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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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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. 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 quides 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 primary purpose of this 510(k) notification is to add PSI Guides for closingwedge and derotation osteotomies.

The provided text describes the Newclip Patient-matched instrumentation non sterile PSI, a device used in osteotomy procedures around the knee. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, but it does not include explicit acceptance criteria, detailed study designs, or specific performance metrics typically expected for AI/Machine Learning-enabled devices.

The device is described as "patient-matched instrumentation," which implies that the design process involves processing patient imaging data (CT scans) to create custom surgical guides. However, the document does not elaborate on the algorithmic aspects of this patient-matching process or how its accuracy is evaluated in a standalone or comparative study setting.

Given the information provided, here's an attempt to answer the questions, highlighting the limitations due to the lack of specific details concerning AI/ML evaluation as per your request:

1. Table of acceptance criteria and the reported device performance

Based on the provided document, explicit quantitative acceptance criteria for the "Newclip Patient-matched instrumentation non sterile PSI" are not stated. The performance is broadly described in terms of "precision and accuracy" in simulated-use cadaver surgeries. No specific numerical thresholds or target values are provided.

2. Sample size used for the test set and the data provenance

The document mentions "simulated-use cadaver surgeries" for performance verification. However:

• Sample Size for Test Set: Not specified. The number of cadavers or surgical approaches evaluated is not provided.
• Data Provenance: Not specified, but given the nature of cadaver studies, it would be laboratory-based rather than from real-world patient data. The study is described as "simulated-use," suggesting a prospective evaluation within a controlled environment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document states "Surgeon evaluation of precision and accuracy."

• Number of Experts: Not specified.
• Qualifications of Experts: Identified as "Surgeon," but no further details such as specialty (e.g., orthopedic surgeon), years of experience, or specific board certifications are provided.

4. Adjudication method for the test set

The document only states "Surgeon evaluation." There is no mention of an adjudication method (such as 2+1, 3+1 consensus, or independent review) for establishing ground truth or assessing outcomes in the simulated-use cadaver surgeries.

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

• MRMC Study: Not mentioned. The study described is a "Surgeon evaluation of precision and accuracy based on simulated-use cadaver surgeries." This focuses on the performance of the device itself in guiding surgical actions, rather than an MRMC study comparing human reader performance with and without AI assistance for tasks like diagnosis or planning.
• Effect Size of AI/Human Improvement: Not applicable, as no such MRMC study is described. The device's role is to guide surgical instruments, not to assist human readers in interpreting images or making diagnostic decisions.

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

The document describes the "patient-matched instrumentation" as derived from CT images and used to guide surgical instruments. This implicitly means there is computational work done to generate these custom guides. However, no specific standalone algorithm-only performance study results are provided. The evaluation mentioned is "Surgeon evaluation of precision and accuracy based on simulated-use cadaver surgeries," which represents a human-in-the-loop scenario where the surgeon uses the device. A standalone validation of the algorithm's ability to precisely match anatomy or generate optimal guide designs is not explicitly detailed.

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

For the "precision and accuracy" evaluation in cadaver surgeries, the ground truth or reference standard against which the device's performance was measured is not explicitly stated. It's likely an assessment by the evaluating surgeon(s) based on intra-operative observation or post-operative measurements of the osteotomy characteristics (e.g., angles, cuts) against the pre-operative plan, but the method for establishing this ground truth is not detailed.

8. The sample size for the training set

The document does not provide any information regarding a training set sample size. This suggests that if an algorithm is used for patient-matching guide design, it was either not developed using a distinct "training set" in the machine learning sense, or the details of its development and validation outside of the simulated-use cadaver study are not included in this summary. The process likely involves computational design based on individual patient CT data rather than a generalizable AI model trained on a large dataset.

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

Not applicable, as no information about a training set is provided.

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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 Wedge Osteotomy and Distal Femoral Lateral Opening Wedge 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. The subject devices are surgical drilling/cutting quides 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 guiding surgical instruments in orthopaedic surgery (High Tibial Medial Opening Wedge Osteotomy and Distal Femoral Lateral Opening Wedge Osteotomy). They are single-use devices provided non sterile for sterilization by health care professionals before use. The Newclip Patient-matched instrumentation non sterile PSI can be used to facilitate implantation of Newclip High Tibial Osteotomy System or the Newclip Activmotion Range devices.

The provided text is a 510(k) summary for the Newclip Patient-matched instrumentation non sterile PSI. It does not contain the specific acceptance criteria or details of a study structured to prove the device meets said criteria as requested.

The document states that "Verification and validation (V&V) activities included... Surgeon evaluation of precision and accuracy based on human clinical cases." It further mentions that "Precision and accuracy of the subject device was demonstrated in published human clinical studies by surgeon-users on patients in Europe using Newclip Patient-matched instrumentation non sterile PSI guides." However, it does not provide:

• A table of acceptance criteria and reported device performance.
• Sample size for the test set or data provenance. (It refers to "human clinical cases" and "published human clinical studies" but gives no numbers or details on whether the data was retrospective or prospective, or from which specific countries beyond "Europe.")
• Number and qualifications of experts for ground truth.
• Adjudication method.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size for human readers improving with/without AI assistance. (This device is a patient-matched surgical guide, not an AI or imaging diagnostic tool, so an MRMC study is unlikely to be relevant in the traditional sense, but the question was asked.)
• If a standalone performance (algorithm only) was done. (Again, not directly applicable as this is a physical surgical guide.)
• The type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides). It lists verification and validation activities conducted, but these are described in broad terms rather than as a detailed study report with specific metrics and results.

Therefore, based solely on the provided text, I cannot fulfill the request for detailed information about acceptance criteria and a study proving those criteria were met.

If this were a medical imaging AI device, the lack of such details in an FDA 510(k) summary would be a red flag. However, for a patient-matched surgical instrument, the V&V activities mentioned (surgeon evaluation, precision/accuracy in design/manufacturing, wear testing, cleanliness/sterilization, dimensional verification) are typical, though the specific data from these activities is not included in this summary.

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