(167 days)
The WaterWorks® Douching Device is indicated for the reduction or abatement of perceived vaginal odor with or without complaints of discharge in women with no infectious cause of vaginitis.
The Water Works® Douching Device is a reusable system consisting of a customized 32 ounce, water container, connecting hose and a stainless steel nozzle. A hose clamp for controlling water flow through the hose and a plastic loop to attach the container to a shower head are also provided. The container is filled with tepid tap water which flows through the hose to the nozzle. The water container is hung approximately 3 feet above the vagina (eye-level).
Here's a breakdown of the acceptance criteria and study details for the WaterWorks® Douching Device, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Proportion of subjects meeting success criteria | WaterWorks® Group: 78% |
| (Implicit) No adverse effects on vaginal eco-system | Changes in lactobacillus score and Nugent Score were similar to the Control Group. |
| (Implicit) No significant increase in other adverse events | Other adverse events were similar in nature and frequency to the Control Group. |
Note: The document doesn't explicitly state numerical acceptance criteria for "no adverse effects" but rather compares the device's performance to the control group, implying that similar or better performance compared to the control satisfies this criterion.
Study Details
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Sample size used for the test set and data provenance:
- The document states "A comparative, randomized, and blinded multicenter clinical trial." It does not explicitly state the total sample size for the test set; it only provides the proportion of subjects meeting the success criterion for the WaterWorks® Group (78%) and the Control Group (38.5%).
- Data provenance: Not explicitly stated, but clinical trials are generally prospective in nature. The country of origin is not mentioned.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the given text. Ground truth for clinical trials often involves clinical endpoints assessed by healthcare professionals, but the details of their role and number are absent.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided in the given text.
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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 device is a physical douching apparatus, not an AI-assisted diagnostic or medical imaging device. Therefore, an MRMC study or AI-related effectiveness is not applicable.
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If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
- No. As stated above, this is a physical device, not an algorithm. Standalone performance is not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "success criterion" for the clinical trial appears to be related to the "reduction or abatement of perceived vaginal odor with or without complaints of discharge." This suggests patient-reported outcomes or clinical assessment by healthcare providers based on pre-defined criteria.
- Adverse effects were quantified by changes in lactobacillus score and Nugent Score, which are objective laboratory/clinical measurements.
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The sample size for the training set:
- This information is not applicable/not provided. The device is a physical product, not an AI model that requires a training set. The study described is a clinical trial to evaluate the device's performance directly.
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How the ground truth for the training set was established:
- This information is not applicable/not provided. There is no "training set" in the context of this physical device's evaluation.
§ 884.5900 Therapeutic vaginal douche apparatus.
(a)
Identification. A therapeutic vaginal douche apparatus is a device that is a bag or bottle with tubing and a nozzle. The apparatus does not include douche solutions. The apparatus is intended and labeled for use in the treatment of medical conditions except it is not for contraceptive use. After filling the therapeutic vaginal douche apparatus with a solution, the patient uses the device to direct a stream of solution into the vaginal cavity.(b)
Classification. (1) Class II (performance standards).(2) Class I if the device is operated by gravity feed. Devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.