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The intended use of VHT 200 wound treatment system is to provide humidified oxygen to open, acute or chronic wounds as an adjunct therapy in wound management and treatment.

The VHT-200 wound treatment system is intended for the following kinds of wounds:

• · skin ulcerations due to diabetes, venous stasis, and post-surgical infections, and gangrenous lesions
• decubitus ulcers
• · amputations/infected stumps
• · skin grafts
• burns
• · frostbite

The VHT-200 Wound Treatment System is a prescription medical device. This system is designed for most topical skin injuries that can benefit from the properties of oxygen and moisture therapy treatments. All the benefits of oxygen and moisture modalities are self-contained into one system and applied without the need of switching applications. The VHT-200 is made for clinical office use. The VHT-200 wound treatment system is designed for the medical provider to add oxygen flow rate and frequency of the treatments based on experience and professional assessment of the individual patient's medical need.

This document is a 510(k) summary for the VHT-200 Wound Treatment System. It does not describe a study involving acceptance criteria and device performance in the way a clinical performance study for an AI-powered diagnostic device would. Instead, it focuses on demonstrating substantial equivalence to a predicate device through various types of engineering and safety testing.

Therefore, many of the requested categories are not applicable to the information provided. The document outlines regulatory and engineering tests, not a clinical study involving human readers or AI algorithms.

Here's a breakdown based on the provided text, indicating where information is missing or not applicable:

No clinical performance study with acceptance criteria in the requested format was performed or described in this 510(k) summary. The provided text describes engineering, safety, and performance testing to demonstrate substantial equivalence to a predicate device, not a human-in-the-loop or standalone AI performance study against specific clinical acceptance criteria.

Here's how the information maps to your request:

1. A table of acceptance criteria and the reported device performance:
   This information is not provided in the context of a clinical performance study with specific metrics like sensitivity, specificity, or accuracy. The document states "The VHT-200 has been evaluated in various conditions and determined to be safe and effective" and lists types of engineering and safety tests, but does not provide a table of acceptance criteria and reported performance for clinical outcomes or diagnostic accuracy.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   Not applicable. This document describes testing for a medical device (topical oxygen chamber), not an AI diagnostic algorithm evaluated on a test set of patient data. The "test set" here refers to conditions for engineering and safety tests.

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):
   Not applicable. This document describes testing for a medical device, not a clinical study requiring expert ground truth for diagnostic purposes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable. This document describes testing for a medical device, not a clinical study requiring adjudication of expert interpretations.

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. This document does not mention any MRMC study or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. The VHT-200 is a physical medical device (topical oxygen chamber) and does not involve an AI algorithm with standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   Not applicable in the context of diagnostic "ground truth." The "ground truth" for the VHT-200 system would relate to its physical performance against engineering standards (e.g., oxygen concentration maintained, biocompatibility, electrical safety).

8. The sample size for the training set:
   Not applicable. This device does not use a training set in the context of AI or machine learning.

9. How the ground truth for the training set was established:
   Not applicable. This device does not use a training set.

Summary of "Performance Testing" from the document:

The 510(k) summary indicates that the VHT-200 Wound Treatment System underwent various tests to demonstrate its safety and effectiveness, and its substantial equivalence to the predicate device. These tests fall under engineering and regulatory compliance, not clinical diagnostic performance.

• Tests Performed:

  • Software validation
  • IEC 60601-1-2 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests)
  • IEC 80601-1-2 (Likely a typo and refers to IEC 60601-1-2 or another specific part of the IEC 60601 series)
  • IEC 80601-2-69 (Medical electrical equipment - Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrators) - This is highly relevant as the device includes an oxygen concentrator.
  • Biocompatibility evaluation
  • Performance testing (general statement, specific metrics not detailed)
  • Cleaning validation
  • Distribution testing

• Conclusion: Based on these tests, the VHT-200 was concluded to be as safe, as effective, and to perform at least as safely and effectively as the predicate device.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

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

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

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

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

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

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

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

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

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

8. The sample size for the training set

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

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

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

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

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

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

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

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

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

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

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

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

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

PowerSculp laser lipolysis system is a diode laser system that emits laser radiation centered at 1064nm in order to achieve non-invasive laser lipolysis. Main components of the device include the laser console with display and controls, and four cooled laser applicators that attach to frames and a belt that is attached to the person being treated. The device is powered by an alternating current electrical power source.

The provided document, a 510(k) Premarket Notification summary for the Lotuxs Medtech (Suzhou) Co., Ltd. Powersculp laser lipolysis system, explicitly states:

"No clinical tests were provided for this pre-market notification." (Page 7, Section 9. Clinical Tests)

Therefore, based on the provided text, there is no study that proves the device meets acceptance criteria, as no clinical studies were submitted. The acceptance criteria and the study details requested cannot be extracted from this document because such a study was not performed or submitted as part of this 510(k) application.

The 510(k) clearance for this device was based on non-clinical tests demonstrating substantial equivalence to a predicate device (K191068 Powersculp laser lipolysis system), not on a clinical effectiveness study.

Here's an breakdown of the information that can be extracted from the provided document, in relation to the prompt's requests:

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

• Acceptance Criteria (Implied by Non-Clinical Testing): The acceptance criteria for this 510(k) submission are based on demonstrating that the proposed device performs as intended and is as safe and effective as the predicate device through non-clinical testing. This primarily involved meeting engineering specifications and safety standards.
  • Software verification and validation: Software performs as intended.
  • Power Output: Meets specification.
  • Electromagnetic Compatibility and Electrical Safety: Complies with IEC 60601-1-2, ANSI AAMI ES60601-1, IEC 60601-2-22, and IEC 60825-1.
  • Biocompatibility: Patient contacting materials assessed per ISO 10993-1 and found to be biocompatible.
• Reported Device Performance (from Non-Clinical Tests): The document confirms that the device met these criteria:
  • Software verification and validation performed, demonstrated software performs as intended.
  • Testing confirmed power output meets specification.
  • EMC and electrical safety testing performed, results confirmed the device meets the standards.
  • All patient contacting materials assessed and found biocompatible.

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

• Not applicable as no clinical test set was used. Non-clinical tests would involve specific units of the device and testing materials, but these are not analogous to patient sample sizes for clinical studies.

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

• Not applicable as no clinical test set requiring expert ground truth was used.

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

• Not applicable as no clinical test set was used.

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 as no clinical effectiveness study, specifically an MRMC study, was conducted or submitted. This device is not an AI-assisted diagnostic tool.

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

• Not applicable. This is a laser lipolysis system, not an algorithm, so standalone performance in the context of an algorithm is irrelevant.

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

• Not applicable for clinical ground truth as no clinical studies were performed. For the non-clinical tests, "ground truth" would be the engineering specifications and safety standards against which the device performance was measured.

8. The sample size for the training set:

• Not applicable as no AI/machine learning model requiring a training set was involved.

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

• Not applicable as no AI/machine learning model requiring a training set was involved.

In summary, the 510(k) clearance for the Powersculp laser lipolysis system (K211402) was based solely on non-clinical testing and a demonstration of substantial equivalence to a predicate device, not on clinical performance data or studies involving human subjects to establish effectiveness for the indicated use.

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

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

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

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

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

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

This 510(k) summary explicitly states:

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

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

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

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

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

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

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

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

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

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

• Not applicable.

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

• No MRMC study was done, as no clinical data was submitted. The device is a "Low Level Laser System For Aesthetic Use" and "Infrared Lamp," not an AI-assisted diagnostic tool for human readers.

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

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

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

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

8. The sample size for the training set:

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

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

• Not applicable.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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The SLIMUS 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.

Vibrator installed inside each hand-piece and operable only in non-laser output condition is intended for relief from minor muscle aches and pains.

The SLIMUS device incorporates a laser system that emits a 1060 nm wavelength using a diode laser. Laser radiation is emitted from the laser main unit to the device's handpieces through the handpiece fibers. The device is used to noninvasively reduce the size of the waist of overweight patients with a Body Mass Index (BMI) of less than 30 (kg/m²). A vibrator function is installed inside of each hand-piece and operable only in non-laser output mode. The device's handpieces are fixed to a belt which then combined provide mechanical vibration to the patient in order provide relief from minor muscle aches and pains.

This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It is a 510(k) premarket notification summary for the SLIMUS device, primarily demonstrating its substantial equivalence to a predicate device (SculpSure™).

Specifically, the document states in section 8: "No Clinical performance testing was performed." This means there isn't a study proving the device's performance against specific acceptance criteria in a clinical setting provided in this document.

Therefore, I cannot provide the requested information in the table or answer the questions related to clinical study design, as no such study is presented in this document. The provided text focuses on non-clinical testing and technological comparisons to establish substantial equivalence.

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The EPIFLO-28 is intended to provide topical oxygen to treat 1) skin ulcerations due to diabetes, venous stasis, post-surgical infections and gangrenous lesions, 2) pressure ulcers, 3) amputations/infected stumps, 4) skin grafts, 5) burns, and 6) frostbite.

EPIFLO-28 is an oxygen delivery device that incorporates a disposable oxygen concentrator. It consists of (1) the oxygen concentrator, and (2) the sterile cannula. The oxygen concentrator is a single patient, single use, disposable, battery-operated device that is capable of delivering 98 to 100 percent oxygen continuously for twenty eight days at a rate of ~3.0 ml/hour. The cannula conveys the oxygen from the oxygen concentrator to the area beneath the bandage overlying the wound.

The provided text is a 510(k) Summary for the EPIFLO-28 device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria with quantified performance metrics against a defined ground truth.

Therefore, many of the requested elements for describing specific acceptance criteria and a study proving their attainment are not explicitly present in the provided text. The document describes performance testing to validate specifications and clinical studies for biocompatibility and usability but does not detail a study designed to prove acceptance criteria in the manner usually seen for AI/ML device clearances (e.g., sensitivity, specificity, AUC against a gold standard).

However, I can extract the information that is available and indicate where the requested information is not provided.

Acceptance Criteria and Device Performance (as inferred or generally stated):

Detailed Study Information:

1. Sample size used for the test set and the data provenance:

   • Biocompatibility (local tissue response): Wounds from an unspecified number of subjects were evaluated. Data provenance is not specified (e.g., country of origin, retrospective/prospective).
   • Usability (EPIFLO-28): 17 lay users and 18 healthcare professionals. Data provenance is not specified.
   • Usability (Predicate device): 61 patients over up to 12 weeks. Data provenance is not specified.
   • For performance testing related to oxygen delivery specifications, LED operation, and EMC compatibility, specific sample sizes and data provenance are not provided.

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

   • Not applicable / Not explicitly stated. For a medical device like the EPIFLO-28 (a topical oxygen delivery system), the "ground truth" for performance is typically objective measurements (e.g., oxygen concentration, flow rate, duration). For biocompatibility, it involves laboratory tests and clinical evaluation of tissue response by qualified personnel (e.g., pathologists, clinicians), but the number and specific qualifications are not detailed. For usability, the "ground truth" is user feedback and observations, not an expert-established clinical diagnosis.

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

   • Not applicable / Not explicitly stated. This type of adjudication method is usually relevant for diagnostic devices where subjective interpretation of images/data by multiple experts is involved to establish a consensus ground truth. For this device, performance is evaluated by objective measurements and biocompatibility by laboratory findings and clinical observations.

4. 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. This type of study is specific to diagnostic AI/ML systems where human readers interpret medical images/data. The EPIFLO-28 is a therapeutic device.

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

   • Not applicable. The EPIFLO-28 is a physical medical device, not an AI/ML algorithm. Its "performance" inherently involves its physical operation, not an algorithm's output.

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

   • Biocompatibility: Laboratory test results (cytotoxicity, sensitization, irritation, pyrogenicity, extractables/leachables analysis) and clinical evaluations of wound fluid, tissue punch biopsies for pro-inflammatory cytokines, proteases, and macrophages.
   • Usability: User feedback, observations, and responses to questions in case report forms.
   • Performance (Oxygen Delivery, etc.): Objective measurements against engineering specifications.

7. The sample size for the training set:

   • Training set concept is not applicable. As this is a physical medical device and not an AI/ML system, there is no "training set" in the context of machine learning.

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

   • Not applicable. See point 7.

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The NATROX™ System is a low-dose tissue oxygenation system intended to provide topical oxygen to aid in the healing of chronic wounds such as:

• Skin ulcerations due to diabetes, venous stasis, post-surgical infections and gangrenous lesions,
• Decubitis ulcers (bedsores), .
• Amputations/infected stumps, .
• Skin grafts,
• Burns, and
• Frostbite

The NATROX™ Topical Oxygen Delivery System is a small battery-powered electronic device approximately the size of a cell phone, containing an oxygen generator that produces 99% oxygen from room air at a rate of approximately 13 mL/hour. A small diameter tube transmits the oxygen to the wound bed, where the wound is exposed to the oxygen atmosphere inside the Oxygen Delivery System (ODS), Island Oxygen Delivery Pad (IODP) wound dressing or into the patient's own wound dressing, The NATROX™ System provides oxygen to diffuse evenly over the wound bed under an occlusive dressing, constantly refreshing the oxygen supply to enhance the normal process of wound healing for chronic and hard-to-heal wounds with compromised oxygen delivery to healing tissue.

The provided text describes the NATROX™ Topical Oxygen Delivery System and its safety and effectiveness. However, it does not contain specific acceptance criteria in a quantifiable format (e.g., "wound size reduction of X% with p-value

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The EPIFLO System is intended to provide topical oxygen to treat 1) skin ulcerations due to diabetes, venous stasis, post-surgical infections and gangrenous lesions, 2) pressure ulcers, 3) amputations/infected stumps, 4) skin grafts, 5) burns, and 6) frostbite.

EPIFLO is an oxygen delivery system that incorporates a disposable oxygen concentrator. It consists of (1) the oxygen concentrator, and (2) the sterile cannula. The oxygen concentrator is a single patient, single use, disposable, battery-operated device that is capable of delivering 98 to 100 percent oxygen continuously for seven or fifteen days (depending on the model) at a rate of ~3.0 ml/hour. The cannula conveys the oxygen from the oxygen concentrator to the area beneath the bandage overlying the wound.

The provided text describes the EPIFLO System, a transdermal continuous oxygen therapy device. However, it does not include a detailed study or specific acceptance criteria for device performance in the way typically expected for a medical device with measurable outcomes like accuracy or sensitivity/specificity.

Instead, the performance testing section (Section 7) states: "Testing was conducted to validate that the EPIFLO performed according to its specifications. These tests included performance testing for oxygen delivery per the specification for labeled durations, EMC compatibility and sterilization validation."

This indicates that the acceptance criteria were related to the device's functional specifications (e.g., oxygen delivery rate, duration, safety features) rather than clinical efficacy or diagnostic accuracy, as this is an oxygen delivery system, not a diagnostic or screening tool.

Given the information, I can only describe the reported device performance as it relates to its functional specifications, as specific metrics for clinical efficacy are not provided in this document.

Here's the breakdown of what can be extracted and what is not available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document only states that testing was conducted to validate performance "according to its specifications." Specific numerical acceptance thresholds (e.g., "oxygen delivery must be 3.0 +/- 0.1 ml/hour") are not explicitly stated, but the reported performance values are presented as meeting these underlying, implied specifications.

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

This information is not provided in the document. The text mentions "Performance Testing" but does not detail the methodology, sample sizes, or nature of the test set (e.g., in-vitro, in-vivo, clinical subjects).

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

This information is not provided. As this is a device for oxygen delivery, not a diagnostic system requiring expert interpretation of images or data, the concept of "ground truth" established by clinical experts in the traditional sense (e.g., radiologists for imaging) is not directly applicable to the functional performance testing described. Ground truth for functional tests would typically be established by calibrated measurement instruments.

4. Adjudication Method for the Test Set

This information is not provided.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done or at least not described in this document. Such studies are typically for diagnostic or screening devices where human readers interpret data, often with and without AI assistance, to measure changes in diagnostic performance. The EPIFLO System is an oxygen delivery device, not a diagnostic tool requiring human interpretation.

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

The described performance testing focuses on the device's functional operation (oxygen delivery rate, purity, duration, EMC, sterilization). This is inherently a "standalone" evaluation of the device's physical and operational characteristics without human intervention influencing its core function. However, it's not "algorithm-only" performance as the device's primary function is mechanical/chemical oxygen generation and delivery, not data processing.

7. Type of Ground Truth Used

For the functional performance testing described (oxygen delivery, EMC, sterilization), the ground truth would likely be established by:

• Instrumental Measurement: Calibrated sensors and measurement tools for oxygen flow rate, purity, and duration.
• Standardized Test Methods: Protocols for EMC (Electromagnetic Compatibility) and sterilization validation, which typically have defined pass/fail criteria.
  The document does not explicitly state the type of ground truth used, but these are the standard approaches for such device validations.

8. Sample Size for the Training Set

This information is not provided. As the EPIFLO System is a physical medical device (oxygen concentrator and cannula) and not an AI/ML algorithm requiring a training set, this question is not applicable in the context of this device.

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

This information is not provided and is not applicable, as the device is not an AI/ML algorithm that requires a training set and corresponding ground truth.

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