(95 days)
The ERBEFLO CleverCap™ Hybrid Tubing/Cap Sets provide sterile water and air from a single source to an endoscope for endoscopic procedures.
The ERBEFLO CleverCap Hybrid Tubing/Cap Sets for Olympus® Model 160 and 180 Series Scopes consist of two (2) tubing segments and a cap. The cap of a Set attaches with an air-tight seal to a water source (i.e., a sterile water bottle). Then from the water bottle, irrigation tubing of a Set interfaces with a designated pump and via ERBEFLO 2 connector accessories to a specified Olympus Scope for endoscopic lavage. The other segment, the air/water tubing, also coming from the same water bottle; connects to an air/water port of a specified Olympus® Scope for air intubation as well as lens cleaning (Note: The air/water tubing is a tube within a tube in which the endoscope's air/water processor pressures the bottle for water flow.). Both the irrigation as well as the air/water tubing segments have a backflow valve and a clamp to pinch off the tubing while not in use. Each Set is designed for use with designated irrigation pumps and have a air/water connector for specified Olympus® Scopes. The Hybrid Tubing/Cap Sets for Olympus® Model 160 and 180 Series Scopes are provided sterile and are disposable.
The acceptance criteria and study detailed in the provided text pertain to the ERBEFLO CleverCap™ Hybrid Tubing/Cap Sets, which are accessories for endoscopes, not an AI device. As such, most of the requested information regarding AI device evaluation (e.g., sample size for test set, data provenance, ground truth, MRMC study, standalone performance, training set details) is not applicable or cannot be extracted from this document.
However, I can extract the acceptance criteria and performance testing details as described for this medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Measurement | Reported Device Performance | Study that Proves Device Meets Criteria |
|---|---|---|---|
| Functional Performance | Flow Rates | Improved flow rates | Performance Testing (Section III, Product Data) |
| Back Flow Pressure | Equivalent | Performance Testing (Section III, Product Data) | |
| Internal Pressure | Equivalent | Performance Testing (Section III, Product Data) | |
| Durability | Comparable | Performance Testing (Section III, Product Data) | |
| Biocompatibility | Material compatibility | Evaluated and deemed acceptable | Biocompatibility Study (Section III, Product Data) |
| Sterility | Sterilization Method | Sterilized via Ethylene Oxide | Device Description |
| Duration of Use | Single-use duration | 24-hour use | Similarities section (matching predicate) |
| Physical/Dimensional | Thread connections | Same as predicate | Similarities section |
| Cap, tubing segments | Same as predicate | Similarities section | |
| Back flow valve placement | Same as predicate | Similarities section | |
| Tubing Durometer, ID, OD | Comparable to predicate | Similarities section | |
| Locking clamp | Same as predicate | Similarities section | |
| Tubing weight insert | Same as predicate | Similarities section | |
| Length of air/water segment | Same as predicate | Similarities section |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The filing focuses on substantial equivalence to predicate devices and reports on internal testing results without specifying sample sizes for performance tests or the origin/nature of the data.
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)
This information is not applicable to this type of device (endoscopic accessories) and is not mentioned in the provided document. Ground truth for performance testing of a physical device would typically involve objective measurements against engineering specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable to this type of device and is not mentioned in the provided document.
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
This information is not applicable as this is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as this is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this medical device, the "ground truth" for performance testing appears to be engineering specifications and objective measurements of physical properties (flow rates, pressures, durability) and material compatibility. Substantial equivalence is also established by comparing these properties to legally marketed predicate devices.
8. The sample size for the training set
This information is not applicable as this is not an AI device.
9. How the ground truth for the training set was established
This information is not applicable as this is not an AI 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.