Search Results

The Wet Organics 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. The product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

The Wet Organics Personal Lubricant is a non-sterile, water-based, over-the-counter personal lubricant. The proposed device contains a blend of organic aloe and other ingredients similar to ingredients found in the predicate device.

The device is designed to supplement the body's own natural lubrication fluids during intimate sexual activity. The device is also compatible for use with natural rubber latex and polyisoprene condoms. The device is neither a contraceptive nor a spermicide.

The Wet Organics Personal Lubricant is packaged in 3 oz. polyethylene terephthalate bottle with a dispensing bottle cap with a disc top.

This document describes the 510(k) summary for the Wet Organics Personal Lubricant and contains information about its acceptance criteria and the studies performed.

Here's the breakdown of the requested information:

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

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

The document does not specify the exact sample sizes used for each test (biocompatibility, condom compatibility, shelf-life). It states "three marketed brands of natural rubber latex condoms, one brand of polyisoprene condoms, and one brand of polyurethane condoms" for condom compatibility. The provenance of the data (country of origin, retrospective/prospective) is not explicitly mentioned. However, given that these are standard laboratory tests for medical device submission to the FDA, they are generally conducted in a controlled, prospective manner following established protocols and standards (e.g., ISO, ASTM).

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)

This is not applicable to the submitted document. The document describes laboratory performance tests for a personal lubricant, not a diagnostic device requiring expert interpretation of results to establish a "ground truth." The ground truth for these tests is based on the results of the standardized assays and measurements themselves.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies where human readers provide interpretations (e.g., medical imaging) and disagreements need to be resolved. The tests described are laboratory-based with objective measurements.

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 as the document is for a personal lubricant and doesn't involve AI or human readers for diagnostic interpretation.

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

This is not applicable. The device is a personal lubricant, not an algorithm.

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

The "ground truth" for the performance tests in this document is based on:

• Quantitative measurements and chemical analyses: For properties like viscosity, pH, specific gravity, osmolality, and microbial counts.
• Established biological assays: For biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity).
• Standardized physical test methods: For condom compatibility (ASTM D7661-10).
• Real-time stability testing: For shelf-life, where samples are tested against specifications over time.

These are objective, laboratory-derived results against predefined specifications and standards.

8. The sample size for the training set

This is not applicable. The device is a manufacturing product (personal lubricant), not an AI/ML model that requires a training set.

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

This is not applicable, as there is no training set for this device.

Ask a specific question about this device

Good Clean Love Personal Lubricant Almost Naked and Natural Cinnamon Vanilla are 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. This product is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

Good Clean Love Personal Lubricants Almost Naked and Natural Cinnamon Vanilla contain water-solvent organic materials. The primary ingredient is aloe vera (95%). The products are provided in tube containers and have a gel consistency. They include aromatics of cinnamon, vanilla, and lemon. The lubricants are not a spermicide or contraceptive. They are compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

The provided document describes the 510(k) premarket notification for "Good Clean Love Personal Lubricants Almost Naked and Natural Cinnamon Vanilla". This documentation is for a medical device (personal lubricant) and as such, the acceptance criteria and supporting studies are focused on its physical and chemical properties, biocompatibility, and compatibility with condoms, rather than performance metrics typically associated with AI/ML-based diagnostic devices.

Therefore, many of the requested points (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC comparative effectiveness study, standalone algorithm performance, training set sample size, ground truth for training set) are not applicable to this type of device submission.

Here's a breakdown of the available information based on your request:

Acceptance Criteria and Reported Device Performance

Non-AI/ML Specific Information (as per document):

2. Sample size used for the test set and the data provenance: Not applicable in the context of typical AI/ML test sets. The tests performed are laboratory-based, chemical, physical, and biological assessments. "Test set" refers to samples of the product itself for analytical and biological evaluation. The data provenance is internal laboratory testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these types of tests is established by adherence to established international standards (e.g., ISO, ASTM) and validated laboratory methods, not by expert consensus in the diagnostic sense.
4. Adjudication method: Not applicable. Lab testing results are objective measurements against defined specifications.
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/ML diagnostic device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical and chemical product, not an algorithm.
7. The type of ground truth used: Ground truth for this device's performance is established by objective laboratory measurements against predefined specifications and internationally recognized standards (e.g., pH, viscosity, microbial counts, compatibility according to ASTM, biocompatibility according to ISO standards).
8. The sample size for the training set: Not applicable. This device does not involve a "training set" in the AI/ML context. Its development and verification involve formulation and testing.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device