(298 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 during craniofacial osteotomies.
SurgiCase Guides are intended for single use only.
The SurgiCase Guides are patient specific devices or templates that are based on a pre-operative 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. Guides are individually designed and manufactured for each patient using a design and manufacturing process with strict procedures and work instructions to guarantee templates that consistently perform in a safe and effective way.
The SurgiCase Guides are based on a software planning generated using the previously cleared SurgiCase software (K073449).
The provided text describes non-clinical tests but does not include a table of acceptance criteria or specific performance metrics with numerical values. Therefore, I cannot generate 'A table of acceptance criteria and the reported device performance'.
Here's the information extracted from the document regarding the study and acceptance criteria:
1. A table of acceptance criteria and the reported device performance
No quantitative acceptance criteria or reported performance metrics are provided in the document. The text broadly states: "The guides meet the predefined acceptance criteria." and "Testing verified that the accuracy and performance of the system is adequate to perform as intended."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document mentions "bone models and cadaveric specimens" but does not give the number used.
- Data Provenance: Not specified. The study involved "bone models and cadaveric specimens," implying a laboratory or simulated environment rather than human patient data, making it prospective in nature for device validation. Country of origin is not mentioned.
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. The ground truth for the "quantitative validation" would be based on measurements against the pre-operative plan, not expert consensus as it's a device accuracy study. Therefore, no experts were explicitly used to establish ground truth in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This study focused on the accuracy of the device in transferring a pre-operative plan, not on diagnostic interpretations requiring adjudication.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The study focused on the device's accuracy in guiding surgical procedures, not on human reader performance with or without AI assistance. The device in question is a surgical guide, not an AI-driven diagnostic tool for interpretation by human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, a standalone performance assessment was conducted for the device. The "Quantitative validation using bone models and cadaveric specimens to validate the accuracy the guides obtain in transferring a surgical planning to the actual surgery during craniofacial osteotomies" evaluated the device's inherent accuracy. This is a standalone assessment of the physical guide's performance.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The ground truth implicitly used for the "quantitative validation" would be the precise measurements and positions defined in the pre-operative software plan against which the actual surgical outcome (guided by the device) was compared. This is a form of direct measurement against a defined target. For "qualitative validation," the ground truth was the expected "fit and stability" as assessed by observers, but the specific criteria for this are not detailed.
8. The sample size for the training set
Not applicable. This device is a physical surgical guide developed through a design and manufacturing process, not a machine learning algorithm that requires a training set. The "SurgiCase software" which generates the planning data for the guides was "previously reviewed under K073449" and is not part of this 510(k) submission. Therefore, no training set for the SurgiCase Guides themselves is relevant here.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for the SurgiCase Guides.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).