(283 days)
The OLYMPIC NAVIGATED INSTRUMENTS are intended to be used in the preparation and placement of OLYMPIC PSFS screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic 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 OLYMPIC NAVIGATED INSTRUMENTS are comprised of nonsterile, reusable instruments including taps and drivers that can be operated manually. These instruments are intended to be used with the Medtronic StealthStation® System (v 2.1.0) and are manufactured from stainless steel, as specified in ASTM F899.
The provided document describes the OLYMPIC NAVIGATED INSTRUMENTS, which are intended to be used with the Medtronic StealthStation® System during spinal surgery for precise anatomical localization. The document includes a 510(k) summary, which often details non-clinical testing for substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical "acceptance criteria" for the OLYMPIC NAVIGATED INSTRUMENTS in the traditional sense of performance metrics (e.g., accuracy thresholds, sensitivity, specificity). Instead, the substantial equivalence claim is based on the device's similarity to predicate devices and the results of non-clinical analyses.
The reported performance is described in terms of demonstrating equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Dimensional equivalence to predicate devices | Dimensional analysis compared to predicate showed equivalence. |
| Acceptable anatomical simulated use performance | Anatomical simulated use evaluation showed equivalence. |
| Acceptable navigation accuracy | Navigation accuracy evaluation showed equivalence. |
| Equivalence in intended use, design, materials, mechanical safety, and performances to predicate devices | The device is considered substantially equivalent to predicate devices in these aspects. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Anatomical simulated use and navigation accuracy" as non-clinical tests. However, it does not specify the sample size used for these tests. It also does not provide information on data provenance (e.g., country of origin, retrospective or prospective nature) as these are non-clinical simulated tests rather than studies involving human data.
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)
This information is not provided in the document. Given that the described tests are "Anatomical simulated use and navigation accuracy," it's likely they involved engineering assessments rather than expert clinicians establishing ground truth on a test set of medical images or patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not mention any adjudication method. This is consistent with non-clinical, simulated tests that would typically involve objective measurements rather than subjective expert 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 MRMC comparative effectiveness study was done or mentioned. The device described is a set of navigated instruments for surgical assistance, not an AI-powered diagnostic or interpretive tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not directly applicable. The device (OLYMPIC NAVIGATED INSTRUMENTS) is explicitly designed for use with the Medtronic StealthStation® System and assists the surgeon. It is an instrument, not a standalone algorithm. Its performance is intrinsically linked to its use in conjunction with other systems and human operators. The "navigation accuracy" test could be considered a form of standalone performance evaluation for the instruments themselves in a simulated environment, but not in the context of an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "Anatomical simulated use and navigation accuracy" tests, the ground truth would likely be based on physical measurements validated against established anatomical models or precise measurement systems in a controlled lab setting, rather than expert consensus, pathology, or outcomes data, which are typically associated with clinical studies on diagnostic devices. The document does not explicitly state the methodology for establishing this ground truth.
8. The sample size for the training set
This information is not applicable/not provided. The OLYMPIC NAVIGATED INSTRUMENTS are physical instruments. They are not an AI/ML algorithm that requires a "training set" in the computational sense.
9. How the ground truth for the training set was established
This information is not applicable, as the device is not an AI/ML algorithm requiring a training set.
§ 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).