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510(k) Data Aggregation
(183 days)
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.
| Performance Metric | "Acceptance Criteria" (Implicit/Target) | Reported Device Performance (Clinical Use Data) |
|---|---|---|
| Accuracy of alignment to trajectory (Entry Point view) | Sufficient for safe and effective interventional procedures using CT/fluoroscopic imaging | 0.43 ± 0.5 mm (average accuracy) |
| Angular deviation of needle | Sufficient for safe and effective interventional procedures using CT/fluoroscopic imaging | 0.79 ± 0.41 degrees (average angular deviation) |
| 95% Confidence Interval (CI) accuracy (position) | Not explicitly stated but expected to be within clinically acceptable limits (e.g., typically a few mm for image-guided procedures) | 0.00 mm to 1.14 mm |
| 95% Confidence Interval (CI) accuracy (angle) | Not explicitly stated but expected to be within clinically acceptable limits (e.g., typically a few degrees) | 0.25 degrees to 1.70 degrees |
| Mechanical accuracy of system (standalone) |
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