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The Contours Lapidus Plating System is intended for revision procedures and joint fusion in the small bones of the foot.

The Contours Lapidus Plating System consists of bone plates, screws and manual, orthopedic, surgical instruments. The plates (left and right versions) are low-profile and anatomically contoured for the 1st metatarsal and cuneiform. Each plate has a trapezoidal screw hole geometry with three angled, threaded holes at both the distal and proximal ends as well as a compression hole for intraoperative compression across the joint. The Contours Lapidus plate and bone screws are made from titanium alloy conforming to ASTM F136.

The provided text describes a 510(k) summary for the "Contours Lapidus Plating System," a bone plate device. The information details the device's technical characteristics, indications for use, and a statement about biomechanical testing and substantial equivalence to a predicate device.

However, the document does NOT contain specific acceptance criteria or the detailed study results that prove the device meets those criteria in a format applicable to evaluating AI/ML-based medical devices. The document focuses on demonstrating substantial equivalence to a predicate device through material characterization and biomechanical testing of mechanical properties, not performance in terms of diagnostic accuracy or clinical outcomes in a statistical sense that would involve sample sizes for testing, expert ground truth, or comparative effectiveness studies.

The provided information is for a conventional medical device (bone plate), not an AI/ML device. Therefore, many of the requested categories (like sample size for test/training sets, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, etc.) are not applicable to this type of submission.

Here's a breakdown of the relevant information provided, and where the requested AI/ML specific information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in terms of performance metrics like sensitivity, specificity, or accuracy that would be typical for an AI/ML device. Instead, it speaks to meeting "testing requirements" and performing "as well as the predicate device" through biomechanical testing.

Regarding the Study:

The study referenced is "Biomechanical Testing" which included:

• Bending strength
• Bending stiffness
• Fatigue life
• Screw torque
• Cadaveric functional testing

The purpose of this testing was to demonstrate:

1. The Contours Lapidus Plating System has the mechanical properties necessary to perform its intended use.
2. The device performs as well as the predicate device (Darco® Locking Plate System: K061808).

The following information is NOT available or NOT APPLICABLE from the provided text, as it pertains to AI/ML device evaluations:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Not Applicable. This device is a bone plate, and the "testing" refers to mechanical and cadaveric biomechanical tests, not the statistical evaluation of an algorithm's performance on a dataset of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not Applicable. Ground truth for mechanical testing is based on physical measurements and engineering specifications, not expert interpretation of medical images or clinical data.

4. Adjudication method (e.g., 2+1, 3+1, none) 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 not an image-reading AI device.

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

• Not Applicable. There is no algorithm.

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

• For biomechanical testing, the "ground truth" would be the measured physical properties and performance against established engineering standards or direct comparison to the predicate device under specific test conditions.

8. The sample size for the training set

• Not Applicable. There is no training set as this is not an AI/ML device.

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

• Not Applicable. There is no training set.

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