(262 days)
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:
| Acceptance Criteria Category | Specific Acceptance Criteria (Not explicitly stated as numerical values, but implied by testing) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Device performs as intended for tissue fixation. (Implied by pullout testing) | Characterized via pullout testing. (Results not quantified in this document) |
| Material Safety | Biocompatible and non-pyrogenic. | Biocompatibility and pyrogenicity testing performed. (Results not quantified in this document) |
| Sterility | Sterilization effective. | Sterilization testing performed. (Results not quantified in this document) |
| Substantial Equivalence | Equivalence to predicate devices (Stryker ICONIX All Suture Anchor System and Ziptek ZipE® Knotless Tissue Repair and Attachment Device) in indications for use, technical characteristics, and function. | Performance testing demonstrates substantial equivalence. |
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.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.