(50 days)
Electromyographic (EMG) needle electrodes are intended to be placed into the muscle or nerve tissue to sense bioelectrical signals. This monopolar needle is an accessory to the electromyography machine, which is used for assessing a series of skeletal muscles. EMG electrodes are for use under the proper direction of a licensed physician and intended for single patient use, only.
Detachable Monopolar EMG Needle Electrode
The provided document is a 510(k) clearance letter from the FDA for a Detachable Monopolar EMG Needle Electrode. This letter is a regulatory document and does not contain information about studies proving the device meets acceptance criteria in the way typically found in a scientific publication or a detailed submission like a PMA.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment cannot be extracted from this document. The FDA's 510(k) clearance process focuses on demonstrating 'substantial equivalence' to a predicate device, rather than detailed performance studies and acceptance criteria as would be required for a novel device or a PMA.
Here's what can be gathered based on the document and the nature of a 510(k) submission:
1. A table of acceptance criteria and the reported device performance
- Cannot be extracted. This document does not specify performance acceptance criteria or report device performance data. A 510(k) submission primarily relies on demonstrating that the new device has the same intended use and technological characteristics as a legally marketed predicate device, or that any differences do not raise new questions of safety and effectiveness. Typically, performance data submitted for a 510(k) are bench tests or limited clinical data demonstrating equivalence, not extensive studies against detailed acceptance criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be extracted. This information is not present in the FDA clearance letter. Any testing data would have been part of the 510(k) submission, not the clearance letter itself.
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)
- Cannot be extracted. This document does not describe any human-read ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be extracted. This document does not describe any test set or 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
- Highly unlikely, and not mentioned. The device is a "Detachable Monopolar EMG Needle Electrode." This is a physical medical instrument used to record bioelectrical signals during electromyography. It is not an AI-powered diagnostic imaging device. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and was almost certainly not performed or submitted for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable and not mentioned. As stated above, this is a physical medical device, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be extracted. This document does not describe any ground truth methodology. For a device like an EMG needle, performance is typically assessed by electrical characteristics, biocompatibility, sterility, and mechanical integrity, rather than a diagnostic "ground truth" in the sense of an imaging or diagnostic algorithm.
8. The sample size for the training set
- Not applicable and not mentioned. This is a physical medical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
- Not applicable and not mentioned. As above, this is not an AI/ML device.
In summary: The provided FDA 510(k) clearance letter confirms that the Detachable Monopolar EMG Needle Electrode has been found substantially equivalent to a predicate device. It does not contain the detailed study information, acceptance criteria, or performance data that would typically be part of a scientific publication or a more comprehensive regulatory submission like a PMA, especially for a device that is not an AI/ML diagnostic.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Samantha L. Draper Quality Assurance Manager Class A Enterprises, Inc. P.O. Box 401964 16039 Walnut Street, Ste. C Hesperia, CA 92340
MAY 2 8 2002
Re: K021118
Trade/Device Name: Detachable Monopolar EMG Needle Electrode Regulation Number: 882.1350 Regulation Name: Needle electrode Regulatory Class: II Product Code: GXZ Dated: May 8, 2002 Received: May 13, 2002
Dear Ms. Draper:
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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Page 2 - Ms. Samantha L. Draper
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 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 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). regaration on 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,
Miriam C. Provost
fur 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: K021118
DEVICE NAME: Detachable Monopolar EMG Needle Electrode
INDICATIONS FOR USE: Electromyographic (EMG) needle electrodes are INDICATIONS FOR OOL. Elooking ographis (into the muscle or nerve tissue to monopolar necules inconded to be mice is an accessory to the electromygraphy sense bloelectrical agrials: "This dothor with electromyography studies (recording machine, whiler to for ass eries of skeletal muscles). EMG electrodes are the inthinsto oloothour propertion of a licensed physician and intended for single patient use, only.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use × (Per 21 CFR 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)
Miriam C. Provost
Division Sign. Off Division of General, Restorative and Neurological Device
510(k) Number K021118
§ 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).