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Always® are unscented menstrual pads for absorption of menstrual and other vaginal discharge, and for absorption of urine loss associated with light incontinence due to stress-related activities such as laughs, coughs, sneezes and exercise.

The menstrual pad device has 4 primary components, 1) The permeable topsheet allows fluid to pass through into the core; 2) the absorbent core acquires and stores fluid; 3) the impermeable backsheet prevents fluid transfer beyond the core; 4) the attachment adhesive holds the pad in place, The absorbent core is held in place between the topsheet and the backsheet.

The provided text is a 510(k) summary for the Always® unscented menstrual pad, which is a Class I medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical trials with specific acceptance criteria and detailed performance studies like those required for higher-risk devices or novel technologies.

Therefore, the information requested in your prompt (acceptance criteria, specific study design details like sample size for test sets, expert involvement, MRMC studies, standalone performance, ground truth establishment, and training set details) is not applicable and not present in this 510(k) summary for a menstrual pad.

Here's why and what information is provided instead:

• Device Type: This is a menstrual pad, classified as a Class I device (unscented menstrual pad, 21 CFR 884.5435). Class I devices are subject to general controls, and typically do not require extensive clinical data to demonstrate effectiveness.
• Regulatory Pathway: A 510(k) submission primarily aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This means it performs as well as or better than the predicate, with the same intended use and similar technological characteristics.
• Focus of the Summary: The summary focuses on:
  • Device Description: What the pad is made of (topsheet, absorbent core, backsheet, adhesive).
  • Intended Uses: Absorption of menstrual fluid, other vaginal discharge, and light urine loss.
  • Technological Characteristics: Designed to acquire and hold fluids similar to the predicate devices.
  • Safety Assessment: A battery of in vitro microbiological testing, biocompatibility testing, and extraction testing. The conclusion is that it is "equally as safe an the predicate devices."
  • Conclusion: Safe for intended use and substantially equivalent to predicate devices regarding safety and effectiveness.

Specific answers to your requested points based on the provided text:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not explicitly stated as quantifiable metrics. The overarching acceptance criterion is "substantial equivalence" to the predicate devices in terms of "safety and effectiveness."
   • Reported Device Performance: The text states, "The device is designed to acquire and hold menstrual fluids or light urine loss similar to the fluid handing capabilities of the predicate devices." No specific quantitative performance metrics (e.g., absorption capacity in grams, leakage rates, etc.) are provided in this summary. The "Safety Assessment" mentions "in vitro microbiological testing, biocompatibility testing and extraction testing," the results of which "support the conclusion that the 510(k) device is equally as safe an the predicate devices."

2. Sample sizes used for the test set and the data provenance:

   • Not applicable/not provided. The "safety tests" are mentioned as a "battery of safety tests," but no details on sample sizes or data provenance are given. These are likely laboratory tests rather than human clinical trials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable/not provided. This type of device evaluation doesn't typically involve expert consensus on a "ground truth" for performance. Safety tests are usually evaluated against established laboratory standards or predicate device results.

4. Adjudication method for the test set:

   • Not applicable/not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable. This is a physical product (menstrual pad), not an AI/imaging device requiring MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used:

   • For safety, the "ground truth" would be established by laboratory testing standards and comparison to the predicate devices' known safety profiles. For "effectiveness," the "ground truth" is that it performs similarly to the predicate devices based on its design and material characteristics. Specific outcome data or pathology are not mentioned.

8. The sample size for the training set:

   • Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:

   • Not applicable.

In summary, this 510(k) pertains to a low-risk device where the primary evidence for regulatory clearance is demonstrating substantial equivalence through a comparison of technological characteristics and safety data, rather than extensive clinical efficacy studies with detailed performance metrics and expert-adjudicated ground truth.

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