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The TriMed Threaded IM Nail System is indicated for the treatment of select fractures and corrective osteotomies of short tubular bones. Specific indications for TriMed Small Threaded IM Nails include:

1. Phalangeal fractures of the hand, non-unions, malunions and corrective osteotomies
2. Metacarpal fractures, non-unions, malunions and corrective osteotomies

TriMed Threaded Intramedullary (IM) Nail System implants are non-sterile, non-bioabsorbable implantable devices used as aids to the treatment of certain types of fractures and osteotomies that lend themselves to the principle of nail/rod/screw fixation. TriMed Threaded IM Nail System implants are cannulated, partially threaded, intramedullary fixation nails used to align and stabilize fractures and osteotomies of short tubular bones. TriMed threaded IM Nails are either made from Ti-6AL-4V ELI per ASTM F 136 or 316L Stainless steel per ASTM F138. TriMed is adding 3.6mm Threaded IM Nails with length ranges between 30 and 70mm to the already cleared 1.8mm – 3.0mm diameter ranges

The provided document is a 510(k) summary for a medical device (TriMed Threaded Intramedullary Nail System), which primarily focuses on demonstrating substantial equivalence to a predicate device based on technical characteristics and non-clinical performance testing. It does not describe acceptance criteria for an AI/software device or a study involving human readers or AI performance in a clinical context.

Therefore, most of the requested information (items 2-9) regarding acceptance criteria, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment cannot be extracted from this document as it pertains to AI/software performance, which is not the subject of this 510(k) submission.

However, I can extract the information related to the non-clinical performance testing conducted for this device to demonstrate its safety and effectiveness.

Here's the relevant information that can be extracted:

1. Table of acceptance criteria and the reported device performance:

The document refers to performance testing based on FDA guidance and ASTM standards. While specific numerical acceptance criteria (e.g., "must withstand X N-mm of torque") and the exact reported values are not provided in this summary, the types of tests and the conclusion can be presented.

Conclusion: The technological characteristics, indications for use, and performance testing support the substantial equivalence of the Threaded IM Nail System with the predicate devices.

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

• Sample Size: Not specified in the summary for the non-clinical tests.
• Data Provenance: Not applicable as these are non-clinical, in-vitro mechanical tests, not clinical data from patients.

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 objective, quantifiable physical properties and test methods, not expert consensus.

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

• Not applicable for non-clinical 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

• Not applicable. This is for a physical medical device (intramedullary nail), not an AI/software device.

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

• Not applicable. This is for a physical medical device (intramedullary nail).

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

• For the non-clinical tests, the "ground truth" is derived from the objective physical measurements obtained through standardized mechanical testing methods (e.g., torsional strength, driving torque, axial pullout strength) as defined by ASTM standards and FDA guidance.

8. The sample size for the training set

• Not applicable. This is for a physical medical device.

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

• Not applicable. This is for a physical medical device.

In summary, the provided document details a 510(k) submission for a physical orthopedic implant (a threaded intramedullary nail system), and the "study" referred to is a series of non-clinical, in-vitro mechanical performance tests to demonstrate substantial equivalence, not a clinical study involving AI or human readers.

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