(30 days)
The Arthrex Knotless SutureTak Anchor is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Specific indications are listed below:
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstructions, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital Tend Transfers
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hip: Capsular Repair, Acetabular Labral repair
The Arthrex Knotless SutureTak Anchor is a tap-in ribbed suture anchor comprised of PEEK material and preloaded with UHMWPE looped suture and assembled to an insertion device. The proposed anchor is being offered in a 3 mm diameter.
The provided text describes the Arthrex Knotless SutureTak Anchor and its substantial equivalence to predicate devices, focusing on its intended use and mechanical properties. However, it does not contain the detailed information required to answer the questions about acceptance criteria and a study proving the device meets those criteria, as typically found in an AI/software device submission.
The document primarily focuses on regulatory clearance for a physical medical device (an anchor) and relies on mechanical testing for performance. There is no mention of an algorithm, AI, or human reader performance.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance: While the document mentions "established minimum acceptance criteria for tensile (pull-out) strength," it does not provide the specific criteria values or the reported performance data in a table format.
- Sample size used for the test set and the data provenance: Not applicable to this type of device submission which focuses on mechanical testing, not a "test set" in the context of an algorithm.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical anchor's mechanical performance is typically established through laboratory testing following engineering standards, not expert consensus on medical images or diagnoses.
- Adjudication method for the test set: Not applicable.
- 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, as this is a physical device, not an AI algorithm assisting human readers.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For mechanical testing, the "ground truth" would be the results obtained from standardized mechanical tests.
- The sample size for the training set: Not applicable. This is not a machine learning model.
- How the ground truth for the training set was established: Not applicable.
Summary of available information related to performance:
The document states:
- "The mechanical testing demonstrates that the proposed device meets or exceeds the established minimum acceptance criteria for tensile (pull-out) strength for the desired indications."
This indicates that mechanical testing was performed, and the device's performance in terms of tensile (pull-out) strength met predefined criteria. However, the specific values for these criteria and the results are not detailed in the provided text.
§ 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.