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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

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

1. 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.

2. 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.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • This information is not provided in the given text.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

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The WORRRY-REMOVER™ IRRIGATOR is designed for use as a vaginal douche apparatus for general feminine hygiene applications.

The irrigating-bottle is hand-squeezed to force the cleaning solution to slowly and completely flow into the vaginal cavity. The one-way liquid valve permits the fluid to flow only from the bottle into the vaginal cavity but not back to the bottle, preventing contaminations of the solution and bottle. The one-way air valve permits air to flow into the bottle to prevent production of negative pressure within the bottle. The flow speed of the liquid is controlled by the user's hand. This system makes the process of vaginal irrigation much easier, neater, and more relaxing than using some other types of irrigators.

This document is a 510(k) premarket notification for the WORRY-REMOVER™ IRRIGATOR, a vaginal douche apparatus. The provided text, however, focuses on establishing substantial equivalence to predicate devices and does not contain detailed information about specific acceptance criteria or an analytical study proving the device meets those criteria.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert qualifications, and ground truth cannot be extracted from this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

Explanation: The document does not specify any quantitative or qualitative acceptance criteria for the device beyond its intended use and comparison to predicate devices. It states that the device is "substantially equivalent" to predicate devices, but doesn't define what specific performance metrics constitute this equivalence or how they were measured.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not mentioned.
• Data Provenance: Not mentioned.

Explanation: The document does not describe any specific testing, clinical study, or data collection that would involve a test set. The submission is based on substantial equivalence to existing devices.

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)

• Number of Experts: Not applicable, as no ground truth establishment for a test set is described.
• Qualifications of Experts: Not applicable.

Explanation: There is no indication of human experts being used to establish ground truth because there's no mention of a study involving a test set that would require such expert review.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: Not applicable.

Explanation: No test set or corresponding adjudication process is mentioned in the document.

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

• MRMC Study: No.

Explanation: The device is a physical vaginal irrigator, not an AI-assisted diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance Study: No.

Explanation: As mentioned, this is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Type of Ground Truth: Not applicable, as no new ground truth was established for this submission. The basis for approval is substantial equivalence to legally marketed predicate devices.

Explanation: The "proof" for this device meeting its criteria is its substantial equivalence to previously cleared devices (La Joie Vaginal Cleaner Container (K000736) and Peri-Bottle (K902830)). The ground truth, in this context, would implicitly refer to the safety and effectiveness of the predicate devices as established when they were originally cleared.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable.

Explanation: This is not an AI/machine learning device, so there is no concept of a "training set."

9. How the ground truth for the training set was established

• Ground Truth Establishment for Training Set: Not applicable.

Explanation: As this is not an AI/machine learning device, there is no training set or associated ground truth establishment process.

Summary of the Study (Based on Provided Text):

The "study" described in the 510(k) submission is not a traditional analytical or clinical study with a test set, ground truth, or performance metrics. Instead, it is a substantial equivalence comparison to predicate devices.

• Device Name: WORRY-REMOVER™ IRRIGATOR
• Intended Use: "designed for use as a vaginal douche apparatus for general feminine hygiene applications."
• Predicate Devices Identified: La Joie Vaginal Cleaner Container (K000736) and Peri-Bottle (K902830).
• Conclusion: The submitter asserts, and the FDA agrees, that "WORRRY-REMOVER™ Irrigator is substantially equivalent to the predicate devices" in terms of its indication for use.

The document does not provide any detailed data from performance testing, clinical trials, or user studies that would typically be associated with proving a device meets specific acceptance criteria via a study. The FDA's clearance is based on the argument that because it's similar enough to already-approved devices, it should be equally safe and effective.

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Ask a specific question about this device