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510(k) Data Aggregation
(78 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 subject ROSA ONE Spine application is identical to the most recent clearance (K182848) with the exception of an additional calibration step (software) and stand-alone arrays (instrumentation).
The ROSA One device is a robotized image-guided device that assists the surgeon during spine 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 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 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.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Reported Device Performance |
|---|---|
| System Applicative Accuracy (In vitro testing) | Robot arm positioning accuracy < 0.75 mm RMS; Device applicative accuracy < 2mm |
| Electrical Safety | Complies with IEC 60601-1:2005/A1:2012 |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2:2014 & FDA EMC guidance document |
| Biocompatibility | Biocompatibility requirements met (evaluated against ISO 10993-1) |
| Software Verification and Validation | Satisfies FDA Guidance and IEC 62304 Standard for "major" level of concern software |
| Cleaning and Sterilization Validation | Complies with FDA Guidance "Reprocessing Medical Devices..." and standards ISO 17665-1, ISO 17664, AAMI TIR 12 |
2. Sample Size Used for the Test Set and Data Provenance
The provided text describes non-clinical performance tests. Therefore, there isn't a "test set" in the traditional sense involving patient or human subject data.
- System Applicative Accuracy: Performance bench testing was conducted in compliance with internal Medtech/Zimmer Biomet robotics procedures. The specific sample size (e.g., number of tests, repetitions) is not detailed.
- Electrical Safety & EMC: Testing was conducted on the device. Specific sample size (e.g., number of units tested) is not detailed.
- Biocompatibility: Tests were performed on the predicate device. The subject device was then evaluated against these predicate test results. No specific sample size for the predicate testing is provided within this document.
- Software Verification and Validation: Software tests were conducted. The specific number of test cases or test runs is not detailed.
- Cleaning and Sterilization Validation: Validation was performed using two cycles.
Data Provenance: The tests are described as non-clinical and conducted by Medtech/Zimmer Biomet, implying internal lab testing. No country of origin for test data or retrospective/prospective status is relevant in this non-clinical context.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the studies are entirely non-clinical performance tests measuring device specifications against engineering and regulatory standards, not against "ground truth" established by clinical experts.
4. Adjudication Method for the Test Set
This is not applicable as there is no human-in-the-loop assessment or expert review for establishing ground truth in these non-clinical performance tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The submission 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."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The device itself is a robotized image-guided surgical device that assists the surgeon. While its performance (e.g., accuracy) is measured independently in non-clinical settings ("robot arm positioning accuracy," "device applicative accuracy"), these are measures of its mechanical and computational precision, not of a standalone diagnostic algorithm's performance. Therefore, a standalone "algorithm only without human-in-the-loop performance" study in the typical AI/diagnostic sense was not performed because it's an assistive surgical device, not a diagnostic algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context refers to established engineering specifications and compliance with recognized standards.
- System Applicative Accuracy: Ground truth is defined by the target accuracy specifications (e.g., < 0.75 mm RMS for robot arm positioning, < 2mm for device applicative accuracy).
- Electrical Safety & EMC: Ground truth is compliance with international standards (IEC 60601-1, IEC 60601-1-2) and FDA guidance.
- Biocompatibility: Ground truth is compliance with ISO 10993-1.
- Software Verification and Validation: Ground truth is compliance with FDA Guidance for software and IEC 62304 standard.
- Cleaning and Sterilization Validation: Ground truth is compliance with FDA Guidance and standards ISO 17665-1, ISO 17664, and AAMI TIR 12.
8. The Sample Size for the Training Set
This information is not applicable. The ROSA ONE Spine application is a robotized surgical assistance device, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its "intelligence" comes from programmed algorithms and controls, validated through engineering means, not trained on large datasets.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as above. The device doesn't use a "training set."
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(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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