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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:

1. 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.

2. 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.

3. 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.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable as this was non-clinical laboratory testing.

5. 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.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is not an AI/imaging device.

7. 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.

8. 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.

9. How the ground truth for the training set was established:

   • Not applicable.

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The Fastin RC Anchor is intended for: Shoulder: Rotator cuff repair.

The Mitek 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 designed to be used in the surgical repair of the rotator cuff, and are made from Titanium 6Al-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 bone. The proposed 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.

I am sorry, but based on the provided document, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) summary for a medical device (Fastin RC Anchor) and it primarily focuses on establishing substantial equivalence to a predicate device.

Here's what the document does state regarding testing:

• "Non-clinical laboratory testing was performed demonstrating that the device is safe and performs as intended." (Page 1, under "Safety and Performance")

However, it does not provide any details about:

• Specific acceptance criteria.
• The methodology, results, or outcome of these non-clinical laboratory tests.
• Any of the specific study parameters you requested such as sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, or training set information.

The document indicates that the determination of substantial equivalence was based on a detailed device description and "changes that intend to be made to currently marketed devices," and that the changes were "either dimensional or a material change." The core argument for substantial equivalence is that these changes are minor and do not affect the safety or effectiveness of the device compared to the predicate device (K983818), and that an existing material (Orthocord suture, K040004) was added as an option.

Therefore, the requested information about acceptance criteria and detailed study results is not present in the provided text.

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The threaded Anchor holds sutures in bone for the period of time required to allow for patient rehabilitation and tissue healing. Rotator cuff repair

The Mitek FASTIN® RC threaded titanium alloy suture anchor is preloaded on a disposable inserter assembly intended for fixation of two strands of #2 suture to bone. The Mitek FASTIN® RC Anchor is designed to be used in the surgical repair of the rotator cuff.

The Mitek FASTIN® RC Anchor is substantially equivalent to the Mitek FASTIN® anchor, which was cleared in March 1995.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the mechanical tests, nor does it specify the country of origin or whether the data was retrospective or prospective. It only mentions "mechanical tests done and contained in the literature."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable and not provided in the document. The performance assessment relies on mechanical testing against a predicate device, not on expert ground truth in a clinical or diagnostic context.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. The study is based on mechanical testing, not on human case adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes mechanical testing for device performance.

6. Standalone (i.e. algorithm only without human-in-the-loop performance) Study

This concept is not applicable here as the device is a physical medical device (suture anchor), not an algorithm or AI system. The performance evaluated is the mechanical holding power of the anchor.

7. Type of Ground Truth Used

The "ground truth" for acceptance in this context is the mechanical holding power of the predicate device (Mitek FASTIN®) established through mechanical tests. The Mitek FASTIN® RC Anchor was then compared against this established performance.

8. Sample Size for the Training Set

This information is not applicable as this is a physical medical device and not an AI/algorithm-based product that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the reasons stated above.

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