Search Results
Found 1 results
510(k) Data Aggregation
(90 days)
Premia Spine XL Instruments are intended to be used during the preparation and placement of Premia Spine screws during surgery to assist the surgeon in precisely locating anatomical structure in either open or minimally invasive procedures.
Premia Spine XL Instruments are specifically 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 for the anatomy.
The XL Instruments are nonsterile instruments that can be used manually. These instruments are intended to be used with the Medtronic's StealthStation Navigation System.
The XL Instruments is comprised of seven instruments:
- Cannulated Screwdriver;
- Cannulated Pedicle AWL;
- Cannulated Pedicle Probe;
- Cannulated TAP XL 4.5, 5.5 and 6.5 mm;
- Straight Pedicle Probe.
The XL Instruments are reusable stereotaxic surgical instruments, designed to be used with the Medtronic StealthStation navigation system.
They are reusable (autoclavable) instruments, intended to be used in a sterile environment, and initially supplied non-sterile to the user and requires the user to process (i.e., clean and sterilize) the device for initial use, as well as after each use.
The Premia Spine XL Instruments are a set of reusable stereotaxic surgical instruments intended for use with the Medtronic StealthStation navigation system. The 510(k) submission (K191854) claims substantial equivalence to the Medtronic Navigated Reusable Instruments for Use with the StealthStation® and IPC® Powerease™ Systems (Predicate K153442).
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Registering and calibration of the instruments on the StealthStation | All tests met predefined acceptance criteria. |
| Failure mode testing | All tests met predefined acceptance criteria. |
| Interfacing of each instrument with the StealthStation, per ASTM F-2554 (Standard Specification for Image-Guided Surgical Tool Accuracy) | All tests met predefined acceptance criteria. |
| Equivalence of the pre-submitted geometric properties of the predicate and subject devices | The document states: - "The system features sufficiently equivalent geometries to the predicate such that the performance of the subject and predicate devices are equivalent." - "Critical dimensions: Identical for Tap 4.5 mm, Tap 5.5 mm, Tap 6.5 mm, Pedicle awl, Pedicle probe; Equivalent for screwdriver." - "The differences of geometry between the subject and the predicate devices are supported by the comparison testing and do not raise different questions of safety and effectiveness." All tests met predefined acceptance criteria. |
2. Sample Size for the Test Set and Data Provenance:
The document describes bench testing, which typically does not involve human subjects or patient data. Therefore, there is no "test set" in the traditional sense of patient data. The tests were performed on the instruments themselves.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable, as this was bench testing of surgical instruments and their compatibility with a navigation system. Ground truth would be established by engineering specifications and objective measurements based on the test protocols.
4. Adjudication Method for the Test Set:
Not applicable, as this was bench testing. Test results would be compared against predefined engineering specifications and criteria.
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 device is a surgical instrument set cleared under a 510(k) for substantial equivalence to a predicate device. It is not an AI/ML-driven diagnostic or interpretative tool that would typically undergo an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical surgical instrument and not an algorithm. The performance evaluation focuses on the instrument's mechanical properties, its ability to be registered and calibrated by the navigation system, and its interface compatibility.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For bench testing of surgical instruments, the "ground truth" is defined by engineering specifications, design tolerances, and established performance standards (e.g., those outlined in ASTM F-2554). The instruments' ability to accurately interact with the Medtronic StealthStation system and meet dimensional requirements constitutes the ground truth.
8. The Sample Size for the Training Set:
Not applicable. This is a physical medical device (surgical instruments), not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set was Established:
Not applicable, for the same reason as point 8.
Ask a specific question about this device
Page 1 of 1