(140 days)
The Latex Condom for Men is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
The Latex Condom for Men is a single-use, non-sterile condom made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom is designed to conform to the standards including ASTM D3492 and ISO 4074. The condoms have either a smooth, dotted, or ribbed surface and have a straight walled nipple-end (SWNE) style within ASTM standard specifications D3492 Table 1 requirements, e.g., minimum length 160 mm, maximum width 54mm, and minimum thickness of 30μM.
The provided text describes a 510(k) premarket notification for a medical device: "Latex Condom for Men." This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study proving the device meets individual acceptance criteria through a clinical trial or a multi-reader, multi-case study, which are typical for AI/CADe devices.
Therefore, the requested information elements related to AI/CADe studies (e.g., sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this document as it pertains to a physical medical device (condom) and its regulatory approval based on material and performance standards.
However, I can extract the acceptance criteria and performance data that are presented in the context of this device.
1. A table of acceptance criteria and the reported device performance
The device's performance is demonstrated through adherence to recognized standards and specific physical properties. The acceptance criteria are implicit in the "Specification" column for the physical parameters and explicit in meeting the relevant ISO and ASTM standards.
| Acceptance Criteria (Standard / Parameter) | Reported Device Performance (Latex Condom for Men) |
|---|---|
| Standards Met: | |
| ISO10993-5:2009 for determining cytotoxicity | Acceptance criteria met |
| ISO10993-10:2010 for determining sensitization | Acceptance criteria met |
| ISO10993-11:2006 for determining systemic toxicity | Acceptance criteria met |
| ASTM D3492-16 Standard Specification for Rubber Contraceptives (Male Condoms) | Conforms to standard |
| ISO4074:2015 Natural rubber latex condoms – Requirements and test methods | Conforms to standard |
| Physical Parameters: | |
| Nominal Length | $180 \pm 10$ mm |
| Nominal Width | $52 \pm 2$ mm |
| Nominal Thickness | 0.06 - 0.07 mm |
| Primary Package Material | Aluminum film |
| Lubricant | Silicone oil |
| Dusting | Silicon dioxide |
| Intended Use | Contraception and prophylactic against STDs |
| Application | Single Use |
| Material | Natural rubber latex |
| Color | Natural |
| Packaging Method | Heat-sealing |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "non-clinical tests" but does not specify sample sizes or data provenance for these tests. It indicates the location of the manufacturer (Zhejiang, China) and the correspondent (Shanghai, China).
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 is not applicable as this is not a study requiring expert readers for ground truth determination, but rather laboratory testing against physical and chemical standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. The "tests" mentioned are non-clinical, laboratory-based evaluations of the condom's material properties and physical dimensions against established international standards.
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
This is not applicable. This document is for a physical medical device (condom), not an AI/CADe device that involves human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This document is for a physical medical device (condom), not an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on established international and national standards and specifications for natural rubber latex condoms (e.g., ASTM D3492-16, ISO 4074:2015, ISO10993 series for biocompatibility). The device's physical properties and material safety are evaluated against these objective, quantifiable criteria.
8. The sample size for the training set
This is not applicable. This document is for a physical medical device (condom) and does not involve AI or machine learning algorithms that require training sets.
9. How the ground truth for the training set was established
This is not applicable. This document is for a physical medical device (condom) and does not involve AI or machine learning algorithms that require training sets with associated ground truth.
§ 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.