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The intended use of the KFx Suture Lock Tissue Fixation System is for the fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow. Specifically:
Shoulder: Bankart lesion repairs, SLAP lesion repairs, acromio-clavicular separation repairs, rotator cuff repairs, capsular shift or capsulolabral reconstructions, biceps tenodesis, deltoid repairs.
Foot and Ankle: Hallux valgus repairs, medial or lateral instability repairs/reconstructions, Achilles repairs/reconstructions, mid-foot reconstructions, metatarsal ligament repair.
Knee: Medial collateral ligament repairs, lateral ligament repairs, posterior oblique ligament repairs, lliotibial band tenodesis, patellar tendon repairs.
Hand, Wrist and Elbow: Scapholunate ligament reconstructions, ulnar or radial collateral ligament reconstructions, tennis elbow repair, biceps tendon reattachment.

The KFx Tissue Fixation System consists of a Nail Bone Anchor with two suture leads pre-loaded in a single use insertion handle and a Bone Screw Anchor (also pre-loaded in a single use delivery handle) used to capture the sutures, eliminating the need to tie suture knots. The KFx Tissue Fixation System also includes re-usable surgical instruments for the implantation of the Nail Bone and Bone Screw Anchors.
Devices are provided "STERILE"; sterilization is by Ethylene Oxide (EO) gas and provides a sterility assurance level of 10-6.

The provided text describes the KFx Suture Lock Nail Bone Anchor, a medical device for tissue fixation. It refers to "Bench test results" that "indicate that the device is safe and satisfies functional performance requirements" and concludes that the device is "substantially equivalent" to a previously cleared predicate device.

However, the document does not provide specific acceptance criteria or detailed results of a study in a tabular format as requested. It states that the device is substantially equivalent to a previously cleared device (K072063). The "Biocompatibility and Performance Data" section provides a high-level summary of the study findings, but lacks the granular details needed to fill out all the requested information about a specific study proving it meets acceptance criteria.

Therefore, much of the requested information cannot be extracted directly from the provided text.

Here is what can be inferred or stated based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Sample size: Not specified.
   • Data provenance: Not specified (bench tests are typically conducted in a controlled lab environment, not on human data in the context of this device). The document refers to "bench test results."

2. 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 this is a mechanical device evaluated through bench testing, not image analysis or clinical expert review.

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

   • Not applicable; this would typically be relevant for studies involving human interpretation or clinical endpoints.

4. 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 MRMC study was done, as this is a mechanical bone anchor device, not an AI or imaging diagnostic tool.

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

   • Not applicable; this is a physical medical device, not a software algorithm.

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

   • The "ground truth" (or basis for evaluation) appears to be derived from established engineering and biocompatibility standards for medical devices and comparison to a predicate device. For mechanical performance, this would involve quantitative measurements against specified thresholds, but these thresholds are not provided.

7. The sample size for the training set:

   • Not applicable, as this is not a machine learning model.

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

   • Not applicable, as this is not a machine learning model.

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