(28 days)
This product is a single use distal end cap required to be attached to certain FUJIFILM endoscopes during clinical use to assist in providing atraumatic passage of the endoscope tip during endoscopic procedures.
Do not use this product for any other purposes.
FUJIFILM Distal End Cap DC-08D is a single use device that is supplied sterile, eliminating the need for reprocessing prior to use. This distal end cap is designed to the distal tip of a FUJIFILM ED-580XT duodenoscope. After an endoscopic procedure, the DC-08D is detached to facilitate easier access to the distal elevator during reprocessing of the ED-580XT.
The available document is a 510(k) Summary for the FUJIFILM Distal End Cap DC-08D. It details the device's characteristics and compares it to a predicate device (FUJIFILM Distal End Cap DC-07D). However, it does not contain details about a clinical study involving human readers or an AI algorithm’s standalone performance, as the device is a medical accessory, not an AI diagnostic tool.
Therefore, many of the requested sections about acceptance criteria and study details for AI performance are not applicable and cannot be extracted from this document.
Here's the information that can be extracted, along with an explanation for the unavailable sections:
1. A table of acceptance criteria and the reported device performance
The document mentions that "Additional performance specifications were evaluated against pre-determined acceptance criteria" and that "Bench testing was conducted to demonstrate that the subject device is attached securely such that it will not detach during use." However, it does not explicitly list the specific acceptance criteria or quantitative performance results in a table format. It only states that the device was evaluated for conformance to ISO 8600-1:2015 and other standards.
| Acceptance Criteria (Not explicitly stated in detail) | Reported Device Performance (Summary) |
|---|---|
| Sterility (Based on consensus standards) | Evaluated using ASTM F1980-16, ISO 11137-1:2006, ISO 11607-1:2019, ISO 11607-2:2019. (Implies successful evaluation). |
| Biocompatibility (Based on international standards) | Evaluated using ISO 10993-1:2018, ISO 10993-5:2009, and ISO 10993-10:2010 per FDA guidance. (Implies successful evaluation). |
| Secure attachment during use | Bench testing conducted to demonstrate secure attachment and no detachment during use. (Implies satisfactory performance). |
| Conformance to ISO 8600-1:2015 | Evaluated for conformance to ISO 8600-1:2015. (Implies successful conformance). |
| Other performance specifications | Evaluated against pre-determined acceptance criteria. (Implies satisfactory performance, but criteria not detailed). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as the document describes the regulatory submission for a physical medical device (an end cap), not an AI algorithm requiring a test set of data. The "testing" mentioned refers to bench testing, sterility testing, and biocompatibility testing of the physical product, not data analysis.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. Ground truth for data analysis is not relevant for this physical device submission. The "ground truth" for this device would be established by validated engineering and scientific methods and standards (e.g., successful sterilization, material safety, secure attachment), not by expert consensus on data interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the reasons stated above.
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
This information is not applicable. The device is an end cap for an endoscope, not an AI system designed to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a physical medical accessory, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As mentioned, the concept of "ground truth" for data analysis is not applicable here. The verification of the device's properties relies on scientific and engineering testing methods, such as:
- Sterility verification: Based on biological indicators and established sterilization cycles.
- Biocompatibility verification: Based on in-vitro and/or in-vivo tests according to ISO standards.
- Mechanical integrity: Based on bench testing to ensure secure attachment and durability during use.
8. The sample size for the training set
This information is not applicable as there is no AI algorithm and therefore no training set for data.
9. How the ground truth for the training set was established
This information is not applicable as there is no AI algorithm and therefore no training set.
§ 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.