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510(k) Data Aggregation
(134 days)
Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, and Grosz Play Strawberry are personal lubricants intended for penile, vaginal and/or anal application to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. They are compatible with natural rubber latex and polyisoprene condoms. They are not compatible with polyurethane condoms.
Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, and Grosz Play Strawberry are water-based personal lubricants intended for penile, vaginal and/or anal application to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The products are compatible with natural rubber latex and polyisoprene condoms. The products are not compatible with polyurethane condoms. They are for over-the-counter (OTC) use. The formula consists of water, propylene glycol. xanthan gum, carbomer, benzoic acid, sodium hydroxide, sodium saccharin and flavor. Grosz Play Aloe, Grosz Play Ylang, and Grosz Play Guarana are packaged in a 200 mL polyethylene terephthalate (PET) bottle fitted with a polypropylene (PP) cap. Grosz Play Cherry and Grosz Play Strawberry are packaged in a 50 mL high density polyethylene (HDPE) bottle fitted with a polypropylene (PP) cap. The bottle and cap feature a tamper evident shrink seal label. The individual bottles may be packaged in an outer cardboard carton.
The document provided describes the acceptance criteria and performance of personal lubricants. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The device is a personal lubricant, and the acceptance criteria are based on various physical, chemical, and microbiological specifications, as well as biocompatibility and condom compatibility. The performance data is reported as meeting these specifications.
| Specification | Acceptance Criteria | Reported Device Performance (all variants unless specified) |
|---|---|---|
| Physical/Chemical Specifications | ||
| Appearance | Clear to slightly translucent, colourless to slightly yellow colour homogeneous gel and free from particulate matter (for Aloe, Ylang, Guarana); Colorless, transparent gel, free from lumps and particulate matter (for Cherry, Strawberry) | Meets criteria |
| Odor | No objectional odor (for Aloe, Ylang, Guarana); Characteristic of cherry (for Cherry); Characteristic of strawberry (for Strawberry) | Meets criteria |
| Viscosity (cps) | 3,300 - 10,000 (for Aloe, Ylang, Guarana); 3,400 - 10,000 (for Cherry, Strawberry) | Meets criteria |
| Osmolality (mOsm/kg) | 695 - 1,095 (Aloe); 720 - 1,120 (Ylang); 710 - 1,110 (Guarana); 683-1,083 (Cherry); 742 - 1,143 (Strawberry) | Meets criteria |
| Benzoic Acid | 0.15-0.22 %w/w | Meets criteria |
| pH at 25°C | 3.5 - 4.5 | Meets criteria |
| Microbiological Specifications | ||
| Total Yeast and Mold Count (TYMC) | < 10 cfu/g | Meets criteria |
| Total Aerobic Microbial Count (TAMC) | < 100 cfu/g | Meets criteria |
| Total Specified Organisms (Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans, Escherichia coli) | Absent | Meets criteria |
| Preservative Effectiveness Testing (PET) - Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus | NLT 3.0 log reduction from the initial count at 7 days, and no increase from the 7 days' count at 28 days | Meets criteria |
| Preservative Effectiveness Testing (PET) - Candida albicans, Aspergillus niger (A. brasiliensis) | 2.0 log reduction from the initiation count at 14 days, and no increase from the 14 days' count at 28 days | Meets criteria |
| Biocompatibility | ||
| Cytotoxicity | Non-cytotoxic | Determined to be non-cytotoxic |
| Vaginal Irritation | Non-irritating | Determined to be non-irritating |
| Sensitization | Non-sensitizing | Determined to be non-sensitizing |
| Acute Systemic Toxicity | Not systemically toxic | Determined to be not systemically toxic |
| Condom Compatibility | Compatible with natural rubber latex and polyisoprene condoms; Not compatible with polyurethane condoms | Determined to be compatible with natural rubber latex and polyisoprene condoms; Determined not to be compatible with polyurethane condoms |
| Shelf-Life | Maintain all specifications above for 2 years (Aloe, Cherry, Strawberry) or 1.5 years (Ylang, Guarana) | Demonstrated to maintain specifications over the duration of its shelf life (2 years or 1.5 years depending on the variant) based on accelerated aging conditions per ASTM F1980-16. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample sizes for each test set (e.g., number of units tested for viscosity, number of animals for biocompatibility, etc.). It mentions that "all variants of the subject device" were tested for biocompatibility, and "Grosz Play Aloe, Grosz Play Guarana, Grosz Play Cherry, and Grosz Play Strawberry" were tested for condom compatibility.
The data provenance is presented as standard laboratory testing results, rather than clinical data from human subjects or retrospective/prospective studies. The tests mentioned (e.g., ASTM, ISO, EP standards) are laboratory-based. Therefore, there is no specific country of origin or retrospective/prospective designation for the data in the context of clinical trials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to the type of device and testing described. The "ground truth" for these tests is established by recognized international standards (e.g., ISO, ASTM, European Pharmacopoeia) and the results are objectively measured in a laboratory setting, not through expert human interpretation.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., medical imaging) where there might be disagreement among readers. For laboratory tests described here, results are quantitatively measured or observed against predefined criteria, eliminating the need for adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was done, as this is a personal lubricant and not an AI-assisted diagnostic or clinical decision support device. Therefore, there is no effect size of human readers improving with AI assistance to report.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a personal lubricant; it does not involve any algorithm or AI for its function.
7. Type of Ground Truth Used
The ground truth used for these tests is based on established international standards and objective laboratory measurements. This includes:
- Predefined physical chemical ranges (e.g., for viscosity, pH, osmolality).
- Specific microbiological limits (e.g., cfu/g, absence of specific organisms).
- Biological responses as defined by ISO 10993 series (e.g., non-cytotoxic, non-irritating).
- Compatibility definitions as per ASTM D7661-10.
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set. The device is a physical product (personal lubricant).
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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