(29 days)
Medtronic Navigated Reusable Instruments for use with StealthStation™ and IPC™ POWEREASE™ Systems
Medtronic Navigated Reusable Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Navigated Reusable 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. Medtronic Navigated Reusable Instruments are also compatible with the IPC™ POWEREASE™ System.
Medtronic Surgical Instruments for use with MAZOR X Stealth™ Edition
Medtronic Surgical Instruments are intended to be used during the preparation and placement of Medtronic implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Surgical Instruments are specifically designed for use with the MAZOR X Stealth™ Edition, 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. Medtronic Surgical Instruments can be navigated or non-navigated manual instruments that may or may not be guided through the MAZOR X Stealth™ Edition Arm Guide. Medtronic surgical drills shall only be used through the MAZOR X Stealth™ Edition arm guides, Medtronic cannulas, and Medtronic drill guides. Some of the Medtronic Surgical Instruments are also compatible with the IPC™ POWEREASE™ System or AO* style quick connect drilling motors. An instrument may incorporate a measuring function which has uses as described on the label and the instrument.
The subject CD Horizon™ Spinal System drivers are non-sterile instruments that may be used during placement of various Medtronic screws during spinal surgery. The Medtronic instruments are made from materials commonly used in orthopedic and neurological procedures which meet available national or international standards specifications. The subject CD Horizon™ Spinal System drivers are compatible with POWEREASE, Medtronic NavLock trackers and Medtronic single-use sterile spheres to allow a Medtronic computer-assisted surgery system to track the instruments in the surgical field.
The provided text is a 510(k) Summary for the Medtronic CD Horizon™ Spinal System Instruments. This document is a regulatory submission for a medical device and describes its intended use, comparison to predicate devices, and testing performed to demonstrate substantial equivalence. It does not contain information about the performance of an AI/ML device in detail as it pertains to acceptance criteria and performance metrics typically expected for such technologies.
The device in question is "CD Horizon™ Spinal System Instruments", which are non-sterile instruments for use during spinal surgery with navigation systems (StealthStation, MAZOR X Stealth™ Edition) and power tools (IPC™ POWEREASE™ System, AO* style quick connect drilling motors). These are physical surgical instruments, not an AI/ML software device.
Therefore, many of the requested categories regarding AI/ML device performance, such as sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, and training set information are not applicable to this submission, as it is for physical surgical instruments.
However, I can extract the relevant information regarding the performance testing for these instruments as described in the document.
Acceptance Criteria and Device Performance for Medtronic CD Horizon™ Spinal System Instruments
The document describes the performance testing undertaken to ensure the functionality and compatibility of the instruments. While specific numerical acceptance criteria (e.g., accuracy thresholds) are not explicitly stated in this summary, the tests confirmed the instruments meet their functional requirements.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Description | Stated Outcome |
|---|---|---|
| Navigation Accuracy Testing | Confirmed navigated instrument accuracy. | Test results show that the subject device and the predicate device are equivalent. |
| CAD Model Verification | Confirm the driver's CAD models are accurately reflected in the application software. | Test results show that the subject device and the predicate device are equivalent. |
| Tools Package Functional Verification Testing | Provides confirmation that the Spine tools package has met the required interface needs of the spine application software. | Test results show that the subject device and the predicate device are equivalent. |
| Navigated Simulated Use | Validate that the design outputs meet the requirements associated with customer needs. | Test results show that the subject device and the predicate device are equivalent. |
| Anatomical Simulated Use Testing | User needs are satisfied by performing simulated testing per the instructions outlined in the surgical techniques. | Test results show that the subject device and the predicate device are equivalent. |
2. Sample size used for the test set and the data provenance: Not applicable. This submission concerns physical instruments, not data-driven AI/ML models. Testing would have involved the instruments themselves, likely in a lab setting or simulated surgical environment. No specific sample sizes for data or data provenance (country, retrospective/prospective) are mentioned as it's not a data-based study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For physical instruments, "ground truth" typically refers to engineering specifications and functional performance. Clinical experts might be involved in defining "customer needs" for simulated use testing, but specific numbers and qualifications are not mentioned.
4. Adjudication method for the test set: Not applicable. This type of regulatory submission for physical instruments does not typically involve adjudication methods like those used for expert consensus in AI/ML model ground truth generation.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done. This is not applicable to physical surgical instruments.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a set of physical surgical instruments, which are used by humans and with other integrated navigation systems. There is no "standalone algorithm" performance to assess for these instruments.
7. The type of ground truth used: For these physical instruments, the "ground truth" would be established through engineering specifications, design requirements, and possibly functional performance benchmarks against predicate devices or industry standards. The document states that testing was "completed to ensure the functionality and compatibility with the identified Medtronic products" and that the "test results show that the subject device and the predicate device are equivalent." This implies a comparison to established performance of predicate devices and adherence to design specifications.
8. The sample size for the training set: Not applicable. This device is not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established: Not applicable. This device is not an AI/ML model.
§ 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).