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Unscented menstrual tampons for the absorption of menstrual fluid.

Unscented menstrual tampons for the absorption of menstrual fluid.

The provided text is a 510(k) summary for Playtex Tampons, asserting their substantial equivalence to previously cleared Playtex tampons. It does not describe a study involving device performance metrics, acceptance criteria, or a test set as would typically be found for a medical device or AI/software product requiring quantitative performance evaluation.

Instead, the submission focuses on demonstrating that the new Playtex tampons have the same technological characteristics and mode of action as the predicate devices, and that nonclinical testing confirms their safety and effectiveness are substantially equivalent.

Therefore, most of the requested information about acceptance criteria, performance, sample sizes, experts, and adjudication methods is not applicable to this type of submission.

Here's a breakdown based on the information that is present:

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

• Acceptance Criteria: The primary "acceptance criterion" for this 510(k) submission is Substantial Equivalence to legally marketed predicate devices. This means the new device must be as safe and effective as the predicate device(s). Specific quantitative performance metrics are not provided here for "device performance."
• Reported Device Performance: The submission states: "Playtex tampons are substantially equivalent to the predicate device in terms of safety and effectiveness."

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 submission does not describe a "test set" in the context of device performance evaluation with a specific sample size. The substantial equivalence claim is based on nonclinical testing and comparison to predicate devices, not typically involving a test set of human subjects or data for a new performance metric.

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

• Not Applicable. There is no "test set" or explicit "ground truth" establishment by external experts described in this submission. The "ground truth" for substantial equivalence is based on regulatory standards and documented safety/effectiveness of predicate devices and nonclinical testing results.

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

• Not Applicable. No test set or adjudication method is described.

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

• Not Applicable. This is not an AI/software device. No MRMC study was conducted.

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

• Not Applicable. This is not an AI/software device. No standalone algorithm performance was assessed.

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

• Implied Ground Truth for Substantial Equivalence: The ground truth for this submission is the established safety and effectiveness of the predicate device(s) as determined by prior regulatory clearances and the results of nonclinical testing conforming to recognized standards (e.g., human sensitization, dermal irritation, acute oral toxicity, subacute vaginal irritations, agar diffusion, Dioxin analysis and TSST-1 toxin testing).

8. The sample size for the training set

• Not Applicable. This is not an AI/software device requiring a training set.

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

• Not Applicable. This is not an AI/software device.

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Unscented menstrual tampons for absorption of menstrual fluid.

Unscented menstrual tampons for the absorption of menstrual fluid.

The provided text is a 510(k) Summary for a medical device (Playtex Tampons). It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include information about acceptance criteria or a study proving that the device meets specific performance criteria in the context of an AI/algorithm-driven device.

The document is a regulatory submission for a physical product (tampons) and focuses on demonstrating substantial equivalence according to FDA regulations existing in 1998. It references nonclinical testing related to biocompatibility and safety (e.g., sensitization, irritation, toxicity, Dioxin analysis, TSST-1 toxin testing) to show that the new tampon has the same technological characteristics and mode of action as previously cleared predicate devices.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving device performance as outlined in your prompt because the provided text does not contain this type of information.

Specifically, it lacks:

1. A table of acceptance criteria and reported device performance: The document mentions "nonclinical testing" but no specific performance metrics or acceptance criteria for those tests are presented in a table format.
2. Sample size, data provenance, number of experts, adjudication method for a test set: This information is not relevant to the type of substantial equivalence submission for a physical product like a tampon.
3. MRMC comparative effectiveness study or standalone algorithm performance: These are concepts related to AI/algorithm performance and are not applicable to the submitted document.
4. Type of ground truth, training set sample size, how ground truth was established for a training set: Also not applicable to this type of device submission.

The document's purpose is to establish substantial equivalence for a physical medical device, not to present performance data for an AI/algorithm.

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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.

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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.

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