(216 days)
The ClearPath Lower GI is intended to connect to standard colonoscopes to help facilitate intraprocedural cleaning of a poorly prepared colon by irrigating or cleaning the colon and evacuating the irrigation fluid (water), feces, and other bodily fluids and matter, e.g. blood. It is for use only by trained medical personnel located in hospitals, clinics, and doctors' offices.
The proposed modified ClearPath Lower Gl is one component of the predicate ClearPath (K091305) which included a number of components: Controller, Tubing Set, Irrigation set (now referred to as the ClearPath Lower GI). We are proposing to only modify the ClearPath Lower GI which attaches to a conventional endoscope. The ClearPath Lower GI includes one suction tube + tip, one irrigation tube + tip, and a sleeve to attach to the endoscope. The ClearPath Lower GI is connected to the ClearPath Controller and the ClearPath Tubing (K091305) and allows for irrigation and evacuation of debris from the colon during an endoscopic procedure. The device can accommodate several sizes and configurations of endoscopes with a change in the attachment ring.
The provided text describes a 510(k) premarket notification for a medical device called "ClearPath Lower GI," an irrigation/evacuation system for colonoscopies. However, the document focuses on demonstrating substantial equivalence to predicate devices through a performance testing summary, rather than presenting a detailed study with specific acceptance criteria and outcome metrics that would typically be found in a clinical trial report.
The performance testing listed aims to verify that the modified device performs as expected and is equivalent to the predicate, but it does not define quantitative acceptance criteria or provide specific numerical results of a study designed to meet those criteria.
Here's an attempt to answer your questions based on the available information, noting where information is not explicitly provided:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria in the format you requested (e.g., a specific success rate, a defined threshold for dislodgement, etc.). Instead, it mentions that "All testing demonstrated that the modified ClearPath Lower GI disposable performed to its specifications and / or was equivalent to the predicate."
Here's a summary of the performance testing categories and the general "reported performance," which is a claim of equivalence/specification compliance rather than specific numerical outcomes:
| Acceptance Criteria (Implied/General) | Reported Device Performance |
|---|---|
| Bench Testing: | |
| Dimensional testing compliance | Performed to specifications |
| Strength testing compliance | Performed to specifications |
| Functional testing compliance | Performed to specifications |
| Mechanical testing compliance | Performed to specifications |
| Endoscope compatibility | Performed to specifications |
| Animal Testing: | |
| Absence of tip dislodgement | Performed to specifications / Equivalent to predicate |
| Ease of maneuverability in colon | Performed to specifications / Equivalent to predicate |
| Quality of visibility | Performed to specifications / Equivalent to predicate |
| Quality of irrigation | Performed to specifications / Equivalent to predicate |
| Absence of occlusion/suction interruption | Performed to specifications / Equivalent to predicate |
| Quality of evacuation | Performed to specifications / Equivalent to predicate |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the sample size for the bench or animal testing. For animal testing, it likely refers to a number of individual animals, but this is not quantified.
- Data Provenance: Not explicitly stated. The applicant is "EasyGlide Ltd." from Israel, but whether the testing was conducted in Israel or elsewhere is not mentioned.
- Retrospective or Prospective: Not explicitly stated. Animal testing, by nature, is prospective. Bench testing is also inherently prospective for verifying specific design elements.
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 provided in the document. The testing involved "trained medical personnel" for the animal studies, but their specific number or qualifications are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. It's unclear if any formal adjudication method was used for evaluating the animal testing outcomes.
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
- MRMC Study: No, a multi-reader multi-case comparative effectiveness study was not conducted. This device is an irrigation/evacuation system, not an AI-powered diagnostic tool, so such a study would not be relevant.
- Effect Size: Not applicable, as no MRMC study or AI component is involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm-only) performance was not done. This device is a physical medical instrument requiring human operation in conjunction with an endoscope, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the animal study, the "ground truth" would be the direct observation and assessment of the device's performance characteristics by trained personnel during the simulated procedure. This would implicitly involve expert judgment on aspects like "ease of maneuverability," "quality of visibility," and "quality of evacuation." There is no mention of pathology or broader outcomes data for these specific tests.
8. The sample size for the training set
This is not applicable as this device is a physical instrument, not a machine learning model, and therefore does not have a "training set."
9. How the ground truth for the training set was established
This is 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.