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The SurgiCase Orthopaedics system is intended to be used as a surgical instrument to assist in pre-operative planning and/or in guiding the marking of bone and/or guide surgical instruments in non-acute, non-joint replacing osteotomies for upper extremity orthopedic surgical procedures and osteotomies around the knee.

The system is to be used for adult patients.

SurgiCase Guides are intended for single use only.

The SurgiCase Orthopaedics system is intended to be used as a surgical instrument to transfer a pre-surgical plan to the surgery with osteotomies on upper extremity orthopedic procedures anound the knee.

The SurgiCase Orthopaedics system is components: SurgiCase Connect (software) and SurgiCase Guides (hardware).

SurgiCase Connect is a medical device for Materialise and a surgeon for pre-surgical simulation of surgical treatment options. This includes transfering, visualizing, measuring, annotating and editing medical data.

The SurgiCase Guides are patient specific templates that are designed and manufactured based on a pre-surgical software plan for a specific patient. In surgery these guides are used to assist a surgeon in guiding the marking of bone and/or guiding surgical instruments to cut and drill according to the pre-surgical plan.

All guides are individually designed and manufactured for each patient using a design and manufacturing process with strict procedures and work instructions to guarantee guides that consistently perform in a safe and effective way. Part of this process is a scientific Stability Model which measures the sensitivity of a guide to movement during surgery. The use of this Stability Model ensures a stable position on the patient's anatomy for accurate guiding of surgical instruments. The Stability Model is anatomy independent, thus it can be applied to any bony structure in upper extremity surgical procedures and osteotomies around the knee.

Here's a breakdown of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

| Acceptance Criteria Category | Specific Test/Study | Reported Device Performance and Acceptance |
| :--------------------------- | :------------------------------------------------ |
| Accuracy | Bone Model Tests | "All results were within the preset acceptance criteria." (Specific numerical criteria not provided) |
| Accuracy | Cadaveric Tests | "All results were within the preset acceptance criteria." (Specific numerical criteria not provided) |
| Safety & Effectiveness | Biocompatibility Test | "Testing verified that the accuracy and performance of the device is adequate to perform as intended." |
| Safety & Effectiveness | Sterilization Dimensional Stability Test | "Testing verified that the accuracy and performance of the device is adequate to perform as intended." |
| Safety & Effectiveness | Cleaning Validation Test | "Testing verified that the accuracy and performance of the device is adequate to perform as intended." |
| Safety & Effectiveness | Packaging and Shipment Test | "Testing verified that the accuracy and performance of the device is adequate to perform as intended." |
| Stability/Fit | Scientific Stability Model | "Ensures the most stable position on the patient's anatomy for accurate guiding of surgical instruments." |
| Software Functionality | Internal and External User Testing & Observations | "Results from this verification and validation testing demonstrate the device's safety and effectiveness is substantially equivalent to the predicate device." |
| Clinical Efficacy | Retrospective Analysis of Clinical Cases (Europe) | "Confirms the subject device's safety and effectiveness is substantially equivalent to the predicate device for use as intended based on surgeon evaluation of expected outcome." |

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

• Bone Model Tests: "On a series of femoral and tibial models" (Specific number of models not provided).
• Cadaveric Tests: "On a series of cadaveric specimens" (Specific number of specimens not provided).
• Retrospective Clinical Cases: "Retrospective analysis of clinical cases performed in Europe" (Specific number of cases not provided).

3. Number of Experts Used to Establish Ground Truth and Qualifications

• For the bone model and cadaveric tests, the "pre-operative planned versus achieved corrected models/specimens were compared." This implies a comparison to a pre-defined plan or standard, rather than a consensus among external experts. The qualifications of who established the "pre-operative plan" and conducted the comparison are not explicitly stated, but it would typically be engineers or qualified personnel involved in the device development.
• For the retrospective clinical cases, "surgeon evaluation of expected outcome" was used. The number and specific qualifications of these surgeons are not provided, other than them being clinical users in Europe.

4. Adjudication Method for the Test Set

• The document implies a comparison of achieved results against "preset acceptance criteria" for the non-clinical tests. This suggests a direct measurement against a standard, rather than a multi-expert adjudication process.
• For the retrospective clinical cases, the ground truth was based on "surgeon evaluation of expected outcome," which might implicitly involve some level of individual surgeon judgment rather than a formal adjudication panel. No specific adjudication method like 2+1 or 3+1 is mentioned.

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

• No MRMC comparative effectiveness study is mentioned that assesses how much human readers improve with AI vs without AI assistance. The device is a surgical planning and guiding system, not an AI for image interpretation that would typically involve human readers.

6. Standalone (Algorithm Only) Performance Study

• A standalone performance was implicitly conducted for the SurgiCase Connect software component through "internal and external user testing and observations" and verification against specifications.
• The SurgiCase Guides were validated through "bone model tests" and "cadaveric tests," which involved applying the guides according to a pre-operative plan and comparing the achieved corrected models/specimens to the planned ones. This represents a standalone performance assessment of the guide's accuracy in transferring the surgical plan.

7. Type of Ground Truth Used

• Non-clinical tests (Bone models, Cadavers): "Pre-operative planned" outcomes served as the ground truth against which the achieved corrected models/specimens were compared. This is an engineered or defined ground truth.
• Retrospective Clinical Study: "Surgeon evaluation of expected outcome" served as the ground truth. This is a form of expert clinical judgment/outcome data.

8. Sample Size for the Training Set

• The document does not provide explicit information on the sample size used for a "training set." The device is primarily a software system for planning and physical guides for execution, rather than a machine learning algorithm that typically undergoes a separate supervised training phase with a dedicated training set. The descriptions focus on verification and validation against specifications and clinical use.

9. How Ground Truth for the Training Set Was Established

• As no explicit training set is mentioned in the context of a machine learning algorithm, the method for establishing its ground truth is not applicable or described in this document. The "training" for such a system would involve software development, engineering, and iterative testing/refinement against design specifications and user feedback, rather than a formal ground truth for a machine learning model.

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