarity. No modifications were made to the core software, algorithms, or fundamental scientific technology.

NONCLINICAL TESTS USED IN DETERMINATION OF SUBSTANTIAL EQUIVALENCE:

The new software has undergone complete verification and validation test scenarios to show that all functions are in compliance with the user requirements, safety standards, and performance specifications. This involved the use of simulated input signals, manual operations and recordings of actual physiological waveforms.

CONCLUSIONS FROM NONCLINICAL TESTING:

The testing of the RespiEvents™ software, version 5.2 demonstrates the performance is substantially equivalent to the predicate device. When used in accordance with the directions for use, by qualified personnel, RespiEvents™ software, version 5.2, is safe and effective, as indicated, for its intended use.

Non-Invasive Monitoring Systems, Inc. RespiEvents™ v5.2

June 2001 APPENDIX G, page G02

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three wavy lines representing its body and wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 1 2001

Mr. Allan F. Brack Chief Executive Officer Non-Invasive Monitoring Systems, Inc. 1840 West Avenue Miami Beach, FL 33139

Re: K012020

Trade Name: RespiEvents™ Software, Version 5.2 Regulation Number: 21 CFR 870.1425 Regulatory Class: II (two) Product Code: 74 DQK Dated: August 3, 2001 Received: August 6, 2001

Dear Mr. Brack:

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 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 regulation (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 regulatory 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 - Mr. Allan F. Brack

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) 594-4645. 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Dank Mella

Tames E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT APPENDIX B

RespiEvents™ software, version 5.2 Indications for Use

510(k) Number:

K012020

Device Name:

RespiEvents™ software, version 5.2

Indications for Use:

This is the same intended use as most recently cleared for the NIMS RespiEvents DOS software, version 4.2, 510(k): K001369, dated July 26, 2000.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use × (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Division of Cardiovascular & Respiratory Devices
510(k) Number K012030

Regulation Number and Section

§ 870.1425 Programmable diagnostic computer.

(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).