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510(k) Data Aggregation
(59 days)
The Tempo Natural Tampon is intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.
The Tempo Natural Tampon will be offered as a traditional unscented menstrual 100% organic 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. It will be offered in two absorbances: Regular and Super.
This document is an FDA 510(k) clearance letter for a menstrual tampon. It does not describe an AI/machine learning medical device, nor does it contain information about expert-level ground truth, multi-reader multi-case studies, or the performance of an algorithm.
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set specifics, as this information is not present in the provided text.
The document focuses on demonstrating substantial equivalence to a predicate device, as opposed to proving novel performance against specific acceptance criteria for an AI model.
Here's an overview of what is provided:
Device: Tempo Natural Tampon
Regulatory Class: Class II, Product Code HEB
Indication for Use: "The Tempo Natural Tampon is intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge."
Acceptance Criteria & Device Performance (Based on Substantial Equivalence to Predicate):
The "acceptance criteria" for this device are effectively demonstrating that it is as safe and effective as a legally marketed predicate device (Taebong CottonDay Tampon K182817) by meeting a set of similar specifications and passing specific non-clinical tests.
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from Predicate Equivalence & Testing) | Reported Device Performance (as presented in the 510(k) Summary) |
|---|---|---|
| Intended Use | Same as predicate device | "The Tempo Natural Tampon is intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge." (Identical to predicate) |
| Sterility | Non-sterile (same as predicate) | No (Non-sterile) |
| Design | Cylindrical shape, bullet-like tip, standard applicator with smooth, rounded tip (same as predicate) | Cylindrical shape, bullet-like tip, applicator with smooth, rounded tip (Identical to predicate) |
| Syngyna Absorbency (gram) | Regular: 6.0 – 9.0; Super: 9.0 – 12.0 (same as predicate) | Regular: 6.0 – 9.0; Super: 9.0 – 12.0 (Identical to predicate) |
| Pledget Length (mm) | Regular: 38; Super: 47 (same as predicate) | Regular: 38; Super: 47 (Identical to predicate) |
| Pledget Diameter (mm) | Regular: 12; Super: 12 (same as predicate) | Regular: 12; Super: 12 (Identical to predicate) |
| Applicator Inner Length (mm) | Regular: 73 ± 5%; Super: 73 ± 5% (same as predicate) | Regular: 73 ± 5%; Super: 73 ± 5% (Identical to predicate) |
| Applicator Outer Length (mm) | Regular: 76.5 ± 5%; Super: 76.5 ± 5% (same as predicate) | Regular: 76.5 ± 5%; Super: 76.5 ± 5% (Identical to predicate) |
| Applicator Inner Diameter (mm) | Regular: 11.8 ± 5%; Super: 11.8 ± 5% (same as predicate) | Regular: 11.8 ± 5%; Super: 11.8 ± 5% (Identical to predicate) |
| Applicator Outer Diameter (mm) | Regular: 14.1 ± 5%; Super: 14.1 ± 5% (same as predicate) | Regular: 14.1 ± 5%; Super: 14.1 ± 5% (Identical to predicate) |
| Materials | Pledget: 100% Organic Cotton; Applicator: Polyethylene (same as predicate) | Pledget: 100% Organic Cotton; Applicator: Polyethylene (Identical to predicate) |
| Performance Testing (per FDA guidance) | Meet standards for: Dimensions, Absorbency range, Chemical residues, Withdrawal cord strength, Fiber shedding, Tampon integrity. | "The following performance characteristics were assessed... and results demonstrate substantial equivalence." (Specific values not provided, only compliance stated) |
| Biocompatibility Testing (per ISO 10993) | Meet standards for: Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity. | "The results satisfied the ISO standards requirements." |
| Microbiology Testing (per FDA guidance) | Not enhance S. aureus growth, not increase TSST-1 production, not alter normal vaginal microflora. | "Microbiology testing was conducted to demonstrate that the subject devices do not: [list of criteria]..." (Compliance stated) |
Regarding the other requested information:
- Sample size used for the test set and the data provenance: Not applicable in the context of a medical device (tampon) performance testing for 510(k). The tests are typically conducted per recognized standards on representative samples of the product. The data provenance would be laboratory testing results.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for medical device performance (e.g., absorbency, strength) is based on objective laboratory measurements against established standards, not expert consensus interpretation.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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/ML device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Objective laboratory measurements and adherence to specified material and dimensional characteristics based on recognized standards (e.g., ISO, FDA guidance).
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
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