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The Unscented Menstrual Tampon is inserted into the vagina to absorb menstrual discharge.

The Unscented Menstrual Tampons are menstrual tampons used to absorb menstrual fluid. These tampons are provided in 4 absorbencies, light (≤ 6 grams absorbency), regular (6-9 grams), super (9-12 grams) and super plus (12-15 grams). These tampons include a pledget made from viscose and cotton as well as a polyester and polypropylene overwrap. The removal string is made of polypropylene yarn and cotton yarn. The applicator tubes are made of low density polyethylene (LDPE). The assembled tampon with applicator is wrapped in a printed polyethylene wrapper.

This document describes the premarket notification for an "Unscented Menstrual Tampon" (K232598) and states its substantial equivalence to a predicate device. It is important to note that this document is for a medical device (menstrual tampons), not an AI/ML powered device, so the requested information about AI model performance, multi-reader multi-case studies, and ground truth establishment from experts or pathology will not be present.

Based on the provided document, here's what can be extracted regarding acceptance criteria and performance:

The document explicitly states: "The performance tests were conducted to demonstrate the effectiveness of the subject device; all samples met the predefined acceptance criteria."

However, the specific numerical acceptance criteria for each test and the reported device performance are not explicitly detailed in a table format with specific values within this document. Instead, it lists the types of performance characteristics assessed and implies that the device met the criteria.

Here's a breakdown of the requested information based on the provided document, with explanations for what is not applicable or not explicitly stated:

1. A table of acceptance criteria and the reported device performance

While the document states that all acceptance criteria were met, it does not provide a table with specific numerical acceptance criteria and the corresponding reported values for the subject device. It only lists the types of tests performed.

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample size used for the performance tests. It states "all samples met the predefined acceptance criteria," but the number of samples is not provided.

Data Provenance: The document does not specify the country of origin for the test data or whether the studies were retrospective or prospective. Given the manufacturer is Chinese (Unibeauty (Hubei) Technology Co.,Ltd.), the testing was likely conducted in China or by a contracted lab.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as the device is a menstrual tampon, not an AI/ML powered medical device. The "ground truth" for the performance characteristics of a tampon (e.g., absorbency, dimensions, fiber shedding) is established through standardized physical and chemical testing methods, not by expert consensus or interpretations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable for this type of device and testing. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., radiology reads) where there can be disagreement among experts. Here, the tests are objective, laboratory-based measurements.

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

This is not applicable as the device is a menstrual tampon and not an AI-powered system. Therefore, no MRMC study or assessment of human reader improvement with AI assistance would have been conducted or is relevant.

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

This is not applicable as the device is a physical product (menstrual tampon), not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the performance characteristics of this device is established through:

• Standardized Physical and Chemical Testing Methods:
  • Syngyna method (for absorbency)
  • Measurement of dimensions and weight
  • Chemical analysis for residues
  • Mechanical testing (e.g., withdrawal cord strength, expulsion force)
  • Microbiological testing (e.g., growth of S. aureus, TSST-1 production, vaginal microflora alteration)
  • Biocompatibility testing (in vitro cytotoxicity, sensitization, irritation, acute systemic toxicity).

This is based on objective measurements rather than subjective expert consensus, pathology, or patient outcomes for device performance.

8. The sample size for the training set

This is not applicable. As a physical medical device, there is no "training set" in the context of machine learning model development. This is a manufactured product tested for its physical and biological properties.

9. How the ground truth for the training set was established

This is not applicable for the same reasons as point 8.

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

The proposed device is a traditional unscented menstrual tampon, and it has two types (i.e. digital tampon and applicator tampon). Each device consists of a tampon, including an absorbent pledget ("absorbent core") completely surrounded by overwap ("security veil") and a removal string ("withdrawal cord"), and an applicator (only for the applicator tampon). The tampon is of the traditional cylindrical, bullet-like shape. The applicator has a smooth, rounded tip to ease insertion. The proposed device is provided in 4 absorbencies: light (≤6g), regular (69g), super (912g) and super plus (12~15g). Each device is individually wrapped and packaged in sealed multi-unit containers for retail sale. And it is provided non-sterile and for single use only.

The provided text describes the 510(k) premarket notification for an Unscented Menstrual Tampon (K222046). It outlines the device's characteristics, its comparison to a predicate device, and the non-clinical testing performed to establish substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document references established guidance documents for menstrual tampons and pads for its performance characteristics. While specific numerical acceptance criteria are not explicitly listed in a consolidated table within the provided text, it states that "All samples met the predefined acceptance criteria" for performance testing.

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

The document does not explicitly state the sample sizes used for each specific test in the performance, biocompatibility, or microbiology testing. It only mentions "All samples met the predefined acceptance criteria."

The data provenance is from non-clinical testing performed by Suzhou Borage Medical Technology Co., Ltd. in China, or by their designated testing facilities. This is retrospective in the sense that the testing was conducted on manufactured devices for the purpose of the 510(k) submission.

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

This information is not applicable as the described study is a non-clinical device performance and safety evaluation for a menstrual tampon. It does not involve establishing ground truth from expert interpretation of data like images or patient outcomes. The "ground truth" here is the objective measurement of physical, chemical, and biological properties according to established standards.

4. Adjudication Method for the Test Set

This is not applicable as the described study is a non-clinical device performance and safety evaluation. Adjudication methods like 2+1 or 3+1 are typically used for expert review of clinical data, not for objective laboratory testing.

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

This is not applicable. The submission is for a physical medical device (unscented menstrual tampon) and does not involve AI or human readers for diagnostic interpretation.

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

This is not applicable. The submission is for a physical medical device (unscented menstrual tampon) and does not involve any algorithm or AI performance.

7. The Type of Ground Truth Used

The "ground truth" for this study is based on objective measurements and laboratory testing conforming to international standards (ISO 10993 series) and FDA guidance documents specific to menstrual tampons. This includes:

• Physical measurements: Dimensions, absorbency, removal string strength, fiber shedding, tampon integrity.
• Chemical analysis: Chemical residues.
• Biological testing: In vitro cytotoxicity, skin sensitization, vaginal irritation, acute systemic toxicity, and specific microbiological tests for Staphylococcus aureus growth, TSST-1 production, and impact on vaginal microflora.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" as this is a physical device evaluation, not an algorithm or AI development.

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

This is not applicable for the same reason as point 8.

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The BiuBiu tampon is inserted into the vagina and used to absorb menstrual and other vaginal discharge.

The BiuBiu tampon is composed of an absorbent pledget (tampon), a withdrawal cord, and an applicator. The pledgets (cleared under K090819) have a cylindrical, bullet-like shape and the applicators have a smooth, rounded tip to ease insertion. The barrel of the applicator has a no-slip grip design to help hold the tampon tightly. Each tampon is individually wrapped and packaged. There are three versions of the BiuBiu tampon with different absorbencies: regular, super and super plus. Each version has a different color applicator. The BiuBiu tampon is provided non-sterile and for single use only.

This is a 510(k) summary for a medical device (BiuBiu Tampon), which establishes substantial equivalence to a predicate device. It does not describe a clinical study comparing the device to acceptance criteria in the way a clinical trial for a novel AI or diagnostic device would.

Therefore, many of the requested elements (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set sample size, ground truth for training set) are not applicable or not provided in this document as they pertain to clinical studies typically conducted for new diagnostic or AI devices.

However, I can extract information related to the device's non-clinical performance and acceptance criteria based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for each test are "predefined" but the specific numerical criteria are not detailed in this summary. The summary states that the tests were performed and the results demonstrate safety and effectiveness.

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 for Test Set: Not specified for any of the non-clinical tests.
• Data Provenance: The document does not specify the country of origin for the non-clinical test data. It refers to "in house methods," suggesting internal testing by the manufacturer (Qingdao Youjia Hygiene Technology Co., Ltd, China). The data is generated prospectively as part of product development and 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. These are non-clinical, laboratory-based tests. No experts are used to establish ground truth in the context of clinical interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a clinical study requiring adjudication of expert interpretations.

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 device is a menstrual tampon, not an AI or diagnostic device that involves human readers or AI assistance.

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

Not applicable. This device is a menstrual tampon, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical performance tests, the "ground truth" (or reference standard) is typically defined by:

• Biocompatibility: Established scientific standards and protocols outlined in ISO 10993 series and FDA guidance, ensuring materials do not cause adverse biological reactions.
• Physical Performance: Predefined engineering and design specifications for the device's physical attributes and functionality.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This device is not an AI algorithm that requires a training set.

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unscented menstrual tampons used to absorb menstrual fluid.

TAMPAX Tampons, Plastic Applicator will be provided in three absorbencies, regular, super and super plus. TAMPAX Tampons, Plastic Applicator have a colored plastic applicator. TAMPAX Tampons, Plastic Applicator are made of rayon fibers and overwrap, a cotton withdrawal cord, and a colored plastic applicator.

This device is a medical device, but not one that typically utilizes the types of acceptance criteria and studies you've requested (e.g., related to algorithms, expert consensus, or specific performance metrics like sensitivity/specificity). The provided text is for a menstrual tampon, and the assessment is focused on safety and equivalence to a predicate device, particularly regarding the addition of a colored applicator.

Therefore, many of the requested fields are not applicable in the context of this 510(k) summary. I will fill in the relevant information and indicate "N/A" (Not Applicable) for those that don't fit this type of device submission.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size (Clinical Test Set): 57 women
• Data Provenance: Not explicitly stated (e.g., country of origin). It was a prospective clinical study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• N/A. Ground truth in this context is self-reported irritation/comfort by the study participants and observation of adverse events by clinical staff, rather than expert interpretation of data.

4. Adjudication method for the test set

• N/A. Not applicable for this type of self-reported outcome and safety observation study.

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

• No. This is not an AI/imaging device, so an MRMC study is not relevant.

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

• No. This is not an algorithmic device.

7. The type of ground truth used

• Clinical Endpoints: Patient-reported comfort and irritation, observation of adverse events during clinical study.
• Bench/Lab Endpoints: Results from irritation, sensitization, cytotoxicity, and extraction assays for biocompatibility.

8. The sample size for the training set

• N/A. There is no "training set" in the context of this type of traditional device submission. The study itself is an evaluation of the finished product.

9. How the ground truth for the training set was established

• N/A. Not applicable.

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