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The ACUFEX Director Application Anatomic Guide System is designed to help orthopedic surgeons and specialists access intraoperative images and provides user controlled visual feedback in order to assist in the planning and historical case review of the location of cruciate ligament tunnel insertion sites.

The ACUFEX Director Application Anatomic Guide System is a software based application that allows surgeons to captured intraonerative still images from a medical fluoroscopic C-arm, display them on a touchscreen computer, visually locate anatomic landmarks of the tibia or femoral footprint using various automated overlays for ACL/PCL single or double bundle placements and mark the selected tunnel placement based on the anatomic landmarks.

Prior to use of the ACUFEX Director Application Anatomic Guide System the surgeon places a microfracture awl or other radio opaque positioning aid in the desired position for tunnel placement per the surgical procedure.

The ACUFEX Director Application Anatomic Guide System software automatically generates the pre-selected ACL/PCL overlays and places the marker positions on the touchscreen. The surgeon identifies and marks the patient's anatomic locations. These marker locations are relative to the sizing of the grid defined by the surgeon selected ACL or PCL anatomical points. The surgeon can adjust the size or rotate the overlay to accommodate their pre-selected position or they can accept the overlay markers. If the surgeon decides to accept the overlay markers a re-positioning of the microfracture awl relative to the overlay markers is made. At this point the tunnel location can be drilled over the final location of the microfracture awl.

The touchscreen computer is purchased by Smith & Nephew as an "off the self" product. The major components are the touchscreen computer, keyboard, mouse, and video converter. A mobile cart is offered as part of the system or as an optional accessory.

Here's an analysis of the provided text regarding the ACUFEX Director Application Anatomic Guide System, focusing on acceptance criteria and study details:

Missing Information: It is important to note that the provided text is a 510(k) summary and not a full clinical study report. Therefore, much of the detailed information typically found in a comprehensive study (like specific acceptance criteria thresholds, detailed methodologies for ground truth establishment, training set details, and comparative effectiveness study results) is not present in this document.

Acceptance Criteria and Device Performance (Based on available information)

Study Details (Based on available information)

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated. The document mentions "Cadaver validation" but does not specify the number of cadavers used or the number of cases/measurements performed on them.
   • Data Provenance: The cadaver validation implies a prospective test set using cadaveric models. The geographical origin of the cadavers is not specified.

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

   • Number of Experts: Not specified.
   • Qualifications of Experts: Not specified.

3. Adjudication method for the test set:

   • Adjudication Method: Not specified. The document does not describe how any discrepancies or ground truth establishment was resolved.

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

   • MRMC Study: No. The document does not describe an MRMC study comparing human readers with and without AI assistance for improved performance. The device is described as assisting surgeons in planning, implying human-in-the-loop, but no comparative effectiveness with AI assistance vs. without is mentioned.
   • Effect Size: Not applicable as no MRMC study is reported.

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

   • Standalone Performance: No. The device is described as "designed to help orthopedic surgeons and specialists access intraoperative images and provides user controlled visual feedback in order to assist in the planning..." This indicates a human-in-the-loop system where the surgeon is actively involved, making a standalone performance evaluation less relevant for its stated use case.

6. The type of ground truth used:

   • Type of Ground Truth: The "Cadaver validation" suggests that the "true" anatomical landmarks and desired tunnel placement locations were likely established through direct anatomical assessment by experts (e.g., surgeons/anatomists) on the cadavers, potentially using anatomical dissection or other direct measurement techniques. However, the specific method is not detailed.

7. The sample size for the training set:

   • Training Set Sample Size: Not provided. The document focuses on the validation of the system and does not disclose details about its development or training data.

8. How the ground truth for the training set was established:

   • Training Set Ground Truth Establishment: Not provided. As with the training set size, this information is not included in the 510(k) summary.

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