Search Results

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

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

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

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

Acceptance Criteria and Reported Device Performance

Study Information Summary

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

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

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

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

3. Adjudication method for the test set:

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

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

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

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

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

6. The type of ground truth used:

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

7. The sample size for the training set:

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

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

   • Not applicable.

Ask a specific question about this device

Unscented menstrual tampons for absorption of menstrual fluid.

Not Found

This document describes a 510(k) submission for Playtex Tampons (K980478), focusing on safety and effectiveness tests rather than AI/machine learning device performance. Therefore, many of the requested categories related to AI models, such as sample size for test sets, number of experts for ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, and training set information, are not applicable.

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 Data Provenance

• Sample Size:
  • Primary Dermal Irritation: Not specified, but "Rabbits" plural implies more than one.
  • Acute Oral Toxicity: Not specified, but "Rats" plural implies more than one.
  • Subacute Vaginal Irritation: Not specified, but "Rabbits" plural implies more than one.
  • Human Repeat Insult Patch Test: 200 persons.
• Data Provenance: Not specified, but assumed to be internal laboratory testing or contract research organization testing for the manufacturer (Playtex). Retrospective or prospective is not clearly stated but typical in vivo/in vitro testing for device clearance is prospective.

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

Not applicable. The "ground truth" for these types of tests (e.g., irritation, toxicity) is based on standard biological and chemical assays and established scientific protocols, not expert consensus interpreting results. The experts involved would be laboratory scientists and toxicologists.

4. Adjudication Method for the Test Set

Not applicable. Results are based on objective measurements and established protocols for biological and chemical assays.

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/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

7. The Type of Ground Truth Used

The ground truth is based on:

• In vitro/In vivo biological assays: For irritation, toxicity, and inhibition studies, ground truth is determined by the direct observed biological response or lack thereof according to established scientific methodologies and endpoints.
• Chemical analysis: For Dioxin analysis, ground truth is determined by chemical quantification against established limits.
• Toxin quantification: For TSST-1, ground truth is determined by laboratory methods to measure toxin levels.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

Ask a specific question about this device

Scented, Scented Deodorant and Unscented menstrual tampons for absorption of menstrual filud: Part 21 C. F. R., Section 884.5460 and Section 884.5470 respectively.

Scented or scented deodorant and unscented menstrual tampons for the absorption of menstrual fluid.

This 510(k) summary (K971979) describes the substantial equivalence of new Playtex tampons to previously cleared Playtex tampons, rather than presenting a study to prove a device meets specific acceptance criteria in the way a diagnostic or therapeutic medical device might. The document focuses on showing that the new tampons have the same technological characteristics and intended use as the predicate devices, and that nonclinical testing supports their safety.

Therefore, many of the requested categories (like sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and detailed ground truth establishment) are not applicable to this type of submission.

Here's an interpretation based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly met through the demonstration of substantial equivalence to predicate devices, particularly regarding safety aspects. Performance is considered equivalent to the predicate.

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

• Sample Size: Not specified for any "test set" in the context of device performance characteristics like accuracy or sensitivity. The nonclinical tests listed (e.g., human sensitization, animal toxicity) would have their own sample sizes but these are not detailed in this summary.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The document refers to "Nonclinical testing," which typically means laboratory and/or animal studies, and potentially human volunteer studies for sensitization/irritation. The context suggests these are likely prospective studies conducted for the purpose of this submission.

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

• Not applicable (N/A): This type of medical device (tampons) does not typically involve expert readers or establishing "ground truth" through consensus in the way image analysis or diagnostic devices do. The testing referenced is primarily physical, chemical, and biological safety testing.

4. Adjudication Method for the Test Set

• Not applicable (N/A): As there's no "test set" requiring expert evaluation or ground truth adjudication in the conventional sense, no adjudication method is mentioned.

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 (N/A): This device is a menstrual tampon and does not involve AI or human readers for comparative effectiveness studies in the diagnostic sense.

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

• Not applicable (N/A): This device is a physical product, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" here is established primarily through laboratory testing results (e.g., in-vitro toxicology, in-vivo irritation, TSST-1 production) and industry standards/benchmarks for tampons, demonstrating that the materials and design are safe and function effectively for menstrual fluid absorption. The "truth" is that the new tampon performs as safely and effectively as existing, legally marketed tampons.

8. The Sample Size for the Training Set

• Not applicable (N/A): This is not a machine learning or AI device, so there is no "training set."

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

• Not applicable (N/A): As there is no training set, this is not relevant.

Ask a specific question about this device

Scented or scented deodorized tampons for absorption of menstrual fluid. Unscented menstrual tampons for absorption of menstrual fluid.

Scented or scented deodorant and unscented menstrual tampons for the absorption of menstrual fluid.

This document describes the 510(k) submission for "Playtex Tampons," specifically for scented deodorant and unscented varieties. However, it does not contain information about formal acceptance criteria, a specific study proving device performance against those criteria, or details regarding ground truth, sample sizes for training/testing, or expert involvement as typically required for AI/algorithm-based medical devices.

Instead, this submission is centered on demonstrating substantial equivalence to previously cleared predicate devices, a common pathway for medical devices that are similar to devices already on the market. The provided text is a 510(k) summary and the FDA's clearance letter.

Therefore, many of the requested sections about acceptance criteria and study details cannot be filled based on the provided text.

Here's an analysis of what can and cannot be extracted:

1. Table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated as performance metrics with thresholds (e.g., sensitivity, specificity). The acceptance criteria for a 510(k) submission like this are generally demonstrating substantial equivalence in terms of safety and effectiveness to a predicate device. This is achieved through nonclinical testing and comparison of technological characteristics.
• Reported Device Performance: No quantitative performance metrics (e.g., absorption capacity, leakage rates) are reported in the provided text. The performance is implied to be equivalent to the predicate devices.

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

• Sample Size: Not specified.
• Data Provenance: Not specified.
• The nonclinical testing referenced includes: Human sensitization, dermal irritation, acute oral toxicity, subacute vaginal irritations, agar diffusion, and TSST-1 toxin testing. These are typically lab-based tests, not clinical studies with "test sets" in the AI sense.

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 not a study requiring expert-established ground truth for a test set as it's a submission for a physical medical device (tampon) rather than an AI algorithm.

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-assisted device.

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

• Not applicable. This is not an algorithm.

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

• Not applicable in the context of an algorithm's ground truth. For the physical device, the "ground truth" for safety and effectiveness would be established through standard laboratory testing methods comparing the device's properties (e.g., toxicity, irritation) to established safety standards and the predicate device.

8. The sample size for the training set

• Not applicable. This is not an AI algorithm requiring a training set.

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

• Not applicable.

Summary of Device and Approval Process from the Provided Text:

• Device Name: Playtex Tampons (Scented Deodorant and Unscented)
• Intended Use: Absorption of menstrual fluid.
• Substantial Equivalence: The device is claimed to be substantially equivalent to previously cleared Playtex Gentle Glide®, Slimfits™, and Soft Comfort™ Tampons. The new tampon has the same technological characteristics and mode of action as the predicate devices.
• Nonclinical Testing: Referenced for substantial equivalence determination. This included tests for human sensitization, dermal irritation, acute oral toxicity, subacute vaginal irritations, agar diffusion, and TSST-1 toxin testing. These tests are typically performed to assess the safety of materials and formulations.
• Outcome: The FDA determined the device to be substantially equivalent to predicate devices, thus allowing it to be marketed.

Ask a specific question about this device

Not Found

TSST-I, Toxin testing was conducted; results are in the range of values of commercially sold tampons and there are no significant differences between Playtex Tampons #29696 and the predicate device
Dioxin Analysis
Primary Dermal Irritation in Rabbits Non-Irritating
Acute Oral Toxicity in Rats - Non-Toxic
Subacute Vaginal Irritation in Rabbits - Non-Irritating
Human Repeat Insult Patch Test Non-Irritating and not a Sensitizer
Agar Diffusion Study No zones of inhibitation were detected

This document, K964269, is a 510(k) premarket notification for Playtex Tampons #29696, submitted on November 29, 1996. It details safety and effectiveness information for a medical device (a tampon). However, it does not contain the information requested in your prompt regarding acceptance criteria, study design for performance, or AI/software validation.

The document primarily focuses on biological safety testing for the tampon and its comparison to a predicate device, which is typical for a device of this nature in a 510(k) submission. It describes tests like:

• TSST-I Toxin testing: Comparing levels to commercially sold tampons.
• Dioxin Analysis: Implied to be performed, but no results are given.
• Primary Dermal Irritation (Rabbits): Resulted in "Non-Irritating."
• Acute Oral Toxicity (Rats): Resulted in "Non-Toxic."
• Subacute Vaginal Irritation (Rabbits): Resulted in "Non-Irritating."
• Human Repeat Insult Patch Test: Resulted in "Non-Irritating and not a Sensitizer."
• Agar Diffusion Study: No zones of inhibition detected.

These are all safety tests, not performance tests in the sense of accuracy, sensitivity, or specificity for a diagnostic or AI-driven device. Therefore, I cannot extract the requested information from this document for the following reasons:

1. AI/Software Component Absence: The document describes a physical medical device (tampon) and its biological safety. It does not refer to any AI, software, or diagnostic capabilities.
2. Lack of Performance Metrics for AI: There are no metrics like sensitivity, specificity, AUC, F1-score, or similar performance indicators for an AI system.
3. No Test Set/Training Set Details: Information on test set size, data provenance, ground truth establishment methods (expert consensus, pathology), number of experts, adjudication methods, or MRMC studies is not present because these concepts are not relevant to the described safety testing of a tampon.

Conclusion: The provided text is unsuitable for generating the specific table and study details you've requested, as it pertains to the biological safety of a physical medical device (tampon) and not to the performance validation of an AI-driven device or diagnostic tool.

Ask a specific question about this device

Not Found

Not Found

This document does not describe a medical device that uses AI or machine learning, nor does it involve the kind of "study" described in the prompt's request for acceptance criteria and performance data related to AI devices.

Instead, the provided text is a summary of safety and effectiveness tests for an epoxy-coated applicator (RAD-KOTE K261). The tests are focused on material biocompatibility and physical integrity, not diagnostic or AI-driven performance.

Therefore, I cannot fulfill the request as it is framed for an AI-enabled medical device. The information provided does not contain:

• Acceptance criteria for an AI algorithm's performance (e.g., sensitivity, specificity, AUC).
• Details about test sets, training sets, data provenance, expert ground truth, or MRMC studies for AI.
• Any mention of AI, machine learning, or algorithms.

The document lists safety tests and their results for a physical medical product component.

Ask a specific question about this device