(418 days)
The Milli Vaginal Dilator is a tool intended for controlled dilation of the vagina. It can be used for dilation for an examination (by your doctor), in preparation for a surgical procedure, or to help relieve the symptoms of vaginismus (condition that involves tightening of the vaginal muscles) and related painful sex.
The Milli Vaginal Dilator is a patient-controlled vaginal dilator that provides therapy for vaginal tightness through stretching of the vaginal tissue under electromechanical expansion, one millimeter at a time. The Milli Vaginal Dilator expands electronically in increments of 1mm from a baseline of 15mm to 40mm in diameter. Dilation and contraction of the Milli Vaginal Dilator is at the control of the user with a simple button push of either the + or - buttons. The Milli Vaginal Dilator is a single vaginal dilator tool that encompasses the diameter range of many commercially available dilator sets, allowing the user to increase the diameter in smaller increments while the device remains inserted, eliminating the need for removal and insertion of larger sizes. The dilation setting is provided on the user interface to allow the user to easily track dilation progress. The Milli Vaginal Dilator also incorporates a vibration feature that may be used as desired to promote relaxation. The Milli Vaginal Dilator is battery powered and provided with a storing/charging case and a USB/adaptor to facilitate charging. The subject device is intended to be sold over the counter (OTC), to be purchased online without the support of a healthcare provider.
The Milli Vaginal Dilator (K220035) does not meet the specified input requirement of being an AI/ML device, as it is a physical medical device. Therefore, a comprehensive analysis of AI/ML-specific acceptance criteria, test sets, ground truth establishment, and comparative effectiveness against human readers is not applicable.
However, based on the provided text, I can extract the following information regarding the device's performance assessment and criteria for its clearance:
The device, Milli Vaginal Dilator, is intended for "controlled dilation of the vagina. It can be used for dilation for an examination (by your doctor), in preparation for a surgical procedure, or to help relieve the symptoms of vaginismus (condition that involves tightening of the vaginal muscles) and related painful sex." The current 510(k) submission (K220035) is for Over-The-Counter (OTC) use, whereas its predicate (K211959) was for Prescription (Rx) use. The primary study presented aims to demonstrate that users can self-select appropriately for the OTC version.
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance and Summary of Evidence |
|---|---|---|
| Nonclinical Performance (Technical) | Established specifications necessary for consistent performance for its intended use. This broadly covers various aspects of device design, manufacturing, and safety. Specific tests included: Shelf-Life Storage and Packaging (Transit) TestingBiocompatibility TestingSoftware Verification TestingElectromagnetic Compatibility and Electrical Safety TestingSize and Dilation Design VerificationCharging/Cleaning VerificationReliability TestingEngineering Evaluation | The collective results of the nonclinical performance testing demonstrate that the materials chosen, the manufacturing processes, and design of the Milli Vaginal Dilator meet the established specifications necessary for consistent performance for its intended use. (The document states that the proposed and predicate device are technologically identical, so all nonclinical tests from K211959 apply.) |
| Clinical Performance (OTC Self-Selection) | Prospective users of the Milli Vaginal Dilator can accurately determine if they are appropriate candidates for use of the device, based on review of the device labeling (website), without the support of a Health Care Professional (HCP). This aimed to establish that OTC use is as effective as prescription use in terms of appropriate patient selection. | 96% (24 of 25) of the potential users of the Milli Vaginal Dilator could correctly determine whether they are appropriate candidates for use of the device, based on review of the Milli ordering webpage prior to purchase. This was determined by comparing the subject's unaided self-assessment with an assessment by a healthcare professional (blinded to the self-assessment). |
| Risk Analysis | No new risks introduced by the OTC indication. | A risk analysis concluded that there were no new risks for the OTC indication. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Clinical (Self-Selection) Study: 25 subjects.
- Data Provenance: Prospective, multi-center study. The text does not specify the country of origin, but generally, FDA submissions involve studies conducted in the US unless otherwise stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: The ground truth for the self-selection study was established by one healthcare professional (HCP) for each subject.
- Qualifications of Experts: The text refers to them generally as "healthcare professional," but does not provide specific qualifications (e.g., "radiologist with 10 years of experience"). However, for a vaginal dilator, it would typically imply a gynecologist, family physician, or similar medical practitioner.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: The study used a comparison method where each subject's "unaided self-assessment" was compared against "the assessment by the healthcare professional, after an in-person evaluation of the subject and blinded to the subject's prior self-assessment." This is a direct comparison against a single blinded expert's assessment for each subject, rather than a multi-expert consensus or adjudication model.
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 MRMC comparative effectiveness study was done. This device is a physical medical device, not an AI/ML diagnostic tool meant to assist human readers. Therefore, this question is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No standalone (algorithm-only) performance study was done. This is a physical device, not an algorithm. The "standalone" performance closest to this concept would be the device's technical performance (e.g., dilation accuracy, reliability), which was assessed through nonclinical testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the self-selection clinical study, the ground truth for appropriate candidacy was the assessment by a healthcare professional (HCP) after an in-person evaluation.
8. The sample size for the training set:
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. As the "training set" concept is not relevant for this physical device.
§ 884.3900 Vaginal stent.
(a)
Identification. A vaginal stent is a device used to enlarge the vagina by stretching, or to support the vagina and to hold a skin graft after reconstructive surgery.(b)
Classification. Class II (performance standards).