(78 days)
The family of THD disposable Anoscope, Proctoscope, Rectoscope and Light-scope is intended for physician use to examine the anal sphincter, anus, rectum, and, using additional accessories, to perform various diagnostic and therapeutic procedures.
The Family of THD disposable Anoscope, Proctoscope, Rectoscope and Light-scope are disposable not sterile rectoscopes, proctoscopes and anoscopes with a light source external or integrated on the handle. The devices are designed for the examination and treatment of the anal (anoscopes) and rectum (proctoscopes and rectoscopes) examination. The devices consist of transparent plastic anoscope, proctoscope or rectoscope for diagnostic or therapeutic use. The Family of THD disposable Anoscope, Proctoscope, Rectoscope and Light-scope is made by two categories of devices: Diagnostic Anoscopes, Proctocope and Rectoscope and Surgical Proctoscopes. The Family of THD disposable Anoscope, Proctoscope, Rectoscope and Light-scope include both models which require the external light source and models which not require the external light source, in this case the light source is integrated on the handle. The external light source is provided as accessory of the family and it can be the THD Shining Light and the THD pen light.
Here's an analysis of the provided text regarding the acceptance criteria and study for the THD disposable anoscopes, proctoscopes, rectoscopes, and light-scope:
1. Table of Acceptance Criteria and Reported Device Performance
| Modification | Test Performed | Acceptance Criteria | Reported Device Performance/Conclusion |
|---|---|---|---|
| New handle designed without integrated light source | Design verification and effectiveness test | Safety and effectiveness of the device | Met (implied by 510(k) clearance) |
| New handle designed with a LED integrated light source | Design verification, Safety and electromagnetic tests | Safety and effectiveness of the device | Met (implied by 510(k) clearance) |
| White tip in the new anoscope models | Design verification | Safety and effectiveness of the device | Met (implied by 510(k) clearance) |
| Lens without hole in the new rectoscope | Design verification | Safety and effectiveness of the device | Met (implied by 510(k) clearance) |
| New packaging of rectoscope with inflation bulb | Design verification and effectiveness test | Safety and effectiveness of the device | Met (implied by 510(k) clearance) |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The tests performed are described as "Design verification and effectiveness test," "Safety and electromagnetic tests," and "Design verification." These descriptions typically refer to internal engineering and functional testing rather than clinical studies with human subjects.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not mention using experts to establish ground truth for a test set. The tests appear to be related to the device's physical and functional properties, as opposed to diagnostic performance requiring expert interpretation.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method. This type of method is typically used in clinical trials where multiple readers interpret results to establish a consensus ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or mentioned in the provided text. The submission is for device modifications to an already cleared predicate device, focusing on functional and safety aspects of the changes rather than clinical effectiveness comparisons.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is a medical device (anescope, proctoscope, rectoscope) for direct observation and intervention, not an imaging or algorithmic diagnostic device. Therefore, a standalone (algorithm only) study is not applicable and was not performed.
7. Type of Ground Truth Used
The ground truth for the "tests performed" appears to be based on engineering specifications, safety standards, and functional requirements to ensure the device's "safety and effectiveness." It is not based on expert consensus, pathology, or outcomes data in the clinical sense for these verification tests.
8. Sample Size for the Training Set
The concept of a "training set" is not applicable to this device's verification and validation process described. Training sets are typically used for machine learning algorithms, which are not involved here.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set in the context of this device and its studies, the method for establishing its ground truth is not applicable.
§ 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.