Search Results

The Intimate Rose Vaginal Dilators are tools intended for controlled dilation of the vagina. They 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 Intimate Rose Vaginal Dilators are intended to treat women suffering from vaginismus (including related dyspareunia). Vaginismus is the involuntary spasm of the muscles in the vaginal wall which then inhibits sexual intercourse by making it painful or impossible. Dyspareunia is the pain experienced during sexual intercourse caused by physical and/or emotional problems. The device is used as a tool to dilate the vagina in controlled stages. It is a reusable device that comes into contact with the vaginal mucosal membrane for a prolonged (> 24 hours to

The provided text describes the regulatory clearance (510(k)) for the Intimate Rose Vaginal Dilators, not a study proving device performance against acceptance criteria in the typical sense of a clinical trial for a novel AI/software medical device.

Therefore, many of the requested sections are not applicable to the information contained in the provided FDA 510(k) summary. The document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing raw performance data against specific acceptance criteria for a new device's functionality.

However, I can extract the relevant information from the document as follows:

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

This information is not provided in a performance-against-acceptance-criteria format. The submission relies on demonstrating substantial equivalence to predicate and reference devices, aligning indications for use, and leveraging a previous self-selection study. There are no quantitative performance metrics (e.g., sensitivity, specificity, accuracy) mentioned, as this is a physical medical device, not an AI or diagnostic software.

The "performance" described is the device's ability to fulfill its intended use and be safe and effective, which is primarily assessed through comparison to existing devices and appropriate labeling.

2. Sample size used for the test set and the data provenance

The document mentions leveraging a "self-selection study conducted for the predicate device."

• Sample Size: Not specified for the predicate device's self-selection study.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). It notes that the study was "previously conducted."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The self-selection study for the predicate device likely assessed lay users' ability to understand labeling and determine if the device was appropriate for them, rather than requiring expert ground truth for medical outcomes.

4. Adjudication method for the test set

Not applicable. No expert adjudication process is described for the self-selection study.

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. This is a physical vaginal dilator, not an AI/software medical device requiring MRMC studies.

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

Not applicable. This is a physical device, not an algorithm.

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

The document refers to a "self-selection study." The "ground truth" for such a study would likely be the user's ability to correctly interpret the labeling and self-assess their indication for use, as determined by the study design and evaluation criteria. It is not expert consensus, pathology, or outcomes data in a direct medical sense for this type of device.

8. The sample size for the training set

Not applicable. This is a physical device; there is no "training set" in the context of an AI/ML algorithm.

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

Not applicable. There is no training set for this type of device.

Ask a specific question about this device

The Intimate Rose Vaginal Dilators are tools intended to dilate the vagina in controlled stages to help relieve symptoms of vaginismus.

The Intimate Rose Vaginal Dilators are intended to treat women suffering from vaginismus (including related dyspareunia). Vaginismus is the involuntary spasm of the muscles in the vaginal wall which then inhibits sexual intercourse by making it painful or impossible. Dyspareunia is the pain experienced during sexual intercourse caused by physical and/or emotional problems. The device is used as a tool to dilate the vagina in controlled stages. It is a reusable device that comes into contact with the vaginal mucosal membrane for a prolonged (> 24 hours to ≤ 30 days) duration. The Intimate Rose Vaginal Dilators are comprised of 8 progressively larger and color-coded medical-grade silicone dilators.

The provided document is a 510(k) summary for the Intimate Rose Vaginal Dilators. It describes the device, its intended use, and compares it to a predicate device to demonstrate substantial equivalence. However, it does not contain information about acceptance criteria or a study that typically involves human readers or an AI algorithm’s performance.

This document describes a device approval process based on non-clinical performance testing for a physical medical device (vaginal dilators), not an AI/ML-driven device. Therefore, the requested information regarding acceptance criteria, human reader studies, AI assistance, ground truth, and training set details for AI/ML performance is not present in the provided text.

Based on the document, I can only provide information related to the device's physical and biological properties.

Here's what can be extracted from the document regarding the device's evaluation, focusing on the non-clinical tests performed:

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

The document doesn't explicitly state "acceptance criteria" for each performance test in a quantitative manner. Instead, it states that the tests demonstrate the device is "acceptable" or "non-" (e.g., non-cytotoxic). The reported performance is the "test results" and the conclusion.

2. Sample size used for the test set and the data provenance:

• Sample size: The document states that "all 8 colors of the subject device" were tested for biocompatibility and physical properties. It does not provide a specific number of individual dilator units tested for each characteristic.
• Data provenance: Not explicitly stated as "country of origin" or "retrospective/prospective." The testing was non-clinical laboratory testing performed to international and FDA guidance standards.

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 question is not applicable. The device is a physical medical device, not an AI/ML diagnostic or interpretive tool that requires expert-established ground truth on clinical data for performance evaluation in the context of this 510(k) submission. The "ground truth" for these tests would be the established biological or physical standards.

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

This question is not applicable. Adjudication methods are typically for subjective clinical assessments or image interpretations, which are not part of this device's non-clinical performance testing.

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:

This question is not applicable. This is not an AI-assisted device.

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

This question is not applicable. This is not an AI device.

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

For the non-clinical tests described:

• Biocompatibility: The "ground truth" is defined by the international standards (ISO 10993 series) for toxicity, sensitization, irritation, and systemic effects.
• Physical Properties: The "ground truth" for physical characteristics like diameter, hardness, compression, and density would be the device's design specifications and material properties, compared against measured values.

8. The sample size for the training set:

This question is not applicable. This is not an AI/ML device, so there is no "training set."

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

This question is not applicable. This is not an AI/ML device.

Ask a specific question about this device

The Intimate Rose Kegel Exercise System is indicated for the strengthening of the perineal pelvic floor muscles by providing resistance to an individual's voluntary contractions of these muscles. It seeks to correct, through exercise, low tone in the pelvic floor, which can cause or contribute to health issues including urinary incontinence and sexual dysfunction.

The Intimate Rose Kegel Exercise System is a pelvic floor exercise device for use in strengthening the pelvic floor musculature. It is a reusable, over-the-counter device that is comprised of 6 progressively heavier and color-coded silicone weights. An Intimate Rose Kegel Exercise System weight is inserted into the vagina and is held in place by contracting the pelvic floor muscles. The weight of the Intimate Rose Kegel Exercise System device provides resistance as it is lifted with each contraction of the pelvic floor muscles. When utilized correctly, the device will move upward and inward when the user contracts her pelvic floor muscles. The body's angle while exercising controls the level of resistance.

This document is a 510(k) Summary for a medical device called the "Intimate Rose Kegel Exercise System." It describes the device, its intended use, and compares it to a legally marketed predicate device.

Based on the provided text, the device in question (Intimate Rose Kegel Exercise System) is a physical, non-AI-powered medical device. Therefore, the questions regarding acceptance criteria and studies related to AI/software performance (such as sample size for test sets/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment) are not applicable to this specific device submission.

This document focuses on establishing substantial equivalence for a physical device, primarily through non-clinical performance testing (biocompatibility, reprocessing, mechanical performance), rather than an AI/software-driven diagnostic or therapeutic device.

If the request was intended for an AI-powered device, the provided text does not contain the information necessary to answer the questions.

Ask a specific question about this device