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The Newclip Patient-matched instrumentation non sterile PSI is indicated to be used as a surgical instrument to assist in pre-operative planning and/or in guiding surgical instruments in High Tibial Medial Opening or Closing Wedge Osteotomy, Distal Femoral Medial or Lateral Closing Wedge Osteotomy, High Tibial Lateral Closing Osteotomy, High Tibial Anterior Closing Osteotomy, Distal Femoral Lateral Opening Wedge Osteotomy and Distal Femoral Medial or Lateral Derotational Osteotomy, when the anatomic landmarks necessary for pre-operative planning can be clearly identified on the patient's radiographic images (i.e., computed tomography (CT)). Each PSI is designed to be compatible with implants from the Newclip High Tibial Osteotomy System or the Newclip Activmotion Range.

The Newclip Patient-matched instrumentation non sterile PSI are patient-matched devices (PSI Guides). The PSI Guides are surgical drilling/cutting guides that are additively manufactured (3D printed) and are designed to match the patient's anatomy. They are intended to assist in pre-operative planning and/or in guiding the marking of bone and/or guiding surgical instruments in non-acute, non-joint replacing osteotomies around the knee. They are single-use devices provided non sterilization by health care professionals before use. The Newclip Patient-matched instrumentation non sterile PSI can be used to facilitate implantation of the Newclip Activmotion Range devices. The purpose of this 510(k) notification is to add PSI Guides for High Tibial Lateral and Anterior Closing osteotomies. Material: Polyamide (PA2200).

The provided document is a 510(k) Summary for the Newclip Patient-matched instrumentation non sterile PSI. It includes information on the device, its intended use, and a comparison to a predicate device (K240415). The document also outlines the performance data used for verification and validation but lacks specific quantitative acceptance criteria or detailed study results for objective efficacy.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format for performance metrics. Instead, it describes acceptance in qualitative terms, primarily relying on comparison to the predicate device and satisfactory outcomes in simulated use.

2. Sample Size and Data Provenance

• Test Set Sample Size: The document does not specify a numerical sample size for the "worst-case guide design and manufacture" or the "simulated use" scenarios. It mentions "worst-case guide design" and "worst-case and subject PSI guides." This implies a limited, representative set rather than a large statistical sample.
• Data Provenance: The studies were conducted by Newclip Technics, a French company (Sponsor Address: F-44115 Haute-Goulaine, FRANCE). The studies were internal verification and validation activities. The country of origin of the data subjects (if any beyond the guides themselves) is not specified, nor whether it was retrospective or prospective. Given the nature of a 510(k) submission for mechanical surgical guides, it's likely a laboratory/simulated environment and not involving human patient data directly for performance validation at this stage.

3. Number of Experts and Qualifications for Ground Truth

• Manufacturing Validation: "Three NewClip operators with low, medium, and high levels of experience (novice, intermediate, expert)" were involved in the manufacturing validation. Their specific qualifications (e.g., years of experience, specific certifications) beyond their experience level are not detailed.
• Simulated Surgery: "The same three novice surgeons" performed the simulated use. Their specific qualifications (e.g., years of surgical experience, board certification) are not detailed other than being designated "novice."

4. Adjudication Method

• The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for establishing ground truth or evaluating performance. For the manufacturing validation, it involved comparison of dimensions, design, correction, and placement, presumably against predefined design specifications or an established 'true' state. For the simulated surgery, it seems the observation of the three novice surgeons' ability to achieve the desired outcomes (positioning, correction, hinge preservation) against unnamed criteria formed the basis of acceptability.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was done. The performance data section describes internal verification and validation activities rather than a comparative study of human readers with and without AI assistance. The device is a surgical guide, not an AI diagnostic tool that assists human readers in interpreting images.

6. Standalone Performance Study

• The performance data described focuses on the device itself (manufacturing precision and simulated usability) and its comparison to a predicate device. It is a standalone assessment of the algorithmic design and physical manufacturing of the guides, though its use is demonstrated in a simulated human-in-the-loop context (by surgeons). The "algorithm" here refers to the design software that creates the patient-matched guides.
  • Manufacturing Test: The assessment of "precision and accuracy of design, correction, and manufacture" of the PSI guides can be considered a standalone algorithm/device performance evaluation as it assesses the output of the CAD/CAM process.
  • Simulated Use: This evaluates the physical guides in use by surgeons, which is a human-in-the-loop scenario, but the performance of the guide itself (its fit, its ability to guide instruments correctly) is the primary focus.

7. Type of Ground Truth Used

• Manufacturing Validation: The ground truth for manufacturing precision and accuracy would be the original digital design specifications of the patient-matched instrumentation. The manufactured guides were compared against these known dimensions and design elements.
• Simulated Surgery: The ground truth for the simulated surgery was the planned surgical correction and the expected function of the guide (e.g., correct positioning, preservation of the hinge). This is established based on the pre-operative planning and surgical goals.

8. Sample Size for the Training Set

• The document does not mention a "training set" in the context of an AI/machine learning model. The device (Patient-matched instrumentation) leverages CT images to create customized physical guides, which are then 3D printed. There is no indication of an AI algorithm being "trained" on a dataset in the typical sense. The "training" here would be for the CAD/CAM software to accurately generate the patient-specific geometry based on the CT scan data, which is typically a deterministic process rather than a machine learning one.

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

• As no training set for an AI/ML model is indicated, this question is not applicable based on the provided text. The "ground truth" for the device's function relies on accurate anatomical segmentation from CT scans and precise mechanical design parameters encoded in the CAD/CAM software.

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