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510(k) Data Aggregation
(307 days)
Good Clean Love Personal Lubricants Almost Naked and Natural Cinnamon Vanilla
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
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance/Conclusion |
|---|---|---|
| Physical/Chemical Specs | Appearance | Met specifications |
| Odor | Met specifications | |
| pH | Met specifications | |
| Viscosity | Met specifications | |
| Osmolality | Met specifications | |
| Microbiological Specs | Antimicrobial effectiveness | Met specifications |
| Total microbial count | Met specifications | |
| Fungal/yeast/mold limits | Met specifications | |
| Absence of pathogenic organisms | Met specifications | |
| Shelf-Life | Established shelf-life | One-year shelf-life established |
| Condom Compatibility | Compatibility with natural rubber latex, polyisoprene, and polyurethane condoms (following ASTM D7661-10) | Concluded to be compatible with natural rubber latex, polyisoprene, and polyurethane condoms. |
| Biocompatibility | Vaginal Mucosa Irritation (ISO 10993-10:2010) | Accepted results |
| Acute Systemic Toxicity (ISO 10993-11:2006) | Accepted results | |
| Maximization Test for Delayed Hypersensitivity (ISO-10993-10:2010) | Accepted results | |
| Cytotoxicity (MatTek EpiVaginal Tissue Model) | Accepted results | |
| Substantial Equivalence | Performance as well as the legally marketed predicate device, Aloe Cadabra (K124044), for intended use and technological characteristics. | The non-clinical tests and predicate comparison demonstrate that the subject device performs as well as the legally marketed device and is substantially equivalent to the cited predicate device for intended use and technological characteristics. Both products consist of 95% organic aloe vera, are compatible with natural rubber latex and polyisoprene condoms, and are biocompatible. |
Non-AI/ML Specific Information (as per document):
- 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.
- 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.
- Adjudication method: Not applicable. Lab testing results are objective measurements against defined specifications.
- 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.
- 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.
- 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).
- 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.
- How the ground truth for the training set was established: Not applicable.
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