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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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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:

• 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 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.

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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.

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:

2. 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.
3. 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.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. 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.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithmic device.
7. 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.
8. The sample size for the training set: Not applicable. This is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

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o.b. Tampons are used to absorb menstrual fluid or other vaginal discharge.

o.b. ® Non-applicator Tampons are used to absorb menstrual fluid. The modified tampon will be available in the 15-18 gram syngyna absorbency range. o.b.® Non-applicator Tampons are made of commercial cotton and rayon, a polyethylene/polyester cover, and cotton or rayon string.

The provided text describes a 510(k) summary for a modified o.b.® Tampon. The objective of this submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to establish new performance criteria for a novel device. Therefore, the information provided does not align with the typical structure of reporting acceptance criteria and a study proving a device meets those criteria for a new or significantly modified medical device that requires clinical performance evaluation.

Specifically, the document focuses on substantial equivalence for the modified o.b.® Tampons. The "acceptance criteria" here are implicitly tied to demonstrating that the modified tampon is as safe and effective as the predicate device.

However, based on the provided text, I can extract the following information relevant to the intent of the questions, reinterpreting "acceptance criteria" as the characteristics that needed to be equivalent or demonstrated as safe.

Here's a breakdown of the available information in response to your questions:

1. Table of acceptance criteria and the reported device performance:

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

• Sample Size: Not explicitly stated for either biocompatibility or clinical testing.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The document only mentions "preclinical and clinical testing."

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

• This information is not provided as the regulatory submission focuses on demonstrating substantial equivalence through specific tests (e.g., syngyna absorbency, biocompatibility, clinical safety comparable to existing products) rather than a diagnostic performance study requiring expert ground truth in the traditional sense.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• This information is not applicable/not provided for this type of submission. Adjudication methods are typically used in studies where a new diagnostic or prognostic tool's output is compared against a consensus expert reading for ground truth.

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:

• This information is not applicable/not provided. The device is a tampon, not an AI-assisted diagnostic or imaging tool.

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

• This information is not applicable/not provided. The device is a tampon.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For absorbency, the ground truth is established by the syngyna test method (21 CFR 801.430), which is a standardized laboratory procedure.
• For biocompatibility, the ground truth would be established by standardized microbiological testing and potentially other biological assays, demonstrating no significant adverse reactions compared to established safety profiles.
• For clinical safety, the ground truth would be based on clinical observation and outcomes data from the "Clinical Testing" to show comparability to legally marketed tampons, likely looking for adverse event rates, irritation, or other safety endpoints. Specific methods are not detailed.

8. The sample size for the training set:

• This information is not applicable/not provided. There is no "training set" in the context of this device and its testing methodology.

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

• This information is not applicable/not provided.

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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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