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510(k) Data Aggregation
(30 days)
RENAISSANCE SYSTEM
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.
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(28 days)
RENAISSANCE SYSTEM
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 is a device modification of the TenZing system (K102130). which is comprised of the original SpineAssist System and the C-InSight System.
The SpineAssist application enables the surgeon to precisely position surgical instruments or implants during general spinal surgery. This is achieved through preoperation planning and virtual placement of the surgical instrument or implant (e.g., a screw) based on the patients' CT data. During the surgical procedure the pre-planned instrument or implant positions are located and projected on Fluoroscopy images relative to the SpineAssist device position while the SpineAssist arm is then guided to the actual position. The SpineAssist is described in previously cleared 510(k) submissions K033413, K051676, K063607 and K073467.
The C-InSight application is a software based product, which converts a sequence of two-dimensional fluoroscopy images into a 3D volumetric image, intraoperatively. The C-InSight computer is connected to a traditional C-Arm in the operating room and grabs all images from the C-Arm. Using a tracking algorithm, the C-InSight software is able to convert a continuous scan around the region of interest into a 3D image, intra-operatively. The C-InSight is described in the previously cleared 510(k) submission K081672.
The TenZing System cleared in 510(k) submission K102130 is a workstation which contains both the C-InSight and SpineAssist components in one workstation. This allows the physician to perform SpineAssist procedures and C-InSight procedures as independent applications, but using the same workstation console. Furthermore, the TenZing System allows the surgeon to perform SpineAssist procedures and obtain an intra-overative 3D verification image using the C-InSight application. Thus, the surgeon can obtain real time feedback regarding instrument and/or implant positioning.
The modified system is called the Renaissance System. The device modifications include a newly designed workstation (hardware change), a slightly modified SpineAssist Guiding Device (with colored LED lights), and modified software with improved GUI for the original TenZing software (software change) and the ability to perform CT-Fluoroscopy registration using the fluoroscopy images obtained from the C-InSight application (i.e., CT to C-InSight registration).
The provided text describes the Renaissance System, a robotic surgical guidance system for spinal surgery. Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Reported Device Performance |
|---|---|
| Software validation (in accordance with FDA Guidance) | Passed: "Software validation testing in accordance with the FDA Guidance for the Premarket Submissions for Software Contained in Medical Devices (January 11, 2002)." (Implicitly, the device met the requirements of this guidance.) |
| CT to C-InSight Registration Accuracy | Not explicitly stated as an "acceptance criterion" with a specific threshold in the provided text. However, it was a "Performance Test" that the device presumably passed for clearance: "CT to C-InSight Registration Accuracy Testing." (The document implies this test was successfully completed, but specific accuracy metrics are not included in this summary.) |
| Electrical and Mechanical Safety (IEC 60601-1) | Passed: "IEC 60601-1 Electrical and Mechanical Safety Testing." (Implicitly, the device met the requirements of this standard.) |
| Electromagnetic Compatibility (IEC 60601-1-2) | Passed: "IEC 60601-1-2 Electromagnetic Compatibility Testing." (Implicitly, the device met the requirements of this standard.) |
| Substantial Equivalence to Predicate Device (TenZing System K102130) | Achieved: "The technological characteristics, e.g., overall design, materials, mechanism of action, mode of operation, performance characteristics, etc., and the intended use of the Renaissance device are substantially equivalent to the predicate device cited above." (This is the overarching "acceptance" for 510(k) clearance, implying that all performance criteria are consistent with or improved over the predicate.) The FDA confirmed substantial equivalence in the clearance letter. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text mentions "Performance Testing" but does not specify the sample size for the CT to C-InSight Registration Accuracy Testing. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective) for any of the performance tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information regarding the number of experts, their qualifications, or their role in establishing ground truth for any of the performance tests. The focus is on technical compliance and equivalence.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss the effect size of human readers with or without AI assistance. The testing described is primarily focused on the device's technical specifications and safety rather than its impact on human performance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The performance testing listed ("Software validation testing," "CT to C-InSight Registration Accuracy Testing," "IEC 60601-1 Electrical and Mechanical Safety Testing," and "IEC 60601-1-2 Electromagnetic Compatibility Testing") primarily describes standalone algorithm and system performance in a technical context. The "CT to C-InSight Registration Accuracy Testing" would specifically assess the algorithm's ability to accurately register CT and C-InSight data without direct human intervention impacting the registration process itself.
7. The Type of Ground Truth Used
For the "CT to C-InSight Registration Accuracy Testing," the type of ground truth is implicit. Typically, such accuracy testing would involve:
- Phantom studies: Using a known physical phantom with measurable fiducials where the "true" positions are precisely known.
- Reference standard imaging: Using a gold-standard imaging modality (e.g., a highly accurate CT scan) as the 'true' representation against which the system's registration of fluoroscopic images to CT is compared.
The document does not explicitly state whether expert consensus, pathology, or outcomes data were used as ground truth for any of the tests reported here.
8. The Sample Size for the Training Set
The document does not provide any information about a training set or its sample size. The focus is on verification and validation of the modified device rather than the development of a new AI model with training data.
9. How the Ground Truth for the Training Set Was Established
Since no information on a training set is provided, there is no information on how its ground truth was established. This device submission is for a modification of an existing system (TenZing) and primarily focuses on technical and safety testing of the modifications, not the development of a new AI algorithm requiring a specific training dataset and ground truth establishment methodology.
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