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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 Extremity Medical IP Fusion System is intended for reduction and internal fixation of arthrodesis of the interphalangeal joints of the hand.

The Extremity Medical IP Fusion System is designed to allow arthrodesis of the interphalangeal joints of the hand. The system has two intra-operative configurations: a cannulated or non-cannulated lag screw, and an intramedullary Post for engaging the lag screw. The Post consists of a threaded cylinder with an eyelet through the head at to accommodate the lag screw. The axis of the eyelet and the lag screw couple at an oblique angle, which forms a reference angle for the intended fusion. The system includes common instrumentation for application of surgical bone screws within the human body, such as drills, guide wires, countersinks, reamers, drill and guide wire guides, and a screwdriver.

The provided text describes the EXTREMITY MEDICAL IP Fusion System, a device intended for arthrodesis of the interphalangeal joints of the hand. However, it does not explicitly state acceptance criteria in the form of quantitative performance metrics, nor does it detail a study that "proves the device meets the acceptance criteria" in the way one might expect for a diagnostic or AI-driven medical device.

Instead, this 510(k) summary focuses on demonstrating substantial equivalence to predicate devices through a comparison of design, materials, indications for use, and mechanical properties. The "study" mentioned primarily consists of non-clinical bench testing and clinical simulations in cadavers.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria for device performance. The "reported device performance" is described qualitatively as being "substantially equivalent" to predicate devices, based on the testing performed.

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

• Sample Size for Bench Testing: Not specified.
• Sample Size for Cadaver Simulations: Not specified.
• Data Provenance: The testing was conducted by Extremity Medical. The document does not specify country of origin for the data or whether the data was retrospective or prospective, though bench testing and cadaver simulations are by nature prospective for the purpose of device evaluation.

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

• This information is not provided in the document. The "ground truth" for mechanical testing would be engineering standards and for cadaver simulations, it would be the successful application of the surgical technique. No external experts for "ground truth" establishment are mentioned.

4. Adjudication Method for the Test Set

• An adjudication method is not described, as the testing involves direct measurement and observation rather than expert consensus on complex interpretations.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a physical implant, not a diagnostic or AI-assisted interpretation tool. The document explicitly states: "No clinical testing was performed."

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

• This question is not applicable. The EXTREMITY MEDICAL IP Fusion System is a medical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

• For bench testing: Engineering specifications and comparison against predicate device performance serve as the "ground truth" for mechanical properties.
• For cadaver simulations: Successful demonstration of the surgical technique and proper device placement within anatomical structures serves as the "ground truth."

8. The Sample Size for the Training Set

• This concept is not applicable as the device is a physical product and not an AI/ML algorithm that requires a training set.

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

• This question is not applicable for the same reason as point 8.

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