(127 days)
The Envision 3D™: Image Guidance System is a stereotaxic image guidance system intended for the spationing 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 posterior approach spine surgery where reference to a rigid anatomical structure can be identified.
The 7D Surgical Envision 3D™: Image Guidance 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 Envision 3D™ integrated structured light scanner and/or user selected points. The system provides guidance data by displaying the locations of wireless optically tracked Envision 3D™ Spinal Instruments (examples include pedicle probe and awl) relative to the patient. Position and orientation data of tracked Envision 3D™ Spinal Instruments are linked to the preoperative scan data using the Envision 3D™ workstation. The system is intended to be used as the primary surgical luminaire for image guided surgery.
The system is intended to be used for both image fusion and navigation for neurological applications where reference to a rigid structure can be identified relative to a preoperative image data of the anatomy.
The Envision 3D™: Image Guidance System is comprised of 5 major components:
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- Cart
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- Arm
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- Head
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- Tracked surgical Envision 3D™ Spinal Instruments
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- Software
The provided text gives limited details about the acceptance criteria and a specific study proving the device meets them. However, it does mention non-clinical performance and accuracy testing. Here's a breakdown based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
The document mentions that "All accuracy specifications have been met" for the "Non Clinical Accuracy" testing. However, the specific numerical acceptance criteria for accuracy are not explicitly stated. It refers to ASTM F2554-10 for the measurement method but doesn't provide the targets.
| Acceptance Criteria (Explicitly Stated - limited) | Reported Device Performance (Summary) |
|---|---|
| System verification requirements | All design requirements have been fulfilled |
| System validation, user needs | All user needs met |
| Usability, reduction of use errors | Validation successful with respect to use errors |
| Risk control requirements | Risk Control requirements are effective and mitigate the associated risks to an acceptable level |
| Compliance with recognized product safety standards (IEC 60601-1, IEC 60601-1-2, etc.) | Compliance with recognized standards have been verified |
| Non Clinical Accuracy (based on ASTM F2554-10 and TRE) | All accuracy specifications have been met |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated. The "Non Clinical Accuracy" testing was performed "on phantom models." The number of phantom models or specific test cases is not provided.
- Data Provenance: The Non-Clinical Accuracy tests were conducted on "phantom models" in a "clinical simulated environment." This indicates simulated, controlled environments rather than data from human patients. The country of origin of the data is not specified. It is a retrospective analysis of device performance on phantom models.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
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Number of Experts: Not specified.
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Qualifications of Experts: Not specified.
The ground truth for accuracy testing (Target Registration Error) is described as "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 measurement-based ground truth rather than expert consensus on images.
4. Adjudication Method for the Test Set
Not applicable/Not specified. The accuracy testing described appears to be objective, measurement-based (comparing system output to physical ground truth), rather than requiring expert 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 Envision 3D™: Image Guidance System. Clinical validation is unnecessary as the Envision 3D™: Image Guidance System introduces no new indications for use, device features are equivalent to the previously cleared predicate device identified." Therefore, no assessment of human reader improvement with AI assistance was conducted or reported.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The "Non Clinical Accuracy" testing refers to the "System's accuracy" using the Envision 3D™ on phantom models. This implies a standalone evaluation of the device's accuracy without a human-in-the-loop performance assessment. The system's ability to spatially position and orient surgical instruments is the core function being tested.
7. The Type of Ground Truth Used
The ground truth used for "Non Clinical Accuracy" testing, specifically for Target Registration Error (TRE), is described as "the ground truth position measured physically or otherwise." This suggests physical measurement or pre-defined true positions on the phantom models, not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
The document does not provide information about a training set specifically for an AI/algorithm component. The device is referred to as an "Image Guidance System" utilizing an "integrated structured light scanner" and "software" that "links all system components," but it does not detail any machine learning or AI models requiring a distinct training dataset. The system seems to rely on established image processing and tracking algorithms rather than a trainable AI model in the context usually meant by "training set" for AI.
9. How the Ground Truth for the Training Set Was Established
Since no separate training set or AI model requiring traditional training data is explicitly described, this information is not applicable or provided in the document.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).