(153 days)
The Endo SmartCap™ is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.
The Endo SmartCap™ supplies sterile water and either air or CO2 to an endoscope during endoscopic procedures when connected to a sterile water source and an air or CO2 source. Two tubes are arranged coaxially; air or CO2 supplied through the outer tube pressurizes the sterile water container, forcing water up through the inner tube and to the endoscope. The proximal end of the tube set includes a bottle cap for attachment to a user-provided sterile water container; the Endo SmartCap™ is compatible with all major brands of sterile water containers. The proximal end of the tube set terminates in a tube weight which keeps the tip of the tubing submerged. A pinch clip prevents water from dripping from the tube's distal end when the device is detached from the endoscope. The distal end of the tube set terminates in a connector which mates with the corresponding brand of endoscope; Endo SmartCap™ models are available for all major brands of endoscopes. The device is provided sterile (EtO). The device is fabricated from metals, plastics, and elastomers. The Endo SmartCap™ is intended for 24 hour multi-patient use and should be discarded daily. No portion of the device comes in direct contact with patients.
The provided text is a 510(k) Premarket Notification for the "Endo SmartCap™" device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that an AI/ML device meets specific performance criteria. The document describes a medical device accessory, not an AI/ML system.
Therefore, many of the requested details about acceptance criteria for AI/ML performance, study design, sample sizes for test/training sets, expert involvement, and ground truth establishment cannot be found in this document because the device is a physical accessory (Endoscope and Accessories), not an AI/ML software.
However, I can extract the information related to the device's functional performance testing.
Here's what can be extracted from the document:
1. Table of Acceptance Criteria and Reported Device Performance (for functional testing):
| Test | Acceptance Criteria | Reported Performance |
|---|---|---|
| Confirmation of flow rate | The average mean flow of the 100551-production sample must be no lower than 10% of the flow of the same tubeset without a filter | PASS |
| Prevention of backflow | The 100551 shall not allow water to backflow into the CO2EFFICIENT insufflator | PASS |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number of devices/tests, but implies multiple production samples for the flow rate test ("average mean flow of the 100551-production sample").
- Data Provenance: The document does not specify the country of origin of the data. The tests conducted are functional performance tests of the device itself, not data-driven performance. The tests are retrospective in the sense that they were conducted for the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as the device is a physical accessory undergoing functional engineering tests (flow rate, backflow prevention), not an AI/ML algorithm requiring expert interpretation of medical images or data for ground truth. The "ground truth" here is the objective measurement of physical properties.
4. Adjudication method for the test set:
- Not applicable for functional engineering tests. The results are objective measurements against predefined engineering specifications.
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. This device is a physical medical accessory, not an AI/ML system for diagnostic assistance. No human reader studies with or without AI were conducted or are relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm. The reported tests are for the standalone physical device's functional performance.
7. The type of ground truth used:
- For flow rate and backflow prevention tests, the "ground truth" is established by engineering specifications and direct physical measurement. For example, for flow rate, it would involve direct measurement of water/gas volume over time. For backflow, it's the observation of whether water backflows into the insufflator.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI/ML algorithm, there is no ground truth for a training set.
In summary, this document is for a traditional medical device accessory (Endo SmartCap™) seeking 510(k) clearance based on substantial equivalence. The "study that proves the device meets the acceptance criteria" in this context refers to engineering performance testing rather than the clinical validation or AI algorithm performance studies typically associated with the detailed questions provided.
§ 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.