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Healix Anchor is indicated for use in the following: Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair: Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis; Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction. Hip: Capsular repair, acetabular labral repair.

The Healix Anchor is a non-absorbable threaded suture anchor manufactured of polyetheretherketone (PEEK) material. The threaded anchor comes preloaded on a disposable inserter assembly and is intended for fixation of #2 suture to bone. The anchor is provided in three sizes: one with an outer diameter of 4.5mm, another with an outer diameter of 5.5mm and the third with an outer diameter of 6.5mm. The suture options may or may not include tapered needles to facilitate suture passage through tissue. The Healix Anchors are currently offered with absorbable Panacryl, non-absorbable Ethibond or partially absorbable Orthocord suture options.

Here's an analysis of the provided text regarding the Healix Anchor, focusing on acceptance criteria and supporting studies:

Based on the provided document, the Healix Anchor is a medical device, and the submission is a 510(k) premarket notification. This type of submission seeks to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving that it meets specific, quantitative acceptance criteria through a clinical study.

Therefore, the information you've requested about acceptance criteria and supporting studies, particularly those involving human readers, sample sizes for test sets, expert ground truth, MRMC studies, or standalone algorithm performance, is not present and not applicable in this context. The document focuses on demonstrating substantial equivalence through technological characteristics and existing performance and safety testing.

Here's a breakdown of what can be extracted from the document in relation to your questions, and where information is inherently missing due to the nature of a 510(k) submission for this type of device:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence)

Missing Information (Not applicable or not typically found in this type of 510(k) summary for a physical medical device)

1. Sample size used for the test set and the data provenance: This device is a physical bone anchor, not an AI or diagnostic imaging device that uses "test sets" of data as understood in that context. The "testing" referred to is likely mechanical, biocompatibility, and sterilization testing, not performance on data sets.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of AI, refers to expert-validated data. For a physical implant, "ground truth" might relate to mechanical strength or biocompatibility standards, and would be established through engineering and biological testing, not expert consensus on images or outcomes.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is a physical implant, not an AI-assisted diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): As stated above, "ground truth" for a physical device would relate to engineering specifications and biocompatibility standards. The document implicitly states that "performance and safety testing" was conducted, but doesn't detail the specific methodologies or "ground truths" used beyond establishing substantial equivalence to predicates.
7. The sample size for the training set: Not applicable. This is not an AI or machine learning device that requires training data.
8. How the ground truth for the training set was established: Not applicable.

Summary of the Study that Proves Acceptance:

The "study" referenced in this 510(k) summary is not a single clinical trial or a data-driven performance study in the way one might think of for an AI diagnostic device. Instead, it refers to a submission demonstrating substantial equivalence to previously legally marketed devices (the predicate devices: Mitek Spiralok Anchor, Arthrex Corkscrew FT Anchor, and Arthrex Biocorkscrew Anchor).

The proof of acceptance rests on the assertion that:

• The indications for use of the Healix Anchor are clearly defined and substantially similar to the predicate devices.
• The technological characteristics (materials, design, sizes, suture options) are similar enough to the predicate devices that they do not raise new questions of safety or effectiveness.
• Performance and safety testing (not detailed in this summary, but typical for these devices includes mechanical strength, fatigue, biocompatibility, and sterilization validation) has been conducted and demonstrates that the device is substantially equivalent to the predicate devices.

The FDA's decision to clear the device (as indicated in the letter from Mark N. Melkerson) signifies their agreement that the device has met the criteria for substantial equivalence under 21 CFR 888.3040, thereby allowing it to be marketed.

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