(162 days)
Streamline Navigated Instruments are intended to be used during the preparation and placement of screws from the Streamline TL and MIS Systems and preparation of screws from the Streamline OCT System 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 vertebra, can be identified relative to a CT- or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.
The Streamline Navigated Instruments are non-sterile, reusable instruments for use with the Medtronic StealthStation Navigation System to assist surgeons in precisely locating anatomical structures in either open or minimally invasive (MIS) procedures for preparation and placement of screws from the Streamline TL Spinal Fixation System and Streamline MIS Spinal Fixation System and preparation of screws from the Streamline OCT Occipito-Cervico-Thoracic System. The Streamline Navigated Instruments include pedicle finders, modular handle, taps, drills, and screw inserters designed for use with Streamline TL, Streamline MIS, and Streamline OCT Systems. The instruments are manufactured from stainless steel (ASTM F899).
Here's a breakdown of the acceptance criteria and the study details for the Streamline Navigated Instruments, as extracted from the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Measure) | Reported Device Performance |
|---|---|
| Positional Accuracy | Tested per ASTM F2554-18 |
| Compatibility with Medtronic StealthStation System | Ensured through dimensional comparison and tolerance analysis |
| Functionality | Ensured through dimensional comparison and tolerance analysis |
(Note: The document doesn't provide specific numerical thresholds for acceptance, only that the device was tested against the standard and deemed sufficient.)
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the traditional sense of a clinical or observational study with human participants. The performance evaluation was based on non-clinical testing.
- Sample Size: Not applicable in the context of a clinical test set. The evaluation involved testing the instruments themselves according to a standard.
- Data Provenance: Not applicable. The "data" comes from engineering and laboratory testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This is not applicable as the evaluation was based on non-clinical testing of device accuracy and compatibility with a navigation system, not on medical image interpretation or clinical outcomes requiring human expert ground truth.
4. Adjudication Method for the Test Set
None. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes where discrepancies might arise. This non-clinical performance evaluation does not involve such a process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The study described is a non-clinical performance evaluation of device accuracy and compatibility, not a comparative effectiveness study involving human readers or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This question is not applicable as the device (Streamline Navigated Instruments) is a physical surgical instrument designed to be used with a navigation system and by a human surgeon. It is not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance evaluation was defined by:
- ASTM F2554-18 "Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems": This standard serves as the benchmark for evaluating positional accuracy.
- Dimensional comparison and tolerance analysis: This establishes whether the instruments meet the required specifications for functionality and compatibility with the Medtronic StealthStation System.
8. The Sample Size for the Training Set
Not applicable. The Streamline Navigated Instruments are physical instruments, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As the device is not an AI model, there is no training set or associated ground truth for it.
§ 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).