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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 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

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Axilum Robotics TMS-Cobot TS MV is a computer controlled electromechanical arm indicated for spatial positioning and orientation of the treatment coil of the MagVita TMS Therapy System.

Axilum Robotics TMS-Cobot TS MV is a computer controlled electromechanical arm based on collaborative robotics technology, providing guidance for the positioning and orientation of a Transcranial Magnetic Stimulation (TMS) coil - connected to its stimulator - under the supervision of an optical tracking system. Axilum Robotics TMS-Cobot TS MV comprises the electromechanical collaborative arm on its cart, its optical tracking system, with its software, 3D camera and a coil adaption kits with its mechanical adaptor, to fix the coil on the robotic arm, as well as a contact sensor. The device is intended to be used in combination with the TMS stimulator, treatment coil and treatment chair from the previously-cleared MagVenture MagVita system.

The provided text describes the acceptance criteria and the study performed for the Axilum Robotics TMS-Cobot TS MV device. However, it does not include details regarding a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it provide specific quantitative results for accuracy, repeatability, or a breakdown of the ground truth establishment process for the test set in the way a typical AI/ML medical device submission might.

The document indicates that the device is a computer-controlled electromechanical arm that assists in positioning a TMS coil, suggesting its role is primarily mechanical assistance rather than an AI/ML algorithm performing independent diagnostic or treatment decisions. Therefore, the "study that proves the device meets the acceptance criteria" focuses on functional performance, safety, and compatibility with a predicate device, rather than the kind of AI/ML performance metrics (e.g., sensitivity, specificity, AUC) typically evaluated for diagnostic AI systems.

Based on the provided text, here's an attempt to extract the information you requested, noting where information is not explicitly available in the document:

Acceptance Criteria and Device Performance for Axilum Robotics TMS-Cobot TS MV

The Axilum Robotics TMS-Cobot TS MV is an electromechanical arm designed to assist in the spatial positioning and orientation of a Transcranial Magnetic Stimulation (TMS) coil. The performance evaluation focuses on safety, functional operation, and compatibility as an accessory to an existing TMS system (MagVita TMS Therapy System).

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size (e.g., number of subjects, cases, or specific test runs) used for the functional and compatibility tests. It reports that "nonclinical testing" was completed, which typically refers to lab-based testing rather than clinical trials with human subjects for this type of accessory device.

• Test Set Sample Size: Not explicitly stated in the provided text.
• Data Provenance: The testing appears to be nonclinical (lab-based) as opposed to a clinical study with patient data. Therefore, details like country of origin or retrospective/prospective nature are not applicable in the context of patient data, but rather pertain to the testing environment.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This type of information (experts establishing ground truth) is typically relevant for AI/ML diagnostic devices where human expert annotations or diagnoses serve as reference standards. For this device, which is an electromechanical arm for positioning, "ground truth" would relate to precise mechanical measurements and functional performance rather than clinical diagnoses.

• Experts: Not explicitly stated or applicable in the traditional sense of clinical ground truth establishment for a diagnostic device. The performance validation relies on engineering measurements and functional verification against specifications and safety standards.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

As the "test set" pertains to nonclinical functional and safety testing of an electromechanical device, an "adjudication method" in the clinical imaging sense (e.g., 2+1, 3+1 consensus) is not applicable. Performance is likely adjudicated by meeting predefined engineering specifications and safety thresholds.

• Adjudication Method: Not applicable in the context of clinical ground truth. Performance is presumably evaluated against documented engineering specifications and regulatory standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No. The provided text does not describe an MRMC comparative effectiveness study involving human readers or AI assistance. This type of study is more common for AI systems that aid in image interpretation or diagnosis. The TMS-Cobot TS MV is a robotic positioning device.

• MRMC Study: No, not mentioned.
• Effect Size of Human Reader Improvement: Not applicable, as no MRMC study was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

The device is an electromechanical arm that is "computer controlled" and provides "guidance for the positioning and orientation" of a TMS coil "under the supervision of an optical tracking system." It also mentions "Robot-automated" head motion compensation and a "Human pilot through the free-drive mode." This indicates it's an accessory that operates in conjunction with a human operator and other system components (MagVita TMS Therapy System). It is not a standalone AI algorithm providing a diagnostic output without human intervention.

• Standalone Performance: The device is presented as an accessory with human supervision and interaction; therefore, a pure "algorithm only" standalone performance evaluation in the context of diagnostics is not applicable. Its performance is integrated with the larger MagVita TMS Therapy System and human oversight.

7. The Type of Ground Truth Used

The "ground truth" is based on established engineering principles, safety standards, and functional specifications for robotic and medical devices. This includes:

• Engineering Specifications: For accuracy, repeatability, range of motion, collision detection, and performance of free-drive mode.
• Safety Standards: Compliance with AAMI, IEC, and EN standards for electrical safety, electromagnetic compatibility, and software validation.
• Usability Standards: Compliance with IEC 62366 and FDA guidance for human factors.
• Compatibility Verification: Ensuring safe and effective operation with the MagVita TMS Therapy System components.

It is not based on expert clinical consensus (e.g., for diagnosis), pathology, or direct patient outcomes data in the way a diagnostic AI would be evaluated.

8. The Sample Size for the Training Set

This device is an electromechanical robot. The concept of a "training set" typically applies to machine learning algorithms where data is used to train a model. While the device utilizes "computer controlled" and "collaborative robotics technology," it's not explicitly described as an adaptive AI/ML system that undergoes a data-driven training phase in the traditional sense for medical imaging AI. Its "training" would be more akin to software development, calibration, and engineering design.

• Training Set Sample Size: Not applicable or not specified in the context of a machine learning training dataset.

9. How the Ground Truth for the Training Set Was Established

As the concept of a training set for an AI/ML model is not explicitly defined for this device, the establishment of "ground truth" for it is not applicable in the way it would be for a data-driven AI. Instead, the design and validation are based on engineering specifications, physical models, and control algorithms.

• Ground Truth for Training Set: Not applicable in the context of a typical AI/ML training dataset.

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The ROSA® Knee System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon in providing software-defined spatial boundaries for orientation to identifiable anatomical structures for the accurate placement of knee implant components.

The robotic arm placement is performed relative to anatomical landmarks as recorded using the system intraoperatively, and based on a surgical plan, optionally determined pre-operatively using compatible X-ray or MRI based surgical planning tools.

It includes a robotic arm, an optical sensor navigation system and accessories, software system, surgical instruments and accessories.

The targeted population has the same characteristics as the population that is suitable for the implants compatible with the ROSA® Knee System. The ROSA® Knee System is to be used with the following fixed bearing knee replacement systems in accordance with their indications and contraindications:

NexGen® CR, NexGen CR-Flex, NexGen CR-Flex Gender, NexGen LPS, NexGen LPS-Flex, NexGen LPS-Flex Gender, Persona® CR, Persona PS, Vanguard® CR, and Vanguard PS.

The ROSA® Knee System is used to assist surgeons in performing Total Knee Arthroplasty (TKA) with features to assist with the bone resections as well as assessing the state of the soft tissues to facilitate implant positioning intra-operatively. The ROSA® Knee System uses a Medical Device Data System (MDDS) called the Zimmer Biomet Drive Portal which manages the creation and tracking of surgical cases. The cases reside on the portal until it is uploaded to the ROSA® Knee System before surgeries.

If the case is image-based, a 3D virtual bone model is generated pre-operatively by the PSI systems (X-PSI Knee System or CAS PSI Knee System) to create a model of the patient's femur/tibia and allows for the preparation of a pre-operative surgical plan as well as visualization of planned cuts. The pre-operative plan is then matched to the landmarks taken intra-operatively on the patient's bony anatomy. An imageless option is also available where landmarks taken intra-operatively on the patient's bony anatomy are used to create the surgical plan directly in the surgery. Accuracy of resections, knee state evaluation, and soft tissue assessment are the same between image-based and imageless options as they are always based on intra-operative landmarks.

The intra-operative workflow and surgical concepts implemented in the system remain close to the conventional TKA workflow. As such, at the time of the surgery , the system mainly assists the surgeon in (1) determining reference alignment axes in relation to anatomical landmarks, (2) planning the orthopedic implants location based on these reference alignment axes and orthopedic implant geometry (planning optionally based on a pre-operative plan using pre-operative imaging),, and (3) precisely positioning the cut guide relative to the planned orthopedic implant location by using a robotic arm.

It includes a robotic arm, an optical sensor navigation system and accessories, software system, surgical instruments and accessories.

The provided text describes a 510(k) premarket notification for the ROSA® Knee System, a stereotaxic instrumentation system for total knee replacement (TKA) surgery. However, the document primarily focuses on demonstrating substantial equivalence to predicate devices and does NOT contain information regarding:

• Specific acceptance criteria with numerical targets.
• A "study" that directly proves the device meets these acceptance criteria in the format requested (e.g., performance metrics against specific targets). The document mentions "Verification and Validation Testing" and "Software Verification and Validation Testing" but does not detail the results against quantifiable acceptance criteria for device performance.
• Sample size for test sets or data provenance.
• Number of experts or their qualifications for ground truth establishment.
• Adjudication method.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
• Standalone (algorithm-only) performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document does mention:

• Biocompatibility testing: "The biocompatibility evaluation for ROSA Knee was conducted in accordance with ISO 10993. The evaluation reveals that the ROSA Knee device meets biocompatibility requirements." This implies an acceptance criterion of "meets biocompatibility requirements" and a study showing compliance with ISO 10993.
• Electrical Safety and Electromagnetic Compatibility (EMC): "The device complies with recognized electrical safety standards: IEC 60601-1 standard for electrical safety and IEC 60601-1-2 standard for electromagnetic compatibility." This implies an acceptance criterion of "compliance with IEC 60601-1 and IEC 60601-1-2" and a study demonstrating this compliance.
• Device Performance Testing: Mentions "Physical/Performance Tests," "Engineering Analysis," and "Validation Lab" on cadaveric specimens to "validate that using the ROSA Knee is safe and effective and that the performances of the ROSA Knee are acceptable." However, specific acceptance criteria and detailed performance results are not provided.
• Software Verification and Validation Testing: States that testing was conducted to satisfy FDA guidance and IEC 62304 for "major" level of concern software. It concludes that "The testing demonstrates that the ROSA Knee does not raise any new issues of safety and effectiveness as compared to the predicate device(s)." This implies acceptance criteria related to software safety and effectiveness, and the V&V testing serving as the study.

Conclusion:

Based on the provided text, it is not possible to fully complete the requested table and descriptions because the document, being a 510(k) summary, focuses on substantial equivalence and general statements of compliance rather than detailed performance study results against specific, quantifiable acceptance criteria.

Information that can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The remaining sections cannot be answered with the given text.

The document is a 510(k) summary, which generally provides a high-level overview of testing and conclusions for substantial equivalence rather than granular details of specific study designs, methodologies, and raw results for performance criteria.

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