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The absorbent pledget consists of a scented pad of cotton and/or rayon . fibers overwrapped with a non-woven fabric. A cotton withdrawal cord with absorbent rayon fibers adjacent to the pad is sewn to the pad, and the pad is compressed into a traditional bullet-shaped pledget.
The formed pledget is inserted into a plastic applicator consisting of an . inner pusher tube and an outer insertion tube with a closed, rounded tip.
Each tampon is wrapped in an individual plastic film wrapper and ● packaged in sealed multi-unit containers for retail sale.

AI/ML Overview

The provided text describes a 510(k) submission for TAMPAX® Pearl Scented Tampons. This is a conventional medical device, not an AI/ML powered device. As such, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of AI performance metrics (like sensitivity, specificity, F1-score, etc.) and ground truth establishment is not applicable here.

However, I can extract the relevant information regarding the safety and effectiveness assessment as presented in the document, which serves a similar purpose in conventional medical device regulation.

Here's a breakdown of the information that can be extracted, framed as closely as possible to your requested structure, but adapted for a non-AI device:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Safety	Equivalence to predicate device in terms of safety. (Implied: device should not pose new or increased risks compared to the predicate, and should meet established safety standards for menstrual tampons.)	"This 510(k) device was subjected to an extensive battery of safety tests, including in vitro microbiological testing, biocompatibility testing, and safety-in-use clinical testing of the finished product. The results of these safety tests support the conclusion that this 510(k) device is equally as safe as the predicate device."
Effectiveness	Compliance with syngyna absorbency requirements as per 21 CFR 801.430. (Implied: device should effectively absorb menstrual fluid to a similar standard as the predicate and regulatory requirements.)	"TAMPAX® Pearl Scented Tampons comply with the syngyna absorbency requirements of 21 CFR 801.430. Therefore, additional testing of these tampons is not necessary to establish their equivalence to the predicate tampon in terms of effectiveness."
Technological Characteristics	Similar to the predicate devices in terms of component materials, overall design, and labeling. (Implied: deviations should not negatively impact safety or effectiveness, and differences, if any, should be well-justified). Specific differences noted: fragrance used and composition of the plastic applicator.	"The device is similar to the predicate devices in terms of component materials, overall design and labeling. This device differs from the predicate device in the fragrance used and in the composition of the plastic applicator." (The successful 510(k) clearance implies these differences were deemed acceptable and did not preclude substantial equivalence.)
Intended Use	The device is intended to be inserted into the vagina to absorb menstrual fluid.	"TAMPAX® Pearl Scented Tampons are scented menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid." (Matches the stated indications for use.)
Substantial Equivalence	The device should be substantially equivalent to a legally marketed predicate device with regard to safety and effectiveness.	"The results of evaluations of this device support the conclusions that it is safe for its intended use and that it is substantially equivalent to the cited predicate device with regard to safety and effectiveness." (This is the ultimate conclusion of the submission, affirmed by FDA clearance.)

Since this is not an AI/ML device, the following points are not directly applicable or are interpreted within the context of a conventional medical device submission:

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

The document mentions "safety-in-use clinical testing of the finished product" but does not specify sample size, study design (retrospective/prospective), or data provenance. For conventional devices like tampons, such details might not be explicitly required in a 510(k) summary if the testing is standard and considered sufficient for substantial equivalence.

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)

Not applicable as "ground truth" in the AI sense is not relevant here. Safety and effectiveness evaluations would be based on established laboratory tests and clinical protocols, not expert consensus on image interpretation.

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

Not applicable.

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, as this is not an AI-assisted diagnostic device.

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

Not applicable.

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

For safety, "ground truth" would be established through:
- In vitro microbiological testing: Laboratory protocols and established standards for microbial assessment.
- Biocompatibility testing: Compliance with ISO standards for medical devices (e.g., cytotoxicity, sensitization, irritation).
- Safety-in-use clinical testing: Clinical observations and self-reported outcomes by participants.
For effectiveness, "ground truth" is compliance with:
- Syngyna absorbency requirements (21 CFR 801.430): This is a standardized laboratory test for measuring absorbency.

8. The sample size for the training set

Not applicable. There is no AI model being "trained."

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

Not applicable.

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