(53 days)
The P&G Miniform #3 Unscented Interlabial Menstrual Pad can be worn any time of the day or night in the following ways:
- Alone for light and medium (menstrual) flow .
- In combination with tampons or pads for extra protection during heavy . (menstrual) flow
- Alone for vaginal discharge or slight urine loss associated with laughs, . coughs, and sneezes.
The P&G Unscented Menstrual Pad can be worn any time of the day or night in the following ways:
- For menstrual flow or other vaginal discharge .
The interlabial pad device has 3 primary components:
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- The permeable topsheet allows fluid to pass through into the core.
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- The absorbent core acquires and stores the fluid.
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- The impermeable backsheet prevents fluid transfer beyond the core.
The absorbent core is held in place between the topsheet and backsheet, which are bonded at the perimeter to form an ellipse-shaped trilaminate structure. An attached tab glued onto the backsheet extends from the back of the device as an aid for application and removal.
The device will be individually wrapped and packaged in sealed multi-unit containers for retail sale.
The provided text does not contain acceptance criteria for an AI/ML powered device, nor does it describe a study proving a device meets such criteria.
The document is a 510(k) premarket notification for a traditional medical device: P&G Miniform #3 Unscented Interlabial Menstrual Pad and P&G Unscented Menstrual Pad.
It is a submission to the FDA for a menstrual pad and specifically mentions:
- Predicate Device: P&G Miniform #2, K003843
- Technological Characteristics: The device's ability to absorb fluid is based on an absorbent fiber core, and is similar to the absorbent technology of the predicate device.
- Clinical Performance: The safety profile of the new device is substantially equivalent to the safety profile of the predicate device, based on the results of biocompatibility testing of component materials of the new device and on the results of a clinical safety test of the new device.
- Conclusions: The similarity of the safety profile of the new device to the predicate device and the lack of negative comments from the predicate device market experience to date indicates that the new device is safe for its intended uses, and that it is substantially equivalent to the cited predicate device with regard to safety and effectiveness.
This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through material biocompatibility and clinical safety testing, not on meeting specific performance metrics derived from AI/ML output.
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, or ground truth for an AI/ML device based on the provided text.
§ 884.5435 Unscented menstrual pad.
(a)
Identification. An unscented menstrual pad is a device that is a pad made of cellulosic or synthetic material which is used to absorb menstrual or other vaginal discharge. This generic type of device includes sterile unscented menstrual pads used for medically indicated conditions, but does not include menstrual pads treated with scent (i.e., fragrance materials) or those with added antimicrobial agents or other drugs.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9 only when the device is made of common cellulosic and synthetic material with an established safety profile.