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The SmartScrew ACL™ is intended for use in interference fixation of bone-patellar tendon - bone and soft tissue grafts in anterior and posterior cruciate ligament reconstructions.

The SmartScrew ACL™ is not intended for use in and is contraindicated for 1) cruciate ligament reconstructions, which would not be appropriate for fixation with metallic screws and 2) situations, where intra-articular replacement is otherwise contraindicated, e.g., active or potential infection and where patient cooperation cannot be guaranteed (e.g., alcoholism).

The SmartScrew ACL™ a fully threaded, cannulated interference screw with slightly tapered head and tip. SmartScrew ACL™ is provided with three different diameter, 7.0, 8.0 and 9.0mm and with three lengths, 20, 25 and 30mm and it is made of poly-L/D-lactide copolymer.

This document, K993073 for the SmartScrew ACL™, is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed studies proving specific acceptance criteria. Therefore, the requested information about acceptance criteria and detailed study results is largely not present within this document.

Here's what can be inferred and what is missing based on the provided text:

1. Table of acceptance criteria and the reported device performance:

This information is not provided in the 510(k) summary. The summary indicates that the SmartScrew ACL™ "has the same intended use, principles of operation and technological characteristics than predicate devices," implying that it is expected to perform similarly to those already approved devices. However, explicit acceptance criteria (e.g., specific tensile strength, degradation rates, biocompatibility metrics) and the SmartScrew ACL™'s performance against those criteria are not detailed.

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

This information is not provided. 510(k) summaries for devices cleared based on substantial equivalence to predicates often do not include specific test set sizes or details about data provenance if no new clinical or performance studies were required. The focus is on comparing the new device's characteristics to the predicates.

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

This information is not provided. This level of detail would typically be found in a detailed study report, which is not part of this 510(k) summary.

4. Adjudication method for the test set:

This information is not provided. Adjudication methods are relevant for studies involving subjective assessments, usually in clinical trials, which are not described here.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable. The SmartScrew ACL™ is a medical device (an interference screw for ligament reconstructions), not an AI-powered diagnostic tool. Therefore, an MRMC study related to human readers and AI assistance would not be relevant.

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

This is not applicable. As mentioned above, this is a physical medical device, not an algorithm.

7. The type of ground truth used:

This information is not explicitly stated. For a device like an interference screw, "ground truth" might refer to in-vitro biomechanical testing results (e.g., pull-out strength, stiffness), material characterization (e.g., degradation profiles), and biocompatibility testing. The summary mentions "minor technological differences... do not raise any new issues of safety or effectiveness," suggesting that standard testing (likely non-clinical) was performed to ensure safety and equivalence, but specific details about what this "ground truth" entailed are absent.

8. The sample size for the training set:

This information is not provided. This concept is typically relevant for machine learning algorithms, which is not the case for this device.

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

This information is not provided. Again, this concept is primarily relevant for machine learning algorithms.

In summary of the provided document (K993073):

The 510(k) summary for the SmartScrew ACL™ primarily relies on demonstrating substantial equivalence to existing predicate devices (Phantom PLLA Interference Screw, Resorbable Interference Screw, BioScrew Fixation System, etc.) rather than presenting detailed data from studies designed to prove specific acceptance criteria for the new device in isolation. The document states:

• "The SmartScrew ACL™ has the same intended use, principles of operation and technological characteristics than predicate devices."
• "Furthermore, the minor technological differences between the SmartScrew ACL™ and the predicate devices do not raise any new issues of safety or effectiveness."

This means that the "acceptance criteria" are implicitly met by demonstrating that the device is fundamentally similar to other devices already deemed safe and effective by the FDA. Specific performance metrics and study designs are not elaborated upon in this type of submission summary.

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