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Dick's Formalwear® Male Latex Condoms is to be used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases, including human immunodeficiency virus (HIV)).

These condoms are made of a high quality natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. These three types of condoms (plain, ribbed, and dotted), have a nominal length of 180 mm, nominal width of 54 mm, and a nominal thickness of 0.05 mm. They are all lubricated with a silicone lubricant and have a reservoir tip for extra safety. The condoms are also printed on the exterior of the latex with a graphic design per section 11.1 of ISO 4074:2002 and have passed toxicity and biocompatibility testing.

The provided text describes a 510(k) summary for Dick's Formalwear® Male Latex Condoms, not a study involving AI or complex medical imaging. Therefore, most of the requested information (like sample size for test/training sets, expert qualifications, MRMC studies, standalone algorithm performance, etc.) is not applicable or available in the document.

However, based on the information provided, here's what can be extracted and formatted:

Acceptance Criteria and Device Performance for Dick's Formalwear® Male Latex Condom

The device performance is primarily evaluated against established industry standards and AQL (Acceptable Quality Limit) levels for manufacturing quality.

1. Table of Acceptance Criteria and Reported Device Performance:

   Criteria	Acceptance Standard	Reported Device Performance
   Conformance to ASTM Latex Condom Standard	ASTM D3492	Designed in conformance
   AQL for ASTM D3492	0.25 (specifically for the standard)	Met (implied by conformance statement)
   Conformance to ISO (manufacturing)	ISO 4074:2002	Manufactured in "recognition of" (implied conformance)
   Air Burst Requirements (part of GMP)	Established and implemented, per ISO 4074:2002	Air burst testing yielded an AQL of 1.0
   Electronic Testing	Not explicitly stated (implied "pass")	Each condom is electronically tested
   Graphic Design	Per section 11.1 of ISO 4074:2002	Printed on the exterior of the latex with a graphic design
   Toxicity and Biocompatibility	Passed	Passed

2. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: Not explicitly stated. The AQL (Acceptable Quality Limit) values (0.25 for ASTM D3492 and 1.0 for air burst testing) indicate statistical sampling was used during manufacturing quality control, but the specific sample sizes are not provided in this summary.
   • Data Provenance: The testing is internal to the manufacturing process, likely conducted at the manufacturing facility. There is no mention of country of origin of data beyond the manufacturing location. The testing would be considered prospective as it's part of the ongoing quality control during production.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

   • This question is not applicable. The "ground truth" for condom quality is established by objective physical and material standards (ASTM, ISO), along with internal quality control procedures and testing. There isn't a subjective "expert review" of individual condoms in the way there would be for image analysis.

4. Adjudication Method for the Test Set:

   • This question is not applicable. Quality control for manufacturing physical devices like condoms typically involves objective measurements and adherence to acceptance ranges, not expert adjudication in the clinical sense.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • This question is not applicable. This device is a physical medical device (condom), not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance Study:

   • This question is not applicable. This device has no embedded algorithm.

7. Type of Ground Truth Used:

   • The ground truth is based on objective, established industry standards and specifications for latex condoms, including:
     • ASTM D3492 (Latex Condom Standard)
     • ISO 4074:2002 (Natural rubber latex condoms – Requirements and test methods)
     • Internal Good Manufacturing Practice (GMP) air burst requirements
     • Electronic testing for defects.

8. Sample Size for the Training Set:

   • This question is not applicable. There is no "training set" in the context of this device. The manufacturing process and quality control learn from adherence to established standards and continuous process improvement, not a data-driven training set for an algorithm.

9. How the Ground Truth for the Training Set Was Established:

   • This question is not applicable for the reasons stated above.

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