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510(k) Data Aggregation
(226 days)
The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be appropriate.
The ROSA BRAIN device is a robotized platform providing guidance of any neurosurqical instruments compatible with the diameter of the adaptors supplied by Medtech (for example, a biopsy needle). The device is composed of a compact robotic arm and a touch screen mounted on a robot stand. Different types of instruments may be attached to the robot arm and changed according to the requirements of the procedure to be completed. The touch screen ensures the communication between the device and its user by indicating the actions to be done as well as by offering various commands. ROSA BRAIN is an image-quided device that assists the surgeon in planning the position of instruments or implants on preoperative images. It provides a stable, accurate and reproducible mechanical guidance in accordance with the planning. An image acquisition of the patient's head (MRI / CT images) is performed prior to surgery and loaded into the device. In the preoperative phase, the surgeon carries out the surgical planning on the patient images using the device software. The desired surgical parameters for positioning of the surgical instruments are defined (for example: target point, entry point and instrument lenath). During surgery, the device provides accurate and rigid guidance of the required instrument according to the previously completed planning. The optical distance sensor used with the ROSA BRAIN is susceptible to Electrostatic Discharge (ESD). The ROSA BRAIN device is intended to be used with anti-static sterile drapes which are designed for the device and listed in the list of compatible devices. The anti-static sterile drapes are mitigations to ROSA Brain device ESD immunity.
The provided text is a 510(k) summary for a medical device called ROSA BRAIN (v3.0.0.5), a computer-assisted surgical device (stereotaxic instrument). This document describes the device, its intended use, and the testing conducted to demonstrate its substantial equivalence to a predicate device (ROSA BRAIN v3.0.0.0).
Based on the information provided, here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document focuses on demonstrating substantial equivalence to a predicate device rather than setting new, specific acceptance criteria for this version's performance at a detailed algorithmic level. The performance data provided are primarily for safety and general functional aspects, and a key 'performance' metric mentioned is system applicable accuracy.
| Test Category | Acceptance Criteria (Implied / Stated) | Reported Device Performance |
|---|---|---|
| System Applicative Accuracy (In vitro) | Performance demonstrated to be substantially equivalent to the predicate device. Specific numerical targets for accuracy are given for the predicate and are implicitly the acceptance criteria for the new device. | - Robot arm positioning accuracy: < 0.75 mm RMS - Device applicative accuracy: < 2mm(These results are stated to be "substantially equivalent to the predicate device") |
| Electrical Safety and EMC | Compliance with recognized electrical safety standards: IEC 60601-1 and electromagnetic compatibility standard IEC 60601-1-2. | "Evaluation and testing were performed on the subject device and demonstrated to be substantially equivalent to the predicate device." Device complies with IEC 60601-1:2005/A1:2012 and IEC 60601-1-2:2014. |
| Biocompatibility Testing | Compliance with FDA Guidance Document: Use of International Standard ISO 10993-1. (Specifically, the predicate device had passed Cytotoxicity, Sensitization, Irritation, and Acute systemic toxicity tests, which implied the new device should not introduce new risks). | "The biocompatibility evaluation for ROSA BRAIN device has been conducted in accordance with FDA Guidance Document... The evaluation reveals that biocompatibility requirements are met by the ROSA BRAIN device." "The subject devices were evaluated against the predicate testing and determined to be substantially equivalent." |
| Software Verification and Validation | Compliance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and IEC 62304 Standard (Medical Device Software - Life Cycle Process). Software considered "major" level of concern. | "Evaluation and testing were performed on the subject device and demonstrated substantially equivalent performance to identified predicate device." Includes code walkthroughs, unit, integration, and system test reports, and verification/validation activities. |
| Cleaning and Sterilization Validation | Compliance with FDA Guidance Document Reprocessing of Reusable Medical Devices and standards such as ISO 17665-1, ISO 17664, ANSI/AAMI ST79, and AAMI TIR 12. | "Evaluation was performed of the subject device and demonstrated to be substantially equivalent to the identified predicate devices." Automated cleaning validation and sterilization validation (using two cycles) were performed. |
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states: "Clinical data were not required to support the safety and effectiveness of ROSA Brain. All validation was performed based on non-clinical performance tests."
Therefore:
- Test Set Sample Size: Not applicable in the context of human patient data or studies. The "test set" refers to the non-clinical bench testing conducted to verify accuracy and other engineering specifications. For physical accuracy, the entry "System applicative accuracy In vitro testing" indicates "Testing on the subject device was performed." This would imply multiple runs or repetitions, but a specific numerical sample size (e.g., number of test cases or measurements) is not provided.
- Data Provenance: Not applicable as no human data was used. The testing was in vitro (bench testing) and non-clinical. Given the manufacturer is Medtech S.A. in Montpellier, France, the testing would presumably have been conducted in a controlled lab environment at or by the manufacturer.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable, as no human-in-the-loop clinical or reader studies were performed, and the evaluation was based on non-clinical performance tests against engineering specifications. The "ground truth" for the accuracy test would have been established by precise measurement tools and calibration standards (e.g., coordinate measuring machines, optical tracking systems) rather than human experts in an interpretive sense.
4. Adjudication Method for the Test Set:
Not applicable, as no human-in-the-loop or interpretive studies requiring adjudication were performed.
5. MRMC Comparative Effectiveness Study:
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The submission explicitly states: "Clinical data were not required to support the safety and effectiveness of ROSA Brain." The device's clearance is based on substantial equivalence to a predicate, primarily through non-clinical performance testing.
6. Standalone (Algorithm Only) Performance:
The device is a robotized platform providing guidance, not an AI algorithm that generates diagnostic outputs or interpretations. Its primary "performance" is in terms of the physical accuracy and reliability of its robotic positioning and guidance, as well as its software's ability to plan and execute these movements. The "System applicative accuracy" testing (Robot arm positioning accuracy < 0.75 mm RMS, Device applicative accuracy < 2mm) represents the standalone mechanical and software performance accuracy.
7. Type of Ground Truth Used:
For the "System applicative accuracy" test, the ground truth was metrological/engineering ground truth, established through precise physical measurements using calibrated equipment (e.g., optical tracking systems, mechanical benchmarks) in an in-vitro testing environment, and compared against predefined engineering tolerances.
8. Sample Size for the Training Set:
Not applicable. This device is a robotic surgical assistance system, not a machine learning model that requires a "training set" in the conventional sense of AI/ML. The software itself undergoes verification and validation, but this refers to traditional software engineering practices, not AI model training.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" for an AI/ML model for this device. The software development and testing follow standard software verification and validation procedures (IEC 62304).
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(212 days)
The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be appropriate.
The ROSA Brain device is a robotized platform providing guidance of any neurosurgical instruments compatible with the diameter of the adaptors supplied by Medtech (for example, a biopsy needle). The device is composed of a compact robotic arm and a touch screen mounted on a robot stand. Different types of instruments may be attached to the robot arm and changed according to the requirements of the procedure to be completed. ROSA Brain is an image-guided device that assists the surgeon in planning the position of instruments or implants on preoperative or intraoperative images. It provides a stable, accurate and reproducible mechanical guidance in accordance with the planning.
The provided document is a 510(k) premarket notification for the ROSA Brain device. It does not describe a study proving the device meets specific acceptance criteria in the context of diagnostic or AI performance.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (ROSA Surgical Device K101797) based on technological characteristics and non-clinical performance data, primarily related to safety, electrical compatibility, and software validation.
Therefore, many of the requested items (e.g., table of acceptance criteria vs. reported performance, sample sizes for test/training sets, expert ground truth, MRMC study, standalone performance) are not applicable or extractable from this specific document, as it pertains to a different type of device clearance (stereotaxic instrument rather than an AI/diagnostic device).
Here's a breakdown of what can be extracted or inferred from the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a table of quantitative performance acceptance criteria with corresponding device results in the way it would for an AI or diagnostic device (e.g., sensitivity, specificity, accuracy thresholds). The "performance data" provided relates to compliance with standards and successful software verification/validation.
| Acceptance Criteria (related to general device function/safety) | Reported Device Performance |
|---|---|
| Biocompatibility requirements met (ISO-10993) | Met |
| Electrical safety (IEC 60601-1) | Complied |
| Electromagnetic compatibility (IEC 60601-1-2) | Complied |
| Software Verification & Validation (FDA Guidance, IEC 62304) | Verification activities performed, conformity with user needs/intended use |
| Mechanical and Acoustic Testing (general function) | Not explicitly detailed in criteria/results but implied by device description and predicate comparison |
2. Sample Size for the Test Set and Data Provenance:
Not applicable in the context of an AI/diagnostic test set. The document refers to "software tests" and "verification tests," but these are functional and safety tests, not performance evaluations against a labeled dataset for an AI algorithm.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable in the context of an AI/diagnostic test set. The device is a surgical guidance robot, not an AI diagnostic tool requiring expert-labeled ground truth for performance evaluation.
4. Adjudication Method for the Test Set:
Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. The document explicitly states: "The 510(k) does not contain clinical information for the ROSA Brain." and "The 510(k) does not contain animal study test results for the ROSA Brain." An MRMC study would fall under clinical information.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable for a surgical robotic system. The device is inherently "human-in-the-loop," assisting a surgeon. Its performance is evaluated through functional metrics and its ability to accurately position instruments, not as a standalone diagnostic algorithm.
7. The Type of Ground Truth Used:
For the software verification and validation, the "ground truth" would be the predefined functional requirements and expected outputs of the software modules. The "Conformity of software with the user needs and intended use of the device" serves as the ultimate validation.
For the mechanical and electrical performance, the ground truth is the established standards (e.g., IEC 60601-1) and the physical measurements/outputs of the device to ensure it meets specifications (e.g., accuracy of positioning).
8. Sample Size for the Training Set:
Not applicable. This device is not an AI model that undergoes "training" on a dataset in the conventional sense. The "training" in this context would be the development and testing of the software and hardware components following engineering principles.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As above, there's no "training set" in the context of an AI algorithm. The validation of the device's components and system is against design specifications, functional requirements, and established safety/performance standards. The "ground truth" for each specific test during development and verification would be defined by those specifications and the expected, correct behavior or output.
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