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Erisma®-LP Navigated Instruments are intended to be used in the preparation and placement of Erisma® 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, 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.

The Erisma®-LP Navigated Instruments are manual, non-sterile, reusable surgical instruments for use with the Medtronic StealthStation™ Navigation System to assist the surgeon in locating anatomical structures in either open, minimally invasive or percutaneous procedures for preparation and placement of the Clariance Erisma®-LP, Erisma®- MIS pedicle screw implants. The Erisma®-LP Navigated Instruments include the following instruments: Drivers, Tap, Bone Awl, Probes. The instrumentation is designed for use with the Medtronic StealthStation™ Navigation System hardware and software. These instruments are made of medical quality stainless steel according to the ASTM F899 and titanium alloy according to the ASTM F136.

The provided text is a 510(k) premarket notification for the Erisma®-LP Navigated Instruments. This document outlines the manufacturer's claim of "substantial equivalence" of their device to a legally marketed predicate device.

It's crucial to understand that a 510(k) submission primarily relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than proving absolute safety and effectiveness through extensive de novo clinical trials.

Unfortunately, the provided text does not contain the level of detail typically found in a clinical study report for AI-powered or diagnostic devices regarding acceptance criteria and performance data. The "Performance Data – Non-Clinical" section explicitly states that mechanical tests were performed, not a clinical study involving human patients or complex AI algorithms.

Therefore, most of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of AI or diagnostic performance (e.g., sensitivity, specificity, human reader improvement with AI) cannot be extracted from this document.

Here's an analysis of the provided information relative to your request:

1. A table of acceptance criteria and the reported device performance

Not applicable in the context of this 510(k) submission.
The document describes non-clinical performance data for mechanical and compatibility aspects of a surgical navigation instrument, not a diagnostic or AI-driven performance study with acceptance criteria like accuracy, sensitivity, or specificity. The "Performance Data – Non-Clinical" section mentions:

• Compatibility between Erisma®-LP Navigated Instruments and Medtronic Naclock Tracker.
• Ability of Erisma®-LP Navigated Instruments to be registered by Medtronic StealthStation™ System.
• Simulation of pedicle insertion.

The reported performance is that these tests "demonstrated the substantial equivalence of the system to legally marketed devices." No specific numerical "acceptance criteria" or "reported device performance" metrics (e.g., within X mm accuracy) are provided, as this is a general statement of equivalency for mechanical function.

2. Sample size used for the test set and the data provenance

Not applicable for a clinical test set.
The testing described is non-clinical/mechanical. There is no mention of a "test set" of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable.
There was no clinical test set requiring expert ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.
There was no clinical test set requiring adjudication.

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

No.
This device is a navigated surgical instrument, not an AI-powered diagnostic or interpretive device for human readers. Therefore, an MRMC study and AI assistance improvement are irrelevant to its nature.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No.
This is a physical surgical instrument system used in conjunction with "human-in-the-loop" (a surgeon) and the Medtronic StealthStation™ Navigation System. It is not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable in a clinical sense.
For the mechanical tests, the "ground truth" would be engineering specifications and the performance of the predicate device.

8. The sample size for the training set

Not applicable.
This device likely does not use machine learning in a way that requires a "training set" of data in the common sense of AI/ML software. Its functionality relies on physical design and interface with the navigation system.

9. How the ground truth for the training set was established

Not applicable.
As above, no training set data.

In summary: The provided document is a 510(k) for a navigated surgical instrument (Erisma®-LP Navigated Instruments) intended to assist surgeons in spine surgery by precisely locating anatomical structures when used with the Medtronic StealthStation® System. The regulatory pathway is based on substantial equivalence to an existing predicate device (Medtronic Navigated CD Horizon Solera Screwdriver/Taps).

The "study that proves the device meets the acceptance criteria" in this context refers to non-clinical mechanical tests and compatibility assessments rather than clinical performance trials or AI/diagnostic performance studies. The document states these non-clinical tests "demonstrated the substantial equivalence of the system to legally marketed devices," which is the fundamental "acceptance criterion" for a 510(k) submission. No detailed quantitative acceptance criteria or clinical performance metrics (like accuracy, sensitivity, or human reader performance) are provided, nor would they typically be for this type of device and regulatory submission.

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