(268 days)
The VP-4440HD unit is used for endoscopic observation, diagnosis, treatment, and image recording. It is intended to process electronic signals transmitted from a video endoscope (a video camera in an endoscope). This product may be used on all patients requiring endoscopic examination and when using Fujinon medical Endoscope, light source, monitor, recorder and various peripheral devices.
The XL-4450 light source is used for endoscopic observation, diagnosis, treatment, and image recording. It is intended to provide illumination to an endoscope. The light source also functions as a pump to supply air through the endoscope while inside the body to assist in obtaining clear visualization to facilitate diagnostic examination. This product may be used on all patients requiring endoscopic examination and when using Fujinon medical Endoscope, video processor, monitor, recorder and various peripheral devices.
This system is intended to be used in conjunction with Fujinon endoscopes to provide illumination, visual display and data storage during endoscopic procedures.
The EPX-4440HD Digital Video Processor consists of three components used in conjunction with one another:
The VP-440HD Video Processor: The Processor relays the image from the endoscope to a video monitor. Projection can be either analog or digital at the user's preference. The Processor also incorporates internal or external digital storage capacity. The Processor also controls the light projected to the body cavity. The Processor also provides for optional structural enhancement at the user's option. Spectral and structural enhancements are achieved through proprietary software. The device is AC operated at a power setting of 120V/60MzJO.8A. The Processor is housed in a steel-polycarbonate case measuring 390X105X460mm.
The XL-4450 Light Source: The Fujinon endoscope employs fiber bundles to transmit light from the light source and subsequently to the body cavity. The Light Source employs a 300W Xenon lamp with a 75W emergency back-up Halogen lamp. Brightness control is performed by the user. The device is AC operated at a power setting of 120V/60MzJ3.3A. The Processor is housed in a steel-polycarbonate case measuring 390X155X485mm.
The DK-440E Keyboard: The Keyboard is used to enter pertinent procedural information (patient, physician, date, etc) for display on the video monitor and digital/analog storage systems. The Keyboard is also used to control operational features of the VP-4440HD Processor. The Keyboard resembles a standard computer keyboard in size and shape.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Fujinon EPX-4440HD Digital Video Processor:
NOTE: The provided 510(k) summary focuses primarily on the safety and performance aspects of a modified device compared to a predicate device, rather than defining and proving specific acceptance criteria in the way one might for a novel AI/software-as-a-medical-device (SaMD) product. The "acceptance criteria" discussed are more about meeting established regulatory and engineering standards, and the "study" is functional testing with physician evaluators for general performance and safety.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (as per document) |
|---|---|
| Software Validation | All testing criteria were met. |
| Electrical Safety | All testing criteria were met (in accordance with IEC 60601 requirements). |
| Performance Testing (Functional) | "Functional testing consisting of visual comparison tests were conducted using physician evaluators. In all cases they passed the required testing regimens." |
| Predicate Equivalence | The sponsor believes the modified device maintains the same safety and performance levels as the previous generation processor. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "physician evaluators" without specifying how many cases, images, or evaluation instances were part of their assessment.
- Data Provenance: Not explicitly stated. The context suggests general functional testing, likely performed in a controlled environment by the manufacturer. It does not mention country of origin or whether clinical patient data was used. It's likely simulated or controlled test conditions given the nature of the evaluation.
- Retrospective/Prospective: Not explicitly stated, but given it's functional testing for a device modification, it would typically be a prospective evaluation of the new device's capabilities in a controlled setting.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not explicitly stated. The document refers to "physician evaluators" (plural), but the exact number is not provided.
- Qualifications of Experts: Not explicitly stated beyond "physician evaluators." No specialty (e.g., gastroenterologist who performs endoscopy) or years of experience are listed.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly stated. The statement "In all cases they passed the required testing regimens" suggests a unanimous agreement or a pass/fail criterion that was met by all evaluators, rather than a formal adjudication process between conflicting interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No, a traditional MRMC comparative effectiveness study as typically understood for AI algorithms (i.e., comparing human readers with and without AI assistance on diagnostic accuracy) was not performed. The study mentioned was a functional performance test for a hardware/software update, not an AI-assisted diagnostic tool.
- Effect size of human readers with vs. without AI assistance: Not applicable, as no such study was conducted.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was a standalone study done? Yes, in a sense. The "software validation" and "electrical safety" testing would represent a standalone evaluation of the device's technical functionality. The "performance testing using physician evaluators" also tested the device itself, although with human interaction. However, this is not an AI algorithm performing a diagnostic task. The spectral and structural enhancements are "achieved through proprietary software," implying an algorithm, but its performance was evaluated by physicians using the system, not as a standalone diagnosis.
7. Type of Ground Truth Used
- Type of Ground Truth: For the "visual comparison tests conducted using physician evaluators," the ground truth was essentially the expert opinion/consensus of the physician evaluators regarding the successful functionality and acceptable image quality produced by the system. This is not pathology, outcomes data, or a pre-established clinical diagnosis.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is a video processor and light source, not a machine learning model that requires a "training set" in the conventional AI sense. While there is proprietary software for "spectral and structural enhancements," the document does not describe the development of this software in terms of machine learning training, but rather as a feature set of the device.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no mention of a training set for a machine learning model. If the "proprietary software" involved some form of learned enhancement, the document does not provide details on how such a model would have been trained or its ground truth established.
§ 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.