(30 days)
The Single Use Cleaning Adapter is intended to be used only to pre-clean the endoscope's air/water channel post-procedure, and not to be used during a patient procedure.
The Defendo Single Use Cleaning Adapter for Olympus Endoscopes is a single use, non-sterile disposable valve that fits onto the air/water cylinder of Olympus endoscopes (that do not contain a balloon channel). It allows air and water to be flushed through the endoscope's air/water channels after an endoscopic procedure is completed to remove debris. The adapter is not intended to be used with patients and a warning tag comes with the device providing this information. The materials of the valve are non-patient contacting. The adapter is used post-procedure to pre-clean the endoscope before it goes thru high-level disinfection and/or sterilization. The adapter is attached to the air/water channel of an endoscope. When the adapter is attached to the endoscope, air can flow down the channel of the endoscope. If water is desired to flow down the channel, the device is depressed. When released, air will once again flow down the endoscope channel. The Defendo Olympus Single-Use Cleaning Adapter for Olympus Endoscopes assembly consists of a cap, a spring, a spring cup, an overmolded boot, the cleaning valve stem, the valve stem backflow umbrella valve, and valve stem sealing gaskets and a warning label.
The provided document describes a 510(k) premarket notification for a medical device (Defendo Single Use Cleaning Adapter for Olympus Endoscopes) and uses the term "acceptance criteria" in the context of non-clinical performance testing. However, the document does not detail a study proving that the device meets acceptance criteria related to an AI/ML component or algorithmic performance, as would be expected for a product with an AI/ML component.
Instead, the "acceptance criteria" mentioned refer to engineering and performance specifications for a mechanical device. The information provided is about a physical cleaning adapter, not a software or AI/ML algorithm.
Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size and ground truth establishment) are not applicable to the device described in this 510(k) submission, as it is a physical, non-AI medical device.
I will populate the table and answer the questions based on the information available in the document, while explicitly stating when information is not present or not applicable due to the nature of the device.
Acceptance Criteria and Device Performance for Defendo Single Use Cleaning Adapter for Olympus Endoscopes
1. Table of Acceptance Criteria and Reported Device Performance
| Testing Conducted | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|
| Button cycling/external leak | Meet acceptance criteria | Pass |
| Water Flow Rate | Meet acceptance criteria | Pass |
| Air Flow Rate | Meet acceptance criteria | Pass |
| Cap breakage strength | Meet acceptance criteria | Pass |
| Force to depress | Meet acceptance criteria | Pass |
| Backpressure Hold Test | Meet acceptance criteria | Pass |
| Force to Attach | Meet acceptance criteria | Pass |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the document. The testing described is for a physical device, and the "sample size" would refer to the number of physical units tested, which is not detailed.
- Data Provenance: Not applicable in the context of clinical AI/ML data. The "data" are results from mechanical and functional tests of the device. The testing was non-clinical, likely conducted in a lab environment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This device is a physical cleaning adapter, not an AI/ML system requiring expert-adjudicated ground truth labels for a test set. The "ground truth" for its performance is determined by engineering specifications and direct physical measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No human adjudication method (like those used for clinical image labeling) is relevant for the non-clinical performance tests of this mechanical device.
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:
- Not Applicable. No MRMC study was conducted as this is a mechanical medical device, not an AI/ML system designed to assist human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is not an algorithm. Its performance is evaluated through direct physical and functional tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. The "ground truth" for this device's performance is objective engineering and functional specifications (e.g., specific flow rates, force measurements, presence/absence of leaks, breakage strength). It does not involve clinical "ground truth" like pathology or outcomes data.
8. The sample size for the training set:
- Not Applicable. This is a physical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established:
- Not Applicable. As there is no AI/ML model or training set, the concept of establishing ground truth for training is irrelevant.
§ 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.