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Pulsaderm ACE-All Blue is indicated to treat mild to moderate acne on the face.

The Pulsaderm ACE-All Blue is a device that uses Blue Light Emitting Diodes to provide LED Light therapy to the skin. Blue light is emitted for the treatment of mild to moderate acne.

The provided document is a 510(k) Pre-Market Notification for the Pulsaderm ACE-All Blue device, which is an LED light therapy system for treating mild to moderate acne. This type of document focuses on establishing substantial equivalence to existing legally marketed devices rather than presenting a standalone study with detailed clinical performance metrics against specific acceptance criteria.

Therefore, the document does not contain the requested information about acceptance criteria and a study proving the device meets those criteria in the typical sense of a clinical trial demonstrating efficacy against a defined endpoint. Instead, it relies on demonstrating equivalence in technological characteristics and safety to predicate devices.

However, I can extract the information that is present concerning performance testing and a lay-user study, and explicitly state what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document focuses on technical specifications comparison, safety standards compliance, and a lay-user study for usability, rather than clinical efficacy against a pre-defined acceptance criteria for acne treatment effectiveness.

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

• Sample Size for Test Set: The document does not specify the exact sample size for the "lay-user study". It only mentions "study data was collected".
• Data Provenance: The lay-user study was described as being conducted "with Institutional Review Board (IRB) approval and oversight." No specific country of origin is mentioned, but the company is based in Fort Myers, FL, USA, suggesting a US-based study. The study was prospective in nature, as it involved observing users reading instructions and attempting to use the device.

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

• This information is not provided as the "ground truth" for the lay-user study was based on observed successful use of the device by the participants themselves, as per the instructions. There were no "experts" establishing a disease-related ground truth, as the study was about usability of instructions.

4. Adjudication Method for the Test Set

• This information is not provided. Given the nature of the lay-user study (observing proper usage based on instructions), an adjudication method in the traditional sense (e.g., 2+1 reads of medical images) would not be applicable. The assessment was likely direct observation of user interaction with instructions and the device.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is irrelevant for this device, which is a standalone light therapy device, not an AI-assisted diagnostic or interpretation tool for human readers.

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

• The device itself is a "standalone" light therapy device. The non-clinical testing included a "lay-user study" which assessed the ability of users to follow instructions to operate the device correctly. This is a form of standalone performance assessment in terms of usability and safety, but not clinical efficacy. No "algorithm only" performance was assessed as it's not an AI/software device.

7. The Type of Ground Truth Used

• For the lay-user study, the "ground truth" was defined by the ability of participants to correctly follow the instructions and use the device as intended. This is an operational or usability ground truth, not a clinical one (like pathology or outcome data).

8. The Sample Size for the Training Set

• This information is not applicable and not provided. The Pulsaderm ACE-All Blue is an LED light therapy device; it does not involve machine learning algorithms that require a "training set" of data.

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

• This information is not applicable as there is no training set for this device.

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Pulsaderm Acne Device is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne on the face.

The Pulsaderm Acne Device is a device that uses Blue and Red Light Emitting (LED) Diodes to provide LED Light therapy to the skin. A combination of red light and blue light is emitted for the treatment of mild to moderate acne.

The Pulsaderm Acne Device is compared against predicate devices to demonstrate substantial equivalence, rather than establishing specific acceptance criteria for performance metrics like accuracy, sensitivity, or specificity commonly seen in diagnostic devices. The acceptance criteria and supporting studies focus on safety, proper use by lay users, and observable clinical benefits relevant to its intended use for mild to moderate acne.

Here's an analysis based on the provided document:

1. Acceptance Criteria and Reported Device Performance

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

• Lay-user study (for proper usage): The document does not explicitly state the sample size for the lay-user study. It mentions the study was conducted to "determine if lay users could read the product labeling and then self-assess if the Pulsaderm acne device would be beneficial for them to use."
• Clinical Study (for effectiveness): 26 male and female subjects
• Data Provenance: Both studies were conducted with "Institutional Review Board (IRB) approval and oversight." This indicates a prospective study design. The country of origin of the data is not specified, but the submission is to the U.S. FDA, suggesting the studies were likely conducted in the U.S. or to international standards acceptable to the FDA.

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

• Lay-user study: No experts were explicitly mentioned for establishing ground truth regarding proper usage. The "ground truth" here was the observed ability of lay users to follow instructions and self-select.
• Clinical Study: An "expert clinical grading of facial lesion redness" was performed.
  • Number of experts: Not specified.
  • Qualifications of experts: Only "expert clinical grading" is mentioned. Specific qualifications (e.g., dermatologist, years of experience) are not provided in this summary.

4. Adjudication Method for the Test Set

• Lay-user study: Not applicable. The assessment was based on direct observation of user behavior and self-assessment of selection criteria.
• Clinical Study: Not explicitly stated. For "expert clinical grading," a single expert could have performed the grading, or multiple experts might have been involved without a specified adjudication method like 2+1 or 3+1. However, the summary does not provide these details.

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

• No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. This device is a light therapy device, not an AI-powered diagnostic or assistive tool, so such a study would not be relevant.

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

• This question is not applicable as the Pulsaderm Acne Device is a physical light therapy device, not an algorithm or software. Its performance is inherent in its physical emission of light, with the subject ("human-in-the-loop") being the direct recipient of treatment.

7. Type of Ground Truth Used

• Lay-user study: The ground truth for proper use was established by observing user behavior against defined instructions and their self-assessment based on provided labeling.
• Clinical Study:
  • Lesion size: Measured by an "electronic caliper," which can be considered an objective measurement providing clinical ground truth.
  • Redness: Established by "expert clinical grading," indicating expert consensus/assessment.
  • Combined lesions: A combination of objective measurements and expert assessment.
  • Consumer perception questionnaires: Used to gather subjective patient feedback, which is also a form of data collection in clinical assessment but distinct from objective or expert-derived ground truth.

8. Sample Size for the Training Set

• Not applicable. The Pulsaderm Acne Device is a hardware medical device and does not involve AI or machine learning algorithms that require a "training set" in the computational sense. The studies described are performance validation studies for the device itself.

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

• Not applicable for the reasons stated in point 8.

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NutraStim Hair Laser Helmet is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood Hamilton Classifications of IIa to V patterns of hair loss and treat Androgenetic Alopecia and promote hair growth in females who have Ludwig (Savin) Scale I-4, II-1, II-2, or frontal, both with Fitzpatrick Skin Types I to IV.

NutraStim Hair Laser Helmet is a low-level laser device and is intended/indicated for over- the -counter use. The device emits laser light with the intention to promote hair growth. The device provides timed treatments of distributed laser light to 100% of the scalp at 650 +/- 5 nanometers. The lasers are configured inside a helmet, designed for hands-free operation during treatment. The helmet is for portable use with rechargeable battery and adapter.

The provided document describes the NutraStim Hair Laser Helmet, a low-level laser device intended to treat Androgenetic Alopecia and promote hair growth. The device is being submitted for 510(k) clearance, asserting substantial equivalence to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and supporting study based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in the format of pass/fail metrics with specified thresholds for clinical efficacy. Instead, it focuses on demonstrating substantial equivalence to predicate devices, primarily through technological characteristics and safety standards.

However, we can infer some key performance and safety characteristics against which the device was evaluated, and its reported performance:

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

The document mentions a "lay-user study and self-selection study" but does not specify the sample size used for this test set.

The data provenance is not explicitly stated in terms of country of origin. The study was conducted with "Institutional Review Board (IRB) approval and oversight," which typically implies prospective data collection, but this is not explicitly confirmed as "prospective" or "retrospective" in the text. Given the nature of a "lay-user study and self-selection study" for device usability, it's highly probable it was a prospective study where participants interacted with the device and its instructions in a controlled setting.

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

For the lay-user and self-selection study, the concept of "ground truth" as it relates to expert medical diagnosis or outcome (e.g., hair growth assessment by radiologists) is not applicable here. The "ground truth" for this usability study would be the observable ability of lay users to correctly understand instructions and self-select.

There is no mention of experts being used to establish a medical or diagnostic ground truth for the device's efficacy. The study focused on usability and understanding of instructions.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for the lay-user and self-selection study. Adjudication, such as 2+1 or 3+1, is typically used for ambiguous or complex diagnostic assessments, which is not the nature of this usability study. The determination of whether a user "successfully follow[ed] the instructions" or "properly self-select[ed] themselves" likely came from direct observation and analysis of their actions and responses during the 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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This device is a direct-to-consumer medical device (infrared lamp/laser for hair growth) and does not involve human readers interpreting images or data, nor does it involve AI assistance in the way a diagnostic AI would. Therefore, the concept of "effect size of how much human readers improve with AI vs without AI assistance" is not relevant here.

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

The device is a physical laser helmet and does not involve an algorithm or AI in the traditional sense. Its performance is inherent in its physical parameters (wavelength, power, treatment protocol) and its interaction with the human scalp. Therefore, a "standalone algorithm-only" performance study is not applicable. The "standalone" performance would be its direct physical output characteristics, which were tested against engineering standards (e.g., IEC 60825-1 for laser classification, output per diode).

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

For the lay-user and self-selection study, the ground truth was based on the observable actions and stated understanding of the lay users regarding the product labeling and user manual. It's an assessment of user comprehension and usability, rather than a clinical ground truth for hair growth outcomes.

The broader "performance data" supporting substantial equivalence relies on:

• Engineering and Safety Standards Compliance: Confirmed by testing to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60825-1, and ISO 14971.
• Comparison to Predicate Device Specifications: Wavelength, output, laser classification, number of diodes, treatment protocol, etc., are directly compared to those of legally marketed predicate devices, implying that the established performance and safety profiles of these predicates serve as a de facto "ground truth" for substantial equivalence.

8. The Sample Size for the Training Set

This document describes a premarket notification for a medical device that does not use machine learning or AI algorithms in its core functionality. Therefore, the concept of a "training set" for an algorithm is not applicable. The data presented supports its safety and technological equivalence, not the training of an AI model.

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

As there is no training set for an AI algorithm, this question is not applicable.

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The Nutra Face LIFT Model PE8050 device is intended for facial stimulation and indicated for over-the-counter cosmetic use.

The Nutra Face Lift is a hand-held device intended to apply low level electrical impulses to strategic locations on the face. The Nutra Face Lift probes are designed for optimal contact with the face. The device continually alternates between the positive and negative probes and allows the user to adjust the settings from 0 to 400 microamps for personalized comfort level by pressing the up/down button. The Nutra Face Lift requires the use of a conductive derma gel.

The Nutra Face Lift unit contains a power supply and internal Ni-MH rechargeable battery. The enclosure is made of medical grade biocompatibility plastics and the output contacts (Probes) consist of chrome-plated spheres. The on/off button on the unit directly allows the user to immediately remove all power from the unit.

The provided document, a 510(k) summary for the "Nutra Face LIFT Model PE8050", primarily focuses on establishing substantial equivalence to a predicate device and does not contain detailed information about the acceptance criteria for a specific performance study in the way a clinical trial might, nor does it present the study for proving those criteria.

However, it does describe a "Usability and Product Self Selection Study" and states that "All four goals of the Study were met." This implies that the 'acceptance criteria' for this specific study were the successful achievement of these stated goals. The document also mentions nonclinical performance data related to compliance with FDA performance standards and electrical safety.

Here's an analysis based on the provided text, addressing your questions where possible:

Description of Acceptance Criteria and Study

The primary study mentioned, the "Usability and Product Self Selection Study," had four goals that served as its acceptance criteria. The document states that all four goals were met, thereby proving the device met these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 80 participants
• Data Provenance: Not explicitly stated, but the submission is to the US FDA, suggesting the study was likely conducted in the United States. The study is referred to as a "Usability and Product Self Selection Study," indicating a prospective design where data was collected specifically for this evaluation.

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

There is no mention of experts being used to establish a 'ground truth' in the context of this Usability and Product Self Selection Study. The study focused on consumer interaction, self-selection, and knowledge, not on expert medical evaluation of outcomes.

4. Adjudication Method for the Test Set

Not applicable for this type of self-selection and usability study. The criteria were based on participants' actions and knowledge, which would likely have been directly observed or assessed.

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

No, an MRMC comparative effectiveness study was not done. The device is a "Transcutaneous electrical nerve stimulator for pain relief" (classified as such, but indicated for "facial stimulation and is indicated for-over-the counter cosmetic use"), not an AI-powered diagnostic tool requiring human reader interpretation of cases.

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 physical electrostimulation device for cosmetic use, not an algorithm. Its performance is evaluated through its physical and electrical characteristics, and user interaction.

7. The Type of Ground Truth Used

For the "Usability and Product Self Selection Study," the "ground truth" was essentially the observed behavior and stated understanding of the participants regarding the device's packaging and instruction manual, and their ability to operate the device correctly. This is a form of behavioral or self-reported data against pre-defined success metrics for usability and comprehension.

The document also mentions compliance with various engineering and electrical safety standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10, ISO 10993) for which the "ground truth" would be the successful adherence to the requirements of these published technical standards, verified through objective laboratory testing.

8. The Sample Size for the Training Set

Not applicable. This device is 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 type of device.

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Nutra Light Advanced is intended/indicated for over the counter use for the treatment of mild to moderate acne and for the treatment of periorbital wrinkles and rythides.

Nutra Light Advanced is a visible light and/or heat source with high spectral purity. The device is made of Lustran ABS 348 with clear cover lenses covering the LED light sources. The device has two exchangeable heads; with one head emitting narrow band blue light at 410mm for the treatment of mild to moderate acne vulgaris, the other head emits red light at 650mm for the treatment of periorbital wrinkles and rhytides. The device consists of a basic-hand-held, battery operated control unit and two optional (Blue and Red LED) interchangeable heads, which allows the operator to select either the blue or red operation. The STOP button directly on the unit allows the user to immediately remove all power to the unit. The device does not allow the operator to select the red and blue light simultaneously.

The provided text is a 510(k) summary for the Nutra Light Advanced device, focusing on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study with specific acceptance criteria and performance metrics of the device itself.

Therefore, many of the requested points cannot be answered from the provided document as it does not describe a clinical study in the way typically required for a novel device proving its efficacy against acceptance criteria. Instead, it relies on demonstrating similar technical characteristics to already approved devices.

Here's a breakdown of what can be extracted and what cannot:

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

This information is not provided in the document. The document states that the device has been tested and found in compliance with performance standards (e.g., IEC 60601-1, EMC 60601-1-2, IEC 60601-2-57, ISO 10993-5, ISO 10993-10) but does not list specific acceptance criteria (e.g., a certain percentage reduction in acne lesions) or the device's measured performance against such criteria. The basis for approval is substantial equivalence to predicate devices, implying their performance is accepted.

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. As no clinical study is described, there's no test set in the context of device efficacy. The "tests" mentioned are nonclinical performance data related to electrical safety, EMC, and biocompatibility, not clinical outcomes.

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 information is not provided. Ground truth would be relevant for a clinical study assessing efficacy, which is not described.

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

This information is not provided. Adjudication methods are typically used in clinical trials to resolve discrepancies in expert assessments, which is not applicable here.

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 provided. The device is an LED light device for acne and wrinkles, not an AI-assisted diagnostic tool for human readers.

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

This information is not provided. This question is not applicable to a physical light therapy device.

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

This information is not provided. As no clinical efficacy study is detailed, no ground truth related to clinical outcomes is discussed. The "ground truth" for the nonclinical performance data would be the defined standards themselves (e.g., passing a specific electrical safety test).

8. The sample size for the training set

This information is not provided. Training sets are relevant for machine learning algorithms, which is not what this device is.

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

This information is not provided. Not applicable for this device type.

Summary of available information regarding acceptance criteria and "study" (nonclinical data):

The "study" presented is a series of nonclinical performance tests to ensure the device meets safety and engineering standards and demonstrates substantial equivalence based on technical specifications rather than a clinical efficacy trial.

In essence, the "acceptance criteria" for K150370 were primarily met by demonstrating compliance with recognized safety and performance standards for medical electrical equipment and establishing substantial equivalence to previously approved devices based on similar technology and intended use, rather than a de novo clinical efficacy study with defined clinical endpoints.

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The Nutra Stim Hair Laser Comb is indicated to treat androgenetic alopecia and promote hair growth in females who have Ludwig (Savin) Scale I-4, LL-1, LL-2, or frontal and Fitzpatrick Skin Types L to IV.

The Nutra Stim Hair Laser Comb is a hand-held low level laser device that emits laser light with the intention to promote hair growth. The device provides distributed laser light to the scalp while the comb teeth simultaneously part the user's hair to ensure the laser light reaches the user's scalp.

The Nutra Stim Hair Laser Comb unit contains the power supply, internal NI-MH rechargeable battery and the control unit. The enclosure and laser lens are made of medical grade biocompatibility plastics via injection molding. The STOP button directly on the unit allows the user to immediately remove all power to the unit. The Nutra Stim Hair Laser Comb does not use any software.

The provided text describes the Nutra Stim Hair Laser Comb, a low-level laser device intended for promoting hair growth and treating androgenetic alopecia in specific female populations. However, the document does not contain a study that establishes acceptance criteria for device performance in terms of clinical efficacy (hair growth), nor does it provide performance data against such criteria.

The document focuses on demonstrating substantial equivalence to a predicate device (HairMax Pro 12 LaserComb, K112524) for regulatory clearance, rather than presenting a clinical trial for performance.

Here's an analysis based on the information provided, highlighting what is present and what is missing:

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

This information is not present in the document. The document discusses regulatory and safety testing but does not provide clinical performance acceptance criteria (e.g., minimum percentage increase in hair count, or specific visual improvement scores) or reported device performance against such criteria.

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

• Sample Size (Clinical): Not applicable for clinical efficacy. The document mentions an "OTC Usability Study" with "80 participants." This study was focused on usability and consumer understanding, not clinical performance for hair growth.
• Data Provenance: Not specified for any clinical performance data, as none is presented. For the OTC Usability Study, the provenance is not mentioned.
• Study Type: The OTC Usability Study was likely prospective, as it involved attracting participants to test the device's labeling and operation.

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 information is not present. The usability study did not involve establishing ground truth for efficacy using experts.

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

This information is not present. No such adjudication method is mentioned, as there was no clinical performance data requiring expert adjudication.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The device is a physical laser comb, not an AI-assisted diagnostic or interpretation tool.

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

• Standalone Performance Study: No, the device is not an algorithm. What was done were non-clinical performance tests for electrical safety, EMC, and biocompatibility, as listed in Section 8. These are tests of the device's physical and electrical properties, not its clinical standalone efficacy for hair growth.

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

This information is not present for clinical efficacy. For the OTC Usability Study, the "ground truth" was whether participants could correctly self-select, understand labeling, assemble, and operate the device. This "ground truth" would have been established by observing participant actions and responses against predefined correct answers or procedures.

8. The sample size for the training set

This information is not present. The document does not describe the development of an algorithm or model that would require a training set.

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

This information is not applicable, as there is no mention of a training set or an algorithm being developed.

Summary of Device and Regulatory Context (based on the provided text):

• Device Name: Nutra Stim Hair Laser Comb Model NSL-6318
• Intended Use/Indications: Treats androgenetic alopecia and promotes hair growth in females with Ludwig (Savin) Scale I-4, LL-1, LL-2, or frontal, and Fitzpatrick Skin Types I to IV.
• Regulatory Class: Class II
• Product Code: OAP (Lamp, nonheating, for promotion of hair growth)
• Regulation Number: 21 CFR 890.5500
• Predicate Device: HairMax Pro 12 LaserComb (K112524)
• Basis for Clearance: Substantial Equivalence to the predicate device.
• Supportive Studies Mentioned:
  • OTC Usability Study: 80 participants, focused on self-selection, understanding labeling/manual, assembly, and operation. All four goals of this study were reportedly met. This study did not assess clinical efficacy.
  • Nonclinical Performance Data: Risk analysis, verification, and validation tests (specifics not detailed in the summary, but referenced as being in Section 10). Compliance with electrical safety (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11) and laser safety (IEC 60825-1) standards. Biocompatibility testing per ISO 10993.

In conclusion, the provided document is an FDA 510(k) clearance letter and its accompanying summary, which primarily establishes substantial equivalence for marketing purposes. It highlights compliance with safety and usability aspects but does not present a clinical study with acceptance criteria and performance data related to the device's efficacy in promoting hair growth. The efficacy is implicitly accepted based on the substantial equivalence to the predicate device, which would have had its own supporting data for clearance.

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The Nutra Stim Hair Laser Comb is indicated to treat androgenetic alopecia, promote hair growth and prevent further hair loss in males who have Norwood Hamilton Classifications of IIa to V patterns of hair loss and Fitzpatrick Skin Types I to IV.

The Nutra Stim Hair Laser Comb is a hand-held low level laser device that emits laser light with the intention to promote hair growth. The device provides distributed laser light to the scalp while the comb teeth simultaneously part the user's hair to ensure the laser light reaches the user's scalp. The Nutra Stim Hair Laser Comb unit contains the power supply, internal NI-MH rechargeable battery and the control unit. The enclosure and laser lens are made of medical grade biocompatibility plastics via injection molding. The STOP button directly on the unit allows the user to immediately remove all power to the unit. The Nutra Stim Hair Laser Comb does not use any software.

The provided text describes a 510(k) premarket notification for the Nutra Stim Hair Laser Comb. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance data for a new device's efficacy.

Therefore, many of your requested details, particularly those related to a clinical study establishing performance against specific acceptance criteria for a novel device, are not directly available in this document. The document primarily relies on the predicate device's established effectiveness and safety, and direct comparison of technological characteristics.

However, I can extract the information that is present:

1. Table of Acceptance Criteria and Reported Device Performance

This specific table, comparing acceptance criteria to performance, is not provided in the document. The document describes an "OTC Usability Study" and lists its goals, which could be interpreted as acceptance criteria for usability, but it does not present quantifiable performance metrics against those goals.

2. Sample Size for Test Set and Data Provenance

The document mentions an "OTC Usability Study" with:

• Sample Size: 80 participants
• Data Provenance: Not explicitly stated, but it's an "OTC Usability Study," implying it was conducted with potential end-users for over-the-counter use, likely within the US, where the FDA is regulating it. It is a prospective study as participants were actively recruited to test the device's usability.

3. Number of Experts and Qualifications for Ground Truth

• This information is not provided as the usability study did not involve establishing a medical ground truth in the way a diagnostic device study would. The "ground truth" for the usability study was whether participants could successfully interact with the device and understand its labeling.

4. Adjudication Method for Test Set

• This information is not provided. Given it's a usability study where success was measured against understanding and operating the device, a formal adjudication process as seen in clinical trials for diagnostic accuracy is unlikely to have been implemented or necessary.

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

• No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices where human readers interpret results, often with and without AI assistance. The Nutra Stim Hair Laser Comb is a therapeutic device for hair growth, not a diagnostic one.

6. Standalone (Algorithm Only) Performance Study

• No, a standalone performance study (algorithm only) was not conducted. The device is a physical laser comb, not an AI algorithm. The document mentions "The Nutra Stim Hair Laser Comb does not use any software," further confirming the irrelevance of an algorithm-only study.

7. Type of Ground Truth Used

• For the "OTC Usability Study," the "ground truth" was essentially observational success/failure in performing tasks (self-selection, understanding instructions, operating the device) and participant feedback. It was not based on expert consensus, pathology, or outcomes data in a medical sense for efficacy.

8. Sample Size for Training Set

• This information is not applicable and therefore not provided. The Nutra Stim Hair Laser Comb is a hardware device for therapeutic use; it does not involve AI or machine learning algorithms that require a "training set."

9. How Ground Truth for Training Set Was Established

• This information is not applicable and therefore not provided for the same reasons as #8.

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The Nutra Light Red is a non-invasive LED light device is intended/indicated for over- the -counter use for the treatment of periorbital wrinkles, and rhytides

The NutraLuxe Red, Model NL-2212 is a device that utilizes Light Emitting Diodes to provide LED light to the body. The NutraLuxe Red is a visible light source of high spectral purity. They provide uniform or "hot-spot" free illumination. The output is pre-tuned to one wavelength with a narrow spectral bandwidth. The output wavelength of Red is 650 +/- 5 at 80 mW. The NutraLuxe Red unit contains the power supply, internal NI-MH rechargeable battery and the control unit. The enclosure and LED lens are made of medical grade biocompatibility plastics via injection molding. It has the capabilities to deliver the light to the skin as the unit is moved over the STOP button directly on the unit allows the user to immediately remove all power to the unit. The Nutra Light Red does not use any software.

Here's an analysis of the provided text, focusing on acceptance criteria and study details for the Nutra Light Red device:

Important Note: The provided text does not describe acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for an AI/algorithm-based medical device. Instead, it details an OTC Usability Study and compliance with electrical, EMC, photobiological safety standards, and biocompatibility for a light-emitting diode (LED) device. This is a crucial distinction. The questions in your prompt are more aligned with the evaluation of algorithmic diagnostics, which this device is not.

However, I will extract the information as best as possible to align with your request, interpreting "acceptance criteria" here as the goals of the usability study and "reported device performance" as the outcome of that study.

Acceptance Criteria and Study Details for Nutra Light Red (Based on provided text)

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for the Test Set

• Sample Size: 80 participants
• Data Provenance: Not explicitly stated, but the study was an "OTC Usability Study," implying it was conducted with representative consumers. No country of origin is specified. It is a prospective study as it involved participants performing tasks with the device.

3. Number of Experts and Qualifications for Ground Truth

• Not applicable for this device and study. This device is an LED light therapy device, and the study was a usability study, not a diagnostic accuracy study requiring expert-established ground truth for a test set. The "ground truth" here was the successful completion of tasks by consumers.

4. Adjudication Method for the Test Set

• Not applicable. There was no ambiguity in "ground truth" (i.e., whether tasks were performed correctly). The study aimed to see if participants could correctly perform actions and understand labeling, not to make a diagnostic determination that would require adjudication.

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

• No. This was not an AI/algorithm-based device, nor was it a diagnostic tool where human readers would be evaluated with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

• No. The device does not contain an "algorithm" in the sense of an AI model that would have standalone performance. It is a hardware device. The "performance data" presented relates to its physical and usability characteristics. The document explicitly states: "The Nutra Light Red does not use any software."

7. Type of Ground Truth Used

• For the usability study: The ground truth was the observed behavior and understanding of the 80 participants when interacting with the device, packaging, and user manual. Whether they could correctly perform actions (assemble, operate, care for) and understand labeling constituted the "ground truth" of usability.
• For safety and compliance: The ground truth was established international standards and regulatory requirements (e.g., IEC, ISO).

8. Sample Size for the Training Set

• Not applicable. This device does not use an AI or machine learning algorithm, therefore there is no "training set."

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

• Not applicable. As there is no training set, there is no ground truth for it.

Summary of Device and Study Type:

The Nutra Light Red is a non-invasive LED light device for treating periorbital wrinkles and rhytides, intended for over-the-counter use. The "study" described in the 510(k) summary is primarily an OTC Usability Study to ensure consumers can understand and safely operate the device without professional assistance. Other "performance data" relates to compliance with electrical, electromagnetic compatibility (EMC), photobiological safety, and biocompatibility standards, which are standard requirements for medical devices. This document does not describe the evaluation of an AI or algorithmic diagnostic device.

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The Nutra Light Blue is a non-invasive LED light device is intended/indicated for over- the-counter use. The device delivers low intensity light emitting diodes (LED's) in the blue region at a wavelength of 410 +/- 5 nanometers, for the treatment of mild to moderate inflammatory acne.

The Nutra Light Blue Model: NL-2213, is deviccs that utilize Light Emitting Diodes to provide LED light to the body. The Nutra Light Blue is a visible light source of high spectral purity. They provide uniform or "hot-spot" free illumination. The output is pre-tuned to one wavelength with a narrow spectral bandwidth. The output wavelength of Blue is 410 +/- 5 at 75 mW. The Nutra Light Blue unit contains the power supplies, internal NI-MH rechargeable battery and the control unit. The enclosure and LED lens are made of medical grade biocompatility plastics via injection molding. It has the capabilities to deliver the light to the skin as the unit is moved over the skin surface. The STOP button directly on the unit allows the user to immediately remove all power to the unit. The Nutra Light Blue does not use any software.

The provided text describes the Nutra Light Blue device, which is an LED light device intended for the treatment of mild to moderate inflammatory acne. It is important to note that this document is a 510(k) Summary of Safety and Effectiveness, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study report with acceptance criteria and comprehensive performance metrics.

Based on the provided information, I can extract the following:

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

The document does not explicitly state numerical acceptance criteria for clinical performance (e.g., a specific percentage reduction in acne lesions). Instead, it focuses on demonstrating that an "OTC Usability Study" met its goals. The "reported device performance" in this context refers to the outcomes of that usability study.

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

• Sample Size: 80 participants.
• Data Provenance: The study was an "OTC Usability Study," implying it was conducted for the purpose of this submission and likely prospective, focusing on how consumers interact with the device. The country of origin is not explicitly stated, but given the FDA submission, it's typically understood to be within the US or compliant with US standards.

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

This information is not provided in the document. The study was a "Usability Study" and not a clinical efficacy trial with expert-assessed outcomes like lesion counts. Therefore, the concept of "ground truth" established by experts in the context of acne treatment efficacy (e.g., dermatologists assessing lesion counts) does not appear to apply to this specific usability study.

4. Adjudication method for the test set:

This information is not provided. As it was a usability study, it's unlikely to have involved the kind of clinical adjudication typically seen in efficacy trials.

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 and not provided. The Nutra Light Blue device is a non-AI, LED light therapy device for acne treatment. The document does not mention any AI component or human-in-the-loop performance.

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

This information is not applicable and not provided. The Nutra Light Blue device does not use an algorithm for diagnosis or treatment decision-making; it delivers light therapy directly. The document explicitly states: "The Nutra Light Blue does not use any software."

7. The type of ground truth used:

For the usability study, the "ground truth" would be the observed user behavior and responses to survey questions regarding packaging understanding, assembly, operation, and care. It's not a clinical ground truth like pathology or physician diagnosis. The document states the goals were to determine if consumers could "correctly self-select" and "correctly assembly, operate and care for the device." The "all four goals... were met" indicates the usability performance was deemed successful.

8. The sample size for the training set:

This information is not applicable and not provided. The Nutra Light Blue device is a hardware device (LED light therapy) and does not involve AI or machine learning models that require a training set.

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

This information is not applicable and not provided for the same reasons as point 8.

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