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Interections of 2-in-1 Massage Crème™ is a personal lubricant, to enhance the ease and comfort of intimate sexual activity and supplement the body's in ural. lubrication. This product is compatible with latex condoms.

This device is developed for non-therapeutic body massage and personal lubricant compatible with latex condom that imparts a warming sensation upon the skin.

The provided document is a 510(k) premarket notification for a medical device: K-Y® Brand IntrigueTM 2-in-1 Massage CrèmeTM. This is a personal lubricant, and the submission primarily focuses on demonstrating its substantial equivalence to a predicate device, K-Y® Brand Touch MassageTM 2-in-1 Warming® body massage + Personal lubricant.

The information provided does not describe a study involving an AI or algorithm-driven device. Instead, it outlines the regulatory submission for a physical personal lubricant. Therefore, I cannot provide details on acceptance criteria and a study that proves an AI device meets these criteria based on the input text.

However, I can extract information related to the performance data presented for this physical device, which addresses some aspects of your request, even though it's not for an AI.

Here's the relevant information based on the provided text, structured to align with your request where applicable, but noting its non-relevance for AI:

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

Since this is not an AI device, there are no specific quantitative acceptance criteria like sensitivity, specificity, or AUC that would typically be reported for an AI. Instead, the "acceptance criteria" are implied by the safety and performance standards for personal lubricants, particularly condom compatibility and lubricity.

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 mentions "laboratory testing, pre-clinical evaluations and testing, and human use data." However, it does not provide specific sample sizes for these tests. The provenance (e.g., country of origin, retrospective/prospective) is also not detailed in the provided text.

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 is not applicable to this type of device submission. Ground truth, in the context of AI, usually refers to labeled data for diagnostic purposes. For a personal lubricant, "ground truth" would be established through physical and chemical testing, and human sensory evaluation, not through expert consensus in the diagnostic sense. The document does not specify the number or qualifications of individuals conducting "pre-clinical evaluation" or participating in "human use data collection."

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

Not applicable, as this is not a diagnostic AI device requiring adjudication of 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 not an AI device, and no MRMC study involving human readers and AI assistance was conducted.

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

Not applicable. This is not an algorithm.

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

For this device, the "ground truth" for its performance characteristics would be based on:

• Laboratory test results: For condom compatibility and lubricity (e.g., measuring force, friction, integrity).
• Pre-clinical evaluation and testing: Likely involving various biological and chemical assays to assess safety.
• Human use data: Direct experience and feedback from individuals using the product to confirm safety and performance (e.g., absence of irritation, desired lubricity).

8. The sample size for the training set

Not applicable, as there is no training set for an AI algorithm here.

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

Not applicable. There is no training set for an AI algorithm here.

In summary, the provided document is a regulatory submission for a physical medical device (personal lubricant) and does not concern an AI or algorithm-driven device. Therefore, most of the questions regarding AI-specific criteria are not applicable. The information describes standard laboratory, pre-clinical, and human use testing to demonstrate the safety and performance of a physical product.

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K-Y® Brand YOURS+MINE™ is intended as a personal lubricant for penile and vaginal application compatible with latex condom.

The devices are personal lubricants compatible with latex condom.

The provided text describes a 510(k) premarket notification for a personal lubricant, K-Y® Brand YOURS+MINE™. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and standalone algorithm performance as would be expected for a typical AI/ML medical device.

Based on the provided information, here's a breakdown of the requested elements:

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly uses the "substantial equivalence" framework, meaning the device's performance should be comparable to a legally marketed predicate device. The acceptance criteria are therefore tied to demonstrating this equivalence through various tests.

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

The document mentions "laboratory testing, pre-clinical evaluations and testing, and human use," but does not specify the sample sizes for these tests.
The data provenance is also not specified, such as country of origin or whether it was retrospective or prospective. It infers prospective testing for "pre-clinical evaluations and testing, and human use."

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 a personal lubricant, "ground truth" would generally refer to established scientific standards for chemical and physical properties, and safety evaluations. The document does not detail who performed these evaluations or their qualifications beyond stating it was "laboratory testing" and "pre-clinical evaluations."

4. Adjudication Method for the Test Set:

This information is not provided. Given the nature of personal lubricant testing, formal adjudication methods (like 2+1 reader consensus) are typically not applicable. The evaluations likely relied on established laboratory protocols and safety assessment methodologies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not conducted as this device is a personal lubricant, not an AI/ML diagnostic tool that would involve human readers interpreting cases.

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

Not applicable. This device is a personal lubricant, not an algorithm or AI/ML product. Therefore, standalone performance of an algorithm is not relevant.

7. The Type of Ground Truth Used:

The ground truth for this device appears to be based on:

• Established scientific and engineering principles for condom compatibility (e.g., integrity, burst pressure).
• Biophysical measurements for lubricity.
• Safety assessments based on pre-clinical evaluations (e.g., toxicology, irritation studies) and human use data (e.g., adverse event reporting, user acceptability).
• Comparison to a legally marketed predicate device and its established performance and safety profiles.

8. The Sample Size for the Training Set:

Not applicable. This device is a personal lubricant and does not involve AI/ML that requires a training set. The term "training set" is not relevant to this submission.

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

Not applicable for the same reasons as above.

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K-Y® Brand Intrigue™ Intense Warming Sensation is intended as a personal lubricant for penile and vaginal application compatible with latex condom.

This device is a personal lubricant compatible with latex condom.

The provided document is a 510(k) Summary for a medical device called "K-Y® Brand Intrigue™ Intense Warming Sensation," which is a personal lubricant. It does not include information about a study involving an AI/algorithmic device with acceptance criteria, ground truth, or expert review in the manner typically described for such technologies.

The performance data mentioned in the document relates to laboratory testing, pre-clinical evaluations, and human use to demonstrate equivalence to a predicate device. This is a very different type of evaluation than what is requested in the prompt for an AI-powered device.

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence of a personal lubricant to a legally marketed predicate device based on its physical and performance characteristics, and its safety for human use and compatibility with latex condoms. It does not involve AI or algorithms that would require the specified acceptance criteria and ground truth methodologies.

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K-Y® Brand Touch Massage® 2-in-1 Tingling™ is intended as a body massage + personal IN-1 - Drain For penile and vaginal application compatible with latex condom.

This device is a body massage + personal lubricant compatible with latex condom that has been specifically developed produce a tingling sensation and a minty scent.

The provided text is a 510(k) Summary of Safety and Effectiveness for a personal lubricant and body massage product. It does not describe an AI medical device or a study involving acceptance criteria and device performance in the way a typical AI medical device submission would. Instead, it focuses on demonstrating substantial equivalence to a predicate device through laboratory testing and pre-clinical evaluations.

Therefore, many of the requested categories (such as sample size for test/training set, number of experts, adjudication method, MRMC study, standalone performance, and ground truth type) are not applicable to this particular submission.

Here's a breakdown of the relevant information from the provided text according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test set sample size: Not explicitly stated as a single "test set" in the context of an AI device. The submission mentions "laboratory testing, pre-clinical evaluations and testing, human RIPT and use test." Specific sample sizes for each of these tests are not provided.
• Data provenance: Not specified (e.g., country of origin, retrospective/prospective).

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

• Not applicable as this is not an AI device relying on expert-defined ground truth for image interpretation or diagnosis. The "ground truth" here is based on chemical and physical properties testing, and human safety testing.

4. Adjudication method for the test set:

• Not applicable.

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, as this is not an AI medical device.

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

• Not applicable, as this is not an AI medical device.

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

• The "ground truth" or basis for claims in this submission is derived from:
  • Laboratory testing: For properties like condom compatibility and lubricity.
  • Pre-clinical evaluations: For ingredient safety.
  • Human Repeat Insult Patch Test (RIPT): For skin sensitization.
  • Use test: Implied for overall performance and user experience, but details are not provided.

8. The sample size for the training set:

• Not applicable, as this is not an AI medical device.

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

• Not applicable, as this is not an AI medical device.

Summary of the Study (as described for this device):

The study to "prove the device meets acceptance criteria" involved a series of laboratory tests, pre-clinical evaluations, and human safety tests.

• Laboratory Testing: Demonstrated compatibility with leading commercial latex condoms and confirmed lubricity comparable to the predicate device.
• Pre-clinical Evaluations: Assessed the safety of the ingredients, noting they are "generally recognized as safe (GRAS)" and that prototype testing confirmed overall safety for use in personal lubricant products.
• Human RIPT (Repeat Insult Patch Test): Concluded that the device is non-sensitizing.
• Use Test: Mentioned generally as contributing to the equivalency demonstration.

The overall conclusion was that these tests collectively demonstrate the proposed device is substantially equivalent to the predicate device (K-Y® Brand ULTRA GEL™) in terms of technology, intended use, safety, and suitability characteristics.

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K-Y® Brand SENSUAL MIST™ is intended as a personal lubricant (for penile and vaginal application) compatible with latex condom.

This device is a condom compatible personal lubricant that has been specifically developed to be delivered via a non-aerosol spray pump.

The provided text describes a 510(k) Special Device Modification for the K-Y® Brand SENSUAL MIST™ Personal Lubricant. The filing emphasizes the device's substantial equivalence to predicate devices, particularly K-Y® Brand Liquid. However, the document does not contain explicit acceptance criteria or a study designed to prove the device meets specific performance criteria in the way one might expect for a new, high-risk medical device.

Instead, the submission focuses on demonstrating substantial equivalence to an existing, legally marketed predicate device (K-Y® Brand Liquid). This means the primary "acceptance criterion" is that the modified device performs equivalently to the predicate and is safe and effective for its intended use.

Here's an analysis of the provided information, framed to answer your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

As explicit quantitative "acceptance criteria" and their corresponding device performance values are not detailed in the provided text (like sensitivity, specificity, accuracy, etc.), I will extrapolate the information based on the nature of a 510(k) substantial equivalence submission for a personal lubricant.

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

• Sample Size: Not explicitly stated in terms of a specific number of instances. The document mentions "leading commercial brands of latex condoms" for compatibility testing, but not the number of condoms tested. For the "human RIPT," it doesn't specify the number of human participants.
• Data Provenance: The studies mentioned ("laboratory testing," "pre-clinical evaluations," and "human RIPT") appear to be prospective studies conducted specifically for this device modification. The country of origin of the data is not specified, but given the submitter's location (Skillman, NJ, USA) and the FDA submission, it's presumed to be conducted or overseen within the US or to standards acceptable for US regulatory submission.

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

• This information is not provided in the document. The studies described are more focused on direct physical/chemical properties (condom compatibility, lubricity, particle size) and biological responses (RIPT) rather than expert-based "ground truth" establishment for diagnosis or interpretation.

4. Adjudication Method for the Test Set

• This information is not applicable/not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where multiple human readers interpret data (e.g., medical images) and their disagreements need to be resolved to establish a ground truth. The studies for this lubricant are laboratory and pre-clinical in nature.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or is not described. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiology AI). The K-Y® Brand SENSUAL MIST™ is a personal lubricant, and its evaluation does not involve human readers interpreting "cases."

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

• Applicable in a different context: While not an "algorithm" in the AI sense, the performance data presented (condom compatibility, lubricity, particle size analysis, RIPT) can be considered "standalone" performance evaluations of the device itself, without human intervention in its efficacy assessment in the way a human-in-the-loop study would assess an AI. The device's properties were tested objectively.

7. Type of Ground Truth Used

• The "ground truth" in this context is established through a combination of:
  • Laboratory measurements: For condom compatibility, lubricity (presumably measured by standardized methods), and particle size analysis.
  • Pre-clinical evaluations: For ingredient safety.
  • Human RIPT (Repeat Insult Patch Test): For skin sensitization, where the "ground truth" is the observed biological reaction (or lack thereof) in human participants.
  • Regulatory standards/guidelines: Underlying the expectation for GRAS ingredients and the design of the RIPT.

8. Sample Size for the Training Set

• Not applicable/not provided. The concept of a "training set" is relevant for machine learning algorithms. This submission is for a physical medical device (personal lubricant), not an AI/ML algorithm.

9. How Ground Truth for the Training Set Was Established

• Not applicable/not provided. As there is no training set for an AI/ML model, the establishment of ground truth for such a set is not relevant to this submission.

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o.b.® Tampons are to be inserted into the vagina in order to absorb menstrual fluid.

The device is a cotton/rayon pledget with a removal string. It is available in various absorbencies.

Acceptance Criteria and Study for o.b.® Tampons:

1. Table of Acceptance Criteria and Reported Device Performance

Study Information:

The provided document describes a modification to the o.b.® Tampons and aims to establish substantial equivalence to legally marketed o.b.® tampons. The study supporting this claim of substantial equivalence is outlined in the "Performance data" and "Clinical Equivalency" sections.

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

• Sample Size for Test Set: The document states "healthy females" for the clinical equivalency study. However, the specific number of subjects in this study is not provided.
• Data Provenance: The document does not explicitly state the country of origin for the clinical study. It does not explicitly state retrospective or prospective, but the description of a "randomized, double-blind, two-way crossover study" implies a prospective clinical trial.

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

• Number of Experts: This information is not provided in the document.
• Qualifications of Experts: This information is not provided in the document. The assessments mentioned (vaginal culture, speculum examinations, colposcopy) would typically be performed by medical professionals (e.g., gynecologists or trained clinicians), but their specific qualifications, number, or role in establishing ground truth (other than performing examinations) are not detailed.

4. Adjudication Method for the Test Set

• The document does not describe an adjudication method for the test set. It mentions assessments were performed, but not how disagreements or interpretations between multiple assessors (if any) were resolved.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance?

• Not Applicable. This document describes the safety and effectiveness of a menstrual tampon, not an AI-assisted diagnostic or imaging device. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study regarding AI assistance is not relevant or mentioned.

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

• Not Applicable. This document describes the safety and effectiveness of a menstrual tampon, not an algorithm or AI device.

7. The Type of Ground Truth Used

• The ground truth for the clinical equivalency study appears to be established through a combination of:
  • Clinical Assessments: Vaginal culture, speculum examinations, vaginal and cervical colposcopy performed by healthcare professionals.
  • Subjective Reporting: Subject diaries detailing tampon use.
  • Lab Tests: The "Performance Data" section also details various in-vitro and animal toxicology studies (e.g., cytotoxicity, irritation tests, TSST-1).

8. The Sample Size for the Training Set

• Not Applicable. As this is not an AI/ML device, there is no "training set." The studies described are for direct evaluation of the medical device itself.

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

• Not Applicable. See response to #8.

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