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Artemis along with the Needle Guide Attachment is used for image-guided interventional and diagnostic procedures of the prostate gland. It provides 2D and 3D visualization of Ultrasound (US) images and the ability to fuse and register these images with those from other imaging modalities such as Ultrasound, Magnetic Resonance, Computed Tomography, etc. It also provides the ability to display a simulated image of a tracked insertion tool such as a biopsy needle, guidewire or probe on a computer monitor screen that shows images of the target organ and the projected future path of the interventional instrument taking into account patient movement. The software also provides a virtual grid on the live ultrasound for performing systematic sampling of the target organ. Other software features include patient data management, multi-planar reconstruction, segmentation, image measurements, 2D/3D image registration, reporting, and pathology management.

Artemis is intended for treatment planning and guidance for clinical, interventional and/or diagnostic procedures. The device is intended to be used in interventional and diagnostic procedures in a clinical setting. Example procedures include, but are not limited to image fusion for diagnostic clinical examinations and procedures, soft tissue ablations and placement of fiducial markers. Artemis is also intended to be used for patients in active surveillance to keep track of previous procedures information and outcomes.

Artemis Cryo Treatment Planning module is an add on to the existing Artemis software that allows physicians to prepare for cryo treatment planning based on positive pathology cores obtained during Artemis guided biopsies and registration results with other imaging modalities such as MRI, CT. The module allows accurate placement of cryo probes on targets, 3D tracking, real-time feedback on extend of cryo ice formation. The technology provided by Artemis generates ice models based on the specifications provided by the cryo device manufacturers and displays the models on the live ultrasound to provide guidance to the users during the procedure.

The module also allows outlining or segmenting other organs that surround the prostate. Organs include bladder and urethra.

Artemis is designed to display the 2-D live video received from commercially available ultrasound machines and use this 2-D video to reconstruct a 3-D ultrasound image. The system has been designed to work with the clinicians' existing ultrasound machine, probe, commercially available biopsy needle guide, needle gun combination, and cryoablation systems. Additional software features include patient data management, multi-planar reconstruction, segmentation, image measurement, reporting and 3-D image registration.

Artemis is comprised of a mechanical assembly that holds the ultrasound probe and tracks probe position. The mechanical tracker is connected to a PC-based workstation containing a video digitizing card and running the image processing software. Control of the ultrasound probe and ultrasound system is done manually by the physician, just as it would be in the absence of Artemis. However, by tracking the position and orientation of the ultrasound probe while capturing the video image, the workstation is able to reconstruct and display a 3-D image and 3-D rendered surface model of the prostate.

The reconstructed 3-D image can be further processed to perform various measurements including volume estimation, which can be examined for abnormalities by a physician. Patient information, notes, and images may be stored for future retrieval, and locations for biopsies may be selected by the physician. The system also allows previously acquired 3-D models to be recalled, aligned, or registered to the current 3-D model of the prostate, which is especially useful for patients under active surveillance.

The physician may attach a commercially available biopsy needle guide compatible to the ultrasound probe and use the probe and needle to perform tissue biopsy and or cryoablation. Whenever the ultrasound machine is turned on by the physician, the live 2-D ultrasound image is displayed on the screen of Artemis during the procedure. As the ultrasound probe with attached needle guide is maneuvered by the physician, the position and orientation of the probe with respect to the organ is tracked. Artemis is able to add, display and edit loaded plans for the procedure as well as provide the probe position and needle trajectory relative to the 3-D image and 3-D rendered surface model of the prostate.

In addition to standard transrectal needle guidance procedures, Artemis also supports transperineal needle guidance by mounting a Needle Guide Attachment (NGA). A commercially available needle guide compatible with the NGA is used. This NGA will be used for both biopsy and cryo needles. The NGA provides additional data to track the needle direction angle. When using transperineal mode, the procedure planning, segmentation, registration and navigation are performed in the same way as the standard transrectal procedure. The only difference lies in how the needle guide needs to be moved to target the different planned locations. For the transrectal procedure, the needle guide is always attached to the probe. Therefore moving the probe moves the needle guide. In transperineal needle guidance procedures the needle is not attached to the probe. Therefore the NGA needs to be moved to move the needle guide. Artemis highlights the closed target to the current needle guide position.

Artemis offers the physician additional 3-D information for assessing prostate abnormalities, planning and implementing biopsy procedures. The additional image processing features are generated with minimal changes to previous Ultrasound probe based procedures, and the physician always has access to the live 2-D ultrasound image during prostate assessment or biopsy procedure. The device also provides automated reports with information and pictures from the procedure.

The provided text describes the acceptance criteria and the study proving the device meets these criteria for the Artemis medical imaging system.

Here's a breakdown of the requested information based on the text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of predetermined acceptance criteria with corresponding performance results. Instead, it broadly states that "Nonclinical and performance testing results are provided in the 510(k) and demonstrate that the predetermined acceptance criteria are met." It mentions that "Measurement validation using, phantoms, clinical CT, and MRI images were used to show that Artemis performs as well as or better than the predicate devices and furthermore shows that Artemis was safe and effective."

Below is a table summarizing the types of tests and the overall conclusion regarding acceptance, as the specific numerical criteria and results are not detailed in this public summary.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify the exact sample size (number of phantoms or clinical images) used for the measurement validation or other performance tests. It states "Measurement validation using, phantoms, clinical CT, and MRI images were used."
• Data Provenance: The provenance (e.g., country of origin, retrospective or prospective) of the clinical CT and MRI images used for measurement validation is not specified in the provided text. The testing appears to be non-clinical and performed at the manufacturer's facility ("at the manufacturer's facility and has passed all in-house testing criteria").

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number of experts used to establish ground truth or their qualifications. The testing described is "nonclinical and performance testing" and "measurement validation," suggesting a focus on technical accuracy rather than human interpretation studies.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method for establishing ground truth, such as 2+1 or 3+1.

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

There is no mention of an MRMC comparative effectiveness study being performed, nor any effect size regarding how human readers might improve with AI vs. without AI assistance. The study described focuses on the device's technical performance and comparison to predicate devices, not on human-in-the-loop performance.

6. Standalone (Algorithm Only) Performance

The testing primarily focuses on the device's technical performance, including "measurement validation." This strongly implies that a standalone (algorithm only) performance evaluation was conducted to ensure the device's core functionalities, such as image reconstruction, segmentation, registration, and ice model generation, meet design specifications independently. The statement "Artemis has been assessed and tested at the manufacturer's facility and has passed all in-house testing criteria including validating design, function and specifications" supports this. Specific performance metrics (e.g., accuracy, precision) for these standalone functions are not provided, only a general statement of meeting acceptance criteria.

7. Type of Ground Truth Used

The type of ground truth used for performance validation included:

• Phantoms: For measurement validation.
• Clinical CT images: For measurement validation.
• Clinical MRI images: For measurement validation.

The basis for the "ground truth" on these phantoms and clinical images (e.g., known measurements for phantoms, expertly annotated features on clinical images) is implied but not explicitly detailed.

8. Sample Size for the Training Set

The document does not provide information regarding the sample size used for any potential training set. The descriptions of "nonclinical and performance testing" and "measurement validation" focus on evaluation (test set) rather than model training. It's possible that a training set was used for specific software features involving image processing or reconstruction, but this is not mentioned.

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

As no information about a training set is provided, there is also no information on how its ground truth might have been established.

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