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The unscented menstrual three-piece applicator tampons are inserted into the vagina to absorb menstrual discharge.

The unscented menstrual three-piece applicator tampon consists of a tampon, including an absorbent pledget ("absorbent core") completely surrounded by an overwrap ("security veil") and a removal string ("withdrawal cord"), and an applicator. The tampon design is cylindrical, bullet-like shape. The applicator has a smooth, rounded tip to ease insertion.

According to different composition materials, the unscented menstrual three-piece applicator tampon of this submission are divided into 4 categories (Cotton tampon with three piece applicator, Organic cotton tampon with three piece applicator, Viscose tampon with three piece applicator, Viscose +Cotton tampon with three piece applicator).

The Tampon are provided in 4 absorbency: Light (L) (absorbency ≤6g), Regular (R) (6-9g), Super (S) (9-12g) and Super Plus (SP) (12-15g).

Each device is individually wrapped and then packaged in sealed multi-unit containers for retail sale. All tampons and applicators are provided non-sterile and for single use only.

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The Unscented Menstrual Tampons are inserted into the vagina to absorb menstrual discharge.

The unscented menstrual tampons consist of a tampon, including an absorbent pledget ("absorbent core") completely surrounded by an overwrap ("security veil") and a removal string ("withdrawal cord"), and an applicator (only for the applicator tampon). The tampon design is cylindrical, bullet-like shape. The applicator has a smooth, rounded tip to ease insertion.

According to different composition materials and design styles, the unscented menstrual tampons of this submission are divided into 3 categories (Unscented menstrual long applicator tampon, Unscented menstrual Cardboard Applicator Tampon, Unscented menstrual Digital Tampons) and 6 sub-categories (Organic cotton + Two Plastic tube, Cotton + cardboard tube, Organic cotton + cardboard tube, Cotton (digital style), Organic cotton(digital style), viscose(digital style).

The tampons are provided in 4 absorbencies: Light(L) (≤6g), Regular(R) (6-9g), Super (S)(9-12g) and Super Plus (SP)(12-15g). Only some sub-categories of tampons contain all absorbencies. Each device is individually wrapped and then packaged in sealed multi-unit containers for retail sale. All tampons and applicators are provided non-sterile and for single use only.

The provided FDA 510(k) clearance letter and summary for K251033 pertains to unscented menstrual tampons, which are medical devices designed for absorbing menstrual discharge. This documentation focuses on demonstrating the substantial equivalence of the new tampons to a predicate device (K232598) primarily through material composition, design, and physical performance characteristics, rather than performance metrics related to diagnostic accuracy or clinical outcomes that would typically involve AI/ML models or human reader studies.

Therefore, many of the requested points regarding acceptance criteria and study details for AI/ML device performance (like sensitivity, specificity, MRMC studies, ground truth establishment by experts, etc.) are not applicable to this type of device submission. The "acceptance criteria" here relate to meeting established safety and performance standards for tampons.

Here's an analysis based on the provided document:

Device Type: Unscented Menstrual Tampons (medical device, not AI/ML driven)

Purpose of the Study (as described): To demonstrate substantial equivalence of the subject device (new tampons) to a legally marketed predicate device (existing tampons) by showing that differences in material composition and design do not raise new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Given this is a tampon submission, the "performance" relates to physical and biocompatibility characteristics, not diagnostic accuracy. The acceptance criteria are implicit in the standards followed and the successful completion of the tests.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated in the provided summary for any of the biocompatibility, microbiology, or chemical residue tests. These tests are typically performed on a representative sample of units to demonstrate compliance with standards.
• Data Provenance: The manufacturing company is Unibeauty (Hubei) Technology Co.,Ltd. in Xiantao City, Hubei Province, China. The document does not specify the country of origin for the data itself (e.g., where the lab testing was performed) beyond the company's location. The studies described are "nonclinical performance testing." implicitly prospective, as they were conducted to support the 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This submission is for a physical medical device (tampons), not an AI/ML diagnostic device that requires expert human interpretation to establish ground truth for testing. The "ground truth" here is established by standardized laboratory testing methods (e.g., chemical analysis, microbiological assays, physical measurements) interpreted by qualified laboratory personnel, not by medical experts forming a consensus on image interpretation.

4. Adjudication Method for the Test Set

Not applicable. As this is not a study involving human readers or interpretation, there is no adjudication method in the sense of resolving discrepancies between expert opinions. Laboratory results are typically verified through standard lab practices and quality control processes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is relevant for AI/ML diagnostic tools to assess the impact of AI assistance on human reader performance. This submission is for a physical device, so no such study was conducted or is relevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device does not involve an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this type of device is established through:

• Standardized Laboratory Testing Results: Biocompatibility (cytotoxicity, sensitization, irritation), microbiology (growth of bacteria, toxin production), chemical residue analysis, and physical property measurements (dimensions, weight, absorbency).
• Compliance with Recognized Standards: The tests were conducted according to international standards like ISO 10993 series and FDA guidance documents specific to menstrual tampons.

8. The Sample Size for the Training Set

Not applicable. This device does not involve an AI/ML model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no AI/ML model, there is no training set and therefore no ground truth establishment for a training set.

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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.

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