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510(k) Data Aggregation
(164 days)
The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by surgeons to guide standard surgical instruments during spine surgeries.
Guidance is based on an intraoperative plan developed with three dimensional imaging software provided that the required fiducial markers and rigid patient anatomy can be identified on 3D CT scans. The device is intended for the placement of pedicle screws in vertebrae with a posterior approach in the thoracolumbar region.
The ROSA One device is a robotized image-guided device that assists the surgeon during spine surgeries.
It provides quidance of surgical instruments compatible with the diameter of the adaptors supplied by Medtech. It allows the user to plan the position of instruments or screws on medical images and provides stable, accurate and reproducible guidance in accordance with the planning.
The device is composed of two stands positioned around the operating table:
- a robot stand with a compact robot arm and a touchscreen .
- . a camera stand with an optical navigation system and a touchscreen
Different types of instruments may be attached to the end of the robot arm and changed according to the intended surgical procedure.
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 Spine application, a robotized image-guided device intended to assist surgeons during spine surgeries. The information focuses on its substantial equivalence to a predicate device (ROSA SPINE, K151511) and the non-clinical performance data supporting this claim.
Here's an analysis of the acceptance criteria and study proving device performance, based only on the information provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implied/Directly Stated) | Reported Device Performance |
|---|---|---|
| System Applicative Accuracy (In vitro) | Robot arm positioning accuracy < 0.75 mm RMS; Device applicative accuracy < 2mm | Robot arm positioning accuracy < 0.75 mm RMS; Device applicative accuracy < 2mm |
| Electrical Safety & EMC | Compliance with IEC 60601-1 and IEC 60601-1-2 standards | Complies with IEC 60601-1:2005/A1:2012 and IEC 60601-1-2:2014 |
| Biocompatibility Testing | Compliance with FDA Guidance ISO 10993-1 | Evaluation reveals biocompatibility requirements are met (predicate device testing used: Cytotoxicity, Sensitization, Irritation, Acute systemic toxicity) |
| Software Verification & Validation | Compliance with FDA Guidance for Software in Medical Devices and IEC 62304 standard (Major level of concern) | Software tests conducted, verification activities performed, and conformity with user needs/intended use through Validation phase. Substantially equivalent performance to predicate. |
| Cleaning & Sterilization Validation | Compliance with FDA Guidance and relevant ISO/AAMI standards | Automated cleaning validation performed; Sterilization validation performed according to ISO 17665-1, ISO 17664, ANSI/AAMI ST79, and AAMI TIR 12. Substantially equivalent to predicate. |
| In vitro studies | Validation of extension of indication to thoracic spine | Evaluation and tests performed demonstrated validation of the extension of the indication for use to thoracic spine (on phantom and cadaver). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for any of the non-clinical tests (e.g., how many robots/devices were tested for accuracy, how many phantom/cadaver units for in vitro studies).
The data provenance is stated as non-clinical performance tests.
- Country of Origin: Not explicitly stated for testing, but Medtech S.A. is located in Montpellier, France.
- Retrospective or Prospective: Not specified, but given these are performance tests (not clinical trials), they are inherently experiments designed to prospectively test specific parameters.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The tests described are primarily engineering and laboratory-based (e.g., accuracy measurements, electrical safety, software validation, cleaning/sterilization validation), which don't typically involve human expert ground truth in the same way clinical image interpretation studies do. The in vitro studies on phantom and cadaver are described, but the method of establishing "ground truth" for the thoracic spine extension is not detailed beyond "evaluation and tests were performed."
4. Adjudication Method for the Test Set
This information is not provided in the document. Adjudication methods are typically relevant for clinical studies involving human interpretation or outcome assessment, not for the technical performance tests described here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical data were not required to support the safety and effectiveness of ROSA ONE Spine application. All validation was performed based on non-clinical performance tests." Therefore, there is no information on how human readers might improve with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is described as "a robotized image-guided device that assists the surgeon." While it has software and automated functions, its purpose is to guide human surgeons. The listed performance tests are for the device system (robot arm accuracy, electrical safety, software function), not a standalone diagnostic algorithm. The "Device applicative accuracy" test likely reflects the system's ability to guide to a target, which is a form of standalone performance for a guidance system. However, it's not an "algorithm-only" performance in the sense of an AI model making a diagnosis without human input.
7. The Type of Ground Truth Used
For the technical performance tests:
- System Applicative Accuracy: The ground truth is likely defined by the physical target points and the robot's measured position relative to those points, verified by precise measurement tools.
- Electrical Safety & EMC / Biocompatibility / Cleaning & Sterilization Validation: Ground truth is compliance with specified regulatory standards and test methods.
- Software Verification & Validation: Ground truth is compliance with software requirements and design specifications.
- In vitro studies (phantom/cadaver): The ground truth for validating the thoracic spine extension is not explicitly detailed but would likely involve comparison against pre-defined planned trajectories or anatomical landmarks in the phantom/cadaver, measured by a precision tracking system. It is not "expert consensus, pathology, or outcomes data" in the clinical sense.
8. The Sample Size for the Training Set
This information is not provided. The document focuses on performance testing for regulatory clearance, not the development or training of an AI model. While the device is "robotized" and "image-guided," the document does not elaborate on machine learning model training. The software verification mentions "Code inspections and software tests at the unit, integration and system levels" which relates to traditional software engineering, not necessarily machine learning training.
9. How the Ground Truth for the Training Set Was Established
Since the document does not provide information about a "training set" for a machine learning model, the method for establishing its ground truth is not applicable/not provided.
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