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Panpac Vaginal Dilators are indicated for women who need vaginal dilation for an examination, a surgical procedure, or for the relief of vaginismus.

Panpac Vaginal Dilators has four different size (small, medium, large and extra large) in three family types; Family A, Family B and Family C with variant sizes.

This document is a 510(k) Premarket Notification from the FDA for a medical device called "Panpac Vaginal Dilators." This type of document is usually a regulatory approval and does not contain or describe a study on the device's technical performance or acceptance criteria in the way you've outlined.

Therefore, I cannot extract the requested information regarding acceptance criteria and study details. The document primarily focuses on:

• Device Identification: Panpac Vaginal Dilators
• Regulation Number/Name: 21 CFR § 884.3900, Vaginal stent
• Regulatory Class: II
• Product Code: HDX
• Applicant: Panpac Medical Corporation
• FDA Determination: Substantially equivalent to legally marketed predicate devices.
• Indications for Use: Vaginal dilation for examination, surgical procedure, or relief of vaginismus.
• General Controls: Mentions requirements for registration, listing, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

There is no mention of performance studies, acceptance criteria, sample sizes, ground truth establishment, or expert reviews in this regulatory clearance letter.

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