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510(k) Data Aggregation
(182 days)
The Unscented W long plastic and cardboard applicator Tampons are inserted into the vagina to absorb menstrual or other vaginal discharge.
The Unscented W long plastic and cardboard applicator Tampons are unscented menstrual tampons consisting of an absorbent pledget and an applicator. The pledget is made of 100% viscose with polymeric overwrap. The applicator is a full size applicator provided in polyethylene or cardboard. The absorbent pledget has a W wadding design and is available in light, regular, super and super plus absorbencies.
I am sorry, but based on the provided text, there is no information about a study that proves a device meets specific acceptance criteria in the context of an AI/ML medical device.
The document is a 510(k) premarket notification for "Unscented W long plastic and cardboard applicator Tampons," which are menstrual tampons, not an AI/ML device. The document discusses performance testing for tampons, such as biocompatibility, absorbency, and microbiological testing, to establish substantial equivalence to a predicate device.
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information for an AI/ML device, as this document does not pertain to one.
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(154 days)
The W long plastic applicator Tampons are inserted into the vagina to absorb menstrual discharge.
The W long plastic applicator Tampons are conventional unscented menstrual tampons consisting of an absorbent pledget and an applicator. The pledget is made of organic cotton. The applicator is in polyethylene and of full size (long). The pledget has a W wadding design. The Tampons are available in regular and super absorbencies.
This document is a 510(k) premarket notification for a medical device, specifically tampons. It does not describe an acceptance criteria or a study that proves a device (like an AI/ML algorithm) meets acceptance criteria.
The document is a regulatory submission to the FDA to demonstrate that a new device ("W long plastic applicator Tampons") is substantially equivalent to a legally marketed predicate device ("Ontex Tampon (Unscented)"). This process is for conventional medical devices, not AI/ML systems.
Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set sizes, or how training ground truth was established) from this document because it pertains to a different type of device and regulatory approval process.
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(270 days)
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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(247 days)
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
| Acceptance Criteria / Performance Metric | Predicate Device Specification (Implicitly the Acceptance Criteria for New Device) | Reported Device Performance (New Device) |
|---|---|---|
| Biocompatibility | Non-cytotoxic, non-irritant, no acute systemic toxicity, no dermal irritation, no allergic contact sensitization (based on predicate) | Non-cytotoxic, non-irritant, no terminal or gross observations in reproductive tracts, no toxic signs, negligible dermal response. No potential for dermal irritation or allergic contact sensitization. |
| Microbiology | Doesn't enhance Staphylococcus aureus growth, doesn't increase TSST-1 production, no effect on culture pH, doesn't alter normal vaginal microflora (based on predicate) | Doesn't enhance Staphylococcus aureus growth, doesn't increase TSST-1 production, no effect on culture pH, doesn't alter normal vaginal microflora. |
| Absorptive Capacity (Syngina) | Within specifications for predicate devices (not quantified in text, but implied to be appropriate for absorption levels like 6-9g, 9-12g, 12-15g) | Gives similar results within predefined specifications (no specific numbers provided) |
| Fiber Loss | Less than 1 mg (for predicate) | Less than 1 mg |
| Cord Strength | Less than 50N (same as predicate Roll Digital Tampon in viscose) | Less than 50N |
| Expulsion Force of Applicator | Less than 6N (specification) | Less than 6N |
| Microbiology Batch Testing: | ||
| - Total Viable Count (TVC) | Less than 200 cfu/g of tampon | Less than 10 cfu/g of tampon |
| - Yeasts/Moulds | Less than 20 cfu/g of tampon | Less than 10 cfu/g of tampon |
| - Candida albicans | Absent in 1g of tampon (negativity) | Absent in 1g of tampon |
| - Gram-negative bacteria | Absent in 1g of tampon (negativity) | Absent in 1g of tampon |
| - Staphylococcus aureus | Absent in 1g of tampon (negativity) | Absent in 1g of tampon |
| - Pseudomonas aeruginusa | Absent in 1g of tampon (negativity) | Absent in 1g of tampon |
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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(268 days)
The Scented Digital and Plastic Applicator Tampons are inserted into the vagina to absorb menstrual discharge.
The Scented Tampons are:
- Scented Digital
- Scented Plastic Applicator (full size (long) and compact)
They are scented versions because of the presence of a fragrance.
Both the Applicator and Digital Tampons are inserted into the vagina to absorb menstrual discharge.
These tampons, both the digital types and the applicator types will be provided with 4 absorbencies: light (<6g), regular (6-9g), super (9-12g), and super plus (12-15g).
These tampons are made from viscose material and polymeric overwrap. The withdrawal cord is in polyester and cotton. Applicators are in polyethylene.
Roll-tampon: sheet of absorbent material is rolled and pressed. W-tampon: sheet of absorbent material is folded and pressed from two sides simultaneously.
Long applicator: inner tube and outer tube are ready to be used immediately. Compact applicator: inner tube and outer tube are slided into each other telescopically. The inner tube needs to be retracted before usage.
Except for the perfume, the materials used in these tampons are similar to materials of legally marketed tampons.
The provided document describes a 510(k) submission for "ONTEX SCENTED DIGITAL AND PLASTIC APPLICATOR TAMPONS". This is a medical device application for tampons, not a diagnostic or AI-driven device. Therefore, the typical acceptance criteria and study designs involving performance metrics like sensitivity, specificity, MRMC studies, and ground truth establishment, which are relevant to image analysis or diagnostic algorithms, are not applicable here.
Instead, the acceptance criteria for this type of device focus on biocompatibility and microbiology to ensure safety and substantial equivalence to a predicate device.
Here's a breakdown of the requested information based on the provided text, while noting the different nature of this device:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Demonstrated) | Device Performance (Reported) |
|---|---|---|
| Biocompatibility | Non-cytotoxic | Passed (non-cytotoxic) |
| Non-irritant | Passed (non-irritant), no terminal or gross observations in reproductive tracts of animals, no toxic signs, negligible dermal response. | |
| No potential for dermal irritation | Passed (no potential for dermal irritation) | |
| No potential for allergic contact sensitization | Passed (no potential for allergic contact sensitization) | |
| Microbiology | Does not enhance growth of Staphylococcus aureus | Passed (does not enhance growth of Staphylococcus aureus) |
| Does not increase production of Toxic Shock Syndrome Toxin-1 (TSST-1) | Passed (does not increase production of TSST-1) | |
| No effect on culture pH | Passed (no effect on culture pH) | |
| Does not alter growth of normal vaginal microflora | Passed (does not alter growth of normal vaginal microflora) | |
| Voluntary Standards Compliance | Complies with applicable voluntary standards for biocompatibility | Passed all testing in accordance with national and international standards. |
| Substantial Equivalence | Differences from predicate device do not raise concerns regarding safety and effectiveness | Demonstrated through biocompatibility and microbiological studies that the scented tampon is substantially equivalent in terms of biocompatibility, microbiological, and safety aspects. |
2. Sample size used for the test set and the data provenance
The document does not specify sample sizes for specific tests. The tests appear to be laboratory-based and conducted on the materials or final product. The provenance of the data is from ONTEX BVBA, Belgium, as stated in the submission sponsor information. The studies are non-clinical performance data, likely conducted prospectively as part of the device development and submission process.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This concept is not applicable to the non-clinical testing performed for this device. Ground truth, in the context of device performance, typically refers to expert consensus or pathology for diagnostic devices. For biocompatibility and microbiological testing, standardized laboratory protocols and expert analysis of results are followed, but "ground truth" as a consensus of clinical experts is not relevant.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are typically used in clinical studies or for diagnostic evaluations where multiple human readers assess cases. The studies described are laboratory-based biocompatibility and microbiology tests, which follow standardized testing procedures rather than human expert adjudication of results from a "test set" in the clinical sense.
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
This is not applicable. MRMC studies are specifically for evaluating diagnostic devices, often AI-powered, where human readers interact with or without AI assistance. This device is a tampon, not a diagnostic tool, and involves no AI component or human reader interpretation for its function.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable, as there is no algorithm or AI component in this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical performance tests for this device is based on standardized laboratory testing protocols and established scientific criteria for biocompatibility and microbiological safety. For example, for Staphylococcus aureus growth, the ground truth is "does not enhance growth," which is determined by comparing growth in the presence of the tampon to a control, according to established microbiological methods.
8. The sample size for the training set
This is not applicable, as there is no training set for an AI/algorithm-driven device.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for an AI/algorithm-driven device.
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(114 days)
The Ontex Unscented Digital and Plastic and Cardboard Applicator Tampons, Available in light, regular, super, and super plus absorbency are inserted into the vagina and used to absorb menstrual or other vaginal discharge.
The Ontex Tampons are:
-
- Unscented Digital
- Unscented Plastic Applicator 2)
-
- Unscented Cardboard Applicator
Both the Applicator and Digital Tampons are inserted into the vagina to absorb menstrual or other vaginal discharge.
These tampons, both the digital types and the applicator types will be provided with 4 absorbencies: light (<6g), regular (6-9g), super, (9-12g), and super plus (12-15g)
These Tampons are made from viscose and/or cotton cellulosic material and polymeric overwrap and cotton or cotton polyester cord. Applicators are either polyethylene or polypropylene.
The materials used in these tampons are similar to those used in other legally marketed tampons..
The provided text describes a 510(k) premarket notification for Ontex tampons and does not contain information about an AI-powered device or a study involving acceptance criteria in the context of device performance metrics like sensitivity, specificity, or F1 score.
Instead, the document details the substantial equivalence determination for a medical device (tampons) based on comparisons to a predicate device and assessments of performance standards and non-clinical testing for safety and effectiveness.
Therefore, I cannot extract the requested information as it is not present in the provided text. The document is a regulatory submission for a physical medical device, not an AI/ML-powered diagnostic or assistive technology.
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