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To provide interference fixation of soft tissue graft and bone-tendon-bone patellar graft during cruciate ligament repair through arthroscopy or arthrotomy.

The titanium cannulated interference screw is tapered and has a smooth threaded design, which provides interference fixation of soft tissue grafts and bone-tendon-bone patellar grafts during cruciate ligament repair through arthroscopy or arthrotomy. The screw comes in lengths between 20 and 50 mm and diameters between 7mm and 12mm, resulting in a screw adapted to the morphology of the graft and patient.

The provided text is a 510(k) summary for a medical device (Titanium Cannulated Interference Screw) and the associated FDA clearance letter. It is not a study report for an AI/ML powered device. As such, it does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically seen in AI/ML performance evaluation.

The FDA clearance for this device is based on substantial equivalence to a predicate device (Alaron interference screw K010595), not on performance metrics against specific acceptance criteria for an AI/ML algorithm.

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set info) from the provided text because it describes a traditional medical device, not an AI/ML device, and its clearance process is different.

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To provide interference fixation of soft tissue graft and bone-tendon-bone patellar graft during cruciate ligament repair through arthroscopy or arthrotomy.

The titanium cannulated interference screw is tapered and has a smooth threaded design, which provides interference fixation of soft tissue grafts and bone-tendon-bone patellar grafts during cruciate ligament repair through arthroscopy or arthrotomy. The screw comes in lengths between 20 and 50 mm and diameters between 7mm and 12mm, resulting in a screw adapted to the morphology of the graft and patient.

The provided text is a 510(k) summary for a medical device called the "Titanium cannulated interference screw." This document primarily focuses on demonstrating substantial equivalence to a predicate device and outlines the intended use and design, rather than detailing a study with acceptance criteria and performance metrics typically found in AI/software device submissions.

Therefore, many of the requested categories for a study proving device performance (acceptance criteria, sample sizes, expert involvement, ground truth, MRMC study, standalone performance) cannot be answered directly from this 510(k) summary. These types of studies are not typically required for a mechanical device like an interference screw seeking substantial equivalence.

Here's what can be extracted based on the provided text, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The 510(k) summary for this mechanical device does not present specific acceptance criteria or quantitative performance metrics in the way a software or AI device submission would. The acceptance is based on demonstrating substantial equivalence to a legally marketed predicate device.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. There is no mention of a "test set" in the context of evaluating performance against specific criteria, as this is a mechanical interference screw, not a diagnostic or AI device. The comparison is primarily dimensional and functional equivalence to a predicate.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. There is no mention of experts establishing a "ground truth" for a test set.

4. Adjudication Method for the Test Set

Not applicable. No test set or adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

Not applicable. An MRMC study is relevant to diagnostic interpretation by human readers, often with AI assistance. This device is a surgical implant, not an imaging or diagnostic tool.

6. If a Standalone (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

Not applicable. "Ground truth" as understood in AI/diagnostic studies is not relevant here. The "truth" in this context is the established safety and efficacy of the predicate device for its intended use.

8. The Sample Size for the Training Set

Not applicable. No "training set" exists for a mechanical device like this in the context of a 510(k) submission focused on substantial equivalence.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary of Device and its Equivalence (from the 510(k) summary):

• Device Name: Titanium cannulated interference screw
• Intended Use: To provide interference fixation of soft tissue grafts and bone-tendon-bone patellar grafts during cruciate ligament repair through arthroscopy or arthrotomy.
• Predicate Device: K010595: Alaron Technologies, LLC.
• Basis for Substantial Equivalence: The submission states, "The titanium cannulated interference screw and the predicate device have the same overall design. In addition, the small differences in design do not affect the use, safety and effectiveness, between the device and the predicate device."
• Design Details: Tapered, smooth threaded design, comes in lengths between 20-50mm and diameters between 7-12mm.

This 510(k) relies on demonstrating that the new device is sufficiently similar to a previously cleared device that no new questions of safety or effectiveness are raised, rather than providing new performance data from a clinical or analytical study with defined acceptance criteria.

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