(239 days)
Disposable Distal Cap is used with the endoscope and installed to the distal end of endoscope to keep appropriate endoscopic field of view.
Disposable Distal Cap is used with the endoscope and installed to the distal end of endoscope to keep appropriate endoscopic field of view. Disposable Distal Cap is a single structural product, a total of 3 types, and each type is divided into different specifications according to different inner diameter and the diameter of attaching endoscopic distal end. The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10⁻⁶ and placed in a sterility maintenance package to ensure a shelf life of one year.
The provided FDA 510(k) clearance letter and summary for the "Disposable Distal Cap" does not describe an AI medical device. Therefore, the requested information regarding acceptance criteria, study details, human reader performance, AI-specific ground truth, and training set information is not applicable and cannot be extracted from the given document.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (K984358) based on intended use, technological characteristics, and various performance and biocompatibility tests typical for a physical medical accessory. These tests ensure the device's physical and biological safety and performance, not the performance of an AI algorithm.
Below is a breakdown of what can be extracted or inferred from the provided text, but it will not fulfill the requirements for an AI device as those details are absent.
Acceptance Criteria and Device Performance (Non-AI Device)
Since this is not an AI device, there are no AI-specific performance metrics like sensitivity, specificity, AUC, etc. The acceptance criteria revolve around physical and biological attributes. The document states that the proposed device, "Disposable Distal Cap," is substantially equivalent to the predicate device, "Disposable Distal Attachment (K984358)". This substantial equivalence forms the primary "acceptance criterion" for clearance.
Table of Acceptance Criteria and Reported Device Performance (Based on Substantial Equivalence and Performance Data provided for a Non-AI Device):
| Item / Acceptance Criteria | Reported Device Performance (Disposable Distal Cap) | Remark |
|---|---|---|
| Intended Use | Used with the endoscope and installed to the distal end of endoscope to keep appropriate endoscopic field of view. | SE (Substantially Equivalent) to predicate's intended use ("keep the suitable depth of endoscope's view field"). |
| Configuration | Single structure, a component is a product | SE to predicate. |
| Sterility | Supplied Sterile | SE to predicate. |
| Sterilization Method | EO (Ethylene Oxide) | SE to predicate. Sterilization validated per ISO 11135:2014+A1:2018 to achieve SAL of 10⁻⁶. |
| Maximum Diameter (Specifications) | 11.35, 11.8, 12.4, 13.4, 14, 15, 15.7 | SE to predicate. Also demonstrated through Dimension Test. |
| Compatibility | Compatible with different diameters of endoscopy | Similar to predicate ("Compatible with different diameters of Olympus endoscopy"). Demonstrated through Endoscope Compatibility Test. |
| Single Use | Yes | SE to predicate. |
| Packaging | One product housed in protective cover and sealed pouch | SE to predicate. Packaging integrity tested per ASTM F1980-21 and ISO 11607-1/2:2019. |
| Shelf Life | One year | Similar to predicate (three years). Shelf-life testing demonstrated three-year stability via accelerated aging per ASTM F1980-21 and ISO 11607-1/2:2019. The "Remark" states "Similar" but the performance data mentions demonstrating "three-year stability", indicating it meets the predicate's shelf life. |
| Biocompatibility | Comply with ISO 10993-1 | SE to predicate. Tests conducted: Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity. |
| Labeling | Conforms to 21 CFR part 801 | SE to predicate. |
| Functional Performance (Specific tests conducted for the device) | Dimension Test: Conducted. | |
| Endoscope Compatibility Test: Conducted. | ||
| Endoscopic Field of View Test: Conducted. | ||
| Connection Force Test: Conducted. | These tests confirm the physical and functional aspects of the cap as intended. Side-by-side comparison testing was reported against the predicate device. |
Information NOT Applicable/Present for an AI Device:
- Sample size used for the test set and the data provenance: Not an AI device, so no "test set" in the context of AI algorithm evaluation. The testing involved physical device samples.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not an AI device. No ground truth established by experts for algorithmic performance.
- Adjudication method: Not an AI device. No adjudication method for algorithmic output.
- 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 an AI device. This type of study is irrelevant.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not an AI device.
- The type of ground truth used: Not an AI device. "Ground truth" for this device refers to meeting established engineering and biological safety standards (e.g., passing a cytotoxicity test, maintaining a certain connection force).
- The sample size for the training set: Not an AI device. No training set.
- How the ground truth for the training set was established: Not an AI device. No training set.
In summary, the provided document details the regulatory clearance for a physical medical accessory, not an AI medical device. Therefore, the questions specifically related to AI device performance and study design cannot be answered from this text.
§ 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.