FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Biosteon™ Screw is used to provide interference fixation during femoral and/or tibial fixation in ACL reconstruction using a soft tissue graft (semi-tendonosis gracilis).

Device Description

The Biosteon™ Screw is a cannulated, sterile, single-use bone screw made of an absorbable polymer similar to that used in bioabsorbable suture and will gradually be absorbed into the body. The Biosteon™ Screw is manufactured from a mixture of Hydroxyapatite (HA) and poly (L-lactide) (PLLA).

AI/ML Overview

The provided 510(k) summary for the Biosteon™ Screw (K003641) does not contain detailed acceptance criteria or a study that explicitly proves the device meets specific quantitative acceptance criteria in the way described in your request (e.g., sensitivity, specificity, or other performance metrics typically associated with AI/software-as-a-medical-device studies).

This document pertains to a physical medical device (an absorbable bone screw), not an AI/software device. Therefore, many of the requested fields, such as those related to AI model performance, expert ground truth, sample sizes for test/training sets, and MRMC studies, are not applicable in this context.

Here's an attempt to extract and interpret the available information according to your request, highlighting what is present and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Requisite strength for early and sustained graft fixation	Test results confirm this composite has the requisite strength.
Favorable pull-out test results compared to predicate devices	Pull out test results compare favourably with the predicate devices.
Equivalence in design, materials, and indications to predicate devices	Biosteon™ Screw is equivalent in design, materials and indications to the predicate devices.

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

Sample Size: Not specified. The document states "Test results" but does not quantify the number of units tested.
Data Provenance: Not applicable in the context of human data. The tests are laboratory-based mechanical performance tests.

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

Not Applicable. This is a physical device; ground truth for its mechanical properties is established through standardized engineering tests, not expert human assessment.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not Applicable. No human adjudication method is described or implied for the mechanical testing of the screw.

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. No MRMC study was conducted as this is not an AI/software device.

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

Not Applicable. This is not an algorithm or software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Mechanical Testing Results / Engineering Standards: The ground truth for the device's performance (strength, pull-out force) would be derived from laboratory measurements against established engineering specifications or benchmarks set by predicate devices.

8. The sample size for the training set

Not Applicable. This is not a machine learning/AI device, so there is no training set in the AI sense. The "training" for the device's design would come from materials science research and iterative design processes.

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

Not Applicable. See point 8.

Summary of Device Performance Study (as described in the 510(k) summary):

The 510(k) summary indicates that the substantial equivalence of the Biosteon™ Screw to predicate devices (Bio Interference Screw, BioScrew, BioLok® Screw) was supported by performance data, specifically mechanical testing.

Study Design (Implied): Comparative mechanical testing.
Primary Outcome: Confirmation of "requisite strength to provide early and sustained fixation of the graft" and "favourable pull out test results" when compared to predicate devices.
Test Method (Implied): Mechanical assays such as tensile strength, compression, and pull-out force tests, likely conducted in a laboratory setting using surrogate materials or cadaveric models that mimic the surgical environment.
Results: The device demonstrated "requisite strength" and "favourable pull out test results" compared to its predicates. This satisfied the FDA's requirement for demonstrating substantial equivalence based on technological characteristics and performance.

Conclusion:

The provided document describes the safety and effectiveness of a physical bone fixation screw. The "study" mentioned refers to mechanical performance testing, which is common for such devices. It does not involve any AI components, human readers, or the complex validation methodologies associated with AI-driven medical devices. The acceptance criteria are implicitly met by demonstrating comparable mechanical performance to legally marketed predicate devices.

Summary

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.