(30 days)
The forceps valve is intended to facilitate passage of an endotherapy device, to prevent leak or back flow of air and/or fluids, and to enable the suction function of a FUJIFILM or Olympus gastrointestinal endoscope.
The FROG forceps valve forms a tight seal with the biopsy port to prevent leakage of biomaterial, provide easy passage of endotherapy devices, and support the suction function.
The provided document is a 510(k) premarket notification letter and a 510(k) summary for the FROG Forceps Valve (VAL1-F1-100). This device is an endoscope accessory and its clearance is based on substantial equivalence to a predicate device (JAZZ Forceps Valve (part of JAZZ Disposable Valve Kit) K210625).
The document does not describe a study involving an AI/Machine Learning device or a multi-reader multi-case (MRMC) comparative effectiveness study. Instead, it focuses on bench testing, biocompatibility testing, and a comparison of technological characteristics to a predicate device.
Therefore, the requested information regarding acceptance criteria, performance data, sample sizes, expert involvement, ground truth establishment, and MRMC studies related to an AI device cannot be extracted from this document, as it pertains to a different type of medical device clearance (forceps valve, not AI/ML).
The information that can be extracted regarding the FROG Forceps Valve is as follows:
FROG Forceps Valve (VAL1-F1-100) Analysis:
This device is a physical accessory for endoscopes, not an AI/ML diagnostic or assistive tool. The performance evaluation is based on bench testing and biocompatibility, not on AI model performance metrics or human reader studies.
1. Table of acceptance criteria and the reported device performance:
The document states: "Additional performance specifications were evaluated against pre-defined acceptance criteria to demonstrate the effectiveness of the device over its stated 2-year shelf life." However, the specific acceptance criteria and the detailed reported performance values are NOT provided in this summary.
2. Sample sizes used for the test set and the data provenance:
- Bench Testing: The document states "Bench testing was conducted to confirm the compatibility of the subject device with Olympus scopes." and "Additional performance specifications were evaluated...". The specific sample sizes for these bench tests are not mentioned.
- Biocompatibility Testing: The document refers to consensus standards (ISO 10993-1, -5, -7, -10) and FDA guidance for biocompatibility. Specific sample sizes for these tests are not provided.
- Data Provenance: The tests are likely laboratory-based bench tests and biocompatibility assessments, not clinical data from patients. The manufacturer is FUJIFILM medwork GmbH, located in Höchstadt, Germany, implying the testing would likely be performed in a controlled laboratory environment. Retrospective or prospective classification is not applicable here as it's not a clinical data study.
3. Number of experts used to establish the ground truth for the test set and the qualifications:
- This is not applicable as the device is a physical medical device (forceps valve), not an AI/ML diagnostic. Ground truth (e.g., for diagnostic accuracy) is not established by human experts in the context of this device's performance evaluation for FDA clearance. Performance is assessed via engineering and biocompatibility testing.
4. Adjudication method for the test set:
- Not applicable for this type of device and performance testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done:
- No, an MRMC study was NOT done. This type of study is relevant for diagnostic AI tools where human readers' performance with and without AI assistance is evaluated. This document concerns a physical endoscope accessory.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithm.
7. The type of ground truth used:
- For biocompatibility: Adherence to ISO standards and FDA guidance for biological evaluation.
- For performance: Engineering specifications and functional requirements (e.g., tight seal, easy passage of devices, support suction function). The "ground truth" is based on the device's ability to meet these pre-defined engineering performance criteria.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- 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.