The CLAW® II Polyaxial Compression Plating System consists of plates and screws of various anatomic configurations and lengths. All plates and screws are manufactured from implant grade stainless steel. The plates accept 2.7mm and 3.5mm ORTHOLOCTM 3DSi locking screws.
The ORTHOLOC™ 3DSi Locking Screws are made from implant grade stainless steel and are available with cortical and cancellous thread forms in multiple length and diameters.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the CLAW® II Polyaxial Compression Plating System, demonstrating substantial equivalence to predicate devices rather than a study proving the device meets specific acceptance criteria with performance metrics. Therefore, many of the requested categories related to clinical study design and performance metrics cannot be directly extracted or are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the document in the format of specific, measurable acceptance criteria and corresponding performance data. The device demonstrates "substantial equivalence" to predicate devices through non-clinical testing.

Acceptance Criteria (Not Explicitly Stated)	Reported Device Performance (Based on Substantial Equivalence)
Mechanical strength/durability comparable to predicates	"The results of the test show that the subject CLAW® II Polyaxial Compression Plating System and ORTHOLOC™ 3DSi Locking Screws can be expected to perform at least as well as the legally marketed predicate identified in this 510(k) submission."
Polyaxial performance comparable to predicates	Demonstrated through "polyaxial performance testing."
Design features comparable to predicates	"The design features... are substantially equivalent to the design features of the predicate devices."
Safety and effectiveness comparable to predicates	"The safety and effectiveness... are adequately supported by the substantial equivalence information, materials information, and analysis data..."

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

Sample Size: Not specified for any test sets. The document describes "worst-case plate analysis, plate mechanical testing, and polyaxial performance testing," but does not detail the number of samples or specimens used in these tests.
Data Provenance: The studies are non-clinical, likely conducted in a laboratory setting by the manufacturer, Wright Medical Technology, Inc. There is no information on country of origin of data or whether it's retrospective or prospective, as these terms usually apply to clinical studies.

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

Not applicable. This device is cleared based on non-clinical substantial equivalence, not on expert-adjudicated ground truth from a clinical data set. The "ground truth" here is the performance of the predicate devices.

4. Adjudication method for the test set

Not applicable, as no external experts were used to establish a ground truth for a clinical test set. The determination of substantial equivalence was made by the FDA based on the presented non-clinical evidence.

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 not an AI/software device, but a physical orthopedic plating system. No MRMC studies or AI involvement are mentioned.

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

Not applicable, as this is a physical medical device, not an algorithm or AI.

7. The type of ground truth used

The "ground truth" in this context is the established safety and effectiveness of the predicate devices. The subject device's performance (mechanical, polyaxial performance) was assessed to be "at least as well as" the predicate devices. The ground truth for the predicate devices themselves would have been established through their original clearance processes, likely including non-clinical testing and potentially clinical data depending on their classification and introduction date.

8. The sample size for the training set

Not applicable, as this is not a machine learning or AI device that requires a training set.

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

Not applicable, as this is not a machine learning or AI device that requires a training set with established ground truth.

Summary

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JAN 3 1 2012

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The Leader in Foot & Ankle Surgery.

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 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the CLAW® II Polyaxial Compression Plating System.

(a)(1). Submitted By:	Wright Medical Technology, Inc.5677 Airline RdArlington, TN 38002
Date:	October 7, 2011
Contact Person:	Peggy S. RiversRegulatory Affairs Specialist(901) 867-4759
(a)(2). Proprietary Name:	CLAW® II Polyaxial Compression PlatingSystemORTHOLOC™ 3DSi Locking Screw
Common Name:	Plate System and Locking Screws
Device Classification Regulation:	21 CFR 888.3030—Class II
Device Product Code & Panel:	HRS: Plate, Fixation Bone87 orthopedics
(a)(3). Predicate Device:	K102352—EVOLVE® EPS ORTHOLOC™SystemK051908—CHARLOTTE® CLAW® PlatingSystemK080295—CHARLOTTE® CLAW® 3.5 PlatingSystem

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K093914- NEWDEAL® COMPRESSION PLATES K091614-OSTEOMED FOOT PLATING SYSTEM K101240-DEPUY ALPS SMALL BONE LOCKED PLATING SYSTEM K083843—LOCKING ANATOMIC & COMPOSITE PLATING SYSTEM K073624-MODULAR FOOT SYSTEM K100618-MAXLOCK EXTREME® EXTREMITY PLATING SYSTEM

(a)(4). Device Description

The ORTHOLOC™ 3DSi Locking Screws are made from implant grade stainless steel and are available with cortical and cancellous thread forms in multiple length and diameters.

The design features of the CLAW® II Polyaxial Compression Plating System and ORTHOLOC™ 3DSi Locking Screws are substantially equivalent to the design features of the predicate devices identified in this premarket notification.

(a)(5). Intended Use

Wright's CLAW® II Polyaxial Compression Plating System is intended to be used for fixation such as:

· Midfoot and hindfoot arthrodeses or osteotomies
· Tarsometatarsal arthrodeses (metatarsocuneiform, metatarsocubid. Lapidus)
· Intercuneiform arthrodeses
· Naviculocuneiform arthrodeses
· Talonavicular arthrodeses
· Calcaneocuboid arthrodeses
· Lisfranc arthrodeses
· Mono- or bi-cortical osteotomies in the forefoot, midfoot and hindfoot
· Fixation of osteotomies for hallux valgus treatment (Scarf and Chevron)
· Akin osteotomies
· First metatarsophalangeal arthrodeses

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(a)(6). Technological Characteristics Comparison

The technological characteristics of the CLAW® II Polyaxial Compression Plating System and ORTHOLOC™ 3DSi Locking Screws are substantially equivalent to technological characteristics of the predicates identified in this 510(k) submission.

The subject designs and indications are substantially equivalent to the predicates identified in this 510(k) submission. The subject screws and locking feature are substantially equivalent to the predicates identified in this premarket submission.

(b)(1). Substantial Equivalence - Non-Clinical Evidence

Substantial equivalence is shown through worst-case plate analysis, plate mechanical testing, polyaxial performance testing, and descriptive information. The results of the test show that the subject CLAW® II Polyaxial Compression Plating System and ORTHOLOCTM 3DSi Locking Screws can be expected to perform at least as well as the legally marketed predicate identified in this 510(k) submission.

The safety and effectiveness of the CLAW® II Polyaxial Compression Plating System and ORTHOLOC™ 3DSi Locking Screws are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this premarket notification.

(b)(2). Substantial Equivalence - Clinical Evidence

N/A

(b)(3). Substantial Equivalence - Conclusions

Substantial equivalence is shown through worst-case plate analysis, plate mechanical testing, polyaxial performance testing, and descriptive information. The subject CLAW® Polyaxial Compression Plating System designs are similar to the previous = CHARLOTTE® CLAW® 3.5 designs in basic plate form, size and hole placement. The subject designs and indications are substantially equivalent to the predicates identified in this 510(k) submission. The subject CLAW® II Polyaxial Compression Plating System locking holes contain the ORTHOLOC™ design feature which was 501(k) cleared with the ORTHOLOC™ EVOLVE® EPS System, 510(k) K102352. No new types of safety and effectiveness questions can be expected. From the evidence given in the Premarket Notification, the subject devices can be expected to perform at least as well as the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

JAN 3 1 2012

Wright Medical Technology, Inc. % Ms. Peggy S. Rivers 5677 Airline Road Arlington, TN 38002

Re: K113014

Trade/Device Name: CLAW® II Polyaxial Compression Plating System ORTHOLOCTM 3DSi Locking Screws 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: January 11, 2012 Received: January 13, 2012

Dear Ms. Rivers:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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Page 2 - Ms. Peggy S. Rivers, Regulatory Affairs Specialist II

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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,
Mark A. Millman

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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K113014

Indications for Use

510(k) Number (if known):

Device Name: CLAW® II Polyaxial Compression Plating System and ORTHOLOC™ 3DSi Locking Screw

Indications For Use:

The CLAW® II Polyaxial Compression Plating System is intended to be used for fixation such as:

· Midfoot and hindfoot arthrodeses or osteotomies
· Tarsometatarsal arthrodeses (metatarsocuneiform, metatarsocubid, Lapidus)
· Intercuneiform arthrodeses
· Naviculocuneiform arthrodeses
· Talonavicular arthrodeses
· Calcaneocuboid arthrodeses
· Lisfranc arthrodeses
· Mono- or bi-cortical osteotomies in the forefoot, midfoot and hindfoot
· Fixation of osteotomies for hallux valgus treatment (Scarf and Chevron)
· Akin osteotomies
· First metatarsophalangeal arthrodeses

Prescription Use X (Part 21 CFR 801 Subpart D)

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 K113014

Page 1 of 1

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.