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The Nextremity Solutions MSP™ System is indicated for fixation of fractures, osteotomies, nonunions, malunions and fusions of small bones and small bone segments, particularly in osteopenic bone. Examples include, but not limited to, the hand, foot (shortening of the lesser metatarsal) and ankle.

The Nextremity Solutions MSP™ Metatarsal Shortening System is a set, consisting of:

1. A bone plate.
2. Specific length, cortical and locking screws.
3. Necessary surgical site preparation and insertion instruments (as a procedure pack).
   The cortical and locking screw(s) are used in conjunction with the bone plate and are individually packaged.
   The plate and screws are fabricated from medical grade Titanium and the design allows for fixation of fractures, osteotomies, non-unions, malunions and fusions of small bones and small bone segments found in the foot, particularly in osteopenic bone.

This document is a 510(k) summary for a medical device called the "MSPTM Metatarsal Shortening System." It focuses on the substantial equivalence to predicate devices and presents mechanical testing data, not a clinical study involving human readers or AI. Therefore, most of the requested information regarding clinical study parameters (sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, training sets) is not applicable or cannot be extracted from the provided text.

Here is the information that can be extracted or deduced from the provided text:

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

Study that proves the device meets the acceptance criteria:

The study performed was a mechanical testing study.

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not specified. Standard mechanical testing involves multiple samples for statistical validity, but the exact number is not provided.
• Data Provenance: Not applicable in the context of mechanical testing. The tests are conducted under laboratory conditions.

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

Not applicable. Mechanical testing does not involve "experts" for ground truth in the way a clinical study would. The ground truth (e.g., failure load) is determined by direct physical measurement and engineering principles.

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

Not applicable. Adjudication is a process for resolving discrepancies in expert opinion in clinical studies; it is not relevant to mechanical testing.

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. This document describes mechanical testing of a physical implantable device, not an AI-powered diagnostic or assistive tool.

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

No. This is a physical medical device, not an algorithm.

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

The "ground truth" for mechanical testing is based on objective physical measurements of force, displacement, torque, and other material properties, as defined by relevant ASTM standards.

8. The sample size for the training set:

Not applicable. This is not a machine learning study.

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

Not applicable.

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