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M1 is used to reduce the circumference of the hips, waist and is indicated for use as a noninvasive dermatological.

M2 is intended to emit energy in the visible and infrared region of the spectrum for use in the treatment of full-face wrinkles.

M3 is intended to emit energy in the visible and IR spectrum intended to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis, pain or muscle spasm, the temporary increase in local blood circulation, and the temporary relaxation of muscles.

The EnergyLounger, Model: TY-01 a device designed similar to a recliner, with 1260 LED lights, a switch for power on/off, and it can automatically stop treatment after 20 minutes use for M1/M2 and after 30 minutes use for M3, 2 buttons for mode selection, and an AC power supply for power supply.

The LED in the EnergyLounger, Model: TY-01 is a 1W imitation current light. It's a 4-in-1 LED, including 630nm, 630nm, 850nm and 940nm.The EnergyLounger, Model: TY-01 includes a detailed Instruction Manual, operators need to read the instructions carefully before use.

This device uses three types of LEDs and has three working modes, which can be selected by the user by pressing a button.

The device consists of an Energy Lounger, power cable, Product protect cover, Reflector, Goggles and User Manual.

I'm sorry, but this document does not contain the detailed information necessary to entirely fulfill your request. The provided text is a 510(k) premarket notification letter and a 510(k) summary for a medical device called "EnergyLounger (TY-01)".

While it discusses the device's indications for use, its comparison to predicate devices, and non-clinical tests performed (electrical safety, EMC, biocompatibility, usability validation), it explicitly states:

"Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively."

This means there was no clinical study, human reader study, or establishment of ground truth regarding clinical outcomes (e.g., reduction of hip/waist circumference, treatment of wrinkles, pain relief) performed for this submission. Therefore, I cannot provide information on:

• A table of acceptance criteria and reported device performance related to clinical effectiveness. The acceptance criteria mentioned are for non-clinical aspects like electrical safety and biocompatibility.
• Sample size used for the test set (clinical).
• Number of experts used to establish ground truth for the test set.
• Adjudication method for the test set.
• MRMC comparative effectiveness study.
• Standalone (algorithm only) performance.
• Type of ground truth used (clinical outcomes/pathology).
• Sample size for the training set (clinical data).
• How ground truth for the training set was established.

The document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical safety/performance standards, rather than direct clinical efficacy trials.

However, I can extract information about the non-clinical acceptance criteria and tests:

1. A table of acceptance criteria and the reported device performance (Non-Clinical):

Regarding the other points, as stated above, the document explicitly indicates that no clinical testing was performed or needed for this 510(k). Therefore, questions related to clinical test sets, ground truth establishment for clinical outcomes, or human reader studies cannot be answered from this document.

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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 Gladiator system contains three handpieces, each of which has its own indications for use.

The PiXel8-RF handpiece is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostatis.

The Bodysculp laser lipolysis handpiece intended for non-invasive lipolysis of the flank and abdomen to achieve disruption of adipocyte cells intended for non-invasive a desired a desired aesthetic affect. This treatment is intended for individuals with a Body Mass Index (BMI) of 30 or less.

The Body Tone handpiece is intended for Relaxation of muscle spasms, Prevention or disuse atrophy, Increasing local blood circulation. Muscle re-education. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, Maintaining or increasing range of motion. Powered muscle stimulators should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.

The Gladiator is a multi-function system that combines RF Microneedling, Low Level Laser and Electronic Muscle Stimulation (EMS) technologies into a single console. The system is intended for dermatologic and general surgery purpose as well as pain relief. The system is comprised of a single console with three handpieces:

• PiXel8-RF - a bipolar radiofrequency micro needling handpiece with disposable tips
• . BodySculp - a low level laser
• . BodyTone (previously called Futura Pro) – an electronic muscle stimulator

The system and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source.

The provided text is a 510(k) premarket notification FDA review letter for the "Gladiator" device. It outlines the device description, indications for use, comparison to predicate devices, and performance testing. However, it does not contain the kind of detailed information about acceptance criteria for an AI/ML diagnostic device, nor does it describe a study specifically proving that the device meets such criteria in terms of algorithm performance against a ground truth.

Specifically:

• There's no mention of an AI/ML component in the Gladiator device. The device is described as a multi-function system combining RF Microneedling, Low Level Laser, and Electronic Muscle Stimulation (EMS) technologies.
• The "Performance Testing" section focuses on electrical safety, EMC, software lifecycle processes, risk management, and thermal testing, which are standard for electrosurgical and laser devices. This is not performance testing for an AI algorithm's diagnostic accuracy.
• There is no ground truth establishment, multi-reader multi-case studies, or standalone algorithm performance data discussed.
• The testing described is primarily engineering and safety-related (e.g., thermal damage profiles in ex vivo tissues), not clinical diagnostic accuracy.

Therefore, I cannot provide the requested information as the input document does not describe a study involving performance assessment of an AI/ML algorithm against acceptance criteria for diagnostic accuracy. The document is for a physical medical device (Gladiator) that does not appear to have an AI/ML component requiring the type of performance evaluation outlined in your request.

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1060nm laser body slimming machine is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs in individuals with a Body Mass Index (BMI) of 30 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen, flank, back, and thighs.

The 1060nm laser body slimming machine is an ultra-thermal laser fat decomposition system that uses the latest technology for non-invasive body shaping. It uses 1060mm wavelength laser penetration to target adipose tissue, selectively heats fat cells, and reduces the number of fat cells in the area through blood and lymph metabolism to achieve shaping the purpose of body contouring. It is a new generation of safe and effective way to lose weight.

The provided text is a 510(k) Summary for the "1060nm laser body slimming machine" (Model: RZ-01). This document assesses the substantial equivalence of a new medical device to a legally marketed predicate device.

It's important to understand that a 510(k) summary for a substantial equivalence determination often does not include detailed clinical study results, particularly regarding acceptance criteria for device performance in terms of patient outcomes or AI model accuracy. Instead, it focuses on demonstrating that the new device is as safe and effective as a predicate device, often relying on non-clinical tests (electrical safety, EMC, laser safety, etc.) and comparisons of technical specifications and intended use.

In this specific document, there is no information about acceptance criteria or a study proving the device meets performance criteria in the context of an AI/algorithm-driven device meeting specific accuracy metrics. The device in question is a laser body slimming machine, not an AI diagnostic or assistive tool.

Therefore, I cannot provide the requested information for an AI/algorithm-based device's performance study based on the provided text. The document states:

• "No clinical study is included in this submission." (Page 7)
• The comparison is based on technical specifications (laser type, wavelength, irradiance, etc.) and adherence to international safety standards (IEC, ISO).

If the request were about the safety and technical performance of this laser device, the "acceptance criteria" would relate to its compliance with the listed IEC and ISO standards, and the "study" would be the non-clinical tests conducted to prove this compliance. However, these are not the types of performance metrics or studies typically associated with AI/algorithm validation (e.g., accuracy, sensitivity, specificity, MRMC studies, ground truth establishment methods).

Therefore, I must state that the provided text does not contain the information requested for an AI/algorithm-driven device, as the device described is a physical laser machine, and the submission explicitly states no clinical study was included.

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The ReBorn device is an LED technology-based system intended for non-invasive lipolysis of the abdomen and flanks in individuals with a Body Mass Index (BMI) of 30 or less.

The ReBorn system is a non-invasive, LED-based system intended for non-invasive lipolysis and indicated for non-invasive lipolysis of the abdomen and flanks. The Lightfective ReBorn System is a Light Emitting Diode (LED) system, generating optical energy at 1050mm. The ReBorn's cooling and electrical systems maintain safe and comfortable skin surface temperatures. The Lightfective ReBorn system delivers power of up to 49 Watts (per each applicator) in continuous wave (CW) mode. The device consists of hardware and software. These elements are integrated in the ReBorn console and applicator/handpiece. The ReBorn system is supplied as a console and 4 identical applicators. The device is portable and was specifically designed to be utilized in clinic environments. The console is floor-standing and portable. It is controlled by a touch screen and consists of the following subsystems: Power Supply, Main Controller unit (CPU), Water cooling system (Chiller), Touchscreen display monitor, System on Module (SOM) and proprietary software, Applicator docking panel (cradle), Four designated applicator connector ports.

The provided text details a 510(k) premarket notification for the ReBorn device, an LED-based system for non-invasive lipolysis. However, it does not include information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of AI/ML performance.

The document primarily focuses on establishing substantial equivalence to a predicate device (Venus Bliss, K190743) based on shared indications for use, technological characteristics, and performance data from non-clinical (bench) testing. There is no mention of an AI/ML component, a test set for AI performance, expert ground truth establishment, MRMC studies, or standalone algorithm performance.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria, as the provided text does not contain this information.

To directly answer your specific points based on the provided text:

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

   • Not applicable. The document does not describe acceptance criteria for an AI/ML device's performance, nor does it report performance metrics relevant to AI/ML. It focuses on demonstrating substantial equivalence to a predicate device through shared characteristics and bench testing. Bench tests performed include:
     • Temperature Control Test
     • Cooling Capacity Test
     • Applicator Power Performance Test
     • Applicator Contact Sensor Test
     • Lifetime Rationale
     • Ex-vivo Animal Study

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

   • Not applicable. There is no mention of a test set for AI/ML performance. The "ex-vivo animal study" is mentioned, but details on sample size or specific "data provenance" (e.g., country) are not provided beyond it being ex-vivo porcine abdominal skin and adipose tissue.

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

   • Not applicable. No experts or ground truth establishment relevant to AI/ML performance is described.

4. Adjudication method for the test set:

   • Not applicable. No test set for AI/ML performance is described, so no adjudication method is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. An MRMC study was not done, as this is not an AI/ML device for diagnostic assistance. The device is for non-invasive lipolysis.

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

   • Not applicable. This isn't an AI/ML algorithm-only device. The "software" mentioned refers to control software for the device's operation.

7. The type of ground truth used:

   • Not applicable. There is no AI/ML component for which ground truth would be established. The "ex-vivo animal study" used the thermal effect on tissue as a measure, compared to the predicate device.

8. The sample size for the training set:

   • Not applicable. There is no mention of an AI/ML training set.

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

   • Not applicable. There is no mention of an AI/ML training set or its ground truth establishment.

In summary, the provided document pertains to the regulatory clearance of a medical device (ReBorn) based on substantial equivalence to an existing predicate, not on a study demonstrating AI/ML performance against specific acceptance criteria.

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The BTL-785S device has the following indications for use:

The BTL-785S with BTL-785-1 applicator is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The BTL-785-1-4 massage device is intended to provide a temporary reduction in the appearance of cellulite.

The BTL-785S with BTL-785-2 applicator is indicated to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.

The BTL-785S with BTL-785-3 applicator is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.

The BTL-785-4 applicator used with tips BTL-785-4-1, BTL-785-4-2, BTL-785-4-5 and BTL-785-4-6 is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. The Applicator BTL-785-4 of BTL-785S device used with tips BTL-785-4-3, BTL-785-4-7 and BTL-785-4-8 is intended for dermatological procedures requiring fractional treatment of the skin. At higher energy levels greater than 62 mJ/pin, use of the BTL-785-4 applicator is limited to Skin Types I-IV.

The BTL-785S with BTL-785-7 Handpiece used with hands-free applicators:

BTL-785-7-1 & BTL-785-7-7, BTL-785-7-2 & BTL-785-7-8 single-use applicators are intended to provide:

• Heating for the purpose of elevaing tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.

BTL-785-7-1 & BTL-785-7-2 single-use applicators are intended to provide:

• Non-invasive temporary reduction of facial wrinkles.

BTL-785-7-9 single-use applicator is intended to:

• Affect the appearance of lax tissue in the submental area.

The BTL-785S is a state-of-the-art radiofrequency device that enables the application of therapy by a high-frequency field.

The control unit of the system is equipped with a large color touch screen that significantly facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen of the device. During the therapy the device displays information about the applied therapy type, remaining therapy time and main therapy parameters on the screen. For easier control, the hand-pieces are equipped with buttons, enabling operation of the device during therapy. The energy flow's quality is indicated by the illuminated treatment tip. The BTL-785S device comes with five different types of applicators.

The BTL-785S device consists of the following main components:

• microprocessor-driven control unit
• radiofrequency generator
• user interface with 15.6" color touch screen
• applicators
• exchangeable applicator tips

The BTL-785S device, specifically with the BTL-785-7 handpiece and BTL-785-7-9 single-use applicator, was studied to support a new indication for use: "Affect the appearance of lax tissue in the submental area."

Here's an analysis of the acceptance criteria and the study results:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: N=56 subjects.
• Data Provenance: The study was a "single-center single-arm, open-label, interventional design" clinical investigation. The document does not explicitly state the country of origin, but given the FDA submission, it implicitly refers to data relevant for the U.S. market. It is a prospective clinical study.

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

• Number of Experts: Three independent reviewers were used for the GAIS (Global Aesthetic Improvement Scale) evaluation.
• Qualifications of Experts: The document does not specify the qualifications of these experts (e.g., radiologist with 10 years of experience). It only states they were "independent reviewers."

4. Adjudication Method for the Test Set:

• The document states "GAIS evaluation by three independent reviewers." This implies a form of consensus or independent grading by multiple experts, but the specific adjudication method (e.g., arithmetic mean, majority vote, or whether disagreements were arbitrated) is not explicitly detailed. It does not mention "2+1" or "3+1" specifically.

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

• No, a Multi Reader Multi Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done. This study focuses on the standalone performance of the device and its effect on patients. The device is a radiofrequency device, not an AI diagnostic tool for human readers.

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

• Yes, a standalone clinical performance study was done for the device when used with the BTL-785-7 handpiece and BTL-785-7-9 single-use applicator. The study assessed the device's direct effect on patient outcomes (appearance of lax tissue, satisfaction, comfort, and safety) without human interpretation of device output in a diagnostic sense.

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

• The ground truth was established through a combination of:
  • Expert Consensus: General Aesthetic Improvement Scale (GAIS) evaluation by three independent reviewers.
  • Objective Measurement/Outcomes Data: Measurable reduction in the submental area (≥ 20 mm²).
  • Patient-Reported Outcomes/Feedback: Subject satisfaction with therapy outcomes and comfort levels.

8. The Sample Size for the Training Set:

• The document does not provide information on a "training set" as it pertains to an AI/algorithm development. This was a clinical study designed to demonstrate the safety and efficacy of the physical device for a specific indication, not to train an AI model.

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

• As mentioned in point 8, there is no information about a training set or how ground truth for a training set was established, as this was not an AI/algorithm development study.

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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 DEKA PHYSIQ 360 is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs, in individuals with a Body Mass Index (BMI) of 30 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, and thighs.

The PHYSIQ 360 is a diode laser device. The device is provided with:

• Up to 4 applicators that deliver the laser energy to the patient (to subcutaneous tissue layers).
• An LCD control panel with touch-screen technology provides information on the status and settings of the PHYSIQ 360 device to input commands into the system.
• One wavelength, 1060 ±20 nm (infrared)
  The PHYSIQ 360 electrical specifications are: 115-230V~ single phase, 50/60Hz, 1200VA (max)

This document is a 510(k) summary for the DEKA PHYSIQ 360 device, a diode laser intended for non-invasive lipolysis. It focuses on demonstrating substantial equivalence to a predicate device (Sculpsure K171992) rather than presenting a study proving that the device meets specific acceptance criteria related to a diagnostic or AI-driven performance.

Therefore, the requested information, such as acceptance criteria for device performance (e.g., accuracy, sensitivity, specificity for a diagnostic device), clinical study data to demonstrate that the device meets these criteria, sample sizes for test sets, expert involvement in ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, is not available in this document.

This document primarily relies on the comparison to a predicate device and non-clinical performance data (electrical safety, EMC, software validation) to demonstrate substantial equivalence, rather than new clinical efficacy or performance studies with specific acceptance criteria that would typically be associated with AI/diagnostic devices.

Here's why the requested information isn't present in this specific type of document:

• Device Type: The DEKA PHYSIQ 360 is a laser for aesthetic use (non-invasive lipolysis). Its clearance is based on demonstrating that it is substantially equivalent to an existing legally marketed predicate device, not on demonstrating a specific diagnostic performance or AI-driven capabilities.
• 510(k) Pathway: The 510(k) premarket notification pathway often relies on comparison to a predicate device and non-clinical testing rather than extensive new clinical studies, especially if the new device has the same technological characteristics and similar indications for use as a cleared predicate.
• "Clinical Performance Data: None": As explicitly stated in the document, no clinical performance data was submitted. This confirms that a study of the type you're asking about (with performance metrics against acceptance criteria) was not part of this submission.
• Focus on Substantial Equivalence: The primary objective of this 510(k) summary is to argue that the DEKA PHYSIQ 360 is "as safe, as effective, and performs as well as the legally marketed predicate device." This is achieved by showing identical or substantially similar technological characteristics and indications for use, and by providing non-clinical safety testing.

In summary, based on the provided document, I cannot fulfill your request for acceptance criteria and a study proving the device meets them, because this type of information is not included in this 510(k) summary for the DEKA PHYSIQ 360.

The document details:

• Non-Clinical Performance Data:
  • Electrical safety and electromagnetic compatibility (EMC) testing based on ANSI AAMI ES60601-1 and IEC 60601-1-2.
  • Software Validation and Verification Testing as per FDA guidance.
  • Additional non-clinical testing per IEC 60601-2-22 and IEC 60825-1.

These non-clinical tests ensure device safety and functionality but are not "performance data" in the sense of diagnostic accuracy or clinical efficacy against specific statistical acceptance criteria for a human performance or AI-driven system.

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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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This product is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs in individuals with a Body Mass Index (BMI) of 30 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, and thighs.

The BL-A10 is a 1060nm Diode Hyperthermic Laser Lipolysis system and is the latest technology for non-invasive body contouring. It applies a 1060nm wavelength laser to target the adipose tissue to reduce fat in areas such as flank and abdomen. The purpose of the device is to breakdown the fat cells in the target area and in doing so contour the body and reduce the number of fat cells in that area. It is designed to meet international safety and performance standards.

The provided text is a 510(k) summary for the "Diode Laser Body Sculpture Systems," a medical device intended for non-invasive lipolysis. While it details the device and its equivalence to a predicate device, it explicitly states, "Clinical Testing: It is not applicable."

Therefore, I cannot provide information on acceptance criteria or a study that proves the device meets those criteria from this document. The manufacturer has determined that clinical testing is not necessary to demonstrate substantial equivalence to the predicate device for this submission.

The document discusses non-clinical testing, including electrical safety, electromagnetic compatibility, and biocompatibility, but these do not involve proving the device meets specific performance criteria for its intended clinical effect through human trials.

To summarize, for your specific request:

1. A table of acceptance criteria and the reported device performance: Not provided in the document as clinical testing was deemed "not applicable."
2. Sample sized used for the test set and the 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.
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: Not applicable (this device is a physical laser system, not an AI diagnostic tool).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document focuses on demonstrating substantial equivalence to an existing legally marketed device (SculpSure K182741) based on similar indications for use, technological characteristics (laser type, wavelength, lipolysis method), and compliance with electrical safety and biocompatibility standards.

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