(100 days)
The CVAC Aspiration System and CVAC Image Processor consists of a sterile single use, steerable ureteral catheter and a reusable software-controlled image processor. It is intended to establish a conduit during endoscopic urological procedures for the treatment and removal of urinary stones (kidney stones, fragments, and dust). It employs flexible ureteroscopy within the urinary tract for endoscopic examination of the urinary tract and the interior of the kidney.
The steerable ureteral catheter is used for irrigation of kidney stones and stone dust with dedicated irrigation and vacuum channels under ureteroscopy. The CVAC Aspiration System and CVAC Image Processor can be used with additional accessories to perform various diagnostic and therapeutic procedures.
The single use CVAC Aspiration System and the reusable CVAC Image Processor are specialized devices designed to allow physicians to locate kidney stones and to establish a conduit during endoscopic urological procedures for the treatment and removal of urinary stones (kidney stones, fragments, and dust). The devices are used in a surgical suite and are compatible with standard hospital monitors, vacuum sources, and irrigation sources.
The CVAC Aspiration System is a sterile single-use steerable ureteral catheter employing ureteroscopy with built-in irrigation and vacuum functionality. Accessories provided with the CVAC Aspiration System include an introducer, a laser bridge, a trigger tie, a 3-way stopcock, and a vacuum port cap. The CVAC Aspiration System catheter is compatible with commercially available accessories for stone removal such as appropriately sized single-use laser fibers and stone baskets, which are inserted and used in the vacuum channel. The CVAC Aspiration System connects to the CVAC Image Processor via an attached video cable.
The CVAC Image Processor is a software-controlled, reusable and electrical image processor. The CVAC Image Processor is connected to a standard 110V hospital electrical outlet via a provided power cord. The internal carrier board inside the CVAC Image Processor houses the LED control circuit, the display interface, and supports electrical interconnect between the image signal processing module and the System-on-Module (SOM). This allows the CVAC Image Processor to generate a video signal compatible with standard hospital grade external monitors. Accessories provided with the CVAC Image Processor include a HDMI-to-DVI adapter, a HDMI cable, and a power cable.
The provided text mainly focuses on the FDA's 510(k) clearance for the Calyxo CVAC Aspiration System and CVAC Image Processor, outlining its intended use, comparison to predicate devices, and general performance testing categories. Crucially, the document does NOT contain detailed information about specific acceptance criteria for AI/image processing performance, nor does it describe a study design for proving the device meets those specific criteria.
The "CVAC Image Processor" is mentioned, and "Optical Testing" and "Software" verification are briefly summarized, but these sections do not include:
- A table of acceptance criteria for image quality or AI performance.
- Reported device performance metrics against such criteria.
- Sample sizes for test or training sets for AI/image analysis.
- Details on ground truth establishment (number of experts, qualifications, adjudication methods).
- Information on Multi-Reader Multi-Case (MRMC) studies or standalone AI performance.
The document indicates that the device's image processing is for "direct vision capability" during endoscopic procedures, implying a live video feed for human users, rather than a diagnostic AI that makes independent interpretations.
Therefore,Based on the provided text, I can only provide general information about the device's testing and highlight what is missing regarding AI/image processing specific acceptance criteria and detailed study data.
Acceptance Criteria and Study for Calyxo CVAC Aspiration System and CVAC Image Processor
The provided document, an FDA 510(k) clearance letter and summary, primarily addresses the substantial equivalence of the CVAC Aspiration System and CVAC Image Processor to existing predicate devices. While the "CVAC Image Processor" is a software-controlled component that generates video, the document focuses on its capability to provide direct vision for the physician during endoscopic procedures, rather than on AI-driven image analysis or diagnostic capabilities with associated performance metrics.
The document does not provide a table of acceptance criteria specifically for the image processor's performance in object detection, segmentation, or other AI-driven tasks, nor does it detail a study proving the device meets such criteria. The "Optical Testing" and "Software" sections are general summaries of regulatory compliance rather than performance studies with quantitative acceptance criteria for image analysis.
Here's an analysis of the information that is present and what is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
Not provided in the document. The document lists general device characteristics (e.g., working length, shaft OD) in Table 1 but does not present quantitative acceptance criteria or reported performance for image processing or any specific AI/algorithmic function beyond stating that it provides "direct vision capability" and meets optical standards (ISO 8600 series).
2. Sample Size Used for the Test Set and Data Provenance
Not provided in the document for image processing/AI evaluation. The document mentions "extensive bench performance verification and validation testing," a "usability assessment," and various compliance tests (biocompatibility, electrical safety, optical, software, sterilization, packaging). However, it does not specify sample sizes for any test sets related to the image processor's performance (e.g., how many images or videos were used to test its visual capabilities, or if any 'test set' for AI was even relevant). No data provenance (country, retrospective/prospective) is detailed for performance evaluation datasets.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable/Not provided for image processing/AI evaluation. Since no explicit AI/algorithmic diagnostic or analytical function requiring expert-defined ground truth is detailed, information on experts or their qualifications for establishing ground truth is absent. The "direct vision" nature of the image processor means the ground truth is the live anatomical view presented to the clinician.
4. Adjudication Method for the Test Set
Not applicable/Not provided. As there's no described diagnostic AI assessment or need for expert consensus on images, no adjudication method is detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not mentioned/Not conducted or applicable based on the description. The device is described as providing "direct vision" for the physician during a procedure, not as an AI assistance tool that alters or enhances human interpretation in a diagnostic setting that would typically warrant an MRMC study.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
Not applicable/Not provided. The device's image processor's primary role is to provide a real-time visual feed to a human operator. There's no indication of a standalone diagnostic algorithm being evaluated.
7. Type of Ground Truth Used
Not applicable/Not detailed for image processing. For the image processor (which provides real-time video), the "ground truth" is the actual anatomical view captured by the camera. For other device functions, "ground truth" might refer to engineering specifications or physical measurements (e.g., flow rates, material properties), which are implicitly covered by "bench performance verification and validation."
8. Sample Size for the Training Set
Not provided. No information on a training set size for an AI component is present, as the image processor is described as a direct visualization tool, not an AI for image analysis.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not provided. As there is no described AI model that would require a ground-truth labeled training set for its image analysis capabilities.
In summary, the provided FDA document focuses on the safety and basic functionality of the CVAC Aspiration System and its integral Image Processor, establishing substantial equivalence to predicates for its intended use in urological procedures. It describes the image processor as a tool for "direct vision capability" and its compliance with optical and software standards, but it does not present the specific type of AI performance evaluation details (acceptance criteria, test/training sets, ground truth establishment by experts) that would be expected for a device incorporating advanced diagnostic AI.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.