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The Atlantech Graft Fixation Screw is an interference screw for use in the fixation of bone-tendon-bone grafts in cruciate ligament reconstructive surgery.

The Atlantech Graft Fixation Screw is for fixation of grafts in cruciate ligament reconstructive surgery. Standard features include a tapered rear profile, which museuzes graft impingement post implantation. The screw is cannulated to accept 1.2mm A-Fech Controlled Flexion Guidewire.

This document (K031937) is a 510(k) summary for a medical device called the "Atlantech Graft Fixation Screw". It describes the device, its intended use, and argues for its substantial equivalence to previously cleared predicate devices.

Based on the provided information, the document does NOT contain a study that proves the device meets specific acceptance criteria in terms of performance metrics.

Instead, the submission argues for "substantial equivalence" based on:

• Indications for Use: The Atlantech Graft Fixation Screw is for fixation of bone-tendon-bone grafts in cruciate ligament reconstructive surgery, which is the same as the predicate devices.
• Technological Characteristics: The document states that the device's technological characteristics are substantially equivalent to the predicate devices.
• Prior Commercial Availability: It explicitly mentions, "Atlantech Graft Fixation Screws have been commercially available in Europe since 1996 and do not differ markedly from others on the market." This suggests a history of safe use, but not specific performance testing conducted for the 510(k) submission.

Therefore, many of the requested elements for describing a study and acceptance criteria cannot be extracted from this 510(k) summary.

Here's a breakdown of what can be inferred or stated from the provided text, and where information is explicitly missing:

1. Table of Acceptance Criteria and 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):

• None provided. The submission does not detail any specific performance testing with a test set. Substantial equivalence claims often rely on comparison to existing devices and their known performance rather than new, experimental test data.

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

• Not applicable. No test set or expert ground truth establishment for a performance study is described.

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

• Not applicable. No test set or adjudication process is described.

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 such study was done or described. This device is a mechanical fixation screw, not an AI or imaging diagnostic device.

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

• Not applicable. This is a mechanical device, not an algorithm.

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

• Not applicable. No specific ground truth data for performance evaluation of the device itself (beyond general safety and effectiveness of the device type) is mentioned in this submission. The "ground truth" for a 510(k) in this context is the regulatory standard of substantial equivalence to predicate devices, supported by existing knowledge and potentially published literature on similar devices.

8. The sample size for the training set:

• Not applicable. This submission does not describe an AI or statistical model requiring a training set.

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

• Not applicable. This submission does not describe an AI or statistical model requiring a training set.

In summary, this 510(k) submission for the Atlantech Graft Fixation Screw relies on demonstrating substantial equivalence to predicate devices already on the market, rather than presenting a new clinical or performance study with defined acceptance criteria and test results. It highlights the device's intended use, technological similarity to existing devices, and its commercial history in Europe as evidence for its safety and effectiveness.

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