(340 days)
This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment. This instrument is intended to be used without DUODENOSCOPE.
The CHOLEDOCHO VIDEOSCOPE CHF-Y0005 is indicated for endoscopy and endoscopic surgery within the biliary tract and the duodenum.
The CHF-Y0005 is designed as a flexible video endoscope used for endoscopy and endoscopic surgery within the biliary tract and the duodenum.
The CHF-Y0005 is modified from the predicate XCHF TYPE T160 as it has two bending sections, a gas feeding function when connected to an Endoscopic CO2 regulation unit, Narrow Band Imaging observation and is now compatible with specified electrosurgical units and electrosurgical accessories.
The provided text describes the regulatory clearance of a medical device, the CHOLEDOCHO VIDEOSCOPE CHF-Y0005, and focuses on its substantial equivalence to predicate devices, rather than an independent performance study with clinical endpoints. Therefore, detailed information about acceptance criteria and a study proving the device meets those criteria, as typically found in a clinical trial report, is not present.
However, based on the Summary of Non-Clinical Testing section, we can infer some aspects related to acceptance criteria and the nature of the evaluation.
Here's a breakdown of the requested information based on the provided document:
1. Table of acceptance criteria and the reported device performance
The document mentions that non-clinical tests were performed and design verification tests and their acceptance criteria were identified and performed as a result of their risk analysis assessment. However, it does not provide a table with specific performance metrics and their corresponding acceptance criteria or actual reported device performance values. Instead, it refers to compliance with general safety and performance standards.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Device Safety & Performance | Demonstrated compliance with IEC 60601-1, 60601-1-1, 60601-1-2, 60601-2-18 standards. |
| Mechanical & Functional Performance | Verification and comparison studies conducted, concluding equivalence to predicate devices. |
| Risk Analysis | Carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. Design verification tests and their acceptance criteria were identified and performed based on risk analysis. |
| Substantial Equivalence (Overall) | Noted that the device does not incorporate any significant changes in intended use, method of operation, material, or design that could affect safety or effectiveness, thus determined substantially equivalent to predicate devices. |
2. Sample size used for the test set and the data provenance
The document describes non-clinical tests, verification and comparison studies, and design verification tests. These are typically engineering or benchtop tests rather than tests on human subjects. Therefore, the concept of "sample size for the test set" in the context of clinical data (e.g., patient images, patient outcomes) is not applicable here.
- Test Set Sample Size: Not applicable (non-clinical, benchtop testing).
- Data Provenance: Not applicable. The tests are described as non-clinical and in-house (e.g., "established in-house acceptance criteria").
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. Given that the testing described is non-clinical/benchtop, the establishment of "ground truth" by clinical experts (like radiologists) for a test set is not relevant to the described studies.
4. Adjudication method for the test set
This information is not provided. As the studies are non-clinical, an adjudication method for clinical test outcomes would not be relevant.
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 such study was mentioned or performed. This submission is for a medical device (endoscope), not an AI algorithm, and therefore an MRMC study comparing human readers with and without AI assistance is not relevant to this filing.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No such study was mentioned or performed. This submission is for a physical medical device (endoscope), not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical and design verification tests, the "ground truth" would be established by engineering specifications, calibration standards, and validated measurement techniques, as dictated by the referenced international standards (e.g., IEC, ISO, ASTM). This is not equivalent to clinical ground truth derived from expert consensus, pathology, or outcomes data.
8. The sample size for the training set
Not applicable. This device is an endoscope and does not employ a training set as would be required for an AI/machine learning algorithm.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
§ 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.