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The LightStim Elipsa is a LED light therapy device which uses specific wavelengths of light emitting diodes (LEDs). It is intended to emit energy in the red and infrared region of the light spectrum to provide treatment for full face wrinkles. The blue and red light spectrum is intentent of mild to moderate inflammatory acne.

The LightStim Elipsa is an over-the-counter light emitting diode (LED) device that emits energy for use in dermatology for the treatment of acne and wrinkles. The device uses four types of LEDs for Wrinkles: 612nm amber, 645nm red, 655nm red, and 850nm infrared and two types of LEDs for Acne: 410nm and 645nm. The treatment time is controlled by the user. There are no user settings or adjustments required. The LightStim Elipsa system components include the device containing the LED module, power supply, goggles, and travel case. The LightStim Elipsa does not contain any user serviceable components. The device is sold as Over-the-counter (OTC)

The provided text describes a 510(k) premarket notification for the LightStim Elipsa device, an over-the-counter LED light therapy device for treating full-face wrinkles and mild to moderate inflammatory acne.

Based on the provided information, the document does not contain acceptance criteria or a study that directly proves the device meets specific performance criteria related to clinical efficacy (e.g., reduction in wrinkles or acne). Instead, the performance testing focuses on safety, electrical compatibility, software validation, and usability for regulatory clearance.

Here's a breakdown of the available information and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, there are no reported clinical performance acceptance criteria (e.g., percentage reduction in wrinkles, or acne lesion count reduction) or corresponding clinical efficacy results in this document. The "Performance Testing" section describes compliance with various safety and electrical standards.

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

• For Usability/Label Comprehension Study: The document states "The sponsor conducted a Usability/Label Comprehension study to acquire data..." but does not specify the sample size of participants or the data provenance (e.g., country of origin, retrospective/prospective).
• For Clinical Efficacy: No clinical test set or efficacy data is presented in this document. The 510(k) submission relied on substantial equivalence to predicate devices, which means they are claiming the new device is as safe and effective as already legally marketed devices, rather than conducting new clinical trials for efficacy.

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

• For Usability/Label Comprehension Study: This type of study typically involves user feedback, not expert ground truth establishment for medical diagnosis. The document does not mention experts establishing ground truth for this study.
• For Clinical Efficacy: Not applicable, as no clinical efficacy test set or ground truth is described in this document.

4. Adjudication method for the test set

• Not applicable, as no clinical efficacy test set or adjudication process is described.

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 an LED light therapy device, not an AI-powered diagnostic or interpretive device that would involve human readers or AI assistance.

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

• Not applicable. This is a physical LED light therapy device, not an algorithm.

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

• For Usability/Label Comprehension Study: The "ground truth" here would be the actual comprehension and successful use of the device by the study participants based on the instructions. This is assessed directly through observation and user feedback, not by expert consensus or pathology.
• For Clinical Efficacy: Not applicable, as no clinical efficacy ground truth is described in this document.

8. The sample size for the training set

• Not applicable. This document pertains to regulatory clearance for a physical device, not an AI/ML algorithm that requires a training set.

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

• Not applicable. (See #8)

In summary, the provided document focuses on regulatory compliance through substantial equivalence to predicate devices and performance testing related to electrical safety, electromagnetic compatibility, software validation, and usability. It does not contain information about clinical efficacy studies, clinical acceptance criteria, or clinical performance data for wrinkle reduction or acne treatment beyond the general indications for use established by the predicates.

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The LightStim Professional LED Bed is an over-the-counter device intended to emit energy in the visible and IR spectrum intended to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and the temporary relaxation of muscles.

The LightStim Professional LED Bed is a device that is similar in design to the bottom half of a tanning bed. It is approximately 6.5 feet in length and 3 feet wide. It has 18,240 LEDs. There is an on/off switch that turns off after 30 minutes of use, and an AC to DC power supply.

This document is a 510(k) premarket notification for the LightStim Professional LED Bed. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than a de novo clinical study with specific acceptance criteria and detailed performance metrics as one might find for a novel, higher-risk device.

Therefore, the requested information, particularly regarding specific acceptance criteria, a standalone study demonstrating performance against those criteria, sample sizes for test and training sets, and expert-adjudicated ground truth, is not present in this document in the typical format for a clinical effectiveness study. The focus here is on demonstrating the new device performs similarly to existing, legally marketed devices.

However, based on the provided text, I can infer and extract some relevant points:

1. Table of Acceptance Criteria and Reported Device Performance

Strict "acceptance criteria" for a clinical outcome are not explicitly stated in this document as it's a substantial equivalence submission. Instead, the performance is demonstrated by showing similar characteristics and results to predicate devices, particularly regarding temperature elevation which is linked to the intended use for pain relief and circulation.

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

The document mentions "The LightStim Professional LED Bed device was tested using the same skin temperature testing as all of the predicate devices. The participants skin temperature was measured..." This implies a test set was used, but the sample size is not specified. The data provenance is implied to be prospective for this specific device's temperature testing, conducted by the manufacturer (LED Intellectual Properties, LLC). Country of origin is not explicitly stated but the manufacturer is based in Irvine, California, USA.

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

This type of information is not applicable here. The "ground truth" for the temperature study is the direct measurement of skin temperature. It does not involve expert adjudication or interpretation as a diagnostic or prognostic AI algorithm would.

4. Adjudication method for the test set

Not applicable. The measurement is direct physical measurement (temperature), not subjective interpretation requiring 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

No, a MRMC comparative effectiveness study was not done. This device is not an AI diagnostic or assistive tool, but a therapeutic energy emission device.

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

A "standalone" performance test in the context of an algorithm was not done because this is not an algorithm. However, performance testing of the device itself (e.g., temperature output, electrical safety) was conducted. The temperature testing described ("participants skin temperature was measured...") represents a form of standalone performance measurement for the device.

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

The "ground truth" for the skin temperature testing was direct physical measurement of skin temperature using a "Mastercool, Infrared Laser Thermometer". For the substantial equivalence claim, the "ground truth" for characteristics like output, wavelengths, treatment time, and safety/performance standards is comparison to the specifications and clearances of the predicate devices.

8. The sample size for the training set

Not applicable. This device is hardware and does not involve AI or machine learning algorithms that require a "training set."

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

Not applicable. See point 8.

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The LightStim Professional System #3A panel is intended for the treatment of full-face wrinkles.

The LightStim Professional System #3B panel is intended for the treatment of mild to moderate acne.

The LightStim Professional System #4 panel is intended for the treatment of mild to moderate acne.

The LightStim Professional 2-Panel Light System is a portable device that has two (2) separate interchangeable 2-panel treatment heads, each containing 1.130 LEDs. Each treatment heads is attached to a fully retractable and articulating arm with a 42" reach. Either one of these arms can be attached to the rolling stand for use. There is an on/off switch, and an AC to DC power supply.

The LightStim 2-Panel Light System is intended to be operated only by a person who has been personally trained by Company personnel. Each device includes a detailed Instruction Manual and includes one-on-one training and instruction by Company training staff. That training includes a thorough review of the Instruction Manual for the device and actual one-on-one training on the operation of the device with the end user.

This document describes the LightStim Professional 2-Panel Light System, a device for treating facial wrinkles and acne. However, it does not contain the specific information required to complete your request about acceptance criteria and a study proving the device meets those criteria. The provided text is a 510(k) summary for FDA clearance, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed performance study results against specific acceptance criteria.

Therefore, I cannot provide the requested information for the following points as they are not present in the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

The document primarily focuses on regulatory approval by demonstrating substantial equivalence to previously cleared devices. It states that "the LightStim Professional 2-Panel Light System raises no new issues of safety or effectiveness and has been found to be substantially equivalent to the predicate devices."

The 'Performance Testing' section only mentions conformance to general electrical and electromagnetic compatibility standards (IEC/EN 60601-1 and IEC/EN 60601-1-2) which are related to device safety and essential performance, not clinical effectiveness or specific acceptance criteria for treating wrinkles or acne. No clinical study data or performance metrics against specific efficacy endpoints are provided in this document.

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The LightStim for Pain LED Belt is an Over-The-Counter device intended to emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and the temporary relaxation of muscles.

The LightStim for Pain LED Belt is a portable device that has between one and four separate LED pods, each of which has 52 LEDs and are attached to a elastic belt that stretches to encircle different sizes from as small as an ankle to as large as the torso, and attaches to itself with Velcro. Each pod has an LED array of 630nm, 865nm, and 940nm. The device is powered by a separate AC to DC 12-volt power supply and has an on/off switch, with a timer that shuts the device off automatically after 30 minutes of operation. Recommended treatment time is 5 to 30 minutes.

Here's an analysis of the provided text regarding the LightStim for Pain LED Belt, focusing on the acceptance criteria and the study performed:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" with quantitative benchmarks for efficacy. Instead, it describes performance testing related to safety and usability. The closest to performance efficacy is the temperature testing, but without pre-defined acceptance criteria, it's hard to classify it as such for clinical effectiveness.

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

• Temperature Testing:
  • Sample Size: 3 individuals
  • Data Provenance: Not specified, but likely prospective (performed for this submission). No country of origin is mentioned.
• Usability Study:
  • Sample Size: 33 male and female participants
  • Data Provenance: Not specified, but likely prospective (performed for this submission). No country of origin is mentioned.

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

• Temperature Testing: Ground truth is objective temperature measurement. No human expert interpretation is mentioned for establishing the truth of the temperature readings themselves.
• Usability Study: The "ground truth" for the usability study would be the correct answers to the instruction manual questions and correct demonstration of device use. This wasn't established by external experts adjudicating subjective data, but rather by comparing participant responses/actions against the intended use and instruction manual.

4. Adjudication Method for the Test Set

• Temperature Testing: No adjudication method mentioned as the data would be objective sensor readings.
• Usability Study: No adjudication method mentioned. The evaluation seems to have been based on direct observation and participant responses to questions.

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 device, an LED belt for pain relief, is not an AI-powered diagnostic or interpretive device that would typically involve human "readers" or be subject to AI assistance.

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

• No, a standalone (algorithm only) study was not done. This device does not feature an AI algorithm.

7. The Type of Ground Truth Used

• Temperature Testing: Objective physical measurement (temperature readings).
• Usability Study: Compliance with the instruction manual and proper device operation (based on pre-defined correct actions/answers).

8. The Sample Size for the Training Set

• There is no mention of a "training set" as this device does not utilize machine learning or AI algorithms requiring such a set.

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

• Not applicable, as no training set was used.

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The LightStim Professional 2-Panel Light System has two (2) interchangeable 2-Panel LED Systems, each mounted on a hands-free, fully articulating arms:
System #1- emitting energy in the visible and IR spectrums intended for use in the treatment of full-face wrinkles.
System #2 - emitting energy in the visible and IR spectrum intended to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and the temporary relaxation of muscles.

The LightStim Professional 2-Panel Light System is a portable device that has two (2) separate interchangeable 2-panel treatment heads, each containing 1,130 LEDs. Each treatment heads is attached to a fully retractable and articulating arm with a 42″ reach. Either one of these arms can be attached to the rolling stand for use. There is an on/off switch, and an AC to DC power supply.

The LightStim 2-Panel Light System is intended to be operated only by a person who has been personally trained by Company personnel. Each device includes a detailed Instruction Manual and includes one-on-one training and instruction by Company training staff. That training includes a thorough review of the Instruction Manual for the device and actual one-on-one training on the operation of the device with the end user.

The provided text is a 510(k) summary for the LightStim Professional 2-Panel Light System. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, many of the requested sections (acceptance criteria table, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) are not applicable or not available in this type of submission.

Here's a breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not applicable. This submission doesn't present specific performance metrics or acceptance criteria for clinical effectiveness because it's a substantial equivalence filing. The FDA's 510(k) clearance process for this device relies on demonstrating that the new device has the same intended use and technological characteristics as a legally marketed predicate device, and raises no new questions of safety or effectiveness.

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

• Not applicable / Not provided. No clinical test set or data provenance is detailed for demonstrating performance against acceptance criteria. The submission focuses on comparing the new device's technical specifications to predicate devices.

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

• Not applicable / Not provided. No clinical ground truth establishment is described.

4. Adjudication Method:

• Not applicable / Not provided. No adjudication method is described as there is no clinical test set requiring ground truth adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Improvement with vs. without AI:

• Not applicable. This device is a light therapy system, not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance comparisons are irrelevant to this submission.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was done:

• Not applicable. This is not an algorithm-based device.

7. The Type of Ground Truth Used:

• Not applicable. No ground truth data is presented as it's not a diagnostic device or a study involving clinical outcomes for proving novel effectiveness.

8. The Sample Size for the Training Set:

• Not applicable. This is not a machine learning or AI device that requires a training set.

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

• Not applicable. No training set ground truth to establish.

What the Study (510(k) Submission) Does Prove:

The 510(k) summary focuses on demonstrating substantial equivalence by:

• Device Description:
  • The LightStim Professional 2-Panel Light System has two interchangeable 2-panel LED systems, each with 1,130 LEDs, mounted on articulating arms.
  • It includes an on/off switch and an AC to DC power supply.
  • It is intended to be operated by a person trained by company personnel.
• Intended Use / Indications for Use:
  • System #1: Emits energy in the visible and IR spectrums for the treatment of full-face wrinkles.
  • System #2: Emits energy in the visible and IR spectrums for topical heating to temporarily relieve minor muscle and joint pain and stiffness, minor arthritis pain or muscle spasm, temporarily increase local blood circulation, and temporarily relax muscles.
• Technological Characteristics Comparison with Predicate Devices:
  • The submission explicitly states that the LightStim Professional 2-Panel Light System has the exact same intended use as the predicate devices (LED Intellectual Properties Light for Wrinkles (K092800), LightStim for Wrinkles (K120775), and Pain Therapy Light (K083580)).
  • Crucially, it states that "the predicate devices and the LightStim Professional 2-Panel Light System are all manufactured by the same LED Intellectual Properties, LLC, and they all utilize the exact same LED parts, with the same engineering and same output." This is the primary "proof" for substantial equivalence.
• Performance Testing (Safety):
  • The device "results in patient contact with an electrically powered component" and includes an electronic component, therefore it was tested according to:
    • 60601-1: Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance.
    • 60601-1-2: Medical Electrical Equipment - Part 1-2: General Requirements for Safety and Essential Performance (for electromagnetic compatibility).
  • The implication is that these tests demonstrate the device meets accepted safety standards for electrical medical equipment, in line with the predicate devices.

Conclusion of the Submission:

Based on the analysis of safety, indications, intended uses, performance, and technological properties, the submitter concludes that the LightStim Professional 2-Panel Light System raises no new issues of safety or effectiveness and has been found to be substantially equivalent to the predicate devices.

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LightStim for Acne/LightStim for Acne Mini is an over-the-counter hand-held device intended for the use in the treatment of mild to moderate acne.

LightStim for Acne / LightStim for Acne Mini, model: LS4A/LS4AM is a hand-held device consisting of low intensity light emitting diodes (LED's) that provide illumination which comes in contact with the skin. The device components include LED's of 415nm and 630nm, a hand piece, a printed circuit board, an on/off switch, a resistor, a receiver jack in the hand piece to plug a power supply into and a separate AC to DC (9 volt) power supply. Treatment time is recommended to be three to four minutes and is controlled by the user.

The provided text describes a 510(k) premarket notification for the "LightStim for Acne/ LightStim for Acne Mini" device. However, it does not provide the detailed information required to describe the acceptance criteria and a study proving the device meets those criteria in the way requested (e.g., acceptance criteria for an AI/ML device, details about ground truth establishment by experts, MRMC studies, training set details).

This document is a regulatory submission for a light therapy device, not an AI/ML diagnostic or prognostic tool. Therefore, the "study" mentioned is a usability study, not a performance study comparing the device's output against a medical ground truth established by experts.

Based on the provided text, here's what can be extracted and what cannot:

What can be extracted:

• Device Name: LightStim for Acne / LightStim for Acne Mini
• Intended Use: Treatment of mild to moderate acne (Over-The-Counter use).
• Type of "Study" mentioned: A usability study.
• Sample size for the "study": 40 participants.
• Purpose of the "study": To show that participants adequately decided whether or not to use the device for their level of acne, and comprehended risks, warnings, cautions, precautions, and proper use from the Instruction Manual.

What CANNOT be extracted (because the document does not contain this information, as it's not a study proving device performance against medical acceptance criteria in the AI/ML context):

1. A table of acceptance criteria and the reported device performance: The document mentions a usability study, not a performance study with quantitative clinical outcomes like sensitivity, specificity, accuracy, etc., for a diagnostic or AI/ML device. The "performance" described is user comprehension and appropriate self-selection for device use, not clinical efficacy or diagnostic accuracy.
2. Sample size used for the test set and the data provenance: A "test set" in the context of AI/ML performance is not described. The 40 participants were for a usability study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment by experts is not applicable to a usability study for a light therapy device.
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/ML diagnostic or assistance device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth in the sense of a medical diagnosis or outcome is not mentioned for the usability study. The "ground truth" was whether users understood the instructions and self-assessed their acne appropriately.
8. The sample size for the training set: Not applicable, as this is not a machine learning device.
9. How the ground truth for the training set was established: Not applicable.

In summary: The provided document is a 510(k) clearance letter and summary for a light therapy device. It discusses a usability study to demonstrate that users can safely operate the device and understand its appropriate use based on the instructions. It does not contain information about acceptance criteria or performance studies relevant to AI/ML devices or diagnostic accuracy, which would typically involve expert-adjudicated ground truth, sensitivity/specificity metrics, or MRMC studies.

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LightStim for Acne Mini is an over-the-counter hand-held device intended for the use in the treatment of mild to moderate acne.

LightStim for Acne Mini, model: LS4AM is a hand-held device consisting of low intensity light emitting diodes (LED's) that provide illumination which comes in contact with the skin. The device components include LED's of 415nm, a hand piece, a printed circuit board, an on/off switch, a resistor, a receiver jack in the hand piece to plug a power supply into and a separate AC to DC (9 volt) power supply. Treatment time is recommended to be three to four minutes and is controlled by the user.

Here's a breakdown of the acceptance criteria and study information for the LightStim for Acne Mini device, based on the provided document:

Acceptance Criteria and Device Performance

The acceptance criteria for the LightStim for Acne Mini are primarily based on demonstrating substantial equivalence to existing predicate devices. This means the device needs to show similar performance characteristics, indications for use, and safety attributes as the predicates. The document doesn't explicitly state quantitative performance targets for effectiveness (e.g., "reduce acne by X%"), but rather focuses on aligning with the established parameters of comparable devices already on the market.

Table of Acceptance Criteria and Reported Device Performance:

Study Details for LightStim for Acne Mini:

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

   • Sample Size: 40 participants.
   • Data Provenance: The document does not explicitly state the country of origin. It appears to be a prospective study, as participants used the device and their comprehension and decision-making were evaluated as part of the study.

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

   • The study described is a usability study, not a clinical efficacy study requiring expert assessment of medical outcomes. Therefore, there is no mention of experts establishing a "ground truth" for acne severity or improvement. The "ground truth" for this study was user comprehension and appropriate device selection, which was assessed through observation and potentially questionnaires.

3. Adjudication Method for the Test Set:

   • Not applicable. The study was a usability study focused on user comprehension, not on medical diagnoses or outcomes requiring adjudication by multiple experts.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC comparative effectiveness study was not done. This study focuses on usability and safety, not on comparing diagnostic accuracy or clinical effectiveness with or without AI assistance. The device is not an AI-powered diagnostic tool.

5. Standalone Performance Study:

   • Yes, a standalone usability study was conducted. The described "Performance Data" section details a study where 40 participants used the device and were assessed on their "adequacy" in deciding to use the device and their "comprehension" of the instruction manual. This evaluates the device's human-interaction performance without comparison to other devices in terms of usability effectiveness.

6. Type of Ground Truth Used:

   • For the usability study, the "ground truth" was user comprehension and appropriate decision-making regarding device use, as evaluated through the study protocol. This is observational/feedback-based, not medical pathology or outcomes data.

7. Sample Size for the Training Set:

   • Not applicable. This device is a light therapy device, not an algorithm or AI model that requires a training set.

8. 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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The LightStim for Wrinkles is an over-the-counter hand-held device intended for the use in the treatment of full-face wrinkles

The LightStim for Wrinkles is a hand-held device with a power output of 65mW/cm2, consisting of light emitting diodes (LED's) that emit Low and Sub IR light for direct exposure to the skin. The components include an LED array of 605nm, 630nm, 660nm, and 855nm wavelength, a (non-flammable plastic) hand piece housing, a printed circuit board upon which the LED's are mounted, single non-timer on/off switch with a resistor, receiver jack in the hand piece accommodating a removable power cord and a separate AC to DC (9-volt) power supply. Treatment time is recommended to be 3 minutes and is controlled by the user.

Here's a breakdown of the acceptance criteria and the study information for the LightStim for Wrinkles K120775, based on the provided text:

Acceptance Criteria and Device Performance

The provided document describes two main types of studies used for the LightStim for Wrinkles (K120775) to establish substantial equivalence to its predicate device (Light for Wrinkles K101190): a Usability Study and a Clinical Study. The acceptance criteria are implicitly tied to demonstrating similar performance to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

• After 8 weeks: 4.54
• 3-month follow-up: 4.2
  This shows an average reduction in full-face wrinkles. The study's premise was to deliver similar results in full-face wrinkle reduction as the predicate device did for periorbital wrinkles, implying the magnitude of reduction or the percentage of participants showing reduction (100% for the predicate) was the implicit criterion. The document states it produced "similar results." |

2. Sample Size and Data Provenance

• Test Set (Clinical Study): 40 participants
• Data Provenance: The document does not explicitly state the country of origin. It indicates it was an 8-week Clinical Study and a 3-month follow-up, suggesting a prospective study design.

3. Number of Experts and Qualifications for Ground Truth

• The clinical study utilized the Fitzpatrick Wrinkle Scale (FWS) to judge wrinkle severity. The specific number of experts or their qualifications for assessing the FWS scores are not mentioned in the provided text. It is implied that trained personnel would have applied this scale, but no details are given.

4. Adjudication Method for the Test Set

• The document does not specify any adjudication method for the Fitzpatrick Wrinkle Scale assessments.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or reported in the provided text. The study focused on the device's efficacy on participants rather than comparing human readers' performance with and without AI assistance.

6. Standalone Performance Study

• Yes, a standalone clinical study was performed to assess the device's effectiveness in reducing full-face wrinkles without human-in-the-loop assistance (beyond what's inherent in user-operated devices). The results (FWS reduction) demonstrate the algorithm's (or device's) standalone impact.

7. Type of Ground Truth Used

• The ground truth used for the clinical study was based on the Fitzpatrick Wrinkle Scale (FWS) scores, which are a standardized assessment of wrinkle severity. This is a form of expert assessment or clinical measurement.

8. Sample Size for the Training Set

• The provided text does not mention a "training set" in the context of an algorithm or AI. This device is a light-emitting device, not an AI/software device that would typically have a training set for an algorithm. The clinical study participants (40 individuals) serve as the test set for the device's performance.

9. How Ground Truth for the Training Set Was Established

• As the device is not an AI/software device that uses a "training set" in the conventional sense, this question is not applicable based on the provided information. The 40 participants in the clinical study are the "test set" to prove the device's efficacy, and their wrinkle severity was assessed using the FWS scale.

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The Light for Winkles is an Over-The-Counter handheld device intended for use in the treatment of periorbital wrinkles.

The Light for Wrinkles is a hand-held device with a power output of 65mW/cm2, consisting of low intensity light emitting diodes (LED's) that emit Low and Sub-IR light for direct exposure to the skin. The device components include an LED array of 605nm, 630nm, 660nm, and 855nm wavelengths, a (non-flammable plastic) hand piece housing a printed circuit board upon which the LED's are mounted, single non-timer on/off switch with 5-ohm resistor, receiver jack in the hand piece accommodating a removable power cord and a separate AC to DC (9-volt) power supply. Treatment time is recommended to be 3 minutes and is controlled by the user.

The provided document is a 510(k) summary for the "Light for Wrinkles" device. It does not contain any performance data or a study that proves the device meets specific acceptance criteria in the manner requested.

Instead, the submission for this device relies entirely on the concept of substantial equivalence to a predicate device. The core argument is stated explicitly:

• "Taking into consideration the statement in '5. Substantial Equivalency' above, after an analysis of the safety, indications and intended uses, performance, features, technological properties and methods of operation, LED Intellectual Properties, LLC believes that no significant differences exist between the Light for Wrinkles and the predicate device listed in Section 3, above." (Page 3)

Therefore, I cannot populate the requested table or answer questions about a study that does not exist in this document.

Here's a breakdown of why the information is not present based on the provided text:

1. Acceptance Criteria and Reported Device Performance: Not provided. The submission asserts substantial equivalence rather than presenting specific performance metrics against defined criteria.
2. Sample size, Data Provenance: No test set was used for this device in this submission, as performance data was not generated.
3. Number of experts, qualifications, adjudication method: Not applicable, as no ground truth was established for a test set for this device in this submission.
4. MRMC comparative effectiveness study: Not conducted or mentioned.
5. Standalone performance study: Not conducted or mentioned for this device.
6. Type of ground truth: Not applicable.
7. Sample size for training set: Not applicable, as this is not an AI/ML device and no training set was used.
8. How ground truth for training set was established: Not applicable.

Summary of Device and 510(k) Approach:

• Device Name: Light for Wrinkles
• Intended Use: Over-The-Counter handheld device for treatment of periorbital wrinkles.
• Predicate Device: LED Intellectual Properties, LLC - Anti-Wrinkle Light, Model AAL
• Basis for Clearance: Substantial Equivalence. The applicant states that the device has "the exact same technological characteristics including design, materials, power output (65nM/cm2), the exact same wavelengths, delivery system and power transformer" as the predicate.
• Performance Data in Submission: None provided; reliance on equivalence to predicate device.

Conclusion: The 510(k) submission for "Light for Wrinkles" did not include a study with acceptance criteria and device performance data. Its clearance was based on its substantial equivalence to a previously cleared predicate device, meaning the FDA did not require new performance data within this specific 510(k) application due to the asserted identicality with the predicate.

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The Anti-Wrinkle Light, model: AAL, is a handheld device intended for use in the treatment of periorbital wrinkles.
The Anti-Wrinkle Light is a hand held device intended to emit energy in the visible and IR regions of the spectrum for use in dermatology for the treatment of periorbital wrinkles.

The Anti-Wrinkle Light, Model AAL is a hand-held device consisting of low intensity light emitting diodes (LED's) that emit Low and Sub- IR light for direct exposure to the skin. The device components include an LED array of 605nm, 630nm, 660nm, and 855nm wavelengths, a (non-flammable plastic) hand piece housing a printed circuit board upon which the LED's are mounted, single non-timer on/off switch with 5-ohm resistor, receiver jack in the hand piece accommodating a removable power cord and a separate AC to DC ( 9-volt ) power supply. Treatment time is recommended to be 3 minutes and is controlled by the user.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Anti-Wrinkle Light, Model AAL:

It's important to note that the provided 510(k) summary (K092800) for the Anti-Wrinkle Light, Model AAL, is extremely limited in the detail it provides about the clinical study conducted. Many of the requested details are not present in the document.

Acceptance Criteria and Reported Device Performance

The document states, "After an analysis of the safety, indications and intended uses, performance, features, technological properties and methods of operation, LED Intellectual Properties, LLC believes that no significant differences exist between the predicate devices listed in Section 3, above. A clinical study has been submitted."

This implies that the acceptance criterion was likely demonstrating substantial equivalence to predicate devices, particularly in performance for the reduction of periorbital wrinkles and rhytides. However, the specific quantitative acceptance criteria (e.g., a certain percentage reduction in wrinkles, or a specific score improvement) and the corresponding reported device performance (i.e., the numerical results from the clinical study) are NOT provided in this summary.

Therefore, a table of acceptance criteria and reported device performance cannot be fully constructed from the given information as the specific performance metrics and outcomes are absent. The general "performance" stated is that it is believed to be "no significant differences" from predicates.

Study Details:

Here's what can be extracted and what is missing:

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

   • Acceptance Criteria: Implicitly, substantial equivalence to predicate devices for the reduction of periorbital wrinkles and rhytides. No specific quantitative criteria (e.g., target percentage reduction, statistical significance) are stated.
   • Reported Device Performance: Not provided in the summary. The summary only states that "LED Intellectual Properties, LLC believes that no significant differences exist between the predicate devices," implying successful performance relative to the predicates, but no specific outcome data is presented.

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: Not specified. The document only mentions "Individual subjects participating in the clinical study."
   • Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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 in the document.

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

   • This information is not provided in the document.

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 therapeutic light device, not an AI diagnostic/interpretive tool that assists human readers.

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 therapeutic light device, not an AI algorithm. Its performance is measured directly on the patient's skin condition.

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

   • The "ground truth" for a device intended for wrinkle reduction would typically involve clinical assessment of wrinkle severity before and after treatment, possibly using standardized grading scales (e.g., Fitzpatrick Wrinkle Scale, photonumeric scales) or objective measurements (e.g., 3D imaging). However, the specific method used is not detailed in this summary. It would fall under "outcomes data" or expert assessment of outcomes.

8. The sample size for the training set:

   • This device is not an AI/machine learning algorithm that requires a "training set" in the conventional sense. It's a light therapy device. The clinical study mentioned would be considered the validation or performance study, typically for demonstrating safety and effectiveness on an independent cohort.

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

   • Not applicable for a therapeutic light device.

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