(70 days)
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.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.