The Stabiliz Fixation System is intended for fixation of fractures, osteotomies and nonunions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula.

Device Description

The Stabiliz Fixation System includes standard straight LCP plates, metal locking screws, cortical screws, and fully-threaded and partially-threaded cancellous screws in various sizes and geometries.

AI/ML Overview

The provided text does not contain information about the acceptance criteria and study proving a device meets these criteria in the context of an AI/ML medical device. Instead, it details a 510(k) submission for a Stabiliz Fixation System, which is a physical orthopedic device (plates, screws).

The 510(k) submission process for such a device focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than defining specific performance acceptance criteria and conducting studies to prove them in the same way an AI/ML device would.

Therefore, I cannot provide the requested table and information based on the given input regarding an AI/ML device. The document describes a traditional medical device clearance process, not an AI/ML device study.

However, I can extract the information relevant to the provided device's "acceptance criteria" and "study" from the text, framed within the context of a 510(k) submission for a non-AI device.

Acceptance Criteria and Study for the Stabiliz Fixation System (Non-AI Device)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (for 510(k) Substantial Equivalence)	Reported Device Performance
Indications for Use Equivalence	Stabiliz Fixation System indications for use are substantially equivalent to predicate devices (fixation of fractures, osteotomies, nonunions of clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula).
Device Design/Composition Equivalence	Stabiliz Fixation System includes standard straight LCP plates, metal locking screws, cortical screws, and fully-threaded and partially-threaded cancellous screws in various sizes and geometries, found to be substantially equivalent to predicates in geometry and available sizes.
Material Equivalence	Materials used in the Stabiliz Fixation System are substantially equivalent to predicate devices.
Method of Fixation to Bone Equivalence	Methods of fixation to bone for the Stabiliz Fixation System are substantially equivalent to predicate devices.
Performance (Mechanical) Equivalence	Preclinical testing demonstrated that the strength of the Stabiliz Fixation System plates and screws is substantially equivalent to legally marketed predicate devices.

2. Sample Size Used for the Test Set and Data Provenance (for mechanical testing)

Sample Size: Not explicitly stated in the provided text. The document mentions "an analysis of strength" but does not detail the number of plates, screws, or test configurations used in the preclinical testing.
Data Provenance: Not explicitly stated. The preclinical testing was "performed by the company" (Stabiliz Orthopaedics, LLC).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This is not applicable to preclinical mechanical testing for a traditional orthopedic fixation system. The "ground truth" for such devices is established through engineering standards and mechanical test methods.

4. Adjudication Method for the Test Set

Not applicable to preclinical mechanical testing. Results are based on quantitative measurements against defined mechanical standards or comparative performance against predicate devices.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This type of study (MRMC) is relevant for AI/ML devices where human readers evaluate cases with and without AI assistance. The Stabiliz Fixation System is a physical implant; its assessment does not involve human readers interpreting images or data.

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

No. This is not applicable as the Stabiliz Fixation System is a physical medical device, not an algorithm.

7. The type of ground truth used

For the preclinical testing, the "ground truth" would be established mechanical and material properties, and comparative performance data against legally marketed devices, demonstrating equivalent strength and function. This is typically based on engineering specifications and empirical measurements.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable. This device is not an AI/ML algorithm.

Summary for AI/ML Context:

Based on the provided input, there is no information about an AI/ML device, its acceptance criteria, or a study to prove it meets those criteria. The document describes a 510(k) submission for a physical orthopedic fixation system.

Summary

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Stabiliz Fixation System Device Trade Name: Stabiliz Orthopaedics, LLC Manufacturer: NOV 2 7 2012 3225 Arch Street Philadelphia, PA 19104 Douglas L. Cerynik, MD Contact: President & CEO Stabiliz Orthopaedics, LLC 3225 Arch Street Philadelphia, PA 19104 Office: (973) 714-5985 Fax: (202) 552- 5798 cerynik@stabilizorthopaedics.com Musculoskeletal Clinical Regulatory Advisers, LLC Prepared by: 1331 H Street NW, 12th Floor Washington, DC 20005 Phone: 202.552.5800 Fax: 202.552.5798 Date Prepared: November 16, 2012 Classifications: 21 CFR 888.3030: Single/multiple component metallic bone fixation appliances and accessories and 21 CFR 888.3040: Smooth or threaded metallic bone fixation fasteners Class: II HRS, HWC Product Codes:

510(k) Summary

Indications for Use:

Stabiliz Fixation System is intended for fixation of fractures, osteotomies and nonunions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula.

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Device Description:

The Stabiliz Fixation System includes standard straight LCP plates, metal locking screws, cortical screws, and fully-threaded and partially-threaded cancellous screws in various sizes and geometries.

Predicate Devices:

Comparative information presented in the 510(k) supports the substantial equivalence of the Stabiliz Fixation System to the following predicate devices: Synthes Small Fragment Dynamic Compression Locking (DCL) System (K000684); and Zimmer® Universal Locking System (K060710).

Substantial Equivalence:

The components of the Stabiliz Fixation System are substantially equivalent to the identified predicates with respect to indications for use, geometry, available sizes, materials, methods of fixation to bone, and performance.

Preclinical Testing:

The non-clinical tests performed by the company include an analysis of strength of the Stabiliz Fixation System plates and screws relative to legally marketed plates and screws. The analyses demonstrate that the Stabiliz Fixation System is substantially equivalent to legally marketed predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is written in all capital letters.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

November 27, 2012

Stabiliz Orthopaedics, LLC % Douglas L. Cerynik, M.D. President & Chief Executive Officer 3225 Arch Street Philadelphia, Pennsylvania 19104

Re: K120651

Trade/Device Name: Stabiliz Fixation System · Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: November 19, 2012 Received: November 19, 2012

Dear Dr. Cerynik:

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 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

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Page 2 - Douglas L. Cerynik, M.D.

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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Ronald P. Jean for

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

Enclosure

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Indications for Use 4.

K120651 510(k) Number (if known): _

Device Name: Stabiliz Fixation System

The Stabiliz Fixation System is intended for fixation of fractures, osteotomies and nonunions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula.

Prescription Use V (Part 29 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (29 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Krishna Asundi for (Division Sign-Off) Division of Orthopedic Devices

2012.11.23 09:42:07 -05'00'

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.