Search Results

The Unscented Menstrual Tampon is inserted into the vagina to absorb menstrual discharge.

The Unscented Menstrual Tampons are menstrual tampons used to absorb menstrual fluid. These tampons are provided in 4 absorbencies, light (≤ 6 grams absorbency), regular (6-9 grams), super (9-12 grams) and super plus (12-15 grams). These tampons include a pledget made from viscose and cotton as well as a polyester and polypropylene overwrap. The removal string is made of polypropylene yarn and cotton yarn. The applicator tubes are made of low density polyethylene (LDPE). The assembled tampon with applicator is wrapped in a printed polyethylene wrapper.

This document describes the premarket notification for an "Unscented Menstrual Tampon" (K232598) and states its substantial equivalence to a predicate device. It is important to note that this document is for a medical device (menstrual tampons), not an AI/ML powered device, so the requested information about AI model performance, multi-reader multi-case studies, and ground truth establishment from experts or pathology will not be present.

Based on the provided document, here's what can be extracted regarding acceptance criteria and performance:

The document explicitly states: "The performance tests were conducted to demonstrate the effectiveness of the subject device; all samples met the predefined acceptance criteria."

However, the specific numerical acceptance criteria for each test and the reported device performance are not explicitly detailed in a table format with specific values within this document. Instead, it lists the types of performance characteristics assessed and implies that the device met the criteria.

Here's a breakdown of the requested information based on the provided document, with explanations for what is not applicable or not explicitly stated:

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

While the document states that all acceptance criteria were met, it does not provide a table with specific numerical acceptance criteria and the corresponding reported values for the subject device. It only lists the types of tests performed.

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

The document does not specify the exact sample size used for the performance tests. It states "all samples met the predefined acceptance criteria," but the number of samples is not provided.

Data Provenance: The document does not specify the country of origin for the test data or whether the studies were retrospective or prospective. Given the manufacturer is Chinese (Unibeauty (Hubei) Technology Co.,Ltd.), the testing was likely conducted in China or by a contracted lab.

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

This information is not applicable as the device is a menstrual tampon, not an AI/ML powered medical device. The "ground truth" for the performance characteristics of a tampon (e.g., absorbency, dimensions, fiber shedding) is established through standardized physical and chemical testing methods, not by expert consensus or interpretations.

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

This is not applicable for this type of device and testing. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., radiology reads) where there can be disagreement among experts. Here, the tests are objective, laboratory-based measurements.

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

This is not applicable as the device is a menstrual tampon and not an AI-powered system. Therefore, no MRMC study or assessment of human reader improvement with AI assistance would have been conducted or is relevant.

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

This is not applicable as the device is a physical product (menstrual tampon), not an algorithm or AI system.

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

The "ground truth" for the performance characteristics of this device is established through:

• Standardized Physical and Chemical Testing Methods:
  • Syngyna method (for absorbency)
  • Measurement of dimensions and weight
  • Chemical analysis for residues
  • Mechanical testing (e.g., withdrawal cord strength, expulsion force)
  • Microbiological testing (e.g., growth of S. aureus, TSST-1 production, vaginal microflora alteration)
  • Biocompatibility testing (in vitro cytotoxicity, sensitization, irritation, acute systemic toxicity).

This is based on objective measurements rather than subjective expert consensus, pathology, or patient outcomes for device performance.

8. The sample size for the training set

This is not applicable. As a physical medical device, there is no "training set" in the context of machine learning model development. This is a manufactured product tested for its physical and biological properties.

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

This is not applicable for the same reasons as point 8.

Ask a specific question about this device