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The KLS Martin Individual Patient Solutions (IPS) Planning System is intended for use as a software system and image segmentation system for the transfer of imaging information from a computerized tomography (CT) medical scan. The input data file is processed by the IPS Planning System and the result is an output data file that may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including anatomical models, guides and case reports for use in the marking of cranial surgery. The IPS Planning System is also intended as a pre-operative software tool for simulating surgical treatment options.

The KLS Martin Individual Patient Solutions (IPS) Planning System is a collection of software and associated additive manufacturing (rapid prototyping) equipment intended to provide a variety of outputs to support reconstructive cranial surgeries. The system uses electronic medical images of the patients' anatomy (CT data) with input from the physician, to manipulate original patient images for planning and executing surgery. The system processes the medical images and produces a variety of patient specific physical and/or digital output devices which include anatomical models, guides, and case reports for use in the marking of cranial bone in cranial surgery.

The KLS Martin Individual Patient Solutions (IPS) Planning System is a software system and image segmentation system used for transferring imaging information from a CT scan. The system processes input data to produce output data files, which can be digital models or physical outputs like anatomical models, guides, and case reports for cranial surgery. It is also a pre-operative software tool for simulating surgical treatment options.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample sizes used for the non-clinical performance tests (tensile, bending, biocompatibility, sterilization, pyrogenicity, software V&V). The data provenance for these tests is internal to the manufacturer, as they were "performed on the subject polyamide guides," "conducted on devices manufactured from polyamide," and for titanium, "leveraged from the reference device." This indicates the studies were likely conducted in a controlled lab or manufacturing environment. The studies are not described as retrospective or prospective clinical studies, but rather as non-clinical engineering and material performance tests.

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

This information is not applicable. The device is a planning and segmentation system that outputs digital models or physical guides/anatomical models. The acceptance criteria and performance data described relate to the physical and software characteristics of these outputs (e.g., material strength, sterility, software functionality), not to a diagnostic or treatment outcome for which expert ground truth would be established from patient data. The process involves a physician providing input for model manipulation and interactive feedback, but this is part of the planning workflow, not establishing ground truth for a test set in the context of algorithm performance.

4. Adjudication Method for the Test Set:

This information is not applicable, as the described studies are non-clinical performance tests focused on material properties, sterility, and software functionality, not on qualitative assessments requiring adjudication from expert readers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not necessary for the determination of substantial equivalence."

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

Yes, the "Software Verification and Validation" section describes testing of individual software applications. This indicates a standalone assessment of the software's performance in implementing requirements and specifications, separate from a human-in-the-loop clinical scenario.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

For the non-clinical tests:

• Tensile & Bending Testing: Ground truth is based on established engineering standards and material science principles (e.g., 85% retention of initial tensile strength after sterilization, comparison to traditional manufacturing methods).
• Biocompatibility Testing: Ground truth refers to pre-defined acceptance criteria in accordance with ISO 10993-1.
• Sterilization Testing: Ground truth is based on achieving a sterility assurance level (SAL) of $10^{-6}$ as per ISO 17665-1:2006.
• Pyrogenicity Testing: Ground truth is based on meeting USP allowed limits for endotoxin levels (< 2.15 EU/device) and pyrogen limit specifications.
• Software Verification & Validation: Ground truth is defined by "all software requirements and specifications" and "pre-defined specifications and acceptance criteria" derived from user requirements and risk analysis.

8. The Sample Size for the Training Set:

The document does not mention a training set. This device is described as utilizing a collection of software and additive manufacturing equipment for planning and producing physical outputs based on patient CT data, not a machine learning model that would require a dedicated training set. The software applications used (Materialise Mimics, Geomagic® Freeform Plus™) are "comedically off-the-shelf (COTS) software applications," implying they were developed and validated independently, prior to their integration into this system.

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

This information is not applicable, as there is no mention of a training set for a machine learning algorithm in the context of this device.

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