(337 days)
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.
| Acceptance Criteria (Inferred/General) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices | Device comparison showed substantial equivalence. |
| Software validation for intended use | SurgiCase Connect software validated. |
| Accuracy of guides for surgical planning/guidance | Testing verified accuracy and performance of guides is adequate. |
| Biocompatibility of SurgiCase Guides | Biocompatibility tests performed and met requirements. |
| Sterilization dimensional stability of Guides | Sterilization dimensional stability tests performed and met requirements. |
| Debris test results for Guides | Debris tests performed and met requirements. |
| Packaging and shipment integrity for Guides | Packaging and shipment tests performed and met requirements. |
| Cleaning validation for Guides | Cleaning validation tests performed and met requirements. |
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.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.