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The VIPER PRIME navigated inserter is a navigated instrument for insertion of VIPER PRIME screws in open or percutaneous procedures. The VIPER PRIME navigated inserter is indicated for use in spinal surgical procedures, in which:

• use of the VIPER System is indicated,
• use of stereotactic surgery may be appropriate, and
• where reference to a rigid anatomical structure, such as the pelvis or a vertebrae can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy using a navigation system which includes universal tracking arrays supplied by the navigation manufacturer.

These procedures include but are not limited to spinal fusion. The VIPER PRIME navigated inserter requires manual calibration.

The VIPER PRIME™ navigated inserter is a reusable manual screwdriver for insertion of the VIPER PRIME screws of the VIPER System in open and percutaneous procedures. The VIPER PRIME navigated inserter also features attachment sites for universal tracking arrays supplied by the navigation manufacturer to enable use with the respective spine navigation system. The VIPER PRIME navigated inserter must be manually calibrated with the third-party navigation system.

This document is not about an AI/ML powered device, but rather a navigated inserter for spinal surgery. Therefore, the questions related to AI/ML specific concepts like training sets, ground truth establishment for training, MRMC studies, and effect size of human reader improvement with AI assistance are not applicable.

However, I can extract information related to the device's acceptance criteria and the study proving it meets these criteria based on the provided text.

Based on the provided text for the VIPER PRIME navigated inserter, the primary method for demonstrating acceptable performance is through non-clinical sawbones testing. The document does not provide a formal table of acceptance criteria with specific numerical thresholds, nor does it detail a comparative study with a "reported device performance" against explicit criteria beyond general confirmation of function.

Here's an attempt to answer the questions based on the available information:

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

The document does not provide a formal table with quantitative acceptance criteria and corresponding reported performance metrics. Instead, the performance evaluation is described qualitatively as "confirm[ing] device performance for the intended use."

The study confirmed the following functions:

• Acceptance Criteria (Implicit): The device should successfully allow for:
  • Assembly with third-party universal tracking arrays.
  • Manual calibration with the third-party navigation system.
  • Navigated insertion of VIPER PRIME screws in a sawbones model.
  • Final screw position in the software should be verifiable by a second imaging modality.
• Reported Device Performance (Qualitative): The non-clinical sawbones testing "confirmed device performance for the intended use" by demonstrating successful assembly, manual calibration, and navigated insertion of screws, with verification of screw position using a second imaging modality.

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

• Sample Size: The document only states "non-clinical sawbones testing" and "insertion of VIPER PRIME screws in a sawbones model." It does not specify the number of sawbones models used, the number of screws inserted, or the number of trials performed.
• Data Provenance:
  • Country of Origin: Not specified, but given the submission is to the FDA in the USA, the testing would likely adhere to US regulatory standards.
  • Retrospective or Prospective: This was likely a prospective study designed to demonstrate performance for regulatory submission.

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

• The document does not mention the use of human experts to establish "ground truth" for the test set in the way one might for an AI/ML diagnostic device (e.g., radiologist reads).
• The ground truth in this context appears to be the physical confirmation of the screw's final position via a second imaging modality. It is implied that the test was performed by qualified individuals, but their specific roles or qualifications (e.g., orthopedic surgeons, engineers) are not detailed.

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

• Not applicable in the context of this device. There is no mention of consensus reading or multi-reader adjudication for establishing ground truth, as the "ground truth" is the physical location of the screw confirmed by imaging.

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

• Not applicable. This device is a surgical instrument, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reader improvement with/without AI assistance was not performed.

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

• Not applicable. This is a hardware device requiring human interaction and navigation system input. There is no standalone algorithm to evaluate.

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

• The ground truth was established by physical verification of the final screw position using a second imaging modality after insertion in a sawbones model. This is a form of objective measurement/outcomes data within the controlled test environment.

8. The sample size for the training set

• Not applicable. This device does not involve a "training set" in the context of machine learning.

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

• Not applicable. There is no training set for this device.

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