(30 days)
The DEFENDO EUS Air/Water Valve is intended to be used to control the air/water function of an endoscope during an GI Endoscopic procedure.
The DEFENDO EUS Suction Valve is intended to be used to control the suction function of an endoscope during a GI Endoscopic procedure.
The DEFENDO EUS Air/Water Valve and the DEFENDO EUS Suction Valve are accessories to an echoendoscope.
The EUS Air/Water valve allows the end user to control air or CO2 insufflation down the endoscope's accessory channel, control water used to wash the lens of the endoscope and insufflate a balloon at the distal end of the echoendoscope
The DEFENDO EUS Suction valve allows the user to control suction through the echoendoscope's accessory channel and suction to the balloon at the distal end of the echoendoscope.
Both devices are single-use devices, supplied sterile.
The provided document is a 510(k) summary for a medical device called "DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS". This document primarily focuses on demonstrating substantial equivalence to a predicate device, specifically for an extended shelf life. It is not a study proving the device meets acceptance criteria in the context of an Artificial Intelligence (AI) or machine learning (ML) enabled medical device, where terms like "ground truth," "expert consensus," "MRMC study," and "training set" are core to the evaluation.
Therefore, I cannot fulfill all parts of your request based on the provided text. The document describes a biological/mechanical device and its non-clinical performance testing for an extended shelf life, not the performance of an AI/ML algorithm.
However, I can extract the information related to the acceptance criteria and study results that are present for this specific type of device.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
This information is present for the non-clinical performance testing of the mechanical device.
| Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Air/Water Valve | ||
| Leakage | Valve shall not continuously leak water | Pass |
| Insertion | No damage shall occur to either the valve or the endoscope during insertion | Pass |
| Valve - Stationary | Valve shall remain in place on the endoscope after being fully seated | Pass |
| Flow (Air and CO2) | Minimum flows of predetermined levels of each air and CO2 shall be demonstrated | Pass |
| Flow (Water with Air/CO2) | Minimum flow of predetermined rates of water shall be demonstrated during flow of each air and CO2 | Pass |
| Flow (Water to fill balloon) | Minimum flow of predetermined rates of water shall fill the balloon during flow of each air and CO2 | Pass |
| Tensile Strength (Stage 1 compression) | Spring compression force shall fall within predetermined range in Stage 1 compression | Pass |
| Tensile Strength (Stage 2 compression) | Spring compression force shall fall within predetermined range in Stage 2 compression | Pass |
| Cap - Torque | Torque force shall be above a predetermined threshold to ensure no separation of cap from the valve stem occurs. | Pass |
| Suction Valve | ||
| Leakage | Valve shall not continuously leak water | Pass |
| Insertion | No damage shall occur to either the valve or the endoscope during insertion. | Pass |
| Insertion (Incorrect insertion prevention) | The valve must not be able to be inserted incorrectly into EUS scope suction port. | Pass |
| Valve - Stationary | Valve shall remain in place on the endoscope after being fully seated | Pass |
| Tensile Strength (Stage 1 compression) | Spring compression force shall fall within predetermined range in Stage 1 compression | Pass |
| Tensile Strength (Stage 2 compression) | Spring compression force shall fall within predetermined range in Stage 2 compression | Pass |
| Cap - Torque | Torque force shall be above a predetermined threshold to ensure no separation of cap from the valve stem occurs. | Pass |
| Packaging | ||
| Pouch Seal – Tensile Testing | Force to open sealed pouch shall be 0.57 lbs or greater | Pass |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document states that "Identical testing was conducted on both the predicate (cleared) 1 year version of the device and proposed 3 year shelf life version of the device." It then clarifies, "The three year shelf life summary is below." However, the specific sample size (N) for each test is not provided. The testing is physical/mechanical in nature, not data-driven in the sense of patient data. Therefore, "country of origin of the data" or "retrospective/prospective" are not applicable.
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 is not applicable as the document describes non-clinical performance testing of a physical medical device, not an AI/ML algorithm requiring expert ground truth for image interpretation or diagnosis.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable for the same reason as point 3.
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 is not applicable as the document is not about an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the document is not about an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable in the context of AI/ML. For this mechanical device, the "ground truth" for each test is a direct measurement against a predefined physical, mechanical, or functional standard (e.g., does it leak? does the spring compress within range?).
8. The sample size for the training set
This is not applicable as the document does not describe an AI/ML device with a training set.
9. How the ground truth for the training set was established
This is not applicable as the document does not describe an AI/ML device with a training set or ground truth in that context.
§ 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.