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For Latex Sensitive Condom Users: This is a TACTYLON® condom. This is not a latex condom. You may use this TACTYLON ® condom if you or your partner are allergic to latex. You should know: The risks of pregnancy and sexually transmitted diseases (STDs), including AIDS . (HIV infection), are not known for this condom. A study is being done. There are laboratory tests on this TACTYLON® material. These tests show that . organisms even as small as sperm and viruses like HIV cannot pass through it. Latex condoms for men, if used correctly with every act of vaginal intercourse are highly effective at preventing pregnancy, as well as STDs, including AIDS (HIV infection).

The TACTYLON® condom is made from styrene-ethylene-butylenestyrene thermoplastic elastomer block copolymer but has physical properties (e.g., strength, elasticity, and tactility) and general form that are substantially equivalent to a NRL condom.

Here's an analysis of the provided text to extract information about acceptance criteria and supporting studies for the LUBRICATED BAGGY CONDOM:

Note: The provided document is a 510(k) summary for a condom, which focuses on demonstrating substantial equivalence to a predicate device rather than setting a new performance standard. Therefore, the "acceptance criteria" discussed here are mainly related to demonstrating equivalence and safety/efficacy, not necessarily numerical performance targets in the way one might expect for a diagnostic or AI device. Many of the requested fields (like MRMC studies, expert qualifications, etc.) are not applicable to this type of medical device submission.

Acceptance Criteria and Supporting Study for LUBRICATED BAGGY CONDOM

1. Table of Acceptance Criteria and Reported Device Performance

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

• Toxicity/Irritation (Rabbit Models): Not explicitly stated, but implies multiple animals for vaginal irritation, surgical mucosal implantation, and primary skin irritation. Data provenance: Pre-clinical animal models.
• Delayed Dermal Sensitization (Guinea Pig Model): Not explicitly stated, but implies multiple animals. Data provenance: Pre-clinical animal model.
• Mutagenicity (Salmonella typhimurium): Not explicitly stated. Data provenance: In-vitro lab tests.
• Cytotoxicity (USP elution method): Not explicitly stated. Data provenance: In-vitro lab tests.
• Draize Test (Human Subjects): 200 human subjects. Data provenance: Clinical trial.
• Latex-Sensitive Individuals Test: 20 latex-sensitive individuals. Data provenance: Clinical trial.
• Viral Surrogate Challenge (φ X174): Not explicitly stated, but in-vitro lab tests. Data provenance: In-vitro lab tests.
• Clinical Breakage & Slippage Trial (Lubricated Condoms): Not explicitly stated, but referred to as a "large clinical trial" (implied to be significant enough to compare rates to predicate devices). The reference Contraceptive Research and Development Program Final Report, April 18, 1997 suggests this was a prospective clinical study. Data provenance: Clinical trial.

Overall, the studies encompass both pre-clinical (in-vitro and animal) and clinical (human) data. The clinical data appears to be prospective in nature.

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

This information is not applicable to this type of device (condom). Ground truth for condom performance primarily relies on objective measurements in lab tests (e.g., material properties, viral penetration) and observed clinical outcomes (breakage/slippage rates, irritation/sensitization in human subjects). There isn't a "ground truth" established by experts in the context of interpretation, like there would be for an AI diagnostic device.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in diagnostic studies where expert (often subjective) interpretation is involved. For condom performance, the outcomes are generally objective (e.g., presence/absence of irritation, breakage occurrence, material measurements).

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

This information is not applicable. This is a medical device for contraception and STD prevention, not an AI-assisted diagnostic tool. No MRMC studies were performed.

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

This information is not applicable. This is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

• Toxicity/Irritation/Sensitization: Direct observation of physiological responses in animal models and human subjects (e.g., absence of lesions, allergic reactions). For in-vitro tests, adherence to established laboratory protocols and measurement thresholds (e.g., USP requirements for cytotoxicity).
• Barrier Efficacy: Objective measurement of viral surrogate penetration in an in-vitro setup.
• Clinical Breakage & Slippage: Observed events during clinical use (direct outcome data).
• Material Properties: Objective measurements of physical characteristics (strength, elasticity) against predetermined specifications (implied, not fully detailed but stated as "substantially equivalent").

8. The Sample Size for the Training Set

This information is not applicable. This is not an AI/machine learning device that requires a "training set." The development of the TACTYLON® material and condom design would involve iterative testing and refinement, but not in the context of machine learning training data.

9. How the Ground Truth for the Training Set was Established

This information is not applicable as there is no "training set" in the machine learning sense. The material development and device design would be based on engineering principles, materials science, and previous pre-clinical and clinical data on similar devices or materials, guided by regulatory requirements for safety and performance (e.g., ISO standards for condoms, FDA guidance).

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For Latex Sensitive Condom Users: This is a TACTYLON® condom. This is not a latex condom. You may use this TACTYLON ® condom if you or your partner are allergic to latex. You should know: - . The risks of pregnancy and sexually transmitted diseases (STDs), including AIDS (HIV infection), are not known for this condom. A study is being done. - . There are laboratory tests on this TACTYLON® material. These tests show that organisms even as small as sperm and viruses like HIV cannot pass through it. Latex condoms for men, if used correctly with every act of vaginal intercourse are highly effective at preventing pregnancy, as well as STDs, including AIDS (HIV infection).

The synthetic TACTYLON® condom contains neither NRL protein allergens nor sensitizing chemicals. The TACTYLON® condom is made from styrene-ethylene-butylene-styrene thermoplastic elastomer block copolymer but has physical properties (e.g., strength, elasticity, and tactility) and dimensions that are substantially equivalent to a NRL condom.

Here's a breakdown of the acceptance criteria and study information for the LUBRICATED HIGH ELONGATION CONDOM, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

The device's acceptance criteria are based on demonstrating substantial equivalence to Natural Rubber Latex (NRL) condoms, particularly concerning barrier properties, clinical breakage/slippage rates, and safety (non-allergenicity, non-toxicity, non-irritating).

Study Information

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

   • Modified Draize Test: 200 human subjects.
   • Latex-Sensitive Individuals Test: 20 latex-sensitive individuals.
   • Clinical Trial for Breakage/Slippage: The document does not specify the exact number of subjects for the lubricated condom trial, but states it was a "large clinical trial" and references a previous study (Trussell J, Warner DL, Hatcher RA: Condom performance during vaginal intercourse: comparison of Trojan-enz and TACTYLON condoms. Contraception 1992;45:11-19) for the non-lubricated version.
   • Data Provenance: Not explicitly stated, but clinical trials are typically prospective. References to published papers (e.g., in Contact Dermatitis and Contraception) suggest scientific rigor. Given the FDA submission context, it's implied these studies were conducted to support the device's market clearance. No specific country of origin is mentioned beyond the company's US address.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document does not explicitly state the number or qualifications of experts used to establish ground truth for the clinical studies. For the modified Draize test and latex-sensitive individual tests, the assessment of "non-irritating," "non-sensitizing," and "no adverse reactions" would have been performed by clinical professionals (e.g., dermatologists, allergists, nurses) following standardized protocols. For the clinical performance trial (breakage/slippage), data collection would likely involve patient self-reporting and/or clinical observation, potentially overseen by clinicians. The cited publications would have peer review by experts in the field.

3. Adjudication method for the test set:

   • Not explicitly described. For the Draize and latex-sensitive tests, a single blinded assessment or consensus among clinical observers might have been used, but no specific method like "2+1" or "3+1" is mentioned. For the clinical performance, outcomes like breakage and slippage are generally observable events, and adjudication often involves clear definitions and reporting protocols.

4. 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:

   • No. This is a medical device (condom) and not an AI/imaging diagnostic tool. Therefore, a MRMC study for AI assistance is not applicable.

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

   • Not applicable, as this is a physical medical device, not an algorithm.

6. The type of ground truth used:

   • Material Safety (Toxicity/Irritation): In vitro assays, animal model histopathology and clinical observation (rabbit, guinea pig), and direct human clinical observation for skin reaction/sensitization.
   • Material Safety (Allergenicity/Sensitization): Clinical observation and specific skin tests (e.g., skin prick tests, patch tests) on human subjects.
   • Barrier Efficacy: In vitro viral surrogate challenge; this uses a controlled laboratory standard to simulate real-world conditions.
   • Clinical Performance (Breakage/Slippage): Real-world clinical use data, likely involving user self-reporting and/or clinical observation during vaginal intercourse.

7. The sample size for the training set:

   • This is not applicable as the device is a physical product, not a machine learning model requiring a "training set." The development process would involve iterative material science and engineering, with testing at various stages, but not in the sense of a machine learning training set.

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

   • Not applicable for the same reason as point 7. The "ground truth" for the material's properties and performance would have been established through a combination of established engineering standards, material science testing (e.g., tensile strength, elasticity), chemical analysis, and preliminary biological/clinical tests to refine the formulation and design.

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