(85 days)
The device is intended to treat women suffering from vaginismus and 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 comes in varying sizes, the most appropriate is then selected by the physician for use by the patient and the patient's partner as an assistant if appropriate. It is used as a tool to DILATE the vagina in controlled stages.
Four smooth, high polished finish, hollow, penile shaped cones which are graduated in size and length. Owen Mumfords Amielle is visually and mechanically similar to that of Young's Vaginal Dilator to which substantially equivalence is claimed.
The provided text is a 510(k) submission for the Amielle Vaginal Dilator, seeking substantial equivalence to Young's Vaginal Dilator. This document does not describe a study with acceptance criteria and reported device performance in the way typically seen for novel or higher-risk devices requiring extensive clinical trials. Instead, it relies on demonstrating substantial equivalence to a legally marketed predicate device.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: No adverse customer reports over 3 years in Europe. | Product has been widely accepted as an excellent product. |
| Effectiveness (Intended Use): Treatment of Vaginismus and Dyspareunia through gradual dilation. | "The concept is gradual dilation of the vagina until the problem is under control." Substantially equivalent to Young's Vaginal Dilator, which also targets Vaginismus and Dyspareunia. |
| Design/Mechanical Similarity: Visually and mechanically similar to Young's Vaginal Dilator (predicate). | Four smooth, high polished finish, hollow, penile shaped cones, graduated in size and length. |
| Operational Principle: Substantially equivalent to Young's Vaginal Dilator. | "The principle and design concepts and application of Amielle and Young's Vaginal Dilators are substantially equivalent." |
| Performance: Substantially equivalent to Young's Vaginal Dilator. | "Performance of both systems are substantially equivalent." |
Explanation: The "acceptance criteria" here are implicitly linked to demonstrating substantial equivalence to the predicate device. The performance is reported in terms of its similarity to the predicate and anecdotal market acceptance, rather than quantitative metrics from a dedicated study.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. No formal "test set" was used in a clinical study for this 510(k) submission.
- Data Provenance: The submission mentions that Owen Mumford has been marketing Amielle throughout Europe for over 3 years without adverse customer reports. This suggests real-world usage data from Europe, but it's not structured as a controlled study. This would be considered retrospective market surveillance/anecdotal evidence rather than a prospective clinical trial.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not applicable. There was no formal test set requiring experts to establish ground truth. The submission relies on the established safety and efficacy of the predicate device and the new device's substantial equivalence.
4. Adjudication Method for the Test Set
- Not applicable. No formal test set or adjudication process was described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence, not on comparing reader performance with or without AI assistance. The device is a physical medical device (dilator), not an AI-powered diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
- The "ground truth" implicitly assumed is the established safety and efficacy of the predicate device (Young's Vaginal Dilator) for treating Vaginismus and Dyspareunia. The submission argues that because Amielle is substantially equivalent in design, intended use, and performance, it will also be safe and effective. The "no adverse customer reports" in Europe serves as supplementary evidence of safety in a real-world setting.
8. The Sample Size for the Training Set
- Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. There is no training set.
§ 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).