(25 days)
The O'Regan Disposable Anoscope is intended for physician use to examine the anal sphincter and anus, and, using additional accessories, to perform various diagnostic and therapeutic procedures.
Similar to device's marketed prior to or after May 28, 1976. The O'Regan Disposable Anoscope is identical to other legal marketed devices such as the Dispos-A-Scope in terms of material, disposability, non-powered, design, and usage. The O'Regan Disposable Anoscope is constructed from a Medical Grade-Atohass Medical SG& 101PH material, and is FDA certified. The O'Regan Disposable Anoscope is for single patient use only, thus disposable eliminating the risk of cross infection and nullifying the need for sterilization. The O'Regan Disposable Anoscope is non-powered. It does not conduct electricity and is nonthermogenic. The O'Regan Disposable Anoscope has a distal and proximal port enabling precise isolation and accuracy of tissue or pathology. The O'Regan Disposable Anoscope has an ergonomic handle facilitating accurate physician manipulation. The O'Regan Disposable Anoscope will not crack or craze during normal one time usage.
The provided text describes a 510(k) submission for the O'Regan Disposable Anoscope. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the manner typically seen for novel AI/software devices.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment will not be present in this type of submission.
Here's an explanation based on the provided text:
- No specific acceptance criteria or device performance metrics are reported. The submission's core argument is that the O'Regan Disposable Anoscope is "identical to other legal marketed devices such as the Dispos-A-Scope in terms of material, disposability, non-powered, design, and usage." The FDA's letter confirms substantial equivalence, which means it met the regulatory requirements for this type of device based on comparison to a predicate, not through a new performance study demonstrating specific metrics against predefined acceptance criteria.
- The study described is a comparison to a predicate device, not a performance study as typically understood for AI/software. The document establishes equivalence to the Dispos-A-Scope (K993738).
- No sample size for test sets or data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone performance studies were conducted or reported. These types of studies are not typically required for a Class II medical device like an anoscope when demonstrating substantial equivalence. The "study" here is a declarative comparison to a predicate device.
- The ground truth is the established safety and effectiveness of the legally marketed predicate device. By establishing substantial equivalence, the O'Regan Disposable Anoscope relies on the "ground truth" that the predicate device (Dispos-A-Scope) is safe and effective for its intended use.
- No training set or ground truth establishment for a training set is mentioned. This information is relevant for AI/machine learning devices, which is not the case here.
Summary Table (with explanations for missing data):
| Information Type | Details / Explanation from the Document |
|---|---|
| 1. Acceptance Criteria and Reported Device Performance | Not applicable in the context of this 510(k) for a physical, non-AI device. The acceptance criterion was demonstrating substantial equivalence to the predicate device (Dispos-A-Scope, K993738). The reported "performance" is that the device is "identical to other legal marketed devices such as the Dispos-A-Scope in terms of material, disposability, non-powered, design, and usage." Specific quantitative performance metrics are not provided as it's a direct comparison. |
| 2. Sample size and data provenance for test set | Not applicable. No test set was used in the context of a performance study. The submission relies on a comparison to a predicate device. |
| 3. Number and qualifications of experts for ground truth (test set) | Not applicable. No external experts were used to establish ground truth for a test set, as no test set (in a performance study sense) was described. The "ground truth" is the regulatory acceptance of the predicate device based on its prior review and market history. |
| 4. Adjudication method (test set) | Not applicable. No test set was used. |
| 5. MRMC comparative effectiveness study (effect size human readers with/without AI) | Not applicable. This device is a physical anoscope, not an AI-assisted diagnostic tool. |
| 6. Standalone "algorithm only" performance study | Not applicable. This device is a physical anoscope, not an algorithm. |
| 7. Type of ground truth for test set | Not applicable. The "ground truth" for this 510(k) is the regulatory finding that the predicate device is safe and effective, and that the new device is substantially equivalent to it. |
| 8. Sample size for training set | Not applicable. This device is a physical anoscope, not an AI/ML model that requires a training set. |
| 9. How ground truth for training set was established | Not applicable. No training set for an AI/ML model was involved. |
In essence, this 510(k) submission is for a conventional medical device seeking market clearance through substantial equivalence, not for a software or AI device that would typically involve the comprehensive performance studies and data described in the prompt.
§ 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.