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The AIS S4 Cervical Navigation Instruments are intended to assist the surgeon in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures. They 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 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. These procedures include but are not limited to spinal fusion during the navigation of pedicle screws (T1-T3).

The AIS S4 Cervical Navigation Instruments are manual surgical instruments which are designed to interface with BrainLAB's already cleared surgical navigation systems. Instruments in this system may be pre-calibrated or manually calibrated to already cleared systems using manufacturers' instructions. These instruments are intended to be used in spine applications to perform general or manual functions within the orthopedic surgical environment.

The provided text describes the Aesculap S4 Cervical Navigation Instrumentation, which is a set of manual surgical instruments designed to interface with BrainLAB's surgical navigation systems. The submission is a Traditional 510(k) Premarket Notification.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list specific quantitative acceptance criteria for the device's performance (e.g., a certain level of accuracy in millimeters). Instead, it describes a more qualitative assessment.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document states that "BrainLAB conducted validation activities including usability testing with the AIS Navigation Instruments." However, it does not specify the sample size (e.g., number of users, number of cases tested) for this usability testing or any other performance testing.
• Data Provenance: The document does not specify the country of origin of the data. The testing appears to be conducted by BrainLAB, a company with international operations, but the specific location of the testing is not mentioned. It is also not explicitly stated whether the data was retrospective or prospective, though usability testing typically involves prospective data collection.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• The document mentions "usability testing with the AIS Navigation Instruments." Usability testing typically involves end-users (surgeons) but does not specify the number or qualifications of these experts for establishing ground truth related to navigational accuracy or effectiveness. The study relies on the outcome of the usability testing and performance testing rather than expert-established ground truth in a clinical or imaging sense.

4. Adjudication Method for the Test Set

• The document does not mention any adjudication method for the test set. Given the nature of the testing described (usability and performance requirements), it's unlikely a formal adjudication process (like 2+1 or 3+1 consensus) would be used as it would be in an imaging diagnostic study. The assessment would likely be based on whether the instruments appropriately facilitated the surgical steps and met performance specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No MRMC comparative effectiveness study was done. The document states, "Clinical data was not needed for the AIS Navigation Instruments." The submission focuses on substantial equivalence based on technological characteristics and performance testing.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• This question is not applicable as the device (AIS S4 Cervical Navigation Instruments) is a set of manual surgical instruments designed to interface with surgical navigation systems. It is not an AI algorithm or a standalone software. The performance testing would inherently involve human interaction with the instruments and the navigation system.

7. The Type of Ground Truth Used

• The document implies that the ground truth for "performance requirements" would be established by the functional specifications and design requirements of the instruments when used with the BrainLAB navigation systems. For usability testing, the "ground truth" would be whether the instruments are usable and meet the functional needs of the surgeons. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this submission, as clinical data was not required.

8. The Sample Size for the Training Set

• This question is not applicable. The device is a set of manual surgical instruments; it is not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• This question is not applicable as there is no AI algorithm or training set involved.

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