(252 days)
The Albaad Plastic Applicator Tampons, Available in regularand super absorbency are inserted into the vagina and used to absorb menstrual or other vaginal discharge.
The Albaad Tampons are unscented Plastic Applicator tampons. The Applicator Tampons are inserted into the vagina to absorb menstrual or other vaginal discharge. These tampons applicator types, will be marketed in 2 absorbencies: regular (6-9g) and super, (9-12g) These Tampons are made from 100% viscose, and a 100% cotton cord. The applicators are low density and high density polyethylene.
This document is a 510(k) premarket notification for a medical device, specifically tampons. It is not a study report about the performance of a device against acceptance criteria in the context of an AI/software device.
Therefore, many of the requested categories about acceptance criteria and study details (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, etc.) are not applicable to this type of document or device.
Instead, this document describes a submission to the FDA demonstrating that a new device is "substantially equivalent" to a previously marketed predicate device. The performance is assessed through non-clinical testing to demonstrate safety and effectiveness, rather than a clinical trial with acceptance criteria for specific performance metrics like sensitivity, specificity, or accuracy which would be relevant for AI devices.
Here's a breakdown of the requested information based on the provided document:
Acceptance Criteria and Device Performance (Not applicable in the typical AI/software device sense):
The document does not present specific quantitative acceptance criteria or reported device performance in the format of an AI or software study. Instead, it relies on demonstrating substantial equivalence to a predicate device in terms of safety and effectiveness, primarily through non-clinical testing.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Not explicitly stated as numerical performance targets) | Reported Device Performance (Summary of non-clinical findings) |
|---|---|
| Biocompatibility (Acute Systemic Toxicity, Vaginal Irritation, Sensitization, Cytotoxicity) | "Lack of toxicity," "lack of impact on vaginal microflora and TSST-1 production." |
| Absorbency (Standard Syngina testing) | "Confirmed the absorbency of these Tampons." |
| Equivalence to predicate device for safety and effectiveness | "The results of these tests demonstrate that these Tampons are equivalent in terms of safety and effectiveness to the predicate device." |
Detailed Study Information (Where applicable, based on the document):
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Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated for specific tests. The non-clinical tests (biocompatibility, absorbency) would have involved a sufficient number of samples/replicates to generate statistically sound results for those specific tests, but these numbers are not provided in this summary.
- Data Provenance: The tests were conducted internally by the manufacturer or a contracted lab ("nonclinical testing program was carried out for the G3 tampon"). The specific country is Israel, as the manufacturer is Albaad Massoud Itzhak Ltd Caesarea Industrial Park, Israel. These were prospective tests performed on the new device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of human expert ground truth for AI/software. The "ground truth" for these tests would be established by standard analytical methodologies and laboratory technicians/scientists in areas like toxicology, microbiology, and materials science, not by human expert review of images or data.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically for resolving discrepancies in human expert labeling or diagnosis in clinical studies, particularly for AI ground truth establishment. This document describes laboratory testing.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a physical medical device (tampon), not an AI or software device. MRMC studies are not relevant here.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the non-clinical tests would be based on:
- Biocompatibility Standards: Adherence to ISO standards (ISO 10993-5, ISO 10993-10, ISO 10993-11) and established toxicological/biological assays.
- Absorbency Standards: Results from standardized "Syngina testing."
- Microbiological Standards: Laboratory assays for vaginal microflora impact and TSST-1 production.
- The "ground truth" for the non-clinical tests would be based on:
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The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
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How the ground truth for the training set was established:
- Not applicable. As above, no training set for this type of device.
Summary relevant to the document provided:
The submission highlights the substantial equivalence of the new Albaad Plastic Applicator Tampons to the predicate device (Rostam Plastic Applicator Tampons K042773). Key non-clinical tests were conducted:
- Biocompatibility testing: Performed according to ISO 10993 standards (cytotoxicity, sensitization, vaginal irritation, acute systemic toxicity). The results indicated "lack of toxicity," and similar findings to historical results for the predicate device.
- Impact on vaginal microflora and TSST-1 production: Showed "lack of impact on vaginal microflora and TSST-1 production," similar to historical results for the predicate device.
- Absorbency: Standard Syngina testing "confirmed the absorbency."
The document states, "Clinical testing: N/A," further confirming that this submission relies on non-clinical data and equivalence rather than human clinical study outcomes.
§ 884.5470 Unscented menstrual tampon.
(a)
Identification. An unscented menstrual tampon is a device that is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge. This generic type of device does not include menstrual tampons treated with scent (i.e., fragrance materials) or those with added antimicrobial agents or other drugs.(b)
Classification. Class II (performance standards).