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

The BioLok® Screw is used to provide interference fixation during femoral and/or The Block Screw is assoc to provise using a soft tissue graft (semi-tendonosis gracilis).

Device Description

The BioLok® 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 BioLok® Screw is manufactured from a mixture of Tri-Calcium Phosphate (TCP) and poly (L-lactide) (PLLA).

AI/ML Overview

The provided text describes a medical device, the BioLok® Screw, and its 510(k) summary for FDA clearance. However, it does not include the detailed information required to fill out all aspects of your request, particularly regarding specific acceptance criteria, detailed study designs, and performance metrics for AI/algorithm-based devices.

The BioLok® Screw is a physical medical device, not an AI or algorithm-driven system, so many of your requested categories (like MRMC studies, standalone algorithm performance, training set details, ground truth for AI, etc.) are not applicable here.

Here's the information that can be extracted or inferred from the provided text, along with explanations for the unfillable sections:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Inferred)	Reported Device Performance
Material Composition: Mixture of Tri-Calcium Phosphate (TCP) and poly (L-lactide) (PLLA).	The device is manufactured from a mixture of Tri-Calcium Phosphate (TCP) and poly (L-lactide) (PLLA).
Cannulated, sterile, single-use, absorbable polymer.	The BioLok® Screw is cannulated, sterile, single-use, and made of an absorbable polymer.
Strength over time to provide early and sustained graft fixation.	"Test results confirm that this composite has the requisite strength over time to provide early and sustained fixation of the graft."
Pull-out strength comparable to predicate devices.	"Pull out test results compare favourably with the predicate devices."
Equivalent in design, materials, and indications to predicate devices.	"The BioLok® Screw is equivalent in design, materials and indications to the predicate devices."
Intended Use: Fixation in ACL reconstruction for patellar bone-tendon-bone grafts and soft tissue grafts.	The device's intended use matches this criterion (as stated in section 5).

Explanation: The document does not explicitly list numerical acceptance criteria (e.g., "pull-out strength must be X Newtons"). Instead, it states that the device "has the requisite strength" and "compares favourably" to predicate devices, which implies that the acceptance criteria were met by demonstrating equivalence or non-inferiority to already cleared devices.

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

Sample Size: Not specified. The document mentions "test results" but does not quantify the number of screws or conditions tested.
Data Provenance: Not specified. The country of origin for the device manufacturer is the United Kingdom (Biocomposites Ltd, Etruscan Street, Etruria, Stoke-on-Trent, ST1 5PQ, England). Whether the testing was conducted there or elsewhere is not stated. The data type is prospective, as it refers to performance testing of the device itself.

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

Not Applicable. This device is a physical implant. The "ground truth" for its performance is established through biomechanical testing and material science, not through expert clinical interpretation of data.

4. Adjudication method for the test set

Not Applicable. See point 3.

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. This is a physical medical device, not an AI or imaging diagnostic tool that would involve human readers.

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

Not Applicable. This is a physical medical device.

7. The type of ground truth used

Biomechanical Testing and Material Science Data: The "ground truth" for the BioLok® Screw's acceptance criteria would be derived from:
- Mechanical Property Measurements: Strength (tensile, compression, shear, torsional, etc.), degradation rates.
- Material Characterization: Composition, purity, molecular weight distribution, etc.
- In Vitro Performance: Pull-out tests, degradation studies in simulated physiological environments.
- Comparison to Predicate Devices: Performance data from legally marketed predicate devices served as a benchmark for substantial equivalence.

8. The sample size for the training set

Not Applicable. This is a physical medical device. There is no "training set" in the context of an algorithm. Material formulation and manufacturing processes are optimized through development, but this is not typically referred to as a "training set" for a device like this.

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

Not Applicable. See point 8.

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.