(89 days)
The Navigated Inserter is intended to be use during implant placement of Medtronic intervertebral body fusion devices during spinal surgery. The Navigated Trials are intended to be used to facilitate implant size selection of Medtronic intervertebral body fusion devices during spinal surgery. The navigated 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.
The Navigated Trials and Inserter are non-sterile, reusable surgical instruments intended to be used to facilitate implant sizing and placement of Medtronic intervertebral body fusion devices, respectively, during spinal surgery and are specifically designed for use with the StealthStation® System. These navigated interbody devices are used in conjunction with system Trackers, which allows for optical navigation of the surgical instrument, and are also designed for use with the Medtronic CAPSTONE® and CLYDESDALE® Spinal Systems.
The acceptance criteria and the study proving the device meets them are detailed below based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Criteria Category | Specific Test | Description of Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Functionality & Compatibility | Accuracy | The navigated instruments should demonstrate acceptable accuracy in both 2D and 3D space. | "Tested navigated instruments accuracy in both 2D and 3D space." (Implies successful demonstration of accuracy to meet predefined internal standards, though the specific quantitative criteria are not elaborated in this summary). |
| Environmental, Life, and Shipping | The navigated instruments should maintain functionality after multiple reprocessing cycles, environmental exposure, and shipping conditions. | "Tested navigated instrument functionality after multiple reprocessing cycles (cleaning and sterilization), simulating environmental exposure under expected use conditions and shipping." (Implies successful functionality post-stress tests, meeting internal performance requirements). | |
| Simulated Use | The navigated instruments should perform according to user needs and intended use in a simulated environment. | "Tested navigated instruments according to the user's needs and intended use." (Implies successful performance in simulated surgical scenarios, aligning with user requirements and intended function). | |
| CAD Model | The CAD models of the devices must be accurately reflected in the application software. | "Verified that the CAD models are accurately reflected in the application software." (Indicates successful verification of accurate digital representation). | |
| Cleaning Verification | The product must be effectively cleanable using both automated and manual methods. | "Verified that the product can be effectively cleaned using automated and manual methods." (Confirms that the cleaning protocols are effective in rendering the devices clean for reuse). | |
| Implant/Instrument Mating | The instruments must attach and mate correctly with appropriate implant/instrument devices. | "Verified that the instruments can be attached and mated with the appropriate instrument and/or implant devices according to their intended use." (Ensures proper fit and function with associated Medtronic products). | |
| Spine Tools (Toolcards) | The Spine Tools package must meet the required interface needs of the spine application software. | "Verified that the Spine Tools package has met the required interface needs of the spine application software." (Confirms software compatibility and proper integration within the StealthStation® System for spinal applications). | |
| Substantial Equivalence | Overall Comparison (Indications, Intended Use, Tech Characteristics) | The device must be demonstrated to be substantially equivalent to identified predicate devices in terms of indications for use, intended use, operating principle, and materials. | The document explicitly states: "The subject devices have the same intended use and technological characteristics as the predicate devices." and "The Navigated Trials and Inserter have been shown through comparison and testing to be substantially equivalent to the identified predicate devices." This is the primary conclusion of the 510(k) submission, confirming all comparisons met the substantial equivalence standard. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific "sample size" for the test set in terms of a number of cases, patients, or specific number of tests conducted for each category. Instead, it lists various tests performed on the device itself. The provenance of the data is internal testing by Medtronic Navigation, Inc. The document does not specify country of origin for the data (beyond the company being based in Louisville, Colorado, USA) or whether it was retrospective or prospective, but given the nature of premarket notification testing, it would generally be considered prospective internal validation testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not specify the number or qualifications of experts used to establish a "ground truth" for the test set. Given that the listed tests are primarily about physical and software functionality, accuracy, and compatibility, the "ground truth" would likely be established through engineering specifications, technical standards, and internal quality control protocols rather than expert clinical judgment in the traditional sense of medical image interpretation.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set. The tests appear to be direct measurements, validations, and verifications against predefined specifications and performance metrics, rather than subjective assessments requiring adjudication.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No Multi Reader Multi Case (MRMC) comparative effectiveness study is mentioned. The device is a navigated surgical instrument, not an AI diagnostic tool primarily evaluated by human readers for diagnostic accuracy. Therefore, the concept of "how much human readers improve with AI vs without AI assistance" is not directly applicable in this context.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No standalone performance study for an algorithm without human-in-the-loop performance is described. The device is a surgical instrument that assists a human surgeon through navigation, implying it is inherently "human-in-the-loop." It is not an autonomous algorithm.
7. Type of Ground Truth Used
The ground truth used for the tests appears to be based on:
- Engineering Specifications: For accuracy, functionality, and compatibility tests.
- Technical Standards: For environmental, life, and cleaning verification tests.
- User Requirements/Intended Use: For simulated use and implant/instrument mating.
- Internal Quality Control Protocols: General framework for all testing.
There is no mention of ground truth based on expert consensus, pathology, or outcomes data in the context of the device's performance testing for this 510(k) submission.
8. Sample Size for the Training Set
The concept of a "training set" is usually applicable to machine learning or AI models. Since this submission is for navigated surgical instruments, not an AI algorithm requiring training, there is no mention of a training set or its sample size.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set (see point 8), there is no information on how its ground truth was established.
§ 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).