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Spineology Navigation Instruments are intended to be used during the preparation and placement of Spineology's Fortress, Threshold V2, and Palisade pedicle 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 a skull, long bone, or vertebra, can be identified relative to a CT- or MR-based model, fluoroscopic images, or digitalized landmarks of the anatomy.

Spineology Navigation Instruments are non-sterile, reusable instruments; including awls, bone taps, drills, and screwdrivers that are operated manually. These instruments are manufactured from stainless steel in accordance with ASTM F899 and are intended to be used within the context and limitations of the indications for use for Spineology's FDA-cleared Fortress™, Threshold™, Threshold™ V2, and Palisade™ Pedicular Fixation Systems and the Medtronic Synergy Experience StealthStation® System S7 (v2.1.0).

The provided text describes a 510(k) premarket notification for Spineology Navigation Instruments, specifically concerning the addition of an Adapter to an existing cleared instrument set.

Based on the document, here's an analysis of the acceptance criteria and the study that proves the device meets them:

This document does NOT describe the performance of an AI-powered device or a study with specific performance metrics (like sensitivity, specificity, AUC, etc.) typically associated with AI/ML systems. Instead, it describes a medical device (surgical instruments) cleared under the 510(k) pathway, where the primary demonstration of safety and effectiveness relies on "substantial equivalence" to a predicate device.

Therefore, many of the requested items (e.g., sample size for test set, expert ground truth, MRMC study, standalone performance, training set details) are not applicable in the context of this specific regulatory submission. The "study" described is primarily non-clinical testing focused on design verification and risk assessment for the adapter, rather than clinical performance of an AI algorithm.

Here's a breakdown based on the provided text, indicating where information is not applicable (N/A) for this type of device clearance:

Acceptance Criteria and Device Performance (as demonstrated for this type of device):

The "acceptance criteria" for a 510(k) submission for a non-AI medical device like this are primarily demonstrating substantial equivalence to a legally marketed predicate device in terms of intended use, technological characteristics, and safety/effectiveness.

Detailed Study Information (largely N/A for this 510(k) submission):

1. Sample size used for the test set and the data provenance:

   • N/A. This clearance is for surgical instruments, not an AI model evaluated on a "test set" of patient data. The "testing" involved non-clinical design verification (e.g., instrument mating, performance confirmation) for the adapter. The exact sample size for these non-clinical tests is not specified in the summary, but it would typically involve a sufficient number of units to demonstrate design integrity, not a patient data sample.
   • Data Provenance: N/A. No patient data provenance specified as clinical data was not required.

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

   • N/A. Ground truth establishment by experts for a test set of patient data is not relevant to this submission, as no clinical study evaluating interpretation or diagnosis was performed.

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

   • N/A. Not applicable, as there was no test set requiring expert adjudication.

4. 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:

   • N/A. This device is a set of surgical instruments, not an AI or imaging diagnostic aid. No MRMC study was performed.

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

   • N/A. Not applicable, as this is not an algorithm.

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

   • N/A. No ground truth from patient data was established or used, as no clinical performance study was conducted. The "ground truth" for the non-clinical testing was based on design specifications and engineering requirements.

7. The sample size for the training set:

   • N/A. This device does not involve a "training set" in the context of machine learning or artificial intelligence.

8. How the ground truth for the training set was established:

   • N/A. Not applicable.

Summary of the "Study" (Non-Clinical Testing for Substantial Equivalence):

The "study" conducted for this 510(k) submission was a series of non-clinical design verification activities focused on the newly added Adapter to the Spineology Navigation Instruments.

• Purpose: To demonstrate that the design outputs of the subject Spineology Navigation Instruments (with the adapter) met the design input requirements and that the adapter did not introduce new issues of safety or effectiveness.
• Methods:
  • Assessment of instrument mating (how the adapter fits with other instruments).
  • Confirmation that the performance of Spineology Navigation Instruments is unaffected by the use of the Adapter.
  • A risk assessment to confirm no new safety or effectiveness issues.
• Conclusion: Spineology demonstrated substantial equivalence to the predicate device, confirming the same intended use and that any differences in technological characteristics (specifically the addition of the adapter) did not raise new issues of safety and effectiveness.
• Clinical Testing: Explicitly stated as "Clinical testing was not performed or required to establish the substantial equivalence of Spineology Navigation Instruments to the predicate device."

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