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The Nextremity Solutions InCore® Lapidus System is a three-part construct intended for internal fixation for First Metatarsocuneiform arthrodesis (also known as Lapidus or First Tarsometatarsal Fusion).

The InCore® Lapidus System consists of a post and two headless compression screws. Posts are available in 28mm and 32mm lengths and in right and left orientations. Screws are available in a 3.5mm diameter and lengths of 24 to 60mm. The post is inserted into the medial cuneiform and compression screws are inserted into the first metatarsal and into the post to maintain apposition of the bones during fusion. A post plug screw is threaded into the top of the post after all components have been implanted to prevent tissue ingrowth into the post and facilitate removal, if needed. All implants are manufactured from color anodized Ti-6Al-4V alloy conforming to ASTM F-136. The system is provided with a set of accessory instruments designed for preparation of the implant site and insertion of the implants into bone.

The provided text is a 510(k) summary for the InCore® Lapidus System, a medical device for internal fixation in foot surgery. It primarily focuses on demonstrating substantial equivalence to predicate devices based on non-clinical testing.

Here's an analysis of the text in the context of your request:

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

The document does not explicitly state "acceptance criteria" as clear numerical thresholds for performance. Instead, it describes "Non-Clinical Testing" designed to "confirm that the strength of the InCore® Lapidus System is substantially equivalent to predicate devices with similar indications and is adequate for its intended use."

The reported device performance is qualitative rather than quantitative in this summary.

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

The document does not specify the exact sample sizes (number of screws or constructs) used for the non-clinical tests. It refers to testing "worst case compression screws" and "worst case constructs," implying a targeted selection, but not the quantity.

The data provenance is not mentioned. Given it's non-clinical (mechanical) testing, it would likely be conducted in a laboratory setting, not tied to a specific country of origin in the same way clinical data would be.

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):

This information is not applicable to the type of testing described. The "testing" here refers to mechanical and material performance tests, where a "ground truth" established by human experts in the context of diagnostic or interpretive tasks is not relevant. The "ground truth" would be objective measurements from testing equipment compared against engineering specifications or predicate device performance.

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

This is not applicable. Adjudication methods are typically used in clinical studies or expert review processes, especially for ambiguous cases in diagnostic tasks. The non-clinical tests are objective mechanical measurements.

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:

This is not applicable. The device is a "Bone Screw System" for internal fixation, not an AI or diagnostic imaging device. No MRMC study or AI assistance is mentioned or relevant to this 510(k) submission.

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

This is not applicable. The device is a physical implant, not an algorithm.

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

For the non-clinical tests, the "ground truth" would be established by:

• Engineering specifications and standards: The device performance (strength, torque, bend) would be measured against predefined physical limits or industry standards for similar implants.
• Predicate device performance data: The performance of the InCore® Lapidus System was compared to the known performance characteristics of the "substantially equivalent devices" (K121349 and K160304) to demonstrate equivalence.

8. The sample size for the training set:

This is not applicable because this document describes a physical medical device (implants), not a machine learning model that requires a "training set."

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

This is not applicable for the same reason as point 8; there is no training set for a physical implant.

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