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The A.I.M.™ Suture Anchor is intended for use in arthroscopic, mini-open or open surgical procedures for fixation of soft tissue to bone.

The A.I.M. ™ Suture Anchor is intended for use in the following applications:

Ankle: Mid-foot Reconstruction
Foot: Hallux valgus reconstruction
Hand: Ulnar or lateral collateral ligament reconstruction
Wrist: Scapholunate ligament reconstruction

The implant system includes a 1.7mm diameter PEEK (polyether-etherketone) anchor. pre-mounted on a disposable inserter. The anchor is preloaded with USP size 0 Ultra High Molecular Weight Polyethylene suture. The device is designed to be inserted into a pre-formed hole using a single use disposable awl

The provided text includes a 510(k) summary for the A.I.M.™ Suture Anchor, but it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices. The study mentioned specifically details "anchor pull-out forces are equivalent or superior to a referenced predicate device", but it does not specify acceptance criteria or the full details of this study to meet your requested information.

Therefore, I cannot provide the requested table and study details. The document is primarily a regulatory submission for substantial equivalence.

Here's a breakdown of why I cannot fulfill your request based on the provided text:

• Acceptance Criteria and Reported Performance: The document states, "Data have been provided in the submission that demonstrates that the anchor pull-out forces are equivalent or superior to a referenced predicate device." This indicates a performance metric (pull-out force) was evaluated and compared to a predicate, but neither specific numerical acceptance criteria nor the precise "reported device performance" values are provided.
• Study Details (Sample size, data provenance, experts, adjudication, MRMC, standalone, ground truth, training set): The document mentions "anchor pull-out forces" were tested, but it does not offer any details about the study design, such as:
  • Sample size for test set
  • Data provenance (country, retrospective/prospective)
  • Number or qualifications of experts
  • Adjudication method
  • MRMC comparative effectiveness study or effect size
  • Standalone algorithm performance
  • Type of ground truth used
  • Sample size for the training set
  • How ground truth for the training set was established

The submission's focus is on declaring substantial equivalence based on material history and general performance comparison to predicates, rather than presenting a detailed performance study with explicit acceptance criteria for a new type of device or an AI/software component, which is what your questions suggest.

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