The Checkpoint® is a single-use sterile device intended to provide electrical stimulation of exposed motor nerves or muscle tissue to locate and identify nerves and to test nerve and muscle excitability. The Checkpoint is available for prescription use only.

Device Description

The Checkpoint® is a small handheld device used by a surgeon to deliver electrical stimulation intraoperatively to test nerve integrity and muscle excitability. This is a sterile disposable device designed to be simple to use with one-handed control.

AI/ML Overview

This 510(k) summary for the NDI Medical Checkpoint® Surgical Nerve Stimulator/Locator does not describe a study involving acceptance criteria and device performance in the manner typically associated with clinical trials or AI algorithm validation.

Instead, the document details a submission for a substantial equivalence determination for a modified version of an existing device (K061365 - Checkpoint Surgical Nerve Stimulator/Locator). The focus is on demonstrating that the modified device is as safe and effective as the predicate device, primarily through technological comparison and standard performance testing (biocompatibility, electrical safety).

Therefore, I cannot provide the requested information in the format you specified, as the provided document does not contain the elements of a study proving device performance against acceptance criteria in the context of, for example, a diagnostic accuracy study or an AI algorithm's performance.

Here's an analysis based on the information available in the document, explaining why the requested details are not present:

A table of acceptance criteria and the reported device performance:
- Not applicable in the provided context. The document presents a table comparing "Feature/Characteristic" between the predicate and modified device, showing "Yes" for each characteristic, indicating technological equivalence rather than performance against specific clinical acceptance criteria. Performance testing mentioned (biocompatibility, electrical testing, design verification and validation) are general categories, not detailed outcome measures with thresholds.
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not applicable. There is no mention of a "test set" in the context of clinical data for performance evaluation in this document. The assessment is based on technological characteristics and general performance testing (electrical, biocompatibility).
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. There is no "ground truth" to be established by experts in this type of submission, as it's not a diagnostic or decision-support device requiring interpretation of complex data by human experts.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No test set requiring adjudication is described.
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. This device is a surgical nerve stimulator/locator, not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant here.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical, handheld surgical tool. There is no "algorithm only" performance to evaluate.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. The "ground truth" for demonstrating substantial equivalence here relies on documented design specifications, manufacturing controls, and standardized performance tests (like electrical conductivity, biocompatibility) rather than clinical outcome measures requiring expert comparison.
The sample size for the training set:
- Not applicable. No training set is mentioned as this is not an AI/machine learning device.
How the ground truth for the training set was established:
- Not applicable. No training set is mentioned.

In summary: The provided 510(k) summary focuses on demonstrating "substantial equivalence" of a modified medical device to a legally marketed predicate device. This process typically involves:

Comparison of intended use and indications for use. (Explicitly stated as equivalent)
Comparison of technological characteristics. (Provided in a table)
Assessment of performance testing. (Mentioned as "biocompatibility testing, electrical testing (safety and electromagnetic compatibility), as well as design verification and validation testing.") These are typically engineering and materials tests rather than clinical performance studies against specific acceptance criteria.

The document does not describe a clinical study with a test set, ground truth acquisition, expert involvement, or statistical performance metrics that would be typically found in an AI/diagnostic device submission.

Summary

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KO 92292

510(k) Summary for the NDI Medical Checkpoint®

1. SPONSOR/APPLICANT

NDI Medical 22901 Millcreek Boulevard, Suite 110 Cleveland. OH 44122 216-378-9106

OCT 2 8 2009

Contact Person: Julie Grill, VP, Regulatory Affairs Telephone: 919-968-4690

Date Prepared: July 29, 2009

2. Device Name

Trade/Proprietary Name: Checkpoint® Surgical Nerve Stimulator/Locator Common/Usual Name: Surgical Nerve Stimulator/Locator Classification Name:

3. PREDICATE DEVICE

K061365 - Checkpoint Surgical Nerve Stimulator/Locator

4. DEVICE DESCRIPTION

ട്. INTENDED USE

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TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The determination of substantial equivalence of the modified Checkpoint and original Checkpoint® devices was based on equivalence of intended use, indications for use, operational characteristics, and fundamental technological characteristics.

Feature/Characteristic	CheckpointK061365	Modified Checkpoint
The Checkpoint is a single-use,sterile device intended to provideelectrical stimulation of exposedmotor nerves or muscle tissue tolocate and identify nerves and totest nerve and muscle excitability.	Yes	Yes
Hand-held	Yes	Yes
Disposable	Yes	Yes
Integral stimulus probe	Yes	Yes
Monopolar stimulation	Yes	Yes
Battery Powered	Yes	Yes
Regulated Current	Yes	Yes
Biphasic rectangular waveformwith no net DC current	Yes	Yes
Separate Stimulus Amplitude andPulse Duration controls	Yes	Yes

· PERFORMANCE TESTING 7.

Testing of this device includes biocompatibility testing, electrical testing (safety and electromagnetic compatibility), as well as design verification and validation testing.

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

NDI Medical, LLC c/o Ms. Julie Grill VP, Regulatory Affairs and Quality Systems 22901 Millcreek Blvd. Suite 110 Cleveland, OH 44122

Re: K092292

OCT 2 8 2009

Trade/Device Name: Checkpoint, Model 9014 Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: II Product Code: ETN Dated: September 24, 2009 Received: September 25, 2009

Dear Ms. Grill.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalient (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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Erich, m
Melvin R. Bobbin, M.D.

Malvina B. Eydelman, M.I Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K092292

Checkpoint® Device Name:

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Meurological and Ear, Division of Ophthalmjo Nose and Throat Devices

510(k) Number K092292

Regulation Number and Section

§ 874.1820 Surgical nerve stimulator/locator.

(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.