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

The Unscented Tampons are traditional unscented menstrual tampons. Except for the raw materials, they share the same design. The Unscented Tampons are provided with a cardboard applicator tampon. Each device consists of a tampon, including an absorbent 100% organic cotton or 100% viscose pledget , a 100% organic cotton or polyester and cotton removal string ("withdrawal cord"), and a cardboard applicator . The tampon is of the traditional cylindrical, bullet-like shape. The applicator has a smooth, rounded tip to ease insertion. The Unscented Tampons are provided in 4 absorbencies: light (less than or equal to 6g), regular (69g), super (912g) and super plus (12~15g). Each device is individually wrapped. It is provided non-sterile and for single use only.

The provided text describes the 510(k) premarket notification for an "Unscented Tampon." As such, the acceptance criteria and performance study details relate to the safety and performance of a medical device (a tampon), not an AI/algorithm-based device or a diagnostic tool.

Therefore, I cannot extract information related to:

• A table of AI acceptance criteria and reported device performance.
• Sample sizes for a test set or data provenance for AI.
• Number of experts, their qualifications, or adjudication methods for ground truth in AI.
• Multi-reader multi-case (MRMC) comparative effectiveness studies for AI.
• Stand-alone (algorithm-only) performance.
• Training set sample sizes or ground truth establishment for AI.

The document discusses "acceptance criteria" and "study" in the context of non-clinical testing for a physical medical device (tampon) to demonstrate its substantial equivalence to a predicate device.

Here's a summary of the non-clinical testing performed for the Unscented Tampon, which serves as the "study that proves the device meets the acceptance criteria" for this type of medical device:

1. Acceptance Criteria and Reported Device Performance (Non-AI Device)

The "acceptance criteria" for this device are established by meeting relevant FDA guidance documents and standards, demonstrating safety and performance comparable to a predicate device. The document states that "Non-clinical testing was conducted to verify that the subject devices meet all design and performance specifications similarly to the predicate device."

Here's a table summarizing the tests (which are the "acceptance criteria" for a tampon) and the reported performance:

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

• Sample Size: The document does not specify the exact number of tampons tested for each non-clinical test (e.g., how many tampons were subjected to biocompatibility testing, how many for dimension checks, etc.). It only mentions "the organic cotton tampon and the viscose tampon" being tested.
• Data Provenance: The tests are described as non-clinical laboratory tests performed to demonstrate substantial equivalence. The country of origin of the data is not explicitly stated in the summary, but the applicant company is SHANDONG INTCO HYGIENE PRODUCTS CO., LTD. in China. The data would be prospective, as it's generated specifically for this submission.

3. Number of Experts Used and Their Qualifications

• This is not applicable as the study described is non-clinical laboratory testing of a physical product (tampon), not an AI/diagnostic software. No experts are mentioned as establishing "ground truth" in the diagnostic sense. The "ground truth" for these tests is defined by established laboratory testing standards and methods (e.g., ISO standards, 21 CFR 801.430).

4. Adjudication Method for the Test Set

• Not applicable as this is a non-clinical laboratory test of a physical product, not an AI/diagnostic software requiring expert adjudication of results.

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

• Not applicable. This is not an AI/diagnostic device. The comparison is between the proposed physical tampon and a predicate physical tampon based on measured attributes and safety profiles.

6. Standalone (Algorithm Only) Performance

• Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is established by validated laboratory testing methods and industry standards (e.g., ISO 10993 series, 21 CFR 801.430, and FDA guidance documents for menstrual tampons). These methods define what constitutes acceptable dimensions, absorbency, biocompatibility, etc.

8. The Sample Size for the Training Set

• Not applicable. As this is a non-clinical submission for a physical device, there is no "training set" in the context of an AI/machine learning model.

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

• Not applicable. There is no training set for a physical medical device.

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The Youjia unscented tampon with plastic applicators are inserted into the vagina and used to absorb menstrual and other vaginal discharge.

Youjia unscented tampon with plastic applicators are composed of an absorbent pledget (tampon), a withdrawal cord and an applicator. The pledgets have a cylindrical, bullet-like shape and the applicators have a smooth, rounded tip to ease insertion. These tampons are provided in three absorbencies: regular (6-9g), super, (9-12g), and super plus (12-15g). Each tampon is individually wrapped and packaged. The Youjia unscented tampon with plastic applicators are provided non-sterile and for single use only.

This document describes the FDA 510(k) clearance for the Youjia unscented tampon with plastic applicators. However, it does not contain the specific detailed acceptance criteria and study results in the format requested for an AI/device performance study. The document focuses on the substantial equivalence of tampons, which are physical medical devices, not AI software.

Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, how training ground truth was established) are not applicable or not provided in the context of this device because it's a physical product, not an AI algorithm.

Below, I will extract the information that is present and indicate where requested information is not applicable or not provided in this document.

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

The document states that "The sponsor completed performance testing consistent with the FDA guidance document: Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) issued on July 27, 2005." It also mentions "pre-defined acceptance criteria" for physical performance testing, but the actual specific criteria values and the reported device performance values are not detailed in this summary.

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

This information is not provided. The document mentions "performance testing," but does not specify sample sizes or data provenance for these tests. It does state that the subject tampon is identical to tampons cleared under K122603, and the sponsor leveraged testing from that previous clearance, as well as biocompatibility data from K190218.

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 device, not an AI algorithm requiring expert ground truth for image/data interpretation.

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

Not applicable. This is a physical device.

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 device, not an AI algorithm.

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

Not applicable. This is a physical device.

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

For biocompatibility, the ground truth is established by standard biological assays (cytotoxicity, sensitization, irritation, systemic toxicity) and chemical extraction tests. For physical performance, the ground truth is against pre-defined physical specifications/criteria.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI algorithm.

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

Not applicable. This is a physical device.

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The Ontex Unscented Tampons with Colored Plastic Applicators are inserted into the vagina to absorb menstrual discharge.

Tampons included in this submission are conventional unscented menstrual tampons consisting of an absorbent pledget (viscose material in a W-shape wadding form), polyester/cotton withdrawal cord, and a polymeric overwrap. The tampon component of this submission is identical to that cleared in the predicate submission (K122603).

Tampons included in this submission are placed in the vagina using a polyethylene applicator. The applicator is available in two sizes: full size (long) or compact size. The full size applicator is ready for use. The compact size consists of an inner and outer tube that requires the inner tube to be retracted prior to use. Applicators included in this submission are provided in different colors including green, yellow, lilac, orange and pink.

The provided text is a 510(k) Summary for a medical device (tampons). It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence. However, it does not contain the kind of detailed study information (like acceptance criteria, sample sizes for test/training sets, expert ground truth qualifications, or MRMC studies) that would be present for a diagnostic AI/ML device.

Therefore, I cannot fulfill your request for information about acceptance criteria and the study that proves the device meets them, as this document does not contain that level of detail for this type of medical device submission.

Here's why the requested information isn't available in the provided text:

• Type of Device: The device is a physical product (tampon) and not a diagnostic AI system or software. The "performance" being discussed relates to physical properties and material safety, not diagnostic accuracy.
• Regulatory Pathway: A 510(k) submission for a Class II device like a tampon focuses on demonstrating substantial equivalence to a legally marketed predicate device. This typically involves performance tests for physical characteristics and biocompatibility, rather than clinical efficacy studies with expert ground truth validation in the way an AI diagnostic tool would require.
• Lack of AI/ML Component: The request specifically asks about "device performance" in a context usually applied to AI/ML or diagnostic devices, which this tampon is not.

If you have a document describing an AI/ML diagnostic device, I would be able to extract the requested details.

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The Roll wadding plastic Applicator Compact size Unscented Tampons are inserted into the vagina to absorb menstrual discharge.

The Roll wadding plastic Applicator Compact size Unscented Tampon is a menstrual tampon. These tampons are unscented tampons it means without any perfume. These tampons are made from viscose material and polymeric overwrap. The withdrawal cord is made from polyester and cotton. These tampons have an applicator. The applicator is made from plastic (polyethylene). . The applicator is in a compact size meaning that the inner tube and the outer tube are slided into each other telescopically so the inner tube needs to be retracted before usage. These tampons have a Roll wadding form. In a roll tampon, the fleece band is folded and then rolled (like a Swiss roll) before being radially pressed. The Roll wadding plastic Applicator Compact size Unscented Tampon is available in 3 absorbencies: regular, super plus absorbency (regular (6-9g), super (9-12g), and super plus (12-15g)).

This document describes a 510(k) summary for the "ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONS." The submission aims to demonstrate substantial equivalence to a previously cleared predicate device rather than presenting a novel device requiring extensive clinical trials for effectiveness. Therefore, the provided text focuses on conformance to existing standards and comparison with the predicate, not a study evaluating human reader improvement with AI or standalone algorithm performance.

Here's the breakdown of the acceptance criteria and the "study" (bench testing and comparison) that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" in the context of a clinical study with human subjects. The testing described is primarily bench testing and relies on the prior testing of the predicate device.

• Bench Testing: The sample sizes for "Absorptive Capacity (Syngina)," "Fiber loss," "Cord strength," "Expulsion force of the applicator," and "Microbiology batch testing" are not explicitly stated. These would typically involve a certain number of tampons tested per batch or per absorbency, but no specific numbers are given.
• Data Provenance: The data provenance is internal testing performed by the manufacturer (ONTEX) and reliance on prior testing of their own predicate device (K122603). The location of this testing is not specified beyond "ONTEX BVBA SPINNERIJSTRAAT 12 9240 ZELE BELGIUM". It is retrospective in the sense that the biocompatibility and broader microbiology claims are based on the predicate's past performance. New bench tests were performed for the "Performance Testing - Bench" section.

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

No experts were used to establish ground truth in the context of human-reviewed data, as this is not a study assessing diagnostic accuracy or similar performance. The ground truth for bench tests is the objective measurement against a predefined specification.

4. Adjudication Method for the Test Set

Not applicable. There was no human-reviewed test set or patient data requiring adjudication in a clinical context.

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

No. The document presents a 510(k) summary for a menstrual tampon, which is a medical device, not a diagnostic or AI-driven system. Therefore, an MRMC comparative effectiveness study involving human readers and AI is not relevant to this submission.

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

No. This submission is for a physical medical device (tampon), not an algorithm or software. Therefore, standalone algorithm performance is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• Objective Bench Test Specifications: For metrics like fiber loss, cord strength, expulsion force, and microbiological counts, the "ground truth" is adherence to pre-defined numerical or qualitative specifications that demonstrate safety and performance equivalent to legally marketed devices.
• Predicate Device Performance: For biocompatibility and the broader microbiological safety profile, the ground truth relies on the established safety and effectiveness of the predicate device. The new device is considered substantially equivalent because its materials, manufacturing, and intended use are identical, and its design modifications do not adversely alter the safety profile.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of an AI/ML algorithm for this physical device.

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

Not applicable.

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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

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TAMPAX® Pearl Plastic Applicator Unscented Tampons are 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, an overwrap, a withdrawal cord, an absorbent braid, and an applicator.

This document provides a 510(k) summary for the TAMPAX® Pearl Plastic Applicator Unscented Tampons. The purpose of this summary is to demonstrate the device's substantial equivalence to predicate devices, focusing on safety and effectiveness.

Here’s an analysis of the provided information, framed by your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) summary for a menstrual tampon, the "AI" related questions are not applicable to this type of medical device submission. The device described does not involve AI, image analysis, or expert-driven diagnostic interpretations. Therefore, sections 2-6 and 8-9 are specifically tailored to human-read diagnostic studies or AI-driven medical devices and cannot be fully answered or are entirely irrelevant for this tampon submission.

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

• Test Set (Clinical Trials): The exact sample size for the clinical trials is not specified in the provided text. The document states "In the clinical trials that were performed..." but does not give numerical details about participants.
• Data Provenance: The document does not specify the country of origin of the data. It implies prospective clinical evaluations ("clinical trials that were performed").
• Preclinical Testing: No sample sizes are provided for the preclinical toxicology or microbiology testing.

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

• Not Applicable. This is a physical medical device (tampon), not a diagnostic device requiring expert interpretation or ground truth establishment in the traditional sense of image analysis or diagnostic studies. The safety and effectiveness are assessed through laboratory tests and clinical observations rather than expert consensus on a diagnostic output.

4. Adjudication Method for the Test Set

• Not Applicable. As above, this is not a diagnostic study requiring adjudication of expert opinions. Clinical observations were made during trials, and laboratory tests were conducted, but an adjudication method for a "test set" in the context of interpretation is not relevant here.

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 not a diagnostic device, and therefore neither an MRMC study nor AI assistance is relevant.

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

• Not Applicable. This device does not involve an algorithm or AI.

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

For this device, "ground truth" is established through:

• Standardized Laboratory Testing: For absorbency, the syngyna absorbency test (21 CFR 801.430) serves as the defined standard. For toxicology and microbiology, standard methods are used to determine parameters like irritation, sensitization, and microbial growth/toxin production. These are objective measures against predefined criteria.
• Clinical Observation: Absence of adverse events in clinical trials serves as "ground truth" for clinical safety, relying on participant reporting and investigator observation.
• Comparison to Predicate: The ultimate "ground truth" for substantial equivalence is that the new device performs equivalently to the legally marketed predicate devices, as demonstrated by the above tests.

8. The sample size for the training set

• Not Applicable. This device does not involve an algorithm or AI, so there is no "training set."

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

• Not Applicable. This device does not involve an algorithm or AI, so there is no "training set" and therefore no ground truth established for it.

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

This device is a conventional unscented menstrual tampon consisting of an absorbent pleget, a withdrawal cord and an applicator. The absorbent pledget consists of a ribbon of rayon fibers. A viscose-polyester blend withdrawal cord is placed on the ribbon and the ribbon is radially wound, then, compressed into a traditional eight-groove bullet-shaped pledget, overwrapped with a non-woven fabric. The formed pledget is inserted into a three-piece plastic applicator consisting of an inner plunger tube, a clear middle telescopic tube and an outer insertion tube (barrel) formed with a closed, rounded tip. Each tampon is wrapped in an individual plastic film wrapper and packaged in sealed multi-unit containers for retail sale.

This document is a 510(k) Summary for a Kimberly-Clark U by KOTEX Click Unscented Menstrual Tampon**. It details the device's characteristics, safety, and effectiveness in comparison to a predicate device. This is a medical device application, not an AI/ML device. Therefore, the questions related to AI/ML specific criteria (such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable.

Here's the information that can be extracted relevant to the acceptance criteria and study proving the device meets them:

1. Table of Acceptance Criteria and the Reported Device Performance

The study that proves the device meets the acceptance criteria:

The document states that the "subject 510(k) device has undergone an extensive series of safety tests, including an assessment of performance characteristics, preclinical microbiological testing and biocompatibility testing." The "results of these studies support the conclusion that the subject 510(k) device is equivalent and as safe as the predicate device."

Specifically, for biocompatibility and genotoxicity, the following preclinical tests were performed:

• Genotoxicity Test (MLA)
• Genotoxicity Test (AMES)
• Genotoxicity Test (Mouse Micronucleus)
• Cytotoxicity Test
• Mucosal Irritation Test
• Mucosal Sensitization Test

For effectiveness, the device's compliance with syngyna absorbency requirements was assessed.

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

• Not Applicable. This is a traditional medical device (tampon), not an AI/ML device. The "test set" here refers to materials and components of the tampon tested against specified standards. Specific sample sizes for each preclinical test are not explicitly provided in the summary but would be detailed in the full 510(k) submission. Data provenance is not specified but is assumed to be from internal lab testing or accredited external labs.

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 is a traditional medical device (tampon). There is no "ground truth" in the AI/ML sense established by human experts for the performance tests. The "ground truth" is the established scientific and regulatory standard (e.g., ISO 10993 parts, 21 CFR § 801.430).

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

• Not Applicable. This is a traditional medical device (tampon). Adjudication methods like those used in clinical trials or AI/ML evaluations are not relevant here. The results of the preclinical tests are directly compared to the specified scientific 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

• Not Applicable. This is a traditional medical device (tampon), not an AI/ML device.

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

• Not Applicable. This is a traditional medical device (tampon), not an AI/ML device.

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

• The "ground truth" is the predefined standards and regulatory requirements for menstrual tampons, specifically:
  • ISO 10993 standards: Part 3 for genotoxicity, Part 5 for cytotoxicity, and Part 10 for irritation and sensitization.
  • 21 CFR § 801.430: For syngyna absorbency requirements.

8. The sample size for the training set

• Not Applicable. This is a traditional medical device (tampon), not an AI/ML device. There is no "training set."

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

• Not Applicable. This is a traditional medical device (tampon), not an AI/ML device. There is no "training set" or corresponding "ground truth" in this context.

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TAMPAX® Compak Pearl Plastic Applicator Scented Tampons and TAMPAX® Compak Pearl Plastic Applicator Unscented Tampons are menstrual trim 180 that are inserted into the vagina and used to absorb menstrual fluid.

The device is a conventional menstrual tampon consisting of an absorbent pledget, a withdrawal cord, and an applicator. It is available in both scented and unscented versions.

• The absorbent pledget consists of a scented or unscented pad of rayon ● fibers overwrapped with a non-woven fabric. A cotton withdrawal cord is sewn to the pad, and the pad is compressed into a traditional bullet-shaped 彩 pledget.
• The formed pledget is inserted into a plastic applicator consisting of an inner . pusher tube and an outer insertion tube with a closed, rounded tip.
• Each tampon is wrapped in an individual plastic film wrapper and packaged . in sealed multi-unit containers for retail sale.

This document describes the Procter & Gamble Company's 510(k) submission for TAMPAX® Compak Pearl Plastic Applicator Scented and Unscented Tampons (K062638). This submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a traditional artificial intelligence or medical imaging context. Therefore, many of the requested fields are not applicable or cannot be extracted from the provided text.

Here is an analysis 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

Not applicable. This is a medical device submission, not an AI or diagnostic imaging study. The "tests" mentioned are referring to laboratory and performance evaluations for the tampon's physical and biological properties.

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

Not applicable. Ground truth as understood in AI/imaging studies (e.g., expert consensus on image interpretation) is not relevant here. The "truth" for safety and effectiveness is established by standardized laboratory testing and regulatory compliance.

4. Adjudication Method for the Test Set

Not applicable. This concept is not relevant to the described testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This type of study is for evaluating the performance of diagnostic systems, often in comparison to human readers. This submission is for a physical medical device (tampon).

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

Not applicable. There is no algorithm or AI component involved in this device.

7. The Type of Ground Truth Used

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

• Regulatory Standards: Compliance with specific CFR (Code of Federal Regulations) requirements, such as 21 CFR 801.430 for syngyna absorbency.
• Laboratory Testing: Results from in vitro microbiological testing, biocompatibility testing, and extraction testing using established scientific methodologies.
• Predicate Device Comparison: Establishing equivalence to previously approved devices.

8. The Sample Size for the Training Set

Not applicable. There is no AI model or "training set" in the context of this device submission.

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

Not applicable.

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TAMPAX® Pearl Scented Tampons & TAMPAX® Pearl Unscented Tampons are tampons that are used to absorb menstrual fluid.

Each tampon is wrapped in an individual plastic film wrapper and packaged in sealed multi-unit containers for retail sale.

This looks like a 510(k) premarket notification for a menstrual tampon. These types of devices generally do not involve AI or complex algorithms with acceptance criteria, ground truth, or multi-reader studies in the way medical imaging or CAD devices do.

The provided text does not contain information about an AI device, acceptance criteria related to algorithmic performance, or a study proving that an AI device meets such criteria.

Instead, the submission focuses on:

• Device Description: TAMPAX® Pearl Scented and Unscented Tampons with plastic applicators.
• Intended Use: To be inserted into the vagina to absorb menstrual fluid.
• Technological Characteristics: Comparison to predicate devices, noting differences in shape of the uncompressed pad, overwrap material, withdrawal cord, fragrance composition, and applicator color.
• Safety Assessment: Relying on in vitro microbiological testing, biocompatibility testing, and safety-in-use clinical testing to demonstrate equivalence to predicate devices.
• Effectiveness: Stating that the device complies with the syngyna absorbency requirements of 21 CFR 801.430. This is the key "acceptance criterion" for effectiveness mentioned, and it's a regulatory standard, not an AI performance metric.
• Conclusion: The device is safe, effective, and substantially equivalent to predicate devices.

Therefore, I cannot provide the requested table or answer the questions related to AI device performance, sample sizes for test/training sets, experts for ground truth, or MRMC studies, as these concepts are not relevant to this traditional medical device submission.

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