The ORTHOLOC® 2.0 / 2.4 Plate System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The system can be used in both adult and pediatric patients. Examples include:

Metatarsal or metacarpal fractures and osteotomies Phalanges fractures and osteotomies

Device Description

The design features of the ORTHOLOC® 2.0 / 2.4 System are described below.

Consists of a variety of flat and pre-contoured plate geometries .
Plates feature compression slots and locking screw holes .
Manufactured from Titanium and Titanium Alloy .
Screws are available in both locking and non-locking designs .
Screws are available in 2 diameters and 7 lengths in the small diameter and 12 lengths in . the large diameter

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way described in the request. The document is a 510(k) summary for the ORTHOLOC® 2.0/2.4 System, which is a premarket notification to the FDA.

Here's what can be extracted and why other points cannot be addressed:

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

Not found: The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance data against specific acceptance criteria. No such table is included.

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

Not found: No information about a "test set," sample size, or data provenance from a study is provided. The submission relies on "substantial equivalence information, materials information, and analysis data" without specifying the nature or origin of this data in a study context.

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 found: As no test set study is detailed, there's no mention of experts or their qualifications.

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

Not found: No adjudication method is mentioned as there's no detailed study description.

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 found: The device is a bone fixation plate and screw system, which is a physical implant, not an AI-assisted diagnostic tool. Therefore, an MRMC study involving human readers and AI is not applicable and not mentioned.

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

Not found: This point is not applicable as the device is not an algorithm.

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

Not found: No ground truth information is provided, as no specific performance study against a "ground truth" is detailed. The submission relies on substantial equivalence.

8. The sample size for the training set

Not found: This is not an AI/algorithm device, so there is no concept of a "training set."

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

Not found: Not applicable for the reasons mentioned above.

Summary of available information:

The K090692 document is a premarket notification (510(k)) that asserts the ORTHOLOC® 2.0 / 2.4 Plate & ORTHOLOC® 2.0 / 2.4 Screw system is substantially equivalent to legally marketed predicate devices. The basis for this claim is "design features, material, and indications for use." The safety and effectiveness are "adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification," but specifics of performance studies or acceptance criteria beyond this equivalence are not provided in the summary.

Summary

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K090692

MAY ー 8 2009

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the ORTHOLOC® 2.0 / 2.4 System.

Submitted By:	Wright Medical Technology, Inc.
Date:	March 13, 2009
Contact Person:	Fred W. Bowman, P.E.
	Senior Regulatory Affairs Specialist
Proprietary Name:	ORTHOLOC® 2.0/2.4 Plate & ORTHOLOC® 2.0/2.4 Screw
Common Name:	Bone Fixation Plate & Bone Screw
Classification Name and Reference:	21 CFR 888.3030 Plate, Fixation, Bone - Class II21 CFR 888.3040 Screw, Fixation, Bone - Class II
Device Product Code and Panel Code:	Orthopedics/87/HRSOrthopedics/87/HWC

DEVICE INFORMATION

A. INTENDED USE

Metatarsal or metacarpal fractures and osteotomies Phalanges fractures and osteotomies

B. DEVICE DESCRIPTION

The design features of the ORTHOLOC® 2.0 / 2.4 System are described below.

Consists of a variety of flat and pre-contoured plate geometries .
Plates feature compression slots and locking screw holes .
Manufactured from Titanium and Titanium Alloy .
Screws are available in both locking and non-locking designs .
Screws are available in 2 diameters and 7 lengths in the small diameter and 12 lengths in . the large diameter

Page 1 of 2

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Image /page/1/Picture/0 description: The image shows a sequence of handwritten characters. The sequence starts with the letter 'K', followed by the numbers '090692'. The characters are written in black ink on a white background and appear to be part of a serial number or identification code.

C. SUBSTANTIAL EQUIVALENCE INFORMATION

The design features, material, and indications for use of the ORTHOLOC® 2.0/2.4 System are substantially equivalent to previously cleared predicate devices. The safety and effectiveness of the ORTHOLOC® 2.0/2.4 System is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

MAY - 8 2009

AY - 8 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Wright Medical Technology, Inc. % Mr. Fred W. Bowman, P.E. Senior Regulatory Affairs Specialist 5677 Airline Road Arlington, Tennessee 38002

Re: K090692

Trade/Device Name: Ortholoc 2.0/2.4 Plate & Ortholoc 2.0/2.4 Screw Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, HWC Dated: March 13, 2009 Received: March 16, 2009

Dear Mr. Bowman:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. Fred W. Bowman, P.E.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Daniel Keane

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K090692

Indications for Use

510(k) Number (if known):

Device Name: ORTHOLOC® 2.0 / 2.4 Plate System

Indications For Use:

Metatarsal or metacarpal fractures and osteotomies Phalanges fractures and osteotomies

Prescription Use (Part 21 CFR 801 Subpart D)

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AND/OR·

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

(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 Surgical, Orthopedic, and Restorative Devices

510(k) Number K090692

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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.