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The joimax® Intracs® m Navigation System is intended to continuously display the position and orientation of joimax® surgical instruments relative to the anatomy in medical image data in either open or minimal invasive orthopedic procedures.

The use 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 the spine or pelvis, can be identified relative to images of the anatomy. This can include spinal procedures, where the target point for the access to the access to the area of interest, is a rigid landmark, such as:

· Transforaminal procedure

• Interlaminar procedure

The joimax® Intracs® em System is a surgical navigation system based on electromagnetic (EM) tracking technology, designed specifically for applications in minimally invasive spine surgery. The system displays instrument position relative to the patient's anatomy.

The joimax® Intracs® em System is a surgical navigation system. The provided text, a 510(k) summary, primarily focuses on demonstrating substantial equivalence to a predicate device (StealthStation S8 Spine Software) rather than detailing a specific clinical study with granular acceptance criteria and performance data for a standalone AI algorithm.

However, based on the performance data section and the comparison table, we can infer the primary performance metric for this stereotaxic instrument: System Accuracy.

Here's an attempt to structure the information based on the provided text, recognizing that this document is a regulatory submission for substantial equivalence, not a detailed research paper on an AI's performance for a diagnostic task. The AI component here is implied within the "surgical navigation system" which uses electromagnetic tracking to continuously display instrument position relative to anatomy. The "device performance" in this context is its accuracy in tracking.

Acceptance Criteria and Device Performance Study for joimax® Intracs® em System

The joimax® Intracs® em System is a surgical navigation system primarily focused on continuously displaying the position and orientation of surgical instruments relative to anatomical structures using electromagnetic tracking. The "performance data" supplied in support of its substantial equivalence to a predicate device focuses on its accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the joimax® Intracs® em System are directly compared to the performance characteristics of its predicate device, the StealthStation S8 Spine Software. The primary performance metric detailed is System Accuracy.

Note: The K192663 document states the predicate has 'mean positional error of 2.0 mm and a mean trajectory error of 2°', implying these were the benchmarks for the subject device.

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

The provided document does not specify the exact sample size used for the performance testing related to accuracy (e.g., number of measurements, number of phantoms/cadavers).

• Test Set Description: Performance testing was conducted using phantoms and human cadavers.
• Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given the context of a 510(k) submission, these would typically be conducted prospectively as part of product development and validation.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not provide information on the number of experts used or their qualifications for establishing ground truth during the performance testing. In the context of a navigation system's accuracy, the ground truth would likely be established by precise measurements (e.g., CMM, optical tracking gold standard) rather than subjective expert consensus.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method as it's not a reader study or a diagnostic performance evaluation in the typical sense of AI for image interpretation. The "ground truth" for system accuracy would be based on physical measurements against known values and not on human interpretation needing adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study was not conducted/mentioned as this device is a surgical navigation system, not a diagnostic imaging AI designed to assist human readers in interpreting medical images. Its performance is about the accuracy of instrument localization, not diagnostic accuracy requiring human reader comparison.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

The "performance testing (accuracy)" mentioned in the document is effectively the standalone performance of the algorithm and hardware system. The reported values for positional and trajectory error (≤2.0 mm and ≤2°) are the standalone performance metrics. The nature of a surgical navigation system means the "in-the-loop" performance is the surgeon using the system, and the accuracy metrics directly reflect the system's ability to provide correct information to the surgeon.

7. Type of Ground Truth Used

The ground truth for the performance testing (accuracy) was established through physical measurements against known values in phantoms and human cadavers. This is implicitly derived from the types of "Performance testing with phantoms and human cadavers" and the quantified "System Accuracy" metrics (positional and trajectory error). It is not expert consensus, pathology, or outcomes data in the usual sense.

8. Sample Size for the Training Set

The document does not specify a separate "training set" as this is not a deep learning or machine learning model that undergoes a distinct training phase on a large dataset for image analysis. The system's "training" refers to its engineering design, calibration, and validation, not a data-driven machine learning training set in the typical AI sense.

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

As there's no mention of a traditional machine learning "training set," this question is not applicable in the context of the information provided for this specific device. The system's underlying principles (electromagnetic tracking) are based on established physics and engineering, validated through rigorous testing and calibration.

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