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Interlude rolled tampons in plastic applicator are inserted into the vagina and used to absorb menstrual or other vaginal discharge.

Interlude rolled tampons in plastic applicator are menstrual tampons used to absorb menstrual fluid. These tampons will be provided with 3 absorbencies - Regular, Super and Super Plus. These Tampons are rolled and made from organic cotton and polymeric overwrap in which a cotton cord is inserted. The applicator tubes are made of plant-based polyethylene and include a cylindrical barrel with finger grip and a one-piece plunger. The assembled tampon with applicator is wrapped in a printed PE wrapper.

This document describes the premarket notification (510(k)) for the Interlude Rolled Tampons in Plastic Applicator. It outlines the device, its intended use, comparison to a predicate device, and performance testing conducted.

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

2. Sample size used for the test set and the data provenance:

The document does not explicitly state the sample sizes used for each specific test (e.g., dimensions, absorbency, chemical residues, biocompatibility, microbiology). However, it implies that the testing was conducted on samples of the "subject tampons and applicators." The data provenance is not specified regarding country of origin or whether it was retrospective or prospective, but it refers to testing performed on the final device product.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided. The testing appears to be objective, lab-based performance and biocompatibility testing rather than expert-driven ground truth establishment.

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

Not applicable. The tests are based on objective measurements against established standards and criteria, not on expert adjudication of interpretations.

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 (tampon) and not an AI-assisted diagnostic or imaging device.

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

Not applicable. This is a medical device (tampon) and not an algorithm.

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

The "ground truth" for the performance testing is based on:

• Established standards and guidance documents: Specifically, the "2005 FDA guidance document 'Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) - Guidance for Industry and FDA Staff'" for performance characteristics and the "FDA guidance document 'Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process' issued in 2016 and ISO 10993 standards" for biocompatibility.
• Objective laboratory measurements: For dimensions, absorbency, chemical residues, withdrawal cord strength, fiber shedding, tampon integrity, and microbiological growth.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

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

Not applicable. As above, this is a physical medical device.

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Interlude 100% Cotton Tampons are inserted into the vagina and used to absorb menstrual or other discharge.

Interlude 100% Cotton Tampons are menstrual tampons used to absorb menstrual fluid. These tampons are made from cotton absorbing fibers and cotton overwrap to which a cotton cord is sewed with a cotton sewing thread. The applicator tubes are made of cardboard and include a cylindrical barrel and a plunger. The assembled tampon with applicator is wrapped in a printed paper, polyethylene (PE), or polypropylene (PP) wrapper. The subject devices are provided with the following three absorbencies: Light:

This document does not contain information about an AI/ML medical device. Instead, it is a 510(k) premarket notification for a menstrual tampon (Interlude 100% Cotton Tampon).

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, ground truth establishment, or sample sizes related to an AI/ML device. The document details the assessment of the tampon based on physical characteristics, absorbency, chemical residues, microbiology, and biocompatibility, as per FDA guidance for menstrual tampons.

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Interlude and private label Unscented 3-piece applicator tampons are inserted into the vagina and used to absorb menstrual or other vaginal discharge.

Interlude and private label Unscented 3-piece compact applicator tampons are menstrual tampons used to absorb menstrual fluid. These tampons are provided in 2 absorbencies, regular and super. These tampons are made from rayon fibers and polymeric overwrap. The withdrawal cord is made of cotton and polyester. The applicator tubes are made of polyethylene (PE) and include a cylindrical barrel with a finger grip and a two-piece plunger. The assembled tampon with applicator is wrapped in a printed PE wrapper.

This document is a marketing authorization (510(k) clearance) for a medical device: "Interlude and private label Unscented 3-piece compact applicator tampon". It does not describe acceptance criteria for an AI/ML powered device, nor does it detail a study proving such a device meets acceptance criteria.

The document clarifies that the device is a menstrual tampon, and the data provided relates to its physical properties, material composition, biocompatibility, and microbial testing, all conducted to demonstrate substantial equivalence to a predicate device (Rostam Fragranced and Unfragranced Compact Applicator Tampons).

Therefore, it is not possible to extract the requested information based on the provided text, as it concerns a completely different type of medical device and regulatory process.

To directly answer your prompt based on the provided text:

1. A table of acceptance criteria and the reported device performance:
There is no table of acceptance criteria for an AI/ML powered device. The document provides performance characteristics for a menstrual tampon.

2. Sample sizes used for the test set and the data provenance:
Not applicable for an AI/ML device. For the tampon, details of sample sizes for the performance tests (biocompatibility, microbial) are not specified in this summary. The data provenance is derived from laboratory testing of the physical product, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth for a tampon is established through objective laboratory testing, not expert interpretation of images or data.

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.

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 concensus, pathology, outcomes data, etc):
For the menstrual tampon, the "ground truth" for performance characteristics was based on established laboratory testing methods and FDA guidance standards for physical properties, material safety, and microbiological impact.

8. The sample size for the training set:
Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established:
Not applicable. This is not an AI/ML device.

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