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The Organic Cotton Tampon and Organic Cotton PESCV cord Tampon are intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.

Organic Cotton Tampon and Organic Cotton PESCVcord Tampon are traditional unscented menstrual tampons. They share the same design and raw materials except the material of the removal strings. Each of them are available in two configurations (i.e., digital tampon and applicator tampon). Each device 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 (only for the applicator tampon). The tampon design is cylindrical, bullet-like shape. The applicator has a smooth, rounded tip to ease insertion. Both of Organic Cotton Tampon and Organic Cotton PESCVcord Tampon are provided in 4 absorbency: light (≤6g), regular (6-9g), super (9-12g) and super plus (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.

The provided document is a 510(k) Premarket Notification for menstrual tampons. It does not contain information about a study proving that a device meets acceptance criteria in the context of an AI/ML medical device. The document describes non-clinical testing for physical and biological properties of tampons and states that "all samples met the predefined acceptance criteria," but it does not detail those acceptance criteria or performance metrics for a software or AI device.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving device performance as it pertains to AI/ML. The provided text is about a physical medical device (tampon) and its safety and effectiveness, not an AI/ML device.

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

The proposed device is a traditional unscented menstrual tampon, and it has two types (i.e. digital tampon and applicator tampon). Each device consists of a tampon, including an absorbent pledget ("absorbent core") completely surrounded by overwap ("security veil") and a removal string ("withdrawal cord"), and an applicator (only for the applicator tampon). The tampon is of the traditional cylindrical, bullet-like shape. The applicator has a smooth, rounded tip to ease insertion. The proposed device is provided in 4 absorbencies: light (≤6g), regular (69g), super (912g) and super plus (12~15g). Each device is individually wrapped and packaged in sealed multi-unit containers for retail sale. And it is provided non-sterile and for single use only.

The provided text describes the 510(k) premarket notification for an Unscented Menstrual Tampon (K222046). It outlines the device's characteristics, its comparison to a predicate device, and the non-clinical testing performed to establish substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document references established guidance documents for menstrual tampons and pads for its performance characteristics. While specific numerical acceptance criteria are not explicitly listed in a consolidated table within the provided text, it states that "All samples met the predefined acceptance criteria" for performance testing.

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

The document does not explicitly state the sample sizes used for each specific test in the performance, biocompatibility, or microbiology testing. It only mentions "All samples met the predefined acceptance criteria."

The data provenance is from non-clinical testing performed by Suzhou Borage Medical Technology Co., Ltd. in China, or by their designated testing facilities. This is retrospective in the sense that the testing was conducted on manufactured devices for the purpose of the 510(k) submission.

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

This information is not applicable as the described study is a non-clinical device performance and safety evaluation for a menstrual tampon. It does not involve establishing ground truth from expert interpretation of data like images or patient outcomes. The "ground truth" here is the objective measurement of physical, chemical, and biological properties according to established standards.

4. Adjudication Method for the Test Set

This is not applicable as the described study is a non-clinical device performance and safety evaluation. Adjudication methods like 2+1 or 3+1 are typically used for expert review of clinical data, not for objective laboratory testing.

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. The submission is for a physical medical device (unscented menstrual tampon) and does not involve AI or human readers for diagnostic interpretation.

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

This is not applicable. The submission is for a physical medical device (unscented menstrual tampon) and does not involve any algorithm or AI performance.

7. The Type of Ground Truth Used

The "ground truth" for this study is based on objective measurements and laboratory testing conforming to international standards (ISO 10993 series) and FDA guidance documents specific to menstrual tampons. This includes:

• Physical measurements: Dimensions, absorbency, removal string strength, fiber shedding, tampon integrity.
• Chemical analysis: Chemical residues.
• Biological testing: In vitro cytotoxicity, skin sensitization, vaginal irritation, acute systemic toxicity, and specific microbiological tests for Staphylococcus aureus growth, TSST-1 production, and impact on vaginal microflora.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" as this is a physical device evaluation, not an algorithm or AI development.

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

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

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