(118 days)
K2M Navigation Instruments are intended to be used in the preparation and placement of K2M screws (DENALI, MESA, EVEREST) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. MESA screw navigation is intended for open procedures only. The K2M Navigation 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 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.
K2M Navigation Instruments are manual surgical instruments intended be used when implanting previously cleared components of MESA, DENALI and EVEREST Spinal Systems.
Function: These instruments are designed to interface with the Medtronic StealthStation® System when used for navigation during spinal surgery.
The provided text describes a 510(k) premarket notification for K2M Navigation Instruments. However, it does not contain the detailed information necessary to answer all parts of your request about acceptance criteria and a specific study that proves the device meets those criteria.
Here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
The document broadly states:
| Acceptance Criteria Category | Device Performance |
|---|---|
| Rigidity | Not specified in detail, but "Rigidity... testing was performed to ensure functionality and compatibility with the Medtronic StealthStation." The conclusion states it is "equivalent to predicate devices." |
| Registration | Not specified in detail, but "Registration... testing was performed to ensure functionality and compatibility with the Medtronic StealthStation." The conclusion states it is "equivalent to predicate devices." |
| Accuracy | Not specified in detail, but "Accuracy testing was performed to ensure functionality and compatibility with the Medtronic StealthStation." The conclusion states it is "equivalent to predicate devices." |
| Functionality (with Medtronic StealthStation) | "Testing determined that the K2M Navigation Instruments are equivalent to predicate devices." |
| Compatibility (with Medtronic StealthStation) | "Testing determined that the K2M Navigation Instruments are equivalent to predicate devices." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document only mentions "testing was performed."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not provided in the document. The type of device (surgical navigation instruments) suggests the "ground truth" might relate to physical measurements or engineering specifications, rather than clinical expert consensus on images.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
There is no indication of an MRMC study or AI assistance in this document. The device is described as "manual surgical instruments" and its function is to "interface with the Medtronic StealthStation® System when used for navigation." This implies it's a tool for surgeons during a procedure, not an AI-powered diagnostic system requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided. Given it's a physical instrument, the concept of "standalone algorithm performance" as typically applied to AI/software might not directly apply in the same way. The performance would be related to its physical properties and its interaction with the navigation system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the type of ground truth. However, given the nature of the device (navigation instruments for surgery), the "ground truth" for "rigidity, registration, and accuracy testing" would likely involve:
- Engineering specifications and measurements: Comparing the instrument's performance to pre-defined physical tolerances and established accuracy benchmarks for navigated surgical systems.
- Physical compatibility testing: Ensuring the instrument physically and digitally integrates correctly with the Medtronic StealthStation System.
8. The sample size for the training set
This information is not provided. The device is an instrument, not an AI/ML algorithm that typically has a "training set."
9. How the ground truth for the training set was established
This information is not provided. (See explanation for point 8).
In summary, the provided document is a 510(k) summary focused on demonstrating substantial equivalence to predicate devices, primarily through non-clinical performance evaluations of physical properties like rigidity, registration, and accuracy. It lacks the detailed study design, participant numbers, and outcome metrics that would be present in a comprehensive clinical or performance study report for an AI/ML or diagnostic device.
§ 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).