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510(k) Data Aggregation
(23 days)
O.B. TAMPONS
o.b.® Tampons are to be inserted into the vagina in order to absorb menstrual fluid.
The device is a cotton/rayon pledget with a removal string. It is available in various absorbencies.
Acceptance Criteria and Study for o.b.® Tampons:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | The device performs equivalently to the predicate device of the same absorbency. |
| Syngyna Values (Absorbency) | Syngyna values were the same as the predicate device. |
| Toxicological Safety (No Untoward Results in Tests) | No untoward results were seen in the following tests on either the new material or the finished proposed device: - Cytotoxicity - Elution Method Cytotoxicity - Agarose Overlay Method Acute Systemic Toxicity in the Mouse - Mucosal (Vaginal) Irritation in the Rabbit - Dermal Irritation and Allergic Contact Sensitization: Human Repeat Insult Patch Test (RIPT) - Acute Intracutaneous Reactivity in the Rabbit - TSST-1, Tampon Sac Method |
| Clinical Safety (No Clinically Significant Differences vs. Commercially Available Tampon) | There were no clinically significant differences between the test (o.b.® Tampons) and control (commercially available tampon) products in a randomized, double-blind, two-way crossover study in healthy females over two menstrual cycles. Assessments included vaginal culture, speculum examinations (at screening, pre-, mid-, and post-menstrual visits), and vaginal and cervical colposcopy (at screening and post-menstruation). Subjects also completed a diary detailing tampon use. |
Study Information:
The provided document describes a modification to the o.b.® Tampons and aims to establish substantial equivalence to legally marketed o.b.® tampons. The study supporting this claim of substantial equivalence is outlined in the "Performance data" and "Clinical Equivalency" sections.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document states "healthy females" for the clinical equivalency study. However, the specific number of subjects in this study is not provided.
- Data Provenance: The document does not explicitly state the country of origin for the clinical study. It does not explicitly state retrospective or prospective, but the description of a "randomized, double-blind, two-way crossover study" implies a prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: This information is not provided in the document.
- Qualifications of Experts: This information is not provided in the document. The assessments mentioned (vaginal culture, speculum examinations, colposcopy) would typically be performed by medical professionals (e.g., gynecologists or trained clinicians), but their specific qualifications, number, or role in establishing ground truth (other than performing examinations) are not detailed.
4. Adjudication Method for the Test Set
- The document does not describe an adjudication method for the test set. It mentions assessments were performed, but not how disagreements or interpretations between multiple assessors (if any) were resolved.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance?
- Not Applicable. This document describes the safety and effectiveness of a menstrual tampon, not an AI-assisted diagnostic or imaging device. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study regarding AI assistance is not relevant or mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done?
- Not Applicable. This document describes the safety and effectiveness of a menstrual tampon, not an algorithm or AI device.
7. The Type of Ground Truth Used
- The ground truth for the clinical equivalency study appears to be established through a combination of:
- Clinical Assessments: Vaginal culture, speculum examinations, vaginal and cervical colposcopy performed by healthcare professionals.
- Subjective Reporting: Subject diaries detailing tampon use.
- Lab Tests: The "Performance Data" section also details various in-vitro and animal toxicology studies (e.g., cytotoxicity, irritation tests, TSST-1).
8. The Sample Size for the Training Set
- Not Applicable. As this is not an AI/ML device, there is no "training set." The studies described are for direct evaluation of the medical device itself.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See response to #8.
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(193 days)
O.B. TAMPON
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:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Technological Characteristics: Equivalent absorbency within a specific range, and similar materials, weight, and dimensions. | The only difference between the modified o.b.® tampons and the predicate tampons is that the absorbency has increased to 15-18 grams absorbency measured by the syngyna test method (21 CFR 801.430). This is accomplished by slight increases in the weight and dimensions of the tampons. |
The tampons are made of commercial cotton and rayon, a polyethylene/polyester cover, and cotton or rayon string, which are the same materials as the predicate.
(The specific absorbency range of the predicate is not explicitly stated, but the modified tampon falls within established regulatory ranges, and the submission argues this change does not alter substantial equivalence.) |
| Intended Use: Same as the predicate device. | The modified o.b.® Tampons are inserted into the vagina to collect menstrual fluid. This is the same intended use as current commercial tampons. |
| Biocompatibility: No adverse biological reactions. | Biocompatibility testing has been conducted on tampons made with these commercial materials. The results of these tests demonstrate that the modified o.b.® Tampon is equivalent to legally marketed tampons. This testing included Microbiological testing. |
| Safety (Clinical): No new or increased safety risks. | Clinical Testing has been conducted. Results of preclinical and clinical testing indicate that the safety of the modified tampon is comparable to current legally marketed, commercial tampons. |
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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(89 days)
APPLICATOR TAMPONS, O.B. TAMPONS
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.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Study Type |
|---|---|---|---|
| Biocompatibility | Cytotoxicity | Modified tampons equivalent to legally marketed tampons. | Preclinical |
| Acute Systemic Toxicity | Modified tampons equivalent to legally marketed tampons. | Preclinical | |
| Intracutaneous Toxicity | Modified tampons equivalent to legally marketed tampons. | Preclinical | |
| Vaginal Irritation (Preclinical) | Modified tampons equivalent to legally marketed tampons. | Preclinical | |
| Ames Mutagenicity | Modified tampons equivalent to legally marketed tampons. | Preclinical | |
| Chromosome Aberration Assay | Modified tampons equivalent to legally marketed tampons. | Preclinical | |
| Unscheduled DNA Synthesis | Modified tampons equivalent to legally marketed tampons. | Preclinical | |
| Microbiological Safety | Microbiological Evaluation | Modified tampons equivalent to legally marketed tampons. | Preclinical |
| Clinical Safety/User Experience | Human Sensitization | Safety comparable to legally marketed, commercial tampons. | Clinical |
| Vaginal Microflora Study | Safety comparable to legally marketed, commercial tampons. | Clinical | |
| Human Vaginal Irritation Study | Safety comparable to legally marketed, commercial tampons. | Clinical |
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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