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The One Touch male natural rubber latex condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

The One Touch condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitting membrane. The condom is straight-walled with a reservoir tip, and is silicone lubricated. Condom dimensions are length 210 ± 10 mm, width 60 ± 2 mm, and thickness 0.07 ± 0.01 mm. The condom is designed to conform to the requirements of ASTM D3492:2016 and ISO 4074:2015.

The provided text describes a 510(k) premarket notification for a male natural rubber latex condom called "One Touch." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria for an AI/algorithm-driven medical device. Therefore, much of the requested information regarding AI device testing is not applicable.

However, I can extract the relevant information from the document as it pertains to the condom's performance and the testing conducted.

Device Name: One Touch (Male Natural Rubber Latex Condom)
510(k) Number: K181844

The device is a physical product (a condom), not an AI/algorithm-driven device. Therefore, questions 2 through 9 regarding sample sizes, ground truth, expert opinions, adjudication methods, and training sets are not applicable in this context.

Here's the closest information available concerning acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance

For a physical device like a condom, "acceptance criteria" are typically defined by recognized standards (ASTM, ISO) and specific measurements and performance requirements. The document indicates the device conforms to these standards.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria consists of various performance tests detailed in the "Summary of Performance Testing" section.

• Biocompatibility testing:

  • Cytotoxicity testing per ISO 10993-5:2009
  • Guinea pig maximization sensitization testing per ISO 10993-10:2010
  • Vaginal irritation testing per ISO 10993-10:2010
  • Acute systemic toxicity testing for ISO 10993-11:2006
  • Result: All biocompatibility tests were passed/met requirements.

• Physical Testing Data:

  • Test: Airburst specifications of ISO 4074:2015 - Natural rubber latex male condoms - Requirements and test methods, and ASTM D3492:2016 - Standard Specification for Rubber Contraceptives (Male Condoms).
  • Result: "Three lots of devices were tested at baseline and met airburst specifications."

• Shelf Life:

  • Test: Stability testing per the requirements of 21 CFR §801.435.
  • Result: Supported a shelf-life of five years.

2. Sample size used for the test set and the data provenance:

• Physical Testing: "Three lots of devices" were tested for airburst specifications. The exact number of condoms per lot is not specified, nor is the country of origin explicitly stated for the testing data (though the manufacturer is Thai Nippon Rubber Industry Public Company Ltd. in Thailand). The data is retrospective, as it's part of a premarket submission.
• Biocompatibility/Shelf-life: Not specified in terms of sample size, but general statements indicate tests were conducted and met requirements.

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 physical device, and its performance is measured against established international and national standards/specifications (e.g., ISO, ASTM, 21 CFR), not by expert consensus on image interpretation or diagnosis.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable. The performance tests involve objective physical and chemical measurements rather than subjective expert review requiring adjudication.

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 a physical condom, not an AI or algorithm-driven device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Not Applicable. This is a physical condom, not an AI or algorithm-driven device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

• Ground Truth for Condom Performance: The "ground truth" for condom performance is defined by the objective, measurable requirements specified in established international and national standards such as ISO 4074:2015, ASTM D3492:2016, and FDA regulations like 21 CFR §801.435, as well as specific biocompatibility standards (e.g., ISO 10993 series). These standards provide quantifiable thresholds for properties like burst pressure, tensile strength, and biocompatibility endpoints.

8. The sample size for the training set:

• Not Applicable. This is a physical device, not an AI/machine learning model that requires a training set.

9. How the ground truth for the training set was established:

• Not Applicable. No training set is used for a physical device.

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