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510(k) Data Aggregation
(92 days)
ROSA ONE Brain Application
The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained 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 neurosurgery may be appropriate.
The ROSA One Brain application device is a robotized image-guided device that assists the surgeon during brain surgeries. It provides quidance of any surqical instruments compatible with the diameter of the adaptors supplied by Medtech. It allows the user to plan the position of instruments or implants on medical images and provides stable, accurate and reproducible guidance in accordance with the planning. The device is composed of a robot stand with a compact robotic arm and a touchscreen positioned close the operating table. Different types of instruments may be attached to the robot arm and changed according to the intended surgical procedure. For Brain applications, these neurosurgical instruments (e.g. biopsy needle, stimulation or recording electrode, endoscope) remain applicable for a variety of procedures as shown below in Figure 1 for the placement of recording electrodes. The touchscreen ensures the communication between the device and its user by indicating the actions to be performed with respect to the procedure. Adequate quidance of instruments is obtained from three-dimensional calculations performed from desired surgical planning parameters and registration of spatial position of the patient.
The provided text describes the ROSA ONE Brain application, a robotized image-guided device for neurosurgery. It's an FDA 510(k) submission seeking substantial equivalence to a previously cleared version of the same device. The submission focuses on non-clinical performance data to demonstrate this equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" for each test in a formal table with pass/fail. However, it does outline the tests performed and the results, implying that the predicate device's performance levels define the acceptance criteria for the new version. The most specific performance metric provided is for accuracy.
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| System applicative accuracy (In vitro) | Robot arm positioning accuracy |
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(128 days)
ROSA ONE Brain application
The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained 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 neurosurgery may be appropriate.
The ROSA One Brain application device is a robotized image-guided device that assists the surgeon during brain surgeries. lt provides guidance of any surgical instruments compatible with the diameter of the adaptors supplied by Medtech. It allows the user to plan the position of instruments or implants on medical images and provides stable, accurate and reproducible guidance in accordance with the planning. The device is composed of a robot stand with a compact robotic arm and a touch screen. Different types of instruments may be attached to the robot arm and changed according to the intended surgical procedure. For Brain applications, these neurosurgical instruments (e.g. biopsy needle, stimulation or recording electrode, endoscope) remain applicable for a variety of procedures as shown below in Figure 1 for the placement of recording electrodes. The touchscreen ensures the communication between the device and its user by indicating the actions to be performed with respect to the procedure. Adequate guidance of instruments is obtained from three-dimensional calculations performed from desired surgical planning parameters and registration of spatial position of the patient.
The provided text describes the 510(k) summary for the ROSA ONE Brain Application (K214065), a robotized image-guided device assisting in brain surgeries. The document highlights the substantial equivalence of the new version (v.3.1.6.0) to its predicate device (v.3.1.3.2) (K200511).
However, the provided document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria beyond general safety and equivalence. Instead, it refers to performance testing completed for the predicate device and states that the subject device was evaluated against that predicate testing and determined to be "substantially equivalent."
Therefore, I cannot provide a table of acceptance criteria or details about a study proving the device meets those criteria directly from the provided text, as the document explicitly states: "All validation was performed based on non-clinical performance tests." and "Clinical data were not required to support the safety and effectiveness of ROSA ONE Brain application."
Based on the provided document, here's what can be inferred and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents the following performance data as part of the summary, largely relying on the predicate device's testing and then asserting equivalence for the new device. It does not explicitly state "acceptance criteria" but rather "results" from testing.
| Acceptance Criteria (Implied from Results) | Reported Device Performance and Remarks |
|---|---|
| Biocompatibility: | Conformity with FDA guidance document Use of International Standard ISO 10993-1. |
| Electrical Safety and EMC: | Compliance with IEC 60601-1 and IEC 60601-1-2 standards and FDA EMC guidance. |
| Software Verification and Validation: | Satisfaction of FDA guidance for Software in Medical Devices and IEC 62304 standard. Software considered "major" level of concern. |
| Cleaning- and Sterilization Validation: | Compliance with FDA guidance "Reprocessing of Reusable Medical Devices," ISO 17665-1, ISO 17664, ANSI/AAMI ST79, and AAMI TIR 12. |
| System Applicative Accuracy (In vitro testing): | Robot arm positioning accuracy |
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(88 days)
ROSA ONE Brain application
The device is intended for the spationing and orientation of instruments holders or tool guides to be used by trained 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 neurosurgery may be appropriate.
The ROSA One Brain application device is a robotized image-quided device that assists the surgeon during brain surgeries. It provides guidance of any surgical instruments compatible with the diameter of the adaptors supplied by Medtech. It allows the user to plan the position of instruments on medical images and provides stable, accurate and reproducible guidance in accordance with the planning. The device is composed of a robot stand with a compact robotic arm and a touch screen. Different types of instruments may be attached to the robot arm and changed according to the intended surgical procedure. For Brain applications, these neurosurgical instruments (e.g. biopsy needle, stimulation or recording electrode, endoscope) remain applicable for a variety of procedures as shown below in Figure 5.1 for the placement of recording electrodes. The touchscreen ensures the communication between the device and its user by indicating the actions to be performed with respect to the procedure. Adequate guidance of instruments is obtained from three-dimensional calculations performed from desired surgical planning parameters and registration of spatial position of the patient.
The provided text describes the ROSA ONE Brain application and its substantial equivalence to a predicate device. However, it does not include detailed acceptance criteria and a study proving the device meets those criteria in the way typically expected for an AI/ML medical device submission (e.g., performance metrics like sensitivity, specificity, AUC for a diagnostic algorithm).
Instead, this document focuses on demonstrating substantial equivalence based on engineering and quality control tests rather than clinical performance of an AI algorithm making diagnostic or treatment recommendations. The "performance data" section primarily discusses electrical safety, EMC, software verification, and biocompatibility, along with a statement about system applicative accuracy derived from the predicate device's testing.
Given the information provided, here's a breakdown of what is and is not available in the document regarding your request:
1. A table of acceptance criteria and the reported device performance
Based on the document, the primary "performance data" that could be interpreted as a performance criterion is the "System applicative accuracy."
| Acceptance Criteria (Implied from Predicate) | Reported Device Performance (Inherited from Predicate) |
|---|---|
| Robot arm positioning accuracy |
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(155 days)
ROSA ONE Brain Application
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 neurosurgery may be appropriate.
The ROSA One Brain application device is a robotized image-guided device that assists the surgeon during brain surgeries.
It provides quidance of any surgical instruments compatible with the diameter of the adaptors supplied by Medtech. It allows the user to plan the position of instruments or implants on medical images and provides stable, accurate and reproducible guidance in accordance with the planning.
The device is composed of a robot stand with a compact robotic arm and a touch screen.
Different types of instruments may be attached to the end of the robot arm and changed according to the intended surgical procedure. For Brain applications, these neurosurgical instruments (e.g. biopsy needle, stimulation or recording electrode, endoscope) remain applicable for a variety of procedures as shown below in Figure 5.1 for the placement of recording electrodes.
The touchscreen ensures the communication between the device and its user by indicating the actions to be performed with respect to the procedure.
Adequate guidance of instruments is obtained from three-dimensional calculations performed from desired surgical planning parameters and registration of spatial position of the patient.
The ROSA ONE Brain Application device is a robotized image-guided device that assists neurosurgeons during brain surgeries by providing guidance for instruments.
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
| Acceptance Criterion | Reported Device Performance |
|---|---|
| System Applicative Accuracy (In vitro) | Robot arm positioning accuracy |
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