(24 days)
The TAMPAX® Pearl Plastic™ unscented and scented Tampons are intended to be inserted into the vagina to absorb menstrual fluid.
Scented or scented deodorized, unscented menstrual tampons for absorption of menstrual fluid.
This document is a 510(k) summary for a medical device (TAMPAX® Pearl Tampons) seeking clearance from the FDA. The information provided focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with detailed acceptance criteria and results.
Therefore, many of the requested sections regarding acceptance criteria, study details, and AI-specific metrics cannot be extracted from the provided text. The document primarily describes the device, its intended use, and a safety assessment, then states conclusions about its safety and substantial equivalence to existing products.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided in the requested format. The document does not describe specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or corresponding quantitative device performance metrics in the way a diagnostic AI study would.
- What is stated: "The results of these safety tests support the conclusion that the 510(k) device is equally as safe as the predicate devices." and "The device is designed to acquire and hold menstrual fluids similar to the fluid handling capabilities of the predicate devices." This indicates a qualitative comparison for safety and functionality rather than quantitative performance against a set of predefined thresholds.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not explicitly stated for a "test set" in the context of device performance. The document mentions "in vitro microbiological testing, biocompatibility evaluation and extraction testing" as part of the safety assessment. However, it does not specify sample sizes or data provenance (country, retrospective/prospective) for these tests in a way that aligns with evaluating a device's diagnostic performance against a ground truth.
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/Not stated. This type of information is relevant for studies validating diagnostic algorithms where expert consensus or pathological analysis establishes ground truth. For a menstrual tampon, the "ground truth" would likely relate to material properties, absorbency, and safety markers, which are evaluated through lab tests, not expert interpretation of outputs.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not stated. Adjudication methods are used in studies involving human interpretation or subjective assessments, typically for diagnostic image analysis or similar tasks. This is not described for a tampon.
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-powered diagnostic tool. Therefore, a multi-reader multi-case comparative effectiveness study involving human readers and AI assistance is not relevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Implied ground truth for safety and function: The "ground truth" for this device would be established through laboratory testing standards for absorbency, material composition, biocompatibility, and microbiological safety. The document refers to "in vitro microbiological testing, biocompatibility evaluation and extraction testing." These tests have their own established methods and criteria for determining safety and performance, which serve as the "ground truth" for evaluating the tampon's characteristics.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device that requires a training set.
Summary of what the document does provide regarding the device and its assessment:
The document describes the submission of a 510(k) premarket notification for TAMPAX® Pearl Tampons (unscented and scented). The primary goal of this submission is to demonstrate substantial equivalence to predicate devices (TAMPAX Pearl Tampons® unscented and scented: K011996; K040312; K051290).
Key "Acceptance Criteria" (implicit, based on 510(k) process for this device type):
- Safety: The device is as safe as predicate devices.
- Effectiveness/Functionality: The device is designed to acquire and hold menstrual fluids similar to the fluid handling capabilities of the predicate devices.
- Technological Characteristics: The device is similar to the predicate devices in terms of basic component materials, overall design, and labeling.
- Intended Use: Consistent with predicate devices.
Study that proves the device meets the (implicit) acceptance criteria:
- Study Type: A battery of safety evaluations was conducted.
- Specific Tests Mentioned:
- In vitro microbiological testing
- Biocompatibility evaluation
- Extraction testing
- Results/Conclusions:
- "The results of these safety tests support the conclusion that the 510(k) device is equally as safe as the predicate devices."
- "The results of evaluations for this device support the conclusions that it is safe for its intended use and substantially equivalent to the cited predicate devices."
In conclusion, this document describes a traditional medical device submission (a tampon) seeking clearance based on substantial equivalence, not a performance study for an AI-driven diagnostic device. Therefore, the detailed metrics and study design elements typically associated with AI performance evaluation are not present.
§ 884.5460 Scented or scented deodorized menstrual tampon.
(a)
Identification. A scented or scented deodorized 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. It has scent (i.e., fragrance materials) added for aesthetic purposes (scented menstrual tampon) or for deodorizing purposes (scented deodorized menstrual tampon). This generic type of device does not include menstrual tampons treated with added antimicrobial agents or other drugs.(b)
Classification. Class II (performance standards).