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The Intrinsic Therapeutics Fixation Staple is intended for providing soft tissue fixation to bone in orthopedic procedures such as:

1. Tendon repairs, transfers, or transplants, such as in the treatment of paralytic conditions, tendon avulsions or ruptures, in which the tendon is fixed to the bone.
2. Ligament repairs, reconstruction, or replacement in which the ligament is fixed to the bone.

The Intrinsic Therapeutics Fixation Staple is made from 6Al 4V ELI Titanium conforming to ASTM F136. The legs of the staple have barbs and are curved to provide strength in bone fixation. The staple is provided sterile. A reusable insertion tool is provided to facilitate insertion of the staple.

The provided text describes a medical device, the Intrinsic Therapeutics Fixation Staple, and its submission for 510(k) clearance by the FDA. The submission focuses on demonstrating "substantial equivalence" to predicate devices rather than proving the device meets specific acceptance criteria through clinical studies or extensive performance testing as might be required for new technologies or higher-risk devices.

Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable or available in this specific document. The document highlights benchtop testing as the primary performance data provided.

Here's a breakdown based directly on the provided text, indicating where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified. The document only mentions "Benchtop testing."
• Data Provenance: Not specified, but generally, benchtop testing is conducted in a lab setting, not typically described by country of origin or as retrospective/prospective in the same way clinical data would be.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not applicable and not available. Benchtop testing typically relies on predefined engineering or material science standards, not expert human assessment to establish "ground truth."

4. Adjudication method for the test set

• This information is not applicable and not available, as there was no human expert assessment or adjudication described.

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

• No MRMC study was done. This device is a physical fixation staple, not an AI-powered diagnostic or assistive technology for human readers.

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

• No standalone algorithm performance study was done. This device is a physical fixation staple, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• For the benchtop testing, the "ground truth" would be the engineering specifications and performance standards established for fixation staples and potentially derived from the predicate devices. This is not explicitly detailed but implied by the nature of benchtop testing.

8. The sample size for the training set

• Not applicable/available. This device is a physical product, not an AI model that requires a training set.

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

• Not applicable/available, as there was no training set for a machine learning model.

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