(216 days)
LifeStyles® Natural Personal Lubricant 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, polyurethane, and polyisoprene condoms.
LifeStyles® Natural Personal Lubricant is a non-sterile, water-based personal lubricant designed to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The formula is a non-staining, long-lasting, biocompatible gel-like liquid that is compatible with natural rubber latex, polyurethane, and polyisoprene condoms. The provided in a plastic pump dispenser.
This document pertains to a 510(k) premarket notification for a personal lubricant, not an AI/ML medical device. Therefore, the questions regarding acceptance criteria and study design for such devices are not applicable. The information provided outlines the regulatory submission for Ansell Healthcare Products, LLC's LifeStyles® Natural Personal Lubricant.
To answer your request, I will explain why each of your specific points is not applicable to the provided document:
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A table of acceptance criteria and the reported device performance: This type of table is used for devices that perform a measurable diagnostic or therapeutic function with specific performance metrics. Personal lubricants are assessed for their physical and chemical properties and biocompatibility, not for performance based on accuracy or efficacy in the way an AI diagnostic tool would be. The document describes "bench testing indicated that the lubricant is non-staining and that it has an appropriate viscosity, pH, specific gravity, appearance, color and odor," and "USP testing for Total Aerobic Microbial Counts, Total Yeast and Mold Counts, absence of microbial pathogens, and antimicrobial effectiveness indicated microbial quality." These are characteristics, not performance metrics against acceptance criteria in the sense of a clinical outcome or diagnostic accuracy.
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Sample size used for the test set and the data provenance: This refers to the number of cases (e.g., medical images, patient records) used to evaluate an AI model. For a personal lubricant, the "test set" would involve samples of the product itself undergoing various laboratory and biocompatibility tests. The document mentions "Testing per ASTM D7661" and "testing for cytotoxicity, vaginal irritation, and systemic toxicity in accordance with ISO 10993." These are standard testing methodologies for medical devices to ensure safety and compatibility, not a dataset of patient information. The provenance would be the manufacturing site and the labs conducting the tests.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: "Ground truth" typically refers to the confirmed correct diagnosis or outcome used to train and validate AI models. For a personal lubricant, ground truth isn't established by medical experts interpreting data. Its safety and effectiveness are determined through established chemical and biological testing standards conducted by qualified laboratory personnel.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Adjudication methods are used in clinical studies to resolve discrepancies among expert readers when establishing ground truth for diagnostic AI. This is irrelevant for a personal lubricant, which does not involve subjective diagnostic interpretations.
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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: MRMC studies are designed to assess the impact of AI assistance on human reader performance in diagnostic tasks. Since a personal lubricant is not a diagnostic device, such a study is not applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Standalone performance testing is for AI algorithms without human intervention. A personal lubricant is a physical product, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): As explained in point 3, the concept of "ground truth" for a personal lubricant relates to objective measurements of its physical properties, chemical composition, and biological compatibility against established scientific and regulatory standards, rather than clinical outcomes or expert diagnoses.
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The sample size for the training set: "Training set" refers to the data used to train an AI model. A personal lubricant does not have a "training set" in this context. Its formulation is developed through research and development, and then tested for compliance with standards.
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How the ground truth for the training set was established: Again, this concept is tied to AI model development. The "ground truth" for a personal lubricant's manufacturing process and formulation would be established by validated scientific principles, raw material specifications, and quality control tests, not by expert consensus on clinical data.
In summary, the provided document describes a regulatory submission for a Class II medical device (personal lubricant) that is evaluated based on its physical, chemical, and biological properties, and its substantial equivalence to a predicate device, rather than on AI/ML-specific performance metrics or clinical study designs involving expert interpretation of data.
§ 884.5300 Condom.
(a)
Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.(b)
Classification. (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.