(341 days)
Cottons Ltd, 100% Cotton Tampons are unscented, digital and applicator menstrual tampons for the absorption of menstrual fluid.
The device is a 100% cotton, conventional unscented menstrual tampon. The device consists of a 100% cotton pledget, a withdrawal cord, with and without an applicator. Three absorbencies are offered as shown above. The cotton absorbent pledget consists of a pad of 100% cotton compressed into the traditional bullet shape. The absorbent pledget is overwrapped with cellophane. A cotton withdrawal cord is sewn to the pad.
The provided text is a 510(k) summary for "Confidential Cottons Ltd, 100% Cotton Tampons," which are menstrual tampons. This document focuses on demonstrating substantial equivalence to a predicate device for regulatory approval, not on the performance of a medical device based on clinical studies with specific acceptance criteria, statistical analysis, or expert-adjudicated ground truth as would be relevant for AI/ML-based diagnostic devices.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not applicable to this submission.
Here's an attempt to extract relevant information, with an emphasis on what is not present given the nature of the device:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for a menstrual tampon are primarily related to absorbency and material composition, demonstrating safety and effectiveness for its intended use. The performance is reported in terms of absorbency ranges. There are no explicit "acceptance criteria" presented as pass/fail thresholds in this summary beyond meeting the definition of specified absorbency categories.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Absorbency Categories | |
| Regular: 6-9 grams | Regular: 6-9 grams |
| Super: 9-12 grams | Super: 9-12 grams |
| Super Plus: 12-15 grams | Super Plus: 12-15 grams |
| Material Composition | |
| 100% natural cotton | 100% natural cotton |
| Not chlorine bleached | Not chlorine bleached |
| Chemical free (no additives, no fragrances) | Chemical free (no additives, no fragrances) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided summary. Testing for absorbency and material composition would typically involve a sample of manufactured tampons, but the specific number is not detailed.
- Data Provenance: Not explicitly stated, but testing would be performed on the product manufactured by Cottons Ltd. (Australia).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. For a menstrual tampon, "ground truth" as conceptualized for diagnostic devices (e.g., disease presence/absence determined by expert radiologists/pathologists) does not apply. Performance is determined by objective physical testing (e.g., absorbency tests) and material analysis, not expert consensus on medical images or diagnoses.
4. Adjudication method for the test set
- Not Applicable. See point 3. Testing involves objective measurements, not expert adjudication of subjective assessments.
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 device is a physical product (menstrual tampon), not an AI-assisted diagnostic tool or a device that involves human readers/interpreters. Therefore, an MRMC study is irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical product, not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Objective Measurements/Material Specifications: The "ground truth" for a tampon's performance relies on standardized physical tests (e.g., absorbency testing methods like the Syngina method, though not explicitly named in this summary) and analytical chemistry to verify material composition. It does not involve medical diagnoses or expert consensus in the diagnostic sense.
8. The sample size for the training set
- Not Applicable. There is no "training set" for a physical product like a menstrual tampon. This concept applies to AI/ML algorithms that learn from data.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 884.5470 Unscented menstrual tampon.
(a)
Identification. An unscented menstrual tampon is a device that is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge. This generic type of device does not include menstrual tampons treated with scent (i.e., fragrance materials) or those with added antimicrobial agents or other drugs.(b)
Classification. Class II (performance standards).