(103 days)
The EndoRings is intended to be attached to the distal end of the endoscope to facilitate endoscopic therapy, to be used for the following: Keeping the suitable depth of endoscope's view field
The EndoRings is a flexible silicone rubber add-on device designed to attach to of the designated endoscope. The product features a short tube like shape with three flexible circular layers of wings that easily fold backwards during intubation and scope forward movement, and fold forward during scope withdrawal, to maintain the field of view and scope centering position.
This submission describes a medical device, the EndoRings, and its comparison to a predicate device, the Arc EndoCuff, for demonstrating substantial equivalence. The information provided is primarily focused on the device's technical characteristics, biocompatibility, and a feasibility clinical study. There is no mention of an AI/ML component in this 510(k) summary. Therefore, many of the requested categories related to AI/ML performance (e.g., test set, training set, ground truth methods, MRMC study, standalone performance) are not applicable.
Here's an analysis of the provided text based on the requested criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Study Objectives / Endpoints) | Reported Device Performance |
|---|---|
| Primary Endpoint: Reaching the cecum | Achieved in 100% of cases. |
| Secondary Endpoint: Incidence of complications | No reports of adverse events, colon tissue damage, or other complications during the procedure or in the 24 hours post-procedure follow-up. |
| Secondary Endpoint: Ability to complete therapeutic interventions | All applicable answers were scored as "Good" to "Excellent". All interventions were successfully completed without operational difficulties. The device did not interfere with inserting tools through the working channel or maneuvering the scope distal tip. |
| Secondary Endpoint: Procedure time | Not explicitly stated as a numerical finding. However, the procedure was conducted "without any interruption." |
| Secondary Endpoint: Ease of scope insertion, advancement, and withdrawal | "None of the users rated any figure of merit as 'unacceptable' or 'difficult'. All answers varied between 'excellent' to 'acceptable', while the vast majority of users' responses related to the device were rated as 'excellent'." |
| Secondary Endpoint: Ability to center the scope inside the gastrointestinal tract | Covered under the overall user feedback: "None of the users rated any figure of merit as 'unacceptable' or 'difficult'. All answers varied between 'excellent' to 'acceptable', while the vast majority of users' responses related to the device were rated as 'excellent'." |
| Secondary Endpoint: Subjective evaluation of the additional area screened by the physician | Not explicitly stated as a distinct finding, but implied by the device's function to "maintain the endoscopes field of view" and user feedback on device performance. |
| Secondary Endpoint: Patient wellbeing | No adverse events, complications or complaints of patient discomfort were observed during the procedures or reported in the 24 hours follow up. |
| Device Malfunction/Reliability Failure | No report of device malfunction or reliability failure. |
| User Rating of Performance (General) | None of the users rated any figure of merit as "unacceptable" or "difficult". Majority of users' responses rated as "excellent"; all varied between "excellent" to "acceptable". |
2. Sample size used for the test set and the data provenance
- Sample Size: 60 patients
- Data Provenance: Prospective clinical study conducted at Elisha Medical Center, Haifa, Israel. The population was described as "diverse adult population in terms of gender, ethnicity and age."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. This study is a clinical feasibility trial of a physical device, not an AI/ML algorithm requiring expert ground truth for classification or detection tasks. The performance metrics are based on clinical outcomes, user feedback, and observations during endoscopic procedures by the medical professionals conducting the colonoscopies.
4. Adjudication method for the test set
N/A. As this is a clinical feasibility study of a physical device, there is no mention of an adjudication method for data. Clinical outcomes and user experience were evaluated directly during the procedures.
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
N/A. This is a 510(k) submission for a physical medical device (EndoRings), not an AI/ML-driven diagnostic tool. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
N/A. The EndoRings is a physical accessory to an endoscope, not a standalone algorithm.
7. The type of ground truth used
The "ground truth" for this study is based on direct clinical observation, objective measurements (e.g., cecum reach), and subjective assessments by the clinicians performing the procedures, as well as patient follow-up for adverse events. This includes:
- Observational Data: Successful cecum reach, absence of complications.
- User Feedback: Clinicians' subjective scoring of ease of use, ability to complete interventions, scope centering, etc.
- Outcome Data: Absence of adverse events or patient discomfort during and after the procedure.
8. The sample size for the training set
N/A. There is no AI/ML component; therefore, no training set is applicable. The study involved clinical testing of a final production unit.
9. How the ground truth for the training set was established
N/A. Not applicable as there is no training set for an AI/ML algorithm.
§ 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.