Search Results
Found 8 results
510(k) Data Aggregation
(57 days)
Good Clean Love, Inc.
Coconut Hybrid is a personal lubricant for penile application intended to moisturize and lubricate, to 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.
Coconut Hybrid is a water-based personal lubricant that is non- sterile, contains coconut oil, 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, hydroxyethylcellulose, fractionated coconut oil, tremella fuciformis extract, hyaluronic acid, propanediol, DL lactic acid, xanthan gum, sodium benzoate, potassium sorbate, and natural coconut flavor. Coconut Hybrid is packaged in a 50 mL polyethylene tubes and is a personal lubricant for over the counter (OTC) use.
This is a 510(k) premarket notification for the "Coconut Hybrid" personal lubricant. This document states that the device is substantially equivalent to the predicate device "Coconut Infused Hybrid Personal Lubricant" (K180712).
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Specification | Observed Performance (from the document) |
|---|---|---|
| Physical/Chemical Specifications | ||
| Appearance | Gel | Gel |
| Color | Opaque | Opaque |
| Odor | Characteristic (coconut) | Characteristic (coconut) |
| pH | 3.5 – 4.2 | "3.5 – 4.2" (Listed as a specification, implicit that it was met) |
| Viscosity | 8,000 - 59,000 cPs | "8,000 - 59,000 cps" (Listed as a specification, implicit that it was met) |
| Osmolality | 200 – 400 mOsm/kg | "200 – 400 mOsm/Kg" (Listed as a specification, implicit that it was met) |
| Microbiological Specifications | ||
| Antimicrobial Effectiveness | Category 2 product: Bacteria should show not less than 2.0 log reduction at 14 days and no increase from 14-day count at the 28-day count. Yeast and molds should show no increase from the initial calculated count at 14 and 28 days. | "Yes" (Indicates testing was done and results met criteria, specifically in Table 2 "Antimicrobial Tested (USP , USP , USP)") |
| Total Aerobic Microbial Count | , USP , USP)") | |
| Total Yeast and Mold Count | , USP , USP)") | |
| Absence of Pathogenic Organisms (Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans, Escherichia coli, Salmonella, Clostridium Species) | Absent | "Yes" (Indicates testing was done and results met criteria, specifically in Table 2 "Antimicrobial Tested (USP , USP , USP)") |
| Biocompatibility | N/A (implied by "non-cytotoxic, non-sensitizing, non-irritating, and non-systemically toxic") | "non-cytotoxic, non-sensitizing, non-irritating, and non-systemically toxic" |
| Condom Compatibility | Compatible with natural rubber latex and polyisoprene condoms. Not compatible with polyurethane condoms. | "compatible with natural rubber latex and polyisoprene condoms. The subject device was determined not to be compatible with polyurethane condoms." |
| Shelf Life | 1-year shelf life, maintaining specifications (as in Table 1) | "Coconut Hybrid has a 1-year shelf life in accordance with the results of an accelerated aging stability study. Results from testing demonstrated that the device could maintain its specifications (as shown in Table 1) over the duration of its shelf life." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the biocompatibility, condom compatibility, or shelf-life test sets. It only mentions that testing was performed. The data provenance is also not specified (e.g., country of origin, retrospective/prospective). This type of information is typically detailed in the full test reports that are summarized in the 510(k).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. For performance testing of a personal lubricant (biocompatibility, condom compatibility, microbial testing), "expert consensus" or "ground truth" in the way it might apply to an AI diagnostic device is not typically applicable. Instead, the ground truth is established by validated laboratory testing methods (e.g., ASTM standards, USP monographs). The qualifications of the laboratory personnel performing these tests would be relevant, but are not disclosed in this summary.
4. Adjudication Method for the Test Set
Not applicable for this type of device and performance testing. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic devices where human readers interpret results and a consensus among experts forms the ground truth. Here, the "truth" is determined by objective laboratory measurements adhering to established standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study is not relevant for this device. Such studies are typically conducted for diagnostic imaging devices or other AI-assisted diagnostic tools where the performance of human readers with and without AI assistance is being evaluated. This device is a personal lubricant, not a diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Yes, in essence. The performance evaluations described (biocompatibility, condom compatibility, shelf life, microbiological testing) are "standalone" in the sense that they assess the device's inherent properties without a human-in-the-loop decision-making process. The device itself is not an algorithm, so "algorithm only" doesn't directly apply, but the tests were performed on the device itself.
7. The Type of Ground Truth Used
The ground truth for the performance testing is established by adherence to recognized national and international standards and validated laboratory methods.
- Biocompatibility: Based on alternate testing comparable to ISO 10993-5: 2009 (Cytotoxicity), Human Repeat Insult Patch Testing (sensitization and irritation), and Acute Systemic Toxicity Testing per ISO 10993: 2017. The "ground truth" is whether the results fall within acceptable toxicity/irritation parameters as defined by these standards.
- Condom Compatibility: Based on ASTM D7661-18 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms." The "ground truth" is whether the lubricant causes unacceptable degradation to the condoms according to the standard.
- Microbiological Testing: Based on USP , USP , and USP monographs. The "ground truth" is whether the microbial counts and antimicrobial effectiveness meet the specified criteria.
- Physical/Chemical Specifications (pH, Viscosity, Osmolality): Based on USP , USP , and USP respectively. The "ground truth" is whether the measured values fall within the specified range.
- Shelf Life: Established through an accelerated aging stability study, where the "ground truth" is the device maintaining its specifications over time under accelerated conditions.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product (personal lubricant), not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this device.
Ask a specific question about this device
(143 days)
Good Clean Love, Inc.
Desnuda Reflect 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. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Desnuda Reflect is a water-based personal lubricant that is non-sterile 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, hydroxyethyl cellulose, xanthan gum, hyaluronic acid, Zemea propanediol, sodium benzoate, potassium sorbate, and DL lactic acid. Desnuda Reflect is packaged in 2 fl. oz high-density polyethylene pump bottles. Desnuda Reflect is a personal lubricant for over-the-counter (OTC) use.
The provided text describes the 510(k) premarket notification for a medical device called "Desnuda Reflect," a personal lubricant. It does not contain information about an AI-powered device or a study involving human readers and AI assistance for medical imaging, which is what your query is geared towards.
Therefore, I cannot provide the detailed information requested in points 1-9 of your prompt, as the document concerns a physical product (personal lubricant) and its testing for safety and effectiveness as a lubricant, not a digital AI medical device.
The document discusses various performance tests relevant to a personal lubricant, such as:
- Biocompatibility testing: Cytotoxicity, sensitization, irritation, and acute systemic toxicity.
- Condom Compatibility testing: Adherence to ASTM D7661-18 for natural rubber latex and polyisoprene condoms.
- Shelf-life testing: Accelerated aging study to confirm maintenance of specifications over one year.
- Device Specifications (Table 1): Appearance, color, odor, viscosity, osmolality, pH, microbial counts (TAMC, TYMC), absence of specific pathogens, and antimicrobial effectiveness.
These tests establish the safety and effectiveness of the lubricant but are not related to the acceptance criteria or study design for an AI medical imaging device.
Ask a specific question about this device
(143 days)
Good Clean Love, Inc.
Medley 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. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Medley is a water-based personal lubricant that is non-sterile 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, hydroxyethylcellulose, xanthan gum, hyaluronic acid, Zemea propanediol, glycerin water, dimethicone, hydrogenated lecithin, sodium benzoate, potassium sorbate, and DL lactic acid. Medley is packaged in 2 fl. oz high-density polyethylene pump bottles. Medley is a personal lubricant for over-the-counter (OTC) use.
The provided text describes the 510(k) summary for a personal lubricant device named Medley. It does not contain information about a study proving the device meets acceptance criteria related to an AI/Software as a Medical Device (SaMD). The document primarily focuses on the device's physical and chemical specifications, biocompatibility, and condom compatibility based on standard testing methods for personal lubricants.
Therefore, I cannot provide a response with the requested information as it pertains to AI/SaMD performance evaluation. The document is about a physical medical device (personal lubricant), not an AI-powered diagnostic or therapeutic device.
If you have a document related to an AI/SaMD, I would be happy to analyze it for the specific criteria you've outlined.
Ask a specific question about this device
(90 days)
Good Clean Love, Inc.
BioNourish 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. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
BioNourish Lubricant is a personal lubricant that is non-sterile, contains hyaluronic acid, 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, hydroxyethylcellulose, hyaluronic acid, carrageenan, sodium chloride, xanthan gum, lactic acid, potassium sorbate, sodium benzoate, ceratonia siliqua (carob) gum, and calcium chloride. BioNourish is packaged in 2 fl. oz plastic tubes. The device is packaged with a low-density polyethylene (LDPE) applicator. BioNourish lubricant is a personal lubricant for over-the-counter (OTC) use.
The provided document is a 510(k) Pre-market Notification for a medical device (BioNourish Lubricant). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study where a device's performance is measured against predefined acceptance criteria for clinical efficacy or diagnostic accuracy. Therefore, the information requested in the prompt, which pertains to a clinical or diagnostic study design, such as sample size for test sets and training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance, is not available in this type of regulatory submission.
However, I can extract the acceptance criteria for the device's physical, chemical, and microbiological properties and the reported performance based on non-clinical testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Property | Acceptance Criteria (Specification) | Reported Device Performance (Implied by meeting spec) |
|---|---|---|
| Appearance | Clear and transparent | Clear and transparent |
| Odor | Characteristic | Characteristic |
| Viscosity | 5,000 – 28,000 cps | Within 5,000 – 28,000 cps |
| Osmolality | 250 – 400 mOsm/kg | Within 250 – 400 mOsm/kg |
| pH at 25 °C | 3.8-4.2 | Within 3.8-4.2 |
| Total Aerobic Microbial Count (USP) | ) | ) |
| Biocompatibility (Cytotoxicity) | Non-cytotoxic | Non-cytotoxic |
| Biocompatibility (Sensitization) | Non-sensitizing | Non-sensitizing |
| Biocompatibility (Irritation) | Non-irritating | Non-irritating |
| Biocompatibility (Acute systemic toxicity) | Not acutely-systemically toxic | Not acutely-systemically toxic |
| Condom Compatibility (Natural rubber latex) | Compatible | Compatible |
| Condom Compatibility (Polyisoprene) | Compatible | Compatible |
| Condom Compatibility (Polyurethane) | Not compatible | Not compatible |
| Shelf Life | 1 year (maintaining specifications) | 1 year (specifications maintained) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document describes pre-market testing to ensure the device meets specified physical, chemical, microbiological, and biocompatibility standards, not a clinical trial with a "test set" in the context of diagnostic performance or clinical efficacy. The data described appears to be from in-vitro and laboratory tests rather than human studies.
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 document does not describe a study involving expert-established ground truth for a test set, as it is not a clinical or diagnostic performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No expert adjudication method is mentioned as this document does not describe a study that would require such a method.
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-assisted diagnostic device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a personal lubricant, not an algorithm-based device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the physical, chemical, and microbiological properties, the "ground truth" or reference standard would be the established scientific and regulatory methods (e.g., USP standards for microbial count, ASTM standards for condom compatibility, ISO standards for biocompatibility). For biocompatibility, the "ground truth" is derived from the results of standardized assays.
8. The sample size for the training set
Not applicable. There is no mention of a "training set" as this is not an algorithm-based device that requires machine learning training.
9. How the ground truth for the training set was established
Not applicable. This information is not relevant to the nature of the device and the studies presented.
Summary of the Study Proving Acceptance Criteria:
The study proving the device meets its acceptance criteria involved a series of non-clinical, laboratory-based tests. These included:
- Biocompatibility Testing: Conducted in accordance with the 2016 FDA guidance document "Use of International Standard ISO 10993-1." Specific tests included:
- Cytotoxicity (per ISO 10993-5: 2009)
- Sensitization and Irritation (using human repeated insult patch testing, an alternative to ISO 10993-10:2010)
- Acute systemic toxicity (per ISO 10993-11:2017)
- Results: The device was determined to be non-cytotoxic, non-sensitizing, non-irritating, and not acutely-systemically toxic.
- Condom Compatibility Testing: Evaluated in accordance with ASTM D7661-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms."
- Results: The device was compatible with natural rubber latex and polyisoprene condoms, but not compatible with polyurethane condoms.
- Shelf Life Testing: An accelerated aging stability study was performed to determine the shelf life.
- Results: The study demonstrated a 1-year shelf life, with the device maintaining all its specified properties (as listed in Table 1) over this duration.
- Device Specifications Testing: Various tests were conducted to confirm the physical (appearance, odor, viscosity), chemical (pH, osmolality), and microbiological (total aerobic microbial count, total yeast & mold count, absence of pathogenic organisms, antimicrobial effectiveness) properties met the defined specifications in "Table 1: Subject Device Specifications."
- Results: All specified properties were met.
The conclusion of these tests was that the BioNourish Lubricant is as safe and effective as the predicate device, supporting its substantial equivalence determination.
Ask a specific question about this device
(218 days)
Good Clean Love, Inc.
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:
| Property | Acceptance Criteria (Specification) | Reported Performance |
|---|---|---|
| Appearance | Gel | Gel |
| Color | Clear | Clear |
| Odor | Characteristic | Characteristic |
| Viscosity | 1,200-10,000 cps | 1,200-10,000 cps (Implied, as this is the specification, and the product is reported to maintain specifications over shelf life) |
| Osmolality | 300–400 mOsm/kg | 300–400 mOsm/kg (Implied, as this is the specification, and the product is reported to maintain specifications over shelf life) |
| pH at 25 °C | 3.8-4.2 | 3.8-4.2 (Implied, as this is the specification, and the product is reported to maintain specifications over shelf life) |
| Endotoxin | ) | ) |
| Pseudomonas aeruginosa | Absent | Absent (Implied, as this is the specification, and the product is reported to maintain specifications over shelf life) |
| Staphylococcus aureus | Absent | Absent (Implied, as this is the specification, and the product is reported to maintain specifications over shelf life) |
| Candida albicans | Absent | Absent (Implied, as this is the specification, and the product is reported to maintain specifications over shelf life) |
| Escherichia coli, Salmonella, Clostridium | Absent | Absent (Implied, as this is the specification, and the product is reported to maintain specifications over shelf life) |
| Antimicrobial Effectiveness (E. coli, P. aeruginosa, S. aureus) | NLT a 2.0 log reduction from initial count at 14 days and no increase from the 14-day count at 28 days | Meets criteria (Implied, as per "Antimicrobial Effectiveness (USP)" testing and statement the product maintains specifications over shelf life) |
| Antimicrobial Effectiveness (C. albicans, A. niger) | No increase from the initial calculated count at 14 and 28 days | Meets criteria (Implied, as per "Antimicrobial Effectiveness (USP)" testing and statement the product maintains specifications over shelf life) |
| Biocompatibility | Meets ISO 10993-5:2009, human repeat insult patch testing (sensitization and irritation), and ISO 10993-11:2006 | Device is biocompatible (tested per ISO 10993-5:2009, human repeat insult patch testing, and ISO 10993-11:2006) |
| Condom Compatibility | Compatible with natural rubber latex and polyisoprene condoms | BioGenesis Fertility Lubricant is compatible with natural rubber latex and polyisoprene condoms (tested per ASTM D7661-10) |
| Shelf Life | 12 months | BioGenesis Fertility Lubricant maintains its specifications over the duration of its proposed shelf life of twelve months (demonstrated through accelerated aging shelf-life testing) |
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.
Ask a specific question about this device
(135 days)
Good Clean Love, Inc.
BioNude 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. This product is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms.
BioNude is a 100% isotonic water-based formula with ingredients including lactic acid, hydroxyethylcellulose, carrageenan, sodium chloride, potassium sorbate, sodium benzoate, carob gum, xanthan gum, sodium hydroxide, and calcium chloride. The product is provided in a tube container and has a gel consistency. Its specifications include appearance, color, pH, specific gravity, viscosity, antimicrobial effectiveness, total aerobic microbial count, total yeast and mold count, and absence of pathogenic organisms. 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.
The document describes the regulatory approval of the BioNude Lubricant (K180136), not a medical device in the context of an AI/ML study. Therefore, the requested information regarding acceptance criteria, study details, human reader performance, ground truth establishment, and sample sizes for an AI/ML device is not available in the provided text.
The document discusses the substantial equivalence of the BioNude Lubricant to a predicate device based on its formulation, intended use, and performance tests (biocompatibility, condom compatibility, and shelf life).
Here's what can be extracted based on the provided text, modified to indicate absence where the requested information is not applicable or not provided for this type of device:
1. Table of Acceptance Criteria and Reported Device Performance
This product is a personal lubricant, not an AI/ML medical device. Therefore, the concept of "acceptance criteria" and "device performance" relating to diagnostic accuracy, sensitivity, or specificity as would be relevant for an AI/ML device does not apply in the same way. The performance data presented are for the physical and chemical properties of the lubricant:
| Acceptance Criteria Category | Reported Device Performance (BioNude Lubricant) |
|---|---|
| Biocompatibility | Met per ISO 10993-5:2009 (cytotoxicity), human repeat insult patch testing (sensitization and irritation), and acute systemic toxicity testing per ISO 10993-11:2006. Found to be biocompatible. |
| Condom Compatibility | Met per ASTM D7661-10. Compatible with natural rubber latex and polyisoprene condoms. Not compatible with polyurethane condoms. |
| Shelf Life | Results demonstrate that BioNude maintains its specifications over the duration of their proposed shelf life. |
| Formulation & Specifications | 100% isotonic water-based formula. Specifications include appearance, color, pH, specific gravity, viscosity, antimicrobial effectiveness, total aerobic microbial count, total yeast and mold count, and absence of pathogenic organisms. (Specific numerical values for these specifications are not provided in the summary but were part of the submission.) |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable to the BioNude Lubricant as it is not an AI/ML device undergoing diagnostic performance testing. The "test sets" would refer to samples tested for biocompatibility, condom compatibility, and shelf-life, but specific sample sizes and data provenance (country of origin, retrospective/prospective) for these tests are not detailed in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is not an AI/ML diagnostic tool requiring expert consensus for ground truth establishment.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical image interpretation studies, which is not relevant here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
Not applicable. MRMC studies are used to evaluate the impact of AI on human reader performance for diagnostic tasks. This is a personal lubricant, not a diagnostic device.
6. If a Standalone Performance Study Was Done
The performance studies conducted (biocompatibility, condom compatibility, shelf life) can be considered "standalone" in the sense that they evaluated the device's intrinsic properties. However, this is not analogous to a "standalone algorithm performance" study for an AI/ML device.
7. The Type of Ground Truth Used
For the BioNude Lubricant, the "ground truth" for its performance claims is based on:
- Established scientific methods and standards: Biocompatibility standards (e.g., ISO 10993), condom compatibility standards (e.g., ASTM D7661-10), and internal quality control specifications for formulation and shelf life.
- Laboratory testing results: The outcomes of these tests directly demonstrated the product's compliance with the relevant properties.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device, so there is no training set in the AI context.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this device in the AI context.
Ask a specific question about this device
(272 days)
Good Clean Love
Good Clean Love BIO-pHRESH 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. This product is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms.
Good Clean Love BIO-pHRESH contains water-solvent materials. The primary ingredient (95%) is aloe vera and it includes aromatics of apple. The product is provided in tube container and has a gel consistency. It is supplied with a vaginal applicator. 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. The product is formulated to match the osmolality and pH found in the human vagina.
The provided document is a 510(k) premarket notification letter and supporting summary for a personal lubricant called "Good Clean Love - BIO-pHRESH." This document DOES NOT describe a study involving an AI-powered device or a medical imaging device.
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, or MRMC studies, as these concepts are not applicable to the information contained within this document.
The document discusses the substantial equivalence of the lubricant to predicate devices based on:
- Non-clinical performance testing: Compatibility with condoms (latex and polyisoprene only), antimicrobial effectiveness, appearance, color, odor, texture, pH, specific gravity, viscosity, osmolality, biocompatibility (cytotoxicity, sensitization, irritation, acute systemic toxicity), and shelf-life.
- Formulation comparison: Similar primary ingredients (aloe vera), thickeners, and preservatives to predicate devices.
- Intended use: Moisturizing and lubricating for intimate sexual activity, supplementing natural lubrication, and compatibility with specific condom types.
The conclusion drawn is that the product is as safe and effective as its predicate devices, supporting a determination of substantial equivalence for marketing.
Ask a specific question about this device
(307 days)
Good Clean Love, Inc.
Good Clean Love Personal Lubricant Almost Naked and Natural Cinnamon Vanilla are personal lubricants 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. This product is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
Good Clean Love Personal Lubricants Almost Naked and Natural Cinnamon Vanilla contain water-solvent organic materials. The primary ingredient is aloe vera (95%). The products are provided in tube containers and have a gel consistency. They include aromatics of cinnamon, vanilla, and lemon. The lubricants are not a spermicide or contraceptive. They are compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
The provided document describes the 510(k) premarket notification for "Good Clean Love Personal Lubricants Almost Naked and Natural Cinnamon Vanilla". This documentation is for a medical device (personal lubricant) and as such, the acceptance criteria and supporting studies are focused on its physical and chemical properties, biocompatibility, and compatibility with condoms, rather than performance metrics typically associated with AI/ML-based diagnostic devices.
Therefore, many of the requested points (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC comparative effectiveness study, standalone algorithm performance, training set sample size, ground truth for training set) are not applicable to this type of device submission.
Here's a breakdown of the available information based on your request:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance/Conclusion |
|---|---|---|
| Physical/Chemical Specs | Appearance | Met specifications |
| Odor | Met specifications | |
| pH | Met specifications | |
| Viscosity | Met specifications | |
| Osmolality | Met specifications | |
| Microbiological Specs | Antimicrobial effectiveness | Met specifications |
| Total microbial count | Met specifications | |
| Fungal/yeast/mold limits | Met specifications | |
| Absence of pathogenic organisms | Met specifications | |
| Shelf-Life | Established shelf-life | One-year shelf-life established |
| Condom Compatibility | Compatibility with natural rubber latex, polyisoprene, and polyurethane condoms (following ASTM D7661-10) | Concluded to be compatible with natural rubber latex, polyisoprene, and polyurethane condoms. |
| Biocompatibility | Vaginal Mucosa Irritation (ISO 10993-10:2010) | Accepted results |
| Acute Systemic Toxicity (ISO 10993-11:2006) | Accepted results | |
| Maximization Test for Delayed Hypersensitivity (ISO-10993-10:2010) | Accepted results | |
| Cytotoxicity (MatTek EpiVaginal Tissue Model) | Accepted results | |
| Substantial Equivalence | Performance as well as the legally marketed predicate device, Aloe Cadabra (K124044), for intended use and technological characteristics. | The non-clinical tests and predicate comparison demonstrate that the subject device performs as well as the legally marketed device and is substantially equivalent to the cited predicate device for intended use and technological characteristics. Both products consist of 95% organic aloe vera, are compatible with natural rubber latex and polyisoprene condoms, and are biocompatible. |
Non-AI/ML Specific Information (as per document):
- Sample size used for the test set and the data provenance: Not applicable in the context of typical AI/ML test sets. The tests performed are laboratory-based, chemical, physical, and biological assessments. "Test set" refers to samples of the product itself for analytical and biological evaluation. The data provenance is internal laboratory testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these types of tests is established by adherence to established international standards (e.g., ISO, ASTM) and validated laboratory methods, not by expert consensus in the diagnostic sense.
- Adjudication method: Not applicable. Lab testing results are objective measurements against defined specifications.
- 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/ML diagnostic device involving human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical and chemical product, not an algorithm.
- The type of ground truth used: Ground truth for this device's performance is established by objective laboratory measurements against predefined specifications and internationally recognized standards (e.g., pH, viscosity, microbial counts, compatibility according to ASTM, biocompatibility according to ISO standards).
- The sample size for the training set: Not applicable. This device does not involve a "training set" in the AI/ML context. Its development and verification involve formulation and testing.
- How the ground truth for the training set was established: Not applicable.
Ask a specific question about this device
Page 1 of 1