(110 days)
The AIR/WATER VALVE MAJ-1444 and SUCTION VALVE MAJ-1443 have been designed for use with an Olympus ultrasound endoscope for the gastrointestinal (GI) tract, as follows.
Air/Water Valve (MAJ-1444)
- To feed air to remove any fluids or debris adhering to the objective lens.
- To feed water for lens washing.
- To fill the balloon with sterile water.
Suction Valve (MAJ-1443)
- To remove any fluids, debris, or air from the patient.
- To remove the water from the balloon.
The Suction Valve MAJ-1443 and Air/Water Valve MAJ-1444 have been designed for use with an Olympus ultrasound endoscope for the gastrointestinal (GI) tract. The subject devices are reusable. The subject devices are compatible with Olympus endoscopes GF-UCT180 and GF-UE160-AL5.
The Suction Valve MAJ-1443 is attached to the suction cylinder of a compatible endoscope to remove any fluids, debris, or air from the patient and to remove water from the balloon. Suction Valve MAJ-1443 has no patient-contacting components and is a reusable device.
The Air/Water Valve MAJ-1444 is attached to the air/water cylinder of a compatible endoscope to feed air to remove any fluid or debris adhering to the objective lens, to feed water for lens washing, and to fill the balloon with sterile water. MAJ-1444 has indirect patient-contacting components and is a reusable device.
The subject device has the same technological characteristics and similar design as the applicable predicate device.
The provided text is an FDA 510(k) clearance letter for two medical device accessories: the Suction Valve (MAJ-1443) and the Air/Water Valve (MAJ-1444). These devices are classified as endoscopic accessories.
Based on the information provided, the study conducted to prove the device meets acceptance criteria focused on bench testing to demonstrate the functionality of reusable accessories, rather than a clinical study involving human patients, AI integration, or multi-reader multi-case (MRMC) studies.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance:
The document states: "The following performance bench tests were conducted. All test samples passed pre-defined acceptance criteria." However, it does not provide the specific numerical acceptance criteria or the quantitative reported performance for each test. It only lists the types of tests performed.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Suction Valve MAJ-1443 | All test samples passed pre-defined acceptance criteria. |
| - Endoscope compatibility | (Specific criteria and performance not detailed) |
| - Suction rate | (Specific criteria and performance not detailed) |
| - Balloon suction rate | (Specific criteria and performance not detailed) |
| - Leakage | (Specific criteria and performance not detailed) |
| - Depression Force | (Specific criteria and performance not detailed) |
| - Composite Durability | (Specific criteria and performance not detailed) |
| Air/Water Valve MAJ-1444 | All test samples passed pre-defined acceptance criteria. |
| - Endoscope compatibility | (Specific criteria and performance not detailed) |
| - Air flow rate | (Specific criteria and performance not detailed) |
| - Water flow rate | (Specific criteria and performance not detailed) |
| - Balloon water rate | (Specific criteria and performance not detailed) |
| - Leakage | (Specific criteria and performance not detailed) |
| - Depression Force | (Specific criteria and performance not detailed) |
| - Composite Durability | (Specific criteria and performance not detailed) |
| - Microbiological Evaluation of Backflow Prevention | (Specific criteria and performance not detailed) |
Therefore, while the document confirms that acceptance criteria were predefined and met, the specific details of these criteria and the quantitative performance results are not included in this FDA clearance letter. This information would typically be found in the full 510(k) submission.
Regarding the other points of your request, much of the requested information (especially concerning AI, human readers, ground truth establishment for AI models, and large-scale clinical studies) is not applicable to this particular device and its clearance.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: The document simply states "Test samples were final, finished devices." It does not specify the number of samples tested for each performance bench test.
- Data Provenance: The tests were "bench testing" performed by Olympus. The data provenance is laboratory/bench data generated internally for regulatory submission. It is not patient data, and therefore, concepts like "country of origin of the data" or "retrospective/prospective" study design in a clinical sense do not apply.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For a device like an endoscope valve, the "ground truth" for its performance is typically established through engineering specifications, material science, and functional testing as defined by recognized standards and internal quality control. This does not involve expert readers establishing ground truth on medical images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are relevant for studies where human interpretation of data (e.g., medical images) is involved and consensus is needed. For bench testing of mechanical or functional properties, the "adjudication" is based on objective measurements against engineering specifications.
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:
- No. This was not an AI-enabled device. The document describes a traditional medical device accessory (valves for endoscopes). MRMC studies are specific to evaluating diagnostic performance, often of AI algorithms assisting human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is not an algorithm. It's a physical accessory; therefore, standalone algorithm performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For these devices, the "ground truth" is defined by engineering specifications and functional requirements (e.g., specific flow rates, suction pressures, resistance to leakage, durability under repeated use, compatibility with specified endoscopes). Successful performance means meeting these pre-defined technical criteria. There is no biological "ground truth" like pathology for these mechanical accessories.
8. The sample size for the training set:
- Not Applicable. This is not an AI/machine learning device; hence, there is no "training set."
9. How the ground truth for the training set was established:
- Not Applicable. Since there is no training set, no ground truth was established for it.
In summary: The provided FDA 510(k) clearance letter pertains to reusable endoscope valves. The clearance was based on bench testing demonstrating the functional performance and durability of the devices. It is a traditional medical device clearance and does not involve AI, clinical efficacy studies with human participants, or complex ground truth establishment methods typical for AI or diagnostic imaging devices. The specific quantitative acceptance criteria and detailed performance results from these bench tests are not present in this summary document but would be part of the full 510(k) submission.
§ 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.