(134 days)
The Navigated Disc Preparation Instruments are intended to be used to facilitate a discectomy during spinal surgery. The Navigated Trials are intended to be used to facilitate implant size selection of Medtronic intervertebral body fusion devices during spinal surgery.
Navigated instruments are specifically designed for use with the StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
The Cobb Elevator. Combo Tool, Curette, Osteotome, and Rotating Shaver are instruments that are manual accessories to the StealthStation System. These instruments can be used to facilitate a discectomy during a spinal surgery procedure. These devices are offered in non-sterile form and are reusable.
The stainless steel material used in the Disc Prep Instruments conforms to ASTM F899, ASTM A693 and ASTM A564 standards.
Implant size and placement is determined by selecting the trial which provides the most satisfactory fit in the prepared disc space. Once trialing is complete, the implant of corresponding size is positioned. The new trials are designed specifically to be used with CAPSTONE and are also compatible with StealthStation. The trials will be provided non-sterile and are reusable.
The stainless steel material used in the CAPSTONE Trials conforms to ASTM F899, ASTM A693 and ASTM A564 standards.
The document describes a 510(k) premarket notification for "Navigated Disc Prep Instruments and CAPSTONE Trials." This submission focuses on medical devices (surgical instruments) and does not involve an AI algorithm with specific performance metrics like sensitivity or specificity. Therefore, many of the requested categories for AI-based device evaluations (such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable to this document.
However, I can extract information related to the device's performance testing and acceptance criteria as described for these non-AI instruments.
1. A table of acceptance criteria and the reported device performance
The document provides a table summarizing the performance testing completed, with descriptions of what each test confirmed. It does not explicitly state numerical acceptance criteria in a "criteria vs. result" format, but rather descriptions of what the tests successfully "confirmed" or "verified."
| Test Name | Acceptance Criteria (Implied by Description) | Reported Device Performance |
|---|---|---|
| Navigation Accuracy Analysis | The navigated instrument's accuracy is confirmed. | Confirmed navigated instrument accuracy. |
| Anatomical Simulated Use | Instrument functionality is confirmed under expected use conditions. | Confirmed instrument functionality under expected use conditions. |
| Navigation Simulated Use | Navigation system functionality is confirmed under expected use conditions. | Confirmed navigation system functionality under expected use conditions. |
| CAD Model Evaluation | CAD models are accurately reflected in the application software. | Verified that the CAD models are accurately reflected in the application software. |
| Implant/Instrument Mating Conditions | Instruments can be assembled with appropriate devices according to intended use. | Verified that the instruments can be assembled with the appropriate devices according to their intended use. |
| Spine Tools Package Functional Testing | Spine Tools package meets the required interface needs of the spine application software. | Verified that the Spine Tools package has met the required interface needs of the spine application software. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for each test. The testing appears to be internal validation (e.g., in a lab or simulated environment) as opposed to human clinical trials with patient data. Therefore, data provenance in terms of country of origin or retrospective/prospective nature is not applicable here.
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 document describes testing of physical surgical instruments and their compatibility with a navigation system, not the performance of an AI algorithm requiring expert ground truth for image interpretation or diagnosis.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human readers or interpretation requiring an adjudication method.
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
Not applicable. This document is not about an AI-assisted device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document is about surgical instruments, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance testing of these physical instruments would be engineering specifications, design requirements, and a functional physical environment (e.g., anatomical models for simulated use). It's not expert consensus, pathology, or outcomes data in the biological sense. The testing confirmed the instruments met their design and functional objectives.
8. The sample size for the training set
Not applicable. There is no AI algorithm being trained.
9. How the ground truth for the training set was established
Not applicable. There is no AI algorithm being trained.
§ 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).