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Scented or scented deodorized menstrual tampon for the absorption of menstrual fluid; unscented menstrual tampon for the absorption of menstrual fluid.

Scented or scented deodorized, unscented menstrual tampons for the absorption of menstrual fluid.

This 510(k) summary is for a menstrual tampon, not a medical device that uses AI or requires complex statistical studies for its approval. Therefore, many of the requested categories regarding acceptance criteria and study design for AI/medical imaging devices are not applicable.

Here's the information that can be extracted and a clear indication of why other sections are not relevant to this specific premarket notification:

Acceptance Criteria and Device Performance for Playtex Gentle Glide Tampons

Note on "Device Input Requirements": The document states the device "meets all device input requirements." These "input requirements" would be the specific pass/fail criteria for each test (e.g., cytotoxicity score below a certain threshold, no irritation observed, TSST-1 production not significantly increased, etc.). The 510(k) summary only states that these requirements were met, not the specific numerical thresholds themselves.

Non-Applicable Sections and Explanations:

Due to the nature of this device (a menstrual tampon), the following information is not provided and is generally not relevant for this type of medical device submission:

1. Sample size used for the test set and the data provenance: Not specified for biocompatibility/safety tests. These tests are typically conducted in vitro or on animal models, not on large human "test sets" in the way an AI algorithm is evaluated.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood in AI/imaging studies (e.g., expert radiological reads) is not relevant for tampon safety testing. Biocompatibility tests rely on standardized laboratory protocols and scientific evaluation.
3. Adjudication method: Not applicable for standard biocompatibility and safety testing. The results are typically objectively measured and interpreted by laboratory personnel.
4. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This type of study assesses how AI impacts human reader performance, which doesn't apply to a physical product like a tampon.
5. Standalone performance (algorithm only without human-in-the-loop performance): Not applicable, as there is no algorithm or human-in-the-loop component for a tampon.
6. The type of ground truth used: For these safety tests, the "ground truth" is established via standardized biological and chemical assay results (e.g., cell viability percentages for cytotoxicity, observed tissue reactions for irritation, quantitative measurements for TSST-1). It's not "expert consensus, pathology, or outcomes data" in the context of an AI/imaging device.
7. The sample size for the training set: Not applicable. There is no AI model or "training set" for a menstrual tampon.
8. How the ground truth for the training set was established: Not applicable, as there is no training set.

Summary of the Device and Basis for Substantial Equivalence:

The Playtex Gentle Glide and Playtex Gentle Glide Multipack Tampons are seeking substantial equivalence to previously cleared Playtex tampons (K961870 and K070745). The submission emphasizes that the new tampon has the "same technological characteristics" and that "The fiber, string, and materials in contact with the vaginal wall are the same or have the same mode of action." The primary differences are noted as "the absorbency (lower), the dimensions of the unformed pledget pads, and the dimensions of the final formed pledget."

The "Performance Data" section demonstrates that despite these minor changes, the modified device still meets established safety and biocompatibility standards, specifically citing:

• Cytotoxicity testing
• Acute systemic toxicity testing
• Vaginal irritation testing
• Allergic contact sensitization tests
• Microbial agar diffusion
• Toxic Shock Syndrome Toxin-1 (TSST-1) testing

The conclusion is that based on these results, the modified Playtex tampon is substantially equivalent to the predicate tampons, meaning it is as safe and effective as the legally marketed devices.

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Scented or scented deodorized menstrual tampon for the absorption of menstrual fluid; unscented menstrual tampon for the absorption of menstrual fluid.

Scented or scented deodorized, unscented menstrual tampons for the absorption of menstrual fluid.

The provided text describes a 510(k) submission for Playtex Gentle Glide and Playtex Gentle Glide Multipack Tampons. It details the device, its intended use, technological characteristics, and conformity to absorbency regulations. However, it does not contain specific acceptance criteria for a device's performance metrics (like sensitivity, specificity, accuracy) or a study proving that the device meets such criteria in the way typically found for AI/medical imaging devices.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices, biocompatibility, and compliance with absorbency regulations for tampons.

Therefore, many of the requested categories cannot be filled as the information is not present in the provided text.

Here's how the available information maps to your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size for test set: Not explicitly stated for biocompatibility or absorbency tests.
• Data provenance: Not specified (e.g., country of origin). The clinical study is described as a "double-blind, randomized, comparative in-use evaluation." This implies prospective data collection, but no specifics on location or demographics are provided.

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

• Not applicable as the device is not an AI/diagnostic device. Ground truth is established through laboratory testing (biocompatibility, absorbency) and clinical observation in the case of the in-use evaluation. No "experts" in the sense of human readers interpreting data are mentioned.

4. Adjudication method for the test set

• Not applicable. The tests mentioned (biocompatibility, Syngyna absorbency, clinical in-use evaluation) are not subject to a human adjudication process in the way a diagnostic image interpretation would be.

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 MRMC study was conducted or is applicable here. 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

• Not applicable. The device is not an AI algorithm.

7. The type of ground truth used

• Biocompatibility: Established through standardized in vitro and in vivo laboratory tests (cytotoxicity, systemic toxicity, irritation, sensitization, microbial, TSST-1).
• Absorbency: Established through the "Syngyna Absorbency Results," which refers to a standardized laboratory test for tampon absorbency as per 21 C.F.R. § 801.430(e)(1).
• Vaginal Micro Flora/Overall Safety: Established through a "double-blind, randomized, comparative in-use evaluation of tampon products." This would involve clinical observation and potentially laboratory analysis of vaginal microflora samples.

8. The sample size for the training set

• Not applicable, as this is not an AI/machine learning device.

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

• Not applicable, as this is not an AI/machine learning device.

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Scented or scented deodorized menstrual tampon for the absorption of menstrual fluid; unscented menstrual tampon for the absorption of menstrual fluid.

Scented or scented deodorized, unscented menstrual tampons for the absorption of menstrual fluid.

This 510(k) submission (K070745) for the Playtex Gentle Glide Plastic and Multipack Tampons is for a medical device modification, not a novel AI/medical imaging device. Therefore, the questions related to AI performance, such as MRMC studies, standalone algorithm performance, and expert ground truth establishment for deep learning models, are not applicable here.

The "acceptance criteria" in this context refer to various safety and performance tests to ensure the modified tampons are substantially equivalent to previously cleared versions.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample sizes used for each of the performance tests (e.g., cytotoxicity, irritation, TSST-1). These are laboratory-based tests on materials and devices, not studies involving human subjects in the sense of clinical trials for imaging. The data provenance is not explicitly stated in terms of country of origin, but it would be expected that these tests were conducted by Playtex Products, Inc. or their contracted laboratories, likely in the US given the submission to the FDA. These are prospective tests conducted on the modified device to demonstrate its safety and performance.

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

This question is not applicable to this type of device modification submission. The "ground truth" for these performance tests is based on established scientific methodologies and standards for cytotoxicity, toxicity, irritation, and microbial testing, rather than expert consensus on diagnostic images. The performance is measured against established biological safety limits.

4. Adjudication Method for the Test Set

Not applicable. The "adjudication method" usually refers to the process of resolving discrepancies among multiple human readers in an imaging study. For laboratory tests, results are typically determined by scientific protocols and analyses, not by adjudication among experts in that fashion.

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 submission for a tampon modification, not an AI-powered device.

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

Not applicable. This is a submission for a tampon modification, not an AI-powered device.

7. The Type of Ground Truth Used

The "ground truth" here is based on the results of established biological safety and material compatibility tests against recognized standards and limits. For example, cytotoxicity testing would compare cell viability to a control, and irritation tests would assess tissue response against a baseline or a known irritant/non-irritant. The "ground truth" for the physical characteristics like pledget shape is visual or dimensional comparison to the predicate device.

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" for this type of device modification. This is not an AI/machine learning device.

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

Not applicable. There is no training set for this device.

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An electrically powered breast pump used to express milk from the breast of a lactating woman.

The Playtex electric breast pump is a small, quiet, safe and effective system for expressing milk from a lactating mother's breast(s). This device is comprised of 3 major assemblies: a pump assembly, a breast cup assembly, and some commercially available items (i.e., bottles, bottle liners, etc). The device is designed with 1 pre-set speed level and 3 pre-set suction setings, which are selectable by the user via a rotating dial. The device is powered by a 12V DC power supply, which is included with the package.

The provided document is a 510(k) summary for the Playtex Embrace Petite Double Electric Breast Pump. It focuses on demonstrating substantial equivalence to predicate devices and does not describe acceptance criteria, a study proving device performance against those criteria, or details regarding algorithm-based device performance.

Therefore, I cannot provide the requested information from the given text. The document explicitly states:

• "No clinical tests have been conducted on this device." This directly addresses and negates the possibility of finding information related to clinical studies, acceptance criteria for such studies, sample sizes, ground truth establishment, or expert evaluations.
• The "Discussion of Non-Clinical Tests" section only states that "Testing of the device has demonstrated that the Playtex breast pump meets established requirements when used in the manner and environment specified in product labeling." It does not provide details about what those "established requirements" (acceptance criteria) are, nor the specific results of those tests. The only performance data given are vacuum settings and cycle speeds, which are presented as a comparison to predicate devices, not as criteria against which the device was tested.

In summary, the provided text does not contain the information needed to answer your request regarding acceptance criteria and a study proving the device meets those criteria, especially in the context of an AI/algorithm-based device as implied by your questions 2-9.

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Playtex tampons are intended to be used as scented or scented deodorized, unscented menstrual tampons for the absorption of menstrual fluid.

Playtex Sport Plastic Tampons (unscented/fresh scent) for the absorption of menstrual fluid.

Scented or scented deodorized, unscented menstrual tampons for the absorption of menstrual fluid.

The provided 510(k) summary (K060981) for Playtex Sport Plastic Tampons does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria.

The 510(k) submission focuses on demonstrating substantial equivalence to a legally marketed predicate device (Playtex Non-deodorant & Deodorant Gentle Glide Playtex Non-deodorant & Deodorant Gentle Glide Multipack Tampons, K830966, K020201, K912002). This means the manufacturer is asserting that the new device has the same technological characteristics and intended use as the previously cleared device, and therefore does not raise new questions of safety and effectiveness.

Instead of presenting specific performance acceptance criteria and a study demonstrating the device meets those criteria, the submission states:

Technological Characteristics:
"The new tampon has the same technological characteristics as the cleared tampon. The fiber, string, and materials in contact with the vaginal wall are the same or have the same mode of action. The only differences in the modified tampons from the predicate devices are: the composition of the colorants incorporated into the polyethylene resin used to manufacture the applicator barrel and plunger; a new fragrance; and the contoured shape of the applicator and pledget."

Performance Data:
"Cytotoxicity testing, acute systemic toxicity testing, vaginal irritation testing, dermal irritation, allergic contact sensitization tests, microbial agar diffusion and toxic shock syndrome toxin-1 (TSST-1) testing indicate that the modified device meets all device input requirements."

Conclusions:
"The modified Playtex tampons are substantially equivalent to the predicate tampons."

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

1. Table of Acceptance Criteria and Reported Device Performance:

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

• The document mentions "Cytotoxicity testing, acute systemic toxicity testing, vaginal irritation testing, dermal irritation, allergic contact sensitization tests, microbial agar diffusion and toxic shock syndrome toxin-1 (TSST-1) testing." However, it does not provide details on the sample sizes used for these tests or the data provenance (e.g., country of origin, retrospective/prospective). These tests are generally laboratory or animal studies, not human clinical trials in this context.

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

• Not applicable. This submission focuses on chemical and biological safety testing and substantial equivalence, not on interpreting images or patient data that would require expert consensus for ground truth.

4. Adjudication Method for the Test Set:

• Not applicable. See point 3.

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

• No. An MRMC study was not done. This type of study is typically used for diagnostic imaging devices where human readers interpret results, and the device aims to assist or replace human interpretation. This submission is for a menstrual tampon.

6. Standalone (Algorithm Only) Performance:

• Not applicable. This device is not an algorithm or AI system.

7. Type of Ground Truth Used:

• The "ground truth" used for this type of submission generally refers to established scientific/regulatory standards for biocompatibility and safety. The performance data mentioned (cytotoxicity, systemic toxicity, irritation, sensitization, microbial, TSST-1) are established methods to assess these safety aspects. There is no "ground truth" in the sense of expert consensus, pathology, or outcomes data for clinical accuracy as would be found in diagnostic device submissions.

8. Sample Size for the Training Set:

• Not applicable. This submission does not involve machine learning or AI, and therefore, there is no training set.

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

• Not applicable. See point 8.

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Playtex tampons are intended to be used as unscented menstrual tampons for the absorption of menstrual fluid.

Unscented menstrual tampons for the absorption of menstrual fluid. The new tampon has the same technological characteristics as the predicate device. The fiber, string and materials in contact with the vaginat wall are the same or have the same mode of action.

This 510(k) summary describes a new menstrual tampon and compares it to a legally marketed predicate device. The information provided is not about an AI/ML powered device, and therefore, many of the requested fields are not applicable.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of N/A for AI/ML criteria: The document describes a physical medical device (a tampon), not an artificial intelligence or machine learning product. Therefore, performance metrics typical for AI/ML devices such as accuracy, sensitivity, specificity, AUC, recall, precision, F1-score, etc., and criteria related to model performance, bias, or generalizability are not relevant or discussed. The acceptance criteria here are based on physicochemical and biological safety testing and a historical comparison to a predicate device for substantial equivalence.

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

• Sample Size for Test Set: Not specified in the provided summary. Clinical and nonclinical testing was conducted, but the number of subjects or samples for these tests is not detailed.
• Data Provenance: Not explicitly stated, but the testing would have been performed by or for Playtex Products, Inc., likely in their R&D facilities or contracted laboratories. The information does not indicate specific countries of origin for the data (e.g., patient demographics for clinical trials), as this is not a study involving patient data in the typical sense of AI/ML evaluation. The study is prospective in the sense that the testing was performed specifically for this 510(k) submission.

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

• Experts for Ground Truth: Not applicable in the context of an AI/ML device. For a physical device like a tampon, safety and effectiveness are typically assessed through laboratory tests (e.g., agar diffusion, toxicity tests) and potentially human use studies (e.g., irritation studies). The "ground truth" is established by the results of these tests and their interpretation by qualified scientists/toxicologists/clinicians, not through expert consensus on diagnostic imaging or similar AI/ML applications.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. Adjudication methods like "2+1" or "3+1" are used in studies where human readers evaluate cases and their discrepancies need to be resolved for ground truth establishment. This is not relevant to physicochemical and biological testing for a tampon.

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:

• MRMC Study: No. This is not an AI/ML device, so an MRMC study comparing human reader performance with and without AI assistance is irrelevant.

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

• Standalone Performance: No. This is not an algorithm.

7. The Type of Ground Truth Used:

• Type of Ground Truth: The "ground truth" for the safety endpoints (sensitization, toxicity, irritation, TSST-1 toxin) is established by the results of standardized laboratory and biological assays (e.g., positive/negative reaction in sensitization tests, specific toxin levels, observed irritation scores). For effectiveness, the ground truth is indirectly supported by the known performance characteristics of the predicate device and the statement that the new device has the "same technological characteristics." There is no "pathology" or "outcomes data" in the sense of disease diagnosis or patient outcomes beyond the general safety profile.

8. The Sample Size for the Training Set:

• Sample Size for Training Set: Not applicable. This is not an AI/ML device, so there is no "training set." The materials used for manufacturing are specified, and their safety properties are investigated.

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

• Ground Truth for Training Set: Not applicable as there is no training set for an AI/ML device. The "ground truth" for the characteristics of the materials used in the manufacturing of the tampon would have been established through material specifications, quality control testing, and adherence to industry standards, not through a "training set" in the AI/ML context.

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An electrically powered breast pump used to express milk from the breast of a lactating woman.

The Playtex electric breast pump is a small, quiet, safe and effective system for expressing milk from a lactating mother's breast(s). This device is comprised of 4 major assemblies: a pump assembly, a breast cup assembly, a carry bag, and some commercially available items (i.e., bottles, bottle liners, etc). The device is designed with 5 pre-set suction levels and 5 pre-set speed settings, which are selectable by the user via a button pad. The device is powered by a 12V DC power supply, which is included with the package.

Here's an analysis of the provided text regarding the Playtex Breast Pump (K022594), addressing the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text for the Playtex Breast Pump (K022594) does not outline explicit acceptance criteria or report specific device performance metrics in the way one would expect for a diagnostic or AI device (e.g., sensitivity, specificity, accuracy). Instead, substantial equivalence for this medical device (a breast pump) is primarily demonstrated through comparison to predicate devices and adherence to material safety standards.

However, based on the comparative table, we can infer some "performance" characteristics relative to the predicate devices:

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

The 510(k) summary explicitly states:

• "No clinical tests have been conducted on this device."
• "Testing of the device has demonstrated that the Playtex breast pump meets established requirements when used in the manner and environment specified in product labeling."

Therefore, there was no "test set" in the context of clinical studies with human subjects or a dataset for algorithm evaluation. The testing mentioned refers to non-clinical, likely engineering or bench testing, to confirm specifications and material compliance.

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

Not applicable. As no clinical tests or data-driven evaluations were performed for a "test set," no experts were used to establish ground truth in this context.

4. Adjudication Method for the Test Set

Not applicable. No "test set" or clinical evaluation requiring adjudication was described.

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 breast pump, not an AI-powered diagnostic or interpretive system that would involve human "readers" or an MRMC study.

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

Not applicable. This device is a mechanical breast pump and does not involve an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's approval is primarily established through:

• Predicate Device Comparison: The functional and performance characteristics (vacuum, cycle speeds, etc.) are deemed acceptable by virtue of being comparable to, or within the established range of, legally marketed predicate breast pumps.
• Material Science and Biocompatibility Standards: Compliance with FDA food additive criteria and biocompatibility testing for human contact components serves as a "ground truth" for safety.
• Engineering Specifications: The "testing of the device" mentioned in the non-clinical tests section implies verification against internal engineering specifications.

8. The Sample Size for the Training Set

Not applicable. This is a medical device, not an AI or machine learning model, so there is no "training set."

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

Not applicable. As there is no training set for an AI/ML model, no ground truth was established in this manner.

Summary of Approach for this Device:

The 510(k) clearance for the Playtex Breast Pump relies on demonstrating substantial equivalence to existing legally marketed predicate devices. This approach primarily involves:

• Comparing the new device's intended use, technological characteristics, and performance specifications to predicate devices.
• Ensuring material safety and biocompatibility through standard testing and compliance with regulations.
• Verifying that non-clinical tests (likely engineering/bench testing) confirm the device meets established requirements.

The submission explicitly states that "No clinical tests have been conducted on this device," which is common for devices seeking 510(k) clearance where substantial equivalence can be demonstrated through non-clinical data and comparison to predicates.

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Scented or scented, deodorized menstrual tampon for the absorption of menstrual fluid; unscented menstrual tampon for the absorption of menstrual fluid.

Scented, Unscented menstrual tampons for the absorption of menstrual fluid.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Playtex tampons (K022882):

It is important to note that this 510(k) summary is for a modification to an existing device (Playtex tampons). The change is specifically the "composition of the colorants incorporated into the polyethylene resin used to manufacture the applicator barrel and plunger." Therefore, the studies focus on confirming that these colorant changes do not negatively impact the safety and performance of the tampons, rather than establishing primary efficacy for menstrual fluid absorption.

Acceptance Criteria and Reported Device Performance

Study Information Summary

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

   • The document does not specify the exact sample sizes for each of the performance tests (human sensitization, dermal irritation, etc.).
   • Data Provenance: Not explicitly stated as retrospective or prospective, nor is the country of origin mentioned. However, these types of in vitro and in vivo (animal/human) safety tests are typically prospective studies conducted in a controlled laboratory setting.

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

   • Not applicable/Not specified. These tests are laboratory-based scientific assays (e.g., cell cultures for cytotoxicity, animal models for irritation, analytical chemistry for extraction, microbiological assays for TSST-1). "Ground truth" in this context is established by the assay's results against predetermined safety thresholds, not by expert consensus on clinical findings.

3. Adjudication method for the test set:

   • Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for subjective evaluations (e.g., image interpretation). These are objective laboratory tests with pre-defined criteria.

4. 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 safety and technological equivalence study for a medical device (tampons), not an AI-assisted diagnostic tool. No human readers or AI are involved in the "interpretation" of results in the way an MRMC study would apply.

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

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

6. The type of ground truth used:

   • The "ground truth" for these studies is based on pre-established scientific safety standards and thresholds for various biological and chemical endpoints (e.g., acceptable levels of irritation, cytotoxicity, extractables, or TSST-1 production). In some cases, it would also involve comparison to the performance of the predicate device.

7. The sample size for the training set:

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

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

   • Not applicable.

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Scented or scented, deodorized menstrual tampon for the absorption of menstrual fluid.

Scented, deodorized menstrual tampons for the absorption of menstrual fluid.

The provided text is a 510(k) Summary for Playtex Tampons, specifically a submission for new scented, deodorized menstrual tampons. It primarily focuses on establishing substantial equivalence to previously cleared predicate devices rather than presenting a study with acceptance criteria and device performance metrics in the way a clinical trial or algorithm validation study would.

Therefore, many of the requested categories (e.g., sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted from this document, as it describes a regulatory submission focused on product characteristics and non-clinical testing for equivalence.

Here's a breakdown of the information that can be extracted, and an explanation for why other information is unavailable:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) or detailed reported device performance data in a structured table. Instead, it relies on demonstrating substantial equivalence to already cleared devices.

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

This document describes non-clinical testing and equivalence to existing products, not a study involving a "test set" in the context of an AI or diagnostic device. Therefore, sample sizes for a test set and data provenance (country, retrospective/prospective) are not applicable and not provided.

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

Given that this is a 510(k) submission for tampons focused on equivalence and non-clinical safety, there is no mention of experts establishing ground truth for a test set. This type of analysis is typically for diagnostic devices or AI algorithms.

4. Adjudication Method for the Test Set

As there is no "test set" in the context of data for an algorithm or diagnostic device, adjudication methods are not applicable and not provided.

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

An MRMC study is relevant for diagnostic devices where human readers interpret cases, often with and without AI assistance. This document describes a medical device (tampons) that does not involve human interpretation in this manner. Therefore, an MRMC study was not done and effect size is not applicable.

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

This document pertains to a physical medical device (tampons) and not an algorithm or AI system. Therefore, standalone algorithm performance is not applicable.

7. The Type of Ground Truth Used

The concept of "ground truth" as pathology, outcomes data, or expert consensus is typically associated with diagnostic or AI device evaluations. For this device, the "ground truth" for demonstrating safety and effectiveness relies on:

• Established performance of predicate devices: The "ground truth" is that the predicate devices are already deemed safe and effective.
• Non-clinical testing outcomes: The results of the non-clinical tests (sensitization, irritation, toxicity, TSST-1) serve as the "truth" for safety aspects, demonstrating that the new device does not pose new or increased risks.

8. The Sample Size for the Training Set

There is no training set in the context of this 510(k) submission as it is for a physical medical device, not an AI or machine learning algorithm.

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

As there is no training set, this information is not applicable.

In summary: The provided document is a regulatory submission for a physical medical product (tampons) seeking substantial equivalence to existing products. It details the product, its intended use, and indicates non-clinical testing was performed to support safety and equivalence. It does not contain the detailed study design, performance metrics, and data analysis typically found in documentation for diagnostic devices or AI-based solutions, which would address many of the questions posed.

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Scented or scented, deodorized menstrual tampon for the absorption of menstrual fluid.

Scented, deodorized menstrual tampons for the absorption of menstrual fluid.

This document describes the 510(k) summary for Playtex Tampons, specifically scented, deodorized menstrual tampons. The submission aims to demonstrate substantial equivalence to previously cleared Playtex tampon models.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

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

   Acceptance Criteria	Reported Device Performance
   Substantial equivalence to predicate devices regarding safety and effectiveness.	Playtex tampons are reported to be substantially equivalent to the predicate devices (Playtex Deodorant Gentle Glide®, Playtex Deodorant Portables®, Playtex Deodorant Gentle Glide Multipack, and Deodorant Slimfits®) in terms of safety and effectiveness. This determination is based on a review of referenced nonclinical testing data. The new tampon has the same technological characteristics as the predicate devices, with the fiber, string, and materials in contact with the vaginal wall being the same or having the same mode of action. The device is intended for the same use: scented, deodorized menstrual tampons for the absorption of menstrual fluid.
   Nonclinical testing (Human sensitization, dermal irritation, acute oral toxicity, subacute vaginal irritations, agar diffusion, and TSST-1 toxin testing) to support safety.	Nonclinical testing referenced for the determination of substantial equivalence includes: Human sensitization, dermal irritation, acute oral toxicity, subacute vaginal irritations, agar diffusion, and TSST-1 toxin testing. (Specific results or thresholds for these tests are not provided in the summary, only that they were referenced and support substantial equivalence.)

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 does not specify a "test set" in the context of a clinical study with human subjects. The supporting data for substantial equivalence is based on nonclinical testing. Therefore, information regarding sample size, data provenance (country of origin, retrospective/prospective) for a clinical test set is not applicable or not provided in this 510(k) summary.

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):

   As the data relies on nonclinical testing rather than human subject data requiring ground truth established by experts (like radiologists for imaging devices), this information is not applicable to this submission.

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

   Given that the supporting data is from nonclinical laboratory tests instead of a clinical test set, an adjudication method for a test set is 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:

   This submission is for a medical device (tampons) and does not involve AI or human readers for diagnostic interpretation. Therefore, an MRMC comparative effectiveness study is not applicable.

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

   This submission is for a medical device (tampons) and does not involve an algorithm. Therefore, a standalone performance study is not applicable.

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

   For this device, the "ground truth" for demonstrating safety and effectiveness stems from the results of the nonclinical laboratory tests (human sensitization, dermal irritation, acute oral toxicity, subacute vaginal irritations, agar diffusion, and TSST-1 toxin testing) in comparison to the same tests performed on the predicate devices. The "ground truth" is that the new device performs equivalently in these specific tests to the predicate devices, which are already considered safe and effective.

8. The sample size for the training set:

   This submission does not involve an algorithm or an AI system that requires a "training set." Therefore, this information is not applicable.

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

   Given that no training set for an algorithm is involved, this information is not applicable.

Summary of Device and Acceptance Criteria Fulfilment:

The core of this 510(k) submission is to demonstrate substantial equivalence to existing, legally marketed predicate devices. The acceptance criteria relate to showing that the new Playtex Tampons have the "same technological characteristics" and achieve equivalent safety and effectiveness based on nonclinical testing. The study supporting this is a comparison of these nonclinical tests between the new device and the predicate devices. The summary states that these tests were "referenced" and support the conclusion of substantial equivalence. No clinical studies in human subjects with specific performance metrics (like sensitivity, specificity, accuracy) were provided or required for this type of device and submission pathway.

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