(220 days)
Lorals are used as a barrier when engaging in oral/anal sex to help reduce the transmission of bodily fluids, harmful pathogens, and sexually transmitted infections.
Lorals are wearable, single-use, natural rubber latex oral dams that are placed over the vagina and/or anus during oral sexual contact. Lorals are designed similar to underwear, with a region that covers the genital region and a waistband to keep the dam in place, all made from natural rubber latex. The dams are available in two designs, Shortie and Bikini, which provide the same coverage of the genital region, but have different waistband heights, based on user preference. Each design is available in 3 different gusset sizes. The dams are scented with vanilla fragrance and are provided in black only.
The provided text describes a 510(k) premarket notification for a medical device called "Lorals," which are oral dams. This submission is for demonstrating substantial equivalence to a predicate device, not for proving an AI device meets acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and study details for an AI device is not applicable to this document.
However, I can extract the information related to the performance testing conducted for the Lorals device, which can be thought of as "acceptance criteria" for a non-AI medical device in the context of demonstrating substantial equivalence.
Here's the relevant information:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Test) | Standard | Reported Device Performance (Outcome) |
|---|---|---|
| Dimensional Testing | ISO 29942:2011 | Results acceptable |
| Tensile Testing and Elongation at Break | ISO 29942:2011 | Results acceptable |
| Tear Resistance and Tearing Force | ISO 29942:2011 | Results acceptable |
| Freedom from Holes and Visual Defects | ISO 29942:2011 | Results acceptable |
| Packaging Integrity Testing | (Implied by ISO 29942:2011 and shelf-life support) | Results acceptable |
| Cytotoxicity | ISO 10993-5:2009 | Results acceptable |
| Irritation Testing | ISO 10993-10:2010 | Results acceptable |
| Sensitization | ISO 10993-10:2010 | Results acceptable |
| Acute Systemic Toxicity | ISO 10993-11:2017 | Results acceptable |
2. Sample size used for the test set and the data provenance:
- Sample size: Not explicitly stated. The document mentions "Performance testing was performed on the subject device per the FDA recognized standard ISO 29942:2011" and similar for biocompatibility. These standards typically specify sample sizes, but the exact numbers used for Lorals are not in this summary.
- Data provenance: Not specified. It's bench testing, so it's not patient data and would be prospective in nature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This relates to a human-in-the-loop or AI evaluation, which is not described for this device. The testing is laboratory-based physical and biocompatibility testing.
4. Adjudication method for the test set:
- Not applicable. This relates to interpretation of clinical data by multiple experts, which is not relevant here.
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:
- Not applicable. This is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI device.
7. The type of ground truth used:
- For physical properties (tensile strength, tear resistance, freedom from holes, dimensions, etc.): Objective measurements defined by the ISO 29942:2011 standard.
- For biocompatibility: Laboratory test results evaluated against the criteria established in the ISO 10993 series of standards.
8. The sample size for the training set:
- Not applicable. This section is for an AI device.
9. How the ground truth for the training set was established:
- Not applicable. This section is for an AI 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.