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The ecoFIX® threaded anchor system is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow, the following procedures:

Shoulder: Rotator Cuff Repair; SLAP Lesion 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; Ulnar or Radial Collateral Ligament Reconstruction; Tennis Elbow Repair and Lateral Epicondylitis Repair.

ecoFIX® is an extension the FIXIT® / ComposiTCP™ threaded anchor system previously cleared by the FDA (K170868 & K180960). ecoFIX® is a threaded anchor system which comprises an anchor made of DUOSORB® 30, a composite bioabsorbable material composed of 30 % Beta-tricalcium phosphate (β-ΤCP) and 70 % Poly L,DL-lactic acid (PLDLLA), and sutures made of ultra-high molecular weight polyethylene (UHMWPE). Different variants of the product are available depending on the number and type of suture combination (2 round sutures, 2 round needled sutures, 3 round sutures, or knotless anchor).

The implant is supplied sterile, ready to use.

The implant is available in the following configurations, supplied with a reusable screwdriver:

· ecoFIX®: hexagonal footprint anchor (3 sizes Ø4.5, Ø5.5, Ø6.5) suppplied in an implant holder with 2 round sutures ;

• · ecoFIX® Needle: hexagonal footprint anchor (3 sizes Ø4.5, Ø6.5) supplied in an implant holder with 2 round needled sutures ;
  · ecoFIX® +: hexagonal footprint anchor (1 size Ø5.5) supplied in implant holder with 3 round sutures ;

· ecoFIX® Band: hexagonal footprint anchor (3 sizes Ø4.5, Ø5.5, Ø6.5) supplied in an implant holder with 2 flat sutures ;

· ecoFIX® Knotless: hexagonal footprint anchor (3 sizes Ø4.5, Ø5.5) supplied in an implant holder.

The provided text does not contain information about acceptance criteria and a study proving a digital health device meets those criteria.

Instead, the document is a 510(k) premarket notification for a medical device called "ecoFIX®", which is a threaded anchor system for fixing soft tissue to bone. The document focuses on demonstrating substantial equivalence to a predicate device (FIXIT® / ComposiTCP™ Threaded Anchor System).

Here's an analysis of the information related to performance testing from the text, as it pertains to the ecoFIX® device:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly list specific acceptance criteria in a quantitative table format. Instead, it states that non-clinical performance testing was conducted to determine substantial equivalence.

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

• Sample Size for Test Set: Not specified. The document mentions "non-clinical performance testing" and "performance tests" but does not give specific sample sizes for these tests.
• Data Provenance: Not specified, but given these are non-clinical (laboratory/bench) tests for a physical implant, the data would originate from the testing facility. The document does not specify country of origin or whether it's retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. The document describes non-clinical performance testing of a physical medical device (an anchor system), not a digital health device requiring expert human input for ground truth establishment.

4. Adjudication Method for the Test Set:

Not applicable. This concept (e.g., 2+1, 3+1) is relevant for studies involving human interpretation or review, typically for medical imaging or similar data, which is not the case for this physical medical device's non-clinical performance tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. An MRMC study is a clinical study design often used for diagnostic imaging devices to compare the performance of human readers with and without AI assistance. This document describes non-clinical testing of a physical implant, not a diagnostic AI device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. This device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used:

For the non-clinical tests mentioned, the "ground truth" would be established by the physical testing methodologies and measurements themselves, according to established engineering and medical device testing standards (e.g., measuring pullout strength, insertion force, etc.). It would not involve expert consensus, pathology, or outcomes data in the way a diagnostic AI device would.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device. It does not involve a "training set" in the context of machine learning or AI.

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

Not applicable, as there is no training set for a physical medical device.

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