(257 days)
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 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 IZI Pedicle Access Kit, 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 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 Tracking System enables the surgeon to view the position and orientation of 7D Surgical System Spinal Instruments relative to registered preoperative image data while performing the surgical procedure. Each of the 7D Surgical System instruments, including the IZI Pedicle Access Kit, utilizes commercially available passive reflective marker spheres to determine the position and orientation of instruments. Each tracked Instruments requires a unique marker position configuration to enable the tracking system to distinguish the tools from one to the other.
The Software links all system components and displays navigational data to the surgeon. It provides methods for loading preoperative scans and guides the surgeon through the process of surface model creation, structured light acquisition, registration, registration verification, and navigation.
The provided text does not contain information about an AI/ML-driven device or study. It describes a 510(k) premarket notification for the "7D Surgical System," which is a stereotaxic image guidance system intended for spatial positioning and orientation of neurosurgical instruments and as a primary surgical luminaire during image-guided surgery. This system appears to be a hardware and software system for surgical navigation, not an AI/ML diagnostic or prognostic tool.
Therefore, many of the requested details regarding acceptance criteria, training/test sets, expert ground truth, MRMC studies, and standalone algorithm performance, which are typical for AI/ML validation, are not applicable or described in this document.
However, I can extract information related to the device's performance testing and general acceptance criteria as described for this non-AI system.
Here's an attempt to answer based on the provided text, highlighting what is missing or not applicable:
1. A table of Acceptance Criteria and the Reported Device Performance:
The document describes performance in terms of verification and validation activities, particularly accuracy.
| Acceptance Criteria Category for 7D Surgical System | Reported Device Performance |
|---|---|
| System Verification | Verification successful, all design requirements have been fulfilled. (Scope: verify design requirement specifications under test case protocols) |
| System Validation | Validation successful, all user needs met. (Scope: validate Indications For Use and Customer Requirements under simulated use case situations) |
| Safety regarding risk analysis | Risk Control requirements are effective and mitigate the associated risks to an acceptable level. (Scope: Implementation and effectiveness of all risk control requirements specified in the 7D Surgical System risk analysis are tested and verified) |
| Product Safety standards conformity | Compliance with recognized standards have been verified in the previous application K142344. (Tested to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-41, IEC 60825-1, ISO 10993-1, and ISO 17665-1). Previous test results have not been affected by this change (addition of IZI Pedicle Access Kit compatibility). |
| Non-Clinical Accuracy | All accuracy specifications have been met for the IZI Pedicle Access Kit. (System's accuracy tested using the 7D Surgical System on phantom models following ASTM F2554-10 Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems, in addition to Target Registration Error (TRE)). Accuracy testing for the currently cleared Reference Frame, Awl and Pedicle Probe have been verified in previous application K180352. The document mentions "TRE evaluates the error discrepancy between the position reported by the image guided surgery system and the ground truth position measured physically or otherwise." The specific numerical accuracy metrics or thresholds met are not explicitly provided in this summary. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: The document mentions "phantom models" for non-clinical accuracy testing. It does not specify a numerical sample size (e.g., number of phantoms, number of measurements per phantom).
- Data Provenance: The studies were "Non-Clinical Performance Surgical Simulations Conducted on Phantom Models" and "Non-Clinical Accuracy" tests on phantom models in a "clinical simulated environment." This indicates the data is synthetic/simulated, not from real patient cases. No information on country of origin for this simulated data.
- Retrospective or Prospective: Not applicable as it's non-clinical, phantom-based testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This information is not provided in the document. Given that the testing was "Non-Clinical Accuracy" on "phantom models" and describes "Target Registration Error (TRE)" as a comparison between the system's reported position and "ground truth position measured physically or otherwise," it's highly likely the ground truth was established through precise physical measurements using metrology tools, not human expert consensus, for this mechanical/optical navigation system.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not mentioned. This concept (adjudication for discordant interpretations) typically applies to human readers interpreting medical images or data, not to the performance measurement of a surgical navigation system's mechanical/optical accuracy on phantoms.
5. 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 study was performed or described. The device is a surgical navigation system, not an AI diagnostic/prognostic tool that assists human image readers. Clinical data (and thus human reader studies) were deemed "unnecessary" because the device introduces "no new indications for use" and its features are "equivalent to the previously cleared predicate device."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document describes "Non-Clinical Accuracy" testing of the "System's accuracy... on phantom models." This testing measures the system's ability to accurately track and report positions relative to a physical ground truth, which can be considered a standalone performance assessment of the navigation component. The device's primary function is to provide guidance (essentially "standalone" positional data) that a human surgeon then uses. The document states, "TRE evaluates 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 direct algorithmic measurement comparison.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For "Non-Clinical Accuracy," the ground truth was established through "physical measurements" or "otherwise" on "phantom models." This is evident from the description of Target Registration Error (TRE) as comparing the system's reported position to the "ground truth position measured physically or otherwise." It is not based on expert consensus, pathology, or outcomes data.
8. The sample size for the training set:
- Not applicable/Not mentioned. This device does not appear to be an AI/ML system that requires a "training set" in the conventional sense for model development. The system's operation is based on structured light sensing and optical tracking of physical markers.
9. How the ground truth for the training set was established:
- Not applicable. As a non-AI/ML system, there is no "training set" for which ground truth would need to be established in the context of machine learning model training.
§ 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).