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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:

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.

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The Milli Vaginal Dilator is a tool intended for controlled dilation of the vagina. It can be used for dilation for an examination, in preparation for a surgical procedure, or to help relieve the symptoms of vaginismus and related dyspareunia.

The Milli Vaginal Dilator is a patient-controlled vaginal dilator that provides therapy through distention of the vaginal tissue under electromechanical expansion. The device is intended for use for adult women (>=18 years) who need controlled vaginal dilation for an examination, in preparation for a surgical procedure, or to help relieve the symptoms of vaginismus and related dyspareunia. 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 are completed by 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. 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. The Milli Vaginal Dilator is battery powered and provided with a storing/charging case and a USB/adaptor to facilitate charging. The Milli Vaginal Dilator is intended for use in a home or healthcare environment. The device is intended for prescription (Rx) use, and the treatment duration, frequency, and length are specified in the Instructions for Use and/or at the discretion of the physician.

The provided text does not contain acceptance criteria or a study that proves the device meets acceptance criteria in the way typically expected for a medical device.

This document is a 510(k) Premarket Notification for the Milli Vaginal Dilator, which is a process to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove the device meets specific performance criteria against a predefined standard in a clinical setting.

Here's a breakdown of why the requested information is largely absent and what is provided:

1. A table of acceptance criteria and the reported device performance:
   The document extensively compares the Milli Vaginal Dilator to two predicate devices (Panpac Vaginal Dilator and Amielle Vaginal Dilator) in "Table 1: Substantial Equivalence Table" (page 6). This table highlights similarities and differences in:

   • Classification, Product Code, Indications for Use, Single Use, Prescription/OTC, Primary Mode of Action, Design, Dilation Size (Outer Diameter), Dilation Jumps, Energy Source, Software, Environment for Use, Sterility.
   • For performance, it lists various nonclinical bench testing performed for the Milli Vaginal Dilator:
     • Shelf Life Storage and Packaging (Transit) Testing
     • Biocompatibility Testing
     • Software Verification Testing
     • Electromagnetic Compatibility and Electrical Safety Testing
     • Size and Dilation Design Verification
     • Charging/Cleaning Verification
     • Reliability Testing
     • Engineering Evaluation
   • Crucially, it states for each of these nonclinical tests that "All Nonclinical Bench Performance Testing performed for the Milli Vaginal Dilator passed the prespecified acceptance criteria/design inputs."
   • However, the specific acceptance criteria values (e.g., what constitutes a pass for "Size and Dilation Design Verification") are not provided nor are the quantitative results of these tests. The table only states that the tests were performed and passed.

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

   • No clinical "test set" in the context of human subjects is mentioned for performance evaluation. The testing described is primarily nonclinical bench testing.
   • For bench testing, the sample sizes of units tested are not provided.
   • The "data provenance" (country of origin, retrospective/prospective) is not applicable or provided for the bench tests.

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):

   • This is not applicable as no clinical study with "ground truth" established by experts for performance evaluation was conducted or presented in this 510(k). The document explicitly states: "Clinical testing was not required to demonstrate substantial equivalence to the predicate device." (page 5).

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

   • Not applicable, as no clinical performance "test set" requiring adjudication by experts was presented.

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:

   • Not applicable. The Milli Vaginal Dilator is a physical medical device, not an AI-assisted diagnostic tool.

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

   • Not applicable, as this is not an AI algorithm.

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

   • For the nonclinical bench testing, the "ground truth" would be the device's own design specifications and engineering standards. The document states that tests passed "prespecified acceptance criteria/design inputs." The specifics of these are not detailed.

8. The sample size for the training set:

   • Not applicable. There is no mention of a "training set" for an algorithm.

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

   • Not applicable.

In summary:

The document describes a 510(k) submission, where the primary goal is a finding of "substantial equivalence" to existing predicate devices. This typically relies heavily on nonclinical (bench) performance testing to show that any differences in technological characteristics do not raise different questions of safety or effectiveness.

The document indicates that all necessary bench testing was conducted, and the results "passed the prespecified acceptance criteria/design inputs." However, the specific quantitative acceptance criteria and the detailed results of these tests that would demonstrate "device performance" in terms of those criteria are not provided in this summary document. The "study" itself is the battery of nonclinical bench tests listed, which collectively demonstrated that the device meets its established specifications, allowing the FDA to conclude substantial equivalence.

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