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Rostam Ltd. Fragranced and Unfragranced plastic applicator tampons are a plug of Cellulosic or synthetic material that is inserted into the vagina and used to apsorb menstrual or other vaginal discharge

Rostam plastic applicator tampons are menstrual tampons used to absorb menstrual fluid. These Tampons will be provided as two absorbencies, slender regular and light. 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.

This document is a 510(k) summary for Rostam Scented and Unscented Plastic Applicator Tampons, indicating the device's substantial equivalence to legally marketed predicate devices. It primarily focuses on the regulatory submission and does not contain detailed information about acceptance criteria or a study proving the device meets specific performance criteria in the way a clinical trial or algorithm performance study would for, for instance, a medical imaging AI.

Here's an analysis based on the provided text, addressing the requested points:

1. A table of acceptance criteria and the reported device performance

Based on the provided text, explicit acceptance criteria and corresponding reported device performance for specific quantitative metrics are not available. The submission focuses on substantial equivalence to existing legally marketed tampons rather than setting new quantitative performance benchmarks.

The document states:

• "The results of these tests demonstrate that these Tampons are equivalent in terms of safety and effectiveness to legally marketed tampons."
• "Standard Syngyna testing confirmed the absorbency of these Tampons."

While "equivalent in terms of safety and effectiveness" and "confirmed the absorbency" are positive statements, they don't provide a table of precise criteria or numerical performance data against those criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The only specific test mentioned with a sample size is:

• Test: Repeated Insult Patch Test
• Sample Size: 100 human subjects
• Data Provenance: Not specified, but likely prospective given it's an "insult patch test" on human subjects. Country of origin not mentioned.

Other tests are alluded to (biocompatibility, safety evaluations, Syngyna testing) but without specific sample sizes or details on data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable in the context of this device and testing. The "ground truth" concept, often used in AI or diagnostic device studies where expert consensus or pathology confirms a condition, does not apply directly to tampon safety and absorbency testing. The Repeated Insult Patch Test uses human subjects as direct biological indicators of irritation/sensitization, not as adjudicators of a "ground truth" diagnosis. Absorbency testing (Syngyna) uses a standardized in-vitro method, not expert judgment for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As noted above, the testing methodologies (patch test, Syngyna) do not involve human adjudication in the sense of reviewing diagnostic outcomes.

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 medical device for menstrual fluid absorption, not a diagnostic imaging or AI-assisted system. No MRMC studies or AI involvement is mentioned or relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

As explained previously, the concept of a "ground truth" in the diagnostic sense is not directly applicable here.

• For the Repeated Insult Patch Test, the "ground truth" is the observed skin reaction (or lack thereof) on the human subjects. This is a direct biological outcome.
• For Syngyna testing, the "ground truth" for absorbency is determined by the standardized in-vitro method, which measures fluid uptake.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI models. The materials and manufacturing processes are likely validated through standard engineering and quality control procedures, but not by training an algorithm.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

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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

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.

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