(253 days)
HD-500 Video Endoscope System
The HD-500 Video Endoscope System, which includes a video colonoscope, image processor, light source, monitor, accessories and other peripheral devices, is intended for endoscopies examination, diagnosis and treatment of the disease of the upper and lower gastrointestinal tract.
HDL-500 Series Light Source, HDL-500E, HDL-500X
The HDL-500 Series Light Source has been designed to be used with the endoscope, image processor and other peripheral devices for endoscopic observation, diagnosis and treatment.
HD-500 Series Image Processor, HD-500, HD-500S, HD-330Plus
The HD-500 Series Image Processor has been designed to be used with the endoscope, light source, monitor and other peripheral devices for endoscopic observation, diagnosis, treatment, and video recording.
EG-500 Series Video Gastroscope, EG-500, EG-500L
The EG-500 Series Video Gastroscope has been designed to be used with the image processor, light source, monitor and other peripheral devices for endoscopic observation, diagnosis and treatment of the upper digestive tract (including the esophagus, stomach and duodenum).
EC-500 Series Video Colonoscope, EC-500, EC-500T, EC-500L, EC-500L/T
The EC-500 Series Video Colonoscope has been designed to be used with the image processor, light source, monitor and other peripheral devices for endoscopic observation, diagnosis and treatment of the lower digestive tract (including the anus, rectum, colon and ileocecal segment).
The proposed device, HD-500 Video Endoscope System, which includes a video gastroscope /video colonoscope, image processor, light source, monitor, accessories and other peripheral devices.
HD-500 Video Endoscope System can be offered in several configurations with the options of different models of primary components
The EG-500 Series Video Gastroscope/ EC-500 Series Video Colonoscope is the hand-held, direct-viewing flexible endoscope used for endoscopy and endoscopic surgery within the upper and lower gastrointestinal tract.
The HD-500 Series Image Processor is a video processing system which is designed to be used with endoscopes, light source, monitor of the proposed system. Apart from the image processing functions, it also provides power supply for the endoscopes.
The HDL-500 Series Light Source provides illumination for endoscopic diagnosis, treatment and video observation.
The provided text is a 510(k) summary for the HD-500 Video Endoscope System. It describes the device, its intended use, and a comparison to a predicate device (EVIS EXERA II 180 System) to demonstrate substantial equivalence.
However, this document does not describe a study that proves the device meets specific acceptance criteria related to AI or a "human-in-the-loop" performance study. The entire document focuses on non-clinical tests and a comparison to a predicate device to establish substantial equivalence for a medical endoscope system, which is a hardware device, not an AI/software as a medical device (SaMD).
Here's a breakdown of why the requested information cannot be fully provided from the given document:
- No AI Component: The document clearly describes a traditional video endoscope system, including gastroscopes, colonoscopes, image processors, and light sources. There is no mention of any artificial intelligence, machine learning, or software for diagnosis/analysis.
- No Clinical Study for Performance Benchmarking: The document explicitly states: "No clinical study is included in this submission." (Page 6, Section 7). This means there is no data on human-in-the-loop performance, MRMC studies, or standalone algorithm performance.
- Focus on Substantial Equivalence: The entire submission is built around demonstrating that the new device is "substantially equivalent" to an existing, legally marketed predicate device. This is primarily done through feature-by-feature comparison and non-clinical engineering tests (electrical safety, EMC, optical performance, physical/functional performance, imaging performance) against established standards (IEC, ISO).
Therefore, I cannot populate the table or answer most of your specific questions related to AI acceptance criteria, data provenance, expert ground truth establishment, MRMC studies, or training sets. The document simply doesn't contain that information.
What the document does provide in terms of "acceptance criteria" and "performance" (though not AI-related):
The "acceptance criteria" in this context are the standards and benchmarks the device needs to meet to be considered safe and effective and "substantially equivalent" to predicate devices. These are primarily engineering and technical specifications.
1. Table of Acceptance Criteria and Reported Device Performance (Non-AI/Traditional Device Focus)
| Acceptance Criteria (Standards/Benchmarks) | Reported Device Performance (Compliance/Comparison) |
|---|---|
| Safety Standards (General) | |
| IEC 60601-1-2005+CORR.1:2006+CORR.2:2007+A1:2012 (Medical Electrical Equipment - Basic Safety & Essential Performance), including US National Differences | Complies (Page 5, Section 6) |
| IEC 60601-1-2:2007 (EMC - Electromagnetic compatibility) | Complies (Page 5, Section 6) |
| IEC 60601-2-18:2009 (Particular requirements for endoscopic equipment) | Complies (Page 6, Section 6) |
| Biocompatibility Standards | |
| ISO 10993-5:2009 (Tests for in vitro cytotoxicity) | Complies (Page 6, Section 6); Proposed device is biocompatible and conforms to ISO 10993 series standards (Page 18, SE Analysis 19). |
| ISO 10993-10:2010 (Tests for irritation and skin sensitization) | Complies (Page 6, Section 6); Proposed device is biocompatible and conforms to ISO 10993 series standards (Page 18, SE Analysis 19). |
| Product Performance Standards | |
| ISO 8600-1:2015 (Endoscopes - General requirements) | Complies (Page 6, Section 6); Field of view for video colonoscope meets requirements (Page 15, SE Analysis 12). |
| ISO 8600-7:2012 (Endoscopes - Water-resistant type) | Complies (Page 6, Section 6) |
| Optical Performance (Comparison to Predicate) | |
| Resolution (vs. Predicate) | Test results satisfactory and "Substantially Equivalent" (Page 6, Section 6) |
| Depth of field (vs. Predicate) | Test results satisfactory and "Substantially Equivalent" (Page 6, Section 6) |
| Optical magnification and distortion (vs. Predicate) | Test results satisfactory and "Substantially Equivalent" (Page 6, Section 6) |
| Image intensity uniformity (vs. Predicate) | Test results satisfactory and "Substantially Equivalent" (Page 6, Section 6) |
| Physical/Functional Performance (Overall System) | |
| Angulation/Deflection maintenance | Demonstrated ability to maintain maximum angulation/deflection (Page 6, Section 6) |
| Appearance visual inspection and handle strength inspection | Testing conducted, results satisfactory (Page 6, Section 6) |
| Image function visual inspection | Testing conducted, results satisfactory (Page 6, Section 6) |
| Sealing performance | Testing conducted, results satisfactory (Page 6, Section 6) |
| Maximum bending angle measurement and body model testing | Testing conducted, results satisfactory (Page 6, Section 6) |
| Imaging Performance (Lifetime Use) | |
| Degradation of imaging performance over lifetime | Degradations are "very little which will not affect the normal use of the endoscope" (Page 6, Section 6) |
| Functional Equivalence (Comparison with Predicate Device Features) | |
| Indications for Use | Identical to predicate device (Page 7, Table 1; Page 8, SE Analysis 1) |
| Input Current (Image Processor) | Similar to predicate; complies with IEC 60601-1 (Page 9, Table 2; Page 10, SE Analysis 2) |
| Size and Weight (Image Processor) | Different from predicate, but "will not affect the safety and effectiveness" (Page 9, Table 2; Page 11, SE Analysis 3) |
| Video Signal Output (Image Processor) | Different types, but both offer standard and high-definition interfaces and versatility; "will not affect the safety and effectiveness" (Page 9, Table 2; Page 11, SE Analysis 4) |
| Image Enhancement (Image Processor) | More selection than predicate, offers physician more adjustment; "will not affect the safety and effectiveness" (Page 9, Table 2; Page 11, SE Analysis 5) |
| IRIS mode selection (Image Processor) | More selection than predicate; "will not affect the safety and effectiveness" (Page 9, Table 2; Page 11, SE Analysis 6) |
| Zoom (Image Processor) | Similar to predicate; "will not affect the safety and effectiveness" (Page 9, Table 2; Page 11, SE Analysis 7) |
| Imaging Modes (Image Processor) | "VIST observation mode" is substantially equivalent to predicate's "NBI modes" for clinical application purposes (Page 9, Table 2; Page 12, SE Analysis 8) |
| Sensor Type (Gastroscope/Colonoscope) | CMOS vs. predicate's CCD, but both provide high-quality images; CMOS commonly used; "does not affect the safety and effectiveness" (Page 13, Table 3; Page 15, Table 4; Page 13, SE Analysis 9) |
| Diameters (Gastroscope/Colonoscope) | Similar to predicate and meet industrial standard (Page 13, Table 3; Page 15, Table 4; Page 14, SE Analysis 10) |
| Insertion Section Length (Gastroscope/Colonoscope) | Similar to predicate (Page 13, Table 3; Page 15, Table 4; Page 14, SE Analysis 11) |
| Field of View (Colonoscope) | Different from predicate, but meets ISO 8600-1 requirements; "does not affect the safety and effectiveness" (Page 15, Table 4; Page 15, SE Analysis 12) |
| Power Supply (Light Source) | Different from predicate, but electrical safety testing demonstrates compliance with IEC 60601-1; "does not affect the safety and effectiveness" (Page 16, Table 5; Page 16, SE Analysis 13) |
| Input Current (Light Source) | HDL-500X is same as predicate; HDL-500E is different but complies with IEC 60601-1; "considered not affectiveness" (presumably 'not affecting effectiveness') (Page 16, Table 5; Page 17, SE Analysis 14) |
| Examination Lamp & Emergency Lamp (Light Source) | HDL-500X same as predicate; HDL-500E uses different common LED light source; "does not affect the safety and effectiveness" (Page 16, Table 5; Page 17, SE Analysis 15) |
| Average Lamp Life (Light Source) | HDL-500X same as predicate; HDL-500E has longer life; "does not affect the safety and effectiveness" (Page 16, Table 5; Page 17, SE Analysis 16) |
| Average Emergency Lamp Life (Light Source) | Longer than predicate; "does not affect the safety and effectiveness" (Page 16, Table 5; Page 17, SE Analysis 17) |
| Automatic Exposure (Light Source) | Both provide function; adjustable levels differ but achieve same purpose; "considered as substantial equivalence" (Page 16, Table 5; Page 17, SE Analysis 18) |
2. Sample size used for the test set and the data provenance: Not applicable. This is a non-clinical submission. The "test set" refers to the specific units of the device that underwent engineering tests (e.g., optical performance, physical performance). The data provenance is these lab tests themselves, conducted by the manufacturer (Sonoscape Medical Corp.) likely in China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the AI/clinical context, is not established for this type of non-clinical device test. The "ground truth" for these tests would be the established engineering standards and specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is not a clinical study involving human readers or interpretation.
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: No, explicitly stated "No clinical study is included in this submission." (Page 6, Section 7). No AI component.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, explicitly stated "No clinical study is included in this submission." (Page 6, Section 7). No AI component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the AI/clinical sense. The "ground truth" for engineering tests are the industry standards (IEC, ISO) and the specifications of the predicate device for comparison.
8. The sample size for the training set: Not applicable. No AI/ML model.
9. How the ground truth for the training set was established: Not applicable. No AI/ML model.
§ 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.