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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 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® Zerona 6 Headed Scamer (EZ6) device is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, thighs and upper abdomen when applied to individuals with body mass index between 25 kg/m2 and 40 kg/m2.

Not Found

The provided document is a 510(k) clearance letter for the Erchonia® Zerona 6 Headed Scanner (EZ6) device. It is a regulatory document and does not contain the detailed study information regarding acceptance criteria, device performance, sample sizes, expert qualifications, or ground truth establishment that you are requesting.

Therefore, I cannot provide the requested information based on the content of input.

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The Zerona® Z6 OTC device is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs.

Zerona® Z6 OTC

The provided document is a 510(k) premarket notification letter from the FDA for the Zerona® Z6 OTC device. It primarily focuses on the substantial equivalence determination and regulatory information.

This document does not contain the specific details required to answer your request regarding acceptance criteria and a study proving those criteria. The letter refers to indications for use but does not provide a table of acceptance criteria, detailed study results, sample sizes for test/training sets, expert qualifications, adjudication methods, or information about MRMC or standalone performance studies.

Therefore, I cannot extract the requested information from this document.

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The Erchonia Zerona is indicated for use as a non-invasive dermatological aesthetic treatment as an adjunct for individuals intending to undergo liposuction procedures for the reduction of circumference of hips, waist, and thighs.

Not Found

The provided text is a 510(k) clearance letter from the FDA for the Erchonia Zerona device. It states that the device is substantially equivalent to a legally marketed predicate device.

Crucially, this document does not contain any information about acceptance criteria, device performance studies, sample sizes for test or training sets, ground truth establishment, expert qualifications, or adjudication methods.

The letter is a regulatory approval, not a scientific study report. It confirms the device's clearance for marketing based on its substantial equivalence to another device and its stated Indications for Use.

Therefore, I cannot provide the requested information from the given input.

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