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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.

• Pledget length (Dry): 37±3.0--50±3.0 mm
• Pledget diameter (Dry): 11.5±1.0--15.2±1.0 mm
• Total length of product: 118.0±2.0 mm
• Length of push rod: 70±1 mm
• Outside diameter (outer tube): 14.5±0.2--16.2±0.2 mm
• Weights: L: 3.90-4.40g; R: 4.45-5.15g; S: 5.65-6.45g; SP: 6.45-7.35g
  These differ from the predicate's specific values but are deemed "not raise different questions of safety and effectiveness." |
  | Functionality (Absorbency) | Meet industry standards for relevant absorbency ratings (e.g., Light (≤6g), Regular (6-9g), Super (9-12g), Super Plus (12-15g)). | Absorbency categories are listed, aligning with standard ranges. Performance data showing the specific absorbency achieved for each tampon type would be in the full submission, but the table indicates these categories are used. |
  | General Safety/Effectiveness | Overall safety and effectiveness comparable to predicate. | "The nonclinical tests demonstrate that the subject device, Unscented Menstrual Tampon, is as safe and effective as the legally marketed predicate device (K232598). Therefore, the subject device is substantially equivalent to the predicate device." |

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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