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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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Intended Use:
The Stryker Navigation System - OrthoMap® 3D 1.1 Module is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery. The system is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The system offers the following features and functions:
• Import of multi-modality image data
• Surgical planning, such as image manipulation and visualization and procedural planning
• Surgical navigation, such as manual and automatic registration and precise positioning of instruments and implants
Indications:
The system should be operated only by trained personnel such as surgeons and clinic staff.
The system can assist surgeons in the following, but not limited to, orthopedic surgical procedures:
• Orthopedic oncology procedures
• Cam type FAI (femoroacetabular impingement) surgery
• ACL (anterior cruciate ligament) reconstruction

The Stryker Navigation System - OrthoMap® 3D 1.1 Module is part of the product series of the Stryker Navigation System. It is based on a wireless optical tracking localization device. The system comprises of hardware and software for surgical planning and computer assisted surgery. It supports orthopedic oncology procedures, cam type FAI (femoroacetabular impingement) surgery procedures and ACL (anterior cruciate ligament) reconstruction procedures.

The provided text describes the Stryker Navigation System - OrthoMap® 3D 1.1 Module, a planning and intraoperative guidance system for computer-assisted orthopedic surgery.

However, the document does not explicitly state specific acceptance criteria in a quantitative or tabular format, nor does it provide a full study report with detailed numerical performance metrics for the device against such criteria. Instead, it offers a summary of verification and validation activities.

Based on the information provided, here's an analysis of the device's performance and the supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of quantitative acceptance criteria. It broadly states that "the specified acceptance criteria for system and clinical accuracy can be reached" but does not detail what these criteria were.

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

The document mentions "cadaveric verification studies" and "clinical confirmative trials."

• Cadaveric Verification Studies (Test Set): Performed on "cadaveric" subjects. The document does not specify the exact sample size (number of cadavers or procedures). The provenance is not explicitly stated as a country, but "Stryker Leibinger GmbH & Co. KG" is based in Germany. The studies were likely prospective in nature for verification.
• Clinical Confirmative Trials (Test Set): The system "has been used clinically for cam type FAI treatments." The sample size and location (country) are not specified. These trials were likely prospective.

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

The document does not specify the number of experts or their qualifications used to establish ground truth for the test sets (cadaveric or clinical). It mentions the system "should be operated only by trained personnel such as surgeons and clinic staff," implying expert involvement during clinical use, but not explicitly in establishing ground truth for validation.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for establishing ground truth in the cadaveric or clinical test sets.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, the document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed. The focus is on the device's performance, not specifically on comparing human readers with and without AI assistance. The device is a "guidance system" for surgery, implying human-in-the-loop, but not in a diagnostic reading context.

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

The device is described as a "planning and intraoperative guidance system" and assists surgeons. This implies a human-in-the-loop system, not a standalone algorithm without human intervention. The performance studies focus on the overall system (hardware and software) in conjunction with clinical use.

7. The Type of Ground Truth Used

• For the cadaveric verification studies, the ground truth for "system and clinical accuracy" would likely be established through precise measurements using gold-standard techniques (e.g., coordinate measuring machines, optical tracking, direct anatomical measurements) compared against the system's output.
• For the clinical confirmative trials, the ground truth would typically be based on intraoperative assessments by experienced surgeons, post-operative imaging, and potentially patient outcomes, confirming the safe and effective use of the system.
  However, the specific methods are not detailed in the summary.

8. The Sample Size for the Training Set

The document does not specify any sample size for a training set. This device is a navigation system for surgery, not an AI/ML diagnostic algorithm that typically undergoes a distinct "training" phase with labeled data in the sense of deep learning or machine learning models. Its algorithms are likely based on established geometric and image processing principles, refined and verified through the described bench and cadaveric testing.

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

As there's no mention of a distinct "training set" in the context of an AI/ML model, this question is not applicable based on the provided information. The software is part of a "Navigation System" that performs planning and guidance based on image data and anatomical structures. Its "ground truth" for development would stem from engineering principles, mathematical models, and knowledge of anatomy and surgical procedures, validated through the performance testing described.

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