(261 days)
FUJIFILM Endoscope Model EC-760S-A/L
This product is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine. Never use this product for any other purposes.
Endoscopy Support Program EW10-VM01
This software provides image information to assist the user in estimating the size of an object displayed in the endoscopic field of view. This software provides no therapeutic or diagnostic function.
FUJIFILM Endoscope Model EC-760S-A/L is comprised of three general sections; a control portion, an insertion portion and an umbilicus. The control portion controls the angulation of the endoscope. This portion also controls the flexibility of the distal end in the endoscope. The insertion portion contains glass fiber bundles, several channels and a complementary metal-oxide-semiconductor (CMOS) image sensor, and laser emitting window in its distal end. The insertion portion assist in delivering air/suction as well as endoscope accessories. such as forceps. The glass fiber bundles allow light to travel through the endoscope and emit light from the tip of the insertion to illuminate the body cavity. This provides enough light to the CMOS image sensor to capture an image and display it on the monitor. The umbilicus consists of electronic components needed to operate the endoscope when plugged in to the video processor and the light source. The endoscope is used in combination with the Company's video processors, light sources and peripheral devices such as monitor, printer, foot switch, and cart.
Endoscopy Support Program EW10-VM01 is a software-only device that detects the laser spot position of the dedicated endoscope in the image obtained via the video processor and displays a superimposed scale ("Virtual Scale") in the endoscopic image (e.g., displayed in a monitor). The Virtual Scale images can be either linear or circular. The virtual scale shows the graduated markings at 5mm, 10mm, and 20mm. EW10-VM01 must be installed on a personal computer (PC) that meets the mandatory system requirements for it to function. When the PC with EW10-VM01 connects to the video processor and the Virtual Scale function is turned ON. EW10-VM01 automatically retrieves the calibration data from the EC-760S-A/L. EW10-VM01 uses the data from the calibration table and detects the relative position of the red laser beam in the endoscopic image. EW10-VM01 superimposes the virtual scale images in the endoscopic image in real-time. The virtual scale acts as the virtual reference for the users to estimate sizes.
Here's a breakdown of the acceptance criteria and study information for the Endoscopy Support Program EW10-VM01, based on the provided document.
Acceptance Criteria and Reported Device Performance
The document states that the "Accuracy of Virtual Scale images with Endoscopy Support Program EW10-VM01 has been evaluated." However, it does not explicitly list quantitative acceptance criteria for accuracy (e.g., a specific percentage error or range of deviation) nor does it provide the reported device performance against any such criteria. It only confirms that the evaluation was performed.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The document mentions "Accuracy of Virtual Scale images ... has been evaluated." | Not explicitly stated in the document. The document does not provide specific accuracy metrics or measurements resulting from the evaluation. |
Study Details for Endoscopy Support Program EW10-VM01
Given the information in the provided text, many details about the specific study proving the device meets acceptance criteria are not explicitly provided. The document focuses on general compliance with standards and the fact that evaluations were performed, rather than furnishing detailed study methodologies or results for the EW10-VM01 software.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). The document generally discusses testing of the Endoscope Model EC-760S-A/L and the EW10-VM01 software.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated.
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Adjudication method for the test set: Not explicitly stated.
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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:
- MRMC Study: Not explicitly stated.
- Effect Size: Not explicitly stated. The software "provides image information to assist the user in estimating the size of an object," implying an assistive role. However, the document does not compare human performance with and without the assistance.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The document implies a standalone evaluation of the software's accuracy: "Accuracy of Virtual Scale images with Endoscopy Support Program EW10-VM01 has been evaluated." It also states, "The software does not have a measuring function—the software only calibrates the virtual scale (e.g., by the object recognition), and does not estimate the measurement by itself." This suggests the calibration and display of the virtual scale is the standalone function evaluated, rather than the software performing a measurement autonomously.
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The type of ground truth used: Not explicitly stated. Given that it relates to the "Accuracy of Virtual Scale images," the ground truth would likely be precise, independently measured physical dimensions of objects in the endoscopic field of view.
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The sample size for the training set: Not explicitly stated.
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How the ground truth for the training set was established: Not explicitly stated.
Summary of available information:
The document confirms that the Endoscopy Support Program EW10-VM01 software was evaluated for "Accuracy of Virtual Scale images" and "in-vivo performance testing of visualization of laser spot". It also states that the software was evaluated using IEC 62304:2015 and in accordance with FDA's guidance for software in medical devices. However, it does not provide specific quantitative results, sample sizes, expert details, or ground truth methodologies for these evaluations. The focus of this 510(k) summary is to demonstrate substantial equivalence through compliance with recognized standards and general performance evaluations, rather than to present detailed efficacy study results.
§ 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.