(163 days)
The Navigation Module of the Momentum System is intended to be used during the preparation and placement of Momentum Posterior Spinal Fixation System screws during spinal surgery, to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Navigation Module of the Momentum System is designed for use with the Medtronic SteathStation 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 vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks for the anatomy.
The Navigation Module of the Momentum System contains non-sterile, reusable manual instruments including taps and screwdrivers. The instruments are designed for use with the Medtronic StealthStation System for implantation of the Momentum Posterior Spinal Fixation System components.
Here's a breakdown of the acceptance criteria and study information for the "Navigation Module of the Momentum System" as extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (as stated in document) |
|---|---|
| Navigation Accuracy | Performed in side-by-side testing. Results demonstrated substantial equivalence to predicate devices. |
| Registration | Performed in side-by-side testing. Results demonstrated substantial equivalence to predicate devices. |
| Rigidity | Performed in side-by-side testing. Results demonstrated substantial equivalence to predicate devices. |
| Simulated Surgery | Performed in side-by-side testing. Results demonstrated substantial equivalence to predicate devices. |
Important Note: The document states that the device performance was "substantially equivalent" to predicate devices, but it does not provide specific numerical acceptance criteria or performance metrics for navigation accuracy, registration, rigidity, or simulated surgery. It only confirms that these validations were performed and met the equivalency standard.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It refers to "side-by-side testing" but gives no further details on the methodology or data characteristics.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not provide information regarding the number of experts used or their qualifications for establishing ground truth for the test set.
4. Adjudication Method
The document does not specify an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not indicate that an MRMC comparative effectiveness study was done, nor does it mention any effect size for human reader improvement with or without AI assistance. The device in question is a navigation system accessory, not an AI-based diagnostic tool for interpretation.
6. Standalone (Algorithm Only) Performance Study
The document does not discuss standalone performance of an algorithm. The device is a "Navigation Module" and instruments designed for use with an existing navigation system (Medtronic StealthStation System), implying it's an integrated component rather than a standalone algorithm.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used. However, given it's a navigation system for spinal surgery, the typical ground truth in such studies would involve highly accurate measurements (e.g., using a coordinate measuring machine or high-resolution imaging) to verify the accuracy of instrument tip localization.
8. Sample Size for the Training Set
The document does not specify a sample size for a training set. This type of medical device (navigation instrument) typically undergoes engineering verification and validation rather than machine learning model training.
9. How Ground Truth for the Training Set Was Established
The document does not describe how ground truth for a training set was established, as it pertains to a hardware device validation rather than a machine learning application that would require 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).