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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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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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