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KLS Martin Cannulated Headless Screws are intended for the treatment of fractures, osteotomies, and nonunions of small bones in the hand, wrist, foot, and ankle.

The KLS Martin Cannulated Headless Screws (CHS) system is comprised of headless cannulated screws intended for bone fixation in the treatment of fractures, non-unions, osteotomies, or to aid in small joint fusions of the hand, wrist, foot, and ankle. Bone fixation is achieved by proximal and distal threads designed with different pitches that, when inserted into the bone, cause compression of the bone fragments for bone reduction, stability, and healing. Cannulation of the screws is designed to allow the user to insert the screw over the guide wire for proper placement prior to compression. The CHS system offers screws in various diameters, overall lengths, and thread lengths to accommodate different sizes and types of bone reduction, such as scaphoid fractures and non-unions. The screws are self-drilling and self-tapping to eliminate the need for drilling a pilot hole prior to implantation. All screws are manufactured from Ti-6Al-4V (ASTM F136:2013). This system also includes the necessary and appropriate instrumentation to facilitate implantation of the screws by qualified and trained physicians.

The provided text describes a 510(k) premarket notification for a medical device, the KLS Martin Cannulated Headless Screws. This document focuses on demonstrating substantial equivalence to predicate devices based on non-clinical performance data, primarily mechanical and pyrogenicity testing.

Therefore, the requested information regarding acceptance criteria and studies focused on AI/algorithm performance, human reader studies, and training/test set details is not applicable to this document. This is a traditional medical device approval, not an AI/software as a medical device (SaMD) submission.

Here's a breakdown of the parts that are directly addressed by the provided text, and clarification for those that are not applicable:

1. A table of acceptance criteria and the reported device performance

The document does not provide a formal table of acceptance criteria with reported performance in a pass/fail format, as might be seen for a software algorithm. Instead, it describes mechanical property tests and pyrogenicity testing, stating they were "successfully completed without any signs of device failure" and that "endotoxin levels [are] below the USP allowed limit."

• Mechanical Properties Testing:
  • Acceptance Criteria Implied: Meeting the requirements of ASTM F543-13:2013 for torsional properties, driving torque, and axial pullout strength.
  • Reported Device Performance: Tests were "successfully completed without any signs of device failure." Comparative testing to the Synthes 3.0 mm cannulated screw "demonstrates substantial equivalence in performance testing."
• Pyrogenicity Testing:
  • Acceptance Criteria Implied: Endotoxin levels below the USP allowed limit for medical devices and meeting pyrogen limit specifications, as per AAMI ANSI ST72.
  • Reported Device Performance: "Endotoxin levels below the USP allowed limit for medical devices and meet pyrogen limit specifications."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size for the mechanical and pyrogenicity tests. Data provenance (country, retrospective/prospective) is not mentioned as these are laboratory tests of the physical device, not human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth in this context refers to defined physical standards outlined in ASTM F543-13:2013 and AAMI ANSI ST72, not expert human interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are relevant for human-interpreted data, not for laboratory physical property testing.

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. This is not an AI/software device.

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

Not applicable. This is not an AI/software device.

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

The "ground truth" for this device's performance is based on established industry standards and test methods:

• For mechanical properties: ASTM F543-13:2013 Standard Specification and Test Methods for Metallic Medical Bone Screws.
• For pyrogenicity: AAMI ANSI ST72.

8. The sample size for the training set

Not applicable. There is no training set for this type of medical device assessment.

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

Not applicable.

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