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Silony Medical Navigation Instruments are intended to be used during the preparation and placement of VERTICALE® pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in open procedures. These instruments are designed for use with 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 Silony Medical VERTICALE® Navigation Instruments are reusable surgical instruments for use with the Medtronic® StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures in open procedures for preparation and placement of pedicle screw system implants.

The VERTICALE® Navigation Instruments include awls, probes, taps, and drivers. The VERTICALE® Navigation Instruments are to be used with the VERTICALE® Posterior Spinal Fixation System.

All instruments are made of stainless steel per ASTM F899. Taps range in size from Ø4.5mm to Ø10.2mm. The VERTICALE® 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 document is a 510(k) premarket notification for the VERTICALE® Navigation Instruments, which are reusable surgical instruments used with a navigation system for spinal surgery. The document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in terms of accuracy or clinical outcomes.

Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not present in this document. The document primarily addresses the safety and effectiveness of the instruments themselves through non-clinical testing for positional accuracy in conjunction with a computer-assisted surgical system.

Here's an attempt to answer the questions based only on the provided text, with clear indications where the information is absent:

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

The document mentions that the instruments were tested per ASTM F2554-18, "Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems." However, it does not explicitly state specific numerical acceptance criteria (e.g., maximum allowed positional deviation) for this test, nor does it provide the reported numerical performance data for the VERTICALE® Navigation Instruments. It only states: "The results of this non-clinical testing show that performance of the VERTICALE® Navigation Instruments is sufficient for its intended use and is substantially equivalent to legally marketed 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)

• Sample size for test set: Not specified in the document. As this is a non-clinical instrument test, the concept of a "test set" in the context of patient data is not applicable here.
• Data provenance: Not applicable in the context of this non-clinical instrument performance test. The testing was conducted to assess the physical instruments' performance in a controlled setting, not on patient data.

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)

Not applicable. This was a non-clinical instrument performance test, not a study involving human interpretation of medical data where expert ground truth would be established.

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

Not applicable. This was a non-clinical instrument performance test.

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 document does not mention any MRMC study or AI assistance. The device is a set of physical surgical navigation instruments, not an AI-powered diagnostic or assistive tool for human readers.

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

Yes, in a sense, the ASTM F2554-18 testing would represent a "standalone" performance evaluation of the instruments when used with the navigation system, without direct human clinical "in-the-loop" performance evaluation in a patient setting. The test assessed the physical accuracy of the instruments themselves.

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

For the ASTM F2554-18 test, the "ground truth" would be the known, precisely measured physical dimensions and positions established by the testing methodology according to the standard. This would involve calibrated measurement systems to determine the positional accuracy of the navigated instruments against reference points.

8. The sample size for the training set

Not applicable. This document describes the testing of physical surgical instruments, not a machine learning algorithm that requires a training set.

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

Not applicable. (See answer to #8).

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