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reVERTO™ Shape Memory Staples are intended for use in:

Fixation of Osteotomies of the Hand, Foot and Tibia

Arthrodesis of the Joints of the Hand and Foot

Fixation of Soft Tissue to Bone, as in the case of the Anterior Cruciate Ligament

reVERTO™ Shape Memory Staples are also indicated for adjunctive fixation of Small Bone Fragments of:

The Upper Extremity, such as the Radius, Ulna, Humerus, Clavicle and Scapula

The Lower Extremity, such as the Tibia, Fibula and the Femur

The Upper Torso, such as the Sternum and the Ribs

reVERTO™ Shape Memory Staples are dynamic compression implants that use shape memory metal nickel-titanium alloy called NiTinol (see below for more information on NiTinol). The NiTinol construction causes the legs of the implant to deflect, thereby creating a compressive force across the site of fixation. reVERTO Shape Memory Staples are advantageous to screws and plates in that they require less disruption of the surrounding bone for implantation and provide a 'low-profile' fixation. The most important factor related to the use of NiTinol is its ability to maintain a compressive force across the site of fixation during the healing process.

This document is a 510(k) summary for the reVERTO™ Shape Memory Staples and does not include performance data from a specific study to demonstrate the device meets acceptance criteria. The submission focuses on establishing substantial equivalence to previously cleared predicate devices based on intended use, materials, and operational principles, rather than presenting a detailed clinical or performance study with acceptance criteria and results.

Therefore, I cannot provide the requested information about acceptance criteria and the study that proves the device meets those criteria from the provided text. The document does not describe such a study or present a table of acceptance criteria and reported device performance.

Here's a breakdown of why the requested information is not available in the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present. The 510(k) summary is for regulatory clearance based on substantial equivalence, not a detailed performance study report.
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, as no such test set or study data is described.
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 no test set requiring ground truth establishment is described.
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: Not applicable. The device is a physical bone fixation staple, not an AI-assisted diagnostic or therapeutic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physical bone fixation staple, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The provided document is a regulatory submission demonstrating substantial equivalence, which is a different type of submission than one detailing a clinical or performance study with specific acceptance criteria and results for a novel device.

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