(46 days)
The Thai Nippon condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and 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-walled with a reservoir tip; nominal length 180-mm, nominal width 52-mm, and nominal thickness 0.06mm. The condom is offered in natural latex color, red, blue, green, and yellow.
The provided text is a 510(k) Summary for a Male Latex Condom and a subsequent FDA clearance letter. It is not a study report for a device using AI, statistical analysis, or comparison metrics like sensitivity, specificity, or AUC, which are typically found in studies with acceptance criteria, sample sizes, and expert ground truth.
Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, experts, and adjudication methods is not available in the provided document.
Here's what can be extracted based on the nature of the document:
1. A table of acceptance criteria and the reported device performance
The document states that the device's design is in conformance with ASTM Latex Condom Standard D3492. This standard sets the acceptance criteria for these types of devices. The reported device performance is presented as a direct comparison of technological characteristics to a predicate device, implying that the new device meets or is equivalent to the predicate's performance, which is presumably compliant with the ASTM standard.
| Acceptance Criteria (Implied by conformance to ASTM D3492) | Reported Device Performance (Table comparing to Predicate) |
|---|---|
| Length (mm): (Defined by ASTM D3492) | Length (mm): 180 (matches predicate) |
| Width (mm): (Defined by ASTM D3492) | Width (mm): 52 (matches predicate) |
| Thickness (mm): Min. (Defined by ASTM D3492) | Thickness (mm): 0.03 min. (matches predicate) |
| Lubricant System: (Defined by ASTM D3492, if applicable) | Lubricant System: Silicone (matches predicate) |
| Reservoir Tip: (Defined by ASTM D3492, if applicable) | Reservoir Tip: Yes (matches predicate) |
Note: The specific numerical acceptance criteria (e.g., minimum burst pressure, maximum pinhole rate) detailed in ASTM D3492 are not explicitly listed in this document but are the underlying performance requirements the device is claiming to meet.
2. Sample size used for the test set and the data provenance
- Sample size: Not specified in the provided documents. The document describes the device and its intended use, along with a comparison to a predicate device, but does not include details of testing methodologies or sample sizes for performance evaluation.
- Data provenance: Not applicable in the context of this 510(k) summary, as it's not a clinical study report with patient data. The device itself is manufactured by Thai Nippon Rubber Industry, Ltd. in Thailand.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This is a submission for a medical device (condom) and does not involve expert interpretation or ground truth establishment in the way an AI diagnostic device would. Compliance with standards and physical properties are the primary evaluation methods.
4. Adjudication method for the test set
- Not applicable. No expert adjudication method is described.
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 not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI algorithm.
7. The type of ground truth used
- The "ground truth" for this device's performance is its physical properties (length, width, thickness, presence of lubricant, reservoir tip) and its ability to conform to established industry standards like ASTM D3492, which includes performance requirements such as burst volume/pressure and freedom from holes. These are typically verified through laboratory testing and quality control processes.
8. The sample size for the training set
- Not applicable. This device does not involve a "training set" like an AI model.
9. How the ground truth for the training set was established
- Not applicable.
§ 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.