The DYmedix Inc. Chin Electrode is a cutaneous electromyography (EMG) electrode. The Chin Electrode supports EMG monitoring of muscles in the chin and other surface EMG monitoring locations as directed by a physician during sleep studies.

Device Description

The Chin Electrode is provided as a convenience to the sleep clinician. The Chin Electrode consists of three cutaneous electrodes within one assembly. In clinical application, the Chin Electrode is placed on the subject's chin. The lead wires are connected to the user's sleep recording instrumentation. The user's sleep recording instrument provides the electrical isolation for patient safety.

AI/ML Overview

The provided text describes a 510(k) submission for the DYmedix, Inc. Chin Electrode. It focuses on demonstrating substantial equivalence to a predicate device rather than providing specific performance metrics against defined acceptance criteria from a study. Therefore, most of the requested information regarding acceptance criteria, study details, expert involvement, and ground truth cannot be extracted directly from this document.

Here's a breakdown of what can and cannot be provided based on the given text:

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

The document does not explicitly state acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy, signal-to-noise ratio) for the Chin Electrode. Instead, it focuses on demonstrating technological equivalence and compliance with safety standards.

Therefore, a table of acceptance criteria and reported device performance cannot be created from this text. The "Data Summary" section vaguely mentions "Laboratory data are presented to demonstrate performance," but no specific performance results are provided.

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

The document does not mention any formal clinical study or test set with a specified sample size. The "Laboratory data" mentioned are likely related to engineering testing for compliance with standards rather than clinical performance evaluation on patient data.

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, as no clinical test set or ground truth establishment is described.

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

Not applicable, as no clinical test set or adjudication process is described.

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

Not applicable. The Chin Electrode is a physical medical device (electrode) for EMG monitoring, not an AI or software-as-a-medical-device (SaMD) product. Therefore, an MRMC study or AI-assistance evaluation is not relevant.

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

Not applicable, as this is a physical device, not an algorithm.

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

Not applicable, as no clinical ground truth establishment is described. The "ground truth" in this context would likely be the accurate measurement of EMG signals, which would be assessed through electrical performance testing, not clinical consensus or pathology.

8. The sample size for the training set

Not applicable, as this is a physical device, not an algorithm that requires a training set.

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

Not applicable, as this is a physical device, not an algorithm that requires a training set.

Summary of Information from the Document:

While the document doesn't provide the requested AI/algorithm-specific details, it does state the following relevant information regarding the device's acceptance and supporting data:

Acceptance Criteria (Implied / Compliance-based):
- Technological Equivalence: The Chin Electrode must be technologically equivalent to existing cutaneous electrodes.
- Biocompatibility: Skin contact materials must be qualified by ISO 10993 or have a history of safe use.
- Lead Wire Safety: Lead wires must comply with FDA requirement 21 CFR Part 898.
- Functional Performance: Must be able to conduct EMG signals. (No specific performance metrics are given, but "Laboratory data are presented to demonstrate performance.")
- Safety and Effectiveness: The overall conclusion of the submission is to support the safety and effectiveness.
Study That Proves the Device Meets Acceptance Criteria (as described):
- Type of Study: The submission primarily relies on "Laboratory data" and "Certification of Conformance" to relevant standards. This indicates engineering testing and compliance documentation rather than a clinical trial.
- Specific Tests/Certifications Mentioned:
  - Certification of Conformance to the FDA Performance Standard for Lead Wires and Patient Cables, 21 CFR Part 898.
  - Compliance with ISO 10993 for biocompatibility.
- Nature of "Data Summary": The document states that "Laboratory data are presented to demonstrate performance," but does not elaborate on the specific tests conducted or their results in a quantitative manner. The FDA's decision is based on a review of the provided 510(k) submission, confirming "substantial equivalence" to the predicate device.

Summary

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1. 1. 1. 1.

DYmedix, Inc.

K020468

Summary of Safety and Effectiveness

Company Name:	DYmedix, Inc.3989 Central Ave. NESuite 116Minneapolis, MN 55421
Contact:	Peter Stasz, CEO
Phone:	(763) 789-8280
Fax:	(763) 781-4120
Summary Date:	April 15, 2002
Trade Name:	Chin Electrode
Common Name:	Cutaneous Electrode
Classification Name:	Predicate electrodes have been found substantially equivalent to882.1320, Cutaneous Electrode, Class II, GXY.

Predicate Device:

510(k) Number:	K931430
Manufacture:	MEDICOTEST, Inc.
Trade Name:	Neuroline Electrodes
Product Code:	BZQ

Description of the Chin Electrode 1.0

During the evaluation of sleep disorders, a variety of electrodes and sensors supporting recording of various parameters are attached to the patient. Measurement of electromyography (EMG) signals at the chin can be performed. Clinicians can place discrete surface electrodes on the chin to acquire the EMG signal.

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connected to the user's sleep recording instrumentation. The user's sleep recording instrument provides the electrical isolation for patient safety.

2.0 Intended Use of the Chin Electrode

3.0 Technological Characteristics

The technology of the Chin Electrode is equivalent to other cutaneous electrodes. A conductive gel, as part of the Chin Electrode assembly conducts the EMG signal to an Ag/AgCl contact in the electrodes. The Chin Electrode is connected to the user's sleep recording instrument for signal amplification and conditioning.

The skin contact materials were qualified by ISO 10993 biocompatibility or have a history of safe use in other medical devices. The Chin Electrode lead wires have recessed sockets. The lead wires comply with the FDA requirement for safe sensor lead wires, 21 CFR Part 898.

4.0 Data Summary

Laboratory data are presented to demonstrate performance of the Chin Electrode. A Certification of Conformance to the FDA Performance Standard for Lead Wires and Patient Cables, 21 CFR Part 898 and ISO 10993 is provided.

5.0 Conclusions

The laboratory data and certification support the conclusion of the safety and effectiveness the Chin Electrode.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DYmedix, Inc. c/o Mr. Gary Syring Ouality & Regulatory Associates, LLC 800 Levanger Lane Stoughton, Wisconsin 53589

APR 1 6 2002

Re: K020468

Trade/Device Name: Chin Electrode Regulation Number: 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: II Product Code: GXY Dated: February 11, 2002 Received: February 12, 2002

Dear Mr. Syring:

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.

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.

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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 premated 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 21 CFR Part 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" (21CFR Part 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,

Muriam C. Provost

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

Enclosure

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510(k) Number (if known):

Device Name: Chin Electrode

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Miriam C. Provost

Division of General, Restorative and Neurological Devices

510(k) Number K620468

Regulation Number and Section

§ 882.1320 Cutaneous electrode.

(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).