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The Evolution Spine navigation instruments are indicated for use during the preparation and placement of Whistler Modular Pedicle Screw System polyaxial screws or Stowe Pedicle Screw System polyaxial screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The navigation instruments are intended to be used with the Medtronic® StealthStation® S8 Navigation System (Software Version 1.3.0)., 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 a vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Evolution Spine Navigation Instruments are reusable surgical instruments for use with the Medtronic® StealthStation® S8 Navigation System. The system is designed to assist surgeons in the precise localization of anatomical structures, preparation and placement of pedicle screw implants during spinal procedures.

The Evolution Spine navigation Instruments include awls, probes, taps and drivers. The navigated instruments are to be used with Whistler Modular Pedicle Screw System (K182478) and Stowe Pedicle Screw System (K181554).

All instruments are made of stainless steel per ASTM F899. The Evolution Spine navigation Instruments are not compatible with implants from other manufacturers and are designed for use only with Medtronic® StealthStation® S8 Navigation System hardware and software.

The provided FDA 510(k) clearance letter for the Evolution Spine Navigation Instruments focuses on establishing substantial equivalence to predicate devices, primarily through non-clinical performance testing. It indicates that clinical testing was not performed. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted to assess human reader improvement with AI assistance, nor was a standalone algorithm performance study performed as part of this submission for establishing substantial equivalence.

The submission relies on a non-clinical test to demonstrate performance, specifically focusing on positional accuracy of the instruments when used with a specific navigation system.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

Note: The exact numerical values for positional accuracy criteria from ASTM F2554-18 and Rampimura et al. are not explicitly stated in the provided text. The document only confirms that the device "meets and exceeds" these established benchmarks.

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: The document does not specify a numerical "sample size" in terms of cases or patients. Instead, it refers to "the worst-case instruments constructs" being tested. This implies a limited number of physical instrument configurations were chosen for rigorous testing, representing the most challenging scenarios for accuracy.
   • Data Provenance: The study described is a non-clinical, laboratory-based performance test. This means the "data" is derived from controlled measurements in a lab setting, not from human subjects or clinical data. Therefore, concepts like "country of origin" or "retrospective/prospective" do not apply in the typical sense; it's an engineering test.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:

   • This is a non-clinical performance test of a physical device's accuracy. "Ground truth" in this context refers to the engineering specifications and established test methods (ASTM F2554-18 and Rampimura et al. reference values) for positional accuracy. No human experts (e.g., radiologists) were used to establish the ground truth for this performance test. The "truth" is an objective, measurable accuracy.

3. Adjudication Method for the Test Set:

   • Not applicable as this was a non-clinical instrument performance test, not a subjective assessment requiring human adjudication. The results are quantitative measurements against established engineering standards.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No. The document explicitly states: "Clinical testing was not necessary to demonstrate the substantial equivalence of the subject devices." This implies that an MRMC study involving human readers and AI assistance was not performed or submitted for this specific clearance.

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

   • No. The device is a set of "navigation instruments" used with a navigation system (Medtronic® StealthStation® S8). It's a physical instrument, not an AI algorithm. Its performance is evaluated in conjunction with the navigation system, but the focus is on the instrument's mechanical and tracking accuracy.

6. The Type of Ground Truth Used:

   • Engineering Specifications / Established Test Standards: The ground truth for this non-clinical study was defined by the performance criteria established in:
     • ASTM F2554-18, "Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems"
     • Rampimura et al: "Accurate pedicle screw insertion under the control of a computer-assisted guiding system: Laboratory test and clinical study"
   • These are recognized industry standards and published research that define acceptable accuracy limits for such devices.

7. The Sample Size for the Training Set:

   • Not applicable. This is a physical medical device (surgical instruments), not an AI/machine learning algorithm that requires a "training set" of data.

8. 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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