(28 days)
Distal Cap Models DH-32EN and DH-17EN2 are intended to be used in combination with the dedicated endoscope to maintain the field of view during endoscopic procedures.
Distal Cap Models DH-32EN and DH-17EN2 are pre-sterilized, single-use accessories that are attached to the tip of an applicable FUJIFILM double balloon endoscope to maintain a clear, unobstructed field of view during endoscopic procedures.
The provided document is a 510(k) premarket notification for Distal Cap Models DH-32EN and DH-17EN2. This document is a regulatory submission for medical devices that demonstrates substantial equivalence to a legally marketed predicate device.
The document primarily focuses on demonstrating the safety and effectiveness of the new devices by comparing their technological characteristics and performance data to a predicate device (Distal Cap Model DH-39CZ). It does not describe a study involving an AI algorithm or human readers for diagnostic purposes. Therefore, most of the requested information regarding AI acceptance criteria, sample sizes for test/training sets, expert involvement, adjudication, MRMC studies, standalone algorithm performance, or the exact nature of ground truth as typically understood for AI/diagnostic studies, is not applicable to this type of medical device submission.
The "acceptance criteria" and "study" described in this document pertain to the physical properties, sterility, biocompatibility, and secure attachment of the distal caps, rather than the diagnostic performance of an AI system.
Here's a breakdown of the relevant information from the document in relation to your request, with an emphasis on what is not applicable:
1. A table of acceptance criteria and the reported device performance:
The document mentions "pre-defined acceptance criteria" for "Additional performance specifications" and states that "Bench testing was conducted to demonstrate that the subject devices are attached securely such that they will not detach during use." However, it does not provide a specific table detailing these acceptance criteria and the exact reported performance results. It only generally states that these evaluations were conducted and demonstrated equivalence.
For the aspects that are detailed, here's a summary of the performance evaluations conducted:
| Performance Evaluation Type | Acceptance Criteria (Implied/Stated) | Reported Device Performance |
|---|---|---|
| Sterility | Compliance with consensus standards: ISO 11135:2014, ISO 11607-1:2019, ASTM F1980-16 | Evaluated using these standards. (Implied successful demonstration of sterility to meet these standards for market clearance) |
| Biocompatibility | Compliance with consensus standards and FDA guidance: ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-7:2008, ISO 10993-10:2010, FDA guidance "Use of International Standard ISO 10993-1" (Sept 4, 2020) | Performed in accordance with these standards and guidance. (Implied successful demonstration of biocompatibility) |
| Secure Attachment | Devices must be attached securely such that they will not detach during use. | Bench testing conducted to demonstrate this. (Claimed successful demonstration) |
| Additional Performance Specifications | Pre-defined acceptance criteria (not specified in detail) | Evaluated against pre-defined acceptance criteria. (Implied successful evaluation) |
2. Sample size used for the test set and the data provenance:
- Not applicable in the context of an AI/diagnostic algorithm. The "testing" here refers to physical, chemical, and mechanical tests on the device itself.
- The document implies that multiple units of the device were tested for sterility, biocompatibility, and secure attachment, but it does not specify the sample sizes of devices (e.g., how many distal caps were tested for secure attachment).
- Data Provenance: The studies were conducted by FUJIFILM Corporation, a Japanese manufacturer, but the specific location of the testing laboratories is not provided. These are likely internal or contracted laboratory tests, not clinical data sets from specific countries. The studies are by nature prospective as they are conducted specifically for this regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of an AI/diagnostic algorithm. "Ground truth" here refers to objective measurements and compliance with scientific testing standards (e.g., a sterile product passes a sterility test, a material is biocompatible if it does not induce a toxic response). This does not involve expert readers reviewing images or clinical cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept typically applies to discrepancies in human reader interpretations of diagnostic data, which is not what this document describes.
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 document describes a medical device (a distal cap for endoscopes), not an AI diagnostic algorithm. There is no mention of human readers, AI assistance, or diagnostic performance evaluation in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical accessory, not an algorithm.
7. The type of ground truth used:
- Objective Test Results / Compliance with Standards: The "ground truth" for this device's performance is established by scientific and engineering principles, and compliance with recognized consensus standards (e.g., ISO for sterility and biocompatibility, ASTM for material testing). It is not pathology, outcomes data, or expert consensus in the diagnostic sense. For example, the ground truth for biocompatibility is whether the material elicits a biological response above acceptable limits, as measured by standard laboratory tests.
8. The sample size for the training set:
- Not applicable. This is not an AI algorithm. There is no concept of a "training set" for this type of device.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set or AI algorithm is involved.
In summary: The provided document is relevant to the regulatory clearance of a physical medical device. It demonstrates the device's safety and effectiveness through engineering specifications, sterility testing, and biocompatibility studies, asserting its "substantial equivalence" to a predicate device. It does not provide any information about the development or validation of an Artificial Intelligence (AI) diagnostic system, which is what most of your questions are geared toward.
§ 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.