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The ActivaPin™ is indicated for fixation of bone fractures, osteotomies, arthrodeses and osteochondral fractures in the presence of appropriate immobilization.

The modified ActivaPin™ is identical to the currently cleared device except for the modification. The only modification to the initial 510(k) K061164 to be cleared is adding a Disposable Pin Applicator with K-wire for installation of ActivaPin™ and revising labeling accordingly. The change does not affect the intended use or alter the fundamental scientific technology of the device.

The ActivaPin" is indicated for fixation of bone fractures, osteotomies, arthrodeses and osteochondral fractures in the presence of appropriate immobilization. Pins are available in several different dimensions, including diameters of 1.5 - 3.2 mm and lengths of 20 - 70 mm.

ActivaPin™ is made of completely bioabsorbable poly(L-lactide-co-glycolide) (PLGA), and they decrade in vivo by hvdrolysis into alpha-hydroxy acids that are metabolized by the body. As the operated bone fracture or osteotomy gains strength during healing, the ActivaPin"1" gradually loses its strength, however, maintaining its function at least 8 weeks. Bioabsorption takes place within two years thus eliminating the need for implant removal surgery.

The provided text describes a Special 510(k) submission for a modification to an existing device, the Bioretec ActivaPin™. The modification involves adding a Disposable Pin Applicator with a K-wire. This submission focuses on demonstrating substantial equivalence to the predicate device, not on proving general effectiveness through clinical studies with acceptance criteria in the way a novel device might.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test and training sets, ground truth establishment, expert involvement, and MRMC studies is not applicable or available within this document.

Here's why and what information is provided:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not applicable / Not provided. The document states: "Microbiological testing determined that the ActivaPin™ and the ActivaPin™ Disposable Pin Applicator with K-wire instrument set has substantially similar performance as compared to its predicate devices." This is a qualitative statement of equivalence, not a report against specific, quantified acceptance criteria for performance. The modification is primarily about adding an accessory, and the core device performance (e.g., strength, bioabsorption) is assumed to be unchanged from the predicate.

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

• Not applicable / Not provided. No "test set" in the context of image analysis or algorithm performance is mentioned. The assessment is based on demonstrating equivalence for the new applicator and confirming the overall device's safety and effectiveness remain unchanged.

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

• Not applicable / Not provided. No "ground truth" establishment in a clinical or imaging context is described.

4. Adjudication Method for the Test Set:

• Not applicable / Not provided. No adjudication needed for this type of submission.

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 / Not provided. This device is a medical implant, not an AI-powered diagnostic or assistive tool for human readers.

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

• Not applicable / Not provided. This device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used:

• Not applicable / Not provided. No "ground truth" in the context of medical imaging or clinical outcome data is used in this submission. The "ground truth" for a device like this would be its physical/material properties and performance in vivo, which are implicitly covered by its predicate status.

8. The Sample Size for the Training Set:

• Not applicable / Not provided. No machine learning "training set" is involved.

9. How the Ground Truth for the Training Set was Established:

• Not applicable / Not provided. No machine learning "training set" is involved.

Summary of what the document does state about the device and its assessment:

• Device: Bioretec ActivaPin™ (a bioabsorbable pin for bone fixation)
• Modification: Addition of a Disposable Pin Applicator with K-wire for installation.
• Purpose of Submission: To demonstrate that this modification does not affect the intended use, alter the fundamental scientific technology, or raise new questions of safety and effectiveness compared to the predicate device (the original ActivaPin™ K061164).
• Evidence for Equivalence:
  • The modified device is "identical to the currently cleared device except for the modification."
  • The change "does not affect the intended use or alter the fundamental scientific technology of the device."
  • "Microbiological testing determined that the ActivaPin™ and the ActivaPin™ Disposable Pin Applicator with K-wire instrument set has substantially similar performance as compared to its predicate devices." (This is the closest the document comes to a "study," albeit briefly mentioned and without details.)
• Conclusion: The FDA reviewed the 510(k) and determined the device (with the modification) is substantially equivalent to the legally marketed predicate device.

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