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pjur® WOMAN Aloe is a personal lubricant for penile, vaginal and/or anal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex condoms. This product is not compatible with polyurethane and polyisoprene condoms.

pjur® med Moisturising glide is a personal lubricant for penile, vaginal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex condoms. This product is not compatible with polyurethane and polyisoprene condoms.

pjur® BACK DOOR water-based is a personal lubricant for penile, vaginal and/or anal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex condoms. This product is not compatible with polyurethane and polyisoprene condoms.

pjur® analyse me! water-based is a personal lubricant for penile, vaginal and/or anal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex condoms. This product is not compatible with polyurethane and polyisoprene condoms.

pjur® med NATURAL glide is a personal lubricant for penile, vaginal and/or anal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

We-Vibe® Lube made by pjur® is a personal lubricant for penile, vaginal and/or anal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polvisoprene condoms. This product is not compatible with polyurethane condoms.

The pjur® WOMAN Aloe, pjur® analyse me! water-based, pjur® BACK DOOR water-based, pjur® med Moisturising glide, pjur® med NATURAL glide, and We-Vibe® Lube made by pjur® are water-based personal lubricants provided non-sterile. These over-the-counter products have similar formulations and contain neither a contraceptive nor a spermicide. The pjur® analyse me! waterbased, pjur® BACK DOOR water-based, and pjur® med Moisturising glide are compatible with natural rubber latex condoms. They are not compatible with polyurethane and polyisoprene condoms. The pjur® med NATURAL glide, and We-Vibe® Lube made by pjur® are compatible with natural rubber latex and polyisoprene condoms. They are not compatible with polyurethane condoms.

The pjur® WOMAN Aloe has a formulation that consists of water, glycerin, xanthan gum, benzyl alcohol, sodium benzoate, citric acid, potassium sorbate, aloe barbadensis leaf juice powder. This lubricant is provided in 30 ml, 100 ml, and 250 ml polyethylene bottles. The pjur® med NATURAL glide, and We-Vibe® Lube made by pjur® have the same formulation that includes the same components as the lubricant above, without aloe barbadensis leaf juice powder. The pjur® med NATURAL glide device is provided in 10 ml and 100 ml polyethylene bottles. We-Vibe® Lube made by pjur® is provided in 30 ml polyethylene bottles, and 125 ml polyethylene/polypropylene pump bottles. The pjur® analyse me! water-based, pjur® BACK DOOR water-based, and pjur® med Moisturising glide have the same formulation that consists of water, glycerin, xanthan gum, benzyl alcohol, sodium benzoate, potassium sorbate, citric acid, sodium hyaluronate. The pjur® analyse me! water-based is provided in 10 ml, 100ml, and 250 ml polyethylene bottles. pjur® BACK DOOR water-based is provided in 10 ml, 100 ml, and 250 ml polyethylene bottles. pjur® med Moisturising qlide is provided in 10 ml and 100 ml polyethylene bottles.

The provided text describes a 510(k) premarket notification for a series of personal lubricants. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving novel safety or effectiveness through clinical trials, especially for common, low-risk devices like personal lubricants.

Therefore, the document does not describe a study with ground truth established by experts, multi-reader multi-case studies, or AI algorithm performance. Instead, it details non-clinical testing/performance data to demonstrate that the new devices meet established safety and performance criteria, primarily through comparison to a predicate device and adherence to recognized standards.

Here's an attempt to answer your questions based on the provided document, highlighting where the information is not applicable to an AI/medical imaging context:

Acceptance Criteria and Device Performance (based on Table 1: Device Specifications)

Study Details:

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

   • Test Set Sample Size: Not explicitly stated as a number of "cases" or "patients" as would be in an AI study. The "test set" here refers to samples of the manufactured lubricant products. For microbiological tests (TAMC, TYMC, pathogenic organisms, antimicrobial preservation), chemical tests (pH, viscosity, osmolality), and physical tests (appearance, odor), samples from production batches would be tested. The specific number of samples tested for each parameter is not detailed.
   • Data Provenance: The data comes from in-vitro laboratory testing of the manufactured lubricant products. The country of origin of the data is not specified, but the applicant's address is in Luxembourg. The testing is prospective in the sense that it's performed on samples of the actual products being brought to market to verify they meet specifications.

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

   • Not applicable in the context of this submission. This is not a study establishing "ground truth" for medical diagnosis via expert consensus. Instead, the "ground truth" for these performance criteria is defined by established scientific/technical standards and laboratory measurements (e.g., pH meter readings, culture results). The expertise lies in the certified laboratory personnel performing these tests according to the USP and ASTM standards.

3. 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 clinical studies, particularly for interpreting medical images, to resolve discrepancies between expert readers. For the physical, chemical, and microbiological tests described here, the results are quantitative or qualitative assessments based on standardized procedures, not subjective interpretations requiring reader adjudication.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools and involves human readers interpreting cases. This submission is for personal lubricants, not diagnostic software.

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

   • No, this is not an AI algorithm. This question is not applicable to the device described.

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

   • The "ground truth" for these tests is based on established measurement standards and chemical/microbiological properties of the product, as defined by recognized pharmacopeial monographs (USP) and ASTM standards. For example, a pH meter provides the "ground truth" for pH, and specific culture methods provide the "ground truth" for microbial presence/count. Condom compatibility is verified through mechanical testing as per ASTM D7661. Biocompatibility relies on adherence to ISO 10993 standards.

7. The sample size for the training set:

   • Not applicable. This is not an AI model, so there is no training set in the machine learning sense. The "training" for such products involves formulation development and process optimization to consistently meet the specified product characteristics.

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

   • Not applicable. As there is no AI training set, this question does not apply.

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

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

pjur® BACK DOOR anal Provitamin B5 for penile, vaginal and/or anal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

pjur® AQUA ProVitamin B5 for penile, vaginal and/or anal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

The piur® AQUA Baseline, pjur® AQUA Guarana, pjur® BACK DOOR anal Provitamin B5, and pjur® AQUA ProVitamin B5 are water-based personal lubricants provided non-sterile. These personal lubricants are for over-the-counter use. They are not compatible with natural rubber latex, polyurethane, and polyisoprene condoms. The products are provided in 30 mL and 100 mL polyethylene bottles.

The pjur® AQUA Baseline consists of water, glycerin, ethoxydiglycol, phenoxyethanol, hydroxypropyl guar hydroxypropyltrimonium chloride, hydroxyethylcellulose, and citric acid. The pjur® AQUA Guarana, pjur® BACK DOOR anal Provitamin B5, and pjur® AQUA ProVitamin B5 have the same formulation and consist of water, glycerin, ethoxydiglycol, phenoxyethanol, hydroxypropyltrimonium chloride, propylene glycol, hydroxyethylcellulose, panthenol, polysorbate 20, citric acid, chamomilla recrutita (matricaria) flower extract, paullinia cupana seed extract, cananga odorata flower oil, alcohol, 1,2hexanediol, decylene glycol, lactic acid, sodium benzoate, and potassium sorbate.

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

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

The acceptance criteria are presented as "Specifications" in "Table 1: Device Specifications" on page 4. The reported device performance is implicitly stated as meeting these specifications.

• Microbiological standards: Total microbial counts and absence of specific pathogens, measured according to USP and USP.
• Antimicrobial effectiveness: Standardized challenge tests per USP.
• Safety standards: Biocompatibility testing conforms to ISO 10993 series for cytotoxicity, sensitization, irritation, and systemic toxicity.
• Functionality standards: Condom compatibility testing follows ASTM D7661-10.
• Stability standards: Real-time and accelerated aging studies for shelf-life determination.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of a personal lubricant's physical, chemical, and biological testing. These are direct measurements of manufactured product characteristics.

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

Not applicable for the same reason as point 8.

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pjur® med SENSITIVE glide for penile, vaginal and/or anal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex condoms. This product is not compatible with polyurethane and polyisoprene condoms.

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

The pjur® med SENSITIVE glide and pjur® WOMAN Nude are water-based personal lubricants provided non-sterile. These over-the-counter products have an identical formulation and contain neither a contraceptive nor a spermicide. They are compatible with natural rubber latex condoms and are not compatible with polyurethane or polyisoprene condoms. The pjur® med SENSITIVE glide is provided in 100 mL polyethylene bottles and the pjur® WOMAN Nude is provided in either 10 mL or 100 mL polyethylene bottles.

The pjur® med SENSITIVE glide and pjur® WOMAN Nude consists of water, 1,2 propylene glycol, ethyoxydiglycol, hydroxypropyl guar hydroxypropyltrimonium chloride, hydroxyethylcellulose, sodium saccharin, and citric acid.

The document describes pjur® med SENSITIVE glide and pjur® WOMAN Nude personal lubricants. These devices are intended for penile, vaginal, and/or anal application to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. They are compatible with natural rubber latex condoms but not with polyurethane and polyisoprene condoms.

Here's the breakdown of the acceptance criteria and supporting studies:

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

The acceptance criteria are presented as "Specification" in two tables (Table 1 and a continuation for Microbial Limits). The reported device performance is implicitly stated as meeting these specifications since the document concludes that performance testing demonstrates the devices are safe and effective and support "substantial equivalence determination."

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 explicitly state the sample sizes for the specific tests. It refers to standardized testing methods (e.g., USP, ASTM, ISO standards). For example, condom compatibility was performed in accordance with ASTM D7661-10, biocompatibility studies in accordance with ISO 10993, and microbial tests according to USP standards. These standards typically define appropriate sample sizes and methodologies for prospective testing. The provenance of the data (country of origin) is not specified. The studies appear to be prospective as they are performance tests conducted to demonstrate compliance with specifications.

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)

This section is not applicable as the device is a personal lubricant, and its performance is evaluated against established physical, chemical, and microbiological standards, as well as material compatibility tests, rather than a diagnostic interpretation where expert ground truth is typically required.

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

Not applicable. As noted above, the evaluation relies on objective measurements against specified standards, not on expert adjudication of diagnostic outcomes.

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 a diagnostic device involving human readers or AI assistance.

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

This question is geared towards AI/algorithmic devices and is not applicable to a personal lubricant. The "standalone" performance here relates to the product's inherent physical, chemical, and biological properties.

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

The "ground truth" for this device is based on established industry standards and regulatory guidelines for personal lubricants and medical devices. These include:

• Physical/Chemical Properties: Measured values against specified ranges (e.g., pH, viscosity, osmolality defined by USP standards).
• Microbial Purity: Absence of specific pathogens and adherence to microbial limits (defined by USP standards).
• Antimicrobial Effectiveness: Performance against challenge organisms as per USP standards.
• Biocompatibility: Results from tests showing no adverse biological reactions as per ISO 10993 standards.
• Condom Compatibility: Demonstrated non-degradation of condoms tested according to ASTM D7661-10.
• Shelf-Life: Stability over time as demonstrated by a real-time stability study.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set" in that context.

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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pjur® Backdoor Anal Glide and pjur® Analyse Me! are personal lubricants for penile, vaginal, and/or anal application . intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. These products are compatible with natural rubber latex, synthetic polyisoprene, and polyurethane condoms.

The pjur® Backdoor Anal Glide or pjur® Analyse Me! device is a non-sterile, silicone-based personal lubricant. This over-the-counter product is formulated to be clear, non-irritating, non-greasy, and odorless. The pjur® Backdoor Anal Glide or pjur® Analyse Me! Device is a silicone based lubricant contains neither a contraceptive nor a spermicide. The product contains Cyclopentasiloxane, Dimethicone, Dimethiconol, and jojoba.

This document is a 510(k) Pre-market Notification for a medical device, specifically personal lubricants. It does not contain information about an AI/ML powered medical device study with acceptance criteria. Instead, it details the substantial equivalence of the "pjur® Backdoor Anal Glide or pjur® Analyse Me!" personal lubricants to a predicate device, "Wet Platinum Premium Lubricant® (K130012)".

The "acceptance criteria" discussed are related to the performance of the lubricant itself and its compatibility with condoms, rather than the performance of an AI algorithm.

Here's a breakdown of the requested information based on the provided document, noting where the information is not applicable to AI/ML studies:

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

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pjur® Original, pjur® Woman, and pjur® MAN Extreme Glide are personal lubricants, for penile and/or vaginal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. These products are compatible with natural rubber latex, polyurethane, and polyisoprene condoms.

The pjur® Original, pjur® Woman, and pjur® MAN Extreme Glide lubricants are non-sterile, silicone-based personal lubricants. These over-the-counter products are formulated to be clear, non-irritating, non-greasy, and odorless. The pjur® silicone based lubricants contains neither a contraceptive nor a spermicide.

The provided document is a 510(k) Premarket Notification for silicone-based personal lubricants (pjur® Original, pjur® Woman, and pjur® MAN Extreme Glide). It describes the device, its intended use, and performance data from various tests. However, it does not describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the format requested, which is typically associated with AI/ML device evaluations in a clinical context.

The document instead focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance. The "performance data" section details the results of biocompatibility and condom compatibility testing, which are the types of tests conducted to support safety and effectiveness for this kind of medical device.

Therefore, many of the requested fields are not applicable or cannot be extracted from this specific document, as it pertains to a chemical-based product, not an AI/ML device requiring clinical study data, ground truth establishment, or human reader performance metrics.

Here's an attempt to answer based on the spirit of the request, interpreting "acceptance criteria" as the successful demonstration of safety standards for a personal lubricant, and explaining why other fields are not applicable:

Description of Acceptance Criteria and Device Performance for pjur® Group Silicone-Based Lubricants

This document describes the regulatory submission for personal lubricants, not an AI/ML device. Therefore, the "acceptance criteria" are related to established safety and performance standards for personal lubricants, primarily encompassing biocompatibility and condom compatibility, rather than typical AI/ML performance metrics like accuracy, sensitivity, or specificity against a clinical ground truth.

1. Table of Acceptance Criteria and Reported Device Performance

Details on the "Study" (Performance Testing)

The "study" in this context refers to the performance testing conducted to demonstrate the safety and effectiveness of the personal lubricants according to established medical device standards, primarily ISO 10993-1 and ASTM D7661.

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

• Sample Size: The document does not specify the exact number of samples (e.g., animals for biocompatibility, lubricant batches for condom testing) used in each test. It refers to general testing procedures (ISO 10993-1, ISO 10993-10 for sensitization, ASTM D7661 for condom compatibility).
• Data Provenance: The document implies the data was generated specifically for this regulatory submission by the submitter (pjur group Luxembourg SA). The location of the testing laboratories is not specified, nor is the country of origin of the test materials (e.g., condoms, test chemicals). It is prospective testing for this specific device.

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

• This question is not applicable as the device is not an AI/ML algorithm or requires interpretation by human experts to establish "ground truth" in a diagnostic sense. The "ground truth" for these tests comes from established laboratory methodologies and measurements (e.g., absence of cell lysis for cytotoxicity, skin reaction scores for irritation, condom burst pressure for compatibility).

4. Adjudication method for the test set

• This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human experts in evaluating diagnostic AI outputs. The evaluation of lubricant performance is based on objective laboratory measurements against defined thresholds.

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 question is not applicable. This document describes a personal lubricant, not an AI/ML system, and therefore no MRMC study was performed.

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

• This question is not applicable. The device is a personal lubricant, not a standalone algorithm.

7. The type of ground truth used

• The "ground truth" for this device's performance is based on objective laboratory measurements and tests against established biological and material science standards. For example:
  • Biocompatibility: In vitro (cytotoxicity) and in vivo (irritation, sensitization, systemic toxicity) biological responses measured according to ISO 10993 series.
  • Condom Compatibility: Physical properties of condoms (e.g., burst pressure, volume) measured after lubricant exposure according to ASTM D7661.

8. The sample size for the training set

• This question is not applicable. "Training set" refers to data used to train an AI/ML model. This document describes a physical product (lubricant) which does not have a training set in this context. The formulation development and optimization of the lubricant would have involved various experimental iterations, but these are not referred to as a "training set."

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

• This question is not applicable for the same reasons as point 8.

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