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The PROSTEP TBC Implant System is indicated for bone reconstruction. Examples include:

• · Bi-Cortical osteotomies in the foot
• Distal metatarsal osteotomies
• · Fixation of osteotomies for Hallux Valgus treatment (such as Transverse, Chevron, etc.)

The PROSTEP TBC Implant System is intended for use in bone reconstruction and osteotomy of the first metatarsal. The implants are provided sterile and consist of one PROSTEP TBC implant, one MICA screw, and one ORTHOLOC 3Di screw. Based on patient anatomy and surgeon's needs, different component sizes can be selected.

This document describes the PROSTEP TBC Implant System, a medical device for bone reconstruction and osteotomy of the first metatarsal. It is a 510(k) summary, which means no specific acceptance criteria or study details regarding device performance against such criteria are provided in the given text.

The document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical evidence, rather than presenting a study proving performance against defined acceptance criteria.

Therefore, many of the requested details cannot be extracted from this document, as they pertain to clinical or performance studies that are not included here.

Here's what can be inferred from the provided text:

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

The document does not provide a table of acceptance criteria nor does it report specific device performance metrics against such criteria. The submission relies on demonstrating substantial equivalence to predicate devices through technological characteristics and non-clinical testing.

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

This information is not provided in the document. The substantial equivalence is based on non-clinical testing (static and fatigue construct testing, bacterial endotoxin assessments), not a clinical test set.

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 provided. No clinical test set with ground truth established by experts is mentioned.

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

This information is not provided. No clinical test set with adjudication is mentioned.

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

There is no mention of an MRMC comparative effectiveness study, AI assistance, or human readers in this document.

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

This device is an implantable system, not an AI or algorithm-based device. Therefore, a standalone algorithm performance study is not applicable and not mentioned.

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

As no clinical study with a test set is described, no specific ground truth type is mentioned. For the non-clinical testing, the "ground truth" would be the engineering specifications and performance standards for static, fatigue, and bacterial endotoxin assessments.

8. The sample size for the training set

This is not applicable as the document describes a physical implant system, not a machine learning model.

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

This is not applicable as the document describes a physical implant system, not a machine learning model.

Summary based on available information:

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The Mini MaxLock Extreme® Plating System is intended to stabilize and aid in the repair of fractures, fusions, and osteotomies for small bones and bone fragments.

The submission is a modification to the Mini MaxLock Extreme® Plating System to add additional plate styles. No modifications were made to the existing plates or screws

The provided text describes a 510(k) submission for a medical device (Mini MaxLock Extreme® Plating System), which is a premarket notification to demonstrate that the device is at least as safe and effective as a legally marketed predicate device.

For this type of device (bone fixation appliances), the FDA review primarily focuses on establishing substantial equivalence to a predicate device, rather than defining specific acceptance criteria for a new, standalone performance study in the way one might for a diagnostic AI algorithm. The 510(k) summary explicitly states:

"Calculations and finite element analysis comparing the strength of the subject and predicate devices were performed and the results support substantial equivalence. Due to similarities in indications, design, and materials, no other testing was required. No new issues of safety and effectiveness have been raised."

This means that a direct "acceptance criteria" and "device performance" in terms of clinical outcomes or diagnostic accuracy were not established or tested in this submission. Instead, the acceptance criteria were implicitly met by demonstrating mechanical equivalence to an already approved device.

Therefore, many of the requested points regarding acceptance criteria, study details, and ground truth establishment are not applicable to this specific 510(k) submission.

Here's an breakdown of the requested information based on the provided text:

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

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. No human or animal test set data was used. The study relied on computational analysis (calculations and Finite Element Analysis).

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. No expert-established ground truth was required for this type of substantial equivalence demonstration. The "ground truth" was derived from engineering principles and comparison to the predicate device's established properties.

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

• Not Applicable. No human adjudication was involved as no patient data or expert review was part of this submission.

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 a hardware device (bone plating system), not an AI diagnostic tool. MRMC studies are irrelevant here.

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

• Not Applicable. This is a hardware device.

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

• Not Applicable / Engineering Equivalent. The "ground truth" for showing substantial equivalence was the known mechanical properties and performance of the predicate device, as assessed through engineering calculations and finite element analysis.

8. The sample size for the training set

• Not Applicable. No machine learning or AI models were involved; therefore, no training set was used.

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

• Not Applicable. No training set was used.

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