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The Micromate™ device is a user-controlled electromechanical arm with a needle guide. It is intended to assist the surgeon in the positioning of a needle or instrument where both computed tomography (CT) and fluoroscopic imaging can be used for target trajectory planning and intraoperative tracking. The needle or electrode is then manually advanced by the surgeon. Trajectory planning is made with software that is not part of the Micromate™ device

The Micromate™ system allows the percutaneous execution of a surgical intervention by providing instrument guidance according to one or more pre-operative plans defined in an external planning or navigation station. The alignment to the surgical plan is performed through a manual gross-positioning using a Positioning Arm, followed by automatic or joystick-controlled movement with image guidance, such as CT and fluoroscopic image. After alignment, the advancement of surgical instruments and delivery of therapy is performed manually by the surgeon, while the position is retained by the system and relying on the displayed navigation information or realtime images.

The system comprises the following main components:

• Targeting Platform, a robotic positioning unit that aligns to the surgical plan and holds the surgical instruments through an end-effector acting as a tool-guide adapter.
• Control Unit, a handheld device that allows the automatic or manual control of the Targeting Platform movement and can communicate with an external planning and navigation station.
• Positioning Arm, a multi-functional arm that is used to gross-position the Targeting Platform in such a way the trajectory is reachable.
• Strain Relief Box, which distributes power and data through the Micromate™ system.
• Power and Network Unit, which connects the system to power and allows an optional direct point-to-point connection to an external planning and navigation station for input of real-time navigation data.
• Sterile Drapes for the Control Unit and Targeting Platform (this one containing also needle guides) for instrument guidance.
• Connecting Cables
• A cart for transport and storage.

The system can be mounted to different bed/table through specific adapter accessories and all components are covered with a sterile drape during use. Third-party needle or tool guides are connected to the Targeting Platform end-effector through a customized mechanical interface that preserves the sterile barrier.

Micromate™ is not patient contacting.

The provided document describes a medical device, the Micromate™, and its substantial equivalence to predicate devices, primarily the iSYS1. It does not contain a detailed study proving the device meets specific acceptance criteria in the way one might expect for a new AI/ML-driven diagnostic device undergoing performance evaluation.

Instead, the document focuses on demonstrating substantial equivalence to a previously cleared device (iSYS1) based on similar technological characteristics and performance data. The "performance data" section states the measured accuracy of the Micromate™ in clinical use, which serves as evidence of its performance, but it doesn't explicitly link these measurements to predefined acceptance criteria in a tabular format as requested.

However, I can extract the reported performance data from the document and present it as if it were the outcome of a study aimed at demonstrating performance.

Here's an analysis based on the provided text, addressing the points you requested to the best of my abilitygiven the lack of specific "acceptance criteria" and a formal "study" in the AI/ML sense.

Device: Micromate™ (Medical Robotic Positioning Unit)

Purpose of the "Study" (Performance Data Section): To demonstrate the clinical accuracy of the Micromate™ device in assisting needle/instrument positioning, supporting its substantial equivalence claim.

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria that the device had to meet to be cleared. Instead, it provides reported clinical performance data. For the purpose of this exercise, I will present the reported performance as if these were the metrics assessed in a "study" to support the device's capability.

Note on "Acceptance Criteria": The document implies that the device's performance needs to be comparable to existing, legally marketed devices (predicates) and sufficient for its indicated use. The actual numerical targets for "acceptance" are not explicitly defined in this summary but are inferred from the context of clinical applicability. The listed performance metrics are the results used to demonstrate the device's capabilities.

Study Details:

1. Sample Size used for the test set and data provenance:

   • Test Set Size: Not explicitly stated. The document mentions "actual clinical data" was used to calculate the 95% CI, but the number of cases or patients yielding this data is not provided.
   • Data Provenance: "Actual clinical data." The document does not specify the country of origin or whether the data was retrospective or prospective. Given the manufacturer (iSYS Medizintechnik GmbH in Austria) and the predicate device, it's plausible the data originates from a European clinical setting, but this is not confirmed.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This document describes a robotic positioning system rather than a diagnostic AI algorithm requiring expert ground truth for interpretation (e.g., lesion detection). The "accuracy" metrics are physical measurements of the device's alignment and positioning capabilities relative to a planned trajectory.
   • Therefore, the concept of "experts establishing ground truth" for image annotations or clinical diagnoses does not directly apply here. The "ground truth" for trajectory alignment would be the planned trajectory itself, and the measurement would be the deviation from that plan, verified by imaging after positioning. No specific mention of expert review of the clinical accuracy measurements is given, but it is implied that clinical use data was collected and analyzed.

3. Adjudication method for the test set:

   • Not applicable in the context of this device's performance evaluation. The accuracy is a direct physical measurement of alignment against a pre-defined plan observed through imaging, not a subjective interpretation requiring adjudication.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. This is a robotic positioning device, not an AI diagnostic algorithm for image interpretation. Therefore, an MRMC study assessing human reader improvement with AI assistance is not relevant or described. The human operator (physician) uses the device to achieve the planned trajectory, but the "accuracy" refers to the device's mechanical and alignment precision.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Yes, a form of standalone testing was performed for the device's mechanical accuracy. The document states: "The mechanical accuracy of the Micromate™ system itself is below 1 mm (relative mechanical accuracy 0.03 mm and absolute mechanical accuracy 0.2 mm), as measured by commanding the Targeting Platform to a predetermined location in air." This represents a "standalone" evaluation of the robot's physical precision, independent of patient interaction or a full surgical workflow.
   • The primary clinical performance data, however, ("actual clinical data") implicitly involves a human-in-the-loop (the surgeon manually advancing the instrument).

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for the performance evaluation appears to be the pre-operative surgical plan (defined using external planning software based on CT/fluoroscopic imaging) and the actual physical position/orientation of the needle guide as measured relative to this plan, under real-time imaging during clinical use.
   • The "mechanical accuracy" ground truth is a predetermined physical location in air that the robot is commanded to, and its deviation from this physical target is measured.

7. The sample size for the training set:

   • Not applicable. This document describes a medical robotic device, not an AI/ML algorithm that undergoes "training" on a dataset in the conventional sense. The device's operation is based on electromechanical principles and software control, not deep learning or statistical model training.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no "training set" in the AI/ML context for this device. The device's functionality is developed through engineering design, calibration, and verification/validation testing against design specifications and international standards, rather than data-driven machine learning.

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