INTRAOSSEOUS FIXATION SYSTEM

• K Number: K141004
• Device Name: INTRAOSSEOUS FIXATION SYSTEM
• Manufacturer: ORTHOHELIX SURGICAL DESIGNS, INC.
• Date Cleared: 2014-08-21 ( 125 days)
• Product Code: HTY
• Regulation Number: 888.3040
• Type: Special
• Panel: OR
• Reference & Predicate Devices: K120165 , K070598 , K100618 , K133636 , K061164 , K050259

Intended Use

The Intraosseous Fixation System is indicated to stabilize and aid in fixation of fractures, fusions, and osteotomies of the phalanges.

Device Description

The Intraosseous Fixation System consists of various size implants to stabilize and aid in the fixation of fracture, fusions, and osteotomies of the phalanges. The implants are offered in different lengths and diameters. All implants are manufactured from implant grade titanium alloy or PEEK.

AI/ML Overview

This document is a 510(k) premarket notification summary for the "Intraosseous Fixation System" by Tornier, OrthoHelix Surgical Designs, Inc. It details the device, its intended use, and its substantial equivalence to previously marketed devices. However, it does not describe an acceptance criteria table, a study proving device performance against such criteria, or any of the other specific items requested in your prompt (sample size, expert qualifications, adjudication, MRMC study, standalone performance, ground truth types, training set details).

This type of submission primarily focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, often relying on mechanical testing to show similar performance characteristics to the predicate, rather than clinical efficacy studies with specific acceptance criteria as you've outlined.

Therefore, I cannot extract the requested information from the provided text. The document does not contain the details for:

1. A table of acceptance criteria and the reported device performance: This document reports mechanical testing (4-point bend, axial pull-out, insertion/removal torque, torque to failure) to establish substantial equivalence, but it doesn't present these as "acceptance criteria" for a specific study, nor does it provide the exact performance values against such criteria.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical study with ground truth establishment is described.
4. Adjudication method for the test set: Not applicable.
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, as this is a physical medical device, not an AI or imaging diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.