(79 days)
Coconut Infused Hybrid Personal Lubricant is a water-based personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Coconut Infused Hybrid Personal Lubricant is a translucent cream, white to off-white in color, semi-viscous personal lubricant that is compatible with condoms made of natural rubber latex and polyisoprene. This device is not compatible with polyurethane condoms. This device is a non-sterile personal lubricant for penile, anal and/or vaginal application, to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is provided in clear, Polyethylene Terephthalate (PET) cylinder bottles. The 1 oz. size bottles are capped with natural disc top dispenser caps and the 4 oz. size bottles are capped with silver disc top dispenser caps. The individual bottles are hermetically sealed during the production process. This product is also available in polyester-faced laminated pouches.
The provided text is a 510(k) summary for a medical device (Coconut Infused Hybrid Personal Lubricant). It describes the device, its indications for use, comparison to a predicate device, and a summary of performance data.
However, the questions you've asked are typically related to the performance evaluation of a diagnostic or AI-powered medical device, which would involve metrics like accuracy, sensitivity, specificity, and studies with human readers or standalone algorithm performance.
The provided document describes a personal lubricant, which is a Class II medical device, and the "performance data" presented focuses on biocompatibility, shelf-life, and condom compatibility. These are very different types of evaluations than what your questions imply.
Therefore, I cannot extract the information you've requested regarding acceptance criteria and study details as they pertain to diagnostic performance, MRMC studies, or ground truth establishment in the context of an AI/diagnostic device.
Here's why I cannot answer your questions with the provided text:
- No Diagnostic Acceptance Criteria: The document does not define acceptance criteria in terms of diagnostic performance metrics (e.g., sensitivity, specificity, AUC). Instead, it focuses on physical and chemical specifications, biocompatibility, and compatibility with other products (condoms).
- No Device Performance Metrics: There are no reported device performance metrics like sensitivity, specificity, or accuracy that would be relevant to diagnosing a condition or aiding in image interpretation.
- No Test Set/Ground Truth: The concept of a "test set" with "ground truth" established by experts is not applicable to a personal lubricant. The "ground truth" here is determined by chemical and biological testing results against established standards.
- No Experts/Adjudication Method: The studies described (biocompatibility, shelf-life, condom compatibility) do not involve human experts establishing ground truth or adjudication methods.
- No MRMC or Standalone Studies: These types of studies are for evaluating diagnostic accuracy or reader improvement with AI assistance, which is irrelevant for a personal lubricant.
- No Training Set: The processes involved in developing a personal lubricant do not include "training sets" in the machine learning sense.
Instead, the document details the following performance and acceptance criteria relevant to a personal lubricant:
1. Table of Acceptance Criteria and Reported Device Performance (as per the document):
| Property | Acceptance Criteria (Specification) | Reported Device Performance (as met) |
|---|---|---|
| Appearance | Translucent, semi-viscous cream | Translucent, semi-viscous cream |
| Color | White to off-white | White to off-white |
| Odor | Odorless | Odorless |
| Viscosity (cps) | 20,000 cps to 31,000 cps | Within range (implied, as device 'met specifications at all time points' for shelf-life study) |
| pH | 5.7 to 6.30 | Within range (implied, as device 'met specifications at all time points' for shelf-life study) |
| Specific Gravity | 0.930 to 1.010 | Within range (implied, as device 'met specifications at all time points' for shelf-life study) |
| Osmolality | 450 to 900 mOsm/kg | Within range (implied, as device 'met specifications at all time points' for shelf-life study) |
| Antimicrobial effectiveness per USP | Meets US acceptance criteria for Category 2 products | Met USP acceptance criteria for Category 2 products |
| Total aerobic microbial count (TAMC) per USP & | Less than 10 cfu/g | Less than 10 cfu/g |
| Total yeast and mold count (TYMC) per USP & | Less than 10 cfu/g | Less than 10 cfu/g |
| **Presence of Pathogens per USP ** | Specification (Absent) | Reported Performance (Absent) |
| Pseudomonas aeruginosa | Absent | Absent |
| Staphylococcus aureus | Absent | Absent |
| Salmonella/Shigella | Absent | Absent |
| Escherichia coli | Absent | Absent |
| Candida Albicans | Absent | Absent |
| Biocompatibility (Cytotoxicity) | Non-cytotoxic (ISO 10993-5:2009) | Non-cytotoxic |
| Biocompatibility (Sensitization) | Non-sensitizing (ISO 10993-10:2010) | Non-sensitizing |
| Biocompatibility (Vaginal Irritation) | Non-irritating (ISO 10993-10:2010) | Non-irritating |
| Biocompatibility (Penile Irritation) | Non-irritating (ISO 10993-10:2010) | Non-irritating |
| Biocompatibility (Acute Systemic Toxicity) | Non-systemically toxic (ISO 10993-11:2006) | Non-systemically toxic |
| Condom Compatibility | Compatible with natural rubber latex and polyisoprene condoms; not compatible with polyurethane condoms (ASTM D7661-10) | Compatible with natural rubber latex and polyisoprene condoms; not compatible with polyurethane condoms |
| Shelf-Life | 3 years (maintaining all device specifications) | Met device specifications at 0, 1, 2, and 3 years in a real-time aging study, demonstrating a 3-year shelf-life. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable in the diagnostic sense. The "test sets" here refer to samples of the lubricant product used in laboratory testing for physical properties, microbiological counts, biocompatibility (animal or in-vitro models), and condom compatibility.
- Provenance: Not specified in terms of country of origin. The studies are performed "in accordance with" international and FDA guidance documents (e.g., ISO, USP, ASTM).
- Nature: These are likely prospective laboratory tests performed on samples of the manufactured device.
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)
- Not applicable. The ground truth for this device is established by standardized laboratory tests and their results, not expert consensus in a clinical diagnostic sense. The expertise lies in the laboratory technicians and scientists performing and interpreting these standardized tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are used to reconcile disagreements among human readers/experts, which is not part of this type of device testing.
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 a personal lubricant, not an AI-powered diagnostic device. MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, this is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device is based on standardized laboratory test results and adherence to established international and national standards (e.g., ISO 10993 for biocompatibility, USP , , , for microbiological quality, ASTM D7661-10 for condom compatibility).
8. The sample size for the training set
- Not applicable. There is no training set in the context of machine learning for this device.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set.
§ 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.