The Oro-Facial Myographic Measurement Instrument is intended as a diagnostic aid for the quantitative evaluation of oro-facial muscle strength. It is indicated for use in the oro-facial cavity.

Device Description

The Oro-Facial Myographic Measurement Instrument (OMMI™) is a myographic measurement method for direct strength measurement of the oro-facial muscles.

AI/ML Overview

The provided text describes the 510(k) submission for the Oro-Facial Myographic Measurement Instrument (OMMI™) and focuses on demonstrating substantial equivalence to a predicate device. It does not contain information about specific acceptance criteria, a detailed study proving performance against those criteria, or the methodology typically associated with evaluating AI/algorithm-based medical devices (such as sample sizes for test/training sets, ground truth establishment, or expert adjudication).

Therefore, many of the requested fields cannot be directly extracted or inferred from the provided document.

Here's a breakdown based on the available information:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated in the document. The submission focuses on demonstrating substantial equivalence to a predicate device rather than meeting pre-defined performance metrics for the OMMI™ itself.	Bench testing (Pressure Validation) and biocompatibility evaluation were performed. The results are reported to "support the substantial equivalence claims" and "effectively demonstrate the OMMI's substantial equivalence to the predicate device." Specific performance values (e.g., accuracy, precision) are not provided.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified. The document mentions "bench testing (Pressure Validation)" but does not provide details on the number of samples or measurements taken.
Data Provenance: Not specified. The nature of "bench testing" suggests laboratory-based data, but geographical origin or whether it was retrospective/prospective is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The "ground truth" for a myographic measurement instrument's bench testing would typically involve calibrated instruments for pressure validation, not expert interpretation of outputs. No human experts are mentioned for ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are relevant for subjective interpretations, often in image analysis. For bench testing of a measurement device, the comparison would be against a known standard or calibrated reference, not through expert adjudication.

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 study is not mentioned. This type of study is relevant for AI-assisted diagnostic tools and involves human readers evaluating cases. The OMMI™ is described as a direct measurement instrument, not an AI-based diagnostic aid that would assist human readers in interpreting complex data.

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

The OMMI™ is a physical myographic measurement instrument. It is not an algorithm or AI product. Its performance would inherently be "standalone" in the sense that it provides measurements directly, without necessarily a human-in-the-loop interpreting algorithm output. However, this question as phrased is typically for software-as-a-medical-device (SaMD) or AI devices. The device's performance was evaluated through "bench testing (Pressure Validation)."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For "Pressure Validation" bench testing, the ground truth would likely be established using calibrated reference instruments or known physical standards for pressure. This is an objective, instrumental ground truth, not based on expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Not applicable. The OMMI™ is a physical measurement device and does not involve a "training set" in the context of machine learning or AI models.

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

Not applicable. As there is no training set for this type of device, ground truth establishment for a training set is irrelevant.

Summary

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K980363

APR 1 6 1998 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

CONTACT PERSON:

Ronald E. Tura

P.O. Box 1082

Alamo, CA 94507

DEVICE NAME:

Oro-Facial Myographic Measurement Instrument (OMMI™) Class II

DEVICE DESCRIPTION:

The Oro-Facial Myographic Measurement Instrument (OMMI™) is a myographic measurement method for direct strength measurement of the oro-facial muscles.

INDICATIONS FOR USE:

The Oro-Facial Myographic Measurement Instrument is intended as a diagnostic aid for the quantitative evaluation of oro-facial muscle strength.

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PREDICATE DEVICE:

John Chatillon & Sons, Inc. Dynamometer (K964685).

TESTING in SUPPORT of SUBSTANTIAL EQUIVALENCE DETERMINATION:

The results of bench testing (Pressure Validation) and biocompatibility evaluation support the substantial equivalence claims of the OMMI™ for its intended use in the oro-facial cavity. Results of the test, in conjunction with the substantial equivalence claims as outlined in the premarket notification, effectively demonstrate the OMMI's substantial equivalence to the predicate device.

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SUBSTANTIAL EQUIVALENCE CONCLUSIONS:

Substantial equivalence is based on the fact that the Oro-Facial Myographic Measurement Instrument has the same intended use, although different indications, and similar technological characteristics as the predicate device. In instances where the technological characteristics are different, it has been demonstrated that there are no new questions raised regarding safety or efficacy of the Oro-Facial Myographic Measurement Instrument. Therefore, it can be concluded that the Oro-Facial Myographic Measurement Instrument is substantially equivalent to the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three abstract human figures. The figures are arranged in a way that suggests movement or progress. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 6 1998

Mr. Ronald E. Tura President OROFACIAL DYNAMICS P.O. Box 1082 Alamo, California 94507

Re: K980363 Oro-Facial Myographic Measurement Instrument (OMMI™) Requlatory Class: II Product Code: LBB Dated: January 23, 1998 January 29, 1998 Received:

Dear Mr. Tura:

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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with . the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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 requlatory In addition, FDA may publish further announcements action. 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. Ronald E. Tura

This letter will allow you to beqin 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) 594-4659. 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,

Stiptran Pluorlu

M. Witten, Ph.D., M.D. irector

Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page

510(k) Number (if known): K 980363

Device Name: ORo-Fabian/ myographic measurement Instrument (ommi,

Indications For Use:

The Oro-Facial Myographic Measurement Instrument is intended as a diagnostic aid for the quantitative evaluation of oro-facial muscle strength. It is indicated for use in the oro-facial cavity.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K980363

Prescription Use	X
(Per 21 CFR 801.109)

OR
Over-The-Counter Use(Optional Format 1-2-96)

Regulation Number and Section

§ 888.1240 AC-powered dynamometer.

(a)
Identification. An AC-powered dynamometer is an AC-powered device intended for medical purposes to assess neuromuscular function or degree of neuromuscular blockage by measuring, with a force transducer (a device that translates force into electrical impulses), the grip-strength of a patient's hand.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.