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The Unscented Tampon is intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.

The Unscented Tampons are traditional unscented menstrual tampons. Except for the raw materials, they share the same design. The Unscented Tampons are provided with a cardboard applicator tampon. Each device consists of a tampon, including an absorbent 100% organic cotton or 100% viscose pledget , a 100% organic cotton or polyester and cotton removal string ("withdrawal cord"), and a cardboard applicator . The tampon is of the traditional cylindrical, bullet-like shape. The applicator has a smooth, rounded tip to ease insertion. The Unscented Tampons are provided in 4 absorbencies: light (less than or equal to 6g), regular (69g), super (912g) and super plus (12~15g). Each device is individually wrapped. It is provided non-sterile and for single use only.

The provided text describes the 510(k) premarket notification for an "Unscented Tampon." As such, the acceptance criteria and performance study details relate to the safety and performance of a medical device (a tampon), not an AI/algorithm-based device or a diagnostic tool.

Therefore, I cannot extract information related to:

• A table of AI acceptance criteria and reported device performance.
• Sample sizes for a test set or data provenance for AI.
• Number of experts, their qualifications, or adjudication methods for ground truth in AI.
• Multi-reader multi-case (MRMC) comparative effectiveness studies for AI.
• Stand-alone (algorithm-only) performance.
• Training set sample sizes or ground truth establishment for AI.

The document discusses "acceptance criteria" and "study" in the context of non-clinical testing for a physical medical device (tampon) to demonstrate its substantial equivalence to a predicate device.

Here's a summary of the non-clinical testing performed for the Unscented Tampon, which serves as the "study that proves the device meets the acceptance criteria" for this type of medical device:

1. Acceptance Criteria and Reported Device Performance (Non-AI Device)

The "acceptance criteria" for this device are established by meeting relevant FDA guidance documents and standards, demonstrating safety and performance comparable to a predicate device. The document states that "Non-clinical testing was conducted to verify that the subject devices meet all design and performance specifications similarly to the predicate device."

Here's a table summarizing the tests (which are the "acceptance criteria" for a tampon) and the reported performance:

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

• Sample Size: The document does not specify the exact number of tampons tested for each non-clinical test (e.g., how many tampons were subjected to biocompatibility testing, how many for dimension checks, etc.). It only mentions "the organic cotton tampon and the viscose tampon" being tested.
• Data Provenance: The tests are described as non-clinical laboratory tests performed to demonstrate substantial equivalence. The country of origin of the data is not explicitly stated in the summary, but the applicant company is SHANDONG INTCO HYGIENE PRODUCTS CO., LTD. in China. The data would be prospective, as it's generated specifically for this submission.

3. Number of Experts Used and Their Qualifications

• This is not applicable as the study described is non-clinical laboratory testing of a physical product (tampon), not an AI/diagnostic software. No experts are mentioned as establishing "ground truth" in the diagnostic sense. The "ground truth" for these tests is defined by established laboratory testing standards and methods (e.g., ISO standards, 21 CFR 801.430).

4. Adjudication Method for the Test Set

• Not applicable as this is a non-clinical laboratory test of a physical product, not an AI/diagnostic software requiring expert adjudication of results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not applicable. This is not an AI/diagnostic device. The comparison is between the proposed physical tampon and a predicate physical tampon based on measured attributes and safety profiles.

6. Standalone (Algorithm Only) Performance

• Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is established by validated laboratory testing methods and industry standards (e.g., ISO 10993 series, 21 CFR 801.430, and FDA guidance documents for menstrual tampons). These methods define what constitutes acceptable dimensions, absorbency, biocompatibility, etc.

8. The Sample Size for the Training Set

• Not applicable. As this is a non-clinical submission for a physical device, there is no "training set" in the context of an AI/machine learning model.

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

• Not applicable. There is no training set for a physical medical device.

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