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The Unscented Menstrual Tampons are inserted into the vagina to absorb menstrual discharge.

The unscented menstrual tampons consist of a tampon, including an absorbent pledget ("absorbent core") completely surrounded by an overwrap ("security veil") and a removal string ("withdrawal cord"), and an applicator (only for the applicator tampon). The tampon design is cylindrical, bullet-like shape. The applicator has a smooth, rounded tip to ease insertion.

According to different composition materials and design styles, the unscented menstrual tampons of this submission are divided into 3 categories (Unscented menstrual long applicator tampon, Unscented menstrual Cardboard Applicator Tampon, Unscented menstrual Digital Tampons) and 6 sub-categories (Organic cotton + Two Plastic tube, Cotton + cardboard tube, Organic cotton + cardboard tube, Cotton (digital style), Organic cotton(digital style), viscose(digital style).

The tampons are provided in 4 absorbencies: Light(L) (≤6g), Regular(R) (6-9g), Super (S)(9-12g) and Super Plus (SP)(12-15g). Only some sub-categories of tampons contain all absorbencies. Each device is individually wrapped and then packaged in sealed multi-unit containers for retail sale. All tampons and applicators are provided non-sterile and for single use only.

The provided FDA 510(k) clearance letter and summary for K251033 pertains to unscented menstrual tampons, which are medical devices designed for absorbing menstrual discharge. This documentation focuses on demonstrating the substantial equivalence of the new tampons to a predicate device (K232598) primarily through material composition, design, and physical performance characteristics, rather than performance metrics related to diagnostic accuracy or clinical outcomes that would typically involve AI/ML models or human reader studies.

Therefore, many of the requested points regarding acceptance criteria and study details for AI/ML device performance (like sensitivity, specificity, MRMC studies, ground truth establishment by experts, etc.) are not applicable to this type of device submission. The "acceptance criteria" here relate to meeting established safety and performance standards for tampons.

Here's an analysis based on the provided document:

Device Type: Unscented Menstrual Tampons (medical device, not AI/ML driven)

Purpose of the Study (as described): To demonstrate substantial equivalence of the subject device (new tampons) to a legally marketed predicate device (existing tampons) by showing that differences in material composition and design do not raise new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Given this is a tampon submission, the "performance" relates to physical and biocompatibility characteristics, not diagnostic accuracy. The acceptance criteria are implicit in the standards followed and the successful completion of the tests.

• Pledget length (Dry): 37±3.0--50±3.0 mm
• Pledget diameter (Dry): 11.5±1.0--15.2±1.0 mm
• Total length of product: 118.0±2.0 mm
• Length of push rod: 70±1 mm
• Outside diameter (outer tube): 14.5±0.2--16.2±0.2 mm
• Weights: L: 3.90-4.40g; R: 4.45-5.15g; S: 5.65-6.45g; SP: 6.45-7.35g
  These differ from the predicate's specific values but are deemed "not raise different questions of safety and effectiveness." |
  | Functionality (Absorbency) | Meet industry standards for relevant absorbency ratings (e.g., Light (≤6g), Regular (6-9g), Super (9-12g), Super Plus (12-15g)). | Absorbency categories are listed, aligning with standard ranges. Performance data showing the specific absorbency achieved for each tampon type would be in the full submission, but the table indicates these categories are used. |
  | General Safety/Effectiveness | Overall safety and effectiveness comparable to predicate. | "The nonclinical tests demonstrate that the subject device, Unscented Menstrual Tampon, is as safe and effective as the legally marketed predicate device (K232598). Therefore, the subject device is substantially equivalent to the predicate device." |

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

• Sample Size for Test Set: Not explicitly stated in the provided summary for any of the biocompatibility, microbiology, or chemical residue tests. These tests are typically performed on a representative sample of units to demonstrate compliance with standards.
• Data Provenance: The manufacturing company is Unibeauty (Hubei) Technology Co.,Ltd. in Xiantao City, Hubei Province, China. The document does not specify the country of origin for the data itself (e.g., where the lab testing was performed) beyond the company's location. The studies described are "nonclinical performance testing." implicitly prospective, as they were conducted to support the 510(k) submission.

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

Not applicable. This submission is for a physical medical device (tampons), not an AI/ML diagnostic device that requires expert human interpretation to establish ground truth for testing. The "ground truth" here is established by standardized laboratory testing methods (e.g., chemical analysis, microbiological assays, physical measurements) interpreted by qualified laboratory personnel, not by medical experts forming a consensus on image interpretation.

4. Adjudication Method for the Test Set

Not applicable. As this is not a study involving human readers or interpretation, there is no adjudication method in the sense of resolving discrepancies between expert opinions. Laboratory results are typically verified through standard lab practices and quality control processes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is relevant for AI/ML diagnostic tools to assess the impact of AI assistance on human reader performance. This submission is for a physical device, so no such study was conducted or is relevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device does not involve an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this type of device is established through:

• Standardized Laboratory Testing Results: Biocompatibility (cytotoxicity, sensitization, irritation), microbiology (growth of bacteria, toxin production), chemical residue analysis, and physical property measurements (dimensions, weight, absorbency).
• Compliance with Recognized Standards: The tests were conducted according to international standards like ISO 10993 series and FDA guidance documents specific to menstrual tampons.

8. The Sample Size for the Training Set

Not applicable. This device does not involve an AI/ML model that requires a training set.

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

Not applicable. As there is no AI/ML model, there is no training set and therefore no ground truth establishment for a training set.

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

The SABA® Tampons are traditional unscented menstrual tampons. The SABA® Tampons are available either with a single use applicator or as a digital tampon (without an applicator). Except for the inclusion of the applicator, both types of tampons are made of the same materials. Each device consists of a tampon, including a 100% viscose pledget ("absorbent core") surrounded by a non-woven fabric cover blend of polyethylene and polyester, a removal cord of 67% polyester/33% viscose, and an applicator (only for the applicator tampon). The applicator is made of an inner tube of high-density polypropylene and an external tube of low-density polyethylene, both with 5% pink pigment. The applicator has a smooth, rounded tip to ease insertion.

Both the applicator and applicator free SABA® Tampons are provided in three absorbencies of regular (6-9g), super (9-12g), and super plus (12-15g). Each device is individually wrapped in a metallized printed bi-oriented polypropylene lamination and packaged in sealed multi-unit containers for retail sale. It is provided non-sterile and for single use only.

This document is a 510(k) clearance letter for SABA® Tampons, a type of menstrual tampon. The provided text does not contain any information about acceptance criteria or study data related to an AI/ML medical device.

The document details the substantial equivalence of the SABA® Tampons to a predicate device (K231341) based on non-clinical performance data, biocompatibility, microbiology testing, and shelf-life testing specific to tampons. It explicitly states:

• "No clinical studies are included in this submission."
• "This device does not include any use of software."
• "The device does not have any electrical source so no electrical safety or EMC testing are included in this submission."
• "No animal studies are included in this submission."

Therefore, it is impossible to describe acceptance criteria or a study proving device performance for an AI/ML medical device based on the provided text. The request's premise about AI/ML device evaluation is not applicable to the SABA® Tampons 510(k) submission.

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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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COHITECH Cottonlock Tampons with Reusable Applicator are inserted into the vagina and used to absorb menstrual fluid.

The subject device is an unscented menstrual tampon consisting of an organic cotton absorbent pledget ("absorbent core"), completely surrounded by an organic cotton cover ("security veil") and with an organic cotton string ("withdrawal cord"). These tampons will be provided on three absorbencies: regular (6-9g), super (9-12g) and super plus (12-15g). Each COHITECH Cottonlock tampon is individual wrapped in a cellulose paper along with the reusable applicator in its carrying case and packaqed in a sealed multi-unit cardboard containers for retail sale. The subject device deals with inclusion of a reusable tampon applicator, cleared under K212479, to the packaging of tampons cleared under K211775.

The provided text is a 510(k) Premarket Notification from the FDA regarding a menstrual tampon with a reusable applicator. It details the device, its intended use, and its comparison to predicate and reference devices to establish substantial equivalence.

Based on the content, this document does not describe an AI/ML-driven medical device. Therefore, a study proving an AI/ML device meets acceptance criteria, an MRMC study, or details about training and test sets, and ground truth establishment for an AI/ML model are not applicable to this document.

The document discusses the substantial equivalence of the COHITECH Cottonlock Tampons with Reusable Applicator to previously cleared devices (K211775 and K212479). The "acceptance criteria" in this context refer to the demonstration of this substantial equivalence through non-clinical testing.

Here's a breakdown of the relevant information provided, adapted to the context of a non-AI/ML device:

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

The "acceptance criteria" here are implicitly meeting the performance characteristics of the predicate device and the reference reusable applicator, as well as adherence to relevant FDA guidance documents. The "device performance" is based on non-clinical testing and leveraging prior clearances.

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

The document does not specify a "test set" in the context of an AI/ML model. Instead, it refers to leveraging "testing on the K211775 tampons and K212479 reusable applicators." This implies that the testing performed for the original clearances of these components serves as the basis for the current submission. The data provenance would be from Cotton High Tech, S.L. and would typically be prospective non-clinical testing. Specific sample sizes for the absorbed fluid, biocompatibility, or other physical/chemical tests are not provided in this summary.

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

Not applicable, as this is not an AI/ML device requiring expert adjudication for a test set.

4. Adjudication method for the test set

Not applicable.

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.

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

Not applicable.

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

The "ground truth" for this device's performance relies on:

• Established industry standards and regulatory guidance: Such as those for tampon absorbency testing, biocompatibility, and reprocessing.
• Prior successful clearances: The fact that K211775 (tampons) and K212479 (reusable applicator) were independently cleared by the FDA implies that their safety and effectiveness characteristics (their "ground truth" for performance) were established during their respective review processes. The current submission leverages this existing "ground truth."
• Bench testing: Though not detailed, "tampon compatibility testing" implies physical testing to ensure the applicator and tampon work correctly together.

8. The sample size for the training set

Not applicable.

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

Not applicable.

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COHITECH Organic Cotton Non-Applicator Cottonlock Tampons (light, regular, super, and super plus absorbencies) are inserted into the vagina and used to absorb menstrual fluid.

The subject device is a conventional unscented menstrual tampon consisting of an organic cotton absorbent pledget ("absorbent core"), completely surrounded by an organic cotton cover ("security veil") and with an organic cotton string ("withdrawal cord"). These tampons will be provided on four absorbencies: light (6g and under), regular (6-9g), super (9-12g) and super plus (12-15g). Each organic cotton non-applicator Cottonlock tampon is wrapped in a cellulose paper individual wrapper and packaged in sealed multi-unit containers for retail sale.

The provided text describes the 510(k) summary for the COHITECH Organic Cotton Non-Applicator Cottonlock Tampons, which is a menstrual tampon. The document details studies performed to demonstrate substantial equivalence to a predicate device, focusing on non-clinical data. It does not describe an AI/ML powered device, therefore no AI-specific acceptance criteria or studies are mentioned.

Here's the information as requested, adapted to what is available in the document:

1. Table of Acceptance Criteria (Performance Standards) and Reported Device Performance

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

The document does not specify exact sample sizes for each test. It refers to "Biocompatibility studies" and "Preclinical microbiology" without providing the number of samples or specimens used in these tests. The provenance of the data (country of origin, retrospective/prospective) is not explicitly stated, but the studies were performed "in accordance with the 2020 FDA guidance... and standard ISO 10993-1" and "Guidance for Industry and FDA Staff - Menstrual Tampons and Pads... 2005," implying they were conducted as part of the regulatory submission process, likely prospectively for the purpose of this submission. The manufacturer is based in Spain, so it's plausible the testing involved European labs, but this is not confirmed.

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 and is not provided. The studies outlined are laboratory tests and measurements against established physical, chemical, and biological standards, not diagnostic assessments requiring expert interpretation of "truth."

4. Adjudication method for the test set

Not applicable. The tests are scientific measurements and biological assays, not interpretations requiring adjudication by experts.

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. The device is a menstrual tampon, not an AI-powered diagnostic or screening tool.

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

Not applicable. The device is a menstrual tampon, not an AI-powered algorithm.

7. The type of ground truth used

The ground truth used for this device's evaluation is based on established physical, chemical, and biological performance standards and regulatory guidance. These include:

• ISO 10993 series for biocompatibility (e.g., Cytotoxicity, Vaginal Irritation, Delayed Hypersensitivity, Acute Systemic Toxicity).
• 21 CFR 801.430(f)(2) for absorbency (Syngyna testing).
• FDA Guidance for Industry and FDA Staff - Menstrual Tampons and Pads (2005) for other performance characteristics like chemical residues, tampon integrity, string strength, fiber shedding, dimensional analysis, and preclinical microbiology regarding Staphylococcus aureus growth, TSST-1 production, and impact on vaginal microflora.

8. The sample size for the training set

Not applicable. The device is a menstrual tampon and does not involve AI/ML requiring a training set.

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

Not applicable. There is no AI/ML training set for this device.

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The Unscented W long plastic and cardboard applicator Tampons are inserted into the vagina to absorb menstrual or other vaginal discharge.

The Unscented W long plastic and cardboard applicator Tampons are unscented menstrual tampons consisting of an absorbent pledget and an applicator. The pledget is made of 100% viscose with polymeric overwrap. The applicator is a full size applicator provided in polyethylene or cardboard. The absorbent pledget has a W wadding design and is available in light, regular, super and super plus absorbencies.

I am sorry, but based on the provided text, there is no information about a study that proves a device meets specific acceptance criteria in the context of an AI/ML medical device.

The document is a 510(k) premarket notification for "Unscented W long plastic and cardboard applicator Tampons," which are menstrual tampons, not an AI/ML device. The document discusses performance testing for tampons, such as biocompatibility, absorbency, and microbiological testing, to establish substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information for an AI/ML device, as this document does not pertain to one.

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Interlude rolled tampons in plastic applicator are inserted into the vagina and used to absorb menstrual or other vaginal discharge.

Interlude rolled tampons in plastic applicator are menstrual tampons used to absorb menstrual fluid. These tampons will be provided with 3 absorbencies - Regular, Super and Super Plus. These Tampons are rolled and made from organic cotton and polymeric overwrap in which a cotton cord is inserted. The applicator tubes are made of plant-based polyethylene and include a cylindrical barrel with finger grip and a one-piece plunger. The assembled tampon with applicator is wrapped in a printed PE wrapper.

This document describes the premarket notification (510(k)) for the Interlude Rolled Tampons in Plastic Applicator. It outlines the device, its intended use, comparison to a predicate device, and performance testing conducted.

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

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

The document does not explicitly state the sample sizes used for each specific test (e.g., dimensions, absorbency, chemical residues, biocompatibility, microbiology). However, it implies that the testing was conducted on samples of the "subject tampons and applicators." The data provenance is not specified regarding country of origin or whether it was retrospective or prospective, but it refers to testing performed on the final device product.

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

This information is not provided. The testing appears to be objective, lab-based performance and biocompatibility testing rather than expert-driven ground truth establishment.

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

Not applicable. The tests are based on objective measurements against established standards and criteria, not on expert adjudication of 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 is a medical device (tampon) and 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 is a medical device (tampon) and not an algorithm.

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

The "ground truth" for the performance testing is based on:

• Established standards and guidance documents: Specifically, the "2005 FDA guidance document 'Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) - Guidance for Industry and FDA Staff'" for performance characteristics and the "FDA guidance document 'Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process' issued in 2016 and ISO 10993 standards" for biocompatibility.
• Objective laboratory measurements: For dimensions, absorbency, chemical residues, withdrawal cord strength, fiber shedding, tampon integrity, and microbiological growth.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

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

Not applicable. As above, this is a physical medical device.

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COHITECH Organic cotton cardboard applicator tampons light are unscented menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.

The device is a conventional unscented menstrual tampon consisting of an absorbent pledget, a withdrawal cord and an applicator. It will be provided on light absorbency (6g and under). Each tampon is wrapped in an individual wrapper and packaged in sealed multi-unit containers for retail sale.

This document describes a 510(k) premarket notification for COHITECH Organic Cotton Cardboard Applicator Tampons Light. The submission seeks to add a "light" absorbency version to an existing family of tampons (Regular, Super, and Super Plus) previously cleared under K091084.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document doesn't explicitly present a single table with acceptance criteria and reported device performance side-by-side. Instead, it lists the performance characteristics assessed and implies that these assessments met predetermined acceptance criteria based on the 2005 FDA guidance "Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s)".

Performance Characteristics Assessed (Implied Acceptance Criteria Met):

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

• Sample Size: The document does not explicitly state the sample sizes for the performance tests (dimensions, absorbency, withdrawal cord strength, fiber shedding, or microbiology testing). It refers to "verification activities" and "testing on the subject device."
• Data Provenance: The document does not specify the country of origin for the data. The studies appear to be retrospective in the sense that they are conducted to demonstrate equivalence for regulatory approval, rather than being part of an ongoing clinical trial. The microbiology testing includes data on the "subject device," indicating it was specifically tested. For biocompatibility, reliance was placed on prior testing from K091084, with a certification that materials are the same.

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 to this type of device (menstrual tampons). The "ground truth" here is defined by established engineering and microbiological performance standards and guidance documents (e.g., 2005 FDA guidance "Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s)"). There are no "experts" in the sense of clinical reviewers establishing a diagnostic ground truth, but rather testing engineers and microbiologists performing standardized tests.

4. Adjudication method for the test set:

This is not applicable as it's not a diagnostic device involving human interpretation. The "adjudication" is based on comparing test results against predefined thresholds in established standards.

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. This is not an AI/CAD device. It is a physical medical device (menstrual tampon).

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

This is not applicable. This is not an algorithm-based device.

7. The type of ground truth used:

The "ground truth" for the device's performance is based on:

• Established industry standards and regulatory guidance: Specifically, the "2005 FDA guidance 'Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s)'". This guidance outlines the required performance characteristics and likely specifies the methodology and acceptable ranges for these tests.
• Predicate device characteristics: The subject device is compared to a legally marketed predicate device (Maxim menstrual tampons and Organyc menstrual tampons, K091084). The "ground truth" for the predicate device's safety and effectiveness was established during its own clearance process, and the subject device aims to demonstrate substantial equivalence to this established benchmark.

8. The sample size for the training set:

This is not applicable. This is not a machine learning or AI device that requires a training set.

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

This is not applicable. There is no training set for this device.

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Playtex® unscented menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid.

The subject devices, which are modified from the predicate devices, are unscented menstrual tampons consisting of a tampon (pledget with string) and an applicator. The tampons are made of rayon fiber and have absorbency ranges: regular (6-9 grams) and super (9-12 grams). The applicators are made of polyethylene and polypropylene and have four color versions.

The provided text is a 510(k) Summary for the Playtex Stella™ Tampons. It details the device, its intended use, comparison to a predicate device, and the non-clinical performance testing conducted. However, it does not contain the specific acceptance criteria or the full study details that you requested.

Here's what I can extract and what is missing based on your request:

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

The document mentions "color leaching studies" and their analysis using "Tolerable Intake (TI) analysis of each component in the colorant formulation using ISO 10993-17:2002." This implies that the acceptance criteria for these studies would be that any leached components are within tolerable intake levels as defined by ISO 10993-17:2002. However, the specific quantitative acceptance criteria (e.g., maximum allowable concentration of a leached substance) and the actual reported performance (e.g., the measured concentrations) are not provided in this document.

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: The document states "The color leaching studies were conducted for new applicators." It does not specify the number of applicators or samples tested.
• Data provenance: Not specified.

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)

This section is not applicable as the studies described are non-clinical (chemical analysis for leaching, biocompatibility leverage) and do not involve human expert interpretation of data like medical imaging would.

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

This section is not applicable as the studies described are non-clinical, involving chemical analysis rather than human interpretation requiring 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

This section is not applicable. The device is a menstrual tampon, not an AI-assisted diagnostic tool.

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

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

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

For the color leaching studies, the "ground truth" would be the established Tolerable Intake (TI) levels for each component, as defined by ISO 10993-17:2002. For the biocompatibility, the ground truth is based on historical data from the predicate device (K132819) which presumably met biocompatibility standards.

8. The sample size for the training set

This section is not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

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

This section is not applicable. There is no mention of a "training set."

In summary:

The provided document describes non-clinical testing (color leaching and leveraging biocompatibility data) for a physical medical device (menstrual tampon). It mentions the methodology used (LC-MS, GC-MS, ISO 10993-17:2002 for tolerance) but lacks specific quantitative acceptance criteria or detailed study results and sample sizes that would typically be found in a full study report. The request for information related to AI or expert adjudication is not relevant to this type of device and submission.

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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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