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The Elevare Plus is an Over-the-Counter (OTC) device intended for the use in treating wrinkles on the face.

The Elevare Plus is an over-the-counter, battery powered, hand-held light emitting diode (LED) device that emits light energy in the red and I/R spectrum for the treatment of wrinkles on the face. The system components include the handheld unit containing the LED array, 2 Li-ion rechargeable batteries, power adapter, charging cord, charging cradle and travel case.

The unit is applied directly to the skin to ensure consistent administration of light during each treatment. The device does not contain any user serviceable components. The device is sold as Over the Counter (OTC).

The provided text does not contain information about acceptance criteria or a study that proves the device meets the acceptance criteria in the way typically found for AI/ML medical devices. The document is a 510(k) summary for a light-based device (Elevare Plus) intended for wrinkle reduction, and its focus is on demonstrating substantial equivalence to predicate devices based on safety and performance testing, rather than a clinical study with detailed performance metrics against a defined acceptance criterion.

However, I can extract the relevant information from the document that pertains to how the device's performance was evaluated and compared, even if it doesn't align perfectly with the structure requested for AI/ML device studies.

Here's an interpretation based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in terms of clinical efficacy endpoints or statistical thresholds for AI/ML performance. Instead, it demonstrates performance through technical specifications and comparison to predicate devices. The "acceptance criteria" are implied to be meeting technical specifications and demonstrating "substantial equivalence" to other legally marketed devices.

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

• Test Set Sample Size: For "Skin Temperature Testing", two devices were tested. For "Predicate Comparison Testing," "several FDA cleared devices" were evaluated against the Elevare Plus device. No other specific sample sizes for testing are mentioned.
• Data Provenance: The testing appears to be prospective bench testing and performance testing conducted by the manufacturer specifically for this submission. The origin of the data (country) is not explicitly stated but is implied to be part of the manufacturer's testing efforts.

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

This type of information is generally not applicable to a submission for a physical device like the Elevare Plus, which relies on technical performance and safety testing rather than interpretation of data by human experts for ground truth. The "ground truth" here is defined by physical measurements against established engineering and safety standards.

4. Adjudication Method for the Test Set

Not applicable. The testing described involves objective measurements against established standards, not interpretation or adjudication by multiple human readers.

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

No. An MRMC study is relevant for assessing the diagnostic performance of an AI system, often comparing AI-assisted vs. unassisted human performance. This document describes the safety and engineering performance of a physical light therapy device, not an AI/ML diagnostic algorithm.

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

This refers to AI/ML algorithm performance. The Elevare Plus is a physical device, not an AI/ML algorithm, so this concept is not applicable.

7. The Type of Ground Truth Used

The ground truth used for the performance evaluation described in this summary consisted of:

• International consensus standards for electrical safety, EMC, biocompatibility, photobiological safety, and home healthcare environments.
• Manufacturer's internal specifications for software validation, skin temperature limits (41+/- 2 ºC, not above 43ºC), and wavelength/power output.
• Technical characteristics and documented performance of legally marketed predicate and reference devices (as detailed in their 510(k) summaries) for comparison purposes to establish substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. The Elevare Plus is a physical light therapy device, 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 submission.

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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 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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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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