(81 days)
The UNIDUS condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)
This condom is made of a natural latex sheath, which completely covers the erect penis with a closely fitted membrane. This condom is straight-walled with a reservoir tip; nominal length 180-mm, nominal width 52-mm, and nominal thickness 0.06mm. It is lubricated with silicone containing one of five flavors (strawberry, mint, vanilla, banana, or chocolate) and cornstarch is used as a dressing material. This condom is designed to conform to established national and international voluntary standards including ASTM D3492 and ISO 4074.
This is a 510(k) premarket notification for a medical device, which generally does not include detailed study reports or acceptance criteria tables in the same way a scientific publication or a PMA would. The purpose of a 510(k) is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to prove safety and effectiveness through extensive new clinical trials.
Based on the provided text, here's what can be extracted and inferred regarding acceptance criteria and supporting information:
1. A table of acceptance criteria and the reported device performance
The document states that the condom is designed to conform to established national and international voluntary standards, specifically ASTM D3492 and ISO 4074. While the document doesn't provide a direct table of acceptance criteria from these standards or the specific reported device performance values against each criterion, it asserts conformance.
For a latex condom, key performance criteria typically covered by these standards include:
- Physical Integrity (Burst Pressure and Volume): To ensure the condom does not break under intended use.
- Dimensions (Length, Width, Thickness): To ensure proper fit.
- Freedom from Holes: To prevent leakage.
- Tensile Properties (Elongation at Break, Tensile Strength): To confirm material strength and elasticity.
- Shelf Life/Stability: To ensure performance over time (though 510(k) typically defers to a separate labeling requirement for expiration dating, as noted in the FDA letter).
Since the submission is an Abbreviated 510(k), it relies on the consensus standards. The "reported device performance" is implicitly stated as "conforming" to these standards.
| Acceptance Criteria (from ASTM D3492 / ISO 4074 - Inferred, not explicitly stated in document) | Reported Device Performance |
|---|---|
| Various physical and mechanical properties (e.g., burst pressure, freedom from holes, dimensions, tensile strength, elongation at break) as specified in ASTM D3492 and ISO 4074. | "This condom is designed to conform to established national and international voluntary standards including ASTM D3492 and ISO 4074." |
| "The design is in conformance with ASTM Latex Condom Standard D3492."
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 does not specify the sample size for any testing, the country of origin of the data, or whether the testing was retrospective or prospective. Such details are typically found in the full test reports referenced by the 510(k), but not included in this summary.
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 question is not applicable to this device submission. This device is a male latex condom, not an AI or diagnostic imaging device that involves expert interpretation or ground truth establishment in that context. The "ground truth" for a condom is its physical performance meeting specified engineering standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is not a study involving human readers or interpretation requiring 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 or diagnostic device that would involve MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device. "Standalone performance" for a condom refers to its physical characteristics and integrity, which are tested against the consensus standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device pertains to its physical and functional properties. These are established through performance testing against recognized national and international consensus standards (ASTM D3492 and ISO 4074). These standards define the acceptable performance parameters (e.g., minimum burst pressure, maximum number of holes allowed per batch).
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning or 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.