(207 days)
PercuNav is a stereotaxic accessory for Computed Tomography (CT), Magnetic Resonance (MR), Ultrasound (US), Positron Emission Tomography (PET), Single Photon Emission Computed Tomography (SPECT), Rotational Fluoroscopy, Endoscopy, and other imaging systems. CT, Ultrasound, PET, MR, and Rotational Fluoroscopy may be fused in various combinations, such as CT with MR, MR with ultrasound, etc. It may include instrumentation to display the 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 organs and the current and the projected future path of the interventional instrument taking into account patient movement. This is intended for treatment planning and guidance for clinical, interventional, and/or diagnostic procedures. The device also supports an image-free mode in which the proximity of the interventional device is displayed relative to another device.
The device is intended to be used in interventional and diagnostic procedures in a clinical setting. The device is also intended for use in clinical interventions to determine the proximity of one device relative to another. Example procedures include, but are not limited to:
- Image fusion for diagnostic clinical examinations and procedures .
- Soft tissue biopsies (liver, lung, kidney, breast, pancreas, bladder, adrenal glands, lymph node, . mesentery, etc.)
- Soft tissue ablation (liver, kidney, breast, pancreas,, lung, etc.) .
- Bone ablation .
- Bone biopsies ●
- Nerve Blocks & Pain Management ●
- t Drainage placements
- Hydrodissections .
- Bladder Stimulation
- Fiducial placements .
- Tumor resections .
- Sinus procedures
- Intranasal procedures
- Transphenoidal procedures
The PercuNav image fusion and navigation feature for the iU22 Diagnostic Ultrasound System is supplied as an on-cart product that is packaged and installed much like a peripheral on the iU22 Diagnostic Ultrasound, similar to a third party VCR which can be placed on the ultrasound cart.
PercuNav computer assisted technology provides image guided intervention and diagnostic information which guides interventional instrumentation to targets that has been defined by the physician. The target can be indicated either pre-procedurally or intra-procedurally using images or relative to an indicated position on the patient. As a diagnostic system, it combines pre-procedural and intra-procedural imaging to assist in locating areas of interest detected on one set of images on the other. The system provides fusion between different modalities. Different imaging modalities such as CT, Ultrasound, PET, MR, and Rotational Fluoroscopy may be fused in various combinations, for example CT with MR. CT with Ultrasound, PET/CT with ultrasound, MR with ultrasound, etc.
When used as a navigation aid, it also transforms two and three-dimensional patient images (scan sets), derived from for example, Computed Tomography (CT), Magnetic Resonance Imaging (MR), Positron Emission Tomography (PET), Single Photon Emission Computed Tomography (SPECT), Ultrasound (US), Rotational Fluoroscopy, etc. into dynamic representations on which a medical instrument can be navigated. The system performs spatial mapping from one image space to another image space or from image space to physical space ("registration") allowing the physician to correlate scan sets with each other and to the patient. The system facilitates minimally invasive interventional procedures. Like other commercially available image guided surgery systems, the PercuNav also offers computer assisted image-free navigation using the same instrumentation. In image-free mode the proximity of an interventional device is displayed relative to another device.
Images used by the PercuNav can include archived image data from a CD, PACS, etc., and live images from an imaging device such as ultrasound, etc. The system can also be used without the use of image data (image-free mode) when appropriate for the procedure being performed.
The PercuNav system consists of an Electromagnetic Measurement System (EMMS) (including a Field Generator and System Control Unit), a System Unit, Field generator stand, PercuNav software, Tool Connection Unit (TCU), and various instrumentation devices. The PercuNav System Unit and the PercuNav software interact with the keyboard, touch-screens, trackball, and visual display of the iU22 Diagnostic Ultrasound System to display and interact with images and data on the system monitor(s).
Targeted use areas for PercuNav include hospital operating rooms, outpatient surgery centers, ultrasound, CT and other scanner suites, and procedure rooms.
The provided text describes the updated PercuNav system, an image fusion and navigation device, and its testing. However, it does not explicitly state quantitative acceptance criteria or provide specific numerical performance results for the device. Instead, it refers to "accuracy targets" being met through "Surgical Simulation Testing" using a metric called "Euclidian System Error" or "Target Registration Error" (TRE). The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance efficacy data against specific, pre-defined quantitative acceptance criteria.
Therefore, the following information is extracted and inferred:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| "Accuracy targets" based on "Euclidian System Error" (TRE) being met. | "System testing to date shows that all accuracy targets for the PercuNav system have been met and the system is safe and effective for its intended use." |
2. Sample size used for the test set and the data provenance
The document mentions "Surgical Simulation Testing" using a "phantom based simulation." It does not specify the sample size used for this test set (e.g., number of phantoms, number of trials).
The data provenance is from non-clinical performance data and bench testing conducted by Philips Healthcare in Toronto, Ontario, Canada (manufacturer location). It is prospective in the sense that these tests were performed to validate the updated device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number of experts or their qualifications used to establish ground truth for the surgical simulation testing. It mentions that TRE is estimated "for example from a CT confirmation scan," implying objective measurements are used for ground truth rather than expert consensus on subjective assessments.
4. Adjudication method for the test set
The document does not describe any human adjudication method for the test set. The ground truth for the "Euclidian System Error" (TRE) is an objective measurement based on deviations from a known position, potentially derived from imaging.
5. 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
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this submission. The device is a navigation aid for interventional procedures, and the testing focuses on its accuracy and functional performance rather than its impact on human reader effectiveness in diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance evaluation was conducted in the sense that the "Surgical Simulation Testing" assesses the accuracy of the PercuNav system (algorithm/device) by determining the "Euclidian System Error" (TRE). This test measures the device's accuracy in tracking and representing instrument location relative to a ground truth, independent of a human operator's performance during the simulated surgical procedure. The document states, "TRE is considered by most researchers as the most clinically relevant measure of error since it is a direct measure of the full system accuracy."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The type of ground truth used for the surgical simulation testing is an objective, measurable position from a "control measurement gauge" and potentially "CT confirmation scan." This ground truth represents the "real location" of a tracked device, allowing for the calculation of the "Target Registration Error" (TRE). It's essentially a physical or imaging-based measurement of the true position.
8. The sample size for the training set
The document does not provide information regarding a training set size. The submission focuses on verification and validation activities for an update to an existing device, primarily through bench testing and simulation, not on the development of a de novo machine learning algorithm that would typically require a training set. The descriptions of "PercuNav software" and "image fusion" suggest underlying algorithms, but details about their development or training data are not included.
9. How the ground truth for the training set was established
As no training set is mentioned, information on how its ground truth was established is not available in the provided text.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.