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510(k) Data Aggregation
(22 days)
TAMPAX(R) L PLASTIC TAMPONS, UNSCENTED
The TAMPAX® L Plastic Applicator Tampons, unscented, are intended to be inserted into the vagina to absorb menstrual fluid.
Unscented menstrual tampons for absorption of menstrual fluid. The tampon is a conventional design consisting of an absorbent pledget, an overwrap, a withdrawal cord and an applicator. The materials of construction are cotton, rayon, polypropylene and polyester. The device functions by absorbing menstrual fluid after being inserted into the vagina.
The provided text is a 510(k) summary for a medical device called TAMPAX® L Plastic Applicator Tampons, unscented. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed device performance metrics typically found in AI/ML performance studies.
Therefore, many of the requested elements for describing an AI/ML acceptance criteria study (sample size for test/training sets, data provenance, ground truth experts, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable or not present in this document.
The document highlights the device's technological characteristics and nonclinical tests to establish safety and equivalence to a predicate device.
Here's an analysis based on the available information:
Description of Acceptance Criteria and Study to Prove Device Meets Criteria
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly based on predicate device performance) | Reported Device Performance (as stated in the document) |
|---|---|---|
| Safety | Biocompatibility | Biocompatibility testing of each material completed in previously cleared devices. |
| Negligible or no tampon pledget exposure to applicator components | Extractions of plastic applicators confirmed negligible or no exposure. | |
| Functionality | Fluid handling capabilities (acquisition and retention) | Similar to fluid handling capabilities of the predicate device. |
| Expulsion force | No change in parameters from the predicate device; results within acceptable limits and similar to predicate. | |
| Tampon withdrawal cord anchor strength | No change in parameters from the predicate device; results within acceptable limits and similar to predicate. | |
| Syngyna testing | No change in parameters from the predicate device; results within acceptable limits and similar to predicate. | |
| Substantial Equivalence | Equivalent safety and efficacy profiles | The subject device and the predicate device have the same performance characteristics and equivalent safety and efficacy profiles. |
2. Sample size used for the test set and the data provenance
- Not Applicable / Not Provided. This document describes nonclinical tests for a physical medical device (tampon), not a software or AI/ML device that would have a "test set" and "data provenance" in the traditional sense of AI/ML. The "tests" here refer to laboratory evaluations of material properties and physical performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable / Not Provided. Ground truth establishment by experts is not relevant in the context of material and physical property testing of a tampon.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided. Adjudication methods are not relevant for the type of nonclinical tests described.
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 medical device, not an AI/ML system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an AI/ML system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided. For the nonclinical tests mentioned (biocompatibility, extractions, Syngyna, expulsion force, withdrawal cord strength), the "ground truth" would be established by validated physicochemical or biomechanical laboratory testing methods, not expert consensus or pathology in the context of an AI/ML model.
8. The sample size for the training set
- Not Applicable. This is a physical medical device, not an AI/ML system, so there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for an AI/ML model, there is no ground truth needed for it.
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