(65 days)
The NRS Global Partners male latex 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 sided, contoured or flared in shape, either textured or non-textured, with a reservoir tip; nominal length 180-mm, nominal width 53-mm, and nominal thickness 0.07mm. It is lubricated with silicone or Astroglide™, and USP grade 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 condom is identical to the predicate device with respect to design, physical properties, and formulation.
The provided document is a 510(k) premarket notification for a male latex condom. It is a regulatory submission for a medical device and, therefore, does not contain information about a clinical study with acceptance criteria, device performance, sample sizes, expert ground truth, or MRMC studies in the context of AI/algorithm performance.
Instead, the submission aims to demonstrate "substantial equivalence" to a legally marketed predicate device (Innolatex Male Latex Condom; K002393). This typically involves showing that the new device has the same intended use and technological characteristics as the predicate device, and that any differences do not raise new questions of safety or effectiveness.
The "acceptance criteria" in this context would generally refer to the standards that the condom must meet (e.g., burst strength, freedom from holes) to be considered safe and effective, as outlined in recognized national and international voluntary standards like ASTM D3492 and ISO 4074. The "device performance" would be the results of testing conducted against these standards.
Here's how to interpret the request in the context of this document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "This condom is designed to conform to established national and international voluntary standards including ASTM D3492 and ISO 4074." and "The design is in conformance with ASTM Latex Condom Standard D3492 and that the condom is made of natural rubber latex."
This indicates that the acceptance criteria are defined by these standards. However, the specific quantitative pass/fail criteria (e.g., minimum burst volume, maximum number of holes per batch) and the actual test results (reported device performance) are not provided in this summary document. Such data would typically be found in the full 510(k) submission, not in the summary or the FDA's decision letter.
2. Sample Sizes Used for the Test Set and Data Provenance:
Not applicable in the context of an AI/algorithm study. The document only references conformance to standards, which would involve testing batches of condoms. No details are given about the number of condoms tested or their origin.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. This is not a study involving expert annotation or ground truth generation in the way an AI study would.
4. Adjudication Method:
Not applicable.
5. MRMC Comparative Effectiveness Study:
Not applicable. This is not an AI-assisted diagnostic device.
6. Standalone (Algorithm Only) Performance:
Not applicable. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used:
For a latex condom, "ground truth" would be established through physical and mechanical testing against predefined standards (e.g., burst tests, leak tests, dimensional measurements, shelf-life studies). The document implies that such testing was done ("conformance with ASTM Latex Condom Standard D3492"), but does not detail the specific results or the methodology for establishing the "truth" beyond adherence to these standards.
8. Sample Size for the Training Set:
Not applicable. Condoms are not "trained" in the AI sense. The manufacturing process is validated and controlled, and batches are tested for quality.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
Summary based on the provided text:
The document states that the male latex condom is designed to conform to and is in conformance with ASTM D3492 and ISO 4074 voluntary standards. These standards define the acceptance criteria for various physical and mechanical properties of latex condoms (e.g., burst volume and pressure, dimensions, freedom from holes). However, the specific quantitative "acceptance criteria" from these standards and the "reported device performance" (i.e., the actual test results demonstrating conformance) are not detailed in this 510(k) summary. The submission's core assertion is that the device is "identical to the predicate device with respect to design, physical properties, and formulation," implying that its performance would be substantially equivalent and therefore also conform to these established standards.
§ 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.