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Synthetic Polyisoprene Lubricated Male Condom - 5 Senses is used for contraception and for prophylactic purposes to help reduce the risk of pregnancy and the transmission of sexually transmitted infections (STI's).

The Synthetic Polyisoprene Lubricated Male Condom – 5 Senses is a male contraceptive and prophylactic device made from synthetic rubber polyisoprene latex with a lubricant coating containing silicone gel with flavor and sensate. The subject condom is provided in a variety pack which includes three variants; Cooling, Tingling, and Warming.

The condom is a fitted sheath with an integral ring at the open end and a reservoir (nipple end) at the closed end to contain semen. The condom dimensions are length 190±10mm, width 53±2mm, and thickness 0.065-0.075mm. The condom is designed to conform to the requirements of ISO 23409:2011. This product has a 3-year shelf-life.

The provided text is related to the FDA 510(k) premarket notification for a medical device: "Synthetic Polyisoprene Lubricated Male Condom - 5 Senses." It describes the device, its intended use, comparison to a predicate device, and performance data.

However, the document does not contain any information about an AI/ML device, nor does it mention anything related to acceptance criteria for an AI/ML model, a study proving an AI/ML device meets acceptance criteria, sample sizes for test or training sets for AI, expert involvement in ground truth establishment for AI, or MRMC studies for AI.

Therefore, I cannot fulfill your request for information related to an AI/ML device's acceptance criteria and study data based on the provided text.

The closest relevant information from the document pertains to device performance testing for a physical medical device (condom):

• Performance Testing Standards: ISO 23409:2011 ("Male Condoms - Requirements and test methods for condoms made from synthetic materials") and the FDA Guidance Document, "Testing guidance for Male Condoms Made from New Material (Non-Latex)."
• Performance Results: "Results of testing showed that the mechanical properties of the subject device were equivalent to the predicate device."
• Shelf-life testing: Demonstrated a three-year shelf-life, including assessment of mechanical burst properties.
• Biocompatibility Testing: Conducted in accordance with ISO 10993-1, including Cytotoxicity, Sensitization, Irritation (Dermal, Vaginal, Penile in Rabbits), and Acute Systemic Toxicity tests.

This information is for a physical product, not a software or AI/ML device.

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LifeStyles® SKYN® Intimate Moments 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 polyisoprene condoms. This product is not compatible with natural rubber latex or polyurethane condoms.

LifeStyles® SKYN® Intimate Moments Personal Lubricant is a non-sterile, propylene glycol/water/silicone-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. It is made of propylene glycol, water, cyclopentasiloxane, dimethicone/ vinyl dimethicone crosspolymer, hydroxyethyl acrylate/sodium acryloyl dimethyl taurate copolymer, cyclohexasiloxane, 1,2-hexanediol, caprylyl glycol and fragrance (aroma). The personal lubricant is packaged in a 100 mL tube or a 5 mL sample sachet.

The device specifications for the LifeStyles® SKYN® Intimate Moments Personal Lubricant include appearance, color, odor, viscosity, specific gravity, osmolality, pH, total aerobic microbial count per USP, total yeast and mold count per USP, absence of specific microorganisms per USP, and antimicrobial effectiveness per USP .

The device is not a contraceptive or spermicide, nor does it contain any such component. It is compatible with polyisoprene condoms but not compatible with natural rubber latex or polyurethane condoms.

This document is a 510(k) summary for the LifeStyles® SKYN® Intimate Moments Personal Lubricant. It demonstrates the substantial equivalence of the subject device to a predicate device.

Here's an analysis of the provided text in the context of your request:

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

The document does not explicitly present a table of "acceptance criteria" in the way one might expect for a diagnostic or imaging device. Instead, it describes performance testing conducted to ensure safety and effectiveness, typical for a personal lubricant. The "acceptance criteria" here are implied by the successful completion of the tests and the device "maintaining its specifications."

2. Sample size 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 the non-clinical performance tests (biocompatibility, condom compatibility, shelf life). It only states that "testing was conducted" and "results... demonstrated." The data provenance (country of origin, retrospective/prospective) is not mentioned.

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 information is not applicable to this type of device and regulatory submission. Personal lubricants do not typically involve expert interpretation or "ground truth" establishment in the way medical imaging or diagnostic devices do. The performance is assessed through standardized laboratory tests.

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

This information is not applicable. Adjudication methods are relevant for studies involving human interpretation or subjective assessments, which are not part of the non-clinical testing for this personal lubricant.

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 information is not applicable. This is not a study involving human readers or AI assistance.

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

This information is not applicable. This is not an algorithm-based device.

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

The "ground truth" for the non-clinical performance tests is derived from standardized laboratory testing and established analytical methods. For example:

• Biocompatibility: In vitro and in vivo tests according to ISO standards.
• Condom Compatibility: In vitro testing according to ASTM D7661-10.
• Shelf Life: Accelerated stability testing measuring various physical and chemical device specifications.
• Device Specifications: Laboratory measurements of properties like pH, viscosity, microbial counts, etc., against predefined acceptable ranges.

8. The sample size for the training set

This information is not applicable. This device does not involve machine learning or AI, and therefore, no "training set" in that context.

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

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

In summary, the provided document is a regulatory submission for a personal lubricant, not a complex diagnostic or AI-driven medical device. Therefore, many of the requested data points related to clinical studies, expert-derived ground truth, and AI performance metrics are not relevant or present in this context. The "study" proving acceptance criteria here refers to the battery of non-clinical laboratory tests performed according to international standards (e.g., ISO, ASTM, USP) that demonstrated the product's safety and effectiveness for its intended use and supported its substantial equivalence claim.

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