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The HammerFiX device is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.

The HammerFiX device is a bone fixation device consisting of a sterile, threaded PEEK implant and a set of instruments used for implant site preparation and delivery. The device is offered in small, medium and large implant sizes to allow for use in the proximal interphalangeal (PIP) joints of the lesser toes of the foot.

The provided text describes a 510(k) summary for the HammerFiX device, a bone fixation device. However, it explicitly states that no clinical testing was performed. Therefore, the information requested regarding acceptance criteria and a study proving the device meets them cannot be fully provided from the given document as it pertains to clinical performance. The 510(k) relies on non-clinical bench testing to establish substantial equivalence to predicate devices, rather than clinical efficacy or specific performance criteria from a clinical study.

Here's a breakdown of the available information based on the provided text, acknowledging the lack of clinical study data:

Acceptance Criteria and Study Details for HammerFiX Device (Based on Non-Clinical Testing)

1. Table of Acceptance Criteria and Reported Device Performance:

Since no clinical study was performed to evaluate performance against clinical acceptance criteria, the table below reflects the non-clinical testing performed and the general statement of equivalence based on those tests. Specific quantitative acceptance criteria or detailed numerical performance metrics from the bench testing are not provided in this summary.

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

• Test Set Sample Size: Not specified in the provided summary. This refers to the number of devices or constructs tested during non-clinical bench testing.
• Data Provenance: The testing was "bench testing," meaning it was conducted in a laboratory setting, likely at the manufacturer's facility or a contracted testing lab. No country of origin for data is stated, and it is inherently prospective for the specific bench tests conducted to support the 510(k).

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

• Not Applicable. For non-clinical bench testing, "ground truth" as it relates to expert clinical opinion is not established. The "ground truth" for mechanical testing is typically defined by standardized test methods and engineering specifications. The tests compare the device's measured mechanical properties to those of predicate devices or established engineering standards.

4. Adjudication Method for the Test Set:

• Not Applicable. Adjudication methods (like 2+1, 3+1) are relevant for clinical studies, especially when multiple readers or experts assess subjective outcomes. For non-clinical mechanical testing, results are typically objective measurements, not subject to adjudication in this manner.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. The document explicitly states: "No clinical testing was performed." Therefore, no MRMC study was conducted.

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

• Not Applicable. The HammerFiX device is a physical bone fixation implant, not a software algorithm or AI-based device. No standalone algorithm performance evaluation would be relevant.

7. The Type of Ground Truth Used:

• Non-Clinical Mechanical Standards and Predicate Device Performance: For the non-clinical testing, the "ground truth" was established by comparing the HammerFiX device's mechanical properties (pull-out, torque, static, and dynamic bending) against:
  • Applicable engineering standards and test methodologies.
  • The known performance characteristics of the predicate devices identified (K120645, K120165, K073674, K061164, K071498, K120449).

8. The Sample Size for the Training Set:

• Not Applicable. This question is relevant for AI/ML algorithm development. Since the HammerFiX device is a physical implant and no AI/ML component is mentioned, there is no "training set."

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

• Not Applicable. See explanation above for training set.

Summary: The 510(k) clearance for the HammerFiX device was based on non-clinical bench testing demonstrating substantial equivalence to predicate devices, rather than a clinical study evaluating human performance or clinical outcomes. The document clearly states that "No clinical testing was performed."

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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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