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KLS Martin Individual Patient Solutions (IPS) is intended as a pre-operative software tool for simulating / evaluating surgical treatment options as a software and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The is processed by the IPS software and the result is an output data file that may then be provided as digital models or used as input in an additive manufacturing portion of the system that produces physical outputs including implants, anatomical models, guides, splints, and case reports for use in maxillofacial, midface, & mandibular surgery.

KLS Martin Individual Patient Solutions (IPS) implant devices are intended for use in the stabilization, fixation, and reconstruction of the maxillofacial / midface and mandibular skeletal regions in children (2 years of age), adolescents (12 years of age - 21 years of age), and adults.

KLS Martin Individual Patient Solutions (IPS) is comprised of a collection of software and associated additive manufacturing equipment intended to produce various outputs to support reconstructive and orthognathic surgeries. The system processes the medical images to produce various patient-specific physical and/or digital output devices which include implants, anatomical models, guides, splints, and case reports.

Patient-specific metallic bone plates are used in conjunction with metallic bone screws for internal fixation of maxillofacial, midface, and mandibular bones. 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 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 output device over a 3D model of the patient's anatomy to ensure its dimensional properties allow an adequate fit.

Implants are provided non-sterile and are manufactured using traditional (subtractive) or additive manufacturing methods from either CP Titanium (ASTM F67) or Ti-6AI-4V (ASTM F136). 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 text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the KLS Martin Individual Patient Solutions device primarily revolve around demonstrating substantial equivalence to predicate devices and ensuring the safety and effectiveness of the device, particularly for the expanded pediatric population and new specifications. The performance is assessed through various non-clinical tests and a review of clinical literature.

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

The provided text primarily details non-clinical testing and a review of clinical literature rather than a specific test set for the device's performance in a diagnostic or predictive context.

• Non-clinical testing: The sample sizes for mechanical, biocompatibility, sterilization, and pyrogenicity testing are not explicitly stated in the provided document. These tests are typically conducted on a representative number of device samples according to established standards.
• Clinical Literature Review: The clinical performance data comes from 6 clinical studies that analyzed patients aged 18 months to 18 years. The provenance of this data is retrospective, as it involves a review of published literature findings rather than a new prospective clinical trial conducted by KLS Martin. The specific countries of origin for these studies are not mentioned.

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

This information is not applicable in the context of the provided document. The document describes a 510(k) submission for a medical device (surgical planning software and implants), not an AI/ML diagnostic or predictive device that typically requires expert-established ground truth for a test set. The "ground truth" for this device's performance would be the successful outcome of surgical planning and the functional stability of the implants, assessed through non-clinical means and literature review, rather than expert annotation of data.

4. Adjudication Method for the Test Set

This information is not applicable for the reasons stated in point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done for this device. The device is a surgical planning tool and implant system, not an AI-assisted diagnostic tool that would typically be evaluated with MRMC studies to assess human reader improvement.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device encompasses both software (for pre-operative planning and image segmentation) and physical outputs (implants, models, guides). The software component, KLS Martin Individual Patient Solutions (IPS), is described as a "pre-operative software tool for simulating / evaluating surgical treatment options as a software and image segmentation system." The software itself undergoes "Software Verification and Validation" to ensure it performs as intended based on user requirements and specifications. This suggests the software functionality is evaluated as a standalone component in terms of its technical accuracy and adherence to specifications. However, its effectiveness is intrinsically linked to its use in the context of surgical planning involving human input (physician feedback). Therefore, while the software's functional performance is verified, it is not described as having an 'algorithm only without human-in-the-loop performance' study in the way an AI diagnostic algorithm might be evaluated.

7. The Type of Ground Truth Used

• Non-clinical Performance: The "ground truth" for the non-clinical tests (mechanical, biocompatibility, sterilization, pyrogenicity) is defined by established industry standards and regulatory requirements (e.g., ASTM F382, ISO 10993-1, ISO 17665-1:2006, AAMI ANSI ST72). The device's performance is compared against these standards or against predicate devices that have already met these standards.
• Clinical Performance (Pediatric Expansion): The "ground truth" for supporting the expanded pediatric indications comes from peer-reviewed clinical literature (6 studies cited) that assessed the safety and effectiveness of similar bone plate devices and the subject device's components in pediatric populations, following FDA guidance on "Use of Real-World Evidence."

8. The Sample Size for the Training Set

This information is not provided in the document. Software for medical devices, especially those involving image processing and CAD/CAM, often utilizes pre-existing algorithms and models rather than being trained from scratch on large datasets in the way a deep learning AI might be. If any training was involved, the details are not disclosed here.

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

This information is not provided in the document. As stated above, it is unclear if a "training set" in the context of machine learning was used. If the software involves image segmentation or manipulation, it likely relies on validated algorithms rather than a dynamically trained model requiring ground truth from human annotations for training.

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