(57 days)
The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections).
This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This device is smooth surfaced, straight-walled, teat-ended, silicone lubricated condom with minimum length 160mm, maximum width 54mm, and minimum thickness of 30μm as required by ASTM Standard D3492.
The provided text describes a 510(k) premarket notification for a new condom product, OKAMOTO ULTRA THIN Male Natural Latex Condom. However, it does not contain a detailed study report with specific acceptance criteria, sample sizes for test or training sets, ground truth establishment, or multi-reader multi-case studies as requested in the prompt.
The document primarily focuses on demonstrating substantial equivalence to existing predicate devices based on technological characteristics and adherence to ASTM standards for condom manufacturing.
Here's a breakdown of what can be extracted and what information is missing based on your request:
1. A table of acceptance criteria and the reported device performance
The document states the device's design is in conformance with ASTM Standard D3492-03 Specification for Rubber Contraceptives (Male Condoms). While the specific acceptance criteria from this standard are not explicitly listed in the text, the document implies that the device performance meets these standards.
The key performance characteristic mentioned for the new device is:
- Nominal thickness: 0.04 +/- 0.01 mm
For predicate devices, the nominal thickness was 0.05 +/- 0.01 mm.
Missing Information: The explicit breakdown of all acceptance criteria from ASTM Standard D3492-03 (e.g., burst pressure, freedom from holes, dimensions, etc.) and the precise reported performance values for each of these criteria for the OKAMOTO ULTRA THIN condom are not present in this document.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Missing Information: The document does not specify any sample size for a test set, nor does it describe data provenance (country of origin, retrospective/prospective). This type of detail would typically be found in a more comprehensive testing report.
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)
Missing Information: This information is not applicable and therefore not present. The device is a physical product (condom), and its performance is evaluated against engineering standards rather than expert-established ground truth like in medical imaging.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Missing Information: Not applicable. Performance testing for condoms against ASTM standards does not typically involve adjudication methods like those used for expert consensus in medical diagnostics.
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
Missing Information: This type of study is entirely irrelevant to a physical product like a condom and is therefore not present. It's a concept used for AI-assisted diagnostic tools.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Missing Information: This is also irrelevant to a physical product and is not present.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance would be the objective measurements taken on the condoms themselves against the specifications defined in ASTM Standard D3492-03. This standard outlines various tests (e.g., burst tests, visual inspections for holes,
dimensional measurements) and acceptable limits.
8. The sample size for the training set
Missing Information: This is not applicable to the development of a physical product like a condom. There is no "training set" in the context of an AI/algorithm. The "training" in manufacturing would relate to process control and quality assurance, not a dataset for an algorithm.
9. How the ground truth for the training set was established
Missing Information: Not applicable for the reasons stated above.
In summary, the provided text is a regulatory submission for premarket clearance of a physical medical device (condom) and therefore does not contain the types of information (AI study data, expert consensus, MRMC studies) that would be relevant for software/AI-based diagnostic devices. The "study" referenced implicitly is the adherence to the ASTM standard for condom manufacturing and performance.
§ 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.