Search Results

The 7D Surgical System is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical 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 posterior approach spine surgery where reference to a rigid anatomical structure can be identified.

The 7D Surgical System is intended for use as a stereotaxic image guided surgical navigation system during spine surgery. The system provides image registration between preoperative scan data and data captured intraoperatively from the 7D Surgical System structured light scanner and/or user selected points. The system provides guidance data by tracking and displaying the position and orientation of wireless optically tracked Spinal Instruments including the 7D Surgical Pedicle Probe and Awl, now including the 7D Surgical Drill Guide, relative to the patient. Position and orientation data of tracked Spinal Instruments are linked to the preoperative scan data using the 7D Surgical System workstation. The system is intended to be used as the primary surgical luminaire for image guided surgery.

The 7D Drill Guide is designed to allow the 7D Spine Module to show real-time interaction of the drill guide with the patient. The 7D Drill Guide is used to extend the initial hole through the cancellous (soft) bone of the vertebra passing the pedicle. The 7D Drill Guide Instrument Set contains several inserts and bits, these can be switched during the procedure. During navigation, the 7D Drill Guide is displayed showing the trajectory of its path, including measurement markings for measuring the depth of the proposed insertion. These measurement markings can be used as a guide to select the appropriate length of the screw for instrumentation.

The provided text describes the 7D Surgical System - Drill Guide and its submission for 510(k) clearance. Here's a breakdown of the acceptance criteria and the study information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states: "Non-Clinical Performance Surgical Simulations Conducted on Phantom Models". This indicates that the testing was performed on non-human models, likely in a laboratory setting. No specific sample size (number of phantom models or tests) is mentioned, nor is the country of origin for the data, but it is implied to be from 7D Surgical Inc. in Canada. The testing is non-clinical, so it's not "retrospective or prospective" in the traditional sense of human data.

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

The document does not explicitly state the number or qualifications of experts used to establish ground truth for the non-clinical tests. However, it references ASTM F2554-10 Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems. This standard likely dictates methods for establishing ground truth, typically involving highly precise measurement instruments and potentially expert calibration. The ground truth for Target Registration Error (TRE) and Absolute Target Error (ATE) involves comparing the system's reported position to a physically measured or otherwise established true position.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method like 2+1 or 3+1. Given that the testing was non-clinical on phantom models, ground truth would likely be established through precise measurements rather than expert consensus requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. The document states: "A clinical trial was not required to demonstrate safety and effectiveness of the 7D Surgical System." Therefore, there is no discussion of human readers, AI assistance, or effect sizes in this context.

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

Yes, the document describes standalone performance testing for the device. The non-clinical accuracy tests, including those following ASTM F2554-10 and the evaluation of Target Registration Error (TRE) and Absolute Target Error (ATE), are conducted on the device itself (the 7D Surgical System and its Drill Guide) without active human surgical intervention during the measurement of accuracy. The goal is to determine the system's inherent accuracy in positioning and orientation.

7. The Type of Ground Truth Used

The ground truth used for the non-clinical accuracy tests was established through:

• Precise physical measurements: For evaluating absolute accuracy, repeatability, and navigation accuracy according to ASTM F2554-10.
• Comparison to a known true position: For Target Registration Error (TRE) and Absolute Target Error (ATE), which involve comparing the system's reported position to a physically or otherwise established ground truth position on phantom models.

8. The Sample Size for the Training Set

The document does not provide information about a "training set" in the context of machine learning or AI algorithms. The 7D Surgical System is described as a "stereotaxic image guidance system" that uses "optically tracked reflective marker spheres" and "structured light scanner" for registration and tracking. This suggests a traditional computer vision/navigation system rather than one based on deep learning requiring a large training dataset.

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

As no training set (in the machine learning sense) is mentioned or implied, there is no information on how its ground truth would have been established.

Ask a specific question about this device