(85 days)
The FASTIN RC Anchor is intended for: Shoulder: Rotator Cuff Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair and SLAP Repair; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis; Elbow: Biceps Tendon Reattachment, Tennis Elbow, Ulnar or Radial Collateral Ligament Reconstruction.
The FASTIN RC Anchor is a threaded titanium alloy implantable suture anchor preloaded on a disposable inserter assembly intended for fixation of two strands of suture. The anchors are made from Titanium 6A1-4V ELI per ASTM F- 136. The attached suture is then used to reattach soft tissue back to bone where it reconnects through the healing process. Once the tissue has healed (about six weeks) the anchor function is complete and the implant becomes dormant in the The FASTIN RC Anchor is available in 5.0mm and 6.5mm sizes and is offered with three suture options, non-absorbable Ethibond, absorbable Panacryl, and composite Orthocord.
The provided text describes the 510(k) summary for the FASTIN RC Anchor. This document focuses on demonstrating substantial equivalence to pre-existing devices rather than presenting the results of a primary study proving performance against acceptance criteria. Therefore, most of the requested information (acceptance criteria table, study sample sizes, expert ground truth details, adjudication methods, MRMC studies, standalone performance, training set details) is not available in this document.
Here's what can be extracted based on the provided text:
Acceptance Criteria and Reported Device Performance:
The document does not explicitly state acceptance criteria in terms of numerical performance metrics for the FASTIN RC Anchor. Instead, the "Safety and Performance" section indicates that substantial equivalence was determined through non-clinical laboratory testing. This testing demonstrated that the device is safe and can be considered substantially equivalent to the predicate FASTIN Anchor for the proposed new intended uses. The specifics of what constitutes "safe" or "substantially equivalent" in terms of measurable performance are not detailed.
Study Type and Design:
The study performed was non-clinical laboratory testing to support the claim of substantial equivalence to predicate devices (FASTIN Anchor - K945203, and Arthrex Titanium Corkscrew Anchor - K003816).
Here's a breakdown of the requested information based on the provided text:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as numerical performance targets. The "acceptance" was demonstrating safety and substantial equivalence to predicate devices through non-clinical laboratory testing.
- Reported Device Performance: The device was found to be safe and substantially equivalent to the predicate device for its proposed new intended uses based on non-clinical laboratory testing. No specific performance metrics (e.g., pull-out strength, fatigue life) are detailed in this summary.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified, but generally, non-clinical lab testing data would originate from the manufacturer's testing facilities. It's prospective in the sense that the tests were specifically conducted for this submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., Radiologist with 10 years of experience):
- Not applicable as this was non-clinical laboratory testing, not a clinical study involving expert interpretation of medical data.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as this was non-clinical laboratory testing.
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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 not an AI/imaging device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/imaging device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For non-clinical laboratory testing, the "ground truth" would be established by the physical and mechanical properties measured during the tests (e.g., material properties, strength, durability) compared against established standards or the properties of the predicate device.
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The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
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How the ground truth for the training set was established:
- Not applicable.
§ 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.