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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

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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