(157 days)
The Twinlotus or Shield 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 high quality natural rubber latex, which completely covers the penis with a closely fitted membrane. This condom is straight-walled with a reservoir tip ; nominal length 160mm, nominal width 52 +/- 2mm, and nominal thickness 0.07 +/- 0.01mm. It is lubricated with methyl silicone and white carbon black is used as a dressing material. The condom is colored and flavored, and designed to conform to the latest national and international voluntary standards including ISO 4074 、 ISO 10993 and ASTM D3492. The condoms will be offered in a variety of colors and flavors. The condoms also are offered in ribbed and studded configurations.
The provided text describes the 510(k) summary for the "Twinlotus Shields" Male Latex Condom. However, it does not include detailed information regarding the specific acceptance criteria, study design, statistical analysis, or performance results of a study to demonstrate the device meets acceptance criteria.
The document mainly focuses on:
- Device Description: Material, dimensions, lubrication, design features (straight-walled, reservoir tip, colored, flavored, ribbed, studded).
- Intended Use: Contraception and prophylaxis against STDs.
- Technological Characteristics Comparison: Stating it has the same characteristics as the predicate device (Durex condom K032227) and conforms to ASTM D3492 and ISO 4074.
- Substantial Equivalence Statement: Claiming equivalence to the Durex flavored condoms (K032227) in materials and testing.
- FDA Clearance Letter: Confirming the substantial equivalence determination.
Therefore, most of the information requested in your prompt is not present in the provided text. I can only report what is explicitly stated or strongly implied.
Here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document states: "The design is in conformance with ASTM D3492 and ISO 4074." and "The Dalian twinlotus and shield condoms are of the same materials, have undergone the same testing and are substantially equivalent to the Durex flavored condoms, K032227."
This implies that the acceptance criteria are the requirements set forth in ASTM D3492 (Standard Specification for Male Latex Condoms) and ISO 4074 (Natural latex rubber condoms — Requirements and test methods). However, the document does not list the specific performance metrics or the actual reported device performance against these standards (e.g., burst pressure, freedom from holes, dimensions, etc.). It only states that the device conforms to them and passed the same testing as the predicate.
| Acceptance Criteria (Implied by standards cited) | Reported Device Performance |
|---|---|
| Conformance to ASTM D3492 | Conforms to ASTM D3492 |
| Conformance to ISO 4074 | Conforms to ISO 4074 |
| Same testing as predicate (K032227) | Undergone same testing |
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 text.
- Data Provenance: Not specified. The device submitter is Dalian Latex Company, LTD. from Dalian City, Liaoning Province, China. Whether the testing data originates from China or elsewhere is not stated, nor is whether the study was retrospective or prospective.
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 information is not applicable and not provided for a condom's performance testing. The "ground truth" for a physical device like a condom would typically be objective measurements against engineering standards (e.g., burst volume, tensile strength, physical dimensions), not expert human interpretation like in medical imaging.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/not provided. This refers to consensus methods for expert-driven ground truth establishment, which is not relevant for the type of testing implied for a condom.
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 a medical imaging concept and not relevant to the performance assessment of a latex condom.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This refers to AI algorithm performance and is not relevant to a latex condom.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For a device like a latex condom, the "ground truth" would be established through objective, standardized physical and chemical testing as defined by the cited standards (ASTM D3492, ISO 4074). This would include measurements of dimensions, burst properties, freedom from holes, lubricant integrity, biocompatibility, etc. It is not expert consensus, pathology, or outcomes data in the medical sense.
8. The sample size for the training set
- Not applicable. There is no mention of machine learning or an AI algorithm that would require a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set for an AI algorithm is mentioned or relevant.
§ 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.