(64 days)
The Unscented Interiabial Menstrual Pad can be wom 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 device has 3 primary components: 1. The permeable topsheet allows fluid to pass through into the core. 2. The absorbent core acquires and stores the fluid. 3. The impermeable backsheet prevents fluid transfer beyond the core. The absorbent core is held in place between the topsheet and backshoet, which are bonded at the perimeter to form an ovoid trilaminate structure. A tab formed from 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 describes a 510(k) submission for an Unscented Interlabial Menstrual Pad, not an AI-powered device or a study with defined acceptance criteria in the manner typically associated with medical device performance studies for diagnostic or treatment technologies. Therefore, I cannot extract the information requested in points 1-9 as they pertain to such studies.
The document discusses non-clinical and clinical performance in the context of demonstrating substantial equivalence to predicate devices, which is a different regulatory pathway than proving performance against specific quantitative acceptance criteria for an AI-driven medical device.
However, I can extract the relevant information regarding the performance and studies mentioned for this specific product:
Acceptance Criteria and Device Performance (as interpreted from the document's context):
The document does not explicitly state quantitative "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy that would be typical for an AI device. Instead, the performance evaluations aim to demonstrate safety and effectiveness for its intended use, and substantial equivalence to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: | |
| - Microbiological stability of product materials | Microbiological (in vitro) testing of the backsheet material and of the whole product confirmed the microbiological stability of the product. |
| - Stability of backsheet material | Analytical testing of the backsheet material confirmed the stability of the backsheet. |
| - Absence of adverse dermatological effects | Under the conditions of the study, the results of Cumulative Irritation and Sensitization tests of components showed that the materials used do not have any adverse dermatological effects. |
| - No negative impact on vulvar skin or microflora | A clinical study using the whole product indicated that this interlabial pad had no negative impact on vulvar skin or on vulvar and vaginal microflora. |
| - Minimal and non-medically-significant complaints | A small percentage of users reported minor complaints related to discomfort (itching, chafing, etc.), none of which required medical intervention. |
| Effectiveness (Implied): | |
| - Ability to absorb fluids | The device is designed to absorb fluids emanating from the female urogenital region. Its ability to absorb fluid is based on an absorbent fiber core, similar to predicate devices. Intended uses include absorption of menstrual or other vaginal discharge and slight urine loss. |
| - Consumer satisfaction | Consumer preference testing showed a high level of satisfaction among women who used the product. |
| - Substantial equivalence to predicate devices | The results of preclinical and clinical testing demonstrate that it is safe for its intended uses, and that it is substantially equivalent to the cited predicate devices with regard to safety and effectiveness. (Predicate devices: Fresh 'n Fit Padette®, K881384; Always® Unscented Pantiliners, K844601) |
Information Not Applicable or Not Provided in the Given Text (for AI/diagnostic studies):
The following points are not applicable to this 510(k) submission for an interlabial menstrual pad or the provided text does not contain the information required for these points, which are typically relevant for AI/diagnostic medical devices:
- Sample size used for the test set and the data provenance: Sample sizes for irritation/sensitization tests and the clinical study are not specified. Data provenance (country of origin, retrospective/prospective) is not detailed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a menstrual pad's safety and performance involves clinical observation, laboratory testing, and user feedback, not expert consensus on diagnostic imaging or signals.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating human performance with and without AI assistance for tasks like image interpretation.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithmic device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for safety involved laboratory analyses (microbiological, analytical), clinical observations (dermatological effects, vulvar health), and user reports. For effectiveness, it included absorption capability inherently and user satisfaction.
- The sample size for the training set: Not applicable. This is not an AI/machine learning device requiring a training set.
- How the ground truth for the training set was established: Not applicable.
§ 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.