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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.

The system is to be used for adult patients.

SurgiCase Guides are intended for single use only.

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

The SurgiCase Orthopaedics system is intended to be used as a surgical instrument to transfer a pre-surgical plan to the lower and upper extremity during orthopaedic surgical procedures.

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

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

Here's an analysis of the provided text regarding the acceptance criteria and study for the SurgiCase Orthopaedics system:

The provided 510(k) summary (K112389) for the SurgiCase Orthopaedics system does not explicitly detail specific acceptance criteria with quantifiable metrics for device performance (e.g., "accuracy of +/- 1mm") nor does it describe a formal clinical or standalone comparative study with human readers or a detailed statistical analysis of performance against such criteria.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through a comparison of intended use, materials, and performance characteristics, and relies on non-clinical testing for validation. This is a common approach for certain types of medical devices, especially when establishing equivalence to existing technology.

However, based on the limited information provided, we can infer some aspects and present what is available:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, specific quantifiable acceptance criteria are not explicitly stated in this document. The "performance" described is more qualitative and relates to successful completion of non-clinical tests to demonstrate safety and effectiveness, and accuracy adequate to perform as intended.

2. Sample Size for the Test Set and Data Provenance

The document states: "SurgiCase Guides were validated through non-clinical studies using bone models and cadaver specimens."

• Sample Size for Test Set: Not specified. The number of bone models and cadaver specimens used is not provided.
• Data Provenance: The validation was non-clinical, using bone models and cadaver specimens. The country of origin for these specimens is not mentioned, nor whether the data was retrospective or prospective (though for non-clinical lab testing, "prospective" would be the more fitting description of how the tests were conducted).

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

This information is not provided in the document. Since the validation was entirely non-clinical using bone models and cadaver specimens, the concept of "experts establishing ground truth" in the diagnostic imaging sense (e.g., radiologists reviewing images) does not directly apply here. Instead, ground truth would be physical measurements and objective assessments against known parameters of the models/specimens, likely performed by engineers, technicians, and potentially surgeons involved in the study design.

4. Adjudication Method for the Test Set

This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human readers or expert review of data where there might be disagreements. Since the validation was non-clinical with bone models and cadavers, and no human reader interpretation of images is described as part of the primary validation for the stated performance, an adjudication method is not relevant.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document does not mention any studies involving human readers, either with or without AI assistance, or comparisons between them. The focus is on the device's standalone performance in non-clinical settings.

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

Yes, implicitly. The non-clinical validation tests using bone models and cadaver specimens assess the performance of the SurgiCase Guides (hardware) and the SurgiCase Connect software (algorithm for planning/design) in isolation from a live surgical scenario involving a human surgeon's real-time interaction. The software is validated for its intended use, and the guides are tested for accuracy. This can be considered a form of standalone performance assessment as it evaluates the device's ability to "perform as intended" without human intervention in the measurement of its accuracy.

7. The Type of Ground Truth Used

The ground truth for the non-clinical validation was likely based on:

• Physical measurements: Precise measurements taken on the bone models and cadaver specimens to assess the accuracy of the guides and the outcomes of the simulated procedures. This would involve comparing the guided cuts/markings to the pre-surgical plan.
• Known parameters of the models: For engineered bone models, the "ground truth" of anatomical features and target osteotomy locations would be precisely known.
• Biocompatibility standards: For biocompatibility, the ground truth would be established regulatory standards and test results.
• Sterilization efficacy: For sterility, established protocols and detection limits.

It is not pathology, expert consensus in a diagnostic sense, or outcomes data from real patients.

8. The Sample Size for the Training Set

This information is not provided in the document. The filing describes the product as an "Image processing system and software for simulating/evaluating implant placement and surgical treatment options." While image processing software often involves machine learning that requires training data, the document does not specify any ML/AI components in detail or reference a training set. The descriptions point more towards conventional computational geometry and visualization software. If a machine learning component were present, its training data size and provenance would be crucial.

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

Since information about a training set or specific machine learning components is not provided, how its ground truth was established is also not described.

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The SurgiCase system is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner or a Magnetic Resonance Imaging scanner. It is also intended as pre-operative software for simulating / evaluating implant placement and surgical treatment options.

SurgiCase Connect for iPad is a component of the SurgiCase system and intended to be used as a software interface to assist in pre-operative planning by simulation / evaluation of surgical treatment options.

The Materialise SurgiCase system is a software medical device to transfer and to segment imaging information from a medical scanner such as a CT or MRI scanner. It allows for presurgical simulation and evaluation of implant placement and surgical treatment options.

SurgiCase Connect is a medical device for pre-surgical simulation and evaluation of surgical treatment options. This includes transferring, visualizing and editing medical data. .

Based on a pre-surgical software plan the patient specific templates - SurgiCase Guides can be manufactured to fit a specific patient. SurgiCase Guides are not a part of this premarket notification submission.

The provided text is a 510(k) summary from Materialise N.V. regarding their SurgiCase system, specifically focusing on the new component, SurgiCase Connect for iPad. The core of the submission is to demonstrate substantial equivalence to a predicate device (SurgiCase K073449).

The document explicitly states:

• Clinical testing: Not applicable.

This means that a clinical study with acceptance criteria and reported device performance, as typically understood in a clinical trial context, was not performed for this submission. The device is being cleared based on its substantial equivalence to a predicate device through non-clinical testing.

Therefore, I cannot provide the detailed information requested regarding acceptance criteria and the study proving the device meets them, because such a study (clinical or performance study with defined acceptance criteria and results) is not described in this 510(k) summary.

The submission focuses entirely on demonstrating substantial equivalence through non-clinical testing, primarily asserting that the new component (SurgiCase Connect for iPad) has equivalent intended use, performance characteristics, design, and function to the predicate SurgiCase system.

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