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The Tempo Tampon is intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.

The Tempo Tampon 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 two absorbances: Regular and Super.

This document is a 510(k) Premarket Notification for the "Tempo Tampon". It aims to demonstrate substantial equivalence to a legally marketed predicate device, the "Taebong CottonDay Tampon" (K182817).

Based on the provided text, here's a breakdown of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

Since this is a submission for a physical medical device (tampon) and not an AI/software device, the concept of "test set" in the context of AI models (e.g., training/test/validation split) does not directly apply. The "studies" described are in vitro and in vivo tests on the device itself.

• Sample Size: The document does not specify the exact number of samples (e.g., individual tampons) used for each performance, biocompatibility, and microbiology test. It only states that the tests were performed.
• Data Provenance: The tests are implicit to have been conducted under controlled laboratory conditions to assess the device properties. There is no mention of "country of origin of the data" in terms of patient data or "retrospective/prospective" as relevant to clinical trial data. These are laboratory studies on the manufactured product.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This information is not applicable to this type of device submission. The "ground truth" for the performance characteristics (e.g., absorbency, dimensions, biocompatibility) is established through standardized laboratory testing methods and accepted scientific protocols (e.g., specific FDA guidance documents, ISO standards). There isn't a "human expert" interpretation of images or symptoms involved in establishing these facts.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human readers or interpretation of complex data that would require an adjudication process. The tests performed yield objective, measurable results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

No. An MRMC study is relevant for AI or diagnostic imaging devices where human readers interpret medical images. This submission is for a menstrual tampon, and no such study was conducted or is required.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

No. This concept is relevant for AI algorithms. The "device" here is a physical product (tampon), not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by:

• Standardized Test Methods: Adherence to established FDA guidance documents ("Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) - Guidance for Industry and FDA Staff") for performance characteristics.
• International Standards (ISO): Compliance with specific ISO 10993 standards for biocompatibility testing.
• Predicate Device Comparison: Direct comparison of key performance metrics (like absorbency) against the legally marketed predicate device.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of an AI/machine learning model for this medical device submission. The device is manufactured, and its properties are tested.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set in the AI/ML sense.

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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.

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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