(69 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 adult patients; in upper extremity orthopedic surgical procedures and orthopedic surgical procedures around the knee.
· For pediatic patients 7 years of age and older; in orthopedic surgical procedures involving the radius and ulna.
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 surgeries involving osteotomies in upper extremity orthopedic surgical procedures and orthopedic surgical procedures around the knee.
For pediatric patients 7 years of age and older, it is intended to be used in osteotomies involving the radius and ulna.
The SurgiCase Orthopaedics system is composed of two 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 transferring, visualizing, measuring, 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. 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 provides a way to find the most stable position of the base plate on the individual 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 and lower extremity surgical procedures.
The provided text is a 510(k) summary for the Materialise N.V. Surgicase Orthopaedics system (K163156). It describes a Class II medical device intended for surgical planning and guiding instruments, particularly for osteotomies. The submission expands the intended use to include pediatric patients aged 7 years and older, specifically for procedures involving the radius and ulna.
Based on the provided text, the acceptance criteria and study proving the device meets those criteria can be summarized as follows:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics. Instead, it focuses on demonstrating substantial equivalence to the predicate device (K132290), particularly for the new pediatric patient population. The primary "acceptance" is tied to the guide's fit despite bone growth in pediatric patients.
| Acceptance Criterion (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Guide maintains good fit despite pediatric bone growth. | "A fit test is performed in which guides were placed on the grown, 3D-printed, pediatric bone models and evaluated." This test determined the maximal allowed growth. Based on this, a "useful life" period of 3 weeks was established for all indicated pediatric patients, meaning the device's performance is not expected to be affected by bone growth within this timeframe. Multiple safety factors were incorporated into useful life calculations due to extrapolations from limited literature. |
| Functional elements (drill sleeves, cutting slots, fixation holes) perform identically to predicate device on pediatric patients. | Stated as: "The functional elements on the guides, i.e. drill sleeves, cutting slots, fixation holes, remain identical to the predicate device when used on a pediatric patient." No specific performance data for these elements for pediatric patients are provided beyond this qualitative statement, implying that their performance is considered equivalent due to identical design and function. |
| Device is as safe and effective as the predicate device. | "All non clinical testing and the retrospective analysis of clinical cases indicate that the subject device is as safe, as effective, and performs as well as the predicate device." This is a general conclusion based on the aggregate of the reported tests. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set (for "Fit Tests"): The text mentions "grown, 3D-printed, pediatric bone models." It does not specify the numerical sample size for these models. The provenance is implied to be from "pediatric clinical cases" that were used to simulate growth.
- Retrospective Analysis: "Retrospective analysis of US and OUS pediatric clinical cases" was conducted. The specific sample size for this analysis is not provided. The data provenance is stated as "US and OUS" (Outside US), indicating a mix of international data, and it was "retrospective."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not mention the use of experts to establish ground truth for the "fit tests" on 3D-printed models. The evaluation of guide fit on these models appears to be an objective measurement against defined criteria for "maximal allowed growth."
For the retrospective clinical cases, there's no mention of experts establishing ground truth or their qualifications. The analysis "helped to further support the safety and short-term efficacy," suggesting a review of clinical outcomes rather than establishing a gold standard for specific measurements performed by the device itself.
4. Adjudication Method for the Test Set:
No adjudication method (e.g., 2+1, 3+1) is described for the "fit tests" or the retrospective analysis, as these are not studies involving subjective interpretations requiring consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No MRMC comparative effectiveness study involving human readers with and without AI assistance is mentioned. The device described (SurgiCase Orthopaedics system) is a surgical planning and guiding system, not an AI diagnostic tool primarily evaluated for human reader improvement.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
The "fit tests" on 3D-printed models and the determination of "useful life" can be considered an assessment of the device's performance (specifically the guide's physical fit) in a standalone manner, independent of a human surgeon's real-time interaction during surgery, but based on the system's design and manufacturing outputs. The "Stability Model" is also described as a scientific model for determining stable placement, which would be a standalone algorithmic component.
7. The Type of Ground Truth Used:
- For "Fit Tests": The ground truth for the fit tests appears to be defined by a "maximal allowed growth" criterion, which was determined through simulating growth on 3D-printed bone models derived from pediatric clinical cases. This is a synthetic or simulated ground truth based on anatomical measurements.
- For Retrospective Analysis: The "safety and short-term efficacy" in the retrospective analysis implies clinical outcomes (e.g., successful procedure, absence of complications related to the device) as the ground truth, rather than a specific measurement.
8. The 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 components described are software for planning and hardware (guides). The "Stability Model" is described as a "scientific Stability Model," not explicitly as a machine learning model that would require a training set. The "design and manufacturing process with strict procedures and work instructions" implies a more traditional engineering approach rather than an AI-driven one.
9. How the Ground Truth for the Training Set Was Established:
Since no distinct "training set" for an AI model is described, there's no information on how its ground truth was established. The "useful life" period calculation was based on a "literature study" covering bone growth and the results of the "fit tests" on 3D-printed models.
§ 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.