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GladRags Cotton Menstrual Pads are washable and reusable. They are meant for personal use (use by only one person) to collect menstrual flow and are designed for external use.

GladRags Cotton Menstrual Pads

The provided document is an FDA 510(k) clearance letter for a medical device: "GladRags Cotton Menstrual Pad." This type of document is a regulatory clearance for a device based on substantial equivalence to a predicate device, not a study report demonstrating acceptance criteria based on performance.

Therefore, the document does not contain any of the requested information regarding acceptance criteria or a study proving the device meets them. This includes:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Number/qualifications of experts for ground truth.
• Adjudication method.
• MRMC comparative effectiveness study results.
• Standalone performance.
• Type of ground truth used.
• Sample size for training set.
• How ground truth for the training set was established.

The FDA 510(k) process for a Class I device like the GladRags Cotton Menstrual Pad typically relies on demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing device characteristics (materials, design, intended use) and safety, rather than extensive clinical performance studies with specific performance metrics and acceptance criteria as would be expected for higher-risk devices or novel technologies.

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