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Grosz Play Feel is intended for penile, vaginal and/or anal application to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. Grosz Play Feel is compatible with natural rubber latex and polyisoprene condoms. Grosz Play Feel is not compatible with polyurethane condoms.

Grosz Play Feel is a personal lubricant that is non-sterile, water-based, and provides lubrication during intimate sexual activity. This device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. Its formulation consists of Water, Propylene Glycol, Xanthan Gum, Carbomer, Benzoic Acid, and Sodium Hydroxide. Grosz Play feel is packaged in 50 mL bottles composed of High Density Polyethylene (HDPE) and fitted with a Polypropylene (PP) cap. The bottle is packaged in an outer cardboard carton. Grosz Play Feel is a personal lubricant for over-the-counter (OTC) use.

The provided text describes a 510(k) premarket notification for the "Grosz Play Feel" personal lubricant. This document details the device's technical specifications and the testing performed to demonstrate its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Grosz Play Feel personal lubricant are primarily derived from its device specifications and performance testing. The reported device performance is indicated by the results of these tests.

Study Proving Acceptance Criteria are Met

The document describes several non-clinical performance tests conducted to demonstrate that the Grosz Play Feel personal lubricant meets the acceptance criteria and is substantially equivalent to the predicate device.

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

   • The document does not explicitly state the specific sample sizes for each test. For chemical and physical properties (appearance, odor, viscosity, pH, osmolality), standard quality control batch testing would be performed, but the exact number of batches or individual samples isn't given.
   • For microbiological tests (TYMC, TAMC, Pathogens, PET), these are typically performed on representative samples from production lots.
   • For biocompatibility, shelf-life, and condom compatibility tests, these would likely involve multiple samples or replicates to ensure robustness.
   • Data Provenance: The studies were non-clinical performance tests, likely conducted in a laboratory setting by RB Health (US) LLC or a contract research organization. There is no mention of country of origin for data specifically, but the company is based in the US. These appear to be prospective tests conducted for the purpose of this 510(k) submission.

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

   • This question is not applicable to this type of submission. The "ground truth" for a medical device like a personal lubricant is established by international standards (e.g., ISO, ASTM, European Pharmacopoeia, USP) and regulatory guidance, not by expert consensus on individual cases or images.
   • The tests described (e.g., pH, viscosity, microbiological assays, biocompatibility, condom compatibility) have objective, quantifiable outcomes measured against established physical, chemical, or biological criteria defined by the relevant standards. There are no human "experts" required to interpret complex data akin to radiographic images or clinical diagnoses to establish a "ground truth."

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

   • This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where human readers are interpreting subjective data (like medical images) and their interpretations need to be reconciled to form a ground truth. For the objective, laboratory-based tests described, there is no need for such adjudication. The results are typically quantitative or qualitative outcomes that either meet or do not meet a predefined specification.

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:

   • This question is not applicable. MRMC studies are associated with AI/CAD software used in image interpretation by human readers. This submission is for a personal lubricant, not an AI-powered diagnostic tool.

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

   • This question is not applicable. This submission is for a physical medical device (personal lubricant), not an algorithm or AI software, so the concept of "standalone" algorithmic performance does not apply.

6. The type of ground truth used:

   • The "ground truth" for the performance of the Grosz Play Feel device is based on International Standards (e.g., ISO 10993 series for biocompatibility, ASTM D7661-10 for condom compatibility), European Pharmacopoeia (EP) standards (e.g., EP 8.0 Sections 2.6.12, 2.6.13, and 5.1.3 for microbiological testing), and internal device specifications (e.g., appearance, odor, viscosity, pH, osmolality) that are deemed appropriate for the intended use and safety of the product. These standards represent scientifically validated methodologies and widely accepted performance benchmarks for medical devices.

7. The sample size for the training set:

   • This question is not applicable. A "training set" refers to data used to train machine learning models. This submission is for a physical medical device, which does not involve any machine learning algorithms requiring a training set.

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

   • This question is not applicable, as there is no training set for this type of device.

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