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H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To Tango for You, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Warming and #LubeLife Sensations Pleasure Kit for Two are personal lubricants for penile, anal and/or vaginal application, intended to lubricate and moisturize, 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 and polyisoprene condoms. These products are not compatible with polyurethane condoms.

H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To Tango for You, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Warming and #LubeLife Sensations Pleasure Kit for Two are clear, semi-viscous personal lubricants that are compatible with natural rubber latex and polyisoprene condoms. These products are not compatible with polyurethane condoms. These devices are non-sterile personal lubricants for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity supplement the body's natural lubrication. These devices are composed of water (aqua), Glycerin, Propylene Glycol, Hydroxyethylcellulose, Chlorphenesin, Capsicum Frutescens Fruit Extract and PEG-60 Hydrogenated Castor Oil.

This document describes the validation of several personal lubricants for over-the-counter use. The products are H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To Tango for You, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Warming, and #LubeLife Sensations Pleasure Kit for Two.

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 a dataset for an AI/algorithm study. The performance data is derived from various laboratory tests and a real-time aging study of the physical lubricant products themselves. Therefore, information on sample size and data provenance in terms of country of origin or retrospective/prospective for a test set is not applicable here.

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 as there is no mention of a test set requiring expert ground truth in the context of an AI/algorithm study. The "ground truth" for the device specifications and biocompatibility is established through adherence to recognized scientific standards (USP, ISO, ASTM) and laboratory testing by presumably qualified personnel in those fields.

4. Adjudication Method for the Test Set

This information is not applicable as there is no test set requiring adjudication in the context of an AI/algorithm study.

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

An MRMC comparative effectiveness study was not done. This document concerns the performance of personal lubricants, not an AI or imaging device that would involve human readers.

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

A standalone performance study for an algorithm was not done. This document is about physical personal lubricant products.

7. The type of ground truth used

The ground truth for the device's performance is based on:

• Established scientific standards and pharmacopeial monographs: USP (United States Pharmacopeia) for viscosity, pH, specific gravity, osmolality, antimicrobial effectiveness, and microbial counts.
• International standards: ISO 10993 for biocompatibility (cytotoxicity, sensitization, vaginal irritation, acute systemic toxicity), and ASTM D7661-10 for condom compatibility.
• Laboratory test results: Derived from direct measurements and analyses of the lubricant's physical and chemical properties, as well as its interaction with biological systems (biocompatibility) and condoms.
• Real-time aging study: For shelf-life determination.

8. The Sample Size for the Training Set

This information is not applicable as there is no mention of a "training set" in the context of an AI/algorithm study for these personal lubricants. The product formulation development and testing would constitute the "development" phase, but it's not described as a training set for an AI.

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

This information is not applicable as there is no "training set" in the context of an AI/algorithm study. The composition and characteristics of the lubricants were developed and confirmed through standard chemical formulation, analytical testing, and quality control processes.

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H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Cooling and #LubeLife Sensations Pleasure Kit for Two are personal lubricants for penile, anal and/or vaginal application, intended to lubricate and moisturize, 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 and polyisoprene condoms. These products are not compatible with polyurethane condoms.

H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, JO 2 To Tango for Me, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Cooling and #LubeLife Sensations Pleasure Kit for Two are clear, semi-viscous personal lubricants that are compatible with natural rubber latex and polyisoprene condoms. These products are not compatible with polyurethane condoms. These devices are non-sterile personal lubricants for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity supplement the body's natural lubrication.

H2O Cooling Personal Lubricant is sold as an over-the-counter (OTC) product in 1 fl. oz./30 mL, 2 fl. oz./60 mL and 4 fl. oz./120 mL sizes. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 1 fl. oz./30 mL size bottles are capped with natural disc tops. The 2 fl. oz./60 mL and 4 fl. oz./120 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process.

H2O Anal Cooling Personal Lubricant is sold as an over-the-counter (OTC) product in 2 fl. oz/60 mL and 4 fl. oz./120 mL. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 2 fl. oz./60 mL and 4 fl. oz./120 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process.

JO 2 To Tango for Me is sold as an over the counter (OTC) product in 2 fl. oz/60 mL. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 2 fl. oz./60 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process.

JO 2 To Tango Couples Pleasure Kit is sold as an over the counter (OTC) product in 2 fl. oz/60 mL. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 2 fl. oz./60 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process.

#LubeLife Sensations Cooling is sold as an over the counter (OTC) product in 4 fl. oz./120 mL. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 4 fl. oz./120 mL size bottles are capped with natural disc tops. The individual bottles are hermetically sealed during the production process.

#LubeLife Sensations Pleasure Kit for Two is sold as an over the counter (OTC) product in 4 fl. oz./120 mL. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 4 fl. oz./120 mL size bottles are capped with natural disc tops. The individual bottles are hermetically sealed during the production process.

These devices are composed of Water (Aqua), Glycerin, Polysorbate 20, Propylene Glycol, Hydroxyethylcellulose, Chlorphenesin, Mentha Piperita (Peppermint) Leaf Extract and Sodium Hydroxide.

The document describes the acceptance criteria and supporting studies for several H2O and JO brand cooling personal lubricants.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Biocompatibility: The document states that "Biocompatibility studies... were performed," implying specific samples were used for testing. However, the exact sample sizes (e.g., number of animals or in-vitro replicates) are not specified. The provenance is not explicitly stated beyond being performed "in accordance with the 2020 FDA Guidance document Use of International Standard ISO 10993-1" and "ISO 10993-1:2019." These are international standards. The study is prospective in nature as it involves testing the device.
• Shelf-Life: The document states "All the devices specifications listed in Table 1 were tested at 0, 1, 2 and 3 years." This indicates longitudinal testing of samples over time. The sample size at each time point is not specified. Data provenance is not detailed, but it's a real-time aging study, implying internal testing by the manufacturer. This is a prospective study.
• Condom Compatibility: The document states "The compatibility... was evaluated in accordance with ASTM D7661-10 (Reapproved 2017)." The number of lubricant and condom samples tested is not specified. This is a prospective study following an ASTM standard.

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 as the device is a personal lubricant, and the testing involves laboratory and in-vivo biocompatibility, shelf-life, and material compatibility tests, not clinical performance requiring expert interpretation of diagnostic images or patient data. The criteria are based on established scientific standards and physical properties.

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

This information is not applicable for the type of testing performed (laboratory and material compatibility). Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for resolving discrepancies in expert interpretations (e.g., radiology reads).

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 information is not applicable. The device is a personal lubricant, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance comparisons are not relevant.

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

This information is not applicable. The device is a personal lubricant, not an algorithm or AI system.

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

The "ground truth" for the performance criteria is established by:

• Established physical and chemical specifications: For properties like appearance, color, odor, viscosity, pH, specific gravity, and osmolality.
• Microbiological standards: For antimicrobial effectiveness (USP <51>) and microbial counts/absence of pathogens (USP <61>, <1111>, <62>).
• International and national testing standards: Specifically ISO 10993 for biocompatibility and ASTM D7661-10 for condom compatibility. These standards define the methodologies and corresponding acceptance criteria.
• Real-time aging study: For shelf-life, the ground truth is the documented stability of the product properties over the specified time period.

8. The sample size for the training set:

This information is not applicable. As a physical product, there is no "training set" in the context of machine learning or AI development.

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

This information is not applicable. There is no training set for this type of device.

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THIS DEVICE IS INTENDED FOR USE IN LONG-TERN RECORDING OF VOLTAGES PRODUCED BY THE BRAIN AND MEASURED ON THE SCALP (EEG) FOR SUBSEQUENT DIAGNOSTIC REVIEW WITH A DIGITAL WORK-STATION SUPPLIED BY THE MANUFACTURER (TELEFACTOR BEEKEEPER) OR SIMILAR COMPATIBLE DEVICE. AN INTEGRATED PULSE OXIMETER PROVIDES SUPPLEMENTAL DIAGNOSTIC DATA IN THE FORM OF BLOOD OXYGEN SATURATION (SpO2 percent).

The H2O system is battery powered, wearable, 32 channel EEG amplifies/recorder. The H2O system operates on a pack of eight Alkaline batteries for twelve hours or a pack of two lithium batteries for 24 hours. Unlike DEEG-LITE, the H2O recorder never operates from mains power, but only from batteries. Like DEEG-LITE, a binary, optically isolated output data stream is utilized by a notebook or desktop computer for initial setup. Unlike DEEG-LITE, all data recording in H2O is performed internally in the wearable device in a Flash-RAM for short recordings, or on an internal rotating disk for long recordings. The DEEG-LITE utilizes DSPs (Digital Signal Processors) for data manipulation and preparation. It uses a Intel-486 or Pentium processor in a notebook computer for data recording and display. H2O uses a single internal INTEL 186 processor for data manipulation and recording and an external notebook or desktop computer only for initial setup and electrode application to verify good EEG waveform at the beginning of the data recording session. To provide an added sensor modality useful in sleep recordings, the H2O incorporates a NONIN pulse oximeter board (NONIN OEM2 Pulse Oximeter Module), with a DB9 Female connector for one of the compatible NONIN finger probes.

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

The provided text, a 510(k) summary for the H2O device, focuses on demonstrating substantial equivalence to a predicate device (DEEG-LITE) rather than outlining specific, quantifiable acceptance criteria and a detailed study against them. This is typical for a 510(k) submission where the primary goal is to show the new device is as safe and effective as a legally marketed device.

Therefore, the "acceptance criteria" are implied through the comparison to the predicate device's performance, and the "study" is largely a non-clinical (bench) test demonstrating identical or better performance.

Here's the breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified, as only non-clinical (bench) tests were deemed necessary. No patient data or clinical sample size is mentioned for testing.
• Data Provenance: Not applicable, as there are no clinical studies or human data mentioned for the H2O device's performance evaluation against the predicate. The "Bench Tests" would typically involve laboratory measurements on the device itself.

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

• Not applicable. There are no clinical studies or expert-driven ground truth establishment mentioned for the performance evaluation.

4. Adjudication Method for the Test Set

• Not applicable. There are no clinical studies or expert adjudication processes described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Because of the identical performance confirmed by Bench Tests, clinical performance tests are deemed unnecessary." This indicates no human reader comparison was performed or considered necessary.

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

• This question isn't directly applicable in the context of this device. The H2O is an EEG recorder/amplifier, a hardware medical device that generates data for a clinician to review, not an algorithm that autonomously interprets data. The performance evaluation focuses on the fidelity of the recording itself, rather than an AI's interpretation of it. The "Bench Tests" would serve as the standalone performance assessment of the hardware's electrical characteristics.

7. The Type of Ground Truth Used

• The "ground truth" for the device's performance appears to be established through engineering specifications and direct measurements against the predicate device's known performance characteristics. The document highlights "equivalent noise performance," "equal or better signal to noise ratio," "equal digital resolution," and "identical sample rates" verified through bench tests. The predicate device (DEEG-LITE) itself, having been previously cleared, serves as the de facto performance standard.

8. The Sample Size for the Training Set

• Not applicable. The H2O device is a hardware EEG recorder and amplifier, not an AI/ML algorithm that requires a training set of data.

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

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

Summary of the Study:

The "study" to prove the H2O device meets its acceptance criteria (which are defined by its equivalence to the predicate DEEG-LITE) consists solely of Nonclinical (Bench Tests). These tests are described as documenting "equivalent noise performance" and verifying that the H2O's wearable amplifiers have "equal or better signal to noise ratio, equal digital resolution, and identical sample rates" compared to the DEEG-LITE system. The H2O also incorporated electrical safety design in accordance with UL2601-1 and IEC601-1 standards. The conclusion drawn from these bench tests is that "the nonclinical (Bench Tests) demonstrate that the device is safe, effective and performs as well as the predicate device." No clinical studies or human performance evaluations were conducted or deemed necessary.

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