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OneTouch™ Lubricant Gel is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

One Touch™ Lubricant Gels by Thai Nippon Rubber Industry Company, Ltd. ("TNR") are a line of personal lubricants, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. These lubricants are compatible with natural rubber latex and polyisoprene condoms, and are not a contraceptive and do not contain a spermicide. One Touch™ Lubricant Gels are made available in three (3) different versions: One Touch™ Plain, One Touch™ Flavored and One Touch™ Colored, and come packaged in either single-use disposable application film/foil sachets, or in multiple application polyethylene tubes with a flip-top closure. OneTouch™ Lubricant Gels use hydroxyethyl cellulose and refined glycerin as the lubricating agent, with the methyl paraben, propyl paraben and cremophor acting as the antiseptic and preservative additives.

Here's an analysis of the provided text regarding the acceptance criteria and study for the OneTouch™ Lubricant Gel:

This document is a 510(k) premarket notification for a medical device, which seeks to demonstrate substantial equivalence to legally marketed predicate devices, rather than establishing de novo acceptance criteria and proving performance against them in a traditional sense. The "acceptance criteria" here largely refer to meeting recognized standards and demonstrating similar performance to the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes used for each individual test (e.g., number of lubricant samples for microbial testing, number of condoms for compatibility testing, or number of batches for shelf-life testing).

The data provenance is from Thailand, as the submission sponsor, Thai Nippon Rubber Industry Co., Ltd., is located in Thailand. The studies would be considered prospective in the sense that they were conducted specifically for this submission to evaluate the OneTouch™ Lubricant Gel.

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

This information is not provided in the document. The tests performed are based on established national and international standards (ISO, ASTM, USP), which have predefined methodologies and acceptance limits. The "ground truth" is therefore derived from meeting these objective, quantitative standards, rather than expert consensus on specific cases.

4. Adjudication method for the test set

This is not applicable as the evaluations are based on adherence to quantitative standards and laboratory test results, not subjective expert review or consensus.

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

A Multi-Reader, Multi-Case (MRMC) comparative effectiveness study is not applicable to this device. This type of study is typically used for diagnostic or screening devices where human interpretation (e.g., of images) is involved, potentially with AI assistance. The OneTouch™ Lubricant Gel is a personal lubricant, and its evaluation does not involve human readers interpreting cases or AI assistance in that context.

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

A standalone algorithm performance study is not applicable as this device does not involve an algorithm or AI.

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

The ground truth for the performance of the OneTouch™ Lubricant Gel is based on objective measurements and adherence to established international and national standards. This includes:

• Quantitative laboratory results for biocompatibility (e.g., cell viability, irritation scores), microbial counts (CFU/g), and physical properties for condom compatibility.
• Conformance to specifications and acceptance limits predefined by standards such as ISO 10993-1, ASTM D7661, USP 37 /, ASTM F1980, and ISO 14971.

8. The sample size for the training set

This is not applicable. The OneTouch™ Lubricant Gel is a physical medical device (personal lubricant), not an AI/ML algorithm or a diagnostic tool that requires a 'training set' in the computational sense. The product formulation development might involve iterative testing, but this is not typically referred to as a "training set" in this context.

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

This is not applicable for the reasons stated in point 8.

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The Thai Nippon Male Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)

This condom is made of a natural rubber latex sheath, which completely covers the erect penis with a closely fitted membrane. This condom is colorless, smooth, flared at the closed end with a reservoir tip; nominal lav flat width 56mm, nominal length 200 mm, and nominal thickness 0.07mm. It is lubricated with silicone (viscosity 250 cps), and cornstarch is used as a dressing material. This condom conforms to current established national and international voluntary standards including ASTM D3492:2008 and ISO 4074:2002.

The provided text is a 510(k) summary for a male latex condom. It does not describe a study involving an algorithm or AI. Therefore, it is not possible to extract information about acceptance criteria or a study that proves a device meets acceptance criteria in the context of AI or algorithm performance, nor can I provide details related to sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance of an algorithm.

The document discusses the substantial equivalence of their male latex condom to a predicate device, focusing on its physical characteristics and adherence to established industry standards for condoms (ASTM D3492:2008 and ISO 4074:2002).

However, I can extract the acceptance criteria (standards) that the physical device is designed to meet as per the document's reference to industry standards:

Further information regarding this specific device:

• Sample size used for the test set and the data provenance: Not applicable to an AI or algorithm study in this context. The document implicitly refers to testing done to conform to the ASTM and ISO standards, but does not provide specific sample sizes or data provenance for these physical tests.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is a physical product and not an AI or algorithm.
• Adjudication method for the test set: Not applicable.
• 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.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: For a physical condom, "ground truth" would be established by physical testing against the parameters defined in the ASTM and ISO standards (e.g., burst pressure, leakage, dimensions).
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory submission for a physical medical device (male latex condom) and does not contain information relevant to AI or algorithm performance studies.

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Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

The Thai Nippon condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and transmission of sexually transmitted diseases).

This condom is made of a natural latex sheath, which completely covers the erect penis with a closely fitted membrane. This condom is straight-walled with a reservoir tip; nominal length 180-mm, nominal width 52-mm, and nominal thickness 0.06mm. The condom is offered in natural latex color, red, blue, green, and yellow.

The provided text is a 510(k) Summary for a Male Latex Condom and a subsequent FDA clearance letter. It is not a study report for a device using AI, statistical analysis, or comparison metrics like sensitivity, specificity, or AUC, which are typically found in studies with acceptance criteria, sample sizes, and expert ground truth.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, experts, and adjudication methods is not available in the provided document.

Here's what can be extracted based on the nature of the document:

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

The document states that the device's design is in conformance with ASTM Latex Condom Standard D3492. This standard sets the acceptance criteria for these types of devices. The reported device performance is presented as a direct comparison of technological characteristics to a predicate device, implying that the new device meets or is equivalent to the predicate's performance, which is presumably compliant with the ASTM standard.

Note: The specific numerical acceptance criteria (e.g., minimum burst pressure, maximum pinhole rate) detailed in ASTM D3492 are not explicitly listed in this document but are the underlying performance requirements the device is claiming to meet.

2. Sample size used for the test set and the data provenance

• Sample size: Not specified in the provided documents. The document describes the device and its intended use, along with a comparison to a predicate device, but does not include details of testing methodologies or sample sizes for performance evaluation.
• Data provenance: Not applicable in the context of this 510(k) summary, as it's not a clinical study report with patient data. The device itself is manufactured by Thai Nippon Rubber Industry, Ltd. in Thailand.

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

• Not applicable. This is a submission for a medical device (condom) and does not involve expert interpretation or ground truth establishment in the way an AI diagnostic device would. Compliance with standards and physical properties are the primary evaluation methods.

4. Adjudication method for the test set

• Not applicable. No expert 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-assisted diagnostic device.

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

• Not applicable. This is not an AI algorithm.

7. The type of ground truth used

• The "ground truth" for this device's performance is its physical properties (length, width, thickness, presence of lubricant, reservoir tip) and its ability to conform to established industry standards like ASTM D3492, which includes performance requirements such as burst volume/pressure and freedom from holes. These are typically verified through laboratory testing and quality control processes.

8. The sample size for the training set

• Not applicable. This device does not involve a "training set" like an AI model.

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

• Not applicable.

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