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The Micromate™ Navi+ device is a user-controlled electromechanical arm with a needle guide. It is intended to assist the user in the positioning of 8-19 gauge needles in the chest, abdomen and musculoskeletal structures when computed tomography (CT) optical navigation can be used for target trajectory planning and intra-operative tracking. The needle is then manually advanced by the user. Trajectory planning is made with software that is a part of the Micromate™ Navi+ device.

The Micromate™ Navi+ system allows the percutaneous execution of a surgical intervention by providing instrument guidance according to one or more pre-operative plans defined by an internal planning and navigation software (MicroNav). 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 optical CT navigation (tracked by camera). After alignment, the advancement of surgical instruments and delivery of therapy is performed manually by the user, while the position is retained by the targeting platform of Micromate™ Navi+, relying on the displayed navigation information or real-time images from third party imaging device.

The Micromate Navi+ device is intended for biopsy and percutaneous tumor ablation procedures, in the abdomen, thorax and musculoskeletal tissue.

The Micromate™ Navi+ 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, device that allows the automatic or manual control of the Targeting Platform movement and can communicate with an internal planning and navigation station,
• Positioning Arm, a multi-functional arm that is used to gross-position the Targeting Platform in such a way the traiectory 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 internal planning and navigation station for input of real-time navigation data,
• Connecting Cables.

and following Accessories:

• Sterile Drapes for the Control Unit and Targeting Platform,
• Needle guides for instrument guidance, packaged together with a drape for the sterile covering of the Targeting Platform,
• Sterile Tracker, to which off-the-shelf mounting spheres can be attached, to enable optical tracking for the localization of the Targeting Platform in space,
• A trolley for transport and storage,
• Medical grade PC,
• Camera tracking system,
• Planning and navigation software (MicroNav).

The provided text describes the 510(k) premarket notification for the Micromate™ Navi+ device, which is a user-controlled electromechanical arm with a needle guide intended to assist in positioning 8-19 gauge needles in the chest, abdomen, and musculoskeletal structures under CT optical navigation.

Here's a breakdown of the acceptance criteria and the study proving the device meets those criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a numbered or bulleted list with specific numerical thresholds for clinical performance. However, it details the performance achieved which, implicitly, must have met internal or regulatory acceptance thresholds for substantial equivalence. The key performance metrics reported are accuracy measurements.

The document states: "The overall scope of accuracy testing supported, with high statistical confidence, a positive conclusion on the safe and effective use of the device in a clinical setting." This suggests that the reported accuracy values and the low needle readjustment rate were deemed acceptable by the manufacturer and, subsequently, by the FDA for substantial equivalence.

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • Clinical Guidance Accuracy: 54 interventions (19 abdominal lesions, 19 thoracic lesions, and 16 musculoskeletal lesions). This constitutes the number of procedures in which performance data was collected.
  • Bench Test Accuracy: The sample size for the bench test is not explicitly stated in terms of number of measurements, but it refers to the validation per ASTM F2554-18.
• Data Provenance: The text does not specify the country of origin for the clinical study data or whether it was retrospective or prospective. It only mentions the manufacturer's location as Austria. It states "data gathered in simulated clinical environment" for pre-clinical performance data and then discusses "clinical guidance accuracy," implying a clinical study for that part.

3. Number of Experts and Qualifications for Ground Truth

The document does not provide information on the number of experts used to establish ground truth for the test set or their specific qualifications (e.g., "radiologist with 10 years of experience"). For the clinical guidance accuracy, it would implicitly be the outcome of surgical procedures, likely assessed post-procedure by imaging or surgical confirmation.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for the test set. Ground truth appears to be based on the outcome of the interventional procedures as measured by CT imaging after needle placement.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was conducted. The study focuses on the device's accuracy in assisting human users, not on comparing outcomes of human readers with vs. without AI assistance in interpretation. The device is a navigation system for needle placement, not primarily an AI for image interpretation.

6. Standalone (Algorithm Only) Performance

The device is described as a "user-controlled electromechanical arm." Its "planning and navigation software (MicroNav)" is an integral part of the device assisting the user. The study focuses on the device's accuracy in assisting the user in needle placement. Therefore, a standalone (algorithm only without human-in-the-loop) performance study, in the sense of an AI interpreting images, is not applicable or described in this context. The "bench-test accuracy" could be considered a form of standalone performance for the mechanical/software system, independent of a live clinical user's influence beyond initial setup.

7. Type of Ground Truth Used

The ground truth for accuracy validation appears to be based on objective measurement of the actual needle position relative to the planned trajectory using imaging (CT) after the procedure. This is inferred from "lateral deviation" and "angular deviation" measurements in both "simulated use environment" (bench-test) and "clinical guidance accuracy." It is not explicitly stated to be "expert consensus" or "pathology outcomes data" in the traditional sense of diagnostic AI.

8. Sample Size for the Training Set

The document does not specify the sample size used for the training set for the planning and navigation software (MicroNav). This information is typically not included in a 510(k) summary relating to substantial equivalence unless significant changes in software algorithms or AI training are explicitly being reviewed.

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

The document does not specify how the ground truth for the training set of the MicroNav software was established. Given the nature of a medical device 510(k) submission, the focus is on verification and validation (V&V) of the final product, rather than the developmental steps like training data ground truth establishment, unless it directly impacts the safety and effectiveness of the device in a novel way. However, software verification and validation testing are mentioned, performed in accordance with FDA Guidance and IEC 62304.

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