(144 days)
SurgiCase Guides are intended to be used as surgical tools to transfer a pre-operative plan to the surgery. The devices are intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical procedures.
SurgiCase Guides are intended for single use only.
The SurgiCase Guides are patient specific devices or templates that are based on a preoperative software planning and are designed to fit a specific patient. These templates are used to assist a surgeon in transferring this pre-operative plan to the surgery by guiding the marking of bone and/or guiding surgical instruments.A standardized design and manufacturing process with detailed procedures and work instructions allows manufacturing patient-specific templates that consistently perform in a safe and effective way during surgery.
The SurgiCase Guides are based on a software planning generated using the previously cleared SurgiCase software (K073449).
SurgiCase is software for pre-operative simulation and evaluation of implant placement and surgical treatment options, based on imaging information from a medical scanner such as a CT scanner or a Magnetic Resonance Imaging (MRI) scanner. The SurgiCase software was previously reviewed under K073449 and is not submitted for review in this 510k submission. References to the software are included to give a complete overview on the guide design process.
The provided text does not contain detailed information about specific acceptance criteria with quantifiable metrics, a formal study demonstrating the device meets these criteria, or granular details about test sets, ground truth establishment, or multi-reader multi-case studies typically associated with AI/ML device evaluations.
The document describes a 510(k) submission for "SurgiCase Guides," which are patient-specific surgical templates based on pre-operative software planning. The performance data section broadly mentions "non-clinical tests such as quantitative validation using bone models and cadaveric specimens" were performed and "verified that the accuracy and performance of the system is adequate to perform as intended." However, it does not provide the specific acceptance criteria or the results of these tests in a quantifiable manner.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Quantitative) | Reported Device Performance |
|---|---|
| Not specified in document | "accuracy and performance of the system is adequate to perform as intended." (No quantitative metrics provided) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not specified. The document mentions "bone models and cadaveric specimens" but does not give the number of models or specimens used.
- Data provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not specified. The term "ground truth" as typically used in AI/ML evaluation referring to expert-annotated data is not mentioned. The device is a surgical guide system, and its validation involves physical accuracy on models/cadavers, not interpretation of images by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. Adjudication methods are typically relevant for cases where multiple experts provide annotations that need to be reconciled to establish a ground truth for a test set in AI/ML contexts. This is not described for a physical device validation.
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
- No, an MRMC comparative effectiveness study is not mentioned. This type of study is usually conducted for AI-powered diagnostic or assistive tools where human readers are involved in interpreting data with and without AI. The SurgiCase Guides are physical surgical tools, not AI for human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The document implies that the "quantitative validation using bone models and cadaveric specimens" focused on the physical accuracy of the guides themselves, which could be considered a form of standalone performance of the device. However, it's not an "algorithm only" performance because the device itself is a physical object designed to guide surgical instruments. The software used to design the guides (SurgiCase software K073449) was previously cleared and is not the subject of this 510(k) submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" in this context would likely refer to the actual surgical plan (as transferred to the models/cadavers) or ideal anatomical positioning, against which the guided surgical actions were compared for accuracy. The document mentions "quantitative validation," suggesting objective measurements of accuracy were taken, but the specific nature of this "ground truth" (e.g., precise measurements of osteotomy planes or screw placement from a gold standard) is not detailed.
8. The sample size for the training set
- Not applicable/Not specified. Surgical guides are precisely manufactured to a patient's anatomy based on imaging and a pre-operative plan. There is no "training set" in the sense of machine learning model development mentioned for the SurgiCase Guides themselves. The underlying SurgiCase software (K073449) generates the plan, but its "training" details are not part of this submission.
9. How the ground truth for the training set was established
- Not applicable/Not specified. As there is no "training set" described for the SurgiCase Guides, the establishment of ground truth for such a set is not discussed.
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.