(49 days)
As a Class II Device, the menstrual tampon is defined as follows: (21CFR884.5460 and 21CFR 884 5470).
Rostam Ltd. Fragranced plastic applicator tampons are a plug of Cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge.
Rostam plastic applicator tampons are menstrual tampons used to absorb menstrual fluid. These Tampons will be provided with 3 absorbencies, regular, super and super plus.
These Tampons are made from rayon and/or cotton polymeric overwrap and cotton cord.
The materials used in these tampons are similar to those used in other legally marketed tampons.
The provided text describes a 510(k) premarket notification for Rostam Scented and Unscented Plastic Applicator Tampons. This document focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing acceptance criteria and conducting a study to prove performance against those criteria in the context of a new, complex medical device or AI system.
Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, and ground truth types is not applicable to this submission.
Here's an attempt to extract relevant information and explain why other points are not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: Demonstrated non-toxicity and safety of materials. | Biocompatibility testing and safety evaluations of tampon components were historically carried out. The results demonstrate equivalence in safety and effectiveness to legally marketed tampons. |
| Absorbency: Meets established standards for menstrual fluid absorption. | Standard Syngyna testing confirmed the absorbency of these Tampons. |
| Materials: Similar to legally marketed tampons (rayon and/or cotton, polymeric overwrap, cotton cord). | The materials used in these tampons are similar to those used in other legally marketed tampons. |
| Allergenicity/Irritation: No significant skin irritation or sensitization. | Repeated Insult Patch Test, 100 human subjects (results not detailed, but implies meeting a "no significant irritation" threshold for clearance). |
2. Sample size used for the test set and the data provenance
- Sample Size: 100 human subjects for the Repeated Insult Patch Test.
- Data Provenance: Not explicitly stated, but the test was conducted to support a US FDA submission, implying the data would be expected to meet appropriate regulatory standards for validity. The exact country of origin for the subjects is not provided.
- Retrospective or Prospective: The "Repeated Insult Patch Test, 100 human subjects" is a prospective test.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable in the context of this device. The "ground truth" for the patch test would be the observed skin reactions, assessed by a qualified medical professional (e.g., dermatologist), but the specific number or qualifications are not detailed in this summary. For absorbency, the "ground truth" is defined by the Syngyna test protocol.
4. Adjudication method for the test set
- Not applicable. This is not a study requiring adjudication of interpretations (like imaging studies). The Repeated Insult Patch Test involves direct observation and scoring of skin reactions.
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
- No, a MRMC comparative effectiveness study was not done. This is a physical product (tampon), not an AI-powered diagnostic or interpretive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, "standalone performance" in the AI sense is not applicable. This is a physical product.
7. The type of ground truth used
- For biocompatibility: Historical data and existing toxicological literature.
- For absorbency: Standardized laboratory testing (Syngyna test) outcome.
- For allergenicity/irritation: Direct clinical observation of skin reactions in human subjects.
8. The sample size for the training set
- Not applicable. This is not a machine learning device, so there is no "training set." The "training" here refers to the development process of the product itself, which included historical biocompatibility data and standard material testing.
9. How the ground truth for the training set was established
- Not applicable. Given this is not an AI/ML device, the concept of a "training set" with established ground truth is not relevant. The safety and effectiveness claims are based on material equivalence, standard physical testing, and prior human subject testing for irritation.
§ 884.5460 Scented or scented deodorized menstrual tampon.
(a)
Identification. A scented or scented deodorized 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. It has scent (i.e., fragrance materials) added for aesthetic purposes (scented menstrual tampon) or for deodorizing purposes (scented deodorized menstrual tampon). This generic type of device does not include menstrual tampons treated with added antimicrobial agents or other drugs.(b)
Classification. Class II (performance standards).