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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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The Tiger Cannulated Screw System is indicated for fixation of fractures, non-unions, arthrodeses, and osteotomies of bones appropriate for the size of the device.

The Tiger Cannulated Screw System is a headed and headless, cannulated, self-drilling, self-tapping screw system for the management of bone orthopedic osteotomies and trauma. The system consists of Ø2.0-Ø7.0 mm screws and washers, and the necessary instruments to facilitate the placement of these implants. The purpose of this submission is to add Ø5.5 mm and Ø7.0 mm headed cannulated screws to the Tiger Cannulated Screw System and to modify the indications for use statement for previously cleared devices (K081510 / K112737).

This document is a 510(k) premarket notification for the "Tiger Cannulated Screw System". It primarily discusses the substantial equivalence of this device to previously marketed predicate devices rather than presenting a study demonstrating the device meets specific acceptance criteria in a clinical or AI-related context.

Therefore, many of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) regarding AI-specific study details, ground truth, expert involvement, and sample sizes for training/test sets are not applicable to this document as it pertains to a traditional medical device (bone screws) and not an AI/ML device.

However, I can extract information related to non-clinical testing and the comparison to predicate devices, which serve as the "acceptance criteria" for this type of submission.

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

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

• Not applicable for this type of device. The non-clinical tests (ASTM F543-07) involve mechanical testing of the screws, not data from human patients or a test set in the AI sense. The number of screws tested for each mechanical property would typically be specified in the full test report, but it's not detailed in this 510(k) summary.

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. This submission relies on engineering and material standards for mechanical properties rather than expert clinical assessment of patient data.

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

• Not applicable. This refers to methods for resolving discrepancies in expert labeling of AI datasets, which is not relevant here.

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 a mechanical device, not an AI-assisted diagnostic or therapeutic tool. No MRMC study was performed.

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

• Not applicable. This device is a surgical implant, not an algorithm.

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

• For the non-clinical tests, the "ground truth" or reference standard would be the defined specifications and performance characteristics of the predicate devices and the requirements of the ASTM F543-07 standard.

8. The sample size for the training set:

• Not applicable. There is no training set as this is not an AI/ML device.

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

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

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