The Tibia OrthoNail is a solid cylinder. The Tibia OrthoNail is available in diameters, 9 - 14 mm and in lengths of 200 - 425 mm. The device is designed to accept transfixing screws. End caps are provided. For use during insertion an Impacting Anvil is provided. An Alignment Tower is provided to ensure proper alignment of transfixation screw holes. The Anvil has an internal proximal thread for attachment of a slaphammer that is used for insertion or distraction.

AI/ML Overview

This document is a 510(k) premarket submission for a medical device (Tibia OrthoNail), not a study evaluating the performance of an AI/ML device. Therefore, it does not contain information related to acceptance criteria or studies proving device performance in the context of AI/ML.

The provided text describes the device, its classification, and makes a claim of substantial equivalence to predicate devices based on technological characteristics (materials, dimensions, design features), but it does not include:

Acceptance criteria for AI/ML performance metrics (e.g., sensitivity, specificity, AUC).
Any study details, sample sizes, ground truth establishment, or expert involvement relevant to AI/ML device evaluation.
Information about training sets, test sets, or comparative effectiveness studies involving AI assistance.

Essentially, the document focuses on regulatory approval for a physical medical implant, not the assessment of an intelligent algorithm.

Summary

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OrthoLogic Corp. Premarket Submission MAR 1 3 1996

945561

OrthoNail 510(k)

510(k) SUMMARY Tibia OrthoNail December 15, 1995

K455061

This summary is provided in accordance with the Safe Medical Devices Act of 1990 (SMDA). The information of to provided in accordance with the Safe Medical Devices Act of 1990 (SMDA). The States
Information provided in the 510(k), premarket notification was in accord

1. Submitter of 510(k)

Company Name: OrthoLogic Corp Address: 2850 South 36th Street Phoenix, Arizona 85034

Contact Person: James Koeneman, Ph.D., Vice President of Engineering
Telephone: (602) 437-5520 Fax: (602) 437-5524

2. Name of Device:

Trade/Proprietary Name:

Tibia OrthoNail

Common/Usual Name:

Intramedullary Fixation Device

Classification Name:

21 CFR 888.3020 "Intramedullary Fixation Rod", Class II.

3. Legally Market Predicate Devices

The Tibia OrthoNail is substantially equivalent to many legally marketed intramedullary
fixation devices inluding those listed Table 1 below fixation devices inluding those listed Table 1 below.

4. Device Description

The Tibia OrthoNail is indicated for stabilizing tibral fractures. All implanted components
are manufactured from titanium alloy, 6AI-4V, conforming to ASTM B 1840 and in a some fan is indicated for stabilizing tibral fractures. All implanted components
are manufactured from titanium alloy, 6AL-4V, conforming to ASTM F 136-92. The components include from thailum alloy, 6AI-4V, conforming to

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Table 1
Comparison of Technological CharacteristicsPredicate Devices and the Tibia OrthoNail

Manufacturer	OrthoLogic	Applied OsteoSystems	Richards
Device	OrthoNail	True/Flex	Russell-Taylor
TechnologicCharacteristic
Tibial	yes	yes	yes
Solid Section	Yes	Yes	Yes
TransfixationHoles	Yes	Yes	Yes
Material	TitaniumAlloy	TitaniumAlloy	Stainless Steel
Diameter	9 - 14mm	9, 10 mm	11-14 mm
Length	200 - 425 mm	285 - 390mm	285 - 380 mm

Based on the information provided, the Tibia OrthoNail is substantially equivalent to legally marketed predicate devices.

510(k)

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.