(245 days)
The Invigra Condom is used for contraception and for prophylactic purposes. Invigra Condoms when properly used are highly effective against pregnancy and will help to reduce the risk of transmission of HIV infection (AIDS) and many other Sexually Transmitted Diseases (STD), including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B and syphilis. No contraceptive can guarantee 100% effectiveness although condoms are highly effective when properly used.
Invigara Male Latex Condom, Lubricated and Black Colored
This document is a 510(k) clearance letter from the FDA for a medical device: "Invigra Male Latex Condom, Lubricated and Black Colored." As such, it does not describe a study involving an algorithm or AI. The document primarily confirms substantial equivalence to a predicate device and outlines regulatory requirements for condom labeling and manufacturing.
Therefore, many of the requested details about acceptance criteria, device performance, study design, expert involvement, and ground truth are not applicable to this type of regulatory document.
However, I can extract the following relevant information:
- Device Name: Invigra Male Natural Rubber Latex Condom
- Indications for Use: Contraception and prophylactic purposes (reducing the risk of transmission of HIV infection (AIDS) and many other Sexually Transmitted Diseases (STD), including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis).
- Regulatory Class: Class II
- Product Code: 85 HIS
- Regulation Number: 21 CFR 884.5300 (Condom)
Regarding "Acceptance Criteria" and "Reported Device Performance":
For a condom, "acceptance criteria" and "device performance" are typically defined by performance standards that relate to physical properties like burst volume, burst pressure, tensile strength, and freedom from holes, rather than AI performance metrics like sensitivity or specificity. While these criteria are crucial for device approval, they are not detailed in this FDA clearance letter. The letter assumes compliance with these standards (e.g., through good manufacturing practices and required testing for expiration dating) but doesn't explicitly list them or report specific performance values.
Therefore, many parts of your request are not directly addressed by the provided document.
Here's how I would answer based on the provided text, indicating what is not applicable (N/A) or not provided (NP):
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Typical for Condoms) | Reported Device Performance (as per this document) |
|---|---|
| Burst Volume/Pressure | NP (Assumed to meet standards for 510(k) approval) |
| Freedom from Holes | NP (Assumed to meet standards for 510(k) approval) |
| Tensile Strength | NP (Assumed to meet standards for 510(k) approval) |
| Expiration Date/Shelf Life | Must comply with 21 CFR 801.435. Supported by test data. Max 5 years. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. This document refers to the regulatory clearance of a physical medical device (condom), not an AI/algorithm-based device. No specific "test set" for an algorithm is mentioned or required for this type of submission. Data provenance for performance testing (e.g., burst testing) would be part of the manufacturer's quality system but is not detailed in this 510(k) letter.
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)
- N/A. As above, this is for a physical device, not an AI. "Ground truth" for condom performance would be established through laboratory testing against recognized standards, not expert clinical interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Not applicable for a physical device 510(k) submission.
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
- N/A. No AI or human reader component for this device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- N/A. Not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Ground Truth (for condom performance): Based on established international and national standards (e.g., ISO, ASTM, FDA guidance) for physical properties like burst volume, burst pressure, and freedom from holes. The document also specifically mentions "test data developed under the conditions specified in §801.435(d)" for expiration dating.
- Ground Truth (for substantial equivalence): The "ground truth" for regulatory clearance is the performance and safety profile of the legally marketed predicate device. The applicant (Indus Medicare Limited) demonstrated that their Invigra condom is "substantially equivalent" to this predicate.
8. The sample size for the training set
- N/A. No AI training set.
9. How the ground truth for the training set was established
- N/A. No AI training set.
§ 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.