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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.

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U by Kotex® Click® Unscented Menstrual Tampon is an unscented tampon inserted into the vagina to absorb menstrual fluid.

The U by Kotex® Click® Unscented Menstrual Tampon is a conventional unscented menstrual tampon consisting of an absorbent pledget and a telescoping three-piece plastic applicator. The device will be manufactured in Regular, Super, and Super Plus absorbencies. The absorbent pledget consists of an absorbent core of radially wound rayon ribbon compressed into a grooved cylinder with a rounded, bullet-like tip, a non-woven overwrap cover, and a rayon-polyester blend withdrawal string. The three-piece applicator consists of an outer insertion tube (barrel) with a textured grip and formed with a closed, rounded tip in a petal-like design, a clear middle telescopic tube (telescope), and an elongated insertion tube (plunger). Each tampon is individually sealed in a plastic film primary wrapper and then packaged in sealed multi-unit containers for retail sale.

The document describes a 510(k) submission for a medical device, which generally means comparing a new device to a legally marketed predicate device to demonstrate substantial equivalence. For this type of submission, extensive acceptance criteria and detailed clinical studies as might be found for novel technologies are often not present in the same format. Instead, the focus is on showing that the modified device performs as safely and effectively as the predicate.

Based on the provided text, here's a breakdown of the requested information:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance for a test set. Instead, it states that the device was assessed against various standards and guidance documents. The "Performance" column in Table 05-02 indicates the outcome of the tests, rather than specific numerical acceptance criteria. Similarly, for other performance characteristics, the document states they "were assessed in accordance with the 2005 FDA guidance document," implying compliance with the requirements within that guidance, but without listing specific numerical targets.

However, we can infer some "performance" outcomes from the biocompatibility tests:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states, "No clinical tests were performed as part of this device modification." Therefore, there is no clinical test set, sample size, or specific data provenance (country, retrospective/prospective) for clinical performance in the traditional sense. The performance data discussed relates to non-clinical laboratory testing. The document does not specify sample sizes for these non-clinical tests (e.g., how many tampons were tested for absorbency, string strength, etc.).

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

Not applicable. Since no clinical tests were performed and no human interpretation of data for diagnostic purposes is relevant to this device, no "experts" in the context of establishing ground truth for a test set are mentioned. The testing was conducted against regulatory standards and guidelines by presumably qualified laboratory personnel.

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

Not applicable. This device is a menstrual tampon, and the performance assessment is based on physical and chemical properties and biocompatibility, not on a diagnostic interpretation requiring adjudication of results from multiple readers.

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 and does not involve AI or human readers for diagnostic purposes.

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

Not applicable. This device is a physical medical device (menstrual tampon), not an algorithm or software.

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

For the non-clinical tests, the "ground truth" is defined by the established regulatory standards and guidance documents (e.g., ISO 10993 series for biocompatibility, 2005 FDA guidance for tampons for performance characteristics). Compliance with these standards indicates acceptable performance. There isn't a "ground truth" derived from expert consensus, pathology, or outcomes data in the typical sense applied to diagnostic devices.

8. The sample size for the training set

Not applicable. This is a 510(k) submission for a physical medical device, not an AI or machine learning device requiring a training set.

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

Not applicable for the reason mentioned above.

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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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The U by Kotex® Click® Unscented Menstrual Tampons are inserted into the vagina to absorb menstrual fluid.

The subject devices are conventional unscented menstrual tampons consisting of an absorbent pledget, an overwrap, a withdrawal string, and a plastic applicator. The absorbent pledget consists of a ribbon of rayon fibers. A rayon-polyester blend withdrawal string is placed on the ribbon and the ribbon is radially wound, then compressed into a traditional eight-groove bulletshaped pledget, overwrapped with a non-woven cover material. The tampon component is inserted into a three-piece plastic applicator consisting of an inner tube (plunger), a clear middle telescopic tube (telescope), and an outer insertion tube (barrel) formed with a closed, rounded tip. Each tampon component with applicator is wrapped in an individual plastic film wrapper, and packaged in a sealed multi-unit container for retail sale. Tampons are available in Regular, Super and Super Plus absorbencies in various counts.

The document you provided is a 510(k) Premarket Notification from the FDA for a menstrual tampon. This type of document is a submission to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device. It doesn't typically contain detailed clinical study reports for AI algorithms.

However, I can extract the acceptance criteria and the self-reported study details regarding the performance testing of the U by Kotex® Click® Unscented Menstrual Tampons as described in the document.

Please note: The requested information regarding sample sizes for training/test sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, and how ground truth for training data was established are not applicable in this context, as the device is a physical menstrual tampon, not an AI/software device. The "studies" referenced are laboratory performance tests for physical and chemical properties and biocompatibility.

Here's the information extracted from your document:

1. Table of Acceptance Criteria and Reported Device Performance:

• Non-sensitizing (per ISO 10993-10:2010)
• Non-irritating (per ISO 10993-10:2010)
• Non-toxic (Acute Systemic Toxicity per ISO 10993-11:2006) | - The pledget was demonstrated to be non-cytotoxic.
• The pledget was demonstrated to be non-sensitizing.
• The pledget was demonstrated to be non-irritating.
• The pledget was demonstrated to be non-toxic. |
  | Performance Testing (Syngyna Absorbency) | Absorbency range meets requirements of 21 CFR §801.430(f)(2) for each absorbency level (Regular, Super, Super Plus) - Specific numerical ranges are not provided in this document, but implied by regulatory compliance. | The subject tampons met the requirements of 21 CFR §801.430(f)(2) for each absorbency level. |
  | Chemical Residues | - No detectable 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD)
• No detectable 2,3,7,8-tetrachlorofuran dioxin (TCDF)
• No detectable pesticide residues
• No detectable herbicide residues | There were no detectable 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD); 2,3,7,8-tetrachlorofuran dioxin (TCDF); or any pesticide and herbicide residues. |
  | Mechanical Performance | - String strength: ≥ 10 lb force
• Fiber shedding: ≤ 2 mg/tampon
• Tampon integrity (dry): ≥ 20 daN
• Tampon integrity (wet): ≥ 15 daN | - The subject tampons met the string strength specification of ≥ 10 lb force.
• The subject tampons met the fiber shedding specification of ≤ 2 mg/tampon.
• The subject tampons met the tampon integrity (dry) specification of ≥ 20 daN.
• The subject tampons met the tampon integrity (wet) specification of ≥ 15 daN. |
  | Microbiology Testing | - Bioburden: Total Aerobic Microbial Count (TAMC) ≤ 200 cfu/g (per USP )
• Bioburden: Total Yeast/Mold Count (TYMC) ≤ 20 cfu/g (per USP )
• Absence of pathogenic organisms (S. aureus, E. coli, P. aeruginosa, Salmonella species, C. albicans, C. sakazakii) (per USP )
• No alteration of normal vaginal microflora growth
• No increase in production of Toxic Shock Syndrome Toxin-1 (TSST-1)
• No enhancement of S. aureus growth | - The subject tampons passed the Bioburden test with TAMC ≤ 200 cfu/g and TYMC ≤ 20 cfu/g.
• The subject tampons passed the test for absence of pathogenic organisms (S. aureus; E. coli; P. aeruginosa; Salmonella species; C. albicans; and C. sakazakii).
• The subject tampons did not alter growth of normal vaginal microflora.
• The subject tampons did not increase the production of Toxic Shock Syndrome Toxin-1 (TSST-1).
• The subject tampons did not enhance the growth of S. aureus. |

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

• Sample Size for Test Set: Not explicitly stated in the document for each test. The document mentions "The following studies have been performed..." and refers to compliance with ISO standards and FDA guidance, which would typically involve specific sample sizes per test methodology, but these are not detailed in this summary.
• Data Provenance: The studies were performed by Kimberly-Clark Corporation to support the substantial equivalence of their device. The exact country of origin for the data generation process is not specified beyond Kimberly-Clark having their main address in Neenah, WI, USA. The studies are prospective in the sense that they are laboratory tests performed on the new device to demonstrate its properties.

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

• Not Applicable. This is a physical medical device, not an AI algorithm requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for these tests comes from established analytical and biological methodologies (e.g., ISO standards, USP chapters).

4. Adjudication method for the test set:

• Not Applicable. As this is not an AI algorithm or clinical trial with subjective assessments, there is no adjudication method by experts. The results are based on objective laboratory measurements against predefined thresholds.

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 a physical medical device (menstrual tampon), not an AI-assisted diagnostic or imaging device.

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

• Not Applicable. This refers to a physical product, not an AI algorithm.

7. The type of ground truth used:

• For biocompatibility: Ground truth is established by the specified ISO 10993 standards.
• For performance testing (Syngyna absorbency): Ground truth is established by the FDA Guidance "Menstrual Tampons and Pads: Information for Premarket Notification Submissions" issued July 27, 2005, and specifically 21 CFR §801.430(f)(2).
• For chemical residues: Ground truth is established by analytical chemistry methods for detecting specific compounds.
• For mechanical performance: Ground truth is established by design specifications (e.g., ≥ 10 lb force, ≤ 2 mg/tampon) based on industry standards and safety considerations.
• For microbiology testing: Ground truth is established by reference to USP and , as well as established microbiological methods for assessing impact on microflora and toxin production.

8. The sample size for the training set:

• Not Applicable. This is a physical product, not an AI product that requires a training set.

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

• Not Applicable. As above, no training set for this type of device.

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Kimberly-Clark* U by Kotex® Security® is an unscented menstrual tampon inserted into the vagina to absorb menstrual fluid.

This device is a conventional unscented menstrual tampon consisting of an absorbent pledget, a withdrawal cord and an applicator. The absorbent pledget consists of a ribbon of rayon fibers and cotton, overwrapped with a non-woven fabric. A withdrawal cord is placed through the pledget and knotted. The tampon pledget is compressed. The formed pledget is inserted into a two-piece plastic applicator consisting of an inner tube (plunger), and an outer insertion tube (barrel) with flexible petals that form a closed, rounded tip. Each tampon is individually wrapped in a plastic film wrapper and multiple tampons are packaged in sealed cartons for commercial sale. Tampons are available in Regular, Super and Super Plus absorbencies in various counts.

This document describes a 510(k) premarket notification for Kimberly-Clark U by Kotex® Security® Unscented Menstrual Tampons*. The purpose of the submission is to demonstrate substantial equivalence to legally marketed predicate devices.

The information provided focuses on the biocompatibility and absorbency of the device. It does not describe an AI medical device or a clinical study with human readers. Therefore, several sections of your request are not applicable to this document.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes for the specific biocompatibility tests. It mentions that "Testing from the reference device, U by Kotex® Sleek® K112635, was used to support the safety of new applicator colors." This indicates that some of the test data was retrospective, drawn from a previously approved device. The country of origin for the data is not specified, but the submission is to the U.S. FDA.

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

Not applicable. This document is for a medical device (menstrual tampon), not an AI device relying on expert-established ground truth from images or clinical assessments. The "ground truth" here is the physical and chemical properties of the materials and the absorbency performance as measured by standardized tests.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human interpretation or adjudication of results. The results are objective measurements against established standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not an AI medical device and therefore no MRMC study comparing human readers with and without AI assistance was conducted.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This is not an AI medical device.

7. Type of Ground Truth Used

The ground truth used for this device's performance evaluation includes:

• Standardized Biocompatibility Test Results: Based on ISO 10993 series and USP 661, these are objective laboratory measurements of material properties and their biological interactions.
• Syngyna Absorbency Requirements: A regulatory standard (21 CFR §801.430) for measuring absorbency, representing a controlled, objective test.

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set. The "training" for this device would be its manufacturing process and quality control.

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

Not applicable for the same reason as above.

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Kimberly-Clark* U by KOTEX Click* is an unscented menstrual tampon inserted into the vagina to absorb menstrual fluid.

This device is a conventional unscented menstrual tampon consisting of an absorbent pledget, overwrap, a withdrawal string and an applicator. The terminology used in describing the device in rest of this 510(k) submission is as follows; Complete device: U by KOTEX Click* Unscented Menstrual Tampons with applicator Tampon component: Absorbent pledget, overwrap and a withdrawal string. Applicator: Inner plunger tube, a clear middle telescopic tube and an outer insertion tube (barrel) formed with a closed, rounded tip. The absorbent pledget consists of a ribbon of rayon fibers. A rayon-polyester blend withdrawal string is placed on the ribbon and the ribbon is radially wound, then compressed into a traditional eight-groove bullet-shaped pledget, overwrapped with a non-woven fabric. The withdrawal string will be available in pink and white colors. The tampon component is inserted into a three-piece plastic applicator consisting of an inner plunger tube, a clear middle telescopic tube and an outer insertion tube (barrel) formed with a closed, rounded tip. Each tampon with applicator is wrapped in an individual plastic film wrapper and packaged in sealed multi-unit containers for retail sale.

The provided text describes a Special 510(k) for Kimberly-Clark U by KOTEX Click Unscented Menstrual Tampons. This submission is for modifications to an already legally marketed device, primarily concerning the addition of new colorants for the applicator and a minor applicator design improvement. The core tampon component remains largely unchanged.

The study presented focuses on demonstrating that the modified device is substantially equivalent to the predicate device in terms of safety and effectiveness. This is not a study to prove a device meets specific acceptance criteria related to an AI algorithm's performance. Instead, it's a regulatory submission demonstrating equivalence for a medical device (menstrual tampon).

Therefore, I cannot populate most of the requested fields because the input document does not pertain to the performance of an AI algorithm or a study designed to establish its acceptance criteria and performance against those criteria. It is a regulatory filing for a physical medical device.

However, I can extract the information related to the preclinical testing performed to demonstrate safety and effectiveness for this specific device.

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

Important Note: The "acceptance criteria" here are the standards and regulations the device must meet to demonstrate safety and effectiveness for a menstrual tampon. This is different from the acceptance criteria for an AI algorithm's performance (e.g., sensitivity, specificity, AUC).

The following information cannot be provided from the given document as it pertains to AI algorithm studies, which is not the subject of this 510(k) summary:

2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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Kimberly-Clark* U by KOTEX Sleek* is an unscented menstrual tampon inserted into the vagina to absorb menstrual fluid.

This device is a conventional unscented menstrual tampon consisting of an absorbent pledget, overwrap, a withdrawal cord and an applicator. The terminology used in describing the device in rest of the 510(k) submission is as follows; Complete device: U by KOTEX Sleek* Unscented Menstrual Tampons with applicator Tampon component: Absorbent pledget, overwrap and a withdrawal cord. Applicator: Inner plunger tube and an outer insertion tube (barrel) formed with a closed, rounded tip with a unique textured grip. The absorbent pledget consists of a ribbon of rayon fibers. A rayon-polyester blend withdrawal cord is placed on the ribbon and the ribbon is radially wound, then compressed into a traditional eight-groove bullet-shaped pledget, overwrapped with a non-woven fabric. The withdrawal string will be available in pink and white colors. The tampon component is inserted into a two-piece plastic applicator consisting of an inner plunger tube and an outer insertion tube (barrel) formed with a closed, rounded tip. Each tampon with applicator is wrapped in an individual plastic film wrapper and packaged in sealed multi-unit containers for retail sale.

The provided document describes a Special 510(k) submission for Kimberly-Clark* U by KOTEX Sleek* Unscented Menstrual Tampons, focusing on demonstrating substantial equivalence to a predicate device (Kimberly-Clark* U by KOTEX Click* Unscented Menstrual Tampons; K091749). The "study" described is a preclinical evaluation to support this substantial equivalence claim, rather than a clinical trial with human subjects.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Sizes Used for the Test Set and Data Provenance:

The document describes preclinical testing rather than clinical testing with human subjects. Therefore, the concept of a "test set" in the context of human data or AI model evaluation is not directly applicable. The "samples" would refer to the materials/components of the tampon and applicator that underwent the various biocompatibility and extraction tests. The document does not specify the number of individual test articles or replicates used for each preclinical test.

• Data Provenance: Not applicable in the sense of country of origin for human data. The tests are laboratory-based.
• Retrospective or Prospective: These preclinical tests are conducted prospectively as part of the device development and submission process.

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

Not applicable. The "ground truth" for preclinical tests like biocompatibility and absorbency is established by adherence to recognized international and national standards (ISO, USP, CFR) and successful completion of the specified assays. These tests are evaluated by laboratory personnel and regulatory bodies against predefined pass/fail criteria, not by experts establishing a subjective ground truth.

4. Adjudication Method:

Not applicable. The results of the preclinical tests are objective and measured against established performance standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The device in question is a menstrual tampon, and the evaluation is preclinical for safety and effectiveness, and for demonstrating substantial equivalence.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

No. This concept applies primarily to AI/ML software as a medical device. The evaluations performed here are for a physical medical device.

7. Type of Ground Truth Used:

The ground truth used for this evaluation is based on:

• Established Performance Standards: International standards (ISO 10993 for biocompatibility) and US Pharmacopeia (USP 661 for colorant extraction).
• Regulatory Requirements: 21 CFR § 801.430 for Syngyna absorbency, which defines the absorbency categories for menstrual tampons.
• Substantial Equivalence to a Predicate Device: The overarching goal is to demonstrate that the new device is as safe and effective as the legally marketed predicate device (K091749) by meeting the same standards and having similar technological characteristics.

8. Sample Size for the Training Set:

Not applicable. There is no concept of a "training set" as this is not an AI/ML model. The "training" for such a device would refer to the historical data, scientific literature, and previous product development that informs the design and manufacturing of the tampon, but it's not a formal "training set" in the context of machine learning.

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

Not applicable, as there is no training set as defined in AI/ML contexts. The "ground truth" for the device's design and manufacturing processes would be based on scientific principles, material science, engineering best practices, and historical performance data for similar predicate devices.

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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

• "The results of these tests demonstrate that TAMPAX Tampons, Plastic Applicator are equivalent in terms of their safety and effectiveness to legally marketed tampons." |
  | - Biocompatibility: No significant leaching of substances (extraction). | |
  | Clinical: | |
  | - Safety: No increased product-related irritation compared to control. | - Clinical study showed "no differences in product related irritation or comfort between TAMPAX Tampons, Plastic Applicator and the control product." |
  | - Safety: No significant or unexpected adverse events. | - "No significant or unexpected adverse events were observed during the study." |
  | - Effectiveness: Equivalent to predicate (implied by safety and "substantially equivalent" claims). | The study focused on safety, and the conclusion states "the addition of colorant to the Plastic Applicator does not alter the safety or effectiveness of the device and that TAMPAX Tampons, Plastic Applicator are as safe and as effective as predicate, legally marketed tampons." This implies equivalence in effectiveness as well, primarily by not diminishing the existing effectiveness of the tampon design due to the colorant. |

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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