The AOS Trochanteric Nail is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric, intertrochanteric and high subtrochanteric fractures and combinations of these fractures. The long trochanteric nail is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fracture, ipsilateral femoral fractures, proximal and distal nonunions and malunions and revisions procedures.

Device Description

The AOS Solid Locking and Telescoping Lag Screws are used in the AOS Trochanteric Nail System, in conjunction with the AOS Trochanteric Nail. Both AOS screws can be locked to the nail. The Telescoping Lag Screw allows the threads to collapse within the barrel.

AI/ML Overview

This document describes a 510(k) premarket notification for the "AOS Trochanteric Nail System, Telescoping (TC") Lag Screw and Solid Locking Lag Screw." This is a medical device for internal fixation of femoral fractures, specifically for the trochanteric and subtrochanteric regions.

The information provided focuses on demonstrating substantial equivalence to predicate devices, rather than a study proving the device meets specific performance acceptance criteria through clinical or comprehensive standalone studies as might be done for an AI/CAD device.

Therefore, many of the requested categories (e.g., sample sizes for test/training sets, number of experts for ground truth, MRMC studies) are not applicable or cannot be extracted from this type of regulatory submission for a traditional orthopedic implant.

Here's an attempt to answer the questions based on the provided text, indicating "Not Applicable" or "Not Provided" where the information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of traditional orthopedic implant, "acceptance criteria" are typically met by demonstrating that the device performs equivalently or better than predicate devices in specific mechanical tests, and shares the same intended use, fundamental technology, and materials. The "reported device performance" is the outcome of these mechanical tests, specifically demonstrating substantial equivalence.

Acceptance Criteria Category	Reported Device Performance (Summary)
Mechanical Performance	Demonstrated substantial equivalence to predicate devices in static and fatigue testing according to ASTM F384.
Mechanical Performance (Telescoping Lag Screw)	Additionally, demonstrated performance in torque testing according to ASTM F543.
Indications for Use	Same indications for use as predicate devices.
Material	Made of the same material as predicate devices.
Design and Technology	Similar in shape and design, and has the same fundamental technology as predicate devices.

2. Sample Sizes Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable in the context of human data or AI model evaluation. The "test set" here refers to the physical devices subjected to mechanical testing. The exact number of devices tested for each mechanical test (static, fatigue, torque) is not specified, but the tests were performed "in accordance with ASTM F384" and "ASTM F543" which would specify sample size requirements.
Data Provenance: Not applicable in the context of human data. The "data" comes from in vitro mechanical testing of the physical device components.

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

Number of Experts & Qualifications: Not applicable. Ground truth, in this context, is established by adherence to recognized industry standards (ASTM F384, F543) and validated mechanical testing methodologies.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. Results are based on physical measurements from standardized mechanical tests.

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

MRMC Study: No. This is a physical orthopedic implant, not an AI/CAD diagnostic device.

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

Standalone Study: Not applicable. This is a physical orthopedic implant, not an algorithm. The "standalone performance" refers to the mechanical performance of the device components themselves in controlled in vitro tests.

7. The Type of Ground Truth Used

Type of Ground Truth: Established through standardized mechanical testing protocols (ASTM F384, ASTM F543). The "ground truth" for this device is the objective physical performance and material properties as measured under these standards, compared to predicate devices.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This is not an AI/ML device where a "training set" would be used to develop an algorithm. The "training" for this type of device occurs during its design and manufacturing process, using engineering principles and established material science.

9. How the Ground Truth for the Training Set was Established

Ground Truth for Training Set: Not applicable as a distinct "training set" with established ground truth, in the context of AI/ML, does not apply here. The "ground truth" influencing the design and development (analogous to 'training') would be engineering specifications, material properties, biomechanical principles, and the performance characteristics of successful predicate devices.

Summary

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AOS

ADVANCED ORTHOPAEDIC SOLUTIONS

K120148

PAGE 1 OF 2

5. TRADITIONAL 510(K) SUMMARY OCT 2 2012 DATE PREPARED: October 1, 2012 Advanced Orthopaedic Solutions, Inc. SUBMITTED BY: 386 Beech Avenue, Unit B6 Torrance, CA 90501 Phone: (310) 533-9966 CONTACT PERSON: Julie Glendrange Advanced Orthopaedic Solutions, Inc. 386 Beech Avenue, Unit B6 Torrance, CA 90501 Phone: (310) 533-9966 DEVICE NAME: AOS Trochanteric Nail System, Telescoping (TC") Lag Screw and Solid Locking Lag Screw COMMON NAME: Internal Fixation CLASSIFICATION: Class II, 21 CFR 888.3020 Rod, Fixation, Intramedullary and Accessories DEVICE CODE: HSB SUBSTANTIALLY EQUIVALENT DEVICE: AOS Trochanteric Nail System (510(k): K021008, Cleared June 20, 2002 and K103533, Cleared Jan. 19, 2011); and EBI® Trochanteric Nail System (510(k): K050118, Cleared Feb. 16, 2005) DEVICE DESCRIPTION: The AOS Solid Locking and Telescoping Lag Screws are used in the AOS Trochanteric Nail System, in conjunction with the AOS Trochanteric Nail. Both AOS screws can be locked to the nail. The Telescoping Lag Screw allows the threads to collapse within the barrel. INDICATIONS FOR USE: The AOS Trochanteric Nail is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric, intertrochanteric and high subtrochanteric fractures and combinations of these fractures. The long trochanteric nail is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic

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use) in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fracture, ipsilateral femoral fractures, proximal and distal nonunions and malunions and revisions procedures.

1129 148

SUBSTANTIAL EQUIVALENCE: Information presented supports substantial equivalence of the AOS Solid Locking and Telescoping Lag Screws to the predicate devices. The proposed systems have the same indications for use, are similar in shape and design, have the same fundamental technology and are made of the same material.

PRECLINICAL TESTING: The AOS Solid Locking and Telescoping Lag Screws were each subjected to static and fatigue testing in accordance with ASTM F384, Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices. The results demonstrate that the Solid Locking and Telescoping Lag Screws are substantially equivalent to the predicate devices. Additionally, the Telescoping Lag Screw was subjected to torque testing in accordance with ASTM F543, Standard Specifications and Test Methods for Metallic Medical Bone Screws.

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Image /page/2/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 bars representing health, services, and human needs. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

OCT 2 2012

Advanced Orthopaedic Solutions, Inc. % Ms. Julie Glendrange 386 Beech Avenue, Unit B6 Torrance, CA 90501

Re: K120148

Trade/Device Name: Solid Locking Lag Screw and TCII - Telescoping Lag Screw Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: September 14, 2012 Received: September 17, 2012

Dear Ms. Glendrange:

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 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the [kit/tray] have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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

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Page 2 – Ms. Julie Glendrange

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Erin S. Keith

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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VANCED ORTHOPAEDIC SOLUTIONS

4. INDICATIONS FOR USE STATEMENT

Traditional 510(k) Premarket Notification Indications for Use Statement AOS Trochanteric Nail System

510(k) Number (if known): K120148

Device Name: AOS Trochanteric Nail System

Indications for Use:

Prescription Use: X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use: (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ashif

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

K120148 510(k) Number .

Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.