(183 days)
Minimally Invasive Prostate Surgery Navigation System (Model: AmaKris SR1-A-1) is intended for use by the trained physician or urologist to perform the computer-assisted procedures through transperineal skin under realtime transrectal ultrasound guidance. It provides the capability to register and fuse with MRI medical images in DICOM format. It provides real-time 3D visualization for prostate, biopsy needle, and probe. It also provides the ability to display an image coordinates and guidewire that means the projected future path of the biopsy needle. Other software feature include patient data management, prostate and tumor modeling, 3D image registration.
Minimally Invasive Prostate Surgery Navigation System (Model: AmaKris SR1-A-1) is intended for treatment planning and guidance for prostate surgical procedures in a clinical setting.
To help physician or urologist to perform needling procedures on prostate, AmaKris SR1-A-1 serves as a needle guide, which enables the needling procedures safer, faster and more precision with lesser side effects such as infection and internal hemorrhage.
AmaKris SR1-A-1 is a computer-assisted medical device to assist the surgeon perform targeted transperineal prostate biopsy in conjunction with the guidance of transrectal ultrasound. The device serves as a needle quide only. Different from the conventional hand-held probe quidance and operator-dependent manual biopsy targeting, AmaKris SR1-A-1 is a platform-hosted motorized device integrating a probe-driving system for 3D image collection and a precise biopsy quidance mechanism (biopsy needle platform) to control the orientation of needle insertion and depth of puncture. This system is intended to be used with adult patients.
The device has a graphics user interface (GUI) that can provide a complete view of the 3D prostate to the physicians. The system allows users to draw contour curves of the organ/tumor referring to the transversal images, then the software performs contour fitting and generates the 3D model, based on which the prostate volume is calculated, and the systematic biopsy plan is made. This plan can be customized and the approved plan will be used to control the biopsy needle platform to guide the needle positioning for the manual puncture.
The device is intended for use by a trained urologist or physician to perform the computerassisted transperineal prostate biopsy under transrectal ultrasound guidance. It shall be used in conjunction with a third-party ultrasound machine and endorectal probe that supports type-B ultrasound, and a third-party prostate biopsy gun and needle. The device services as a biopsy needle guide only. The insertion of biopsy needle will be done by the urologist.
AmaKris SR1-A-1 is composed of two modules: Navigation Manipulator and Intelligent Surgical Console.
Here's an analysis of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided text:
Minimally Invasive Prostate Surgery Navigation System (Model: AmaKris SR1-A-1)
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Table of Acceptance Criteria and Reported Device Performance:
Acceptance Criteria Reported Device Performance Positioning accuracy within 1.0 mm radius (biopsy specification) Mean overall positioning accuracy: 0.404 mm (mean total variance 0.2243) Navigation system able to navigate biopsy needles to targets within a defined boundary (Egg Phantom Test) All punctures on eight random target points for three cycles placed inside the egg boundary. Biopsy needle tip to metal needle tip distance (navigation accuracy) satisfactory Mean distance: 0.435 mm (mean variance 0.1903) for 80 punctures Model fusion accuracy satisfactory Mean distance: 1.2801 mm (mean variance 0.92556) for 4 cases -
Sample Size Used for the Test Set and Data Provenance:
- Positioning Accuracy & Precision (Needle Pen Test):
- Sample Size: 325 sample points tested.
- Provenance: This appears to be a laboratory phantom test setup rather than clinical data from patients. The description refers to a "needle pen" and a "target sheet."
- Egg Phantom Test:
- Sample Size: The number of eggs used is not explicitly stated, but it mentions "three cycles" of testing on "eight random target points" per egg.
- Provenance: Laboratory phantom test using a shelled hard-boiled pigeon egg.
- Metal Needle Phantom Test:
- Sample Size: 16 metal needles, with "80 punctures" (likely 5 repetitions per needle).
- Provenance: Laboratory phantom test using a gelatin phantom box with metal needles.
- Model Fusion Accuracy & Precision:
- Sample Size: 4 cases.
- Provenance: The exact source of these "cases" (whether phantom or real images) is not explicitly detailed, but it refers to "MRI model and ultrasound model," suggesting image data.
- Positioning Accuracy & Precision (Needle Pen Test):
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Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- The document describes phantom tests and the determination of physical measurements (e.g., actual needle tip location, distances) as ground truth.
- For the egg phantom test, it mentions that the software's definition of the 3D model was verified, and "clinical safety requirements defined by the urologists" were considered. However, explicit details about the number or qualifications of these urologists for establishing ground truth for the test set itself (i.e., verifying the phantom's properties or the placement of ground truth markers) are not provided. The ground truth for these tests primarily comes from physical measurement and the known experimental setup.
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Adjudication Method for the Test Set:
- There is no mention of an adjudication method (like 2+1 or 3+1) for establishing ground truth in these performance tests. The ground truth is established through the physical setup of the phantom models and direct measurement, rather than human interpretation needing adjudication.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study is mentioned. The studies described are focused on the standalone performance of the device in phantom tests. The device is a "Minimally Invasive Prostate Surgery Navigation System" intended for human use (physician/urologist) and acts as a "needle guide." While it assists the human, the performance data provided is for the system's accuracy and precision in a controlled phantom environment, not for measuring how much human readers improve with AI assistance.
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Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes, the performance tests documented (Positioning Accuracy, Egg Phantom, Metal Needle Phantom, Model Fusion Accuracy) describe the standalone performance of the device's navigation and image processing capabilities in controlled, laboratory settings. These tests evaluate the system's ability to accurately guide a needle or fuse images based on its internal algorithms and mechanics, without direct human intervention in the measurement of its accuracy. The human operator is involved in setting up the system and initiating the navigation, but the performance metrics are objective measurements of the system's output.
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Type of Ground Truth Used:
- The ground truth predominantly used is physical measurement and known experimental setup parameters.
- For the positioning accuracy test, the target circles on a template served as ground truth.
- For the egg phantom test, the boundary of the egg (as delineated by the software and verified implicitly by clinical safety needs) and the physical placement inside it served as ground truth.
- For the metal needle phantom test, the physical tips of the embedded metal needles served as ground truth, measured against the biopsy needle tip placement.
- For model fusion accuracy, the O-points and intersection points on MRI/ultrasound models (likely defined within the software based on input data) served as ground truth for distance measurements.
- The ground truth predominantly used is physical measurement and known experimental setup parameters.
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Sample Size for the Training Set:
- The document does not provide any information regarding the sample size used for the training set.
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How the Ground Truth for the Training Set Was Established:
- The document does not provide any information regarding how the ground truth for the training set was established, as details about a training set are absent.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).