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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 Erchonia® FX-405 laser is generally indicated:
a. while using the red and violet diodes, for the adjunctive use in providing temporary relief of nociceptive musculoskeletal pain.
b. and while using the red diodes, as an adjunctive treatment of postoperative pain.

Erchonia® FX-405 is low level laser system that uses three semi-conductor diodes (visible light) 630nm to 650nm with a mean power output of 17.25mW per diode and one semi-conductor diode 400nm to 410nm with a mean power output of 23.00mW. The Erchonia®FX-405 is a variable hertz device. The variable hertz feature of the Erchonia® FX-405 is a pulsed wave, defined as containing a selected series of breaks, variances that are preprogrammed. The Erchonia® FX-405 has been classified by the FDA/EC as a Class II device and a Class 2 Laser. The components of the device include a mobile base which plugs into the wall, using a hospital grade power cord, equipped with a medical grade transformer. 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 device has an adjustable main arm that is attached to the mobile baser head assembly located at the end. The adjustable main arm is capable to collapse into the mobile base for storage and transporting or extends to position the laser heads above the area of involvement. The laser head assembly that is attached to the adjustable main arm that is manually raised and lowered utilizes internal mechanics that collects the light emitted from each of the four (4) laser diodes and processes each through a proprietary patented lens which redirects the beam with a line refracted light is then bent into a spiraling circle pattern that is totally random and independent of the other diodes. This assembly can be rotated 120 degrees for proper positioning to patient for accurate treatment. The laser head assembly includes arms and pivots that allow the four (4) laser output heads to be rotated, titled, and raised / lowered independently. 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 exterior materials consist of 6061 T6 AL, Kydex 430 and Copolymer Acetal with powder coating and carbon fiber finish.

The provided text does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria. Instead, it describes a 510(k) premarket notification for the Erchonia FX-405, where substantial equivalence to predicate devices is established.

The document highlights the device's characteristics and compares them to existing cleared devices (Erchonia FX-405, K212595 as primary predicate, and Erchonia XLR8, K211186 as secondary predicate) to demonstrate that the new device is as safe and effective.

Here's an analysis of the information that is not present in the provided text, based on your request:

1. Table of acceptance criteria and reported device performance: This is not present. The document focuses on demonstrating substantial equivalence to predicate devices, not on setting and meeting specific performance metrics against pre-defined acceptance criteria.

2. Sample size used for the test set and data provenance: No clinical test set data is presented in this 510(k) summary, as stated in the "Performance Testing-Clinical" section: "No clinical data was used to establish Substantial Equivalence."

3. Number of experts used to establish ground truth and qualifications: Not applicable, as no clinical test set with ground truth was used for this submission.

4. Adjudication method for the test set: Not applicable, as no clinical test set with ground truth was used.

5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not mentioned and not performed, as no clinical data was used for substantial equivalence.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) study: Not applicable. The Erchonia FX-405 is a physical laser device, not an AI algorithm.

7. Type of ground truth used: Not applicable, as no clinical test set requiring ground truth was used.

8. Sample size for the training set: Not applicable, as this is a physical device and not an AI/machine learning algorithm requiring a training set.

9. How the ground truth for the training set was established: Not applicable, as this is a physical device and not an AI/machine learning algorithm.

Summary of available information related to performance and equivalence:

The document states that "No clinical data was used to establish Substantial Equivalence." Instead, the submission relies on a comparison of technological characteristics with predicate devices and compliance with voluntary and performance standards.

The device is substantially equivalent to the primary predicate device (Erchonia FX-405, K212595) because it is described as the "exact same model." For the secondary predicate (Erchonia XLR8, K211186), equivalence is established by comparing technical specifications:

• Wavelength, Energy Source, Mechanism of Action: Identical to the secondary predicate (Erchonia XLR8).
• Number of Diodes, Power, Total Joules Per Minute: Differences are deemed "negligible" and not affecting safety or effectiveness when applied over the treatment area.
• Recommended Treatment Duration: Same for the Indications for Use (IFU) regarding postoperative pain.
• Energy Delivery & Target Size: Differences in floor model vs. handheld, and electronically scanned vs. manually scanned, are stated not to change the physiological mechanism or affect safety/effectiveness.
• Indications for Use: The subject device's indication for adjunctive treatment of postoperative pain (using red diodes) is identical to one of the XLR8's indications. The added indication for nociceptive musculoskeletal pain (red and violet diodes) is covered by the primary predicate.

Performance Data (General Compliance, not specific acceptance criteria):

• Compliance with Voluntary Standards: IEC 60601-1-2:2014 Edition 4.0, IEC 60601-1:2005 Edition 3.1, IEC 60825-1:2014 Edition 3.0.
• Performance Standards: Complies with FDA's performance standards for light-emitting products (21CFR 1040.11 by Laser Notice #50).
• Software: Software verification and validation testing conducted, classified as "minor" level of concern. No patient data storage, no cybersecurity risk of safety or effectiveness, no wireless interfaces.
• Biocompatibility: Not applicable, as the device does not contact patient skin or tissue.
• Sterilization and Shelf-Life: Not provided sterile; device is electro-mechanical, components will not degrade during storage.

Therefore, the "study" referred to in the prompt is essentially the technical comparison and compliance with standards presented in the 510(k) summary, rather than a clinical trial or performance study against specific acceptance criteria.

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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 Erchonia® GVL laser is generally indicated:

a. while using the green and violet diode simultaneously, for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin,

b. and while using the violet diode, to treat dermatological conditions, and specifically indicated to treat moderate inflammatory Acne Vulgaris.

The Erchonia® GVL (Model# GVL) is a low-level laser system that uses two semi-conductor diodes (visible green and violet light), green: 520 nm and violet: 405 nm ± 10. The Erchonia® GVL (Model# GVL) is a variable hertz device. The variable hertz feature of the Erchonia® GVL (Model# GVL) is a pulsed wave, defined as containing a selected series of breaks, variances. The Erchonia® GVL (Model# GVL) has been classified by the FDA/EC as a Class II/IIa device and a Class II/2 laser.

The components of the device consist of:

An ultra-slim hand-held battery-operated control device with a docking station providing two laser diodes a 520 nanometer and a 405 nanometer. Each laser diode emits its wavelength with a tolerance of ±10 nanometer. The lasers are powered by an internal battery that is recharged using a separate inductive charging base powered by an external class II medical power supply. This configuration offers portability as well as consistency of power.

The internal battery powers the two specially created and patented electronic diodes with an output of 7.5mW ± 1mW green and

This document describes the Erchonia® GVL device, which is an infrared lamp cleared for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin (using green and violet diodes simultaneously) and to treat moderate inflammatory Acne Vulgaris (using the violet diode). The device's substantial equivalency is based on a comparison to the Erchonia® EVRL (predicate device).

Here's the information about the acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

For temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin:

Individual subject success was pre-established as a 30% or greater decrease in Visual Analog Scale (VAS) rating at endpoint relative to baseline.

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

The study was a single-group non-inferiority design.

• Test Set Sample Size: 43 subjects completed the study for the Erchonia® GVL device.
• Data Provenance: The document does not explicitly state the country of origin. The study was prospective, as it involved administering the Erchonia® GVL to new subjects. The comparative data for the predicate device (Erchonia® EVRL) was attained from a 2019 trial, which would also be considered prospective at the time it was conducted.

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

The ground truth for the test set was based on self-reported Visual Analog Scale (VAS) pain ratings from subjects, not expert medical assessment for individual cases. Therefore, this section is not applicable in the traditional sense of medical image or diagnostic device evaluation.

4. Adjudication Method for the Test Set

The adjudication method for the test set (regarding pain relief) was based on individual subject self-reporting of VAS pain ratings, with success defined as a 30% or greater decrease from baseline. There was no mention of an expert adjudication panel.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The study was a non-inferiority clinical study comparing the device to a previously established predicate device's clinical trial results. The outcome measure (VAS pain rating) is a subjective patient-reported outcome, not an interpretation by multiple readers.

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

This is a physical medical device (laser system), not an algorithm or AI system for diagnosis or interpretation. Therefore, a standalone (algorithm only) performance study is not applicable. The performance evaluated was the direct effect of the device on patients.

7. The Type of Ground Truth Used

The ground truth used for the pain indication was patient-reported outcomes, specifically the change in Visual Analog Scale (VAS) neck and shoulder pain ratings.

8. The Sample Size for the Training Set

The document describes a clinical study for the Erchonia® GVL device. This study is a non-inferiority clinical trial to demonstrate effectiveness, not a study for training an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The clinical data from the Erchonia® EVRL 2019 trial (n=44) and the Erchonia® PL2000/EVRL (K012580, K152196) (n=43) serve as comparative effectiveness data from prior studies, not training data for the subject device's approval.

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

As noted above, there is no "training set" in the machine learning sense for this device. The comparative data (from previous trials for the Erchonia® EVRL and PL2000) also used patient-reported outcomes (VAS pain ratings) as their ground truth for establishing effectiveness.

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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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The Erchonia® FX-405 laser is indicated for the adjunctive use in providing temporary relief of nociceptive musculoskeletal pain.

The Erchonia® FX-405 (Model#: MLS-AC) is low level laser system that uses three semi-conductor diodes (visible light) 630nm to 650nm with a mean power output of 17.25mW per diode and one semi-conductor diode 395nm to 415nm with a mean power output of 23.00mW. The Erchonia® FX-405 (Model#: MLS-AC) is a variable hertz device. The variable hertz feature of the Erchonia® FX-405 (Model#: MLS-AC) is a pulsed wave, defined as containing a selected series of breaks, variances that are preprogrammed. The Erchonia® FX-405 (Model#: MLS-AC) has been classified by the FDA/EC as a Class II device and a Class 2 Laser.

The components of the device include a mobile base which plugs into the wall, using a hospital grade power cord, equipped with a medical grade transformer. 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 can only be on or off; there is no user interface that allows the end user to alter the laserdiode output. The device has an adjustable main arm that is attached to the mobile base with the laser head assembly located at the end. The adjustable main arm is capable to collapse into the mobile base for storage and transporting or extends to position the laser heads above the area of involvement. The laser head assembly that is attached to the adjustable main arm that is manually raised and lowered utilizes internal mechanics that collects the light emitted from each of the four (4) laser diodes and processes each through a proprietary patented lens which redirects the beam with a line refracted light is then bent into a spiraling circle pattern that is totally random and independent of the other diodes. This assembly can be rotated 120 degrees for proper positioning to patient for accurate treatment. The laser head assembly includes arms and pivots that allow the four (4) laser output heads to be rotated, tilted, and raised / lowered independently. 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 exterior materials consist of 6061 T6 AL, Kydex 430 and Copolymer Acetal with powder coating and carbon fiber finish. The associated accessories include: (1) Hospital grade power cord, (1) Patient protective eyewear (sufficiently and effectively block the laser light spectrum at OD 2+ @ 635nm, OD 0.75 @ 405nm VLT60), (2) Power safety lockout keys.

The provided text describes an FDA 510(k) premarket notification for the Erchonia® FX-405 device, a low-level laser system indicated for the adjunctive use in providing temporary relief of nociceptive musculoskeletal pain.

Crucially, the document states: "No new clinical study results are being submitted as part of this [submission]. Clinical data previously reviewed in 510(k) submissions of the predicate device, the Erchonia® FX-635 Laser K190572, as well as the reference device, the Erchonia® EVRL Laser K191257 were provided to demonstrate safety of using the red and violet diodes simultaneously."

This means there is no new performance data or a new clinical study specifically conducted to establish acceptance criteria or prove device performance for the Erchonia® FX-405 in this submission. Instead, the submission relies on the substantial equivalence to previously cleared devices (predicate and reference devices) and data from their respective clinical trials.

Therefore, many of the requested details regarding acceptance criteria, study design, sample size, ground truth, and expert involvement for a new study are not applicable to this specific submission. The information provided relates to the comparison justifying substantial equivalence based on the technological characteristics and previously collected clinical data.

Based on the available information, here's a breakdown of what can and cannot be answered:

Acceptance Criteria and Reported Device Performance

There are no explicit "acceptance criteria" presented for a new clinical study of the FX-405 device in this document, as no new clinical study was performed. The "performance" being demonstrated is the substantial equivalence to the predicate and reference devices, implying that the FX-405 would achieve similar results as those demonstrated by the previous devices.

The table below summarizes the comparison of shared characteristics between the subject device (FX-405) and the predicate device (FX-635), which is used to argue substantial equivalence, rather than a direct performance outcome table for the FX-405 itself.

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

As stated above, no new clinical study was conducted for the FX-405. The "performance" is implicitly tied to the performance of the predicate and reference devices. The document does not provide a table of performance outcomes for the FX-405, but rather a comparison of its technical specifications to the predicate device leading to the conclusion of substantial equivalence.

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

• Sample Size: Not applicable for a new study of the FX-405. The submission refers to clinical data from previous 510(k) clearances (K190572 for FX-635 and K191257 for EVRL). The sample sizes for those studies are not detailed in this document.
• Data Provenance: Not specified in this document for the previously conducted studies (e.g., country of origin, retrospective/prospective).

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

• Not Applicable: No new study with a "test set" and "ground truth" establishment was conducted for this specific submission of the FX-405. These details would pertain to the clinical trials supporting the predicate and reference devices, but are not provided here.

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

• Not Applicable: Similar to point 3, no details on adjudication methods for establishing ground truth are 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

• Not Applicable: The device is a low-level laser system for pain relief, not an AI-assisted diagnostic device involving human readers or image interpretation. Therefore, an MRMC study and AI assistance are not relevant.

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

• Not Applicable: This is a physical therapy device, not a diagnostic algorithm.

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

• Relevant to previous studies: For the previous clinical studies that supported the predicate and reference devices, the "ground truth" for the device's efficacy would have been outcomes data related to nociceptive musculoskeletal pain relief (e.g., pain scores, functional improvement). The specifics are not detailed in this document.

8. The sample size for the training set

• Not Applicable: This is not an AI/machine learning device with a "training set." The term "training set" is typically used in the context of data used to train AI models.

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

• Not Applicable: See point 8. No training set for an algorithm is discussed. The "ground truth" for previous clinical studies (on which this submission relies) would have been established through clinical assessments and patient-reported outcomes for pain relief, but the methodology details are not included in this document.

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The Erchonia® XLR8 is generally indicated:
a. as adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin
b. as an adjunct to liposuction procedures of the thighs, hips and stomach for reduction of pain associated with the recovery process
c. for the temporary reduction in post-surgery pain at 24 hours after surgery following bilateral breast augmentation surgery
d. as an adjunctive treatment of postoperative pain

The Erchonia® XLR8 (Model# HLS) is a low-level laser system that uses two semi-conductor diodes (visible red light), red: 640nm ±10. The Erchonia® XLR8 (Model# HLS) is a variable hertz device. The variable hertz feature of the Erchonia® XLR8 (Model# HLS) is a pulsed wave, defined as containing a selected series of breaks, variances. The Erchonia® XLR8 (Model# HLS) has been classified by the FDA/EC as a Class II/IIa device and a Class II/2 laser. The Erchonia® Laser is applied externally and has proven through clinical trials to treat post-surgical pain associated with liposuction and breast augmentation surgery. The Erchonia ® XLR8 laser emits a 640-nanometer wavelength with a tolerance of ±10 nanometer, from each of the two laser are powered by an internal battery that is recharged using a separate inductive charging base powered by an external class II medical power supply. This configuration offers portability as well as consistency of power. The internal battery powers the two specially created and patented electronic diodes with an output of

The document provided describes an FDA 510(k) premarket notification for the Erchonia® XLR8 laser, primarily focusing on expanding its indications for use. It states that the subject device (Erchonia® XLR8 Laser, Model# HLS) is identical to its predicate device (also Erchonia® XLR8 Laser, Model# HLS) previously cleared under K130996. Therefore, no new performance testing (bench, animal, or clinical) was conducted for this specific submission to demonstrate compliance with acceptance criteria for the expanded indication.

Instead, the submission relies on:

1. The substantial equivalence to the previously cleared predicate device, which itself had previously demonstrated substantial equivalence to another predicate (Erchonia EML Laser, K041139, K072206).
2. Supportive published literature on low-level laser therapy (LLLT) to justify the expanded indication for "adjunctive treatment of postoperative pain."

Given this context, the request for specific acceptance criteria and a study demonstrating the device meets those criteria for the current submission cannot be fully answered with new data from this document. The document explicitly states: "No new clinical data is being submitted in this 510(k) submission." and "No clinical study results are being submitted as part of this submission."

However, I can extract the information provided about the device and how the expanded indication is justified.

1. Table of Acceptance Criteria and Reported Device Performance

Since no new performance criteria or clinical study results are provided for this submission for the expanded indication, I will present the key performance characteristics that define the device and how its substantial equivalence to the predicate (which previously met acceptance criteria for its indications) is established. The "acceptance criteria" here implicitly refer to the proven safety and effectiveness of the identical predicate device and the general principles of LLLT supported by literature.

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

• Test Set Sample Size: Not applicable for this specific 510(k) submission, as no new clinical studies were conducted or submitted. The justification for the expanded indication relies on a review of published literature on low-level laser therapy (LLLT).
• Data Provenance: The document states that "Seven randomized controlled clinical trials published in scientific peer-reviewed journal publications were identified wherein low-level laser therapy (LLLT) was evaluated for its therapeutic ability to reduce post-operative pain following surgical procedures." The specific countries of origin for these studies are not mentioned, nor is whether they were retrospective or prospective.

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

• Not applicable for this submission. The ground truth for the efficacy of LLLT in reducing postoperative pain, if inferred from the cited literature review, would have been established by the authors, reviewers, and editors of the scientific journals in which those studies were published. No specific experts are mentioned as being involved in establishing a ground truth for a new test set in this 510(k).

4. Adjudication Method for the Test Set

• Not applicable for this submission, as no new clinical test set was used 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

• Not applicable. This device is a therapeutic laser, not an AI-assisted diagnostic or interpretive system.

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

• Not applicable. This device is a therapeutic laser.

7. The Type of Ground Truth Used

• For the expanded indication, the "ground truth" is asserted based on outcomes data (reduction in postoperative pain) reported in seven randomized controlled clinical trials of low-level laser therapy (LLLT) published in scientific peer-reviewed journals. This is a general ground truth for the category of therapy, not a specific ground truth for the Erchonia® XLR8 in a new clinical study.

8. The Sample Size for the Training Set

• Not applicable for this submission. There is no mention of a training set as this is a medical device submission based on substantial equivalence and literature review, not a machine learning algorithm.

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

• Not applicable. (See #8).

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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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a. while using the red and violet diode simultaneously, for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin,

b. and while using the violet diode, to treat dermatological conditions, and specifically indicated to treat moderate inflammatory Acne Vulgaris.

The Erchonia® EVRL (Model# EVRL) is a low-level laser system that uses two semi-conductor diodes (visible red and violet light), red: 630-650 nm and violet: 380-450 nm. The Erchonia® EVRL (Model# EVRL) is a variable hertz device. The variable hertz feature of the Erchonia® EVRL (Model# EVRL) is a pulsed wave, defined as containing a selected series of breaks, variances. The Erchonia® EVRL (Model# EVRL) has been classified by the FDA/EC as a Class II/IIa device and a Class II/2 laser.

The Erchonia® EVRL (Model# EVRL) is indicated for use:

a. while using the red and violet diode simultaneously, for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin,

b. and while using the violet diode, to treat dermatological conditions, and specifically indicated to treat moderate inflammatory Acne Vulgaris.

The Erchonia® Laser is applied externally and has proven through clinical trials to treat neck and shoulder pain with the red diode.

The components of the device consist of:

An ultra-slim hand-held battery-operated control device with a docking station providing two laser diodes a 640 nanometer and a 405 nanometer. Each laser diode emits its wavelength with a tolerance of ±10 nanometer. The lasers are powered by an internal battery that is recharged using a separate inductive charging base powered by an external class II medical power supply. This configuration offers portability as well as consistency of power.

The internal battery powers the two specially created and patented electronic diodes with an output of 7.5mW ± 1mW red and

The provided text describes a 510(k) premarket notification for the Erchonia® EVRL device. The document primarily focuses on demonstrating substantial equivalence to a predicate device (the same model, K152196) and presents clinical data to support the device's expanded indication for use in relieving neck and shoulder pain.

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

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this 510(k) submission appear to be centered around demonstrating non-inferiority or superiority of the Erchonia® EVRL when using both red and violet diodes simultaneously for neck and shoulder pain, compared to the previously cleared red diode only application.

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