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KLS Martin Individual Patient Solutions implant devices are in the stabilization and fixation of mandibular fractures and mandibular reconstruction.

KLS Martin Individual Patient Solutions is comprised of patient-specific models and metallic bone plates used in conjunction with metallic bone screws for internal fixation of mandibular bone. The devices are manufactured based on medical imaging (CT scan) of the patient's anatomy with input from the physician during virtual planning and prior to finalization and production of the device. The physician only provides input for model manipulation and interactive feedback by viewing digital models of planned outputs that are modified by trained KLS Martin engineers during the planning session. For each design iteration, verification is performed by virtually fitting the generated device model over a 3D model of the patient's anatomy to ensure its dimensional properties allow an adequate fit. Implants are provided non-sterile, range in thickness from 1.0 - 3.0 mm, and are manufactured using traditional (subtractive) or rapid prototyping (additive) methods from either CP Titanium (ASTM F67) or Ti-6Al-4V (ASTM F136) materials. These patient-specific devices are fixated with previously cleared KLS Martin screws.

Here's a summary of the acceptance criteria and study information for the KLS Martin Individual Patient Solutions device, based on the provided document:

This document focuses on the mechanical and material performance of the device rather than the performance of an AI algorithm in a diagnostic or clinical decision support context. Therefore, many of the typical AI/ML study questions (like effect size of human readers with/without AI, standalone algorithm performance, number of experts for ground truth, etc.) are not applicable here.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated in terms of number of physical devices or specific data points for performance testing. The document refers to "the subject plates" for mechanical testing, implying a representative sample was tested.
• Data Provenance: The studies are non-clinical bench tests and conducted by the manufacturer, KLS Martin LP. The data originates from these laboratory tests, not from patient data or clinical settings. It is a retrospective analysis of device performance against established standards.

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

• This device is a medical implant, not a diagnostic AI device. There is no concept of "ground truth" established by human experts in the context of diagnostic interpretation for its performance testing. The "ground truth" for its performance is derived from established engineering and materials science standards (ASTM, ISO, etc.).

4. Adjudication Method for the Test Set

• Not applicable. The performance tests are objective measurements against engineering standards, not subjective interpretations requiring adjudication.

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 medical implant, not an AI diagnostic or decision support tool. No human reader studies with or without AI assistance were conducted or are relevant.

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

• Not applicable. This is a medical implant. The "algorithm" in this context refers to the manufacturing process driven by patient CT data and physician input for design, not an AI algorithm for diagnosis or interpretation. The device itself is "standalone" in that it performs its mechanical function once implanted, but its pre-market testing does not involve "algorithm-only performance" as would be understood for an AI/ML product.

7. The Type of Ground Truth Used

• Engineering Standards and Specifications: The "ground truth" for this device's performance is derived from compliance with established international standards for medical devices and materials, specifically:
  • ASTM F382 (Standard Specification for Metallic Bone Plates) for mechanical performance.
  • ISO 17665-1:2006 (Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices) for sterilization.
  • ISO 10993 (Biological evaluation of medical devices) for biocompatibility.
• For the patient-specific design process, the "ground truth" for dimensional fit is a virtual fitting against a 3D model of the patient's anatomy derived from a CT scan.

8. The Sample Size for the Training Set

• Although the device design is patient-specific and involves a "virtual planning" phase, this is not an AI/ML product that learns from a "training set" in the conventional sense. Each device is unique to a patient based on their CT scan. The "training" for the manufacturing process (both traditional and additive) happens through engineering validation and quality control procedures, not through a data-driven training set for an algorithm.

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

• Not applicable, as there is no traditional "training set" for an AI/ML algorithm. The "ground truth" for the device's manufacturing and material properties is established through adherence to design specifications, material standards (ASTM F67, ASTM F136), and manufacturing quality control processes. The patient's CT scan provides the anatomical data for each individual device's design.

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