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The Hope&Her 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.

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I'm sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document appears to be an FDA 510(k) clearance letter for a medical device called "Hope&Her Vaginal Dilator (Various)".

The letter confirms that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices. It discusses regulatory matters such as general controls, additional controls for Class II/III devices, Quality System regulations, and reporting requirements. It also includes the official Indications for Use statement for the device.

However, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, or the number/qualifications of experts.
• Information on adjudication methods, MRMC studies, or standalone algorithm performance.
• The type of ground truth used or details about training set size and ground truth establishment.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

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Hope&Her Vaginal Dilators are indicated for women who need vaginal dilation for an examination, in preparation for a surgical procedure, or for the relief of vaginismus.

Hope&Her Vaginal Dilators is a series of reusable, non-sterile, single user vaginal dilators that are used by patients to provide passive distention of the vaginal tissues using various sized dilators. The subject device has various sized rigid dilators that range from 15 mm to 38 mm in diameter (15, 22, 26, 30, 34, and 38 mm) and a handle to hold the dilator. The subject device is prescription-only. The subject device is composed polyester and polyamide. The subject device is distributed in heat-seal plastic bags.

This document is a 510(k) Summary for the Hope&Her Vaginal Dilators. It describes the device, its indications for use, and a comparison to a predicate device, along with non-clinical performance testing. The document states that performance testing was conducted to demonstrate substantial equivalence, but it does not contain information about acceptance criteria, clinical studies, or AI/software performance.

Therefore, I cannot extract the requested information regarding acceptance criteria and the study that proves the device meets them from the provided text. The document focuses on physical properties, biocompatibility, and reprocessing validation, which are non-clinical aspects.

Here's why I cannot fulfill your request based on the provided text:

• No Clinical Study Data: The document explicitly states "Summary of Non-Clinical Performance Testing" and lists tests like Biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity) and Physical Properties (appearance, diameter, tensile strength). There is no mention of clinical studies, human subject testing, or any performance metrics related to diagnostic accuracy or effectiveness in a clinical setting.
• No Acceptance Criteria for Clinical Performance: Since no clinical performance study is described, there are no acceptance criteria for such a study.
• No AI/Software Component: The device described is a physical medical device (vaginal dilators). There is no mention of any AI or software component, which would be necessary for "device performance" in the context of diagnostic accuracy, human reader improvement with AI assistance, or standalone algorithm performance.
• No Ground Truth Information: Ground truth establishment typically refers to clinical or diagnostic accuracy studies. As none are described, this information is not present.

The 510(k) process for a device like a vaginal dilator often relies on substantial equivalence based on technological characteristics and non-clinical performance (like biocompatibility and physical properties) rather than extensive clinical efficacy trials, especially if a well-established predicate device exists and the indications for use are similar.

In summary, the provided text does not contain the information requested about acceptance criteria and a study proving the device meets them in the context of clinical performance, diagnostic accuracy, or AI-assisted performance.

Ask a specific question about this device