(240 days)
The PENTAX EPK-i5010 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 EPK-i5010 includes PENTAX i-Scan™ a digital, post-processing imaging enhancement technology. i-Scan is intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling. i-Scan is compatible with PENTAX k-series and i-series gastrointestinal videoscopes and colonovideoscopes.
The PENTAX EPK-i5010 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. It is intended to process electrical signals from a video endoscope.
The PENTAX EPK-i5010 offers an optional digital, post-processing imaging enhancement technology called the PENTAX i-Scan™ modes 1, 2, and 3, which is intended to give the user an enhanced view of the texture of the mucosal surface and blood vessels. i-Scan 1 provides the user with a view that sharpens surface vessels and enhances surface texture of the mucosa. i-Scan 2 provides the user with increased visibility of blood vessels while also providing the same enhancements to the mucosa achieved in i-Scan 1. i-Scan 3 provides the user with increased visibility of blood vessels including dimly illuminated far-field regions while also providing the same enhancement to the mucosa achieved in i-Scan 1. The user can select either white light image or i-Scan modes by pressing a pre-programmed button on the scope, by using a pre-programmed foot pedal or by pressing a keyboard button. i-Scan is intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling.
The EPK-i5010 video processor incorporates the hardware of the EPK-i5020 video processor model (K 113873) and the PENTAX i-Scan™ technology.
The EPKi-5010 is compatible with PENTAX flexible and rigid k-Series and i-Series videoscopes. The subject premarket notification is specific for gastrointestinal videoscopes and colonovideoscopes.
The provided text describes the PENTAX EPK-i5010 Video Processor and its i-Scan™ technology, intended for endoscopic diagnosis, treatment, and video observation. However, it does not contain specific acceptance criteria for "device performance" in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC) or a detailed study specifically designed to prove these criteria are met for the i-Scan technology itself.
Instead, the document focuses on:
- Substantial Equivalence: The primary aim of the 510(k) submission is to demonstrate that the PENTAX EPK-i5010 is substantially equivalent to legally marketed predicate devices, meaning it does not introduce new questions of safety or effectiveness.
- Safety: The clinical studies mentioned are primarily to establish the safety of the device, not its diagnostic performance against specific acceptance criteria for imaging enhancement.
Based on the provided text, here is an analysis of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Not explicitly stated for diagnostic performance) | Reported Device Performance (Focus on Safety and Equivalence) |
|---|---|
| Implicit Acceptance Criteria: | Reported Performance: |
| - No safety issues associated with the device. | - "Out of the 975 patients in the seven (7) clinical studies conducted with the PENTAX EPK-i video processor there were no safety issues reported." |
| - Substantially equivalent to predicate devices regarding intended use, method of operation, material, or design, ensuring no adverse effect on safety or effectiveness. | - "The EPK-i5010 does not incorporate any significant changes in the Intended Use, in the Method of Operation, Material or Design that could be considered to affect the safety or effectiveness of the Medical Device" compared to predicate devices (Olympus EVIS EXERA III VIDEO SYSTEM, PENTAX EPK-i5020 Video Processor). |
| - Software validation performed according to IEC 62304. | - Software validation performed in accordance with IEC 62304. |
| - Electrical testing according to IEC 60601. | - Electrical testing according to IEC 60601. |
| - Image Enhancement Analysis (method not specified). | - Image Enhancement Analysis was conducted. (No quantitative performance metrics reported for this analysis in the provided text). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The text mentions 7 clinical studies for safety evaluation:
- Sample Size: A total of 975 patients.
- Data Provenance:
- Germany (3 studies)
- Japan (1 study)
- Korea (3 studies)
- Retrospective/Prospective: Not specified, but "clinical studies" typically imply prospective data collection for safety and efficacy endpoints. However, without further details, it cannot be definitively determined from this summary.
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 does not provide this information. The clinical studies mentioned were for safety, and there's no indication of a diagnostic performance evaluation with expert-established ground truth for the i-Scan technology.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not provide this information as it does not detail a diagnostic performance study requiring ground truth adjudication.
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
- MRMC Study: No, the document does not describe a MRMC comparative effectiveness study. The i-Scan technology is described as an "optional adjunct" and "not intended to replace histopathological sampling," implying it's a visual enhancement tool rather than a diagnostic AI that would be compared with human performance or AI assistance.
- Effect Size: Not applicable, as no MRMC study or quantitative diagnostic performance study is described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No, the document does not describe a standalone performance study for the i-Scan algorithm. The i-Scan is an imaging enhancement technology integrated into a video processor, intended to be used by a clinician during endoscopy. It's not presented as a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document does not specify a type of ground truth because it does not detail a diagnostic performance study where ground truth would be needed for evaluating the i-Scan's diagnostic accuracy. The safety studies would primarily rely on adverse event reporting and clinical observation for safety endpoints.
8. The sample size for the training set
The document does not provide this information. As a post-processing imaging enhancement technology, the i-Scan likely uses algorithms that are developed and refined, but the document does not specify a "training set" in the context of machine learning model development or validation.
9. How the ground truth for the training set was established
The document does not provide this information as it does not mention a training set or the establishment of ground truth for it.
§ 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.