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The Nirvana device is indicated for hair removal and permanent hair reduction.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

The NIRVANA is a diode laser device indicated for hair removal and permanent hair reduction. The device is provided with two different handpieces that deliver the laser energy to the patient. The NIRVANA electrical specifications are: 100-115V~, 50/60Hz, 1600VA.

The provided document is a 510(k) premarket notification for a medical device called "Nirvana," a diode laser indicated for hair removal and permanent hair reduction. It details the device's characteristics, its comparison to predicate devices, and non-clinical performance data.

However, the document does not contain information about acceptance criteria or a study that proves the device meets those criteria in a clinical performance context. Specifically, there is no mention of:

• Clinical performance data: The document explicitly states "Clinical Performance Data: None."
• Acceptance criteria for device performance: There is no table or description of specific metrics (e.g., accuracy, sensitivity, specificity, reduction percentage) that the device must achieve to be considered effective or safe, especially in terms of hair reduction.
• Study design for clinical evaluation: No information on sample size, data provenance, ground truth establishment, expert involvement, or statistical analysis for clinical effectiveness is provided.
• AI/Algorithm performance metrics: This device is a laser hair removal system, not an AI-driven diagnostic or assistive device. Therefore, metrics like MRMC studies, standalone algorithm performance, or human-in-the-loop improvement with AI assistance are not applicable.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on:

• Intended Use/Indications: The Nirvana device's indications for use are a subset of or identical to the predicate and reference devices.
• Technical Specifications: Comparison of wavelengths, spot sizes, fluence, pulse duration, and power to predicate devices.
• Non-Clinical Performance Data: Electrical safety, EMC, and software validation testing to relevant standards.

Therefore, I cannot fulfill your request for: "A table of acceptance criteria and the reported device performance" (clinical performance), "Sample sized used for the test set and the data provenance," "Number of experts used to establish the ground truth," "Adjudication method," "MRMC comparative effectiveness study," "Standalone performance," "Type of ground truth," "Sample size for the training set," and "How the ground truth for the training set was established" because this information is not present in the provided 510(k) summary.

The manufacturer has demonstrated substantial equivalence through non-clinical means and comparison to legally marketed predicate devices, rather than through a new clinical performance study. This is a common pathway for 510(k) clearances when a device is sufficiently similar to existing ones.

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Nirvana D is a personal lubricant for penile 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. This product is compatible with natural rubber latex and polyisoprene condoms. Not compatible with polyurethane or other condoms.

The Nirvana D Personal Lubricant is an anhydrous, non-sterile, clear silicone-based personal lubricant composed of dimethicone, dimethiconol, vanillyl butyl ether ("VBE") and hexyl nicotinate. Nirvana D Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms. This product is not a spermicide or a contraceptive. The product is packaged in a polyethylene terephthalate (PET) bottle with a screw-on, flip top polypropylene (PP) closure constituting the device's primary packaging. One bottle is packaged into a cardboard carton, which constitutes the device outer packaging

The provided document describes the 510(k) submission for the Nirvana D Personal Lubricant. The information requested pertains to studies typically performed for AI/ML-driven medical devices, which involve performance metrics like sensitivity, specificity, and reader studies. However, the Nirvana D Personal Lubricant is not an AI/ML-driven device. It is a silicone-based personal lubricant, and its evaluation focuses on biocompatibility, condom compatibility, and shelf-life, rather than statistical performance metrics like those used for diagnostic algorithms.

Therefore, the requested information cannot be fully provided in the context of this device. I will extract the relevant information that is present in the document.

Here's a breakdown of the relevant information from the document:

1. Table of acceptance criteria and the reported device performance:

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

• Biocompatibility Testing: The specific sample sizes for the in vivo animal tests (Rabbit Vaginal/Penile Irritation, Acute Systemic Toxicity, Guinea Pig Maximization, Primary Rabbit Skin Irritation) are not explicitly stated in the provided text. Cell cultures would be used for cytotoxicity. The data provenance is not specified beyond "testing was performed in accordance with ISO 10993."
• Condom Compatibility Testing: "Three marketed brands of pre-lubricated and un-lubricated dry natural rubber latex condoms and one brand of polyisoprene condoms were tested." This refers to the types of condoms, not necessarily the number of individual condoms tested. The provenance is not specified.
• Shelf-life Testing: The sample size for the accelerated aging study is not specified.

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

This is not applicable as the device is not an AI/ML diagnostic tool. Performance is based on standardized biological and physical testing, not expert consensus or interpretation of images/data. The "ground truth" would be established by the results of the scientific tests themselves, according to established protocols like ISO 10993 and ASTM D7761-10.

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

Not applicable. This device is not an AI/ML diagnostic tool requiring adjudication of expert 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 device is a personal lubricant, not an AI/ML system, so no MRMC study was performed.

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.

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

The "ground truth" for this device's evaluation is primarily based on:

• Biological responses: Observed reactions in established in vitro (cytotoxicity) and in vivo (irritation, sensitization, systemic toxicity) models, conforming to recognized standards (ISO 10993).
• Physical performance standards: Compatibility with condoms assessed against an ASTM standard (ASTM D7761-10, modified).
• Physicochemical stability: Evaluation of viscosity, odor, color, appearance, and microbial counts over time.

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not an AI/ML device.

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

Not applicable. There is no "training set" as this is not an AI/ML device.

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TINGLY WARMTH is a personal lubricant for penile 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. This product is compatible with natural rubber latex and polyisoprene condoms. Not compatible with polyurethane or other condoms.

The TROJAN™ LUBRICANTS Tingly Warmth Personal Lubricant is an anhydrous, non-sterile, clear silicone-based personal lubricant composed of dimethicone, dimethiconol, menthol, and vanillyl butyl ether. TROJAN™ LUBRICANTS Tingly Warmth Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms. This product is not a spermicide or a contraceptive. The product is packaged in a polyethylene terephthalate (PET) bottle with a screw-on, flip top polypropylene (PP) closure constituting the device's primary packaging. One bottle is packaged into a cardboard carton, which constitutes the device outer packaging.

The provided document is a 510(k) Premarket Notification for a personal lubricant, not a device that relies on algorithms or AI for performance. Therefore, many of the requested categories related to algorithm performance, ground truth, experts, and multi-reader studies are not applicable.

Here's a breakdown of the acceptance criteria and supporting studies as described in the document for the TROJAN™ LUBRICANTS Tingly Warmth Personal Lubricant:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Biocompatibility: The specific number of animals/samples used for each biocompatibility test (e.g., number of rabbits, guinea pigs) is not specified in the summary. The tests are general biological evaluation tests as per ISO 10993.
• Condom Compatibility: The document states that "Three marketed brands of pre-lubricated and un-lubricated dry natural rubber latex condoms and one brand of polyisoprene condoms were tested." The number of individual condoms tested per brand is not specified.
• Data Provenance: The document does not specify the country of origin of the data. Given it's a US FDA 510(k) submission, it's regulated for the US market. The studies appear to be prospective tests specifically conducted for this submission.

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

• This question is not applicable as the device is a personal lubricant, and its performance is evaluated through laboratory and non-clinical (biocompatibility, condom compatibility, shelf-life) testing, not by expert interpretation of data like medical images.

4. Adjudication Method for the Test Set

• This question is not applicable. The tests performed are objective laboratory and physical property evaluations, not subjective assessments requiring adjudication among multiple readers.

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 as the device does not involve AI or human interpretation of data.

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

• This question is not applicable as the device is a physical product (lubricant), not an algorithm or software.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is established by objective laboratory measurements and standardized test methods.
  • For biocompatibility: Standardized ISO 10993 assays with pass/fail criteria (e.g., non-cytotoxic, non-irritating).
  • For condom compatibility: ASTM D7761-10 (modified) with criteria for compatibility.
  • For shelf-life: Results from accelerated aging studies (and later real-time studies) according to established stability protocols.

8. The Sample Size for the Training Set

• This question is not applicable as there is no "training set" for this type of device. The product is a physical chemical formulation, not an algorithm that requires training data.

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

• This question is not applicable for the reasons stated in point 8.

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[Continuous Silkiness - Warm & Tingling][Continuous Silkiness] is a personal lubricant, for penile 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. This product is compatible with natural rubber latex and polyisoprene condoms. Not compatible with polyurethane or other condoms.

The device will be available in two forms - as the TROJAN™ LUBRICANTS Continuous Silkiness- Warm & Tingling Personal Lubricant and as the TROJAN™ LUBRICANTS Continuous Silkiness Personal Lubricant - each an aqueous, non-sterile, clear personal lubricant compatible with natural rubber latex and polyisoprene condoms. TROJAN™ LUBRICANTS Continuous Silkiness- Warm & Tingling Personal Lubricant consists of low levels of sensory ingredients.

TROJAN™ LUBRICANTS Continuous Silkiness Personal Lubricant is composed of propylene glycol, water, dimethicone, dimethicone/vinyl dimethicone crosspolymer, hydroxyethyl acrylate, sodium acryloyl dimethyl taurate copolymer, methylparaben, and propy|paraben, TROJAN™ LUBRICANTS Continuous Silkiness- Warm & Tingling Personal Lubricant is composed of propylene glycol, water, dimethicone, dimethicone/vinyl dimethicone crosspolymer, hydroxyethyl acrylate, sodium acryloyl dimethyl taurate copolymer, methylparaben, menthol, propylparaben, and vanillyl butyl ether. Each product is not a spermicide or a contraceptive and is packaged in a polyethylene terephthalate (PET) bottle with a screw-on, flip top polypropylene (PP) closure constituting the device's primary packaging. One bottle is packaged into a cardboard carton, which constitutes the device outer packaging.

The provided text is a 510(k) Premarket Notification for a personal lubricant, not a device that uses AI or requires the extensive study types mentioned in your request (MRMC, standalone algorithm, ground truth establishment for training/test sets with experts).

Therefore, I cannot fulfill your request as it pertains to a medical device that would involve the requested AI-specific acceptance criteria and study details. The document describes biocompatibility testing, condom compatibility testing, and shelf-life studies for a personal lubricant.

Here's an attempt to extract relevant information from the provided text, reinterpreting your request to fit the context of a personal lubricant:

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

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

• Biocompatibility Testing: The specific sample sizes for each biocompatibility test (e.g., number of rabbits, number of guinea pigs) are not specified in the provided document. The data provenance is not explicitly stated but would typically be from laboratory studies.
• Condom Compatibility: The document states "Three marketed brands of pre-lubricated and un-lubricated dry natural rubber latex condoms and one brand of polyisoprene condoms were tested." This indicates a sample size of at least 4 types of condoms (3 natural rubber latex + 1 polyisoprene). The data provenance is laboratory testing using ASTM D7761-10.
• Shelf-life: Not specified, but likely refers to samples of the lubricant product itself.

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 to the type of device and testing described. Biocompatibility and condom compatibility tests rely on standardized protocols and objective measurements, not expert human interpretation in the way an AI diagnostic tool would.

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

This question is not applicable. The tests are laboratory-based with objective endpoints measured according to established standards.

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 is not applicable as the device is a personal lubricant, not an AI-assisted diagnostic or imaging device.

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

This is not applicable as the device is a personal lubricant, not an algorithm.

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

For the tests described:

• Biocompatibility: Ground truth is established by the observed biological responses in accordance with ISO 10993 standards and comparison to known safe materials/responses.
• Condom Compatibility: Ground truth is based on the physical integrity and burst properties of condoms after exposure to the lubricant, as measured by ASTM D7761-10.
• Shelf-life: Ground truth is based on chemical and physical stability measurements over time.

8. The sample size for the training set

This is not applicable as there is no "training set" for a personal lubricant in the context of AI development.

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

This is not applicable as there is no "training set" for a personal lubricant in the context of AI development.

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