(214 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 bronchoscopic 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 bronchoscopes.
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 bronchoscopic diagnosis, treatment and video observation.
The PENTAX Medical EPK-i7010 Video Processor contains PENTAX i-Scan and Optical Enhancement (OE) technologies.
The PENTAX i-Scan technology is a digital filter-based image enhancement technique with three modes, i-Scan 1, 2, and 3. PENTAX i-Scan™ is intended to give the user an enhanced view of the texture of the mucosal surface and blood vessels.
In addition to i-Scan, OE is intended to provide alternative methods to improve blood vessel visibility by using band limited light illumination source. The OE technology emphasizes mucosal microvasculature and fine mucosal structures on the bronchial surface.
The following accessories are provided for use with the PENTAX Medical EPK-i7010 Video Processor and EB Family of Scopes:
- . Keyboard - input device for the video processor.
- . Foot Switch - used to remotely control processor functions.
- . White Balance Adjuster - used as the object of white balance feature.
- Condenser Earth Cable - used to reduce high-frequency noise generated during highfrequency electro cautery device use with Pentax endoscopes.
The provided text describes the 510(k) premarket notification for the PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes. However, it does not contain a table of acceptance criteria or a detailed study that proves the device meets specific performance acceptance criteria in terms of clinical efficacy or diagnostic accuracy.
The document focuses on demonstrating substantial equivalence to a predicate device (PENTAX Medical EPK-i5010 Video Processor with EB Family) and a reference device (PENTAX Medical EPK-i7010 Video Processor with GI Family), primarily through bench testing comparing optical parameters and a qualitative animal study to show similar visual experience.
Here's a breakdown of the requested information based on the provided text, and where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
This information is NOT explicitly provided in a table format within the document. The document describes various tests performed but does not list specific numerical acceptance criteria for each test or a direct comparison demonstrating the device "meets" those criteria in a quantitative sense. Instead, it states that the performance of the subject and predicate devices are "equivalent" or show "similarity of visual experience."
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Bench Testing (Optical): Not specified (e.g., number of scopes, measurements taken).
- Animal Testing: "A library of images was captured." The exact number of images or individual animal cases is not specified.
- Data Provenance:
- Bench Testing: In-house testing, likely derived from laboratory measurements.
- Animal Testing: Porcine animal study (not human data). No specific country of origin is mentioned, but "PENTAX Medical performed a porcine animal study" implies it was conducted by the manufacturer or a contracted lab. The study type is prospective for the animal model.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is NOT provided. The studies described (bench testing and animal testing) do not mention the use of experts to establish a "ground truth" in a clinical diagnostic sense. The animal study focused on showing "similar visual experience" which would likely involve subjective assessment, but expert involvement and their qualifications are not detailed.
4. Adjudication Method for the Test Set
This information is NOT provided. Given the nature of the tests described (bench and animal studies focusing on optical/visual similarity rather than diagnostic accuracy), a formal adjudication method like "2+1" or "3+1" for clinical ground truth establishment is not mentioned or applicable.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
No, an MRMC comparative effectiveness study was NOT done. This device is an endoscope video processor with image enhancement technologies (i-Scan and OE), not an AI-assisted diagnostic tool for which human reader improvement would typically be measured. The study focused on demonstrating optical equivalence and similar visual experience compared to a predicate device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not directly applicable in the typical sense of a diagnostic algorithm. The i-Scan and OE technologies are "imaging enhancement technologies" intended to be an "optional adjunct following traditional white light endoscopy." They are not standalone diagnostic algorithms that provide a diagnosis without human interpretation. The "performance testing" described (bench and animal) assesses the technical performance of the imaging system itself, not the diagnostic performance of the enhancement algorithms in a standalone mode.
7. The Type of Ground Truth Used
- Bench Testing: Physical properties and measurements (e.g., signal-to-noise ratio, resolution, color accuracy, light distribution). The "ground truth" would be the standard physical measurements or specifications for these parameters.
- Animal Testing: Visual observation of pig laryngeal anatomy. The "ground truth" here is the visual appearance of the anatomy as rendered by different processors, to assess "similarity of visual experience." It is not a pathological or outcomes-based ground truth for disease detection.
8. The Sample Size for the Training Set
This information is NOT provided and is not applicable. The document describes a video processor with image enhancement technologies, not a machine learning or AI-based system that would typically require a "training set" in the context of diagnostic algorithm development. The "software verification and validation" (IEC 62304:2006) refers to standard software engineering practices for medical devices, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established
This information is NOT provided and is not applicable. As noted above, this device does not appear to be an AI/ML system that requires a "training set" with established ground truth.
§ 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.