(112 days)
The Pde-neo is an imaging system used in capturing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used during plastic, micro-, reconstructive, and organ transplant surgeries.
The pde-neo is an imaging system used in capturing and viewing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used during plastic, micro-, reconstructive, and organ transplant surgeries. The pde-neo is intended for intraoperative visual assessment of blood vessels and related tissue perfusion by enabling surgeons to observe fluorescent images of blood vessels and related tissue perfusion. Indocyanine green (ICG) is injected intravenously into patients. Infrared light-emitting diodes (LEDs) are used to excite the fluorescence of ICG and illuminate the regions of a patient's anatomy to be observed. A charge coupled device (CCD) camera captures the fluorescent image that is used to assess the blood vessels and related tissue perfusion.
The pde-neo consists of the following components: Camera Unit, Controller, and Remote Controller. The Camera Unit contains a CCD camera and LED light sources and is used either by hand or attaching it to a mechanical arm. The Controller receives the video signal of the fluorescent image from the Camera Unit and outputs the processed fluorescent image to the external video monitor and recorder. Adjustments of the fluorescent image are possible either by the Camera Unit or the Remote Controller.
This document describes the 510(k) summary for the pde-neo, a fluorescent angiographic system.
1. Table of acceptance criteria and the reported device performance:
The document does not explicitly state quantitative acceptance criteria in terms of performance metrics (like sensitivity, specificity, accuracy). Instead, the performance evaluations focus on functional aspects, safety, and image quality comparison to a predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conformance to IEC 60601-1-2 (Electromagnetic Compatibility) | Successfully completed. |
| Conformance to IEC 60601-1 (General Requirements for Safety) | Successfully completed. |
| Conformance to IEC 60825-1 (Safety for laser products) | Successfully completed. |
| Functional testing of camera lens (focus rotation) | Successfully completed to evaluate the angle of rotation required to focus the image. |
| Image quality analogous to predicate device | A study of image quality was successfully completed to demonstrate that the quality of fluorescence images obtained from the predicate and proposed pde-neo devices are substantially equivalent. |
| Software operates as intended | Verification testing of the proposed device software was performed to demonstrate that the software operates as intended. |
| Substantial Equivalence to predicate device (K110480 - Hamamatsu's PDE) | The intended use, indications for use, fundamental scientific technology, and principles of operation are the same. Minor differences do not raise different questions of safety or efficacy. The pde-neo is at least as safe and effective as the predicate device. This leads to the conclusion of substantial equivalence. The proposed pde-neo offers enhancements such as color visualization, pseudo-color display, adjustable camera focus, and integrated white LEDs for illumination, which are considered improvements rather than safety/efficacy concerns. |
2. Sample size used for the test set and the data provenance:
- Test set sample size: Not explicitly stated for image quality or functional testing. The "study of image quality" is mentioned but without the number of images or cases.
- Data provenance: Not specified. Given that Hamamatsu Photonics K.K. is the submitter in Japan, the data likely originates from Japan, but it's not confirmed whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The image quality study is mentioned but lacks details on human expert involvement or ground truth establishment.
4. Adjudication method for the test set:
This information is not provided in the document.
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 comparing human readers with and without AI assistance was not conducted or reported. This device is not an AI-assisted diagnostic tool in the sense of providing automated interpretations or predictions that would require such a study. It's an imaging system providing visual information to the surgeon.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
A standalone algorithm-only performance study was not explicitly reported or necessary for this device type. The device provides visual information for human interpretation, not automated diagnostic outputs. The "software verification" indicated that the software operates as intended but doesn't describe an algorithm's standalone performance in a medical context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The document does not explicitly define the type of ground truth used. For the "image quality study," the implication is that images from the new device were compared against those from the predicate device to establish "substantial equivalence" in quality, likely based on visual assessment.
8. The sample size for the training set:
There is no mention of a "training set" as this device does not appear to employ machine learning or AI that would require one for its primary function.
9. How the ground truth for the training set was established:
Not applicable, as no training set for machine learning/AI is described.
§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.