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The SECURE-LOCK is indicated for fixation of bone or soft tissue to bone, and is intended as a fixation device, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair such as Anterior Cruciate Ligament (ACL) and Posterior Cruciate Ligament (PCL) Repair and Reconstruction.

The SECURE-LOCK fixation device consists of a sterile and non-absorbable polyester and ultrahigh molecular weight polyethylene blended braid that forms a loop on a titanium alloy button. The button sits on the cortex over the exit to a bone tunnel, suspending the loop inside the tunnel to provide secure, strong fixation for ligament repair and reconstruction. The SECURE-LOCK fixation device is supplied with polyester sutures that are used to assemble and deliver the device.

The provided text describes the 510(k) summary for the SECURE-LOCK device, a suspensory fixation device for ACL/PCL repair and reconstruction. It outlines the device's characteristics, intended use, and performance data to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative table format with corresponding "reported device performance" values for clinical efficacy. Instead, it lists various performance tests conducted to demonstrate the device's mechanical properties, safety, and substantial equivalence to a predicate device. The conclusion states that the device provides "appropriate mechanical properties and is relatively safe for its use."

However, based on the tests conducted, we can infer performance areas:

Study Details

The document describes performance testing rather than a clinical study with a test set of human subjects. The assessment is based on bench testing of the device itself and its materials.

2. Sample size used for the test set and the data provenance: Not applicable in the context of a clinical test set. The "test set" here refers to physical devices and materials undergoing various laboratory tests (tensile strength, fatigue, etc.). There is no mention of the specific number of devices tested for each performance test, but it is implied that representative samples were used. Data provenance is internal laboratory testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical and material properties is established by recognized engineering and material science standards and measurement techniques, not expert consensus in the diagnostic sense.

4. Adjudication method for the test set: Not applicable for device performance testing against established standards. Results are compared directly to pre-defined specification limits or industry standards (e.g., ISO, USP, ANSI/AAMI).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is a device 510(k) submission focused on demonstrating substantial equivalence through bench testing and material characterization, not a comparative clinical effectiveness study involving human readers or patient outcomes, especially not in the context of AI.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This is a medical device (fixation implant), not a software algorithm or AI device.

7. The type of ground truth used:

   • Mechanical Performance: Engineering specifications, industry standards (e.g., for tensile strength, fatigue, suture properties).
   • Biocompatibility: ISO 10993-1 standards.
   • Pyrogenicity: FDA requirements ( specification limits.
   • MRI Compatibility: Recognized standards for safety in MR environments.

8. The sample size for the training set: Not applicable. There is no training set as this is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable.

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The Infinity-Lock™ Button System is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruption and as an adjunct in external and intramedullary fixation systems involving plates.

The Infinity-Lock™ Button System is indicated for patients with acromioclavicular separations resulting from disruption to the coracoclavicular ligaments.

The Infinity-Lock™ Button System comprises a permanent implantable 240 mm Tube-Tape and titanium alloy Button together with a disposable cannulated drill bit and guidewire. A coracoid passer, such as the Xiros CCHook, is also required.

This document is a 510(k) Premarket Notification from the FDA regarding the "Infinity-Lock™ Button System," a medical device for bone fixation. It primarily focuses on demonstrating substantial equivalence to a predicate device, not on proving the device meets specific acceptance criteria via a study on its diagnostic performance, as would be the case for an AI/ML medical device.

Therefore, the requested information for acceptance criteria and a study proving the device meets them (especially points 2-9 related to test sets, experts, ground truth, and training sets for an AI/ML device) is not applicable to this submission. This document describes a traditional medical device (implantable system) and its performance is evaluated through mechanical testing against a predicate device.

Here's how to interpret the provided information in the context of your request:

Acceptance Criteria and Reported Device Performance

The document describes performance testing, but not in the framework of diagnostic performance or AI model validation. Instead, it focuses on the equivalence of mechanical properties.

1. A table of acceptance criteria and the reported device performance

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