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510(k) Data Aggregation
(87 days)
ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate.
ROSA Surgical Device is a computer controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments.
Acceptance Criteria and Study for ROSA Surgical Device
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mean accuracy for in vitro application | Below 2 mm (for both fiducial markers and optical registration) |
The acceptance criterion for the ROSA Surgical Device was that its in vitro application accuracy should be below 2 mm, which is stated to be equivalent to other commonly used surgical localization systems. The device met this criterion for both fiducial markers and optical registration methods.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: A total of 45 measurements were collected for fiducial markers and another 45 measurements for optical registration. This sums to 90 measurements for the test set.
- Data Provenance: The data was collected "in vitro," implying it was generated in a controlled laboratory setting using a phantom skull. There is no information regarding the country of origin of the data provided in the document. The study was prospective in the sense that the tests were specifically designed and executed to evaluate the device's performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not indicate the involvement of human experts to establish the ground truth for the test set. The ground truth was established by precise measurements using a portable CMM (Coordinate Measuring Machine) with a known accuracy.
4. Adjudication Method for the Test Set
No human adjudication method (e.g., 2+1, 3+1) was used for the test set, as the ground truth was established mechanically through a CMM.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. The study focused on the standalone performance of the device and not on human readers' improvement with or without AI assistance.
6. Standalone Performance Study
Yes, a standalone performance study was conducted. The "Device performance tests" were explicitly performed to validate the absolute accuracy and repeatability of the robot arm and the application accuracy for both fiducial markers and optical registration. This involved the algorithm and mechanical system alone, without human-in-the-loop performance being assessed in this specific accuracy study.
7. Type of Ground Truth Used
The ground truth used was based on physical, objective measurements of target points in a phantom skull using a high-accuracy mechanical device. Specifically:
- A phantom skull featuring small metallic balls was used to materialize target points.
- A portable CMM (FARO Titanium arm) with a 50 µm single point accuracy was used to measure the distance between the targeted point and the attained instrument tip position.
8. Sample Size for the Training Set
The document does not provide information on the sample size used for the training set. The ROSA Surgical Device is an electromechanical arm and navigation system, and while it's computer-controlled and uses "calculations," the typical concept of a "training set" for machine learning algorithms (as might be present in AI/ML medical devices) is not explicitly detailed or indicated as relevant for its core accuracy validation in this submission. The validation described is for the precision of the mechanical and navigational components.
9. How the Ground Truth for the Training Set Was Established
As no training set is explicitly described or detailed in terms of its ground truth establishment, this information is not available in the provided text. The accuracy study focuses on the device's performance against a known physical ground truth, rather than validating an AI model's training.
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(117 days)
ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate.
ROSA Surgical Device is a computer controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments.
The ROSA Surgical Device is a computer-controlled electromechanical arm intended for the spatial positioning and orientation of an instrument holder or tool guide in neurosurgery. Guidance is based on a pre-operative plan developed with three-dimensional imaging software and uses fiducial marker registration.
Here's a breakdown of the acceptance criteria and study information:
1. Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Accuracy | Not explicitly stated in quantitative terms in the provided text, but implied as sufficient for neurosurgical guidance. | "Device performance tests were performed to validate the accuracy and repeatability of the device." |
| Repeatability | Not explicitly stated in quantitative terms in the provided text, but implied as sufficient for neurosurgical guidance. | "Device performance tests were performed to validate the accuracy and repeatability of the device." |
| Electrical Safety | Compliance with IEC 60601-1 standard for electrical safety. | "Testing was carried out to assure compliance with recognized electrical safety standards: IEC 60601-1 standard for electrical safety..." |
| Electromagnetic Compatibility | Compliance with IEC 60601-1-2 standard for electromagnetic compatibility. | "...and IEC 60601-1-2 standard for electromagnetic compatibility." |
| Software Regulations | Compliance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and IEC 62304 (Medical Device Software - Life Cycle Process). | "Tests were also carried out to satisfy the requirements of the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and IEC 62304 (Medical Device Software - Life Cycle Process)." |
2. Sample Size and Data Provenance
The provided text does not explicitly state a sample size for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It mentions "Device performance tests were performed," but no details on the specifics of these tests are given.
3. Number of Experts and Qualifications for Ground Truth
The provided text does not specify the number or qualifications of experts used to establish ground truth for any testing.
4. Adjudication Method for the Test Set
The provided text does not describe any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study in the provided text. The submission focuses on the performance of the device itself, not on human-in-the-loop performance or the effect size of AI assistance on human readers.
6. Standalone Performance Study
Yes, the information implies a standalone (algorithm only without human-in-the-loop performance) study was done. The "Device performance tests" focused on validating the "accuracy and repeatability of the device" itself, suggesting an evaluation of the system's inherent performance.
7. Type of Ground Truth Used
The type of ground truth used is not explicitly stated. However, given the nature of a computer-controlled electromechanical arm for spatial positioning and orientation, it is highly likely that the ground truth for "accuracy and repeatability" would be established through precision measurements and validated spatial references within a controlled environment, rather than expert consensus, pathology, or outcomes data in the traditional sense of diagnostic AI.
8. Sample Size for the Training Set
The provided text does not state the sample size for the training set. It refers to "pre-operative planning developed with three-dimensional imaging software," which would require data for algorithm training, but no details are given.
9. How Ground Truth for the Training Set Was Established
The provided text does not describe how ground truth for the training set was established. The device uses "fiducial markers registration" and "three-dimensional imaging software" for planning, which implies that the training data would be related to accurate spatial mapping and image processing, but the method of establishing their ground truth is not detailed.
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