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The Synthes Navigable Pedicle Preparation Instruments are intended to assist the surgeon in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures. These are indicated for use in surgical spinal procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or a vertebra 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. These procedures include but are not limited to spinal fusion.

The Navigable Pedicle Preparation Instruments are manual surgical instruments which are designed to interface with already-cleared surgical navigation systems. Instruments in this system may be pre-calibrated to already-cleared surgical navigation systems, or may be manually calibrated to already-cleared surgical navigation systems using manufacturers' instructions. These instruments are intended to be used in spine applications to perform general manual functions within the orthopaedic surgical environment.

This is a 510(k) summary for a set of surgical instruments, not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study data, expert involvement, and ground truth for an AI device is not applicable and cannot be extracted from the provided text.

The document describes the Synthes Navigable Pedicle Preparation Instruments, which are manual surgical instruments designed to interface with existing surgical navigation systems.

Here's a breakdown of the relevant information provided:

1. Acceptance Criteria and Reported Device Performance (Non-AI/ML):

2. Sample size used for the test set and data provenance (Not applicable for AI/ML):

The document mentions "usability testing" as a validation activity in the "Performance Data" section. However, it does not specify sample sizes for test sets, data provenance (e.g., country of origin), or whether the data was retrospective or prospective, as these details are typically associated with clinical studies or AI/ML performance evaluations, not characterization of manual surgical instruments.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (Not applicable for AI/ML):

This information is not provided because the validation involved usability testing of manual instruments, not the establishment of ground truth for an AI/ML algorithm.

4. Adjudication method (Not applicable for AI/ML):

This concept is not relevant to the validation described.

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 for AI/ML):

No MRMC study was conducted as this device is not an AI/ML system or a reading assistance tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done (Not applicable for AI/ML):

This is not applicable as the device is a set of manual surgical instruments.

7. The type of ground truth used (Not applicable for AI/ML):

Ground truth as it relates to AI/ML performance is not relevant here. The validation focused on the functional performance and usability of the physical instruments.

8. The sample size for the training set (Not applicable for AI/ML):

There is no "training set" in the context of manual surgical instrument validation, as this is a concept associated with AI/ML model development.

9. How the ground truth for the training set was established (Not applicable for AI/ML):

This is not applicable for the reasons stated above.

In summary: The provided 510(k) summary focuses on demonstrating the substantial equivalence of manual surgical instruments through non-clinical performance testing (usability testing). It does not contain the detailed information related to AI/ML device validation, such as specific acceptance criteria for algorithm performance, sample sizes for test/training sets, expert involvement in ground truth establishment, or comparative effectiveness studies of AI assistance. The document explicitly states: "Clinical data was not needed for the Navigable Pedicle Preparation Instruments."

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