(267 days)
A personal lubricant, for vaginal and penile application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. YES® oil-based Personal Lubricant is not compatible with natural rubber latex, polyurethane or polyisoprene condoms.
A personal lubricant, for vaginal and penile application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. YES® water-based Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
A personal lubricant, for vaginal and penile application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. YES® Vaginal Moisturizer is compatible with natural rubber latex and polvisoprene condoms. This product is not compatible with polyurethane condoms.
YES® oil-based Personal Lubricant: This non-sterile and oil-based personal lubricant consists primarily of Sunflower oil and Shea butter, and is not compatible with condoms. It is neither a contraceptive nor a spermicide. The formulation is a cream-colored thick paste that melts at body temperature. The product is packaged in a high density polyethylene (HDPE) tube with a flip-top cap.
YES® water-based Personal Lubricant: This non-sterile and water-based personal lubricant contains Aloe vera and other components, and is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. It is neither a contraceptive nor a spermicide. The formulation is a lightly opaque, non-greasy liquid gel. The product is packaged in a HDPE tube with a flip-top cap, and a HDPE single-use applicator.
YES® Vaginal Moisturizer: This non-sterile and water-based personal lubricant contains Aloe vera and other components, and is compatible with natural rubber latex, and polyisoprene condoms. This product is not compatible with polyurethane condoms. It is neither a contraceptive nor a spermicide. The formulation is a lightly opaque, non-greasy liquid gel. The product is packaged in a HDPE tube with a flip-top cap, and a HDPE single-use applicator.
The provided document is a 510(k) premarket notification for personal lubricants. It does not contain information about a study proving a device meets acceptance criteria in the manner requested (e.g., involving AI, human experts, or clinical comparative effectiveness). Instead, it details the acceptance criteria in the form of product specifications for three personal lubricant products and briefly mentions performance testing to demonstrate their safety and effectiveness compared to predicate devices.
Therefore, many of the requested fields cannot be directly answered from this document as they are not applicable to the type of device and study described. However, I can extract the acceptance criteria (product specifications) and the performance testing mentioned for the device.
1. Table of Acceptance Criteria and the Reported Device Performance
The document provides product specifications for each lubricant, which serve as the acceptance criteria. The "Reported Device Performance" refers to the results of the performance testing.
YES® oil-based Personal Lubricant
| Parameter | Acceptance Criteria (Specification) | Reported Device Performance |
|---|---|---|
| Color | Opaque paste | Met (implied by "met all device specifications") |
| Odor | Slight beeswax and/or cocoa odor | Met (implied by "met all device specifications") |
| Viscosity | N/A (not feasible to measure) | N/A |
| Total yeast/mold count | ) | Met (implied by "met all device specifications") |
| Total aerobic mesophilic count | ) | Met (implied by "met all device specifications") |
| Absence of Pathogenic bacteria (Staphylococcus aureus, Candida albicans, gram negative bacteria e.g., Pseudomonas aeruginosa) | Absent in 1g (USP) | Met (implied by "met all device specifications") |
| Biocompatibility (Cytotoxicity) | Non-cytotoxic (ISO 10993-5:2009(R)2014) | Non-cytotoxic |
| Biocompatibility (Vaginal Irritation) | Non-irritating (ISO 10993-10:2010(R)2014) | Non-irritating |
| Biocompatibility (Sensitization) | Non-sensitizing (ISO 10993-10:2010(R)2014) | Non-sensitizing |
| Biocompatibility (Acute Systemic Toxicity) | Non-systemically toxic (ISO 10993-11:2006) | Non-systemically toxic |
| Condom Compatibility (Polyurethane) | Not compatible per ASTM D7661-10 | Not compatible with polyurethane condoms |
| Condom Compatibility (Natural rubber latex, Polyisoprene) | Not compatible (testing not performed) | Not compatible with natural rubber latex or polyisoprene condoms |
| Shelf Life | 9 months, met all device specifications | Met all device specifications for 9 months |
YES® water-based Personal Lubricant
| Parameter | Acceptance Criteria (Specification) | Reported Device Performance |
|---|---|---|
| Color | Opaque gel | Met (implied by "met all device specifications") |
| Odor | Slight-mild, delicate linseed / leather note | Met (implied by "met all device specifications") |
| Viscosity | 2,000 - 20,000 cP | Met (implied by "met all device specifications") |
| pH | 3.70 - 4.50 | Met (implied by "met all device specifications") |
| Osmolality | 100 - 400 mOsm/kg | Met (implied by "met all device specifications") |
| Antimicrobial Effectiveness | At least 2.0 log reduction at 14 days; no increase from 14 days at 28 days; no increase from initial calculated count at 14 and 28 days (USP ) | Met (implied by "met all device specifications") |
| Total yeast/mold count | ) | Met (implied by "met all device specifications") |
| Total aerobic mesophilic count | ) | Met (implied by "met all device specifications") |
| Absence of Pathogenic bacteria (Staphylococcus aureus, Candida albicans, gram negative bacteria e.g., Pseudomonas aeruginosa) | Absent in 1g (USP) | Met (implied by "met all device specifications") |
| Biocompatibility (Cytotoxicity) | Non-cytotoxic (ISO 10993-5:2009(R)2014) | Non-cytotoxic |
| Biocompatibility (Vaginal Irritation) | Non-irritating (ISO 10993-10:2010(R)2014) | Non-irritating |
| Biocompatibility (Sensitization) | Non-sensitizing (ISO 10993-10:2010(R)2014) | Non-sensitizing |
| Biocompatibility (Acute Systemic Toxicity) | Non-systemically toxic (ISO 10993-11:2006) | Non-systemically toxic |
| Condom Compatibility (Natural rubber latex, Polyisoprene) | Compatible per ASTM D7661-10 | Compatible with natural rubber latex and polyisoprene condoms |
| Condom Compatibility (Polyurethane) | Not compatible per ASTM D7661-10 | Not compatible with polyurethane condoms |
| Shelf Life | 9 months, met all device specifications | Met all device specifications for 9 months |
YES® Vaginal Moisturizer
| Parameter | Acceptance Criteria (Specification) | Reported Device Performance |
|---|---|---|
| Color | Opaque gel | Met (implied by "met all device specifications") |
| Odor | Slight-mild, delicate linseed / leather | Met (implied by "met all device specifications") |
| Viscosity | 2,000 - 20,000 cP | Met (implied by "met all device specifications") |
| pH | 3.50 - 4.50 | Met (implied by "met all device specifications") |
| Osmolality | 250 - 400 mOsm/kg | Met (implied by "met all device specifications") |
| Antimicrobial Effectiveness | At least 2.0 log reduction at 14 days; no increase from 14 days at 28 days; no increase from initial calculated count at 14 and 28 days (USP ) | Met (implied by "met all device specifications") |
| Total yeast/mold count | ) | Met (implied by "met all device specifications") |
| Total aerobic mesophilic count | ) | Met (implied by "met all device specifications") |
| Absence of Pathogenic bacteria (Staphylococcus aureus, Candida albicans, gram negative bacteria e.g., Pseudomonas aeruginosa) | Absent in 1g (USP) | Met (implied by "met all device specifications") |
| Biocompatibility (Cytotoxicity) | Non-cytotoxic (ISO 10993-5:2009(R)2014) | Non-cytotoxic |
| Biocompatibility (Vaginal Irritation) | Non-irritating (ISO 10993-10:2010(R)2014) | Non-irritating |
| Biocompatibility (Sensitization) | Non-sensitizing (ISO 10993-10:2010(R)2014) | Non-sensitizing |
| Biocompatibility (Acute Systemic Toxicity) | Non-systemically toxic (ISO 10993-11:2006) | Non-systemically toxic |
| Condom Compatibility (Natural rubber latex, Polyisoprene) | Compatible per ASTM D7661-10 | Compatible with natural rubber latex and polyisoprene condoms |
| Condom Compatibility (Polyurethane) | Not compatible per ASTM D7661-10 | Not compatible with polyurethane condoms |
| Shelf Life | 9 months, met all device specifications | Met all device specifications for 9 months |
Regarding the Study Information:
The document describes performance testing rather than a "study" in the sense of clinical trials or AI model validation. The testing focused on biocompatibility, condom compatibility, and shelf-life/microbial limits.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the document for any of the tests.
- Data Provenance: Not specified, but implied to be laboratory testing conducted by Biotech Lubricants Ltd. or its contracted labs. This would be considered prospective experimental testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not applicable. The "ground truth" for these tests are physical/chemical measurements and biological responses from laboratory assays, not expert consensus on medical images or diagnoses.
- Qualifications of experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study requiring adjudication of expert opinions.
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:
- No, this is not an MRMC comparative effectiveness study, nor does it involve AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this is not an algorithm, but a physical device (lubricant). Performance testing was conducted on the product itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance testing cited standard methodologies and specifications. For example:
- Biocompatibility: ISO 10993 series standards.
- Condom Compatibility: ASTM D7661-10.
- Microbial Limits: USP and USP .
- Antimicrobial Effectiveness: USP .
- These standards define the methods and criteria for evaluating the safety parameters of the device.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning study, so there is no training set.
9. How the ground truth for the training set was established:
- Not applicable. There is no training set or AI model.
§ 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.