(98 days)
Black Colored Condoms [Parallel Sided or Contoured or Flared or Non-textured, Lubricated or Non-lubricated]
a) Parallel sided smooth, 53mm Black colored condom
b) Parallel sided dotted, 53mm Black colored condom
c} Parallel sided ribbed, 53mm Black colored condom
d) Parallel sided smooth, 56mm Black colored condom
e) Contoured studded, 53mm Black colored condom
f) Contoured ribbed & studded, 53mm Black colored condom
g) Contoured ribbed, 52mm Black colored condom
h) Flared smooth, 56mm Black colored condom
The Karex condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
Not Found
The provided text is related to the FDA's acceptance of "Black Colored Condoms" by Karex Industries Sdn. Bhd. for marketing. It is a 510(k) premarket notification, which establishes substantial equivalence to a legally marketed predicate device.
This document is not a study report for a medical device that uses algorithms or AI, so many of the requested criteria are not applicable. This document is for a physical product (condoms), not a software-based medical device.
Therefore, I cannot provide information for most of the requested points, as they pertain to the evaluation of AI/algorithm-based medical devices. However, I can extract the relevant information from the provided text.
Here's the information that can be extracted or deduced:
1. A table of acceptance criteria and the reported device performance
Based on the document, the "acceptance criteria" are not explicitly stated in a quantitative performance table like one would expect for an AI/algorithm. Instead, the acceptance is based on meeting regulatory requirements and demonstrating "substantial equivalence" to a predicate device. The performance is implied by the generic indications for use of condoms.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | The FDA determined the device is substantially equivalent to legally marketed predicate devices. |
| Indications for Use: | |
| Contraceptive Purposes | "The Karex condom is used for contraceptive purposes (to help prevent pregnancy...)" (Implied performance consistent with predicate condoms) |
| Prophylactic Purposes (STD prevention) | "...and for prophylactic purposes (to help prevent...the transmission of sexually transmitted diseases)." (Implied performance consistent with predicate condoms) |
| Physical Characteristics: | Black Colored Condoms |
| Parallel sided smooth, 53mm black colored condom | |
| Parallel sided dotted, 53mm black colored condom | |
| Parallel sided ribbed, 53mm black colored condom | |
| Parallel sided smooth, 56mm black colored condom | |
| Contoured studded, 53mm black colored condom | |
| Contoured ribbed & studded, 53mm black colored condom | |
| Contoured ribbed, 52mm black colored condom | |
| Flared smooth, 56mm black colored condom |
For the following points (2-9), the information is not present in the provided document because it describes the regulatory clearance of a physical consumer product (condoms), not an AI/algorithm medical device study.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. This document does not describe a study involving a test set of data for an AI/algorithm.
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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. This document does not describe a study involving experts establishing ground truth for an AI/algorithm.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. This document does not describe a study involving adjudication for an AI/algorithm.
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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. This is not an AI/algorithm device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is not an AI/algorithm device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A. This document does not describe a study involving ground truth for an AI/algorithm. For condoms, performance is typically assessed through physical testing methods (e.g., burst tests, water leak tests) and clinical studies for efficacy. These details are not in this 510(k) letter.
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The sample size for the training set
- N/A. This document does not describe an AI/algorithm device with a training set.
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How the ground truth for the training set was established
- N/A. This document does not describe an AI/algorithm device with a 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.