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The Pulse™ H2Oh! personal lubricant is intended for vaginal and/or penile application to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication.

This personal lubricant is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

The Pulse H2Oh! is a personal lubricant intended for overthe-counter sale. It is sold, and used, not sterile. The lubricant is colorless to slightly yellow and unfragranced.

The product is used for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication.

The Pulse H2Oh! lubricant is supplied in the form of individual plastic pump canisters, called pods. A pod is ~2.5 inches tall, has a diameter of ~1 inch and contains ~6.7 ml of lubricant. The pod pump allows the user to receive an aliquot of lubricant without touching the nozzle or inside of the container.

The Pulse H2Oh! lubricant is a gel with a pH of 4.8 - 5.2, and is comprised of the following ingredients:

• Purified water
• Propanediol / Zemea Propanediol ●
• Hydroxyethylcelluose / Natrosol 250H Pharm ●
• Potassium Sorbate ●
• Chia Seed Extract ●
• Citric Acid ●

Device specifications are: color, odor, appearance, weight gain/loss % (w/w), pH, specific gravity, viscosity, osmolality, total aerobic microbial count, total yeast and mold count, absence of specified microorganisms (P. aeruginosa, S. aureus and C. albicans) and antimicrobial effectiveness.

Here's an analysis of the acceptance criteria and supporting studies for the Pulse™ H2Oh! personal lubricant, based on the provided FDA 510(k) summary:

This device is not an AI/ML medical device, therefore many of the requested categories are not applicable. The information below reflects the type of testing typically done for personal lubricants.

1. Table of Acceptance Criteria and Reported Device Performance

Study Information

As this is a traditional medical device (a personal lubricant) and not an AI/ML device, many of the requested categories regarding AI specific testing (like sample size for test set/training set, number of experts, adjudication methods, MRMC studies, standalone algorithm performance) are not applicable.

Here's the relevant information based on the provided document:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Sample Size: Not explicitly stated for each test type. For physical/chemical tests, this would typically involve a statistically relevant number of batches or samples. For biological tests (e.g., irritation, sensitization), in vitro tests use specified cell cultures, and in vivo tests use animal models (e.g., Guinea Pig Maximization Test). Condom compatibility testing would involve a specific number of condoms and lubricant applications as per ASTM D7661-10.
   • Data Provenance: The document states that testing was "performed by independent laboratories/test centers." The country of origin of these labs is not specified. The studies are prospective in nature, as they are conducted specifically to demonstrate the product's compliance.

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)

   • Not Applicable for this type of device. "Ground truth" in the context of AI/ML refers to human expert annotations. For a personal lubricant, compliance is determined by adherence to established, objective scientific standards and test methods recognized by regulatory bodies (e.g., USP, ISO, ASTM). The "experts" are the scientists and technicians performing and interpreting these standardized laboratory tests. Their qualifications would be in chemistry, microbiology, toxicology, and other relevant scientific disciplines.

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

   • Not Applicable. Adjudication methods like 2+1 or 3+1 are used in AI/ML studies to resolve discrepancies in human expert annotations for ground truth. For this device, test results are typically objective (e.g., pass/fail for microbial growth, specific pH values, absence of adverse reactions in animal models).

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. MRMC studies are for evaluating the performance of diagnostic devices often involving human interpretation (e.g., radiologists reading images). This is a physical/chemical/biological product.

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

   • Not Applicable. This is a physical product, not an algorithm.

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

   • The "ground truth" for this device, in a general sense, is derived from established scientific standards and methodologies.
     • Condom Compatibility: Adherence to ASTM D7661-10 (a published standard for test methods).
     • Microbiological: Adherence to USP , , (pharmacopeial standards for microbial limits and antimicrobial effectiveness).
     • Biocompatibility: Adherence to ISO 10993 series of standards (international standards for biological evaluation of medical devices), which involve specific in vitro (cytotoxicity) and in vivo (irritation, sensitization, systemic toxicity in animal models) tests.
     • Shelf Life: Results of real-time aging studies, demonstrating the device maintains its pre-defined specifications over time.

8. The sample size for the training set

   • Not Applicable. There is no "training set" as this is not an AI/ML device.

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

   • Not Applicable. There is no "training set" for this device.

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I am sorry, but based on the provided text, I cannot provide a description of the acceptance criteria and the study that proves the device meets them. The document is a 510(k) substantial equivalence determination letter from the FDA to Toaster Labs, Inc. regarding their Pulse™ Aloe-ahh product (a condom).

This letter states that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices. However, it does not contain any information regarding specific acceptance criteria, device performance metrics, study design (sample size, data provenance, expert qualifications, adjudication methods), or details about standalone/MRMC studies or ground truth establishment.

The letter is primarily focused on regulatory compliance and the substantial equivalence determination, not the specific technical details or performance study results.

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