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Actively Trying Personal Lubricant Rose Scented is a personal lubricant for penile, and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of sexual activity and supplement the body's natural lubrication. This product is compatible with sperm, oocytes and embryos and can be used by couples trying to conceive.This product is compatible with natural rubber latex and polvisoprene condoms. This product is not compatible with polyurethane condoms.

Actively Trying Personal Lubricant Rose Scented is a clear, semi-viscous personal lubricant that is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. This product is compatible with sperm, oocytes and can be used by couples trying to conceive. Actively Trying Personal Lubricant Rose Scented is sold as an over-the-counter (OTC) product in 4 fl. oz./120 mL size. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The individual bottles are hermetically sealed during the production process. This device is composed of Water (Aqua), Hydroxyethylcellulose, Sodium Chloride, Sodium Phosphate, Potassium Phosphate, Propylene Glycol, Chlorphenisen, Fructose, Arabinogalactan, and Rose water (Damascena).

This document describes the acceptance criteria and the study results for the "Actively Trying Personal Lubricant Rose Scented" to demonstrate its substantial equivalence to a predicate device.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" in the context of clinical trials with human subjects. The testing described is primarily non-clinical, involving laboratory assays and material compatibility tests. Therefore, typical "sample size" for a clinical test set and "data provenance" (country of origin, retrospective/prospective) are not applicable in the way they would be for a diagnostic device or a drug.

For the biocompatibility studies and non-clinical performance testing (Human Sperm Survival Assay, Endotoxin Testing, Lubricant Barrier Assay), these are laboratory-based tests conducted under specific standards (e.g., ISO 10993, USP, ASTM D7661-10). The sample size would refer to the number of lubricant batches or test replicates used in each assay, which is not detailed in the document beyond stating that the tests were performed.

For shelf-life, tests were conducted at 0, 1, and 2 years. This is a prospective aging study performed on the device product itself.

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

This information is not applicable to the non-clinical performance and biocompatibility testing described. These studies rely on standardized laboratory protocols and measurement techniques rather than expert consensus on a "ground truth" derived from human data. The "ground truth" for these tests comes from the established scientific and regulatory standards themselves (e.g., ISO, USP, ASTM).

4. Adjudication method for the test set

Not applicable, as the tests are objective laboratory measurements against defined acceptance criteria, not subjective interpretations 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 not an AI-powered diagnostic device, but a personal lubricant undergoing non-clinical performance testing for substantial equivalence to a predicate device.

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

Not applicable, as this is not an algorithm or AI-based device.

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

The "ground truth" for the performance and safety of this device is established by adherence to internationally recognized standards and pharmacopoeial methods. These include:

• ISO 10993 series: for biocompatibility (Cytotoxicity, Sensitization, Vaginal Irritation, Acute Systemic Toxicity).
• USP (United States Pharmacopeia) methods: for physical/chemical properties (Viscosity , pH , Specific Gravity , Osmolality ), endotoxin , antimicrobial effectiveness , and microbial counts , , .
• ASTM D7661-10 Standard Test Method: for condom compatibility (Lubricant Barrier Assay).
• Human Sperm Survival Assay: an established method for evaluating sperm compatibility.

Meeting the predefined specifications and passing these standardized tests constitutes the "ground truth" for demonstrating the device's acceptable performance and safety.

8. The sample size for the training set

Not applicable, as this device does not involve machine learning or AI algorithms requiring a training set.

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

Not applicable, as there is no training set for this type of device.

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Actively Trying Personal Lubricant Unfragranced is a personal lubricant for penile, and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of sexual activity and supplement the body's natural lubrication. This product is compatible with sperm, oocytes and embryos and can be used by couples trying to conceive. This product is compatible with natural rubber latex and polvisoprene condoms. This product is not compatible with polyurethane condoms.

Actively Trying Personal Lubricant Unfragranced is a clear, semi-viscous personal lubricant that is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. This product is compatible with sperm, oocytes and can be used by couples trying to conceive. Actively Trying Personal Lubricant Unfragranced is sold as an over-the-counter (OTC) product in 4 fl. oz./120 mL size. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The individual bottles are hermetically sealed during the production process. This device is composed of Water (Aqua), Hydroxyethylcellulose, Sodium Chloride, Sodium Phosphate, Potassium Phosphate, Propylene Glycol, Chlorphenisen, Fructose and Arabinogalactan.

This document describes the regulatory submission for the Actively Trying Personal Lubricant Unfragranced (K212705). The information provided focuses on the device's characteristics and the non-clinical performance testing conducted to demonstrate its safety and effectiveness.

Here’s a breakdown as requested:

1. Table of Acceptance Criteria and the Reported Device Performance

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

The document does not specify the exact sample sizes for each non-clinical test (e.g., number of animals for toxicity, number of sperm samples for HSSA). The data provenance is not explicitly stated in terms of country of origin or whether the studies were retrospective or prospective, but they are described as "non-clinical performance testing" and "real time aging study", implying prospective testing for the shelf life.

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 non-clinical device that does not involve human readers or interpretation of medical images. Ground truth is established through laboratory test results against predefined scientific and regulatory standards (e.g., USP, ISO, ASTM).

4. Adjudication method for the test set

Not applicable. As noted above, this device does not involve expert adjudication for ground truth.

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 document is for a personal lubricant, not an AI-powered diagnostic or interpretive device.

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

Not applicable. This is not an algorithm or AI device.

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

The ground truth for the performance criteria is established by:

• Physical and Chemical Property Standards: USP (United States Pharmacopeia) standards for viscosity, pH, specific gravity, osmolality.
• Biological Standards: ISO (International Organization for Standardization) standards for biocompatibility (Cytotoxicity, Sensitization, Vaginal Irritation, Acute Systemic Toxicity), USP standards for LAL (endotoxin) and antimicrobial effectiveness, and HSSA guidelines.
• Microbiological Standards: USP standards for total aerobic microbial count, total yeast and mold count, and presence of specific pathogens.
• Material Compatibility Standards: ASTM (American Society for Testing and Materials) standards for condom compatibility.
• Real-time aging study: to determine shelf life.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

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Pre-Seed™ Fertility Lubricant is a personal lubricant 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. Pre-Seed™ Fertility Lubricant is compatible with sperm, oocytes, and can be used by trying to conceive couples. It is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms.

Pre-Seed™ Fertility Lubricant can be used to lubricate genital tissues and devices to facilitate use of diagnostic and therapeutic devices during fertility interventions and reproductive medicine.

Pre-Seed™ Fertility Lubricant is a non-sterile, water-based personal lubricant formulated to supplement the body's own natural lubrication. The product is also compatible with sperm, oocytes, and embryos, can be used by trying to conceive couples, and can also be used to lubricate diagnostic and therapeutic devices during fertility interventions and reproductive medicine.

Pre-Seed™ Fertility Lubricant is packaged in a High-Density Polyethylene tube with a Polypropylene closure. A foil seal is present over the tube opening under the cap closure. The provided with single-use, piston type, Low Density Polyethylene applicators for delivering the product to the vagina.

The provided document is a 510(k) summary for the Pre-Seed™ Fertility Lubricant. It details the device's characteristics, indications for use, comparison with a predicate device, and the non-clinical performance data used to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study data based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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BioGenesis Fertility Lubricant is a personal lubricant 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. BioGenesis Fertility Lubricant is compatible with sperm, oocytes, and embryos and can be used by trying to conceive couples. BioGenesis Fertility Lubricant is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms.

BioGenesis Fertility Lubricant can be used to lubricate genital tissues and devices to facilitate use of diagnostic and therapeutic devices during fertility interventions and reproductive medicine.

BioGenesis Fertility Lubricant is water-based formula with ingredients including lactic acid, hydroxyethylcellulose, sodium chloride, potassium sorbate, sodium benzoate, potassium chloride, sorbic acid, magnesium chloride, and calcium chloride. The product is provided in a tube container and has a gel consistency. Its specifications are listed in Table 1 below. The lubricant is not a spermicide or contraceptive. It is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. It is also compatible with compatible with sperm, oocytes, and embryos and can be used by trying to conceive couples.

This document is an FDA 510(k) summary for the BioGenesis Fertility Lubricant (K190872). It describes the acceptance criteria and performance data used to demonstrate its substantial equivalence to a predicate device (BabyDance Fertility Lubricant, K162319).

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and reported device performance:

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

• The document does not specify the exact sample sizes for each non-clinical performance test (e.g., number of replicates for viscosity, number of samples for microbial counts, number of individuals for biocompatibility, etc.). It only mentions that testing was conducted.
• The data provenance is non-clinical laboratory data. There is no indication of country of origin for the data provided, but given the FDA submission, it would adhere to US regulatory standards for testing. The data is retrospective in the sense that the tests were completed before the 510(k) submission.

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

• This information is not applicable to this type of device and study. The "ground truth" here is established by validated laboratory test methods and industry standards (e.g., USP, ISO, ASTM). There are no human experts "adjudicating" diagnostic images or clinical outcomes in this context. The experts involved would be those performing the lab tests, who are qualified by their adherence to the specified test methods.

4. Adjudication method for the test set:

• This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies, particularly in medical imaging, where multiple human readers assess data and their interpretations need to be reconciled to form a ground truth. For this type of non-clinical device, "adjudication" is replaced by standardized laboratory procedures and validated analytical methods, where a clear pass/fail or specification adherence is determined by the test results themselves.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No, an MRMC comparative effectiveness study was not performed, nor is it relevant for this non-clinical device. MRMC studies are used to evaluate the impact of a diagnostic aid (like AI) on human reader performance for tasks such as disease detection or diagnosis. This submission focuses on the chemical and physical properties, and biological compatibility of a lubricant.

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

• This concept is not applicable to the BioGenesis Fertility Lubricant. This is not an AI/algorithm-based medical device. The "performance" is the inherent chemical, physical, and biological properties of the lubricant itself as measured by laboratory tests.

7. The type of ground truth used:

• The ground truth for this device is based on established scientific and technical standards, laboratory assays, and relevant consensus standards (e.g., ISO, ASTM, USP). It is not clinical "outcomes data" or "expert consensus" in the sense of medical diagnosis. Specifically:
  • Chemical and Physical Properties: Defined by specific ranges and characteristics (e.g., viscosity, pH, appearance).
  • Microbiological Purity/Effectiveness: Defined by USP standards and specified microbial limits.
  • Biocompatibility: Defined by ISO 10993 series of standards.
  • Sperm Compatibility: Defined by Human Sperm Survival Assay (HSSA) and lubricant barrier assay, with a specific quantitative acceptance criterion identified (≥ 70% sperm survival).
  • Condom Compatibility: Defined by ASTM D7661-10.
  • Shelf Life: Defined by accelerated aging studies demonstrating maintenance of all other listed specifications over time.

8. The sample size for the training set:

• This refers to the development of an AI algorithm. Since BioGenesis Fertility Lubricant is a physical product (a lubricant) and not an AI/software device, the concept of a "training set" for an algorithm is not applicable. The product's formulation and manufacturing processes are developed through traditional chemical and pharmaceutical engineering, not machine learning.

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

• As stated above, this question is not applicable as there is no AI training set for this device. The "ground truth" for the device's formulation and manufacturing would be established through chemical principles, quality control standards, and iterative product development/testing.

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JO Actively Trying Personal Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of sexual activity and supplement the body's natural lubrication. This product is compatible with sperm, oocytes and can be used by couples trying to conceive. This product is compatible with natural rubber latex, polyurethane and polyisoprene condoms.

JO Actively Trying Personal Lubricant is a clear, semi-viscous personal lubricant that is compatible with condoms made of natural rubber latex, polyurethane and polyisoprene. This device is a non-sterile personal lubricant for penile and/or vaginal application, to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with sperm, oocytes and embryos and can be used by couples trying to conceive. This product is provided in clear, Polyethylene Terephthalate (PET) cylinder bottles are capped with silver disc top caps. The individual bottles are hermetically sealed during the production process. This device is composed of Water (Aqua), Propylene Glycol, Hydroxyethylcellose, Fructose, Arabinogalactan, Sodium Phosphate, Salt, Potassium Phosphate, Methylparaben.

Here's a breakdown of the acceptance criteria and study information for the JO Actively Trying Personal Lubricant, based on the provided FDA 510(k) summary:

This device is a personal lubricant, and the studies performed are primarily non-clinical laboratory tests to demonstrate its safety, effectiveness, and compatibility for its intended use, rather than clinical studies in humans. Therefore, many of the typical categories for AI/medical device clinical studies (like sample size for test sets, expert ground truth, adjudication methods, MRMC studies) are not applicable here.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not applicable in the context of a typical AI/ML clinical test set. The studies performed are non-clinical laboratory tests on the product itself.
• For tests like HSSA, LAL, antimicrobial, and pathogen tests, the "sample size" would refer to the number of lubricant product samples tested, biological reagents used, or microbial cultures, which are not specified in this summary. The data provenance is from laboratory tests conducted presumably by or for the manufacturer.

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

• Not applicable. This summary does not describe a study involving human experts establishing ground truth for a test set in the way it would for an AI diagnostic device. The "ground truth" for the lubricant's properties (e.g., pH, viscosity, sperm survival, microbial counts) is established by adherence to recognized laboratory standards and methods.

4. Adjudication method for the test set

• Not applicable. No adjudication method is described as this is not a study requiring human interpretation or consensus.

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 product (personal lubricant), not an AI-based diagnostic or assistive device that would involve human readers or cases.

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

• The "ground truth" for this product is based on objective measurements, quantitative laboratory assays, and adherence to established industry and regulatory standards as defined by:
  • Device specifications (e.g., pH, viscosity, osmolality).
  • Standardized microbiological tests (e.g., USP , , , ).
  • Biocompatibility standards (e.g., ISO 10993 series).
  • Specific performance assays (Human Sperm Survival Assay, Limulus Amebocyte Lysate Gel-Clot Method, Lubricant Barrier Assay, Condom Compatibility per ASTM D7661-10).

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 type of product.

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BabyDance Fertility Lubricant is a personal lubricant 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. BabyDance Fertility Lubricant is compatible with sperm, oocytes, and embryos and can be used by trying to conceive couples. BabyDance Fertility Lubricant is compatible with natural rubber latex and polyurethane condoms.

BabyDance Fertility Lubricant can be used to lubricate genital tissues and devices to facilitate use of diagnostic and therapeutic devices during fertility interventions and reproductive medicine.

This device is a non-sterile, water-based personal lubricant for vaginal and/or penile application. The formulation does not harm sperm function and has a pH and osmolality that are physiologic ("balanced") to that of fertile cervical mucus and semen. The device is compatible with latex and polyurethane condoms.

BabyDance Fertility Lubricant™ is formulated using purified water, cetyl hydroxyethylcellulose, hypromellose, carbomer homopolymer type B, sodium phosphate, potassium phosphate, sodium chloride, xvlose, sodium hydroxide, phenethyl alcohol, caprylyl glycol, and Salvia sclarea. This device is supplied with an applicator.

The device specifications for the BabyDance Fertility Lubricant™ include appearance, odor, pH, viscosity, osmolality, total aerobic microbial count, total yeast and mold count, absence of pathogenic orqanisms (Escherichia coli, Staphylococcus. aureus, Salmonella, Pseudomonas aeruginosa, and Candida albicans), endotoxin, mouse embryo assay (MEA), and human sperm survival assay (HSSA). These specifications were evaluated during the length of the proposed shelf-life and will be tested before lot release.

This document describes the acceptance criteria and supporting studies for the BabyDance Fertility Lubricant™.

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a summary of performance testing but does not present a formal table of acceptance criteria with specific numerical thresholds and reported performance values for each criterion. Instead, it describes the types of tests performed to ensure safety and effectiveness.

Here's an inferred table based on the descriptions:

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

The document does not explicitly state a sample size for a "test set" in the context of clinical trials or performance studies with human subjects for the lubricant's primary function. The studies listed are primarily laboratory-based non-clinical performance and biocompatibility tests.

• Animal Models:
  • Mouse Embryo Assay (MEA) (one-cell mouse embryos)
  • Guinea Pig Maximization Sensitization (Guinea Pigs)
  • Skin Irritation (e.g., rabbits or guinea pigs, typical for ISO 10993-10)
  • Vaginal Irritation (e.g., rabbits, typical for ISO 10993-10)
  • Acute Systemic Toxicity (e.g., mice, typical for ISO 10993-11)
  • Bovine Mucosal Penetration Testing (bull sperm, bovine cervical mucus)
• Human-derived specimens (in vitro):
  • Human Sperm Survival Assay (HSSA) (washed human sperm)
  • Lubricant Barrier Assay (neat human semen samples)
  • Computer Assisted Sperm Analysis (CASA) (human sperm samples)
  • Semen Assessment (neat human semen samples)
  • Sperm Chromatin Structure Assay (SCSA) (neat human semen samples)

The data provenance is from various laboratory settings, likely in the US or other countries adhering to ISO/USP standards. The studies appear to be prospective in nature, as they involve testing the manufactured device and its components according to pre-defined protocols.

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

This information is not provided in the document. For the non-clinical performance testing described, "ground truth" is typically established by:

• Adherence to validated test methodologies (e.g., USP, ISO, ASTM standards).
• Laboratory technicians and scientists performing the tests and interpreting results against pre-defined specifications or controls.
• The qualifications of these individuals would typically include degrees in relevant scientific fields (e.g., microbiology, toxicology, reproductive biology) and experience in GLP (Good Laboratory Practice) compliant testing.

4. Adjudication Method for the Test Set:

Not applicable, as this refers to a multi-reader, often clinical, consensus process. The studies performed are laboratory-based with clear predefined endpoints and standardized methods, not subjective clinical evaluations requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typical for diagnostic imaging devices where multiple readers interpret cases with and without algorithmic assistance. The BabyDance Fertility Lubricant™ is a medical device for use in conception support and general lubrication, not a diagnostic imaging AI tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This device is not an algorithm or AI system. Its performance is evaluated through direct physical, chemical, and biological testing, sometimes in the presence of biological specimens, but not through an algorithm operating autonomously.

7. Type of Ground Truth Used:

The "ground truth" for the non-clinical tests is established by:

• Established scientific/medical standards: (e.g., acceptable pH ranges, acceptable osmolality ranges, absence of specific pathogens, non-cytotoxic, non-irritating, non-toxic as defined by ISO/USP standards).
• Comparison to controls: Many studies compare the lubricant's effect to a control (e.g., culture medium without lubricant) to determine if there is a statistically significant detrimental effect on sperm function, embryo development, etc.
• Conformance to predicate device properties: While not a true "ground truth," the predicate device's known characteristics serve as a benchmark for substantial equivalence.

8. Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a "training set."

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

Not applicable.

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Astroglide® TTC is a personal lubricant 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. Astroglide TTC is compatible with sperm, oocytes, and embryos and can be used by couples trying to conceive. Astroglide® TTC is compatible with natural rubber latex, polyisoprene and polyurethane condoms.

Astroglide® TTC Fertility Friendly Personal Lubricant is a non-sterile, clear, and water-based personal lubricant for penile and/or vaginal application. Astroglide® TTC has a pH and osmolarity that is compatible with sperm survival and migration. The device is packaged in pre-filled tube applicators which may be used for single use intra-vaginal application or applied directly to penis or vagina. Astroglide® TTC is formulated using water, propylene glycol, hydroxyethylcellulose, fructose, methylparaben, sodium phosphate, potassium phosphate, propyl paraben, galactose, and sodium hydroxide. This device is batch lot tested for appearance, color, viscosity, pH, microbial count, osmolality, endotoxin, mouse embryo assay and human sperm survival assay.

The provided text discusses the premarket notification for Astroglide TTC Fertility Friendly Personal Lubricant, detailing its characteristics and comparison to a predicate device. It includes a summary of performance data to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the studies mentioned:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for the test sets (e.g., number of mouse embryos, human sperm samples, or animals for biocompatibility). The studies performed are laboratory-based and animal studies (New Zealand White Rabbits for irritation, Guinea Pig for sensitization, mice for embryo assay). The data provenance is not explicitly stated as "country of origin" but implies controlled laboratory settings, which are typically retrospective in terms of analyzing the results from a pre-defined experiment.

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

The document does not mention the use of experts to establish a "ground truth" for the test set in the traditional sense of medical image analysis or diagnostic studies. The ground truth for these types of in vitro and in vivo studies is established by the experimental protocols themselves, with results interpreted against scientific and regulatory standards (e.g., ISO standards for biocompatibility).

4. Adjudication Method for the Test Set

Not applicable. The studies described are laboratory, animal, and in vitro tests, not clinical trials requiring adjudication of observer interpretations.

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 medical device (personal lubricant) and the studies do not involve AI or human readers for diagnostic interpretation. Therefore, an MRMC study and effect size in human reader improvement are not relevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is not an algorithm or AI.

7. The Type of Ground Truth Used

The ground truth used in these studies is primarily:

• Experimental Results against predefined thresholds/standards: For pH, osmolarity, endotoxin, MEA, HSSA, and condom compatibility, the "ground truth" is whether the measured values or observed outcomes meet the established scientific and regulatory criteria (e.g., >80% expanded blastocysts, ≥80% sperm survival).
• Biocompatibility Standards: For cytotoxicity, sensitization, irritation, and systemic toxicity, the ground truth is whether the device passes the requirements of specific ISO 10993 standards.
• Functional Assays: For sperm function (penetration, motility, DNA integrity) and IVF, the ground truth is the scientific demonstration that the device does not impede or harm these biological processes.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable. There is no training set for this type of device.

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CONCEIVE PLUS® is a personal lubricant, 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.

CONCEIVE PLUS® is compatible with sperm, oocytes and embryos and can be used by couples trying to conceive. This product can be used in fertility interventions to facilitate entry of diagnostic and therapeutic devices into the vaginal cavity.

CONCEIVE PLUS® is compatible with natural rubber latex and polyurethane condoms. CONCEIVE PLUS® is not for use with polyisoprene condoms.

CONCEIVE PLUS® is non-sterile water-based personal lubricant and vaginal moisturizer that is isotonic. The device contains calcium and magnesium ions and is formulated to meet a pH range that is compatible with sperm survival and migration. CONCEIVE PLUS® supplements the body's own natural moisture and is compatible with sperm, oocytes and embryos and can be used by couples trying to conceive. The device is packaged in a plastic tube or a pre-filled applicator for intra-vaginal application.

CONCEIVE PLUS® is formulated using Deionized Water, Hypromellose, Sodium Phosphate, Sodium dihydrogen Phosphate, Potassium Chloride, Sodium Chloride, Magnesium Chloride, Calcium Chloride, Glycerol and Methylparaben.

This device is batch lot tested for appearance, color, odor, viscosity, osmolarity, specific gravity, pH, microbial limits, endotoxin, mouse embryo assay, and human sperm survival assay.

This document describes acceptance criteria and performance data for CONCEIVE PLUS®, a personal lubricant. It is a 510(k) premarket notification (K131355) for a Class II medical device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

Due to the nature of medical device premarket notifications for lubricants, specific numerical sample sizes for each test are not detailed in this summary. The studies involve laboratory-based assays rather than human clinical trials with 'test sets' in the typical sense of AI/image analysis.

• Data Provenance: The origin of the data is from in vitro (Mouse Embryo Assay, Human Sperm Survival Assay, Bovine Cervical Mucus Studies, Biocompatibility tests) and in situ (Condom Compatibility testing) laboratory testing of the CONCEIVE PLUS® product itself. Given the context of a European manufacturer (SASMAR SPRL, Brussels, Belgium) seeking FDA clearance, these tests would have been performed in compliance with international standards (ISO, ASTM) and likely in designated testing facilities.
• Retrospective or Prospective: All tests would have been prospective, as they were conducted specifically to demonstrate the safety and effectiveness of CONCEIVE PLUS® for its 510(k) submission.

3. Number of Experts and Qualifications

This document does not specify the number or qualifications of experts used to establish ground truth. For these types of laboratory tests, "ground truth" is established by the validated methodologies of the tests themselves (e.g., ISO standards for biocompatibility, established protocols for MEA/HSSA). The expertise lies in the certified laboratories and trained personnel conducting these assays according to recognized standards.

4. Adjudication Method

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used for clinical studies involving interpretation of data (e.g., medical images) by multiple human readers. The tests performed for this lubricant are laboratory-based assays with objective endpoints.

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

Not applicable. This is not a study involving human readers or AI in an assistive capacity for diagnostic tasks.

6. Standalone (Algorithm Only) Performance

Not applicable. This product is a personal lubricant, not an algorithm or AI device. The "performance" refers to its physical and biological compatibility characteristics.

7. Type of Ground Truth Used

The ground truth used for performance evaluation is based on established scientific and regulatory standards for safety and compatibility in laboratory settings:

• Laboratory Assay Results: Objective measurements from tests like osmolarity, pH, endotoxin levels, and direct observation of biological effects (sperm motility, embryo development, cellular response in biocompatibility tests).
• Standardized Test Protocols: Adherence to international standards (e.g., ISO 10993 for biocompatibility, ASTM D7661 for condom compatibility) which define acceptable ranges and methodologies.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML product and does not involve a training set.

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

Not applicable.

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• To lubricate vaginal tissues to facilitate entry of diagnostic or therapeutic devices including those used in fertility interventions. Pre~Va may be applied directly to the device or may be deposited intravaginally using the applicator, prior to the insertion of diagnostic or therapeutic devices used in fertility interventions.
• As a personal lubricant Pre-Va supplements the body's own natural lubricating fluids, to moisturize, relieve friction and to enhance the ease and comfort of intimate sexual activity. Pre~Va is safe for use by couples who are trying to conceive and may be applied to vaginal or penile tissues for lubrication and moisturization purposes. It is compatible with latex and polyurethane condoms.

This product is a non-sterile, water-based personal lubricant formulated to supplement the body's own natural lubricating fluids. Pre~Va is used to lubricate vaginal tissues to facilitate entry of diagnostic or therapeutic devices including those used in fertility interventions. It is also used as a personal lubricant to supplement the body's own natural lubricating fluids and to enhance the comfort of intimate sexual activity. The formulation does not harm sperm function and has a pH and osmolarity that are physiologic ("balanced") to that of fertile cervical mucus and semen. The product is compatible with latex and polyurethane condoms.

This document is a 510(k) summary for the Pre~Va Vaginal Lubricant. It states that the device is substantially equivalent to a predicate device, and as such, it does not present acceptance criteria or a study proving that the device meets those criteria.

The 510(k) summary explicitly states:
"All of the technological characteristics of PreVa are identical to the predicate device."
"The performance data of PreVa are identical to the predicate."
"Pre~Va Vaginal Lubricant is safe for its intended use and substantially equivalent to the predicate device Pre' Vaginal Lubricant."

Therefore, the requested information regarding acceptance criteria and performance studies is not available in this document because the device's approval is based on its substantial equivalence to a previously approved predicate device, not on a new performance study against specific acceptance criteria.

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• To lubricate vaginal tissues to facilitate entry of a diagnostic or therapeutic a devices including fertility interventions.
• As a personal lubricant to supplement the body's own natural lubricating As a personal labriount to cappion and to enhance the ease and comfort nfinate sexual activity. This lubricant may be safely applied to vaginal or penile tissues for lubrication and moisturization purposes. It is also compatible with latex and polyurethane condoms.

This product is a non-sterile, water-based personal lubricant formulated to supplement the body's own natural lubricating fluids. This product may be used to facilitate entry of diagnostic or therapeutic devices, enhance the comfort of intimate sexual activity, or provide personal lubrication when vaginal dryness causes discomfort. The formulation does not harm sperm function and is pH balanced to match fertile cervical mucus. The product is compatible with latex and polyurethane condoms.

This document describes a 510(k) submission for a vaginal lubricant, not an AI-powered medical device. Therefore, many of the requested categories are not applicable. I will provide the information directly relevant to the submission and note when a category is not applicable for this type of device.

1. A table of acceptance criteria and the reported device performance

This product is a Class II medical device (vaginal lubricant) seeking substantial equivalence to a predicate device (K-Y Brand Ultra Gel, K020827). For such devices, acceptance criteria are typically met by demonstrating that the new device has "technological characteristics" and "preclinical/clinical performance data" that are substantially equivalent to the predicate device, especially regarding safety and effectiveness for its intended use.

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 for Test Set:
  • Preclinical Animal Studies: Not explicitly stated, but "studies in rabbits" and "Mouse Embryo Assay (MEA) studies" are mentioned, implying multiple animals were used. "No detrimental effects on the ability to fertilize bovine embryos in vivo" suggests a study involving bovine subjects.
  • Human Biocompatibility: Not explicitly stated, but "Biocompatibility studies found no evidence of skin irritation or sensitization in humans" implies a cohort of human subjects.
  • Focus Groups & Consumer-Use Testing: Not explicitly stated, but "Focus groups and consumer-use testing" implies a group of participants.
  • In vitro studies: Tests on human sperm and material compatibility (latex/polyurethane condoms) were conducted, but specific sample sizes of sperm or condom units are not provided.
• Data Provenance: Not explicitly stated for specific studies. Given the applicant is in the USA (Washington), it's reasonable to infer studies were conducted in the USA or under internationally recognized standards (e.g., ICH guidelines). The studies appear to be prospective for the purpose of this submission.

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. This is a medical device (lubricant) submission, not an AI model requiring "ground truth" established by experts in the context of image interpretation or diagnosis. The evaluation relies on standardized biological, chemical, and physical tests, and performance assessments.

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

Not applicable. This is a medical device (lubricant) submission. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials involving expert interpretation of medical images or outcomes where discrepancies need resolution. For this device, standard laboratory and clinical study protocols would be followed, and results are typically analyzed statistically or qualitatively based on predefined endpoints.

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 diagnostic performance (e.g., radiologists reading images). This is a lubricant.

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

Not applicable. This is a lubricant, not an algorithm or AI system. Its performance is evaluated through laboratory and preclinical/clinical studies.

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

Not applicable in the AI sense. The "ground truth" or reference standards for evaluating this device were based on:

• Established biological and chemical standards: For pH, osmolarity, sperm viability, embryo development, material compatibility.
• Preclinical irritation assessments: Observation of animal tissues, validated irritation tests (e.g., Slug Mucosal Irritation Test).
• Human irritation/sensitization clinical observations: Direct observation and potentially patient reporting.
• Consumer feedback: For effectiveness as a personal lubricant through focus groups and consumer-use testing.

8. The sample size for the training set

Not applicable. This is a lubricant, not an AI model that requires a training set.

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

Not applicable. See point 8.

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