(18 days)
The Tosama 100% Cotton Tampon is intended for insertion into the vagina for absorption of menstrual or other vaginal discharge.
The device will be offered as a traditional unscented menstrual 100% cotton tampon consisting of an absorbent pledget, a withdrawal cord, and an applicator. The pledget is of the traditional cylindrical, bullet-like shape and the applicator has a standard rounded tip to ease insertion. Each tampon is individually wrapped and packaged in multi-unit containers for retail sale. It will be offered in three absorbencies: Regular, Super, and Super Plus.
The provided document describes a medical device (Tosama 100% Cotton Menstrual Tampon) and its substantial equivalence to predicate devices, rather than an AI-powered diagnostic tool. Therefore, many of the requested categories for acceptance criteria and study design (such as Number of experts used to establish the ground truth, Adjudication method, MRMC comparative effectiveness study, Standalone performance, Type of ground truth, and Sample size for the training set and Ground truth for training set) are not applicable.
However, I can extract information related to the device's performance, the tests conducted, and the basis for its equivalence.
Here's the information derived from the provided text, adapted to the closest relevant categories:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" but lists various physical and functional specifications for the tampon, along with reported values for the Tosama 100% Cotton Menstrual Tampon and the predicate devices. The study objective was to demonstrate substantial equivalence, meaning the Tosama device performs within the same established ranges as the predicates.
| Feature / Acceptance Criteria (Implied) | Reported Device Performance (Tosama 100% Cotton Menstrual Tampon) | Predicate Performance (Naturalena / Cottons 100% Natural Cotton Tampon) |
|---|---|---|
| Indications for Use | Intended for insertion into the vagina for absorption of menstrual or other vaginal discharge. | Same |
| Design | Tampon with cylindrical shape and bullet-like tip. Applicator with smooth, rounded tip. | Same |
| Pledget Material | 100% Cotton | 100% Cotton |
| Withdrawal Cord Material | 100% Cotton | 100% Cotton |
| Applicator Material | Polyethylene | Polyethylene |
| Individual Wrapping Material | Polypropylene | Polypropylene (Naturalena), Cellophane (Cottons) |
| Additives & Finishing Agents | Hydrophobic coating on withdrawal cord. | Hydrophobic coating on withdrawal cord (Naturalena), None (Cottons) |
| Digital Regular Tampon | ||
| Length | 43.0mm – 46.0mm | 43.0mm – 46.0mm |
| Diameter | 11.0mm – 12.0mm | 11.0mm – 12.0mm |
| Mass | 2.30g – 2.70g | 2.30g – 2.70g |
| Withdrawal Cord Length | 130mm – 160mm | 130mm – 160mm |
| Syngina Absorbency | 6.0g - 9.0g | 6.0g - 9.0g |
| Digital Super Tampon | ||
| Length | 48.0mm – 51.0mm | 48.0mm – 51.0mm |
| Diameter | 12.0mm – 13.0mm | 12.0mm – 13.0mm |
| Mass | 2.70g – 3.10g | 2.70g – 3.10g |
| Withdrawal Cord Length | 130mm - 160mm | 130mm - 160mm |
| Syngina Absorbency | 9.0g - 12.0g | 9.0g - 12.0g |
| Digital Super Plus Tampon | ||
| Length | 48.0mm - 51.0mm | 48.0mm - 51.0mm |
| Diameter | 14.0mm - 15.0mm | 14.0mm - 15.0mm |
| Mass | 3.30g – 3.80g | 3.30g – 3.80g |
| Withdrawal Cord Length | 130mm - 160mm | 130mm - 160mm |
| Syngina Absorbency | 12.0g – 15.0g | 12.0g – 15.0g |
| Applicator Regular Tampon | ||
| Tampon Length | 43.0mm – 46.0mm | 43.0mm - 46.0mm |
| Applicator Length | 120mm ± 5% | 120mm ± 5% |
| Tampon Diameter | 11.0mm – 12.0mm | 11.0mm - 12.0mm |
| Applicator Diameter | 13mm | 13mm |
| Tampon Mass | 2.00g - 2.30g | 2.00g - 2.30g |
| Applicator Mass | 3.40g - 3.60g | 3.40g - 3.60g |
| Total Mass | 5.40g - 5.90g | 5.40g - 5.90g |
| Withdrawal Cord Length | 130mm - 160mm | 130mm - 160mm |
| Syngina Absorbency | 6.0g - 9.0g | 6.0g - 9.0g |
| Applicator Super Tampon | ||
| Tampon Length | 43.0mm - 46.0mm | 43.0mm - 46.0mm |
| Applicator Length | 120mm ± 5% | 120mm ± 5% |
| Tampon Diameter | 12.0mm - 13.0mm | 12.0mm - 13.0mm |
| Applicator Diameter | 16mm | 16mm |
| Tampon Mass | 2.60g - 3.00g | 2.60g - 3.00g |
| Applicator Mass | 4.10g - 4.30g | 4.10g - 4.30g |
| Total Mass | 6.70g - 7.30g | 6.70g - 7.30g |
| Withdrawal Cord Length | 130mm - 160mm | 130mm - 160mm |
| Syngina Absorbency | 9.0g - 12.0g | 9.0g - 12.0g |
| Applicator Super Plus Tampon | ||
| Tampon Length | 43.0mm - 46.0mm | 43.0mm - 46.0mm |
| Applicator Length | 120mm ± 5% | 120mm ± 5% |
| Tampon Diameter | 14.0mm - 15.0mm | 14.0mm - 15.0mm |
| Applicator Diameter | 18mm | 18mm |
| Tampon Mass | 3.00g - 3.50g | 3.00g - 3.50g |
| Applicator Mass | 4.20g - 4.40g | 4.20g - 4.40g |
| Total Mass | 7.20g - 7.90g | 7.20g - 7.90g |
| Withdrawal Cord Length | 130mm - 160mm | 130mm - 160mm |
| Syngina Absorbency | 12.0g - 15.0g | 12.0g - 15.0g |
The "study that proves the device meets the acceptance criteria" is described as a non-clinical data summary. This non-clinical data was used for substantial equivalence determination to predicate devices already on the market.
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: Not explicitly stated for each test, but it is implied that representative samples of the Tosama 100% Cotton Menstrual Tampon and its components were tested.
- Data Provenance: The manufacturer is TOSAMA, d.o.o. from Slovenia, EU. The testing appears to have been conducted by or for the manufacturer. The data is likely prospective, as it relates to testing the specific device for regulatory 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. This is a physical and chemical testing study for a medical device, not an AI-powered diagnostic tool requiring expert ground truth for interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a physical and chemical testing study, not based on human review/adjudication.
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 is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI device. The device itself is a standalone medical product.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" in this context refers to established test methodologies and results for similar predicate devices, and the physical, chemical, and microbiological properties of the materials and finished product. Testing followed "recommended requirements."
- Chemical Analysis: Tests for pesticide, dioxin, heavy metal, phthalate, and PCB residues.
- Microbiological Testing: Enumeration per USP /, Toxic Shock Syndrome Toxin-1 production, vaginal microflora growth alteration, and S. aureus growth enhancement.
- Biocompatibility Testing: In vitro cytotoxicity, intracutaneous and vaginal irritation, sensitization, and acute systemic toxicity.
- Efficacy Testing: Syngina absorbency, fiber loss, withdrawal cord pull-out resistance, and tampon integrity.
- Physical Characteristics: Length, diameter, mass, withdrawal cord length, applicator dimensions.
8. The sample size for the training set
Not applicable. This is not an AI device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set as it is not an AI 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).