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510(k) Data Aggregation
(203 days)
A.P.DEAUVILLE, LLC.
The Power Stick Male Latex Condom is used for controptive fic fower belen cric purposes (to help prevent pregnancy and for prophylaction of sexually transmitted diseases).
This condom is made of a natural latex sheath, which completely covers the penis with a closely fitted membrane. These two types of condoms, ribbed and dotted-ribbed, are at a nominal length of 170mm., a nominal width of 52 mm (±2mm) and are at a nominal thickness of .06 mm (±.02 mm).
The provided text describes a 510(k) premarket notification for a male latex condom device, not an AI/ML powered device. Therefore, the information typically requested for AI/ML device studies (such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance) is not applicable or present in this document.
The document focuses on demonstrating substantial equivalence to a predicate device by conforming to established standards for male latex condoms.
Here's an analysis based on the provided text, using the closest applicable information:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from recognized standards) | Reported Device Performance |
|---|---|
| Conformance with ASTM Latex Condom Standard D3492 | "This design is in conformance with ASTM Latex Condom Standard D3492" and "All physical testing and final release testing revealed in conformance with required specifications." |
| Conformance with ISO 4074 | "The condom design conforms to domestic and international regulations: ASTM D3942, ISO 4074 and EN 600." |
| Conformance with EN 600 | "The condom design conforms to domestic and international regulations: ASTM D3942, ISO 4074 and EN 600." |
| Nominal Length: 170mm | Reported as "a nominal length of 170mm." |
| Nominal Width: 52 mm (±2mm) | Reported as "a nominal width of 52 mm (±2mm)" |
| Nominal Thickness: .06 mm (±.02 mm) | Reported as "are at a nominal thickness of .06 mm (±.02 mm)." |
| Same intended use as predicate device (K040185) | "This latex condom has the same intended use as the predicate condom. The condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)." This is an "Indications For Use" statement, not a performance metric directly, but implies the device is expected to meet the same functional criteria as the predicate. |
| Same technological characteristics as predicate device (K040185) | "The condom is made of natural rubber latex and has the same technological characteristics as the predicate condoms identified [510(k) Number K040185]. The condoms described in K040185 are manufactured ribbed and dotted/ribbed Natural Rubber Latex male condoms with a silicone lubricant." This is a descriptive statement, which, paired with the conformance to standards, implies the device performs equivalently to the predicate. |
Study Information (as applicable to a physical device/510(k))
- Sample size used for the test set and the data provenance: Not explicitly stated. The document refers to "All physical testing and final release testing," which implies that a sample of manufactured condoms would have been tested against the specified standards. The provenance of this testing data (e.g., in-house testing by the manufacturer or third-party lab) is not specified.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For a physical device like a condom, "ground truth" is established by physical measurement and testing against international and domestic standards, not by expert consensus in an observational or diagnostic context.
- Adjudication method for the test set: Not applicable. The testing would involve objective measurements (e.g., length, width, thickness, burst pressure tests as per standards) rather than subjective interpretation requiring adjudication.
- 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 a physical medical device, not an AI/ML diagnostic or assistive technology.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
- The type of ground truth used: The "ground truth" for this device's performance would be the specifications outlined in the referenced standards (ASTM D3492, ISO 4074, EN 600) and the device's own design specifications (e.g., nominal length, width, thickness). These standards define acceptable ranges for various physical properties and performance characteristics (e.g., integrity under stress, lubricity).
- The sample size for the training set: Not applicable. There is no "training set" in the context of a physical device like a condom. Manufacturing processes are refined through engineering and quality control, not machine learning training.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a 510(k) submission for a conventional male latex condom, demonstrating conformance to recognized standards for physical devices. It does not contain the types of studies or data relevant to AI/ML powered devices.
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