(234 days)
The Daye Tampons are indicated for insertion into the vagina to absorb menstrual discharge.
The Daye Tampons are unscented menstrual tampons consisting of an absorbent cotton pledget and a plastic (polyethylene) full-size applicator. The tampon pledget is made entirely of organic cotton, is fashioned with a W'wadding design and protective sleeve/overwrap. A withdrawal cord, made from mercerised organic cotton, is attached to the pledget. The Daye Tampons are available in regular (6-9 grams) and super (9-12 grams) absorbencies. The Daye Tampons and applicator are gamma irradiated in the finalpackaging. The Daye Tampons and applicators are repackaged together.
The provided document is a 510(k) summary for the Daye Tampon, which is a medical device, not an AI/ML powered diagnostic device. Therefore, the information required to answer the prompt regarding acceptance criteria and a study proving a device meets acceptance criteria using AI/ML specific methods is largely not present. The document focuses on demonstrating substantial equivalence to a predicate menstrual tampon based on performance characteristics, biocompatibility, and microbiology.
However, I can extract and restructure the available information to fit the spirit of the request, interpreting "device performance" in the context of a tampon and its established safety and effectiveness. I will explicitly state where the requested information is not applicable or not provided in the document.
Acceptance Criteria and Study for Daye Tampon (based on 510(k) Summary)
The Daye Tampon is a menstrual tampon, and its performance and safety are assessed against established regulatory standards and comparison to a legally marketed predicate device (Ontex W long plastic applicator Tampons, K162746). The "acceptance criteria" here are essentially the demonstration of substantial equivalence, ensuring the device is as safe and effective as the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion Type | Specific Acceptance Criterion (Standard or Predicate Equivalence) | Reported Device Performance and Confirmation |
|---|---|---|
| Biocompatibility | Non-cytotoxic, non-sensitizing, non-irritating, and not acutely systemically toxic (for tampon). Non-cytotoxic, non-sensitizing, and non-irritating (for applicator). (Complies with ISO 10993-1, -5, -10) | Tampon: Demonstrated to be non-cytotoxic, non-sensitizing, non-irritating, and not acutely systemically toxic. |
| Applicator: Demonstrated to be non-cytotoxic, non-sensitizing, and non-irritating. | ||
| Physical & Performance Characteristics | ||
| Dimensional Analysis | Gamma radiation should have no adverse effect on measured product dimensions (e.g., tampon length/diameter, applicator length/diameter, withdrawal cord length). | Gamma radiation had no effect on any of the measured product dimensions (tampon: Length 45±5mm, Diameter 13.5±0.2mm (Reg) / 15.5±0.2mm (Super), Weight 1.9-2.3g (Reg) / 3.0-3.4g (Super); applicator: Closed 77mm, Extended 115-135mm, Diameter 14.9/16.9mm; withdrawal cord: 120±15mm). |
| Absorbency (Syngyna Method) | Regular: 6-9 grams; Super: 9-12 grams (per 21 CFR 801.430). | Regular Daye Tampons: Remained within 6-9 grams absorbency range. |
| Super Daye Tampons: Remained within 9-12 grams absorbency range. | ||
| Withdrawal Cord Strength | Should maintain adequate strength after irradiation, similar to non-irradiated tampons. | Withdrawal cord strength of irradiated tampons is similar to non-irradiated tampons. |
| Fiber Loss | Gamma radiation should not increase fiber shedding compared to non-irradiated tampons. | Gamma radiation did not increase fiber shedding as compared to non-irradiated tampons. |
| Tampon Integrity | Maintain integrity (details not specified, but implied to be acceptable). | (Results confirmed acceptable for substantial equivalence, specific metrics not detailed in summary). |
| Chemical Residues | Acceptable chemical residue profile, leveraged from predicate. | Chemical residue testing leveraged from the predicate device due to identical composition, demonstrating acceptable profile. |
| Microbiology Characteristics | Does not enhance Staphylococcus aureus growth, increase TSST-1 production, or alter normal vaginal microflora (Complies with FDA Guidance). | Does not enhance the growth of Staphylococcus aureus, increase the production of Toxic Shock Syndrome Toxin-1 (TSST-1), or alter the growth of normal vaginal microflora. (Leveraged from predicate device). |
| Wrapper Testing | Not adversely affected by humidity, dissolves in water as designed. | Wrapper not adversely affected by 90% humidity for 30 minutes; dissolves completely in approximately 15 seconds when placed in water. |
| Overall Equivalence | As safe and effective as the predicate device. | Non-clinical data demonstrate the Daye Tampons are as safe and effective as the predicate device, supporting a determination of substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the specific sample sizes for each test (e.g., number of tampons tested for absorbency, dimensions, etc.). It refers to "tests" being performed.
- Data Provenance: The study was conducted by Anne's Daye Ltd. The country of origin for the data is not specified, but the applicant's address is in London, UK. The studies are implicitly prospective in the sense that they are specifically performed for the purpose of this 510(k) submission to demonstrate compliance and substantial equivalence to the predicate where comparative testing was done (e.g., post-irradiation effects). For chemical residues and microbiology, leverage from the predicate device implies reliance on data previously generated for the predicate, which could have been retrospective for that predicate, but for the Daye Tampon submission, it's a forward-looking use of existing data.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
- Not Applicable. This device is a menstrual tampon, not an AI/ML diagnostic system requiring expert interpretation or ground truth establishment in a clinical context. The "ground truth" here is defined by established regulatory standards (e.g., 21 CFR 801.430 for absorbency, ISO standards for biocompatibility) and direct physical/chemical measurements.
4. Adjudication Method for the Test Set
- Not Applicable. As this is not an AI/ML diagnostic study involving human readers and interpretations, an adjudication method for a test set is not relevant. Tests are performed according to established methods (e.g., Syngyna method, ISO 10993).
5. MRMC Comparative Effectiveness Study
- Not Applicable. This is not an AI/ML diagnostic device, and thus, no Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed. There are no human readers assisting with an AI to improve performance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not Applicable. This is not an AI or algorithm-based device. Its performance is inherent to its physical and chemical properties.
7. Type of Ground Truth Used
- The "ground truth" for this device is based on:
- Regulatory Standards: Specific performance requirements defined by FDA regulations (e.g., 21 CFR 801.430 for absorbency ranges).
- International Standards: Biological evaluation standards (ISO 10993 series) for biocompatibility.
- Direct Measurement & Empirical Testing: Objective measurements of physical dimensions, strength, and laboratory tests for fiber loss, absorbency, and dissolution.
- Comparison to Predicate: Establishing equivalence to the performance and safety characteristics of a legally marketed predicate device.
8. Sample Size for the Training Set
- Not Applicable. As this is not an AI/ML device, there is no "training set."
9. How Ground Truth for the Training Set Was Established
- Not Applicable. There is no training set as it's not an AI/ML device.
§ 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).