Search Results

The 7D Surgical System is a stereotaxic image guidance system intended for the spatial positioning and orientation of neurosurgical instruments used by surgeons. The system is also intended to be used as the primary surgical luminaire during image guided surgery. The device is indicated for cranial surgery where reference to a rigid anatomical structure can be identified.

The 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application is intended for use as a stereotaxic image guided surgical navigation system during cranial surgical procedures. The Cranial Application software assists in guiding surgeons during cranial surgical procedures such as biopsies, tumor resections, and Ventricular Catheters placement. The Cranial Application software works in conjunction with 7D Surgical Machine Vision Guidance System which consists of clinical software, optically tracked surgical Pointer, a reference frame instrument and platform/computer hardware which is substantially equivalent to K181041. Image guidance tracks the position of instruments in relation to the surgical anatomy and identifies this position on DICOM images or intraoperative structured light images of the patient. The Cranial software functionality is described in terms of its feature sets which are categorized as imaging, registration, planning, and views. Feature sets include functionality that contributes to clinical decision making and are necessary to achieve system performance.

The 7D Surgical System Cranial Application is comprised of 5 major components:

1. Cart
2. Arm
3. Head
4. Tracked 7D Surgical System Cranial Instruments
5. Software

Here's a breakdown of the acceptance criteria and study information for the 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

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

   • The document states that device performance tests were conducted "on phantom models in a clinical simulated environment." It does not specify the exact sample size (number of phantom models or individual measurements) for the TRE and ATE testing.
   • The data provenance is from non-clinical studies conducted by 7D Surgical Inc. There is no information regarding country of origin for the data or if it was retrospective or prospective in the context of clinical data, as this was a non-clinical study.

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

   • The document does not explicitly state the number or qualifications of experts used to establish ground truth for the non-clinical phantom model testing. It mentions that TRE and ATE evaluate "the error discrepancy between the position reported by the image guided surgery system and the ground truth position measured physically or otherwise." This implies a physical measurement standard was used as ground truth rather than expert consensus on images.

3. Adjudication method for the test set:

   • Not applicable as the ground truth was established by physical measurement on phantom models, not by expert review requiring adjudication.

4. 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:

   • No MRMC comparative effectiveness study was done. This device is a surgical navigation system, not an AI-based diagnostic imaging tool that would typically involve human readers interpreting images. The document explicitly states: "A clinical trial was not required to demonstrate safety and effectiveness of the 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application."

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

   • The "Non-Clinical Accuracy" testing, specifically the TRE and ATE measurements on phantom models, represents a standalone performance evaluation of the system's accuracy in tracking and reporting positions without a human surgeon's interaction being part of the measurement of error. The system itself is designed to be used with a human surgeon.

6. The type of ground truth used:

   • For the non-clinical accuracy testing (TRE and ATE), the ground truth was established by physical measurement on phantom models. The document states it's "the ground truth position measured physically or otherwise."

7. The sample size for the training set:

   • The document does not mention a "training set" in the context of machine learning. The 7D Surgical System uses "Machine Vision Guidance System" and structured light imaging. While these technologies involve algorithms, the submission focuses on the performance verification of the integrated system and its components. It does not detail the development or training of specific machine learning models with a distinct training dataset.

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

   • As no specific "training set" for machine learning is detailed in the document, information on how its ground truth was established is not provided. The system uses pre-calibrated geometry of instruments and structured light scanning, which inherently rely on engineering and metrological standards for accuracy rather than a labeled training dataset in the typical AI sense.

Ask a specific question about this device