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510(k) Data Aggregation
(255 days)
Interlude and private label Unscented 3-piece compact applicator tampon
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.
| Performance Characteristic | Reported Device Performance (Interlude tampon) | Acceptance Criteria (from FDA guidance) |
|---|---|---|
| Regular size length | 114.4 mm | n/a (compared to predicate) |
| Regular size diameter | 14 mm | n/a (compared to predicate) |
| Regular size weight | 2.25 g | n/a (compared to predicate) |
| Super size length | 114.4 mm | n/a (compared to predicate) |
| Super size diameter | 16 mm | n/a (compared to predicate) |
| Super size weight | 2.4 g | n/a (compared to predicate) |
| Regular size absorbency | 6-9 grams | n/a (compared to predicate) |
| Super size absorbency | 9-12 grams | n/a (compared to predicate) |
| Biocompatibility | Non-cytotoxic, non-irritating, non-sensitizing, non-systemically toxic | Meets ISO 10993-1, 10993-5, 10993-10, 10993-11 standards |
| Microbiological effects | Does not enhance Staphylococcus aureus growth, does not increase TSST-1 production, does not alter normal vaginal microflora growth. | Meets recommendations of 2005 FDA guidance document. |
| Other performance tests (Dimensional, Absorbency, Chemical residues, Withdrawal cord strength, Fiber shedding, Tampon integrity) | Assessed in accordance with 2005 FDA guidance. Details not specified, but implied to meet requirements. | Meets recommendations of 2005 FDA guidance document. |
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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