Synthes Clavicle Hook Plate is an anatomically designed L-shaped plate featuring a distal joint bridging hook with a rounded end. The shaft of the plate contains either dynamic compression screw holes or LCP plate holes. The plates accept 3.5 mm cortex, 4.0 mm cancellous and 3.5 mm locking screws (LCP Clavicle Hook Plate only).

AI/ML Overview

The provided text is a 510(k) summary for a medical device, the Synthes Clavicle Hook Plate. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner requested (i.e., a performance study with metrics like accuracy, sensitivity, specificity, etc., typically associated with AI/software devices or diagnostic tools).

This document demonstrates "substantial equivalence" to predicate devices, which is a regulatory pathway for medical devices that are similar to devices already on the market. This typically involves comparing design specifications, materials, and intended use, rather than conducting new performance studies that generate specific metrics like those requested.

Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided text.

Here's what can be inferred or stated based on the text:

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

Acceptance Criteria	Reported Device Performance
Not applicable.	Not applicable.
(No specific performance criteria or metrics (e.g., accuracy, sensitivity) are mentioned. The acceptance criteria for a 510(k) for this type of device typically revolve around demonstrating substantial equivalence to a predicate device in terms of design, materials, and intended use.)	(No specific performance metrics are reported other than the device being "substantially equivalent" to predicate devices.)

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 performance study with a test set is described. The approval is based on substantial equivalence to predicate devices, not on a new clinical study.

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 performance study with ground truth established by experts is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No performance study with a test set 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 metallic bone fixation appliance, not an AI or diagnostic tool where MRMC studies would typically be performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a metallic bone fixation appliance, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. No performance study requiring ground truth is described.

8. The sample size for the training set:
Not applicable. This device is a metallic bone fixation appliance, not an AI or data-driven device that requires a training set.

9. How the ground truth for the training set was established:
Not applicable. This device is a metallic bone fixation appliance, not an AI or data-driven device that requires a training set.

Summary

{0}------------------------------------------------

AUG 2 1 2003

3. 510(k) Summary:

Sponsor	Synthes (USA)1690 Russell RoadPaoli, PA 19301(610) 647-9700
Contact	Bonnie Smith
Device Name	Synthes (USA) Clavicle Hook Plate
Device Classification	21 CFR 888.3030 - Single/multiple component metallic bonefixation appliance and accessories
Predicate Device	Synthes Small T- Plate, Synthes LCP T-Plate and Howmedica'sBosworth Screw
Description of Device	Synthes Clavicle Hook Plate is an anatomically designed L-shapedplate featuring a distal joint bridging hook with a rounded end.The shaft of the plate contains either dynamic compression screwholes or LCP plate holes. The plates accept 3.5 mm cortex, 4.0 mmcancellous and 3.5 mm locking screws (LCP Clavicle Hook Plateonly).
Indications	Intended for fixation of lateral clavicle fractures and dislocations ofthe acromioclavicular joint
Material	316L Stainless SteelTitanium
Substantial Equivalence	Documentation is provided which demonstrates that the SynthesClavicle Hook Plate is substantially equivalent* to other legallymarketed Synthes devices.
	* The term "substantial equivalence" as used in this 510(k)notification is limited to the definition of substantial equivalencefound in the Food, Drug and Cosmetic Act, as amended and asapplied under 21 CFR 807, Subpart E, under which a device can bemarketed without pre-market approval or reclassification. Adetermination of substantial equivalency under this notification isnot intended to have any bearing whatsoever on the resolution ofpatent infringement suits or any other patent matters. Nostatements related to, or in support of substantial equivalenceherein shall be construed as an admission against interest under theUS Patent Laws or their application by the courts.

CONFIDENTIAL

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 1 2003

Ms. Bonnie J. Smith Senior Regulatory Affairs Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301

Re: K031677

Trade/Device Name: Synthes Clavicle Hook Plate Regulation Numbers: 21 CFR 888.3030 Regulation Names: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Codes: HRS Dated: May 29, 2003 Received: May 30, 2003

Dear Ms. Smith:

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

{2}------------------------------------------------

Page 2 – Ms. Bonnie J. Smith

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 (301) 594-4659. 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,

Mark A. Melleuson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

2. Indications for Use

Page 1 of 1

510(k) Number (if known):	K031677
Device Name:	Synthes Clavicle Hook Plate
Indications for Use:	Intended for fixation of lateral clavicle fractures and dislocations ofthe acromioclavicular joint.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR Over-The-Counter Use
Mark n Millerm

(Division Sign-C I) Division of Gene al, Restorative and Neurological Devices

510(k) Number K031677
CONFIDENTIAL 90004

Premarket Notification 510(k) Synthes (USA) Clavicle Hook Plate

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.