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The Adaptive Wedge has a distinct design to help facilitate bony integration once implanted. It has angular teeth to prevent backing out. It is offered in varying widths and thicknesses to accommodate a variety of small bone applications.

Materials:
PEEK Optima LT1 per ASTM F2026. Titanium alloy per ASTM F136.

Function:
Used for angular correction of gaps and bony voids of small bones in the ankle and foot.

AI/ML Overview

The provided text describes a 510(k) submission for the "Adaptive Wedge" bone fixation device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than de novo clinical studies with acceptance criteria in the traditional sense of AI/software performance.

Therefore, the requested information elements related to AI and software performance, such as sample sizes for test sets and training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types (pathology, outcomes data), are not applicable to this document as it pertains to a physical medical device.

The study presented here is a non-clinical study involving mechanical testing, not a clinical study on human subjects or an AI/software performance study.

Here's a breakdown of the applicable information:

1. Table of "Acceptance Criteria" and Reported Device Performance:

Since this is a substantial equivalence claim for a physical bone wedge, the "acceptance criteria" are implied by meeting the performance of the predicate devices. The performance is reported through mechanical tests.

Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (Non-Clinical Test Summary)
Equivalent static compression strength to predicate devices	Passed static compression testing
Equivalent dynamic compression strength to predicate devices	Passed dynamic compression testing
Equivalent coefficient of friction to predicate devices	Passed determination of the coefficient of friction
Equivalent subsidence and debris generation during static and dynamic compression-shear testing to predicate devices	Passed determination of subsidence and debris generation during static and dynamic compression-shear testing
As safe and effective as predicate devices	The conclusions drawn from the comparison between the devices demonstrate that the Adaptive Wedge is as safe, as effective, and performs as well as, or better, than the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: Not specified in the document. The testing refers to mechanical properties of the device itself, not a test set of data.
Data Provenance: Not applicable in the context of clinical or AI data. The "data" comes from engineering/benchtop mechanical testing of the device.

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

Not Applicable. Ground truth, in the context of clinical or AI studies, refers to a definitive diagnosis or outcome. For a physical device, the "ground truth" for mechanical properties would be established through standardized engineering test methods and observed physical characteristics, not expert consensus on medical data.

4. Adjudication Method for the Test Set:

None. Not applicable to mechanical testing of a physical device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. No clinical studies, let alone MRMC studies, were performed.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

No. This is a physical bone wedge, not an algorithm.

7. Type of Ground Truth Used:

Mechanical Test Results against Predicate Performance. The "ground truth" for demonstrating substantial equivalence was the performance of predicate devices in specific mechanical tests. The Adaptive Wedge's performance in these same tests was then compared to show equivalence.

8. Sample Size for the Training Set:

Not Applicable. This is a physical device, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable. No training set was used.

Summary of Relevant Study Information from the Document:

Study Type: Non-clinical (mechanical) testing.
Purpose: To demonstrate substantial equivalence to predicate devices (BIOFOAM™ Bone Wedge, K073535 / K093950).
Tests Performed:
- Static compression testing
- Dynamic compression testing
- Determination of the coefficient of friction
- Determination of subsidence and debris generation during static and dynamic compression-shear testing
Conclusion: The tests indicated that the Adaptive Wedge is equivalent to the predicate devices in terms of mechanical safety and performance.
Clinical Studies: None were performed.

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