(63 days)
The JUD custom fit condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
The JUD custom fit condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The condom is shaped with a reservoir end and is flat with a cylindrical shape. JUD custom fit condoms are available in 23 sizes of different length/width combinations. There is a fitting kit and instructions included as part of safe and effective usage of the condom.
JUD custom fit condoms are provided pre-lubricated with a silicone-based lubricant. JUD custom fit condoms are not provided with spermicide, and contain no flavors or color additives. The user must use a fitting kit to select the appropriate size of the JUD custom fit condom.
The document describes the JUD custom fit condom and its clearance via a 510(k) premarket notification. The study primarily relies on nonclinical bench testing and biocompatibility testing to demonstrate substantial equivalence to predicate devices, rather than a clinical study evaluating human-AI interaction or diagnostic accuracy.
Here's an breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test Description | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensional | ISO 4074:2015 | Acceptance criteria met; dimensions conform to standards. |
| Lubricant Quantity | ISO 4074:2015 | Acceptance criteria met. |
| Burst Volume and Pressure | ISO 4074:2015 | Acceptance criteria met; conform to standards. |
| Freedom from Holes and Visible Defects | ISO 4074:2015 | Acceptance criteria met; no visible defects identified. |
| Package Seal Integrity | ISO 4074:2015 | Acceptance criteria met; no damaged package seal identified. |
| Shelf Life | Maintain specifications for 5 years | Each condom variant maintained specifications for 5 years. |
| Cytotoxicity | ISO 10993-5:2009 | No cytotoxic reactivity found. |
| Acute Systemic Toxicity | ISO 10993-11:2006 | No mortality or evidence of systemic toxicity. |
| Vaginal Irritation | ISO 10993-10:2010 | Non-irritating; no signs of vaginal irritation. |
| Skin Sensitization | ISO 10993-10:2010 | Did not induce skin sensitization. |
While not explicitly called "acceptance criteria" in the text, the "Summary and Conclusion" column effectively reports that the device met the requirements of the specified ISO standards, which represent the acceptance criteria for these tests.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to "tested samples" for bench testing and a "single condom variant" for biocompatibility testing. Specific sample sizes are not provided in the excerpt for any of the nonclinical tests. The data provenance (country of origin, retrospective/prospective) is also not specified, though the manufacturer is located in Malaysia.
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)
This is not applicable as the evaluation relies on objective bench testing and biocompatibility rather than expert interpretation of a test set related to medical imaging or diagnostics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the type of testing described (bench and biocompatibility).
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 MRMC comparative effectiveness study was performed or described. This device is a condom, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the device is a medical device (condom) and not an algorithm or AI system. The testing performed was standalone for the device itself (e.g., burst pressure of the condom).
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the bench tests was adherence to established international standards (ISO 4074:2015 and WHO 2010) for physical properties. For biocompatibility, the ground truth was biological response in animal models or in-vitro tests as defined by ISO 10993 series standards.
8. The sample size for the training set
This is not applicable as the device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable as the device is not an AI/ML algorithm that requires a 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.