(90 days)
Mano and Mano Personal Lubricant is a water-based personal lubricant, for penile 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 not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
Mano and Mano Personal Lubricant (additionally branded as Nooky, Hello Sailor, or Lulu) is a clear, colorless, water-based personal lubricant composed of purified water, propylene glycol, hydroxethyl cellulose, sodium pyrrolidone carboxylic acid, potassium sorbate and citric acid.
The provided document is a 510(k) premarket notification for a medical device: "Mano and Mano Personal Lubricant". It focuses on establishing substantial equivalence to a predicate device through bench testing and biocompatibility.
Based on the document, here's an analysis against your requested information:
This document does NOT describe the type of study where an AI/algorithm's performance is tested against established ground truths, involving human experts, and a multi-reader, multi-case study. The device is a personal lubricant, not an AI or diagnostic imaging device. Therefore, many of your requested points are not applicable to this type of medical device submission.
However, I can extract information related to the performance data and "acceptance criteria" presented for this specific product.
Acceptance Criteria and Reported Device Performance (Bench Testing & Biocompatibility)
The "Performance Data" section details several bench tests and biocompatibility tests. For these, the "acceptance criteria" are the "Specifications" listed in the table and the "passed" declarations for biocompatibility.
1. A Table of Acceptance Criteria and the Reported Device Performance
| Criteria | Specifications (Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Appearance | Not explicitly stated in the table, but described as "clear, colorless" for both subject and predicate device. Implied to be met. | Met (implied, as "the subject device met the physical specifications (appearance...)") |
| pH | Not explicitly stated in the table, but considered a "physical specification." | Met (implied, as "the subject device met the physical specifications (ph...)") |
| Viscosity | Not explicitly stated in the table, but considered a "physical specification." | Met (implied, as "the subject device met the physical specifications (viscosity...)") |
| Osmolality | Not explicitly stated in the table, but considered a "physical specification." | Met (implied, as "the subject device met the physical specifications (osmolality...)") |
| Total Aerobic Microbial Count | ≤100 cfu/g | Met (Implied, as "demonstrated that the subject device met...microbiology specifications") |
| Total Yeast and Mold Count | ≤10 cfu/g | Met (Implied, as "demonstrated that the subject device met...microbiology specifications") |
| Absence of Pathogenic Organisms | Absence of pseudomonas aeruginosa, staphylococcus aureus, and candida albicans | Met (Implied, as "demonstrated that the subject device met...microbiology specifications") |
| Antimicrobial Effectiveness | At least 2.0 log reduction from the initial count at 14 days; no increase from the 14 days count at 28 days; no increase from the initial calculated count at 14 and 28 days | Met (Implied, as "demonstrated that the subject device met...microbiology specifications") |
| Shelf-life (stability) | Maintenance of all physical and microbiology specifications at the end of the shelf-life period. (Initial shelf-life of 10 months, to be extended later). | Met ("Shelf-life (stability) testing...demonstrated that the subject device maintained all physical and microbiology specifications at the end of shelf-life period.") |
| Biocompatibility: Cytotoxicity | Compliance with ISO 10993-5:2009 standards (specific criteria not detailed in this summary, but implied by "passed") | Passed ("The subject device has passed the following biocompatibility testing...") |
| Biocompatibility: Sensitization | Compliance with ISO 10993-10:2010 standards (specific criteria not detailed in this summary, but implied by "passed") | Passed ("The subject device has passed the following biocompatibility testing...") |
| Biocompatibility: Irritation | Compliance with ISO 10993-10:2010 standards (specific criteria not detailed in this summary, but implied by "passed") | Passed ("The subject device has passed the following biocompatibility testing...") |
| Biocompatibility: Acute Systemic Toxicity | Compliance with ISO 10993-11:2006 standards (specific criteria not detailed in this summary, but implied by "passed") | Passed ("The subject device has passed the following biocompatibility testing...") |
Regarding the AI/Algorithm specific questions (most are Not Applicable to this device):
2. Sample sized used for the test set and the data provenance:
- For physical and microbiology tests: The sample size is not explicitly stated in this summary. It would be typical for these tests to use a number of batches or samples as per the test methodologies (USP and ISO standards).
- Data Provenance: Not specified, but generally refers to in-house or third-party laboratory testing. The document states "Shelf-life (stability) testing conducted by a third-party laboratory".
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This applies to expert-driven evaluations, such as reading medical images. For a personal lubricant, "ground truth" is established by laboratory measurements against defined standards (e.g., USP monographs, ISO standards). The "experts" are the lab technicians and chemists performing and interpreting these standardized tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. This refers to consensus building among human readers for diagnostic studies. Lab tests follow pre-defined analytical methods, not adjudication.
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:
- N/A. This is irrelevant for a personal lubricant. It pertains to AI-assisted diagnostic tools.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This does not apply to this product. Standalone performance refers to AI algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Laboratory Standards and Measurements: For this device, the "ground truth" for its performance is derived from quantitative measurements and qualitative observations made according to established United States Pharmacopeia (USP) monographs and International Organization for Standardization (ISO) standards for microbiological, chemical, and biocompatibility properties.
8. The sample size for the training set:
- N/A. There is no "training set" in the context of this device. This concept applies to machine learning models.
9. How the ground truth for the training set was established:
- N/A. Not applicable, as there is no training set for this device.
§ 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.