(85 days)
The TAMPAX® C Plastic™ Tampons, unscented, are intended to be inserted into the vagina to absorb menstrual fluid.
Unscented menstrual tampons for absorption of menstrual fluid
The provided document is a 510(k) summary for a medical device (TAMPAX® C Plastic™ Tampons, unscented). This type of document is submitted to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. As such, the study design and acceptance criteria differ significantly from what would be expected for a novel AI/software device. The document primarily focuses on non-clinical testing to establish equivalence based on material safety and specific design characteristics, rather than diagnostic performance metrics typical for AI studies.
Here's an analysis of the "acceptance criteria" and "study" described, interpreted within the context of a 510(k) submission for a tampon:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from testing) | Reported Device Performance |
|---|---|---|
| Material Safety | Negligible or no tampon pledget exposure to applicator components via extraction. | Extractions of the 510(k) device plastic applicators performed under exaggerated conditions confirmed negligible or no tampon pledget exposure to the applicator components. (Similar to predicate device applicator extracts). |
| Applicator Expulsion Force | Within acceptable limits for safe and effective use. | Tests showed that the force is within acceptable limits. (Similar to the current applicator of the predicate device). |
| Wrapper Seal Strength | Within specified limits to maintain integrity. | Thwing-Albert measurement showed that the seal strength is within specified limits. (Similar integrity to the current wrapper of the predicate device). |
| Wrapper Peel Strength | Within specified limits to allow proper opening while maintaining integrity. | Instron measurement showed that the peel strength is within specified limits. (Similar integrity to the current wrapper of the predicate device). |
| Pledget Design | Identical to the predicate device pledget design. | The tampon pledget design was not changed from the predicate device. |
| Fluid Handling Capabilities | Similar to the fluid handling capabilities of the predicate devices. | The device is designed to acquire and hold menstrual fluids similar to the fluid handling capabilities of the predicate devices. (No specific numerical performance provided, but stated as similar to predicate). |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not explicitly state numerical sample sizes for each test in the way an AI study would. Instead, it mentions "Extractions of the 510(k) device plastic applicators were performed," "Tests of the 510(k) tampon applicator expulsion force showed," "Tests of the seal strength... and peel strength... of the 510(k) modified wrapper showed."
- Test Set Sample Size: Not specified quantitatively. The implication is that sufficient units were tested to demonstrate compliance with the criteria and similarity to the predicate.
- Data Provenance: This is not applicable in the context of clinical data provenance (e.g., country of origin, retrospective/prospective). The data is generated from laboratory testing of the physical device and its components.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. For this type of device, "ground truth" is established by direct physical measurements and engineering standards, not by expert interpretation of clinical data.
- Qualifications of Experts: Not specified, but implied to be technicians or engineers qualified to perform the described physical and chemical tests (e.g., performing extractions, operating Thwing-Albert and Instron machines).
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no expert adjudication for physical/chemical test results as there would be for medical image interpretation or clinical outcomes. The results are objective measurements against predefined specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret output (e.g., medical images) and AI assists that interpretation. This is a physical, non-AI medical device.
- Effect Size of Human Reader Improvement: Not applicable, as no MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: No, a standalone performance study as typically understood for an AI algorithm was not done. This device is not an algorithm. Its "performance" is its physical characteristics and safety, measured directly.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for this submission is based on engineering specifications, material science principles, and direct physical/chemical measurements. The primary method for establishing "equivalence" (which is the goal of a 510(k)) is by comparing these measured characteristics to those of the predicate device and established safety standards.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This is not an AI/machine learning device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for this device.
Summary in the Context of a 510(k) Submission:
This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (TAMPAX® Pearl Tampons, unscented, K081555). The "study" conducted for this device is a series of non-clinical, laboratory-based tests. The acceptance criteria essentially boil down to:
- The new device (TAMPAX® C Plastic™ Tampons) must exhibit material safety equivalent to or better than the predicate.
- Its functional physical characteristics (applicator expulsion force, wrapper integrity, pledget design, fluid handling) must be similar to or within acceptable limits compared to the predicate device.
The study "proves" the device meets these criteria by showing that the results of the specific physical and chemical tests either match the results of the predicate device (where available) or fall within established acceptable ranges for safe and effective use. The changes made (pigment addition, applicator shape, wrapper modification) were assessed to ensure they did not negatively impact the safety or fundamental performance, and the evidence provided supports this conclusion for FDA's substantial equivalence determination.
§ 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).