(63 days)
The Dispos-A-Scope is intended for physician use enabling visual examination and certain treatment procedures involving the anal-rectal anatomy.
The Dispos-A-Scope is intended for physician use enabling visual examination and certain treatment procedures involving the anal-rectal anatomy. The Dispos-A-Scope has 11cm speculum length enabling visualization of the ano-rectal canal. The Dispos-A-Scope is constructed totally of a quasi-transparent resin. The resin has passed USP Class VI testing. The scope is designed for one time use and then disposal eliminating the risk of cross infection and nullifying the need for sterilization of the instrument. The Dispos-A-Scope is non-powered. It does not conduct electricity and is non-thermogenic. The Dispos-A-Scope resin is quasi-compliant to external forces and will not crack or craze during normal usage. The Dispos-A-Scope has an operative port enabling precise isolation of tissue and pathology. The Dispos-A-Scope has a replaceable obturator facilitating device insertion and rotation for precise operative port placement during examination and treatment procedures. The Dispos-A-Scope has an ergonomic handle facilitating accurate physician manipulation.
This submission for the Dispos-A-Scope does not contain information about a study proving the device meets specific acceptance criteria in the manner typically associated with AI-driven medical devices or complex diagnostic tools.
Instead, the provided text is a 510(k) summary for a disposable anoscope, which is a physical medical device. The "acceptance criteria" discussed are primarily related to general device characteristics, material safety, and functionality, rather than quantitative performance metrics from a clinical study. The "study" mentioned is the USP Class VI testing for the resin, which is a biocompatibility standard, not a performance study in the traditional sense of comparing a device's diagnostic output against a ground truth.
Therefore, many of the requested categories for a study (e.g., sample size for test/training set, number of experts, adjudication methods, MRMC study, standalone performance) are not applicable or cannot be extracted from this document, as they pertain to the evaluation of algorithms or diagnostic efficacy, which is outside the scope of this particular device's submission.
Here's an attempt to address the request based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Derived from device description) | Reported Device Performance (from submission) |
|---|---|
| Intended Use: Visual examination and certain treatment procedures involving anal-rectal anatomy. | The Dispos-A-Scope is intended for physician use enabling visual examination and certain treatment procedures involving the anal-rectal anatomy. |
| Speculum Length Requirement: Enable visualization of the ano-rectal canal. | The Dispos-A-Scope has 11cm speculum length enabling visualization of the ano-rectal canal. |
| Material Safety/Biocompatibility: Resin construction. | The Dispos-A-Scope is constructed totally of a quasi-transparent resin. The resin has passed USP Class VI testing. |
| Sterilization/Cross-infection Risk: Designed for single-use and disposal. | The scope is designed for one time use and then disposal eliminating the risk of cross infection and nullifying the need for sterilization of the instrument. |
| Power Requirements: Non-powered, non-conductive, non-thermogenic. | The Dispos-A-Scope is non-powered. It does not conduct electricity and is non-thermogenic. |
| Material Integrity: Quasi-compliant, resistant to cracking/crazing during normal usage. | The Dispos-A-Scope resin is quasi-compliant to external forces and will not crack or craze during normal usage. |
| Functionality: Operative port for tissue isolation. | The Dispos-A-Scope has an operative port enabling precise isolation of tissue and pathology. |
| Functionality: Replaceable obturator for insertion and precise port placement. | The Dispos-A-Scope has a replaceable obturator facilitating device insertion and rotation for precise operative port placement during examination and treatment procedures. |
| Ergonomics: Ergonomic handle for accurate physician manipulation. | The Dispos-A-Scope has an ergonomic handle facilitating accurate physician manipulation. |
| Substantial Equivalence: To legally marketed predicate devices. | The FDA determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act. (This is the primary "acceptance criterion" for 510(k) clearance). |
2. Sample size used for the test set and the data provenance
The document refers to USP Class VI testing for the resin material. This is a standard battery of biocompatibility tests conducted on materials to demonstrate their safety for medical device use.
- Sample Size for Test Set: Not specified in this document. USP Class VI testing involves standardized tests on biological systems, often using a certain number of animal subjects (e.g., mice, rabbits) or cell cultures per test, depending on the specific battery of tests performed (e.g., systemic toxicity, intracutaneous reactivity, implantation). The document only states that the resin "has passed" this testing.
- Data Provenance: Not specified, but generally, such testing would be conducted in a laboratory setting, typically in the country of manufacture or a certified testing facility. It is a prospective test specifically for the material in question.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. USP Class VI testing involves standardized biological response evaluations, not expert clinical interpretation of results. The "ground truth" is defined by the passing criteria of the USP (United States Pharmacopeia) standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for USP Class VI testing. The results are typically quantitative measurements and observations against predefined criteria, not subjective interpretations requiring adjudication.
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
Not applicable. This is a physical medical device, not an AI-assisted diagnostic tool.
6. 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.
7. The type of ground truth used
For the material safety aspect, the "ground truth" is defined by the passing criteria outlined in the USP Class VI standard for biocompatibility and toxicity. For the functional aspects (e.g., ergonomic handle, operative port), the implicit ground truth is that the device possesses these features as designed and these features contribute to the device's intended use and substantial equivalence to predicate devices. There is no external "ground truth" in the sense of pathology or outcome data generated by this device's use that is presented here.
8. The sample size for the training set
Not applicable. The specific device described is a physical anoscope, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. There is no AI model or training set discussed in this document.
§ 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.