(230 days)
The Renaissance X System is indicated for precise positioning of surgical instruments or implants during general spinal surgery. It may be used in either open or minimally invasive or percutaneous procedures.
Renaissance X 3D imaging capabilities provide a processing and conversion of 2D fluoroscopic projections from standard C-Arms into volumetric 3D image. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of high contrast objects.
The Renaissance X System hosts guidance for spine procedures and intraoperative 3D image processing capabilities. It enables the surgeon to precisely position surgical instruments and/or implants. The planning of the surgical procedure and virtual placement of surgical instruments and/or implants (e.g., a screw) can be achieved through pre-operation planning based on the patient's CT scan or intra-operative planning based on Renaissance X 3D Scan image or on a 3D image uploaded from an external 3D image acquiring system. With the imaging capabilities of the system the user can also visualize the implants on the patients CT.
The provided text describes a 510(k) premarket notification for the Mazor Robotics Ltd.'s Renaissance System, but it does not contain information about acceptance criteria or a specific study proving the device meets those criteria, especially in the context of AI performance metrics like sensitivity, specificity, or AUC.
The document primarily focuses on regulatory approval, substantial equivalence to a predicate device, and general performance testing (software validation, accuracy/repeatability, rigidity, collision avoidance). These are device-level safety and functional tests, not typically clinical performance studies that establish detailed acceptance criteria for diagnostic or AI-driven performance.
Here's a breakdown of what can be extracted or inferred from the document and what's explicitly missing:
Missing Information (and why it's missing from this document):
- A table of acceptance criteria and the reported device performance: This document does not specify quantitative acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy). The "Accuracy and Repeatability Testing" mentioned would likely have internal, engineering-level acceptance criteria (e.g., +/- X mm deviation), but these are not disclosed.
- Sample sized used for the test set and the data provenance: Not mentioned, as no specific clinical performance study for an AI component is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method: Not mentioned.
- Multi Reader Multi Case (MRMC) comparative effectiveness study: Not mentioned. The focus is on the device's functionality, not how it improves human reader performance with AI assistance.
- Standalone (i.e. algorithm only without human-in-the loop performance) study: Not mentioned.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not mentioned.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
What can be inferred/extracted from the document regarding "performance testing" (though not directly "acceptance criteria" in the AI sense):
The document lists "Performance Testing" undertaken, which includes:
- Software validation testing: "demonstrate that the modified software version meets its design requirements."
- Accuracy and Repeatability Testing: "demonstrate that the Renaissance X System has maintained the required accuracy, as specified in the device design requirement. These tests have established that the system is accurate every time as an integrated system, including the full assembly as will be performed in the Operating Room, and that it is able to repeatedly perform in the same standard when required." (No specific metrics or acceptance values are given).
- Rigidity Testing: "These tests demonstrate the mechanical integrity of the Renaissance X System. It shows that the system's design meets the functional requirements with safety margins."
- Collision Avoidance Testing: "these tests validates the system's ability to avoid collisions in the operating field, both with the patient and various objects used during the operation."
Summary of what's provided vs. requested:
The provided document details the regulatory clearance (510(k)) of the Renaissance System, emphasizing its substantial equivalence to a predicate device and its overall safety and functional performance tests. It states that "dence X 3D imaging capabilities provide a processing and conversion of 2D fluoroscopic projections from standard C-Arms into volumetric 3D image. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of high contrast objects." However, it does not delineate specific (AI-related) acceptance criteria or detailed study results for its imaging or surgical guidance capabilities in the way a clinical trial or AI validation study would. The performance tests listed are general engineering and software validation tests, not clinical performance metrics against a defined ground truth.
§ 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).