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Unscented tampon for women's personal hygiene with respect to intra vaginal absorption of menstrual or other vaginal discharge. The plastic applicator is for easing the placement of the tampon correctly into the vagina.

The Opal by Femtex Pull & Snap Unscented Compact Applicator Tampon is an unscented, compact menstrual tampon. It is intended for over-the-counter use for women's personal hygiene with respect to intra-vaginal absorption of menstrual or other vaginal discharge. The plastic applicator is for easing the placement of the tampon correctly into the vagina. The tampon itself is made of a strip of viscose rayon fibers in which a cord is inserted. A thin strip of nonwoven fiber covers the tampon, and the tampon is pressed firmly together. The applicator tubes are made of polyethylene (PE) and Polypropylene (PP) and include a barrel and a two-piece plunger. The assembled tampon with applicator is wrapped in a printed PE wrapper. The tampons are marketed in Regular, Super, and Super Plus absorbencies.

The provided document is a 510(k) premarket notification for a medical device: "Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Regular, Super, and Super Plus."

This document describes the regulatory approval process for a menstrual tampon, not an AI/ML powered medical device. Therefore, the questions related to AI/ML specific concepts like test sets, training sets, ground truth, experts, adjudication methods, multi-reader multi-case studies, and standalone algorithm performance are not applicable to this document.

However, I can extract the acceptance criteria and performance data for this device based on the non-clinical testing performed.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission for a physical medical device (tampon), the following points are not relevant to the provided text and would be N/A (Not Applicable):

2. Sample size used for the test set and the data provenance: N/A (Not an AI/ML study)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (Not an AI/ML study)
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: N/A (Not an AI/ML study)
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: N/A (Not an AI/ML study)
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: N/A (Not an AI/ML study)
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A (Not an AI/ML study; ground truth for physical device testing typically refers to reference standards or validated measurement methods, which are implicitly covered by the "Acceptance Criteria" column above).
8. The sample size for the training set: N/A (Not an AI/ML study)
9. How the ground truth for the training set was established: N/A (Not an AI/ML study)

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Unscented tampon for women's personal hygiene with respect to intra vaginal absorption of menstrual or other vaginal discharge. The plastic applicator is for easing the placement of the tampon correctly into the vagina.

The Opal by Femtex and Private Label Unscented Compact Applicator Tampons is an unscented, compact applicator menstrual tampon. The tampon itself is made of a strip of viscose fibers in which a cord is inserted and pressed firmly together. The viscose tampon is covered with a thin layer of non-woven fiber material which is melted on the strip. The applicator tubes are made from polyethylene (PE). The tampon with applicator is wrapped in printed polypropylene (PP) wrapping. The tampon is marketed in Light, Regular, Super, and Super Plus Absorbencies.

This document describes the premarket notification (510(k)) for the Opal by Femtex and Private Label Unscented Compact Applicator Tampon. It includes information about the device's acceptance criteria, performance studies, and comparison to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific "sample sizes" for the test sets beyond mentioning "any sample tested" for bioburden and "each tampon tested for every absorbency level" for withdrawal cord strength. It implies testing was conducted on an adequate number of samples to meet the relevant standards and confidence levels. For example, for absorbency, it states data was "analyzed for 90% population distribution at 90% confidence."

The data provenance is not explicitly stated in terms of country of origin. The testing references European, Australian, and US Pharmacopeia standards, and FDA guidance, suggesting a mix of internationally recognized testing methodologies. The data appears to be prospective as it was generated specifically for the 510(k) submission to demonstrate the safety and effectiveness of the new device.

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

This information is not provided in the document. The "ground truth" for the performance tests outlined (e.g., absorbency, chemical residues, biocompatibility) is established by adherence to recognized national and international standards and validated testing methodologies, rather than expert consensus on individual cases.

4. Adjudication Method for the Test Set

Not applicable for this type of device and testing. The tests performed are objective, laboratory-based physical, chemical, and microbiological tests against defined standards, not subjective assessments requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

Not applicable. This is a medical device (menstrual tampon), not an AI-powered diagnostic or assistive technology for human readers.

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-based device.

7. The Type of Ground Truth Used

The "ground truth" used for this device's performance assessment is based on:

• Established Regulatory Standards: For absorbency (21 CFR 801.430), chemical properties (EC Regulations, 21 CFR), and material safety (21 CFR 177-178).
• International Consensus Standards: For biocompatibility (ISO 10993 series) and withdrawal cord strength (AS/NZS 2869:1998).
• Pharmacopeia Standards: For microbiological evaluations (European Pharmacopeia, United States Pharmacopeia).
• FDA Guidance: For pre-clinical microbiological testing (July 27, 2005 Guidance for Menstrual Tampons and Pads).

These standards and methods define the acceptable performance characteristics and are considered the objective "ground truth" for the device's safety and effectiveness.

8. The Sample Size for the Training Set

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

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

Not applicable, as there is no training set for this device.

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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.

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Femtex and Private Label 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 Plastic Applicator Tampons are menstrual tampons used to absorb menstrual fluid. The tampons will be provided in Regular absorbency within a slender plastic applicator.

Femtex and Private Label Slender Regular Plastic Applicator Tampons are made from rayon absorbent, cotton cord and cotton sewing thread.

The material used in Femtex and Private Label Slender Regular Plastic Applicator Tampons are similar to those used in other legally marketed tampons.

The provided text is for a 510(k) premarket notification for Femtex and Private Label Slender Regular Plastic Applicator Tampons. This document focuses on demonstrating substantial equivalence to a previously marketed device (K023479), rather than establishing new acceptance criteria or proving performance through a study against specific criteria. Therefore, much of the requested information regarding acceptance criteria, specific study design, and performance metrics is not explicitly stated or applicable in this type of regulatory submission.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the 510(k) summary. The document does not define specific quantitative acceptance criteria (e.g., minimum absorbency in Syngyna testing) that the new device must meet. Instead, it relies on the predicate device's established safety and effectiveness.

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

• Test Set Sample Size: Not explicitly stated.
• Data Provenance: The document states "review of existing toxicological data in the public literature" and that "the following tests have been previously conducted on components relevant to the safety of Femtex plastic applicator tampons." This suggests that some of the data might be retrospective or historical, potentially from previous testing on similar components or the predicate device. However, it also mentions "Standard Syngyna testing confirmed the absorbency of these tampons," which implies some current testing was performed on the new device, but the details of the test set are not provided.

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

This information is not applicable and therefore not provided. The 510(k) submission for tampons does not involve expert-based ground truth establishment in the way medical diagnostic devices do. The assessments are based on laboratory testing (biocompatibility, absorbency) against defined standards or equivalency to a predicate.

4. Adjudication Method for the Test Set:

This information is not applicable and therefore not provided. Given the nature of the non-clinical tests (biocompatibility, Syngyna absorbency), no expert adjudication method (like 2+1, 3+1) would be employed.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. It is not applicable to a menstrual tampon.

6. Standalone (Algorithm Only) Performance Study:

No, a standalone study was not done. This concept is relevant for AI algorithms without human intervention. A menstrual tampon is a physical device, not an algorithm.

7. Type of Ground Truth Used:

The "ground truth" for the non-clinical testing appears to be based on:

• Established Biocompatibility Standards: The results of cytotoxicity, sensitization, and vaginal irritation testing would be compared against recognized biological safety standards for medical devices and/or data from the predicate device to establish safety.
• Standard Absorbency Measurement (Syngyna Test): The absorbency of the tampons is measured quantitatively using a standardized laboratory method (Syngyna test), which provides an objective ground truth for absorbency.

8. Sample Size for the Training Set:

This information is not applicable and therefore not provided. Training sets are relevant for machine learning algorithms. The provided document concerns a physical medical device.

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

This information is not applicable and therefore not provided. (See point 8).

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First Quality Hygienic, Inc. Femtex and Private Label Scented Plastic Applicator tampons are a menstrual tampon 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.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Femtex and Private Label Scented Plastic Applicator Tampons:

It's important to note that the provided documents are a 510(k) summary and an FDA clearance letter, which focus on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed clinical study for novel device performance. As such, many of the typical clinical study elements you've requested (like sample sizes for test sets, expert ground truth, MRMC studies, etc.) are not applicable or not present in these types of submissions.

The "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical testing performed to show the device's safety and performance equivalence to existing tampons.

Acceptance Criteria and Reported Device Performance

Further Details on the "Study" (Non-Clinical Testing)

The document refers to non-clinical testing rather than a traditional clinical study.

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

   • Test Set Sample Size: Not specified for any of the non-clinical tests. These tests typically use laboratory samples of materials or finished products, not human subjects.
   • Data Provenance: Not explicitly stated, but it would be laboratory testing data, presumably conducted in the United States or by a qualified lab following international standards. It is retrospective in the sense that the testing was performed on manufactured components/products, not on prospective human cohorts.

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

   • Not Applicable. For non-clinical tests like biocompatibility and Syngyna absorbency, "ground truth" is established by standard laboratory protocols and measurements, not by expert consensus on individual cases. The interpretation of the results would be done by qualified toxicologists or laboratory personnel.

3. Adjudication method for the test set:

   • Not Applicable. This concept applies to human reader studies or clinical trials where discordant interpretations might need resolution. Non-clinical lab tests have defined pass/fail criteria.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No. This is a non-clinical device, not an imaging or diagnostic AI device.

5. 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.

6. The type of ground truth used:

   • Laboratory Standard Results/Measurements: For biocompatibility, the ground truth is established by the outcome of standard toxicology assays (e.g., cell viability in cytotoxicity, animal skin reactions in irritation/sensitization). For absorbency, it's the measured fluid uptake compared to established Syngyna test standards.

7. The sample size for the training set:

   • Not Applicable. There is no "training set" as this is not an artificial intelligence/machine learning device. The non-clinical tests are performed on the device or its components directly.

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

   • Not Applicable. (As above, no training set).

In summary: The provided 510(k) summary focuses on demonstrating that Femtex and Private Label Scented Plastic Applicator Tampons are substantially equivalent to existing, legally marketed tampons based on standard non-clinical safety (biocompatibility) and performance (absorbency) testing. It explicitly states "Assessment of Performance Standards: Not Applicable" in the summary because it's a predicate-based submission, not a novel device requiring new performance standards to be met. The "study" here is rigorous laboratory testing to confirm material safety and functional absorbency according to established industry and regulatory norms, rather than a clinical trial with human subjects.

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Femtex and Private label Scented Plastic Applicator Tampons are menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.

As defined in 21 CFR 884.5460 and 21 CFR 884.5470, First Quality Hygienic Femtex and Other Private Label Scented Plastic Applicator Tampons, a Class II device, are a plug made 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 with 4 absorbencies, Junior, 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 material used in Femtex and Private label Scented Plastic Applicator Tampons are similar to those used in other legally marketed tampons.

The provided text is a 510(k) summary for "Femtex and Private label Scented Plastic Applicator Tampons." It describes the device, its intended use, and the non-clinical testing performed to establish substantial equivalence to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and study information, addressing the points requested:

1. Table of Acceptance Criteria and Reported Device Performance

• Cytotoxicity testing: Results not detailed, but stated as "0 cytotoxicity testing" (implies none or no cytotoxicity found).
• Sensitization testing: Results not detailed, but stated as "0 sensitization testing" (implies none or no sensitization found).
• Vaginal irritation testing: Results not detailed, but stated as "0 vaginal irritation testing" (implies none or no vaginal irritation found). |
  | Absorbency | Standard Syngyna testing to confirm declared absorbencies (Junior, Regular, Super, Super Plus). | "Standard Syngyna testing confirmed the absorbency of these tampons." (Specific absorbency values for each size are not provided in this summary, but the general criteria of confirmation was met). |
  | Material Composition | Materials similar to legally marketed tampons. | "The material used in Femtex and Private label Scented Plastic Applicator Tampons are similar to those used in other legally marketed tampons." (Material listed: rayon absorbent, cotton cord, cotton sewing thread, fragrance). |
  | Fragrance Safety | Biocompatibility tests imply safety of added fragrance. | Included in the "0 irritation testing," "0 cytotoxicity testing," "0 sensitization testing," and "0 vaginal irritation testing" for the overall tampon, which includes the fragrance. |

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

The 510(k) summary does not explicitly state the sample sizes for the non-clinical tests (irritation, cytotoxicity, sensitization, vaginal irritation, Syngyna absorbency). It refers to "tests have been conducted" but does not give numerical sample sizes for these tests.

The data provenance is retrospective, as the submission refers to the review of "existing toxicological data in the public literature" in addition to the new tests conducted. The country of origin of the data is not specified.

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

This document does not describe the use of human experts to establish "ground truth" in the way it would for a diagnostic device (e.g., expert radiological review). The tests performed (biocompatibility, Syngyna absorbency) are laboratory-based and rely on established scientific methods and instrumentation rather than expert interpretation of a 'test set' in the context of disease diagnosis. Therefore, this information is not applicable to this 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable. As explained in point 3, the "test set" here refers to samples of the tampon material undergoing laboratory tests, not a set of cases requiring human expert adjudication.

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

No. This is a 510(k) premarket notification for a medical device (tampon), not a diagnostic algorithm. Therefore, an MRMC comparative effectiveness study, which is typically used for assessing reader performance with and without AI assistance in diagnostic imaging, was not performed and is not applicable.

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

Not applicable. This device is a physical product (tampon), not an algorithm or AI system. Its performance is intrinsic to the product itself, not an algorithm's output.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to the established scientific methods and accepted safety/performance profiles for tampons.

• Biocompatibility: Absence of irritation, cytotoxicity, or sensitization as determined by standardized laboratory assays. The "ground truth" is that the materials do not elicit adverse biological responses.
• Absorbency: The absorbency capacity as measured by the Syngyna test, which is a standardized method for determining tampon absorbency. The "ground truth" is the measured absorbency value, which is then compared against established ranges for stated absorbencies (Junior, Regular, Super, Super Plus).
• Material Equivalence: The composition of the materials used in the new device must be similar to those in legally marketed predicate devices. "Ground truth" here is the established safety and performance of existing, cleared tampon materials.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an AI or machine learning model that requires a training set.

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

Not applicable, as there is no training set for a physical device like a tampon.

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First Quality Hygienic slender regular and Junior tampons are a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge

Femtex Junior and Slender Regular Tampons are menstrual tampons used to absorb menstrual fluid. These Femtex Open-End Tampons will be provided with 2 absorbencies: Slender Regular and Junior.

Femtex Open-End Junior and Slender Regular Tampons are made from rayon absorbent, cotton cord and cotton sewing thread.

The material used in Femtex Open-End Junior and Slender Regular Tampons are similar to those used in other legally marketed tampons.

The provided text is for a 510(k) premarket notification for Femtex Open-End Tampons. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study with specific acceptance criteria and detailed device performance metrics in the way medical AI/imaging devices typically do.

Therefore, the requested information elements related to acceptance criteria, specific performance metrics, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable in this context.

Here's why and what information can be extracted:

• Type of Device: Menstrual Tampons. These are Class II medical devices, and their regulatory pathway (510(k)) primarily requires demonstrating substantial equivalence, especially in terms of materials, absorbency, and safety (biocompatibility), rather than demonstrating diagnostic accuracy or efficacy through clinical studies with complex statistical endpoints.
• Performance Standards: The document explicitly states "Assessment of Performance Standards: Not Applicable" under "Non-Clinical Testing."
• "Study" Conducted: The non-clinical testing performed involves biocompatibility testing and Syngyna testing for absorbency. These are standard tests for tampons to ensure safety and function, but they don't generate the kind of data typically requested for AI device studies.

Information that can be extracted or inferred:

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

   • Acceptance Criteria/Standards: The criteria are implicitly tied to the performance of the legally marketed predicate device and general safety standards for similar devices. Specifically mentioned are:
     • Biocompatibility (irritation, oral toxicity, cytotoxicity).
     • Absorbency (confirmed by Standard Syngyna testing).
   • Reported Device Performance:
     • Biocompatibility testing "demonstrate that the Femtex Tampons are equivalent in terms of safety and effectiveness to legally marketed tampons."
     • Standard Syngyna testing "confirmed the absorbency of the Femtex Tampons."

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

   • Not specified. The document mentions "review of existing toxicological data in the public literature" and "tests have been conducted on components relevant to the safety of Femtex tampons." The sample sizes for these specific component tests are not detailed.
   • Provenance is not mentioned for the testing itself.

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. The "ground truth" for tampon performance is established by standardized physical/chemical tests (e.g., Syngyna for absorbency, lab tests for cytotoxicity), not expert clinical review in the sense of diagnostic imaging.

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

   • Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable. This is not an AI device.

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

   • Not applicable. This is not an AI device.

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

   • For biocompatibility: Laboratory assays for irritation, oral toxicity, and cytotoxicity, likely compared against established safety thresholds.
   • For absorbency: Results from the "Standard Syngyna testing," which is a standardized laboratory method for measuring menstrual tampon absorbency.

8. The sample size for the training set:

   • Not applicable. This is not an AI device, so there is no concept of a "training set" in this context.

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

   • Not applicable.

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First Quality Hygienic plastic applicator tampons are a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge.

First Ouality Hygienic Plastic Applicator Tampons are menstrual tampons used to absorb menstrual fluid. These Tampons will be marketed in four absorbencies: junior regular, super and super plus. These Tampons are made from rayon and cotton cord. The material used in these tampons are similar to those used in other legally marketed tampons in the US.

Here's a summary of the acceptance criteria and study information for the "Femtex" Tampons, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For the "Femtex" Tampons, the key performance standard mentioned is absorbency, measured by the Syngyna methodology. The acceptance criteria are defined by absorbency ranges for each tampon type. The reported device performance aligns with these ranges.

(Note: While the document states "Standard Syngyna testing confirmed the absorbency of these Tampons," it doesn't explicitly list the exact absorbency values obtained for each specific absorbency type. It relies on the assertion that these values were confirmed to be within the defined ranges.)

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

The document does not explicitly state the sample size used for the Syngyna absorbency testing or the other non-clinical tests mentioned (irritation, sensitization, acute oral toxicity, eye irritation, cytotoxicity).

The data provenance is implied to be historical testing and a review of existing toxicological data in the public literature. There is no mention of specific country of origin for the data or if it was retrospective or prospective.

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

This information is not provided in the document. The Syngyna absorbency test is a standardized laboratory test, and the other tests are standardized non-clinical evaluations, not typically requiring "expert" establishment of ground truth in the way a clinical study might (e.g., diagnosing a disease from images).

4. Adjudication Method for the Test Set

This information is not applicable as the tests described are laboratory and non-clinical evaluations, not interpretive assessments that would require human adjudication.

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

No, an MRMC comparative effectiveness study was not done. This device is not an AI-assisted diagnostic tool but a physical menstrual product.

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

No, a standalone algorithm study was not done. This device is a physical product, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for absorbency was established through standardized laboratory testing (Syngyna methodology), which provides objective, quantifiable data. For biocompatibility and safety, the ground truth was established through standardized non-clinical testing (irritation, sensitization, acute oral toxicity, eye irritation, cytotoxicity) and review of existing toxicological data in public literature.

There is no mention of expert consensus, pathology, or outcomes data being the primary ground truth for the performance of this specific device, as these are typically more relevant for diagnostic or clinical devices.

8. The Sample Size for the Training Set

This information is not applicable. This is a physical medical device, not an AI model that requires a "training set." The testing described is for performance and safety evaluation, not for training an algorithm.

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

This information is not applicable as there is no "training set" for this device.

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Femtex Gentle Touch tampons are menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.

Femtex Gentle Touch Tampons are menstrual tampons used to absorb menstrual fluid. Femtex Gentle Touch Tampons will be provided with 3 absorbencies, regular, super and super plus.

Femtex Gentle Touch Tampons are made from rayon and, cotton cord and sewing thread.

The material used in Femtex Gentle Touch tampons are similar to those used in other legally marketed tampons.

This 510(k) summary for K963034 describes a physical medical device (tampons), not an AI/ML powered device. As such, the requested information regarding acceptance criteria, study design for AI/ML performance, sample sizes for AI/ML models, expert involvement, and ground truth establishment for AI/ML is not applicable.

The summary focuses on demonstrating substantial equivalence to legally marketed tampons based on material composition, intended use, and non-clinical biocompatibility and absorbency testing.

Here's a breakdown of the specific points requested and why they are not relevant in this context:

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

• Not applicable for AI/ML. The document states "Assessment of Performance Standards: Not Applicable" in its own section. The non-clinical testing focused on safety (biocompatibility, irritation, sensitization) and absorbency. For absorbent devices like tampons, acceptance criteria would typically relate to absorption capacity, leakage, and material safety, not diagnostic or risk assessment performance metrics.

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 for AI/ML. This refers to a dataset for evaluating an algorithm. For a physical device, testing involves physical samples tested in a lab or in vivo. The document mentions "results of these tests" in a general way, but doesn't specify sample sizes for biocompatibility or absorbency tests, nor is there "data provenance" in the sense of patient data.

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 for AI/ML. Ground truth refers to the true label in an AI/ML context. For a physical device, testing results are typically objective measurements (e.g., absorbency in Syngyna testing, cellular response in irritation tests) based on established scientific protocols, not expert consensus on an image or medical record.

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

• Not applicable for AI/ML. Adjudication is a method to resolve discrepancies in expert labeling of a dataset for AI/ML. This is not relevant for testing a physical product like 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 for AI/ML. MRMC studies are specifically for evaluating the impact of AI on human diagnostic performance. Tampons do not involve "human readers" or AI assistance in their use or evaluation.

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

• Not applicable for AI/ML. This refers to the performance of an AI algorithm on its own. Tampons are not an algorithm.

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

• Not applicable for AI/ML. As explained above, for a physical device, testing involves objective metrics rather than "ground truth" labels. For example, "0 irritation testing" implies a measurable outcome of no irritation, which is a direct observation/measurement, not a consensus interpretation.

8. The sample size for the training set

• Not applicable for AI/ML. This refers to data used to train an AI model. Tampons are not an AI model.

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

• Not applicable for AI/ML. This refers to labeling data for AI training. Tampons do not have a training set or ground truth in this context.

In summary, the provided 510(k) pertains to a traditional physical medical device and therefore the questions regarding AI/ML performance evaluation are not applicable. The device's safety and effectiveness are demonstrated through non-clinical biocompatibility and absorbency testing, which aligns with the regulatory pathway for such products.

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Femtex Digital tampons are menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.

Femtex Digital Tampons are menstrual tampons used to absorb menstrual fluid. Femtex Digital Tampons will be provided with 3 absorbencies, regular, super and super plus. Femtex Digital Tampons are made from rayon, polyethylene and polypropylene overwrap and cotton cord. There is no applicator

It appears that the provided text is a truncated 510(k) summary for a medical device called "Femtex Digital Tampons." This document type primarily focuses on demonstrating substantial equivalence to a predicate device, rather than reporting on clinical performance against specific acceptance criteria for a diagnostic algorithm or device.

Therefore, the input does not contain the information necessary to answer the questions about:

1. Acceptance criteria and reported device performance: This document explicitly states "Assessment of Performance Standards: Not Applicable" as it focuses on equivalence rather than meeting pre-defined performance thresholds for analytical or clinical performance (which are more common for diagnostic devices).
2. Sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, or training set details. These are all concepts related to clinical studies for performance evaluation, which are not detailed in this 510(k) summary for a tampon. The "Non-Clinical Testing" section refers to biocompatibility and absorbency tests, not clinical performance for diagnostic accuracy.

In summary, the provided content is a 510(k) summary for a tampon, which focuses on material equivalence and non-clinical safety (biocompatibility, irritation, absorbency) rather than performance criteria and studies typically associated with "device meets acceptance criteria" in the context of diagnostic or interventional devices with quantifiable outcomes like sensitivity, specificity, or accuracy.

To answer your questions, I would need a different type of document, such as a clinical study report or a 510(k) summary for a diagnostic device that includes performance data.

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