(94 days)
The BiuBiu tampon is inserted into the vagina and used to absorb menstrual and other vaginal discharge.
The BiuBiu tampon is composed of an absorbent pledget (tampon), a withdrawal cord, and an applicator. The pledgets (cleared under K090819) have a cylindrical, bullet-like shape and the applicators have a smooth, rounded tip to ease insertion. The barrel of the applicator has a no-slip grip design to help hold the tampon tightly. Each tampon is individually wrapped and packaged. There are three versions of the BiuBiu tampon with different absorbencies: regular, super and super plus. Each version has a different color applicator. The BiuBiu tampon is provided non-sterile and for single use only.
This is a 510(k) summary for a medical device (BiuBiu Tampon), which establishes substantial equivalence to a predicate device. It does not describe a clinical study comparing the device to acceptance criteria in the way a clinical trial for a novel AI or diagnostic device would.
Therefore, many of the requested elements (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set sample size, ground truth for training set) are not applicable or not provided in this document as they pertain to clinical studies typically conducted for new diagnostic or AI devices.
However, I can extract information related to the device's non-clinical performance and acceptance criteria based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for each test are "predefined" but the specific numerical criteria are not detailed in this summary. The summary states that the tests were performed and the results demonstrate safety and effectiveness.
| Test Type | Acceptance Criteria (Not explicitly quantified in summary) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Non-cytotoxic, non-irritating, non-sensitizing | The applicator was demonstrated to be non-cytotoxic, non-irritating, and non-sensitizing. |
| Cytotoxicity (ISO 10993-5) | Non-cytotoxic | Non-cytotoxic |
| Vaginal Irritation (ISO 10993-10) | Non-irritating | Non-irritating |
| Skin Sensitization (ISO 10993-10) | Non-sensitizing | Non-sensitizing |
| Physical Performance | Conformed to predefined acceptance criteria (details not provided) | Tests performed per in-house methods with predefined acceptance criteria. Results demonstrate safety and effectiveness. |
| Appearance | Conforms to visual specifications | Tested (details not provided) |
| Dimensions | Conforms to dimensional specifications | Tested (details not provided) |
| Compatibility of tampon and applicator | Proper fit and function | Tested (details not provided) |
| Applicator integrity | Maintains structural integrity | Tested (details not provided) |
| Applicator expulsion force | Within specified force range for proper tampon expulsion | Tested (details not provided) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified for any of the non-clinical tests.
- Data Provenance: The document does not specify the country of origin for the non-clinical test data. It refers to "in house methods," suggesting internal testing by the manufacturer (Qingdao Youjia Hygiene Technology Co., Ltd, China). The data is generated prospectively as part of product development and submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. These are non-clinical, laboratory-based tests. No experts are used to establish ground truth in the context of clinical interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a clinical study requiring adjudication of expert interpretations.
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
Not applicable. This device is a menstrual tampon, not an AI or diagnostic device that involves human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a menstrual tampon, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance tests, the "ground truth" (or reference standard) is typically defined by:
- Biocompatibility: Established scientific standards and protocols outlined in ISO 10993 series and FDA guidance, ensuring materials do not cause adverse biological reactions.
- Physical Performance: Predefined engineering and design specifications for the device's physical attributes and functionality.
8. The sample size for the training set
Not applicable. This device is not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI algorithm that requires a training set.
§ 884.5470 Unscented menstrual tampon.
(a)
Identification. An unscented menstrual tampon is a device that is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge. This generic type of device does not include menstrual tampons treated with scent (i.e., fragrance materials) or those with added antimicrobial agents or other drugs.(b)
Classification. Class II (performance standards).