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

o.b. ® non-applicator and applicator Tampons are used to absorb menstrual fluid. The modified tampon will be available in Regular, Super, and Super Plus syngyna absorbency ranges. o.b.® non-applicator and applicator Tampons are made of commercial cotton and rayon, a polyethylene/polyester cover, and cotton or rayon string.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the modified o.b.® Tampons are primarily based on biocompatibility and user safety, demonstrating equivalence to legally marketed tampons. The performance is reported through the results of specific preclinical and clinical evaluations.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: The document does not explicitly state the sample sizes for the preclinical or clinical evaluations.
• Data Provenance: The document does not explicitly state the country of origin of the data. The studies are referred to as "Preclinical Evaluations" and "Clinical Evaluations," implying that they were conducted specifically for this submission. The nature of these tests (e.g., vaginal irritation, microflora studies) suggests they would be prospective studies.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The nature of the studies (biocompatibility, clinical safety) suggests that the interpretation of results would have been performed by qualified professionals (e.g., toxicologists, microbiologists, clinicians), but specifics are not given.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1) for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging or similar devices where different human readers interpret cases. Tampons are a medical device for menstrual fluid absorption, and their evaluation focuses on safety, performance, and biocompatibility, not interpretive tasks for human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable to the device described. The device is a physical product (tampon), not an algorithm or AI system. Therefore, there is no "standalone" algorithm performance to evaluate.

7. The Type of Ground Truth Used

The "ground truth" for this device's safety and performance is established through experimental data from preclinical and clinical studies, demonstrating the physical, chemical, and biological properties of the modified tampons. The ultimate ground truth essentially compared the modified tampon's characteristics to the known safe and effective profile of the predicate device and general medical standards for such products.

• For biocompatibility: Lab test results (e.g., cytotoxicity assays, genotoxicity assays, irritation studies).
• For clinical studies: Human physiological responses (e.g., absence of sensitization, maintained vaginal microflora, absence of irritation).

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical product, not an AI or machine learning model that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This question is not applicable, as there is no "training set" for this type of device.

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o.b.® Applicator Tampons are inserted into the vagina to collect menstrual fluid. This is the same intended use as current commercial tampons.
o.b. applicator tampons are used to absorb mentrual fluid or other vaginal discharge.

o.b.® Applicator Tampons are used to absorb menstrual fluid or other vaginal discharge. These tampons will be available in regular, super and super plus absorbencies.
o.b.® Applicator Tampons are made of cotton and rayon, a polyethylene/polyester cover, and cotton or rayon string.
The applicator consists of a cardboard laminate with a coating.

This document describes the premarket notification (510(k)) for the o.b.® Applicator Tampon, focusing on its substantial equivalence to an already marketed device. The changes relate to the applicator coating, not the tampon itself.

Here's an analysis of the provided text in the context of your questions:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes Used for the Test Set and Data Provenance

• Non-clinical testing: Not explicitly stated how many samples were used for cytotoxicity, vaginal irritation, and microbiological testing. It only mentions extracts of the coated applicator were tested.
• Clinical testing (Repeat Insult Patch Test): The sample size for this human study is not specified in the provided document.
• Data Provenance: Not specified. Given the manufacturer (Personal Products Company, Skillman, NJ), the testing was likely conducted in the USA or a region adhering to similar regulatory standards, but this is an inference, not explicit in the text. The type of study is a premarket approval study for a medical device modification.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This information is not applicable to this type of submission. This 510(k) is comparing a modified device to a predicate device based on specific non-clinical and clinical tests, not evaluating interpretations by human experts or establishing a "ground truth" for diagnostic purposes. The "ground truth" here is the safety of the materials as determined by established scientific laboratory and human safety testing protocols.

4. Adjudication Method for the Test Set

• Not applicable. As above, this submission does not involve adjudication of expert readings or diagnoses. The "adjudication" is essentially the FDA's review and concurrence with the testing results presented by the manufacturer.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. This is not a diagnostic device or an AI-based system, so an MRMC study is not relevant to this submission.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• No. This is a physical medical device (tampon applicator), not an algorithm or AI system.

7. The Type of Ground Truth Used

• The ground truth used here is based on scientific laboratory test results (biocompatibility, microbiological) and human safety study outcomes (dermal irritation/sensitization). The "ground truth" is that the modified material is safe and comparable to the predicate device, as evidenced by these tests.

8. The Sample Size for the Training Set

• Not applicable. This is a physical medical device. There is no "training set" in the context of an AI/ML algorithm. The "training" for the device design would be based on general scientific and engineering principles and prior knowledge about materials used in similar devices.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As mentioned, there is no "training set" in the AI/ML sense. The "ground truth" for the development of medical devices generally relies on established scientific literature, regulatory standards, and previous experience with similar materials and designs. Any modifications are then rigorously tested against these established safety and performance benchmarks.

In summary, the provided document details a 510(k) summary for a modified tampon applicator. The focus is on demonstrating substantial equivalence to a predicate device through non-clinical biocompatibility and microbiological testing, and a clinical (human) patch test for dermal safety. It does not involve AI, diagnostic accuracy, or expert consensus on interpretations, which explains why many of your questions are not applicable to this specific submission.

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