(326 days)
The Richter Male Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)
This condom is made of a natural rubber latex sheath, which completely covers the erect penis with a closely fitted membrane. This condom is colorless, non flavored, non scented; straight walled with a reservoir tip. The nominal length is 185 mm, nominal width, 54 mm and nominal thickness 0.07mm. It is lubricated with silicone (viscosity 250 cps), and cornstarch is used as a dressing material. This condom conforms to current established national and international voluntary standards including ASTM D3492 and ISO 4074.
The provided document is a 510(k) premarket notification for a male latex condom. It describes the device, its intended use, and its conformance to established standards. However, it does not include a study that proves the device meets specific acceptance criteria with detailed performance metrics, sample sizes, ground truth establishment, or comparative effectiveness studies.
Instead, the document states: "This condom conforms to current established national and international voluntary standards including ASTM D3492 and ISO 4074." It also mentions: "This condom has the same technological characteristics as the predicate condoms identified above. It is made from natural rubber latex and the design is in conformance with ASTM D3492 and ISO 4074 Male Latex Condom Standards."
Therefore, based solely on the provided text, I cannot complete a table of acceptance criteria with reported device performance or answer most of the specific questions about a study, as the detailed study data is not present in this document.
However, I can infer the acceptance criteria based on the referenced standards. For the purpose of answering your request, I will interpret the conformance to ASTM D3492 and ISO 4074 as the acceptance criteria, and the statement of conformance as the "reported device performance."
Here's the closest possible answer based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from ASTM D3492 & ISO 4074)* | Reported Device Performance |
|---|---|
| Physical Dimensions: | Conforms to ASTM D3492 & ISO 4074 |
| - Nominal Width | |
| - Nominal Length | |
| - Thickness | |
| Burst Properties (Volume and Pressure): | Conforms to ASTM D3492 & ISO 4074 |
| - Before aging | |
| - After accelerated aging | |
| Freedom from Holes (Water Leak Test): | Conforms to ASTM D3492 & ISO 4074 |
| Tensile Properties: | Conforms to ASTM D3492 & ISO 4074 |
| - Tensile Strength | |
| - Elongation at Break | |
| Package Integrity: | Conforms to ASTM D3492 & ISO 4074 |
| Labeling Requirements: | Conforms to ASTM D3492 & ISO 4074 |
Note: The specific numerical values for each criterion are detailed within ASTM D3492 and ISO 4074, which are not included in this document. The document only states conformance to these standards, implying that the device meets all their stipulated requirements.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided document. Testing under ASTM D3492 and ISO 4074 would involve specific sampling plans, but these details are absent.
- Data Provenance: Not specified. The manufacturer is Richter Rubber Technology SBN BHD, Malaysia. It is plausible that testing took place in Malaysia or a contracted lab. The document does not state if the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not specified. For condom testing as per ASTM/ISO standards, ground truth is established by objective physical and mechanical measurements according to specified test methods, not by expert consensus (e.g., radiologists).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/None. Performance is determined by objective measurements against predefined thresholds in the standards directly, not through adjudication of expert opinions.
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 device is a physical product (male latex condom), not an AI-powered diagnostic tool, so an MRMC comparative effectiveness study is irrelevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth is established by objective, standardized physical and mechanical test methods and measurements as defined in ASTM D3492 and ISO 4074. For example, for "burst volume," the ground truth is the measured volume of air the condom can contain before bursting under specific conditions.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/machine learning 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.