The Arthrex Fingershield finger guards are intended to be used over surgical gloves for the protection of wearer while tensioning suture or tying knots with suture products.

Device Description

The Arthrex Fingershield Finger Guards are woven polyester with a marker thread of radio opaque Micropake®. These are offered in a one size fits all cylinder shape. They are offered sterile.

AI/ML Overview

The provided 510(k) summary does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way typically associated with AI/ML devices or diagnostic tools.

The Arthrex Fingershield is a Class I medical device (Finger Cot) and the submission focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing performance against quantitative metrics through a clinical study with acceptance criteria.

Therefore, the requested information elements (1-9) which are relevant to clinical performance studies, ground truth establishment, and AI/ML evaluation, are largely not applicable to this 510(k) submission.

Here's a breakdown based on the provided document:

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

Not Applicable. The submission does not specify quantitative acceptance criteria. The basis for clearance is substantial equivalence to predicates (Percuguard by Digit-Pro, K992539, and Latex Finger Cot by Tucker & Associates, K980827). The general criteria for substantial equivalence are having the same intended use and technical characteristics, or the same intended use and different technological characteristics but demonstrably as safe and effective.

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

Not Applicable. No test set or clinical study data is reported for performance evaluation as part of this 510(k) summary. The submission relies on the characterization of material properties and intended use.

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. No ground truth establishment by experts for a test set is described.

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

Not Applicable. No test set requiring adjudication 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. This device is a finger cot, not an AI-assisted diagnostic or imaging tool. Therefore, an MRMC study is not relevant or described.

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

Not Applicable. This is a physical device, not an algorithm.

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

Not Applicable. No ground truth in the context of clinical performance evaluation is described. The "ground truth" for this type of submission is typically based on the established safety and effectiveness of the predicate devices and the material properties of the new device.

8. The sample size for the training set

Not Applicable. No training set is described as this is not an AI/ML device.

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

Not Applicable. No training set or associated ground truth establishment is described.

In summary, the 510(k) for the Arthrex Fingershield focuses on demonstrating substantial equivalence based on the device's physical characteristics (woven polyester with radio-opaque marker, sterile, one-size-fits-all cylinder shape) and its intended use (protection over surgical gloves while tensioning suture or tying knots). This type of device's clearance process relies on material characterization and comparison to legally marketed predicate devices, rather than a clinical performance study with defined acceptance criteria and ground truth as would be required for a diagnostic or AI-enabled device.

Summary

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K052387

NOV 2 9 2005

510(k) Summary

510(k) Number:
Company:	Arthrex, Inc.
Address:	1370 Creekside Blvd., Naples, FL 34108-1945
Telephone:	(239) 643-5553
Facsimile:	(239) 598-5508
Contact:	Ann Waterhouse
Device Name:	Arthrex Fingershield
Classification:	Finger Cot
Product Code:	LZB
Regulation #:	21 CFR 880.6250

Description:

The Arthrex Fingershield Finger Guards are woven polyester with a marker thread of radio opaque Micropake®. These are offered in a one size fits all cylinder shape. They are offered sterile.

Indications for Use:

The Arthrex Fingershield finger quards are intended to be used over surgical gloves for the protection of wearer while tensioning suture or tying knots with suture products.

Substantially Equivalent Product:

Percuguard by Digit-Pro, K992539 Latex Finger Cot by Tucker & Associates, K980827

Substantial Equivalence:

By definition, substantial equivalence means that a device has the same intended use and technical characteristics as the predicate device, or has the same intended use and different technological characteristics, but can be demonstrated to be as safe and effective as the predicate device for the previously cleared indications. The materials used in construction of these devices are well characterized in regards to strength and biocompatibility. The Arthrex Fingershield finger guards do not raise any questions regarding safety and effectiveness.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem depicts a stylized eagle or bird-like figure with three curved lines representing its wings or body. The logo is simple and monochromatic.

NOV 2 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Ann Waterhouse, RAC Regulatory Affairs Project Manager Arthrex, Incorporated 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K052387

Trade/Device Name: Arthrex Fingershield Finger Guard Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZB Dated: November 10, 2005 Received: November 14, 2005

Dear Ms. Waterhouse:

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.

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Page 2 - Ms. Waterhouse

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.

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), n Jose contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

Syndie Y. Michael Omd

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

Enclosure

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510(k) Number (if known):

Device Name: Arthrex Fingershield Finger Guard

Indications for Use:

The Arthrex Fingershield finger guards are intended to be used over surgical gloves for the protection of wearer while tensioning suture or tying knots with suture products.

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× Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Shule H. Murphy, hQ 4/24/05

Ansion of Anesthes ... ory. General Hospital. infaction Control. Declai

2(k) Number: K 052387

Regulation Number and Section

§ 880.6250 Non-powdered patient examination glove.

(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.