MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I by MYOTRONICS-NOROMED, INC.

Tracks mandibular movement and position .
. For the diagnosis of functionaldisorderssuch as TMJ/MPD syndrome, muscle tension, bruxing, and instability of occlusion
Identification of mandibular rest position .
Identification of interocclusal distance and freeway space .
. Monitors the position of the jaw in three dimensions
Represents the spatial position of the mandibular incisal edge relative to the skull .

For electromyographic function of this device:

Intended for use for muscles of mastication, especially temporalis, masseter, and digastric ●
. Designed to perform a limited number of functions in dental diagnosis
For use as a stand alone system for clinical monitoring of up to eight differentmuscles. it is ■ ideally suited for diagnosis and treatment evaluation by recording function of the muscles of the stomatognathic system
The determination of the degree of relaxation of a particular muscle or muscle group at rest .
The precise measurement of relative levels of contraction of several muscles during a ■ functional test

For both functions of this device:

Diagnosis and management of TMJ/MPD disorders, orthodontic patients, denture patients, . and reconstruction patients.
The addition of the feature described in this new Premarket Notification does not expand upon the above indicated uses.

Device Description

The Model K6-I Diagnostic System is a surface electromyographic device that measures and records electrical potential emanating from muscle (in addition to its ability to track and document mandibular position/range of motion). The feature being added to the software of this device, Fast Fourier Transformation (FFT) of captured data, has the same technological characteristics as other legally marketed devices described above and in the Special 510(k).

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA to Myotronics-Noromed, Incorporated, regarding their Model K6-I Diagnostic System. It primarily addresses the substantial equivalence of the device to legally marketed predicates, especially concerning the addition of a Fast Fourier Transformation (FFT) feature to its software.

The document does not contain detailed information about specific acceptance criteria or an explicit study proving performance against those criteria in a quantitative manner. Instead, it focuses on regulatory clearance based on substantial equivalence.

However, based on the information provided, we can infer some aspects and highlight what is missing:

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from regulatory context and predicate device comparison)	Reported Device Performance (Inferred from substantial equivalence claim)
Functional Equivalence: The added Fast Fourier Transformation (FFT) feature should perform its intended function of transforming captured electromyographic data.	The FFT feature in the Model K6-I software has the same technological characteristics as the FFT features found in the predicate devices (ProComp DSP & ProComp, Myosystem 1000 Electromyograph, I-330 Physiological Monitor).
Safety and Effectiveness: The device, with the added FFT feature, should be as safe and effective as the predicate devices for its stated indications for use.	The FDA found the device substantially equivalent to legally marketed predicate devices, implying comparable safety and effectiveness for the stated indications.
Indications for Use: The device (with FFT) should remain within the indications for use of the predicate devices.	The added feature (FFT) does not expand upon the previously indicated uses for jaw tracking and electromyographic functions.

Missing Information from the Provided Document:

The following information, as requested in the prompt, is not present in the provided 510(k) letter:

Sample size used for the test set and the data provenance: The document does not describe a specific test set or its sample size for evaluating the FFT feature.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: There is no mention of experts or ground truth establishment for a test set.
Adjudication method for the test set: Not applicable as no explicit test set or expert evaluation is detailed.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: No MRMC study is mentioned.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The document describes the device as a diagnostic system which implies human interpretation. No specific standalone algorithm performance study is described for the FFT feature.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth is described for a performance study of the FFT feature.
The sample size for the training set: The document does not describe a training set as it pertains to software algorithms.
How the ground truth for the training set was established: Not applicable.

Context from the Document:

Device Name: Model K6-I Diagnostic System
Added Feature: Fast Fourier Transformation (FFT) of data to the K6-I Software.
Method of Proof: Substantial Equivalence. The document states that the new FFT feature "has the same technological characteristics as other legally marketed devices described above and in the Special 510(k)." The predicate devices listed are:
- ProComp DSP & ProComp mfg. by Thought Technology
- Myosystem 1000 Electromyograph mfd. by Noraxon
- I-330 Physiological Monitor mfd. by J & J Engineering
Indications for Use: The device tracks mandibular movement and position for diagnosis of functional disorders (e.g., TMJ/MPD syndrome, muscle tension), identification of mandibular rest position and interocclusal distance. For its electromyographic function, it's intended for use with muscles of mastication (temporalis, masseter, digastric) for clinical monitoring, determining muscle relaxation, and measuring contraction levels during functional tests. The added FFT feature does not expand these indications.

In summary, the provided FDA letter relies on the concept of substantial equivalence to existing, legally marketed predicate devices rather than detailing a specific, quantitative performance study with explicit acceptance criteria, ground truth, and sample sizes for the new FFT feature. The "study" in this context is the comparison made by the manufacturer (Myotronics-Noromed) and reviewed by the FDA to determine that the technical characteristics of the new feature are comparable to those in existing devices.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 23 2005

Mr. Fray Adib President Myotronics-Noromed, Incorporated 15425 53rd Ave South Tukwila, Washington 98188

Re: K992694

Trade/Device Name: Model K6-I Diagnostic System Regulation Number: 21 CFR 890.1375 Regulation Name: Diagnostic electromyograph Regulatory Class: II Product Code: KZM and NFS Dated: August 11, 1999 Received: August 12, 1999

Dear Mr. Adib

This letter corrects our substantially equivalent letter of September 10, 1999, regarding the classification of your device which was incorrectly identified in the previous letter.

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 (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 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 - Mr. Fray Adib

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 (OS) 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 continue 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 specificadvice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 (301) 443-6597 or at its internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Carl

Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known): _ K 99 x 94

Device Name: __ Model K6-I Diapnostic System

Indications for use

For Jaw Tracking functions of this device:

Tracks mandibular movement and position .
. For the diagnosis of functionaldisorderssuch as TMJ/MPD syndrome, muscle tension, bruxing, and instability of occlusion
Identification of mandibular rest position .
Identification of interocclusal distance and freeway space .
. Monitors the position of the jaw in three dimensions
Represents the spatial position of the mandibular incisal edge relative to the skull .

For electromyographic function of this device:

Intended for use for muscles of mastication, especially temporalis, masseter, and digastric ●
. Designed to perform a limited number of functions in dental diagnosis

(continued on page 2)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUEON ANOTHER PACE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K972694

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

Page 1

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510(k) Number: K 992694_

Device Name: Model K6-I Diagnostic System

Indications for use = electromyographic functions of this device (continued from page ■ >

For use as a stand alone system for clinical monitoring of up to eight differentmuscles. it is ■ ideally suited for diagnosis and treatment evaluation by recording function of the muscles of the stomatognathic system
The determination of the degree of relaxation of a particular muscle or muscle group at rest .
The precise measurement of relative levels of contraction of several muscles during a ■ functional test

For both functions of this device:

Diagnosis and management of TMJ/MPD disorders, orthodontic patients, denture patients, . and reconstruction patients.
The addition of the feature described in this new Premarket Notification does not expand upon the above indicated uses.

(PLEASEDO NOT WRITE BELOW THIS LINE = CONTINUE ON ANOTHER PACE TE NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	L992694

Prescription Use		OR	Over-The-Counter Use
(Per 21 CFR 801.109)

Page 2

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SEP 1 0 1999

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MYOTRONICS-NOROMED, INC. Leading in Musculoskeletal Evaluation Technologies For Over 25 Years

Attachment 4

K992694

510(k) SUMMARY

Kooztez

1. Submitter's Information
  Date of Submission: Name and address:

August 11, 1999

Myotronics-Noromed. Inc.. 15425 - 53 Ave. So., Tukwila, WA 98188 Tel: (206) 243-4214 FAX: (206) 243-3625

Contact Name:

Mr. Fray Adib

Device Trade Name: Common name: Classification name:

Model K6-I Diagnostic System Surface EMG System Electromyograph

Myotronics-Noromed's intended addition of Fast Fourier Transformation (FFT) of data to the K6-I Software is substantially equivalent to that feature found in:

ProComp DSP & ProComp mfg. by Thought Technology Myosystem 1000 Electromyograph mfd. by Noraxon I-330 Physiological Monitor mfd. by J & J Engineering

1. Description of the device:
  The Model K6-I Diagnostic System is a surface electromyographic device that measures and records electrical potential emanating from muscle (in addition to its ability to track and document mandibular position/range of motion).

The feature being added to the software of this device, Fast Fourier Transformation (FFT) of captured data, has the same technological characteristics as other legally marketed devices described above and in the Special 510(k).

Image /page/4/Picture/20 description: The image shows two logos. The logo on the left has the word "Intertek" in a circular fashion around a globe with a structure on top. The logo on the right has a triangle inside of a circle with the words "Accredited by the Council for Accreditation (RvA)" below it. Above the two logos are the words "Certified ISO 9001".

Regulation Number and Section

§ 890.1375 Diagnostic electromyograph.

(a)
Identification. A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.(b)
Classification. Class II (performance standards).