(24 days)
The Spirus Medical, Inc. Endo-Ease Endoscopic Overtube is indicated for use with a flexible endoscope to aid in endoscopic insertion and advancement during diagnostic and therapeutic lower GI flexible endoscopy.
The device described in this 510(k) consists of a a modified sterile, single use, flexible over ube designed for use with currently marketed flexible endoscopes in the lower GI tract.
The provided text is related to a 510(k) submission for a medical device called "Endo-Ease Endoscopic Overtube." This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with acceptance criteria for device performance.
Therefore, the input does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. The text explicitly states it's a "Special 510(k): Device Modification" and relies on compliance with design control requirements and verification/validation testing of the modifications, implying that extensive clinical studies with new performance metrics were not required for this specific submission.
Here's a breakdown of why each requested point cannot be answered:
- A table of acceptance criteria and the reported device performance: This information is not present. The submission focuses on device modification and equivalence to a predicate, not new performance metrics from a clinical study.
- Sample sized used for the test set and the data provenance: Not applicable as a clinical performance study with a test set is not described. The text mentions "verification and validation testing methods and results" but does not detail the sample sizes or data provenance for these engineering/design tests.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth is typically for diagnostic devices or those requiring expert interpretation, which is not the primary focus of this overtube device's submission.
- Adjudication method for the test set: Not applicable as a clinical performance study with expert adjudication is not described.
- 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 an endoscopic overtube, not an AI-powered diagnostic or assistive tool for human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as detailed clinical performance studies requiring ground truth are not outlined. The "safety and performance" claim refers to demonstrated equivalence and successful engineering/design verification.
- The sample size for the training set: Not applicable as this is not an AI/algorithm-based device.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a 510(k) summary for a device modification, emphasizing substantial equivalence and design control compliance, rather than presenting clinical study data with specific acceptance criteria as you would find for a de novo device or a device requiring new clinical evidence.
§ 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.