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The Tyber Medical BioTy™ Nanotopography Trauma Screw, TyFix Screw is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion appropriate for the size of the device. The screw is intended for single use only.

General trauma screw for compression and fixation of bone. The BioTy™ Nanotopography provides a microscopic roughened surface with nano-scaled features. The screws will be provided sterile in both solid and cannulated form, made of from titanium and stainless steel.

This document describes the regulatory submission for a medical device (bone screw) and does not contain information about Artificial Intelligence (AI) or machine learning (ML) device performance, acceptance criteria for AI/ML, or studies involving AI/ML.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance for an AI/ML device.
• Sample size used for an AI/ML test set or data provenance.
• Number of experts used to establish ground truth for an AI/ML test set.
• Adjudication method for an AI/ML test set.
• MRMC comparative effectiveness study results for AI/ML.
• Standalone performance for an AI/ML algorithm.
• Type of ground truth used for an AI/ML device.
• Sample size for training set for an AI/ML device.
• How ground truth for an AI/ML training set was established.

The provided text pertains to a traditional 510(k) submission for a mechanical medical device (Tyber Medical BioTy™ Nanotopography Trauma Screw, TyFix Screw). The acceptance criterion mentioned is for mechanical and material testing (Pull out Test per ASTM F543, Static Torsion Test per ASTM F543, and Pyrogenicity testing) and states that the device "met the acceptance criteria" for these physical tests. It explicitly states "Clinical Test Summary: n/a".

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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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