Search Results

The Scented Digital and Plastic Applicator Tampons are inserted into the vagina to absorb menstrual discharge.

The Scented Tampons are:

1. Scented Digital
2. Scented Plastic Applicator (full size (long) and compact)
   They are scented versions because of the presence of a fragrance.
   Both the Applicator and Digital Tampons are inserted into the vagina to absorb menstrual discharge.
   These tampons, both the digital types and the applicator types will be provided with 4 absorbencies: light (

The provided document describes a 510(k) submission for "ONTEX SCENTED DIGITAL AND PLASTIC APPLICATOR TAMPONS". This is a medical device application for tampons, not a diagnostic or AI-driven device. Therefore, the typical acceptance criteria and study designs involving performance metrics like sensitivity, specificity, MRMC studies, and ground truth establishment, which are relevant to image analysis or diagnostic algorithms, are not applicable here.

Instead, the acceptance criteria for this type of device focus on biocompatibility and microbiology to ensure safety and substantial equivalence to a predicate device.

Here's a breakdown of the requested information based on the provided text, while noting the different nature of this device:

1. 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 specify sample sizes for specific tests. The tests appear to be laboratory-based and conducted on the materials or final product. The provenance of the data is from ONTEX BVBA, Belgium, as stated in the submission sponsor information. The studies are non-clinical performance data, likely conducted prospectively as part of the device development and submission process.

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

This concept is not applicable to the non-clinical testing performed for this device. Ground truth, in the context of device performance, typically refers to expert consensus or pathology for diagnostic devices. For biocompatibility and microbiological testing, standardized laboratory protocols and expert analysis of results are followed, but "ground truth" as a consensus of clinical experts is not relevant.

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

This is not applicable. Adjudication methods are typically used in clinical studies or for diagnostic evaluations where multiple human readers assess cases. The studies described are laboratory-based biocompatibility and microbiology tests, which follow standardized testing procedures rather than human expert adjudication of results from a "test set" in the clinical sense.

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. MRMC studies are specifically for evaluating diagnostic devices, often AI-powered, where human readers interact with or without AI assistance. This device is a tampon, not a diagnostic tool, and involves no AI component or human reader interpretation for its function.

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

This is not applicable, as there is no algorithm or AI component in this device.

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

The "ground truth" for the non-clinical performance tests for this device is based on standardized laboratory testing protocols and established scientific criteria for biocompatibility and microbiological safety. For example, for Staphylococcus aureus growth, the ground truth is "does not enhance growth," which is determined by comparing growth in the presence of the tampon to a control, according to established microbiological methods.

8. The sample size for the training set

This is not applicable, as there is no training set for an AI/algorithm-driven device.

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

This is not applicable, as there is no training set for an AI/algorithm-driven device.

Ask a specific question about this device

Playtex scented (or scented deodorized) and unscented menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid.
Absorbency Ranges:
Absorbs menstrual flow

Scented (or scented deodorized) and unscented menstrual tampons for the absorption of menstrual fluid. The tampon consists of a pledget, string and applicator (barrel and plunger).

The provided text is related to a 510(k) submission for menstrual tampons, specifically regarding a change in the applicator color. It is not an AI/ML device, and therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance is not applicable.

However, I can extract the relevant "acceptance criteria" and the "study" that proves the device meets them from the document in the context of this specific regulatory submission.

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

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

This information is not applicable as this is a regulatory submission for a physical medical device (menstrual tampon) with a minor change (applicator color), not an AI/ML device relying on test sets of data. The "tests" mentioned are laboratory tests (Leaching Studies, Syngyna testing) performed on the device itself or its materials, not on a data set.

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 information is not applicable. Ground truth, in the context of expert consensus, is relevant for AI/ML diagnostic or measurement devices. For this physical device, "ground truth" refers to established scientific/regulatory standards for material safety and absorbency, measured through laboratory methods, not expert interpretation of data.

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

This information is not applicable. Adjudication methods are typically used in clinical trials or studies for AI/ML devices or human reader performance. The studies performed here are laboratory tests.

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 information is not applicable. MRMC studies are specific to evaluating the impact of AI on human reader performance, which is not relevant for a menstrual tampon.

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

This information is not applicable. There is no algorithm involved in the performance or evaluation of this menstrual tampon.

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

The "ground truth" in this context is based on established regulatory standards and scientific methodologies for biocompatibility (evaluated through leaching studies, indirectly confirming safety) and absorbency (Syngyna testing against 21 CFR §801.430(f)(2)). It's not based on expert consensus, pathology, or outcomes data in the way these terms are used for AI/ML devices.

8. The sample size for the training set

This information is not applicable. There is no AI/ML algorithm requiring a training set for this device.

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

This information is not applicable. Since there is no training set, there's no ground truth to establish for it.

Ask a specific question about this device

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

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

Absorbency Ranges:

Absorbs menstrual flow

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

The Playtex® Gentle Glide Scented and Unscented Tampons (K120245) have specific acceptance criteria related to absorbency, which were verified through performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device

Playtex scented or scented deodorized menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid; Playtex unscented menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid.

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

This document describes the regulatory submission for Playtex Sport Tampons with OdorShield™, not a medical device that uses artificial intelligence or requires a clinical study with image data. Therefore, many of the requested categories for AI/clinical study information are not applicable.

Here's an analysis based on the provided text:

Device: Playtex Sport (Unscented/Scented) Tampons with OdorShield™

1. Table of Acceptance Criteria and Reported Device Performance

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

• Biocompatibility (Sensitization): A panel of women was used for the Human Repeat Insult Patch Test. Specific number not provided, but the description implies a prospective study involving human subjects.
• Biocompatibility (Irritation & Acute Systemic Toxicity): A panel of women of appropriate age was provided with tampons over 2 menstrual cycles. Specific number not provided. This was a randomized double-blind study, indicating a prospective design.
• Odor Absorption: An "expert panel" was used, followed by "consumer testing." Specific sample sizes for both are not provided. The study design (expert panel, consumer testing) suggests prospective data collection.
• Syngyna Testing: This is an in vitro laboratory test, not involving human subjects. The sample size would refer to the number of tampons tested, which is not specified. Data provenance would be laboratory-based.

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

• Biocompatibility (Irritation & Acute Systemic Toxicity): "Expert assessments were made at baseline, midpoint and termination of study by colposcopy." The number of experts is not specified, but they are implied to be medical professionals capable of performing and interpreting colposcopic exams.
• Odor Absorption: An "expert panel" was used for assessment. The number of experts and their specific qualifications are not provided beyond being an "expert panel."

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

The document does not describe any specific adjudication method like 2+1 or 3+1 for resolving discrepancies in expert assessments. It only mentions "expert assessments" and "expert panel assessment."

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 product (tampon) and not an AI-powered diagnostic or assistive device. Therefore, no MRMC study or AI assistance evaluation was performed.

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

Not Applicable. This is a physical product and does not involve any algorithms or standalone AI performance.

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

• Biocompatibility:
  • Sensitization: Human physiological response (skin reaction/sensitization).
  • Irritation & Acute Systemic Toxicity: Medical expert (colposcopy) assessment of vaginal health, and implied absence of acute systemic toxicity symptoms.
• Microbiology: Laboratory results (Zone of Inhibition, TSST-1 detection thresholds).
• Odor Absorption: Expert panel consensus and consumer perception.
• Absorbency (Syngyna): Gravimetric measurements of liquid absorption against established regulatory standards.

8. The sample size for the training set

Not Applicable. This is a physical product, not an AI 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, this question is not relevant.

Ask a specific question about this device

The TAMPAX® Pearl Plastic™ unscented and scented Tampons are intended to be inserted into the vagina to absorb menstrual fluid.

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

This document is a 510(k) summary for a medical device (TAMPAX® Pearl Tampons) seeking clearance from the FDA. The information provided focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with detailed acceptance criteria and results.

Therefore, many of the requested sections regarding acceptance criteria, study details, and AI-specific metrics cannot be extracted from the provided text. The document primarily describes the device, its intended use, and a safety assessment, then states conclusions about its safety and substantial equivalence to existing products.

Here's a breakdown of what can and cannot be answered:

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

• Cannot be provided in the requested format. The document does not describe specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or corresponding quantitative device performance metrics in the way a diagnostic AI study would.
• What is stated: "The results of these safety tests support the conclusion that the 510(k) device is equally as safe as the predicate devices." and "The device is designed to acquire and hold menstrual fluids similar to the fluid handling capabilities of the predicate devices." This indicates a qualitative comparison for safety and functionality rather than quantitative performance against a set of predefined thresholds.

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

• Not explicitly stated for a "test set" in the context of device performance. The document mentions "in vitro microbiological testing, biocompatibility evaluation and extraction testing" as part of the safety assessment. However, it does not specify sample sizes or data provenance (country, retrospective/prospective) for these tests in a way that aligns with evaluating a device's diagnostic performance against a ground truth.

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/Not stated. This type of information is relevant for studies validating diagnostic algorithms where expert consensus or pathological analysis establishes ground truth. For a menstrual tampon, the "ground truth" would likely relate to material properties, absorbency, and safety markers, which are evaluated through lab tests, not expert interpretation of outputs.

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

• Not applicable/Not stated. Adjudication methods are used in studies involving human interpretation or subjective assessments, typically for diagnostic image analysis or similar tasks. This is not described 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

• Not applicable. This device is a menstrual tampon, not an AI-powered diagnostic tool. Therefore, a multi-reader multi-case comparative effectiveness study involving human readers and AI assistance is not relevant and was not performed.

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

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

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

• Implied ground truth for safety and function: The "ground truth" for this device would be established through laboratory testing standards for absorbency, material composition, biocompatibility, and microbiological safety. The document refers to "in vitro microbiological testing, biocompatibility evaluation and extraction testing." These tests have their own established methods and criteria for determining safety and performance, which serve as the "ground truth" for evaluating the tampon's characteristics.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable. This is not an AI/ML device that requires a training set.

Summary of what the document does provide regarding the device and its assessment:

The document describes the submission of a 510(k) premarket notification for TAMPAX® Pearl Tampons (unscented and scented). The primary goal of this submission is to demonstrate substantial equivalence to predicate devices (TAMPAX Pearl Tampons® unscented and scented: K011996; K040312; K051290).

Key "Acceptance Criteria" (implicit, based on 510(k) process for this device type):

• Safety: The device is as safe as predicate devices.
• Effectiveness/Functionality: The device is designed to acquire and hold menstrual fluids similar to the fluid handling capabilities of the predicate devices.
• Technological Characteristics: The device is similar to the predicate devices in terms of basic component materials, overall design, and labeling.
• Intended Use: Consistent with predicate devices.

Study that proves the device meets the (implicit) acceptance criteria:

• Study Type: A battery of safety evaluations was conducted.
• Specific Tests Mentioned:
  • In vitro microbiological testing
  • Biocompatibility evaluation
  • Extraction testing
• Results/Conclusions:
  • "The results of these safety tests support the conclusion that the 510(k) device is equally as safe as the predicate devices."
  • "The results of evaluations for this device support the conclusions that it is safe for its intended use and substantially equivalent to the cited predicate devices."

In conclusion, this document describes a traditional medical device submission (a tampon) seeking clearance based on substantial equivalence, not a performance study for an AI-driven diagnostic device. Therefore, the detailed metrics and study design elements typically associated with AI performance evaluation are not present.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

First Quality Hygienic, Inc. Femtex and Private Label Scented plastic applicator tampons are a plug of Cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge.

Femtex and Private Label Scented Plastic Applicator Tampons are menstrual tampons used to absorb menstrual fluid, with fragrance added for aesthetic purposes. The tampons will be provided in five (5) styles/absorbencies: Light, Slender Regular, Regular, Super and Super Plus with a plastic applicator. Femtex and Private Label Scented Plastic Applicator Tampons are made from rayon absorbent, cotton cord and cotton sewing thread, and added fragrance.

The provided document is a 510(k) premarket notification for Femtex and Private Label Scented Plastic Applicator Tampons. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not typically for establishing acceptance criteria with a study comparing device performance against those criteria as would be done for novel devices or those undergoing a PMA.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria in the way a medical diagnostic or therapeutic device might. Instead, it focuses on demonstrating equivalence to an existing product through non-clinical testing.

Here's why the requested information cannot be fully provided from this document:

• Acceptance Criteria & Reported Performance: The document states "Assessment of Performance Standards: Not Applicable." This indicates that there are no specific, quantitative performance metrics with associated acceptance criteria like sensitivity, specificity, accuracy, etc., that are being measured and reported against. The focus is on demonstrating safety and general absorbency equivalence.
• Study Details (Sample Size, Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): These are all elements typically found in clinical studies or performance validation studies designed to quantify a device's effectiveness or accuracy in a diagnostic or therapeutic context. This 510(k) submission, for a tampon, relies on biocompatibility testing and absorbency testing to show equivalence to a predicate device.

However, I can extract the information that is present in the document related to testing, even if it doesn't fit the requested format exactly:

1. Table of Acceptance Criteria and the Reported Device Performance

Note: The document explicitly states "Assessment of Performance Standards: Not Applicable" as the regulatory pathway is substantial equivalence based on predicate device and non-clinical testing, rather than meeting specific quantifiable performance standards like a diagnostic device. The performance is reported as "equivalent in terms of safety and effectiveness" for biocompatibility and "confirmed" for absorbency, without providing numerical acceptance criteria or results.

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: Not specified in the provided summary for any of the non-clinical tests (sensitization, vaginal irritation, Syngyna testing).
• Data Provenance: Not specified. These tests are typically laboratory-based non-clinical studies.

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. This information is relevant for studies involving human interpretation (e.g., diagnostic imaging). The tests performed (biocompatibility, absorbency) are non-clinical laboratory tests, not requiring expert consensus on ground truth in the same manner.

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

• Not applicable. This information is relevant for studies involving human interpretation or clinical endpoints.

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 type of study is for diagnostic or AI-assisted devices for human interpretation and is not relevant for a tampon.

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

• Not applicable. This type of study is for AI/algorithm-based devices and is not relevant for a tampon.

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

• For biocompatibility testing (sensitization, vaginal irritation): Ground truth/determination of safety and equivalence would be based on established toxicological principles and responses observed in standard biological models (e.g., in vitro, animal models).
• For absorbency testing (Standard Syngyna testing): Ground truth is based on the standardized measurement of fluid absorption under controlled laboratory conditions, as defined by the Syngyna method.

8. The sample size for the training set

• Not applicable. This concept pertains to machine learning models, which are not used here.

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

• Not applicable. This concept pertains to machine learning models, which are not used here.

Ask a specific question about this device