The proposed Diaphyseal Plate is intended for the fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, pelvis, distal tibia, and fibula, particularly in osteopenic bone.

Device Description

The proposed Diaphyseal Plate is fabricated from 316L Stainless Steel and is available in five configurations - 6, 8, 10, 12, and 14 hole plate configuration. The proposed Diaphyseal Plate has both slotted holes, for accommodating the Multi-Directional Screws, and round holes for accommodating either Multi-Directional or 90° Lock Screws. 90° Set Screws are used to secure the 90° Lock Screws within the plate to prevent backout.

AI/ML Overview

The provided text describes a medical device, the "Hand Innovations Diaphyseal Plate," and its regulatory clearance process, including information on its intended use, design, and comparison to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, specifically concerning AI/algorithm performance.

The document is a 510(k) summary and an FDA clearance letter, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting performance metrics against predefined acceptance criteria for an AI or algorithm.

Therefore, I cannot provide a response to your request, as the necessary information regarding acceptance criteria and a study demonstrating algorithmic performance is absent from the provided text.

Here's why each numbered point cannot be addressed:

A table of acceptance criteria and the reported device performance: This document does not establish performance acceptance criteria in the context of an AI or algorithmic output, nor does it report such performance.
Sample sized used for the test set and the data provenance: No test set for an AI/algorithm is described. The "testing" mentioned refers to pre-clinical testing for substantial equivalence, not algorithmic validation data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there is no AI/algorithm test set.
Adjudication method: Not applicable as there is no AI/algorithm test set requiring ground truth adjudication.
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 is a traditional mechanical implant, not an AI-assisted diagnostic or therapeutic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as there is no algorithm described.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable as there is no AI or algorithm discussed.
How the ground truth for the training set was established: Not applicable.

The "Performance Testing" mentioned in the "Summary of Substantial Equivalence" section refers to pre-clinical (e.g., mechanical) testing to ensure the device's physical properties are comparable to the predicate device, not the performance of an AI or algorithm.

Summary

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MAR 2 2 2006

20 March 2006

Amendments to K060294 – Hand Innovations Diaphyseal Plate 510(k) Summary of Safety and Effectiveness

General Provisions	The name of the device is:
--------------------	----------------------------

	Proprietary Name	Common or Usual Name
	Hand Innovations Diaphyseal Plate	Plate Fixation Bone

Name of Predicate Devices	The proposed Diaphyseal Plate is substantially equivalent to the following predicate device:3.5mm LCP® Plate - SYNTHES (USA) (510(k) No. K000684- April 28, 2000).
Classification	Class II.
Performance Standards	Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act.
Indications for Use	The proposed Diaphyseal Plate is intended for the fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, pelvis, distal tibia, and fibula, particularly in osteopenic bone.
Device Description	The proposed Diaphyseal Plate is fabricated from 316L Stainless Steel and is available in five configurations - 6, 8, 10, 12, and 14 hole plate configuration. The proposed Diaphyseal Plate has both slotted holes, for accommodating the Multi-Directional Screws, and round holes for accommodating either Multi-Directional or 90° Lock Screws. 90° Set Screws are used to secure the 90° Lock Screws within the plate to prevent backout.
Biocompatibility	The proposed Diaphyseal Plate do not require biocompatibility testing because 316L stainless steel is used in all fabrications per the requirements of ASTM F 138-03. 316L is universally regarded as biocompatible and suitable for surgical implant per the requirements of ISO 10993-1.
Summary of Substantial Equivalence	The proposed Diaphyseal Plate is substantially equivalent to the predicate competitive 3.5mm LCP® Plate SYNTHES (USA) with regards to the intended use, materials, biocompatibility, and overall performance characteristics. The equivalence was confirmed through pre-clinical testing. See Section 8 Performance Testing for a summary of tests used to demonstrate safety and effectiveness of the proposed device. Attachment 9 Engineering Test Protocol and Report presents the detailed test results demonstrating safety and effectiveness.

(original page 19)

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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 a stylized eagle with three lines forming its wings and body. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 2 2006

Hand Innovations, LLC c/o Mr. Richard Jones QA Manager 8905 SW 87th Avenue Suite 220 Miami, Florida 33176

Re: K060294

Trade/Device Name: Hand Innovations Diaphyseal 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: February 1, 2006 Received: February 7, 2006

Dear Mr. Jones:

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

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Page 2 - Mr. Richard Jones

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), 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/dsma/dsmamain.html

Sincerely yours.

Harlan Lenner co

Mark N. Melkerson 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: Diaphyseal Plate

Indications for Use Statement

The Diaphyseal Plate is intended for the fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, pelvis, distal tibia, and fibula, particularly in osteopenic bone.

(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
------------------	---	----	----------------------

(Division Sign-Off)

Division of General, Restorative,

and Neurological Devices

510(k) Number	K060294
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Diaphyseal Plates Traditional 510(k)

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.