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The PROSTEP™ TBI™ (Tailor's Bunion Implant) system is indicated for the fixation of 5th metatarsal osteotomies made in the correction of Tailor's Bunion.

The PROSTEP™ TBI™ (Tailors Bunion Implant) System is intended for use in bone reconstruction and osteotomy of the fifth metatarsal. The implants are provided sterile and consist of one MIS Bunion implant and one ORTHOLOC 3Di screw. Based on patient anatomy and surgeon's needs, different component sizes can be selected.

This is a 510(k) premarket notification for a medical device (PROSTEP™ TBI™ System), which typically establishes substantial equivalence to a predicate device rather than conducting extensive clinical studies with acceptance criteria and performance metrics in the same way a de novo or PMA submission might. Therefore, many of the requested categories related to clinical performance and AI algorithm evaluation may not be directly applicable or explicitly detailed in this type of submission.

Based on the provided document, here's an analysis of the requested information:

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

The document describes non-clinical evidence (construct fatigue testing and bacterial endotoxin testing) to support substantial equivalence. It does not provide specific acceptance criteria or reported performance in a table format for clinical device performance in terms of diagnostic accuracy or reader improvement metrics, as the device is an implant and not an AI-driven diagnostic tool.

For the non-clinical testing, the document states: "The subject was evaluated to the predicate through construct fatigue testing to support the safety and effectiveness of the subject device system. Additionally, bacterial endotoxin testing was done on a representative part." While these tests would have internal acceptance criteria (e.g., fatigue cycles survived, endotoxin limits), those specific criteria and detailed results are not provided in this summary. The conclusion is simply that the testing "shows no new worst case" and supports substantial equivalence.

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 is not an AI diagnostic device, so there is no "test set" of clinical images or patient data in the typical sense for evaluating algorithm performance. The "testing" mentioned is mechanical (fatigue) and biocompatibility (endotoxin) on the device itself.

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, as there is no test set for clinical performance evaluation requiring expert ground truth in this context.

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

Not applicable.

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 study was not done. This is not an AI diagnostic device. The submission explicitly states under "SUBSTANTIAL EQUIVALENCE - CLINICAL EVIDENCE": "N/A."

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

No, a standalone algorithm performance study was not done. This is not an AI diagnostic device.

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

Not applicable for clinical performance. For the described non-clinical testing, the "ground truth" would be established engineering standards and biocompatibility requirements.

8. The sample size for the training set

Not applicable. This is not an AI device, so there is no training set for an algorithm.

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

Not applicable.

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