(58 days)
CoreLink Navigation Instruments are intended to be used in the preparation and placement of CoreLink screws 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 S8 (V1.2.0), 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.
CoreLink Navigation Instruments are non-sterile, re-usable manual surgical instruments made from stainless steel. These instruments are designed to interface with the Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures. The purpose of this submission is to add instruments to the previously cleared CoreLink Navigation Instruments set to offer navigation compatibility with more CoreLink pedicle screws.
The FDA document K220973 concerns the "CoreLink Navigation Instruments" and includes a brief summary of performance data. However, it does not contain the detailed information necessary to fully address all the points in your request regarding "acceptance criteria" and a "study that proves the device meets the acceptance criteria" for an AI/device performance evaluation.
This 510(k) submission is for navigation instruments, which are described as non-sterile, re-usable manual surgical instruments designed to interface with a navigation system (Medtronic StealthStation® System S8). The performance data section states: "CoreLink, LLC has conducted an engineering analysis to demonstrate that the system modifications provide adequate and substantially equivalent accuracy for their intended use."
This implies a mechanical/engineering performance evaluation, not a study involving AI assistance for human readers, nor detailed clinical outcome data in the context of an AI-driven diagnostic or prognostic device. Therefore, many of the requested fields are not applicable or cannot be extracted from the provided text.
Here's a breakdown based on the information available:
Acceptance Criteria and Device Performance (Based on provided text)
The document primarily focuses on demonstrating substantial equivalence to predicate devices through an engineering analysis, rather than setting specific quantitative acceptance criteria for a new AI application.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy for Intended Use | Demonstrated through engineering analysis to provide "adequate and substantially equivalent accuracy for their intended use." (Specific quantitative metrics for accuracy are not detailed in this summary.) |
| Technological Characteristics | "Nearly identical technological characteristics" to predicate devices, with "minor differences [that] do not raise any new issues of safety and effectiveness." This includes identical indications for use, materials of manufacture, and principles of operation. |
Study Details (Based on provided text)
Most of the requested study details are not applicable or not provided in this 510(k) summary, as it describes an engineering analysis for mechanical instruments, not an AI performance study.
- Sample size used for the test set and the data provenance: Not explicitly stated for performance testing; the "engineering analysis" suggests bench testing or simulations rather than a clinical dataset in the context of AI.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; ground truth establishment as typically understood in AI studies (e.g., for image interpretation) is not relevant for this device's type of performance evaluation.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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 is not an AI-assisted diagnostic or prognostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a manual surgical instrument intended to be used by a surgeon in conjunction with a navigation system.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For mechanical accuracy, ground truth would typically refer to known physical measurements or engineering specifications against which the instrument's performance is compared. Details are not provided in this summary.
- The sample size for the training set: Not applicable for this type of device and performance evaluation.
- How the ground truth for the training set was established: Not applicable.
In summary:
The provided FDA letter and 510(k) summary pertain to a Class II surgical instrument (CoreLink Navigation Instruments) used with a separate navigation system. The "performance data" mentioned refers to an "engineering analysis" to demonstrate mechanical accuracy and substantial equivalence to existing devices, not the performance of an AI algorithm based on clinical data. Therefore, the detailed questions about AI study design, ground truth establishment, reader studies, and training/test sets are outside the scope of the information provided in this regulatory document.
§ 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).