The subject monitor detects bioelectrical signals from muscles for the purpose of guiding injections into the muscles identified. Although the monitor is indicated for guidance of any muscle-specific injection, it is typically used for injections into muscles of the head and neck. This includes botulinum toxin injections of facial and laryngeal muscles.

The subject monitor is intended to detect bioelectrical signals from muscles for the subject monitor in intentions into the muscles identified, including botulinum toxin injections of eye muscles.

Device Description

The proposed EMG monitoring system is composed of a small, handheld monitor, a reusable patient interface cable and a disposable injector needle electrode. Commercially available surface electrodes, to act as references, may elcotrode. Onlinerally aranabitropoposed system as these are readily available or may not be provided with the proposed keys on the front console -- ON/OFF, at the politic of the of Check, Volume Down, and Mute. The software of the proposed EMG monitoring system interprets console key presses from the user and performs the action associated with that key.

AI/ML Overview

The provided text is a 510(k) summary for the XOMED® AccuGuide Muscle Injection Monitor. As a 510(k) submission, the primary goal is to demonstrate substantial equivalence to a predicate device, not necessarily to prove absolute performance against predefined acceptance criteria from novel studies. Therefore, the information provided focuses on comparing the new device to existing, legally marketed devices.

Based on the document, here's a breakdown of the requested information, with specific answers where available and explanations where information is not present in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) submission does not present specific quantitative acceptance criteria or a dedicated performance study with a table of results. Instead, it relies on demonstrating that the proposed device, the AccuGuide, is substantially equivalent to a predicate device (Allergan BOTOX® Injection Amplifier) in terms of intended use, technology, and safety/effectiveness. This means it's assumed to meet the same unstated performance benchmarks as the predicate.

For the purpose of this request, we can infer the "acceptance criteria" and "reported performance" are met if the device is deemed substantially equivalent to the predicate.

Acceptance Criteria (Inferred from Substantial Equivalence to Predicate)	Reported Device Performance (as implied by 510(k))
Detect bioelectrical signals from muscles	The AccuGuide system uses "identical injection needle electrodes to pick-up EMG from the target muscle" as the predicate.
Guide injections into muscles identified	Both the AccuGuide and predicate "transform the EMG signal into an audible response." The AccuGuide also provides a "visible response via an LCD bargraph display." The presence of an appropriate EMG response, in conjunction with a specific muscle movement, confirms the location.
Be safe and effective for intended use (e.g., botulinum toxin injections)	The device's components and operating principles are sufficiently similar to the predicate that it would not raise new questions of safety or effectiveness.

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

The provided 510(k) summary does not describe a specific "test set" or a performance study with a defined sample size for the AccuGuide device. The submission relies on a comparison to a predicate device and existing knowledge of EMG technology. Therefore:

Sample Size for Test Set: Not applicable / Not provided.
Data Provenance: Not applicable, as no specific test data set is described for the new device. The comparison is based on the known performance and characteristics of the predicate device (Allergan BOTOX® Injection Amplifier), which is a "currently marketed" device. This implies its performance is established from its prior marketing and regulatory clearance, which would have involved some form of testing, but details are not provided here for the predicate either.

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

This information is not provided in the 510(k) summary. Given that no specific test set or performance study is detailed for the AccuGuide, there is no mention of experts establishing a ground truth for such a study. The substantial equivalence argument relies on the established use and safety/effectiveness of the predicate device.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary. As there's no described test set or performance study, there's no mention of an adjudication method.

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

MRMC Study Done: No, an MRMC comparative effectiveness study was not conducted or reported in this 510(k) submission.
AI Assistance: The device described is an EMG monitor, a hardware medical device that provides bioelectrical signal detection. It does not incorporate Artificial Intelligence (AI) for interpretation or assistance in the way current AI-driven diagnostic tools do. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

Standalone Performance: Not applicable. The AccuGuide is a hardware device (EMG monitor) designed to provide real-time feedback (audible and visible through LCD bargraph) to a human user (clinician) to guide injections. It does not operate as a standalone "algorithm" generating diagnoses or interpretations without human involvement in the clinical context. Its function is to assist in real-time muscle localization during a procedure.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Since no specific performance study is detailed, the type of ground truth for the AccuGuide's performance is not explicitly stated. However, the basis for its perceived "truth" or effectiveness stems from the functionality of its predicate device, the Allergan BOTOX® Injection Amplifier. The fundamental "ground truth" for these types of EMG monitors is the accurate detection of muscle electrical activity (bioelectrical signals) in the target muscle, confirmed by clinical observation (e.g., specific muscle movement in conjunction with the EMG response) and the subsequent successful and safe injection into that muscle, leading to the desired therapeutic outcome. This is a clinically established method for guiding precise injections.

8. The Sample Size for the Training Set

The provided 510(k) summary does not describe a "training set" for the AccuGuide. This device is a traditional hardware medical device, not a machine learning model that requires a training set in the conventional sense. The design and validation would have followed standard engineering and quality system processes, rather than machine learning training.

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

Not applicable, as no training set for a machine learning model is described for this device.

Summary

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XOMED® K 990793

OCT 22 1999

510(k) Summary EMG Monitor

1.0 Date Prepared March 5, 1999
Submitter (Contact) 2.0 David Timlin Xomed Surgical Products Jacksonville, FL (904) 279-7532

3.0 Device Name

Proprietary Name:

AccuGuide Muscle Injection Monitor (The product's trade name has not been finalized and may be changed at a later date.)

Common Name(s):

Electromyographic (EMG) Monitor, Muscle locator

Classification Name:

Electromyographic (EMG) Monitor Nerve locator / stimulator,

4.0 Device Classification

Current NIM EMG monitors manufactured by Xomed were classified via K934426 and K982595 as follows:

Nerve locator / stimulator 21 CFR 874.1820 Procode 77 ENT Class II ;

Electromyographic (EMG) Monitor Procode 89 CAB Class II ; 21 CFR 890.1375

The accessory, disposable, injector needle electrodes that are provided with the system could be classified as follows:

Electromyograph needle electrode Procode 89 IKT Class II: 21 CFR 890.1385

Needle electrode Procode 89 GXZ Class II: 21 CFR 882.1350

132

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REVISED) 10/19/91

Device Description 5.0

Device Description
The proposed EMG monitoring system is composed of a small, handheld monitor, a reusable patient interface cable and a disposable injector needle electrode. Commercially available surface electrodes, to act as references, may elcotrode. Onlinerally aranabitropoposed system as these are readily available or may not be provided with the proposed keys on the front console -- ON/OFF, at the politic of the of Check, Volume Down, and Mute. The software of the proposed EMG monitoring system interprets console key presses from the user and performs the action associated with that key.

6.0 Intended Use

7.0 Substantial Equivalence

Currently marketed EMG monitors are used to locate specific target muscles prior to making an injection of a solution or medication, such as botulinum toxin. Typically, the currently marketed monitors are large and contain features that are not necessary for merely locating target muscles. A simple raw EMG monitor is all that is needed.

Allergan, Inc. is currently marketing the BOTOX® Injection Amplifier, a simple EMG monitor specifically intended for guiding muscle specific injections. The 510k for the monitor is believed to be K900098, and the needle electrodes sold with this system are manufactured by TECA Corporation as cleared via K973444. The Xomed EMG monitoring system proposed in this 510k, a nandheld, battery-operated EMG monitor with iniection needle electrodes, is equivalent to the Allergan BOTOX® Injection Amplifier and Allergan / TECA Myoject needle electrodes, respectively.

Both systems use identical injection needle electrodes to pick-up EMG from the target muscle, which is then processed by the EMG monitor. As with other commercially available EMG monitors (e.g. Xomed's NIM monitors), both the proposed AccuGuide and predicate Allergan system transform the EMG signal into an audible response. In the case of the proposed AccuGuide monitor, the EMG signal is also transformed into a visible response via an LCD bargraph display. The presence of an appropriate EMG response, in conjunction with a specific muscle movement, confirms the location of the injection needle. Once confirmed, the solution or medication is injected through the injection needle electrode using a standard disposable syringe (not provided with this system).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image is a seal for the U.S. Department of Health & Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized symbol of three human profiles facing to the right, stacked on top of each other.

OCT 22 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. David Timlin Manager, Regulatory Affairs XOMED Surgical Products, Inc. 6743 Southpoint Drive, North Jacksonville, Florida 32216

Re: K990793

Trade Name: Electromyography (EMG) Monitor Regulatory Class: II Product Code: GXZ, IKT, CAB Dated: July 22, 1999 Received: July 26, 1999

Dear Mr. Timlin:

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 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 requirement, 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. David Timlin

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) 594-4595. 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,

tosefa

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):_

Electromyography (EMG) Monitor Device Name:

Indications for Use:

The subject monitor is intended to detect bioelectrical signals from muscles for the subject monitor in intentions into the muscles identified, including botulinum toxin injections of eye muscles.

(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 K990793
510(k) Number.

Labels	Values
Prescription Use (Per 21 CFR 801.109)	X
Over-the-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 882.1350 Needle electrode.

(a)
Identification. A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.(b)
Classification. Class II (performance standards).