The Shoulder Nail Plate of the Shoulder Fixation System is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal Humerus.

Device Description

The bilaterally symmetric Shoulder Nail Plate is intended to treat fractures in both left and right Humerus. The plate segment of the Shoulder Nail Plate is intended to be attached to the metaphysis of the humerus. The nail segment of the Shoulder Nail Plate is intended to be inserted into the humeral diaphysis for optimal stabilization of the fracture.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the "Shoulder Nail Plate." This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, rather than a clinical study report detailing acceptance criteria for performance verification with data.

Therefore, many of the requested elements about acceptance criteria, device performance metrics, study design, and ground truth establishment are not applicable. The document focuses on demonstrating equivalence to predicate devices through intended use, materials, biocompatibility, and overall performance characteristics, and not on establishing specific performance metrics against a set of acceptance criteria in a clinical or analytical study.

Here's an assessment based on the available information:

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

This information is not provided in the document. The 510(k) summary states, "The Shoulder Nail Plate is substantially equivalent to the predicate Shoulder Side Plate of the Shoulder Fixation System with regards to the intended use, materials, biocompatibility, and overall performance characteristics. The equivalence was confirmed through pre-clinical testing." This indicates that performance was assessed relative to the predicate, but specific acceptance criteria and detailed quantitative performance data are not included in this summary.

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

This information is not provided. The document mentions "pre-clinical testing" but does not detail the nature of these tests, 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 (e.g. radiologist with 10 years of experience)

This information is not applicable/not provided. The device is a bone fixation plate, not an AI or diagnostic device that requires expert ground truth for a test set.

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

This information is not applicable/not provided. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not detailed for this 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

This information is not applicable. An MRMC study is relevant for AI-assisted diagnostic or interpretation devices, which this is not.

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

This information is not applicable. This device is a physical medical implant, not an algorithm.

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

This information is not applicable/not provided in the context of typical "ground truth" as described for diagnostic or AI devices. The substantial equivalence relies on demonstrating similar physical and mechanical properties, biocompatibility, and intended use as predicate devices. The "ground truth" for non-AI medical devices generally refers to established scientific principles, consensus standards regarding material properties, and clinical outcomes for predicate devices. The document states biocompatibility was based on meeting ASTM F 138-03, which serves as a standard for stainless steel, indicating compliance with a recognized material standard.

8. The sample size for the training set

This information is not applicable/not provided. As a physical medical device, there is no "training set" in the context of machine learning or AI.

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

This information is not applicable/not provided.

In summary:

The provided document is a 510(k) summary, which is a regulatory submission focused on demonstrating substantial equivalence to existing legally marketed devices. It does not contain details of a clinical or analytical study with defined acceptance criteria and performance metrics in the way these questions are framed for, for example, diagnostic or AI devices. The "study" mentioned is "pre-clinical testing" to confirm equivalence, but no specific data or methodology from this testing is provided in this summary.

Summary

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K052294 v°/i

0CT 2 1 2005

510(k) Summary of Safety and Effectiveness

GeneralProvisions	The name of the device is:
	Proprietary Name	Common or Usual Name
	Shoulder Nail Plate	Plate Fixation Bone
Name ofPredicateDevices	The Shoulder Nail Plate is substantially equivalent to the following predicatedevices:• Shoulder Fixation System, 510(k) No. K051728 - June 20, 2005 - HandInnovations, LLC• Dorsal Nail Plate of the Distal Radius Fracture Repair System, 510(k) No.K023007 - December 5, 2002 - Hand Innovations, LLC• T2TM Proximal Humeral Nailing System, 510(k) No. K043404 - December27, 2004 - Stryker Corporation.
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 Shoulder Nail Plate of the Shoulder Fixation System is intended forfractures and fracture dislocations, osteotomies, and non-unions of the proximalHumerus.
DeviceDescription	The bilaterally symmetric Shoulder Nail Plate is intended to treat fractures in bothleft and right Humerus. The plate segment of the Shoulder Nail Plate is intended tobe attached to the metaphysis of the humerus. The nail segment of the ShoulderNail Plate is intended to be inserted into the humeral diaphysis for optimalstabilization of the fracture.
Biocompati-bility	The Shoulder Nail Plate do not require biocompatibility testing because the stainlesssteel used in fabrications meets the requirements of ASTM F 138-03.
Summary ofSubstantialEquivalence	The Shoulder Nail Plate is substantially equivalent to the predicate Shoulder SidePlate of the Shoulder Fixation System with regards to the intended use, materials,biocompatibility, and overall performance characteristics. The equivalence wasconfirmed through pre-clinical testing.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" written around the edge. Inside the circle is a stylized image of an eagle with three lines representing its wings.

Public Health Service

OCT 2 1 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: K052294 Trade/Device Name: Shoulder Nail Plate 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 19, 2005 Received: August 30, 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 1000-1050.

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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) I mis lotter with and n your e FDA finding of substantial equivalence of your device to a legally promaticated predicated 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 n you don't 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 other general micromational 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,

Mark N. Mellon

Mark N. Melkerson 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): ____________________________________________________________________________________________________________________________________________________

Device Name: Shoulder Nail Plate

Indications for Use Statement

The Shoulder Nail Plate of the Shoulder Fixation System is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal Humerus.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	✓	OR	Over-The-Counter Use
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(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number	K052294
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Shoulder Nail Plate 510(k) Premarket Notification

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.