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510(k) Data Aggregation
(56 days)
INNOVERSE Navigation Instruments
INNOVERSE Navigation Instruments are intended to be used during the preparation and placement of INNOVERSE Spinal System implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in spinal procedures. These instruments are designed for use with the stereotactic navigation system Medtronic® StealthStation™, 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
The INNOVERSE Navigation Instruments are reusable surgical instruments for use with the Medtronic® StealthStation™ Navigation System to assist surgeons in precisely locating anatomical structures in open or minimally invasive procedures for preparation and placement of pedicle screw implants.
The INNOVERSE Navigation Instruments include awls, probes, taps, and drivers and are to be used with the INNOVERSE Spinal System.
All instruments are made from Stainless Steel per ASTM F899. The INNOVERSE Navigation Instruments are not compatible with implants from other manufacturers and are designed for use only with Medtronic® StealthStation™ Navigation System hardware and software.
The provided text is a 510(k) Summary for the "INNOVERSE Navigation Instruments." This document primarily focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and, in this case, a single performance test. It does not contain information about a study designed to prove the device meets specific acceptance criteria in the way one might expect for an AI algorithm or diagnostic tool.
Instead, the performance data section of this document describes non-clinical testing for positional accuracy of the instruments themselves, not a clinical study involving human-in-the-loop performance or AI-driven diagnostic capabilities.
Therefore, many of the requested categories for the description of "the study that proves the device meets the acceptance criteria" are not applicable to the information provided.
Here's an attempt to answer based on the available text, with significant caveats where information is missing or not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
The document only explicitly mentions one performance test and its results.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Positional Accuracy | The results of non-clinical testing show that the performance of the INNOVERSE Navigation Instruments is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices. (The specific numerical acceptance criteria and the actual measured positional accuracy are not provided in this summary, only the qualitative statement of sufficiency and substantial equivalence.) |
2. Sample Size Used for the Test Set and Data Provenance
The document describes "non-clinical testing" for positional accuracy (per ASTM F2554-18). This typically involves testing the instruments in a laboratory setting, not on a "test set" of patient data.
- Sample size for the test set: Not applicable in the context of patient data for an algorithm. The "sample" would refer to the number of instruments tested or the number of measurements taken, which is not specified.
- Data provenance: Not applicable. The testing is non-clinical, likely performed in a lab.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. The ground truth for positional accuracy would be established by precision measurement equipment in a laboratory setting, not by human experts interpreting data.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods are relevant for human interpretation or multi-expert assessment, which is not described here. Positional accuracy is typically measured objectively.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The document focuses on the instruments themselves and their positional accuracy, not on human reader performance with or without AI assistance.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) was done
No, this is not a study of an algorithm's standalone performance. The device is a set of surgical instruments, not an AI or imaging algorithm.
7. The Type of Ground Truth Used
The ground truth for the single mentioned performance test (positional accuracy) would be based on precise physical measurements using calibrated equipment, as per the ASTM F2554-18 standard. It is not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
Not applicable. This device is a set of physical surgical instruments and does not involved a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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