(30 days)
The Renaissance System is indicated for precise positioning of surgical instruments or implants during general spinal surgery. It may be used in either open or percutaneous procedures.
Renaissance 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 System hosts guidance for spine procedures and intra-operative 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 patients' CT scan. The "Scan-and-Plan" new feature enables intra-operative planning on the 3D Scan (formerly the C-Insight) image or on a 3D image uploaded from an external 3D image acquiring system (e.g., Medtronic O-arm). The new "Scan-and-Plan" feature replaces the need for a pre-operative CT scan and pre-operative planning, although this feature is still available in the system.
The modified Renaissance System also allows retrieving DICOM files from the hospitals' PACS system for operation planning purposes.
In addition, the modified Renaissance System enables the user to download MRI data and fuse it with CT data in order to provide the user with additional information on the patient's anatomy during the pre-operative planning stage.
The Mazor Robotics Renaissance System (K113228) is a surgical guidance system for spinal procedures. The provided documentation does not explicitly list acceptance criteria in a table format with corresponding device performance values, nor does it detail a standalone human-in-the-loop study with specific accuracy metrics. However, it mentions performance testing and a comparison to a predicate device.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not provide a table of acceptance criteria with quantitative performance metrics. It generally states that software validation and registration accuracy tests were performed.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Software Validation | "The modified software version meets its design requirements." |
| Registration Accuracy | "The modified Renaissance System has maintained its accuracy, as specified in the device design requirements." |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The tests mentioned (software validation and registration accuracy) appear to be internal engineering tests rather than clinical studies on patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not mention using experts to establish ground truth for a test set. The performance tests described are related to software and system accuracy, which would typically be verified against known specifications or physical standards rather than expert consensus on medical images.
4. Adjudication Method
Since the document does not describe the use of experts or a test set requiring ground truth adjudication, there is no mention of an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided information does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was performed, or any effect size related to human reader improvement with AI assistance. The device is a surgical guidance tool, not an AI diagnostic imaging system that would typically be evaluated in an MRMC study for reader performance enhancement.
6. Standalone Performance Study (Algorithm Only)
The document does not explicitly describe a standalone (algorithm only) performance study in terms of diagnostic accuracy or precise guidance error metrics. The performance tests mentioned pertain to software functionality and maintenance of accuracy according to design requirements. The system's core function is to guide a surgeon; its "performance" is inherently linked to its integration into a surgical workflow.
7. Type of Ground Truth Used
Based on the described tests:
- Software Validation: Ground truth would likely be the defined software design requirements and expected outputs.
- Registration Accuracy: Ground truth would be the known physical coordinates or measurements of a phantom or calibrated test object against which the system's registration capabilities are verified. There's no indication of pathology, outcomes data, or expert consensus being used as ground truth for these tests.
8. Sample Size for the Training Set
The document does not provide information regarding a training set sample size. The description of the device and its capabilities (e.g., 3D image processing, planning on CT/MRI) suggests that it's a rule-based or image processing system rather than a machine learning model that requires a distinct "training set" in the conventional sense.
9. How Ground Truth for the Training Set Was Established
Since there's no mention of a traditional machine learning training set, there is no information on how ground truth for a training set was established.
§ 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).