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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 current submission adds disposable instruments to the InCore® Lapidus System. The disposable instruments are packaged in sterile kits with the 28mm post and post plug screw implant. The implant components of the system are unchanged aside from the change in packaging of the 28mm posts and post plug screws.

This is a 510(k) premarket notification for a medical device called "InCore® Lapidus Sterile Kits". Based on the provided text, the device is a bone fixation fastener used for First Metatarsocuneiform arthrodesis. The document states that clinical testing was not necessary to demonstrate substantial equivalence, meaning a study proving the device meets acceptance criteria as typically understood for AI/ML devices or clinical trials was not conducted or required.

The submission is primarily focused on demonstrating substantial equivalence to a predicate device, specifically regarding a change from re-usable, non-sterile instruments to disposable, sterile instruments packaged with the implants.

Therefore, the requested information cannot be fully provided in the context of a typical acceptance criteria study for device performance (e.g., sensitivity, specificity, accuracy). However, I can extract the relevant information from the document regarding the non-clinical testing performed to support the substantial equivalence claim for the instrument change.

Here's an adaptation of the requested information based on the provided 510(k) summary:

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

Since this is a substantial equivalence submission primarily for a change in instruments and packaging, the "acceptance criteria" are related to biocompatibility, sterility, and endotoxin levels for the new disposable instruments and packaging, rather than clinical performance metrics. The document implies acceptable results for these non-clinical tests.

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

• Sample Size: Not specified for biocompatibility, packaging validation, or endotoxin testing. These types of tests typically follow established standards that dictate sample sizes based on lot size or statistical confidence, but the specific numbers are not in this summary.
• Data Provenance: Not specified, but generally, non-clinical tests for medical devices are performed in controlled laboratory environments.

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. This is not a study requiring expert clinical assessment for ground truth. Biocompatibility and endotoxin testing rely on laboratory analyses and adherence to standardized protocols.

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

Not applicable. Adjudication methods are typically used in clinical studies or studies involving human interpretation of data where consensus among experts is needed.

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

No, an MRMC comparative effectiveness study was not conducted. The document explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the InCore® Lapidus Sterile Kits to the predicate device." This device is not an AI/ML-driven diagnostic or assistive tool for human readers.

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

No, a standalone performance study was not conducted as the device is a physical bone fixation fastener, not an algorithm.

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

For the non-clinical tests mentioned:

• Biocompatibility: Ground truth is established by adherence to ISO 10993 series standards, assessing biological responses to medical devices.
• Packaging Validation: Ground truth is established by demonstrating the ability of the packaging to maintain sterility over a defined shelf life and withstand shipping realities, often using standards like ISO 11607.
• Endotoxin Testing: Ground truth is established by reference standards for endotoxin and validated analytical methods (e.g., LAL assay).

8. The sample size for the training set

Not applicable. This is not an AI/ML device requiring a training set.

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

Not applicable. This is not an AI/ML device requiring a training set.

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