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The FIXIT® threaded anchor system is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow, but not limited to, the following procedures:

Shoulder: Rotator Cuff Repair; Bankart Repair; Biceps Tenodesis; Acromio-clavicular Separation Repair; Deltoid Repair; Capsule Shift or Capsulolabral Reconstruction;

Ankle/Foot: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy Knee: Anterior Cruciate Ligament Repair: Medial Collateral Ligament Repair: Lateral Collateral Ligament Repair: Patellar Tendon Repair ; Posterior Oblique Ligament Repair; Iliotibial Band Tenodesis ;

Wrist/Hand: Scapholunate Ligament Reconstruction: Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.

Elbow: Biceps Tendon Reattachment: Unar or Radial Collateral Ligament Reconstruction: Temis Elbow Repair and Lateral Epicondylitis Repair

FIXIT® is a threaded anchor system made of Duosorb® 30 (β-TCP 30%/ PLDLA 70%), a composite, bioabsorbable material.

The implant is available in 2 different configurations:

• · FIXIT®Knotless: supplied in a holder,
• FIXIT®: pre-loaded on a disposable screwdriver with 2 sutures.
  The implant is supplied sterile, ready to use.

The provided text describes a medical device submission (K170868) for the FIXIT® Threaded Anchor System. This device is a suture anchor, and the submission aims to demonstrate its substantial equivalence to a predicate device, the Arthrex Bio-Composite Corkscrew (K082810).

It is crucial to understand that this document describes a non-AI/ML medical device. Therefore, the concepts of "acceptance criteria," "study that proves the device meets the acceptance criteria," "sample size for the test set," "data provenance," "number of experts used to establish ground truth," "adjudication method," "multi reader multi case (MRMC) comparative effectiveness study," "standalone performance," "type of ground truth used," "sample size for the training set," and "how the ground truth for the training set was established" do not apply in the context of an AI/ML device validation study.

Instead, the acceptance criteria for this type of device (traditional medical device) are outlined by regulatory bodies such as the FDA. For a Class II medical device like the FIXIT® Threaded Anchor System, the primary acceptance criteria for market clearance via a 510(k) pathway revolve around demonstrating substantial equivalence to a legally marketed predicate device. This is achieved through comparisons of:

• Intended Use: Must be the same or very similar to the predicate.
• Technological Characteristics: Must be similar to the predicate.
• Performance Data: Non-clinical testing (e.g., mechanical, biocompatibility) must show that the new device performs as safely and effectively as the predicate, and any differences in technological characteristics do not raise new questions of safety or effectiveness.

Here's a breakdown based on the provided text, adapted for the context of a traditional medical device:

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

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

This information is not provided in the document as it pertains to AI/ML validation studies. For this traditional device, non-clinical tests typically involve:

• Mechanical testing: A certain number of samples (e.g., a statistically significant number of anchors) would be tested for properties like pull-out strength or fixation strength. The specific sample sizes are not detailed in this summary.
• Biocompatibility testing: This is typically performed under ISO standards (e.g., ISO 10993) using standardized biological models (e.g., cell cultures, animal models) with a defined number of replicates, but the specifics are not in this summary.
• Bacterial Endotoxin Testing: This involves testing samples of the final sterile device using established methods like the Limulus Amebocyte Lysate (LAL) assay, with specific sample numbers.

The data provenance is inherent to laboratory testing rather than clinical data sets. The testing would have been conducted by the manufacturer or contracted labs following established protocols.

3. 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)

This concept is not applicable to this type of traditional device submission. "Ground truth" established by experts is relevant for AI/ML diagnostic or interpretative devices. For the FIXIT® Threaded Anchor System, the "ground truth" for performance is established by objective, quantifiable physical and chemical tests (e.g., measuring force, observing cell reaction, detecting endotoxins) against industry standards or predicate device performance.

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

This is not applicable for a traditional medical device like a suture anchor. Adjudication methods are typically employed in clinical trials or AI/ML evaluations to resolve disagreements among human readers or experts on ground truth.

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

This is not applicable. MRMC studies are specific to evaluating diagnostic devices, especially those involving human interpretation, often in the context of AI assistance. The FIXIT® Threaded Anchor System is a surgical implant, not a diagnostic tool, and involves no "human readers" or "AI assistance" in its intended function.

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

This is not applicable. This refers to AI/ML algorithm performance without human intervention. The FIXIT® Threaded Anchor System is a physical implant; there is no algorithm involved.

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

The "ground truth" for this device's performance is based on objective measurements and adherence to established standards in non-clinical testing:

• Biocompatibility: Adherence to ISO 10993 series standards, using established biological models and endpoints.
• Mechanical Performance: Quantifiable physical measurements (e.g., pull-out strength, torque, fatigue life) compared against engineering specifications, predicate device performance, or relevant biomechanical literature. The "ground truth" here is the physical measurement itself.
• Bacterial Endotoxin: Quantitative measurement of endotoxin levels, compared against specified regulatory limits.

8. The sample size for the training set

This is not applicable as there is no AI/ML algorithm requiring a training set.

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

This is not applicable as there is no AI/ML algorithm requiring a training set or its associated ground truth establishment.

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