(259 days)
The PENTAX Medical EPK-i7010 Video Processor is intended to be used with the PENTAX camera heads, endoscopes, light sources, monitors and other ancillary equipment for gastrointestinal endoscopic diagnosis, treatment and video observation.
The PENTAX Medical EPK -7010 includes a digital post-processing imaging enhancement technology (PENTAX i-Scan™) and an optical imaging enhancement technology (OE).These imaging enhancement technologies are intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling. i-Scan and OE are compatible with PENTAX video gastrointestinal endoscopes.
The PENTAX Medical EPK-i7010 video processor consists of a video system, integrated light source, monitor, and ancillary equipment. This processor is intended for endoscopic diagnostic, treatment and video observation.
The PENTAX Medical EPK-i7010 video processor contains two types of contrast enhancement techniques: PENTAX i-Scan technology, and optical enhancement (OE) technology.
White light is captured from a 300 Watt xenon lamp housed in the PENTAX Medical EPKi7010 video processor. All visualization is done with the white light mode first. White light (BGR) illuminates the tissue and transfers the captured light through the video scope or a charged coupled device (CCD). Note that the white light visualization mode is always used first by the physician.
For i-Scan image enhancement, the modification of the combination of RGB components for each pixel occurs when the i-Scan function is turned on in the PENTAX Medical EPKi7010 video processor. The resulting i-Scan image is then displayed on the observation monitor. For OE image enhancement, one of the two optical filters corresponding to Mode1 and Mode2 are inserted into illumination light path when the OE function is turned on in the PENTAX Medical EPK-i7010 video processor. The resulting OE image is then displayed on the observation monitor.
The provided document describes the Pentax Medical EPK-i7010 Video Processor with GI Family, which includes digital (PENTAX i-Scan™) and optical (OE) imaging enhancement technologies for use as an adjunct to traditional white light endoscopy in gastrointestinal endoscopic diagnosis, treatment, and video observation.
However, the document does not provide specific acceptance criteria or an explicit study proving the device meets those criteria in the typical sense of a diagnostic performance study with sensitivity, specificity, or similar metrics. Instead, the performance data focuses on establishing substantial equivalence to a predicate device (PENTAX Medical EPK-i5010 Video Processor) and a reference device (OLYMPUS EVIS EXERA III Video System) through compliance with standards and non-clinical testing.
Here's an attempt to answer your questions based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not present a table of acceptance criteria with corresponding performance metrics like sensitivity or specificity for its imaging enhancement technologies. Instead, the performance is demonstrated through compliance with electrical safety, EMC, software standards, and non-clinical (optical bench and animal) testing to show comparability with predicate devices.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Electrical Safety (ES) | Confirmed by testing in accordance with IEC 60601-1:2005+A1:2012, IEC 60601-1-6 Edition 3.0:2010, and IEC 60601-2-18 Edition 3.0:2009. |
| EMC | Confirmed by testing in accordance with IEC 60601-1-2:Edition 3:2007. |
| Software Verification & Validation | Conducted and documented as per FDA guidance. Classified as CLASS B software (IEC 62304:2006) with a "Moderate" level of concern. Compliance with ISO 14971:2007, IEC 62304:2006, and IEC 62471:2006. All testing demonstrated that the device performs as intended and did not raise safety or effectiveness questions despite additional functionalities compared to the predicate device. |
| Optical Performance (Bench & Animal Testing) | Animal Study: A library of images (white light, PENTAX OE, Olympus NBI) was obtained from porcine gastrointestinal mucosa for image evaluation and quantitative data analysis. |
| Bench Testing: Optical Enhancement (OE) and Artifact Analysis were performed using images from porcine gastrointestinal locations with PENTAX and Olympus gastrointestinal endoscopes. Effects of processing features on Limited Resolution optical bench testing were also conducted. | |
| Conclusion: These tests established the equivalence of the subject device to the predicate device and that the EPK-i7010 performs comparably to the predicate for the same indications for use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: The document refers to "a library of images" from porcine gastrointestinal mucosa for the animal study and "images from the porcine gastrointestinal location" for the bench testing. No specific numerical sample size (e.g., number of images, number of animals) is provided.
- Data Provenance: The animal study used porcine (pig) gastrointestinal mucosa. The country of origin for the data is not specified. The nature of the image acquisition for the animal and bench studies would be prospective as these were generated specifically for the testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document mentions "image evaluation" for the animal study but does not specify the number of experts, their qualifications, or how they established ground truth for the test set. Given the context of a 510(k) summary focused on substantial equivalence and non-clinical data, it's likely that a formal expert review for diagnostic accuracy wasn't the primary endpoint.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method for establishing ground truth for a test set, as the performance evaluation in this 510(k) application focuses on technical and comparative performance, not a human reader diagnostic accuracy study.
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 assessing human reader improvement with or without AI (or in this case, imaging enhancement technologies) was not explicitly mentioned or described in the provided text. The document focuses on demonstrating substantial equivalence through technical performance and animal/bench testing, not direct clinical or reader performance improvement studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes the device as including "digital post-processing imaging enhancement technology (PENTAX i-Scan™) and an optical imaging enhancement technology (OE)." These technologies process images to enhance visualization. The "performance data" section focuses on "Optical Performance Testing (Bench and Animal non-clinical testing)" and states "The optical data analysis demonstrate that the PENTAX Medical EPK-i7010 Video Processor performs comparably to the predicate device." This implies an assessment of the algorithm's output (images) in a standalone fashion, determining features like resolution, artifact analysis, and enhancement capabilities without direct human diagnostic decision-making as the primary endpoint for the 510(k). The "image evaluation and quantitative data analysis" of porcine images would fall under this.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the animal study, the ground truth explicitly stated or implied is for "image evaluation and quantitative data analysis" comparing white light, PENTAX OE, and Olympus NBI images from "porcine gastrointestinal mucosa." This likely refers to inherent characteristics of the mucosa as visualized under different modalities or technical imaging quality parameters, rather than a diagnostic 'ground truth' in the clinical sense (e.g., presence/absence of disease confirmed by pathology). The focus is on the imaging enhancement capability, not the diagnostic accuracy of the enhancement itself.
8. The sample size for the training set
The document does not provide any information about a training set size. The device uses "digital post-processing imaging enhancement technology" and "optical imaging enhancement technology." These might be based on pre-defined algorithms rather than machine learning models that require explicit training sets in the sense of supervised learning.
9. How the ground truth for the training set was established
Since no training set is mentioned in the context of machine learning, there is no information on how its ground truth might have been established. The technologies are described as "imaging enhancement," likely relying on fixed algorithms or optical filtering techniques rather than a trained AI model in the typical sense that would necessitate a labeled training set for diagnostic classification.
§ 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.