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510(k) Data Aggregation
(28 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 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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(262 days)
The SpineAssist™ System is indicated for precise positioning of surgical instruments or implants during thoracic and lumbar spinal surgery. The SpineAssist™ system may be used in either open or percutaneous procedures.
The SpineAssist™ system is a computer controlled miniature medical image-guided surgery (IGS) system which serves as a technological platform for solutions that provide unprecedented levels of accuracy, precision and accessibility in performing orthopedic procedures. The SpineAssist™ is designed to assist surgeons in precisely guiding handheld surgical tools or implants in line with a computerized, image-based pre-operative plan along given trajectories. The system's software processes fluoroscopic and CT images via proprietary algorithms and automatically exports the desired coordinates to the SpineAssist device, which positions its articulating arm and tool guide. Using a special bone attachment component (i.e., a clamp and bridge or the Hover-T bridge) the SpineAssist device attaches to the bone in the area where the procedure is being performed and assists surgeons in precisely guiding handheld surgical tools or implants according to the computerized, image-based, preoperative plan.
The main components of the SpineAssist™ system include:
- A. SpineAssist™ device
- B. Workstation
- A. Accessories including clamp, bridge, Hover-T bridge, targets, prism, wedge, etc.
The provided text does not contain detailed acceptance criteria or a comprehensive study report with the specific information requested in the prompt (e.g., specific quantitative benchmarks for acceptance, detailed performance metrics with numerical results, sample sizes for test and training sets, expert qualifications, or adjudication methods).
However, based on the summary of non-clinical performance data and conclusions, I can infer the general acceptance criteria and report the mentioned performance.
Here's an analysis of what can be extracted from the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a table format. However, it implicitly suggests that the system's performance for "accuracy" and "safety and effectiveness" during "general spinal surgical procedures" were the key criteria.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Safe and Effective for general spinal surgical procedures | Performance tests demonstrate that SpineAssist system may be safely and effectively used in general spinal surgical procedures. |
| Meets design and performance specifications | Software validation and accuracy performance tests demonstrate that the SpineAssist system meets its design and performance specifications. |
| Substantial Equivalence to predicate devices (original SpineAssist™ and StealthStation System) | The system is found to be substantially equivalent to the predicate devices. |
| Compliance with relevant standards | Complies with IEC 60601-1-4 (Software Validation) and ISO 10993 (Biocompatibility Testing). |
| Demonstrates "precision" in guiding instruments/implants | Indicated for "precise positioning of surgical instruments or implants." |
| Accuracy in new imaging scenarios | "New Imaging and Lateral to 30 degree Accuracy Test" completed. |
| Accuracy with Hover-T and Prisms | "Hover-T Accuracy Test Results Report" and "Use of Prisms in Translaminar Facet Cases Study" completed. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "non-clinical performance data" and lists several "case studies" and "accuracy tests." It does not specify the sample size (e.g., number of cases, number of measurements) for any of these tests.
The data provenance is not explicitly stated. However, given the nature of "non-clinical performance data" for a surgical device involving "accuracy tests" and "case studies," it is highly likely that these were conducted in a controlled laboratory or cadaveric setting, rather than on human patients (since "Clinical Performance Data" is marked as "Not Applicable"). It is likely prospective for the specific tests conducted for this submission. The company is based in Israel, so the studies were likely conducted there or in a partnered facility.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not provide any information regarding the number of experts, their qualifications, or how ground truth was established for the "accuracy tests" or "case studies."
4. Adjudication Method for the Test Set
The document does not provide any information regarding adjudication methods.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done or reported in this summary. The device is a surgical navigation system, not an AI diagnostic tool that assists human readers in interpreting medical images. "Clinical Performance Data" is explicitly stated as "Not Applicable," further reinforcing that human reader studies are outside the scope of this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the "Non-Clinical Performance Data" listed are all standalone algorithm/system performance tests. The device itself is designed to guide surgical tools based on algorithmic processing of imaging data, and the tests like "General Spinal Accuracy Test," "Hover-T Accuracy Test," and "New Imaging and Lateral to 30 degree Accuracy Test" directly assess the system's performance in this standalone capacity. The lack of "Clinical Performance Data" and MRMC studies further supports that the reported performance reflects the algorithm/system without human-in-the-loop performance for this specific submission.
7. The Type of Ground Truth Used
While not explicitly stated, for "accuracy tests" in a surgical navigation system, the ground truth would typically be established by:
- Precise measurements using highly accurate calibration tools or coordinate measuring machines in a controlled environment (e.g., phantom, cadaveric models).
- Known physical dimensions or fiducial markers on phantoms or cadavers which the system is attempting to target or guide to.
- For "case studies" (e.g., Osteoid Osteoma, Thoracic Hover-T), the "ground truth" might refer to the actual anatomical position or intended trajectory as confirmed by intra-operative imaging or post-operative assessment against the surgical plan.
8. The Sample Size for the Training Set
The document does not provide any information regarding the sample size for the training set.
9. How the Ground Truth for the Training Set Was Established
The document does not provide any information regarding how the ground truth for the training set was established.
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