DORSAL NAIL PLATE, ANATOMICAL by HAND INNOVATIONS, LLC.

The Dorsal Nail Plate™, Anatomical is intended to treat fractures in both left and right Radius. The distal segment of the nail plate is intended to be attached to the dorsal surface of the distal Radius. The proximal segment of the nail plate is intended to be inserted into the Radial shaft.

AI/ML Overview

This document describes a medical device called the "Dorsal Nail Plate™, Anatomical" for bone fixation, and not an AI/ML device. Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device, such as sample size, ground truth establishment, expert qualifications, and AI-specific comparative effectiveness studies, is not applicable to this submission.

The document primarily focuses on establishing substantial equivalence to a predicate device for regulatory approval.

Here's an analysis of the provided information in relation to the query:

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

Acceptance Criteria (Implicit): Substantial equivalence to the predicate device in terms of intended use, materials, biocompatibility, and overall performance characteristics.
Reported Device Performance: The document states that "The equivalence was confirmed through pre-clinical testing." No specific performance metrics or thresholds are explicitly provided in the summary.

2. Sample sized used for the test set and the data provenance

Not Applicable: This pertains to clinical studies for AI/ML devices. For this orthopedic implant, the "test set" would typically refer to mechanical or bench testing. The document mentions "pre-clinical testing" but does not specify sample sizes or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable: This relates to expert annotations for AI/ML models. For this device, "ground truth" would be established through engineering specifications, material standards (e.g., ASTM F 136 for Titanium Alloy), and results of mechanical testing. No expert panel for "ground truth" establishment as understood in AI/ML is described.

4. Adjudication method for the test set

Not Applicable: This is relevant for expert disagreement resolution in AI/ML performance evaluation. Not mentioned for this orthopedic device.

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 is specific to AI-assisted human performance studies. No such study was conducted or is relevant for a bone plate.

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

Not Applicable: This refers to the performance of an AI algorithm itself. Not relevant for a physical medical device.

7. The type of ground truth used

Type of "Ground Truth": For this device, the "ground truth" is based on:
- Material Standards: ASTM F 136 (for Titanium Alloy) for biocompatibility and material properties.
- Engineering Specifications: Implicit in the design and manufacturing of the plate to meet the functional requirements for fixation.
- Pre-clinical Testing Results: Physical and mechanical testing to demonstrate performance equivalence.

8. The sample size for the training set

Not Applicable: This is a concept for AI/ML model development.

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

Not Applicable: This is a concept for AI/ML model development.

In summary, the provided document is a 510(k) submission for a traditional medical device (bone plate) and does not contain the kind of information requested for an AI/ML-based device.

Summary

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SEP 1 4 2005

K052248 pi/

510(k) Summary of Safety and Effectiveness

GeneralProvisions	The name of the device is:
	Proprietary Name	Common or Usual Name
	Dorsal Nail Plate™, Anatomical	Plate Fixation Bone
Name ofPredicateDevices	The device is substantially equivalent to:
	• Dorsal Nail Plate of the Distal Radius Fracture Repair System (510(k) #K023007 - December 5, 2002) - Hand Innovations, Inc.
Classification	Class II.
PerformanceStandards	Performance standards have not been established by the FDA under section 514 ofthe Food, Drug and Cosmetic Act.
Indications forUse	The Dorsal Nail Plate™, Anatomical is intended for the fixation of fracturesand osteotomies involving the distal Radius.
DeviceDescription	The Dorsal Nail Plate™, Anatomical is intended to treat fractures in both left andright Radius. The distal segment of the nail plate is intended to be attached to thedorsal surface of the distal Radius. The proximal segment of the nail plate isintended to be inserted into the Radial shaft.
Biocompati-bility	The Dorsal Nail Plate™, Anatomical do not require biocompatibility testingbecause the Titanium Alloy used in fabrication meets the requirements of ASTMF 136.
Summary ofSubstantialEquivalence	The Dorsal Nail Plate™, Anatomical is substantially equivalent to the predicateDorsal Nail Plate in regards to the intended use, materials, biocompatibility, andoverall performance characteristics. The equivalence was confirmed through pre-clinical testing.

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing left and has its wings spread. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

SEP 1 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Ernesto Hernandez Vice President RA/QA Hand Innovations, LLC 8905 SW 87th Avenue, Suite 220 Miami, Florida 33176

Re: K052248 Trade/Device Name: Dorsal Nail Plate™, Anatomical Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: August 16, 2005 Received: August 18, 2005

Dear Mr. Hernandez:

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 100-1.050.

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Page 2-Mr.Ernesto Hernandez

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), please contact the Office of Compliance at (240) 276-0120. 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,

Mark N. Metkerson

Acting 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): K052348

Device Name: Dorsal Nail Plate™, Anatomical

Indications for Use Statement

The Dorsal Nail Plate™, Anatomical is intended for the fixation of fractures and osteotomies involving the distal Radius.

Prescription Use______________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use

(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, and Neurological Devices

Dorsal Nail Plate™, Anatomical 510(k) Premarket Notification

510(k) Number_LOS UZ48 0024

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.