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The Erchonia Zerona® VZ8 is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of body circumference.

The Zerona® VZ8 laser is designed for clients seeking noninvasive circumference reduction without invasive surgery. Zerona® VZ8 allows the patient to continue their daily activities without interruptions from surgery, pain, wounds or garments. The Zerona® VZ8 works by emulsifying adipose tissue which then releases into the interstitial space. Zerona VZ8 was built on the clinical foundation of its predecessors, Violet ZERONA® Z6 and ZERONA® Z6 OTC, which were proven through clinical studies to be safe and effective in the application of circumference reduction.

The Zerona® VZ8 is identical to the predecessor device, the Erchonia Violet ZERONA® Z6 OTC cleared under K231474, with the difference in the number of laser diodes (eight compared to six). The Installation and Proper Use Reference Guide for use for the Zerona® VZ8 is identical to the predecessor laser, the Erchonia® Violet ZERONA® Z6 OTC: consisting of the similar treatment set-up and same treatment protocol involving 6 treatments occurring over 2 weeks: 3 treatments per week; each treatment every other day.

The Zerona® VZ8 emits a 405-nanometer wavelength with a tolerance of ±10 nanometer, from each of the eight specially created and patented electronic diodes. Laser devices are typically constructed to emit a "spot" of light. The Zerona® VZ8 laser utilizes internal mechanics that collects the light emitted from the laser diode and processes it through a proprietary patented lens, and then redirects the beam with a line refractor. The laser applicator heads, each produce an output power of 23mW (± 2mW) measured. Laser diodes and adjustable laser arms are positioned no greater than 3-4 inches away from the client's target treatment areas.

The software incorporated into the operation of the Zerona® VZ8 complies with FDA and ISO Software Development and Validation regulations.

The provided text is a 510(k) summary for the Erchonia Zerona® VZ8 device. It states that no clinical study results were submitted as part of this submission, and therefore, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through clinical data. The submission relies on demonstrating substantial equivalence to predicate devices, particularly the Erchonia Violet ZERONA Z6 OTC and the Erchonia Emerald, based on similar technology and the safety and efficacy data previously established for those devices.

Specifically, the document states:

• "No clinical study results are being submitted as part of this submission" (Page 7, "Performance Testing-Clinical").

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them, as presented in the format of the questions, because this information is not present in the provided text. The submission focuses on demonstrating substantial equivalence rather than presenting new clinical performance data for the Zerona® VZ8 itself.

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The BIOPHOTAS Celluma CONTOUR is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs.

The BIOPHOTAS Celluma CONTOUR is intended to deliver heat in the near infra-red spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis, and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.

The BioPhotas Celluma CONTOUR is intended to emit energy in the visible and infrared region of the spectrum for use in the treatment of full-face wrinkles.

The BioPhotas Celluma CONTOUR is a Light emitting diode (LED) system that applies 640nm light for the purpose of reducing the circumference of the hips, waist, and thighs for aesthetic benefit, 640nm and 880nm light for the purpose of temporarily elevating skin temperature and 640nm and 880nm light for the purpose of treating full face wrinkles.

The BioPhotas Celluma CONTOUR comprises of a flexible, shape-taking frame upon which is mounted an array of LEDs, this allows the device to be contoured to the treatment area. The LEDs are embedded within a biocompatible foam covering that holds a transparent polycarbonate cover recessed within it. The biocompatibility nature of allows the device to be placed in contact with the skin.

The flexible LED panel is permanently connected by a three-foot long cable attached to a control panel that contains the circuitry and software that controls the device. The control panel contains several push buttons beneath a sealed cover. A power button that switches the device ON/OFF, a mode button that allows the user to select from 3 preprogrammed treatment modes "Contour" "wrinkles" and "Aches and Pains", and a Start button that activates the desired treatment mode. The control panel receives its power from a separate cable that connects via an AC adaptor for 110-220 Volts to a standard U.S. electrical power outlet. The control panel contains an automatic shut-off safety feature.

The provided FDA 510(k) summary for the Biophotas Celluma CONTOUR (K232977) does not contain comprehensive details on acceptance criteria and specific study results in a format that would typically be described for a diagnostic AI device. This document is a premarket notification for a Class II medical device (Low Level Laser System For Aesthetic Use), and the information presented focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance metrics through large-scale clinical trials with defined acceptance criteria and statistical proofs.

However, based on the information provided, I can extract and infer some points regarding performance testing and acceptance, particularly concerning safety and usability for an Over-The-Counter (OTC) device.

Here's a breakdown of the available information structured to address your questions, with the understanding that this device is not an AI diagnostic tool and thus many of your questions related to AI-specific metrics (e.g., MRMC, standalone algorithm performance, training set ground truth) are not applicable or explicitly stated for this type of device submission.

Description of Acceptance Criteria and Studies

1. Table of Acceptance Criteria and Reported Device Performance

For this device, "acceptance criteria" are mainly focused on demonstrating compliance with safety standards, usability for OTC use, and equivalence of technological characteristics to predicates. Performance is assessed through compliance with these standards and comparison to predicates.

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

• Usability/Label Comprehension Study:

  • Sample Size: 24 test subjects.
  • Data Provenance: Not explicitly stated, but typically these studies are conducted prospectively with recruited participants in a controlled environment. The country is not specified.

• For other non-clinical performance tests (electrical safety, EMC, software validation, biocompatibility), these are typically engineering tests performed on the device itself or its components (e.g., materials for biocompatibility) rather than human subjects. Thus, the concept of "sample size" for a test set (like for a diagnostic device) doesn't directly apply in the same way.

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

This question is largely not applicable as this device is not an AI diagnostic tool that requires expert ground truth for performance evaluation in the context of disease detection or measurement.

For the usability study, "ground truth" refers to whether lay users can correctly understand and operate the device safely based on labeling. This is assessed through questions and observation, not expert consensus on medical images or patient outcomes. The experts involved would be human factors engineers or usability specialists who design and analyze the study. The document does not specify the number or qualifications of such experts.

4. Adjudication Method for the Test Set

This question is not applicable for the type of studies described in this submission (safety, EMC, software validation, usability). Adjudication implies resolving disagreements among experts for ground truth establishment, which is relevant for diagnostic performance studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This device is a light-emitting diode (LED) system for aesthetic and pain relief uses. It does not involve AI for diagnostic interpretation or human reader assistance.

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

Not Applicable. This device does not feature a standalone diagnostic algorithm. The software mentioned is for controlling the device's operational modes and safety features, not for standalone diagnostic performance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• For safety and performance characteristics (electrical, EMC, software): The "ground truth" is adherence to established international and national engineering standards (IEC 60601-1, IEC 60601-1-2, IEC 62304). Third-party testing labs or in-house engineering teams confirm compliance.
• For usability/label comprehension: The "ground truth" is the correct understanding and safe operation of the device by lay users, as measured by their responses to questions and observed interactions, compared against the intended use and safety protocols.
• For biocompatibility: The "ground truth" is the material's previously established biocompatibility or demonstration of compliance with relevant biocompatibility standards (e.g., ISO 10993 series), confirmed by testing (which was not repeated here due to material identity to cleared devices).

8. The Sample Size for the Training Set

Not Applicable. This device is not an AI/ML system that utilizes a training set for model development in the context of diagnostic performance. The software is noted as a Class A medical device software (lowest risk) and its validation focuses on life cycle processes and functional correctness, not machine learning training.

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

Not Applicable. As there is no "training set" in the context of an AI/ML algorithm for this device, this question does not apply.

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The Violet ZERONA® Z6 OTC is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of body circumference.

The Violet ZERONA® Z6 OTC laser is designed for client's seeking noninvasive circumference reduction without invasive surgery. Violet ZERONA® Z6 OTC allows the patient to continue their daily activities without interruptions from surgery, pain, wounds or garments. The Violet ZERONA® Z6 OTC works by emulsifying adipose tissue which then releases into the interstitial space. The Violet ZERONA® Z6 was built on the clinical foundation of its predecessors, Zerona® and Zerona®-AD, and ZERONA® Z6 OTC, which were proven through clinical studies to be safe and effective in the application of circumference reduction.

The Erchonia Violet ZERONA® Z6 OTC is identical to the predecessor device, the Erchonia ZERONA® Z6 OTC cleared under K162578, with the differences being light output (visible violet compared to visible red) and duration of treatment administrations (20 minutes compared to 40 minutes, which is automatically programmed into the device). The Installation and Proper Use Reference Guide for use for the Erchonia® Violet ZERONA® Z6 OTC are identical to those for use of the predecessor laser, the Erchonia® ZERONA® Z6 OTC; consisting of the same device set-up and same treatment protocol involving 6 treatments occurring over 2 weeks: 3 treatments per week; each treatment every other day.

The Violet ZERONA® Z6 OTC emits a 405-nanometer wavelength with a tolerance of ±10 nanometer, from each of the six specially created and patented electronic diodes. Laser devices are typically constructed to emit a "spot" of light. The Violet ZERONA® Z6 OTC laser utilizes internal mechanics that collects the light emitted from the laser diode and processes it through a proprietary patented lens, and then redirects the beam with a line refractor. The laser applicator heads, each produce an output power of 23mW (± 2mW) measured. Laser diodes and adjustable laser arms are positioned no greater than 3-4 inches away from the client's target treatment areas.

The software incorporated into the operation of the Violet ZERONA® Z6 OTC complies with FDA and ISO Software Development and Validation regulations.

Here's an analysis of the acceptance criteria and the study proving device performance, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 25 subjects completed the study.
• Data Provenance: The document does not explicitly state the country of origin. It indicates it was an "open-label single-arm design" clinical study, which implies it was prospective.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

This device focuses on biometric measurements (circumference reduction) rather than image interpretation or diagnosis. Therefore, there is no mention of "experts" being used to establish ground truth in the traditional sense of medical imaging or diagnostic devices. The ground truth (circumference measurements) would have been taken by trained study personnel using standardized methods. Their qualifications are not specified but are implied to be sufficient for accurate measurement taking.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this device does not involve subjective interpretations requiring adjudication by experts. Measurements would have been taken according to a defined protocol.

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

No, an MRMC comparative effectiveness study was not done. This study did not involve human readers interpreting cases with and without AI assistance. It was a clinical study evaluating the efficacy of a laser device for circumference reduction.

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

This concept is not directly applicable to this device, as it is a physical laser device applied to a patient, not an AI algorithm performing analysis. The study assessed the device's performance directly on human subjects.

7. Type of Ground Truth Used

The ground truth used was biometric measurements of body circumference (waist-hips-bilateral thighs circumference) taken directly from subjects at baseline and at the study endpoint.

8. Sample Size for the Training Set

This document does not describe the development or training of an algorithm in the traditional sense that would require a dedicated training set. The "clinical foundation" of the device was built upon predecessors, and this study served as a validation study for the new violet laser, comparing its performance to historical data from the red laser. The predicate device (Erchonia ZERONA® Z6 OTC) had a clinical study (K162578 and K143007) that involved 22 subjects (as seen in Table 1). This could be considered a comparative dataset, but not a "training set" for an algorithm in this context.

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

As explained above, there isn't a "training set" in the context of an AI algorithm described here. The previous studies (K162578, K143007) that established the efficacy of the red laser (which the violet laser is compared against) would have established their ground truth through similar direct biometric measurements of circumference reduction on their respective subject cohorts.

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The Zerona® Z-Bed Laser is indicated for use as a non-invasive dermatological aesthetic treatment of body circumference.

The Zerona® Z-Bed laser is specially designed for non-invasive fat loss. Zerona® Z-Bed is a new body-sculpting procedure designed for client's seeking noninvasive fat loss without invasive surgery. Zerona® Z-Bed allows the individual to continue their daily activities without interruptions from surgery, pain, wounds or garments. The Zerona® Z-Bed works by utilizing proven low level laser technology to emulsify adipose tissue (defined as leakage of the fat out of the cell) which then releases into the interstitial space. The excess fat is passed through the body during its normal course of detoxification. The Zerona® Z-Bed was built on the clinical foundation of its predecessors, Zerona® Z6 OTC, Zerona® and Zerona®-AD which were proven through a double-blind, randomized, multi-site, and placebo controlled studies to be safe and effective in the application of circumference reduction and noninvasive fat loss.

The Zerona® Z-Bed emits a 635 nanometer wavelength with a tolerance of ±10 nanometer, from each of the twelve specially created and patented electronic diodes. Laser devices are typically constructed to emit a "spot" of light. The Zerona® Z-Bed laser utilizes internal mechanics that collects the light emitted from the laser diode and processes it through a proprietary patented lens, and then redirects the beam with a line refractor. The laser applicator heads, each produce an output power of 17.5mW (± 1.25mW) measured, per non-convergent beams. Laser diodes and adjustable laser arms are positioned no greater than 3-4 inches away from the client's target treatment areas. In this position the diode emits a line width of 3mm and a mean length of 3.5in. (8.9cm), each line emits approximately (.0002 joules per cm² / minute) per area at 3inches and approximately (.0001 joules per cm2 / minute) per area at 4inches. The treatment time of 20 minutes would be approximately .004 /cm² at 3 inches and approximately .002 //cm² at 4 inches away from the skin.

The Zerona® Z-Bed laser device has been classified by the FDA/EC as a Class II/IIa device and a Class I/2 Laser. This designation represents a current standard for use in order to ensure the safety of the individual. A Class II/Ia Laser is determined to have a chronic viewing hazard. Pointing the laser beam directly into the eye and maintaining it there for an extended period of time could prove to be damaging.

The Zerona® Z-Bed laser device has been classified by the FDA Class II device and a Class 2 laser in accordance IEC 60825-1 (Complies with 21CFR 1040.10 and 21 CFR 1040.11 by Laser Notice #50). The performance parameters and intended use of the Erchonia® Zerona® Z-Bed are compliant to the internationally recognized safety testing standards for medical devices. The testing of the Zerona® Z-Bed device includes functional performance, electrical, safety and component verification, in accordance with the FDA QS requirement, validated annually through ISO 13485 audits. The software incorporated into the operation of the Zerona® Z-Bed complies with FDA and ISO Software Development and Validation regulations.

The Zerona® Z-Bed laser package is comprised of (1) Zerona® Z-Bed Laser Device, (1) Laser Safety Glasses, (1) Power Cord, (1) Power Supply, (1) Tape Measure, (1) Pack of Disinfectant Wipes, and (1) Operation & Maintenance Manual. This following information is included to familiarize you with the components of the device.

The provided document is a 510(k) summary for the Erchonia Zerona Z-Bed, a low-level laser system for aesthetic use. It does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/human reader performance study.

The document states: "No clinical study results are being submitted as part of this submission." (Page 6)

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Erchonia Zerona Z6 OTC) based on technological characteristics and safety standards. The "Performance Data" section discusses compliance with voluntary standards (IEC 60601-1-2:2014, IEC 60601-1:2005, IEC 60825-1:2014), software verification and validation, risk assessment, and electromagnetic compatibility/electrical safety.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance in the context of AI assistance or human reader improvement, as this information is not present in the provided text.

Based on the provided document, the device's performance is demonstrated through:

• Compliance with established safety and performance standards: IEC 60601-1-2, IEC 60601-1, IEC 60825-1, and FDA's performance standards for light-emitting products (21CFR 1040.10 and 21 CFR 1040.11 by Laser Notice #50).
• Demonstration of substantial equivalence to a legally marketed predicate device: The Zerona Z6 OTC, which was "proven through a double-blind, randomized, multi-site, and placebo controlled studies to be safe and effective in the application of circumference reduction and noninvasive fat loss" (Page 4). The current device's design change (adding more diodes for simultaneous anterior/posterior treatment) does not affect the safety or effectiveness, as the number of diodes, laser power, and treatment time per treated area remain the same as the predicate device.

To directly answer the questions based on the provided text, where applicable, and mark non-applicable questions:

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

• Acceptance Criteria: The primary "acceptance criteria" for this 510(k) submission is demonstration of substantial equivalence to a predicate device and compliance with relevant safety and performance standards. There are no specific quantitative performance metrics provided for the subject device (Zerona Z-Bed) in the context of clinical efficacy, as "No clinical study results are being submitted as part of this submission." The predicate device was proven safe and effective.
• Reported Device Performance:
  • Safety Standards Compliance: IEC 60601-1-2:2014 Ed 4.0, IEC 60601-1:2005 AMD1:2012, IEC 60825-1:2014 Ed 3.0.
  • Regulatory Compliance: 21CFR 1040.10 and 21 CFR 1040.11 (Laser Notice #50), FDA QS requirement (ISO 13485 audits), ISO 14971 (risk assessment), FDA and ISO Software Development and Validation regulations.
  • Technological Equivalence (to predicate):

    Characteristic	Erchonia® Zerona® Z-Bed (Subject Device)	Erchonia Zerona® Z6 OTC (Predicate Device)
    Laser Power	17.25mW ± 1.25mW	17.25mW ± 1.25mW
    Wavelength	630 nm - 640 nm (Red)	630 nm - 640 nm (Red)
    Waveform	Constant Wave	Constant Wave
    Energy Source	Multi diode collected then line dispersed (coherent)	Multi diode collected then line dispersed (coherent)
    Power Supply	100 - 240V~ 1.5-.5A, 50-60 Hz electrical outlet	100 - 240V~ 1.5-.5A, 50-60 Hz electrical outlet
    Number of Laser Diodes Applied Per Treatment Area	6	6
    Treatment Time Applied Per Area	20 minutes	20 minutes
    Treatment Frequency	3 x week, 2 weeks	3 x week, 2 weeks
    Total Fluency	248 J	248 J
    Target Size Per Diode	Line pattern, electronically scanned over area of treatment (516 cm²)	Line pattern, electronically scanned over area of treatment (516 cm²)
    User Interface	LCD Touchscreen	LCD Touchscreen
    Principles of Operation	Mains power, converted to DC, powering semi-conductor diodes	Mains power, converted to DC, powering semi-conductor diodes
    Mechanism of Action	Low level light energy used as an adjunct to emulsify adipose tissue	Low level light energy used as an adjunct to emulsify adipose tissue

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

• N/A. No new clinical performance test set data was submitted for the subject device. The predicate device's efficacy was established via "double-blind, randomized, multi-site, and placebo controlled studies." Details about those studies (sample size, provenance, etc.) are not provided in this 510(k) summary for the subject device.

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)

• N/A. This information is not relevant to this 510(k) submission, as it focuses on technological equivalence and safety standards, not a new clinical performance study for the subject device involving expert ground truth.

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

• N/A. Not applicable, as no new clinical performance test set data was provided.

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

• N/A. This device is a low-level laser system for aesthetic use, not an AI diagnostic tool. No MRMC study was performed or mentioned.

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

• N/A. This is a hardware device, not an algorithm.

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

• N/A. For the subject device, the ground truth for its "performance" is primarily its compliance with established electrical and laser safety standards, and its technological equivalence to a predicate device whose efficacy was previously established in clinical studies (details of which are not included here). The predicate device's efficacy was based on "circumference reduction" (an outcomes measure).

8. The sample size for the training set

• N/A. This information is not relevant to this 510(k) as it describes a physical device, not an AI model requiring a training set.

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

• N/A. Not applicable, as there is no AI training set discussed.

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Resurgeonz pHantom Trilogy(TM) is indicated for use as a non-surgical, non-invasive aesthetic treatment for the temporary reduction of the circumference of waist, hips, thighs through the process of disrupting adipocyte cells, within the fat layer, for the release of fat and lipids from the targeted cells.

The Resurgeonz pHantom Trilogy™ is a non-surgical, non-invasive, fat reducing low level laser system using a combination of Red and Infrared light spectrums to propagate laser frequencies of 660nm, 808nm and 980nm into a patient's dermal and adipose tissues for the reduction of the measured circumference of the patients waist, hips, and thighs. The device features an LCD touchscreen. Mode of operation is continuous. Allows individual patient session controls of: treatment time, energy, pulse and delay. Emergency safety cut off switch. Treatment applicators (multi diode paddles) connected to the device console can number 8,10, or 12. Paddles include built in air fan cooling. Combination of Coherent Frequencies of red and infrared: 26 diodes per big paddle, (13 red diodes at 660nm) and thirteen (13 infrared diodes) of the 13 infrared diodes, (6 diodes) are 808nm and (7 diodes) are 980nm. Two smaller paddles are available to swap out in place of two big paddles. The two smaller paddles only have 2 diodes each of red diodes at 660nm and are used for smaller hard to reach body areas. Power output or each diode is variable up to 72mW to per diode for all red and infrared diodes. The device does not have wireless and/or external wired communication. The device is powered by 120V, 60Hz. There is a side holder for paddles when not in use.

The provided document is a 510(k) summary for the Resurgeonz PHantom Trilogy™ low-level laser system. It details the device's characteristics, intended use, and claims of substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or specific study data proving the device meets acceptance criteria in the way requested for an AI/ML medical device.

The questions provided in the prompt (acceptance criteria, study details, sample sizes, ground truth establishment, expert adjudication, MRMC studies, standalone performance, training set details) are typically relevant for the regulatory review of Diagnostic AI/ML-enabled devices, particularly those that involve image analysis, disease detection, or treatment recommendations based on complex algorithms.

The PHantom Trilogy™ is described as a "low-level laser system for aesthetic use" for temporary reduction of circumference, operating via physical principles (laser light disrupting adipocyte cells). Its regulatory clearance is based on substantial equivalence to existing predicate devices, meaning it has similar technological characteristics and performs similarly in its intended use. This type of device's "performance data" typically refers to non-clinical (bench) tests to demonstrate its physical and electrical characteristics meet safety and performance standards, and potentially limited clinical data demonstrating the stated aesthetic effect, rather than the complex statistical validation required for AI/ML diagnostic tools.

Given the nature of this document and the device, I cannot fill in the requested table and answer the detailed questions relevant to an AI/ML device because that information is not present in this 510(k) summary. The document states:

• "Resurgeonz pHantom TrilogyTM overall performance testing passed all specified test requirements of non-clinical (bench) tests conducted for determination of Substantial Equivalence (SE) results, and show of Substantial Equivalence (SE) with the predicate devices." (Page 3-4)
• "The Resurgeonz PHantom Trilogy™ meets the functional claims, and Intended Use as described in the product Labeling." (Page 5)
• "The safety and effectiveness are equivalent to the predicate device K192275 and predicate device K130341." (Page 5)

These statements indicate that the "study" proving the device meets acceptance criteria was primarily a comparison to predicate devices, supported by bench testing, rather than a clinical trial with the detailed statistical and ground truth methodologies typically found for AI/ML diagnostic tools.

Therefore, the requested information cannot be extracted from this document. If this were a submission for an AI/ML device, the detailed sections on performance, study design, and clinical data would be significantly different and much more extensive.

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The Contour Light CL-100 device is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs.

The Contour Light CL-100 device is indicated to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle spasm, and pain and stiffness associated with arthritis, for promoting relaxation of the muscle tissue, and to temporarily increase local blood circulation.

The Contour Light CL-100 is a low level laser (red light LED) system that applies 635nm light for the purpose of reducing the circumference of the hips, waist and thighs for aesthetic benefit, and 630nm light for the purpose of temporarily elevating skin temperature.

The Contour Research, LLC Contour Light CL-100 device applies a light emitting diode (LED) technology, and is used to perform red light LED-based circumferential reduction of the hips, thighs and waist in adults, or red light and IR LEDs for temporary elevation of skin temperature, within a treatment time of 30 minutes. The device is comprised of a panel of LEDs that is adjustable to conform generally to the outer dimensions of the individual being treated, a software controlled console that is used to select and maintain the application of the LED light, a power adaptor, and cables that connect to the energy source. The device is powered by connecting it to an 85-264 VAC, at 3 amps, 47-63 Hz. power source.

The provided document is a 510(k) summary for a medical device called "Contour Light CL-100". It focuses on establishing substantial equivalence to previously cleared predicate devices rather than proving the device meets specific performance acceptance criteria through a clinical study.

Therefore, the information required to answer your request (acceptance criteria, details of a study proving the device meets acceptance criteria, sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is largely absent from this document.

This 510(k) summary explicitly states:

• "9. Clinical Performance Data: None submitted." (Page 7)

This means no clinical study was conducted or submitted as part of this 510(k) application to demonstrate the device's performance against pre-defined acceptance criteria. The basis for clearance is substantial equivalence to predicate devices, supported by non-clinical performance data (electrical safety, EMC, software, shelf life, internal design validation).

However, I can extract the following relevant, albeit limited, information:

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

• Acceptance Criteria: Not explicitly defined in terms of specific performance metrics (e.g., accuracy, sensitivity, specificity, or quantifiable reduction in circumference). The "acceptance criteria" for this 510(k) revolved around demonstrating substantial equivalence in intended use and technological characteristics to legally marketed predicate devices, and passing non-clinical safety tests.
• Reported Device Performance:
  • The device passed Electrical safety testing per IEC 60601-1.
  • The device passed Electromagnetic Disturbance testing per IEC 60601-1-2.
  • Software verification and validation per IEC 62304/FDA Guidance were Completed.
  • Shelf Life Testing Supports useful device life of 5 years.
  • Internal Design Validation Testing results were also mentioned (no specific metrics provided).

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

• Sample Size: Not applicable. No clinical test set data was submitted.
• Data Provenance: Not applicable.

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

• Not applicable. No clinical test set and thus no expert ground truth establishment method was described.

4. Adjudication method (e.g. 2+1, 3+1, none) 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:

• No MRMC study was done, as no clinical data was submitted. The device is a "Low Level Laser System For Aesthetic Use" and "Infrared Lamp," 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:

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

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

• Not applicable. No clinical ground truth was established, as no clinical study was performed or submitted.

8. The sample size for the training set:

• Not applicable. There is no indication of machine learning or deep learning models being trained with a training set for this device.

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

• Not applicable.

Summary of what the document does describe as the basis for clearance:

The device (Contour Light CL-100) was cleared based on its substantial equivalence to predicate devices (Strawberry and Cream Low Level Laser system, Zerona Z6 OTC, BioPhotas LifeLight). This equivalence was argued through:

• Identical/Similar Indications for Use: The Contour Light CL-100's indications for reducing circumference of hips, waist, and thighs, and topical heating for pain relief and circulation, are presented as essentially identical to those of the predicate devices.
• Similar Technological Characteristics: All devices are low-level light/laser systems for aesthetic use and/or pain relief. Minor differences in wavelength and intensity were deemed not to raise new safety or effectiveness concerns.
• Non-Clinical Performance Data: As listed in point 1, the device successfully completed various safety and performance tests (electrical safety, EMC, software validation, shelf life, internal design validation).

This 510(k) submission chose a pathway that did not require a clinical study demonstrating performance against specific quantitative acceptance criteria on human subjects, relying instead on the established safety and effectiveness of the predicate devices and the non-clinical testing of the subject device.

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UltraSlim DIGITAL is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs.

UltraSlim DIGITAL is also indicated for use in dermatology for the treatment of superficial, benign vascular, and pigmented lesions.

UltraSmooth DIGITAL is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs.

The Massager component is indicated for the temporary reduction in the appearance of cellulite.

UltraSlim® Digital and UltraSmooth® Digital are LED light therapy devices. The UltraSlim Digital uses 625nm red light (UltraSlim Digital), and the UltraSmooth Digital uses 532nm green light (UltraSmooth Digitial). The devices are generally described as pole-mounted and free-standing on a rolling base as shown in the figures below.

Both devices, UltraSlim® Digital and UltraSmooth® Digital, continue to share the same design platform, and only differ in the color of the LED light array. The associated branding/names, warning labels, and differences due to their respective indications for use will remain the same as previously cleared, and do not change as a result of this proposed controller change.

All design and manufacturing parameters are very similar in both devices including the power supply, drivers, internal components, physical form, and control. The devices consist of a main control unit, LED panel, and cable connections. The main control unit contains the main input, fuses, power supply, control circuits, and Minutes selector switch. The power switch has a failsafe system that ensures the voltage from a wall socket can never come in contact with the user. A hospital-approved isolation transformer is mounted on the base of the medical pole cart whose low center of gravity also supports the main control unit and the light fixture from tipping. The console is mounted to the pole with an articulated arm. Treatment time is selected from pre-determined options programmed into the digital timer relay that do not allow the user to vary treatment times. System operation is preset. Both units operate at a frequency of 50Hz – 60Hz and a total power output of 300 W.

A design change was implemented, in an identical way, in the control of both devices that changes the unit from manual control to WiFi control. In general terms, the design change effectively replaces the electronic relay from the old design with a WiFi relay switch that is activated via WiFi from a mobile, desktop, tablet, or laptop device.

The new control design centers around replacing the manual time interval select and start button with a 4-Channel WiFi Relay Switch. Initiating a start sequence of the unit will be performed via internet control using a Relay Switch that receives its instructions from the user through WiFi control. Users continue to be restricted to the treatment time options of 8 and 20 minutes in the web app, and are able to start the device from the WiFi control.

The push button momentary start switch is removed in the new design. Users only have the ability to start the device by way of WiFi control.

The devices with the new design change do not contain any software. However, a web app accessible through the internet allows users to log in, select treatment time options of 8 minutes or 20 minutes, and to initiate treatment. The built-in timer control via the 4-Channel WiFi Relay Switch automatically stops the treatment at the end of the approved treatment time based upon the input received from the user.

Each device has a unique local IP address that is associated with its assigned router. Each router has its own unique client's ISP-assigned Static IP and may be controlled by WiFi from any phone, tablet, or computer with Internet access.

I am sorry, but the provided text does not contain information regarding a study that proves the device meets specific acceptance criteria in the way you've outlined for clinical performance. The document explicitly states:

• "No new Clinical Testing was conducted." (page 8)
• "The submission does not contain clinical performance data." (page 8)

The document is a 510(k) summary for a premarket notification for device modifications (changing from manual control to WiFi control) for existing devices (UltraSlim® Digital and UltraSmooth® Digital). The focus is on demonstrating substantial equivalence to predicate devices and compliance with non-clinical performance standards and safety evaluations for the design change, rather than providing new clinical data for acceptance criteria directly related to the treatment efficacy.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, or details about sample size, expert ground truth, adjudication methods, MRMC studies, or standalone performance for clinical efficacy, as this information is not present in the provided text.

The information I can extract that is somewhat related to your request, but not directly for clinical acceptance criteria, pertains to non-clinical testing for the design change:

• Non-Clinical Performance Data: The device was tested for compliance with applicable standards given in the "Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use." This includes IEC 60601-2-57 (Medical electrical equipment for basic safety and essential performance of non-laser light source equipment).
• Electromagnetic Disturbances and Wireless Compliance: Testing was conducted by SGS in Suwannee, Georgia, to ensure compliance with IEC 60601-1-2:2014 (Electromagnetic disturbances) and ANSI C63.10: 2013 (FCC Part 15 Subpart C, § 15.247) for RF emissions due to the addition of a 4-Channel WiFi Relay Switch. All test results were compliant.
• Software Validation: The web app control for logging in and initiating treatments was validated.
• Cybersecurity: A risk-based cybersecurity safety evaluation was performed, and the device was classified as Tier 2 "Standard Cybersecurity Risk."

These points demonstrate compliance with certain safety and performance standards for the device's design and control system, but they are not clinical acceptance criteria for the device's intended aesthetic treatment efficacy (e.g., reduction of circumference).

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The InvisaRED™ Technology ELITE is indicated for use as a non-invasive dermatological aesthetic treatment for the temporary reduction of the circumference of waist, hips, and thighs through the process of photobiomodulation, affecting adipocyte cells within the adipose layer for the release of lipids from these cells.

Device console:

• Electrical Power: 110v
• Cooling: Air Cooled
• Operation: LCD touch screen
• Allows Control of Individual Patient Session Protocol (Time, Energy, Pulse, Delay)
• Integrated Device Power-On Self Test
• Emergency Safety cut off switch
• Treatment applicators (multi diode paddles) connected to the device console can number 8,10, or 12
• Paddle Cooling: Air cooled
• . Dual Coherent Frequencies: Thirteen (13) 680nm and thirteen (13) 980nm laser diodes on each paddle
• Concurrent Laser Diode Mode of Operation: pulsed or continuous output
• . Power output: Variable up to 200mw per diode for both 680nm and 980mm wavelengths

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The core acceptance criterion for the InvisaRED™ Technology ELITE, as inferred from the clinical study, is the demonstration of superiority over a sham device in temporarily reducing the circumference of the waist, hips, and thighs.

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The Erchonia® Emerald (Model # SHL) Laser is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of body circumference in individuals with a Body Mass Index (BMI) up to 40 kg/m².

The Erchonia® Emerald (Model#: SHL) is low-level laser system that uses ten (10) semi-conductor diodes (visible green-light) 522nm to 542nm. The Erchonia® Emerald (Model#: SHL) has been classified by the FDA as a Class II device and a Class II Laser in accordance with IEC 60825-1 (Complies with 21 CFR 1040.10 and 21 CFR 1040.11 by laser notice #50. The performance parameters and intended use of the Erchonia® Emerald (Model#: SHL) are compliant to the internationally recognized safety testing standards for medical devices. The Erchonia® Emerald (Model#: SHL) device includes functional performance, electrical, safety and component verification, in accordance with the FDA QS requirement, validated annually through ISO 13485 and MDSAP audits. The software incorporated into the operation of the Erchonia® Emerald (Model#: SHL) complies with FDA and ISO Software Development and Validation regulations.

The components of the device include a mobile base that plugs into the wall, using a hospital grade power cord, equipped with a medical-grade transformer. The device runs on AC power of 120 Volt 60 Hz or 220 Volt 50 Hz by plugging to mains power. Four (4) antistatic wheels that enable ease for maneuverability. A touch screen that functions as a display screen and input panel. The touch screen communicates with the PCB to initiate, stop or pause the energy flow to the laser diodes. The laser diodes can only be on or off; there is no user interface that allows the end-user to alter the laser diode output. The protocol is factory set and cannot be altered by the end-user. The device has an adjustable main arm that is attached to the mobile base with the laser head assembly located at the laser head assembly that is attached to the adjustable main arm utilizes internal mechanics that collects the light emitted from each of the ten (10) laser diodes that rotate in a spiraling circle pattern that is totally random and independent of the other diodes. The laser head assembly can be manually adjusted for positioning the lasers 3-4 inches from the patient's skin to deliver treatment for body contouring. The device laser head assembly can be moved vertically (raised or lowered) over the subject for proper height placement of lasers for treatment. The device laser head assembly can be moved horizontally (left or right) over the patient for proper placement of lasers for treatment. The device laser head assembly has two adjustable outside laser arms with each arm housing two (2) laser diodes that can be moved in and out for proper positioning to the patient for accurate treatment distance.

The device contains software that is loaded into the PCB drivers. This data includes the touch screen images (GUI), and the command prompts that activate the screen icons; work in conjunction with the component platform to ensure the device operates as intended.

The provided text describes the Erchonia Emerald (Model # SHL) Laser, a low-level laser system intended for non-invasive dermatological aesthetic treatment for the reduction of body circumference in individuals with a Body Mass Index (BMI) up to 40 kg/m².

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Erchonia Emerald Laser are based on its substantial equivalence to predicate devices, which were proven safe and effective through clinical trials. The reported device performance is therefore inferred from the performance of these predicate devices.

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

The submission explicitly states: "Erchonia Corporation did not perform a clinical study for the indication for use proposed in this premarket notification. Substantial equivalence is based on the primary predicate device, the Erchonia® SHL Laser (Model# SHL) K142042, as well as the secondary predicate device, the Erchonia® Zerona™ 2.0 Laser (Model# GLS) K123237."

Therefore, there is no new test set data generated for the Erchonia Emerald device itself to directly prove its acceptance criteria. The data provenance is from the clinical trials conducted for the predicate devices. The document does not specify the sample sizes or country of origin for the predicate device studies.

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

Since no new clinical study was conducted for the Erchonia Emerald, this information is not available in the provided text. The ground truth for the predicate devices' clinical trials would have been established by clinical outcomes and measurements, typically interpreted by qualified medical professionals.

4. Adjudication Method for the Test Set

As no new clinical study was performed for the Erchonia Emerald, there's no adjudication method described.

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

No MRMC comparative effectiveness study was done for the Erchonia Emerald Laser as no new clinical study was conducted.

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

This device is a physical laser system, not an algorithm, so the concept of a "standalone algorithm" performance study is not applicable.

7. Type of Ground Truth Used

The ground truth for the performance claims is based on the clinical outcomes data from the clinical trials performed for the predicate devices (Erchonia® SHL Laser K142042 and Erchonia® Zerona™ 2.0 Laser K123237). These trials demonstrated the safety and effectiveness of those devices in reducing body circumference.

8. Sample Size for the Training Set

As this is a physical medical device and not an AI/ML algorithm that requires a "training set" in the computational sense, this concept is not applicable. The device's design and operation are based on established scientific principles of low-level laser therapy and its equivalence to previously cleared devices.

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

Not applicable, as there is no "training set" in the context of an AI/ML algorithm for this device. The efficacy and safety are established via substantial equivalence to predicate devices that underwent clinical trials.

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Cellulize® is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs.

The Massager component is indicated for the temporary reduction in the appearance of cellulite.

The Cellulize is a non-invasive green light system with a power output of 105mW/cm2, consisting of 150 light emitting diodes (LEDs) that emit visible light at nominal wavelength of 532nm ± 3nm (visible green light spectrum) and a spectral bandwidth of 10nm. Cellulize® is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs. The Massager component is indicated for the temporary reduction in the appearance of cellulite.

The components of the device include a mobile pole cart, controller console which plugs into a hospital-grade isolation transformer (attached with a bracket clamp to the pole cart), LED array mounted on an articulated arm (attached with a bracket clamp to the mobile pole cart), digital timer pre-selected for 8-minutes or 20-minutes, on/off switch, and a hospital-grade power cable. The articulated arm allows the light fixture to be positioned in a wide variety of functional positions. The knuckles and joints on the arm allow the light fixture to be rotated, tilted, and raised/lowered independently. The timer is set to a preset value of 8 minutes for circumference reduction treatment via a validated internal timer delay relay. The light fixture is positioned 17cm (6.8″) from the patient's skin to deliver the standard dose output intensity of 105mW/cm-and standard energy dose of 50 J/cm² with 8 minutes. Cellulize does not use any software.

This document describes the acceptance criteria and the study that proves the Cellulize device meets these criteria for its indication as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs.

1. Table of Acceptance Criteria and Reported Device Performance

The core acceptance criterion for the Cellulize device directly relates to its ability to achieve inch loss. The primary outcome measure for the clinical study was "Average Change in Inches of Total Circumference Measurements for effect of Cellulize, a LED 532nm green light low level laser system for aesthetic use for the non-invasive reduction in fat layer for body contouring from baseline measurements, and after treatment."

Note: The FDA 510(k) clearance is based on the substantial equivalence of the device, which in this case relies on meeting the inch loss criteria, even though the cellulite reduction criterion was not met. The legally marketed predicate devices support the inch loss claim.

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

• Sample Size for Test Set: A total of 52 patients participated in the clinical study.
  • 25 patients were in the Active Cellulize group.
  • 27 patients were in the Placebo Control group.
• Data Provenance: The document does not explicitly state the country of origin of the data. However, given the FDA submission, it can be inferred that the study was conducted to meet U.S. regulatory standards. The study was a prospective, double-blind, placebo-controlled randomized evaluation.

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

The document does not provide details on the number or qualifications of experts used to establish the ground truth for the test set. For objective measurements like circumference reduction, the "ground truth" would typically be derived from direct, quantitative measurements rather than expert consensus on subjective interpretation. For cellulite reduction using the Nurnberger-Muller Scale (NMS), the scale itself is an industry standard and implies a structured assessment, likely by trained personnel, but their specific qualifications or number are not mentioned.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1) for establishing the ground truth measurements. As direct measurements were taken, an adjudication process for subjective interpretation might not have been deemed necessary or explicitly documented. The study was double-blinded, meaning neither the participants nor the measurement takers (to the extent possible) would know if the active or placebo device was being used, which inherently reduces bias.

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

There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, nor is there information on the effect size of how much human readers improve with AI vs. without AI assistance. This type of study is more common for diagnostic AI tools where human interpretation is the primary endpoint. For a device like Cellulize, the effectiveness is measured by physical changes (circumference reduction), not by human perception of diagnostic images.

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

The Cellulize device does not use any software for its operation (as stated in Section 14, "No Software" and the comparison table, item 3). Therefore, a standalone (algorithm-only) performance study is not applicable. The device's efficacy is based on the direct application of green light, and the study evaluated the device's physical effect on the body with human subjects.

7. Type of Ground Truth Used

The ground truth used for the primary outcome measure (inch loss) was direct, quantitative measurements of cumulative circumferences of the waist, hip, and thighs. These measurements were taken "before" and "after" treatment, as well as at 7-day and 14-day follow-ups.

For the assessment of cellulite, the Nurnberger-Muller Scale (NMS), a four-stage scale, was used as an industry standard. This would be a form of clinical assessment or qualitative measurement.

8. Sample Size for the Training Set

The document describes a clinical study in support of the 510(k) submission, which is typically a validation study (test set). There is no information provided on a separate training set or its sample size. Devices like Cellulize that do not use software or AI/machine learning models typically do not have a "training set" in the computational sense. The design and parameters of the device (such as wavelength, power output, treatment time) are based on scientific principles and potentially prior research or predicate device characteristics, which serve as the "training" for the device's physical design and treatment protocol.

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

As noted above, there is no explicit "training set" in the context of an AI/ML model for this device. The physical design and treatment protocol would have been established through a combination of:

• Bench Testing: As described in the document (e.g., IEC 60601-1-2 EMC Test Report, IEC 62471 Photobiological Safety, Device Life Report), these tests validate that the system meets design specifications and performance requirements.
• Scientific Principles and Prior Knowledge: The device utilizes 532nm green light, which is also used by a predicate device (Verju Laser) that causes lipolysis. This indicates that the foundational scientific understanding of how such light interacts with biological tissue to achieve the desired effect informed the device's design.
• Predicate Device Comparison: Extensive comparison to predicate devices (Verju Laser and Photonica Professional) was performed to establish substantial equivalence in design, operation, and intended use, effectively leveraging the "ground truth" demonstrated by those previously cleared devices.

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