(60 days)
The Trojan Supra Lubricated Polyurethane Male Condom is intended to prevent pregnancy, HIV/AIDS, and other sexually transmitted infections.
The TROJAN SUPRA™ Lubricated Polyurethane Condom is a male condom consisting of a sheath of polyurethane with a lubricated coating. The condom is a straight-walled, non-textured, nipple-end condom with a nominal length of 190 mm and a nominal flatwidth of 58 mm. This product has a 5-year shelf-life.
The provided text describes a 510(k) submission for a male condom, which is a Class II medical device. The submission focuses on a change to the device's labeling regarding personal lubricant compatibility. This type of device and submission does not fit the typical framework of AI/ML-driven diagnostic devices that would have the requested "acceptance criteria" and "study" details (e.g., test sets, ground truth, expert opinions, MRMC studies).
The information provided pertains to the regulatory review of a medical device (a condom) and its safety and effectiveness. The "performance testing" described is related to the physical properties of the condom and its compatibility with lubricants, not the diagnostic accuracy of an AI algorithm.
Therefore, many of the requested fields cannot be answered from the provided text as they are not applicable to this type of device and submission.
Here's an attempt to answer the applicable parts based on the input:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail table format as one might see for an AI algorithm's performance metrics (e.g., sensitivity, specificity). Instead, it implicitly refers to adherence to standards for condom performance. The primary "performance testing" mentioned is for lubricant compatibility.
| Acceptance Criteria (Implicit from standards/predicate device) | Reported Device Performance (Subject Device) |
|---|---|
| Burst volume (expected to be similar to predicate) | 9.4 dm³ |
| Burst pressure (expected to be similar to predicate) | 10.31 kPa |
| Compatibility with cleared personal lubricants | Results did not support all personal lubricants are compatible; permissible with FDA-cleared lubricants labeled for polyurethane condoms. |
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not explicitly stated. The document mentions "Condom compatibility testing was performed on Polyurethane condoms (subject device) with current commercial lubricant per ASTM D7661-10." The ASTM standard, if referenced, would contain details on sample size, but it's not provided here.
- Data provenance: Not explicitly stated. Likely laboratory testing of manufactured condoms.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable and not provided. The testing relates to physical properties (burst, lubricant compatibility) measured against an ASTM standard, not interpretation by human experts.
4. Adjudication method for the test set:
Not applicable and not provided. The testing involves physical measurements, not expert review or 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:
Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI algorithm.
7. The type of ground truth used:
The "ground truth" here would be defined by the physical specifications and performance requirements for condoms as established in standards (e.g., ASTM D7661-10) and regulatory guidelines, rather than expert consensus, pathology, or outcomes data in the context of diagnostic algorithms.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/ML device 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.