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The Paratrooper™ Plantar Plate Repair System is intended for fixation of tissue to tissue to tissue. Specific indications:

Foot/ankle:

• · Lateral Stabilization
• · Medial Stabilization
• · Achilles Tendon Repair
• Metatarsal Ligament and Tendon Repair
• · Hallux Valgus Reconstruction
• · Digital Tendon Transfers
• · Mid-foot Reconstruction
• · Plantar Plate Repair

The Paratrooper™ Plantar Plate Repair System includes an all-suture soft tissue fixation device. The suture implant comes in one size and is provided attached to a needle or preloaded on an inserter.

The provided text describes a medical device, the Paratrooper™ Plantar Plate Repair System, and its FDA 510(k) clearance. However, it does not include information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML powered device. This document is a regulatory submission for a physical medical device, specifically a soft tissue fixation device, and not an AI or imaging diagnostic tool.

Therefore, the requested information elements related to AI/ML device testing (such as "type of ground truth used," "sample size for the training set," "number of experts used to establish the ground truth," "adjudication method," "multi-reader multi-case study," and "standalone performance") are not applicable and cannot be extracted from this document.

The document discusses the substantial equivalence of the Paratrooper™ Plantar Plate Repair System to a predicate device, based on:

1. Indications for Use: The modified device has the same intended use.
2. Technological Characteristics: Similar performance, basic design, material, sterilization, and sizes.
3. Performance Testing: Mechanical performance testing and usability testing were conducted, along with bacterial endotoxin testing.

There is no information in the provided text to populate the requested table or answer the specific questions related to AI/ML device acceptance criteria and study design.

If you are looking for information about an AI/ML medical device, please provide a different document.

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The Paratrooper™ Plantar Plate Repair System is intended for fixation of tissue to tissue to tissue. Specific indications: Foot/ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament and Tendon Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction, Plantar Plate Repair

The Paratrooper™ Plantar Plate Repair System includes an all-suture soft tissue fixation device. The suture implant comes in one size and is provided attached to a needle.

The provided text describes the 510(k) premarket notification for the Paratrooper™ Plantar Plate Repair System. It is a medical device, specifically an all-suture soft tissue fixation device used for tissue-to-tissue and tissue-to-bone fixation. The information provided is primarily for regulatory clearance and does not detail a study proving the device meets acceptance criteria in the context of an AI/ML algorithm or diagnostic accuracy study.

Therefore, many of the requested categories related to AI/ML or comparative effectiveness studies (e.g., sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this document. This document focuses on demonstrating substantial equivalence to predicate devices through performance testing, biocompatibility, and sterilization, rather than clinical efficacy or diagnostic accuracy.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified for any of the tests. The document only states that "All necessary testing has been performed on representative Paratrooper™ Plantar Plate Repair System components."
• Data Provenance: Not applicable in the context of clinical data. The testing mentioned appears to be bench testing on the device components themselves.

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

• Not applicable. This is not a study requiring expert-established ground truth for diagnostic accuracy.

4. Adjudication method 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. This is not an AI/ML device or a diagnostic device, so an MRMC comparative effectiveness study is not relevant.

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

• Not applicable. This is a hardware medical device.

7. The type of ground truth used:

• Not applicable in the conventional sense of ground truth for a diagnostic study. The "ground truth" for this device's performance would be the established engineering and biological standards for mechanical strength, biocompatibility, and sterility, which are verified through the specified tests.

8. The sample size for the training set:

• Not applicable.

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

• Not applicable.

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