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Fractional CO2 Laser Therapy System is used for body soft tissue ablation, vaporization, excision and coagulation in dermatology plastic surgery and general surgery.

Fractional CO2 Laser Therapy System consists of a main unit, a light guide arm (including a treatment head), a foot switch, and protective goggles. The fractional CO2 laser penetrates directly into the dermis utilizing the thermal effect of laser, instantly vaporizes the tissue in the lesion area. Parameters such as the laser energy density required for the treatment are set by the user appropriately. The Fractional CO2 Laser Machine has two operational modes, fractional mode and normal mode.

Based on the provided text, the device in question is a "Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2)". The document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI/algorithm performance.

Instead, the document is a 510(k) premarket notification for a medical device (a laser system) and focuses on demonstrating its substantial equivalence to a legally marketed predicate device through non-clinical testing. It explicitly states:

"No clinical study is included in this submission."

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or any studies related to AI/algorithm performance. The document only discusses the physical and electrical characteristics of the laser device and its general safety and effectiveness in comparison to a predicate device, as required for a 510(k) submission.

The questions you've asked (sample size for test/training sets, data provenance, expert consensus, MRMC studies, standalone algorithm performance) are highly relevant to the evaluation of AI/ML-based medical devices. This document, however, describes a traditional medical device submission for a laser system which does not appear to involve AI/ML components for which such performance criteria would be established and studied.

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The Intensity Pulsed Light Therapy System is intended for medical use in the treatment of the following conditions: -Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles); -Cutaneous lesions including scars; - Benign cutaneous vascular lesions including port wine stains, hemangiomas, facial truncal and leg telangiectasias, erythema of rosacea, leg veins, spider angiomas and venous malformations. -Permanent hair reduction-long-term stable reduction in number of hairs re-growing after a treatment regimen.

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I apologize, but the provided text from the FDA 510(k) clearance letter for the "Intensity Pulsed Light Therapy System" (K233307) does not contain any information regarding acceptance criteria, device performance studies, or details about the validation of an AI/algorithm-based medical device.

The document is a standard FDA clearance letter confirming substantial equivalence to a predicate device. It outlines:

• The device name and regulation details.
• The FDA's determination of substantial equivalence.
• General controls and regulatory requirements the manufacturer must adhere to (e.g., Quality System regulation, adverse event reporting, labeling).
• Indications for Use for the device.

There is no mention of:

• Specific performance metrics or acceptance criteria for the device (e.g., sensitivity, specificity, accuracy).
• Any study data, sample sizes, data provenance.
• Expert involvement for ground truth, adjudication methods.
• Multi-reader multi-case (MRMC) studies or standalone algorithm performance.
• Details about training sets or how ground truth was established for "AI" or "algorithm" components.

Therefore, I cannot fulfill your request for a table of acceptance criteria, study details, or information about AI/algorithm validation, as this information is not present in the provided text.

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The Diode Laser Therapy System (Model: FG2000-B/FG2000-B Pro) is indicated for temporary hair reduction.

The Diode Laser Therapy System(Model: FG2000-D+Pro/FG2000-D) is indicated for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen. It is suitable for all skin types (Fitzpatrick skin type I-VI), including tanned skin.

The Diode Laser Therapy System consists of main unit, handpiece, and its accessories. Diode Laser Therapy System is intended for hair removal, mainly based on the principle of selective photothermal interaction, which means that lasers of specific wavelengths can only be selectively absorbed by the target color base.

The Diode Laser Therapy System(Model: FG2000-B/FG2000-B Pro) are desktop devices, which combines 3 wavelengths (755+808+1064 nm) into a single handpiece to achieve purpose for temporary hair reduction.

The Diode Laser Therapy System (Model: FG2000-D+Fro/ FG2000-E) are vertical device, which is a single wavelength (808 nm only) device.

This document describes the FDA's 510(k) premarket notification for the "Diode Laser Therapy System" by Beijing ADSS Development Co., Ltd. A 510(k) submission aims to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and effectiveness de novo through clinical trials, as would be required for a PMA (Premarket Approval) device.

Therefore, the provided document does not contain information typically found in a study proving a device meets acceptance criteria derived from a clinical trial for AI/ML-based medical devices. The device in question is a laser therapy system, not an AI/ML-based device that would require complex performance metrics like sensitivity, specificity, or AUC, nor would it involve human readers, expert ground truth adjudication, or MRMC studies.

The "acceptance criteria" discussed in this document relate to the substantial equivalence to predicate devices and compliance with relevant performance and safety standards for laser devices.

Here's an analysis based on the provided text, addressing the points you raised where applicable to a non-AI/ML device:

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

The document does not present a formal table of "acceptance criteria" in terms of performance metrics like sensitivity/specificity for an AI/ML device. Instead, "acceptance criteria" are implied by the demonstration of "substantial equivalence" to predicate devices and compliance with recognized international standards for medical electrical equipment and laser products.

The tables provided in Section 6, "Summary of technological characteristics of device compared to the predicate device," serve as the primary comparison metrics to show substantial equivalence.

Acceptance Criteria (Implied by Substantial Equivalence and Standards Compliance) and Reported Device Performance:

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

• No clinical test set was used. Section 8 explicitly states: "There was no clinical testing performed."
• The "test set" for this submission consists of non-clinical bench testing for performance and compliance with relevant standards. The data provenance is implied to be from Beijing ADSS Development Co., Ltd. (China), given their location and the submission coming from them.

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. As there was no clinical testing or AI/ML component, there was no need for experts to establish ground truth in the context of diagnostic or treatment efficacy. The "ground truth" for substantial equivalence is the predicate device's proven characteristics and compliance with recognized standards.

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

• Not applicable. No clinical data requiring adjudication was generated.

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 relates to AI/ML device assessment, which this product is not.

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

• Not applicable. This relates to AI/ML device assessment, which this product is not.

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

• The "ground truth" in this context is the established safety and performance of the legally marketed predicate devices and compliance with internationally recognized performance and safety standards (e.g., IEC 60601 series, ISO 10993 series for biocompatibility, IEC 60825-1 for laser safety).

8. The sample size for the training set

• Not applicable. This device does not use a training set as it is not an AI/ML device.

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

• Not applicable. No training set was used.

In summary:

This document is a 510(k) clearance letter for a diode laser therapy system. The "study" proving the device met "acceptance criteria" was primarily a non-clinical assessment based on:

• Bench testing: To confirm the device's technical specifications and performance (e.g., laser wavelength, pulse characteristics, energy fluence).
• Comparison to predicate devices: Demonstration of "substantial equivalence" in terms of intended use, technological characteristics, and safety features to legally marketed devices.
• Compliance with recognized standards: Adherence to national and international safety and performance standards for medical electrical equipment, laser devices, and biocompatibility.

The "acceptance criteria" are implied by meeting these requirements and showing that any differences from predicate devices do not raise new questions of safety or effectiveness. Clinical testing, human reader studies, and AI/ML specific evaluations (like those mentioned in your prompt) were not part of this clearance process for this type of device.

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The device is indicated to be used for:

• · Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
• Strengthening, Toning and Firming of buttocks and thighs.

The Electromagnetic stimulator device consists of a host, hand tools and power cord. The host contains a power supply unit, a control unit, and a cooling unit. The control unit includes a control element and a liquid crystal display. The hand tools include electromagnetic induction coils and cooling fans, it is a non-invasive therapeutic device.
The subject device has two models, Tesla Duet and EM contouring. The two models are exactly the same except for the color of the host shell, one is black and other is white.
The device produces electromagnetic field that interacts with the tissues of the human body. By muscle stimulation, the Electromagnetic stimulator device helps to strengthen, tone and firm the abdomen, buttocks and thighs. The device two outputs enable simultaneous treatment by two applicators.
The Electromagnetic stimulator device is equipped with a large color touch screen with wide view angle 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 and buttons on the device. During the therapy the device keeps information about the applied therapy type, remaining therapy time and main therapy parameters on the screen.

The provided document is a 510(k) summary for a medical device (Electromagnetic Stimulator Device). It details the device's characteristics and its equivalence to a predicate device. However, it explicitly states "No clinical study is included in this submission" under section 8.0 Clinical Test Conclusion and that "Performance testing contained in this submission demonstrates the minor differences in technological characteristics between the subject device and the predicate do not raise different questions of safety and effectiveness." Therefore, the document does not contain the information required to answer your request regarding acceptance criteria and a study proving the device meets those criteria.

The submission focuses primarily on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of technological characteristics, rather than reporting on a standalone clinical study with acceptance criteria.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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The Picosecond Laser System is intended for use in surgical and aesthetic application in the medical dermatology and general and plastic surgery as follows:

1064nm wavelength:

• Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple.
• Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.

532nm wavelength:

• Removal of tattoos on Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange.
• Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.

The Picosecond Laser System consists of a host, a treatment handpiece, a light guide system, a foot switch, power cords and accessories. The host contains a laser, a cooling device, a laser power supply, a control device (including a control device and a LCD) and a protective device. Accessories include a foot switch, a laser protective qlasses, power cords, and a water filling device.

The Picosecond Laser System is a multi-wavelength, pulsed laser system. A key feature of the device is its ability to produce two laser wavelengths (i.e., 1064 nm and 532 nm).

The provided document is a 510(k) summary for a Picosecond Laser System, which is a medical device for dermatological and surgical applications. It is not an AI/ML-driven device, nor does it involve a study aimed at proving the device meets acceptance criteria related to AI/ML performance metrics (e.g., accuracy, sensitivity, specificity).

Therefore, I cannot extract information related to:

1. A table of acceptance criteria and reported device performance in the context of AI/ML.
2. Sample sizes for test sets, data provenance, number of experts for ground truth, or adjudication methods for AI/ML performance.
3. Multi-reader multi-case (MRMC) comparative effectiveness studies.
4. Stand-alone AI algorithm performance.
5. Type of ground truth used for AI/ML.
6. Sample size for the training set or how ground truth for the training set was established for an AI/ML model.

The document focuses on demonstrating substantial equivalence to a predicate device (PicoSecond Nd: YAG Laser System, K200116) through non-clinical testing and comparison of technical specifications. It highlights:

• Identical Intended Use & Indications for Use between the subject device and the predicate device.
• Comparable technological parameters such as wavelength, pulse duration, pulse energy, repetition rate, and spot size.
• Compliance with recognized electrical safety, EMC, laser safety, and biocompatibility standards.
• Software validation according to FDA guidance for moderate level of concern.
• Bench testing to ensure the device delivers set energy parameters within specifications.

The document explicitly states:
"No clinical study is included in this submission." (Section 8.0 Clinical Test Conclusion)

Given this, I cannot answer the request in the context of an AI/ML-driven device or study. The information provided pertains to a traditional medical laser system undergoing a 510(k) clearance process based on substantial equivalence, not a performance study of an AI algorithm against specific acceptance criteria.

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The red light is intended for the treatment of periorbital wrinkles and the blue light is intended for the treatment of the mild to moderate inflammatory acne. The device is indicated for adults only.

The LED THERAPY DEVICE is a facemask-shaped device, which directly applies light onto the face skin surface and makes use of specific light spectral characteristics. The proposed device has total of 150 LEDs and operates in two modes. One mode emits blue light with wavelengths centered at 415nm ±5nm, and the other mode emits red light with wavelengths centered at 630nm ±5nm. The red light is intended for the treatment of wrinkles. The blue light is intended for the treatment of the mild to moderate inflammatory acne. The blue light mode has ten level energy output settings, 5mw/cm2-50mw/cm2. The red light mode has ten level energy output settings, 8mw/cm2-80mw/cm2. The user can change the treatment mode according to their own needs. The LED THERAPY DEVICE is powered via a plug-in power adapter.

The provided document is a 510(k) Summary for an LED Therapy Device. It does not describe an acceptance criteria table with reported device performance in the typical sense of a clinical or performance study for a diagnostic AI device. Instead, it focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and non-clinical testing for safety and usability.

However, I can extract information related to the device's "performance" in the context of its regulatory submission and translate usability study results into a format that approximates acceptance criteria and reported performance metrics.

Here's an attempt to structure the information based on your request, with the understanding that the "device performance" in this context primarily relates to usability and safety, not diagnostic accuracy:

1. Table of Acceptance Criteria and Reported Device Performance

For this device, "performance" is primarily assessed through usability and safety testing, as no clinical efficacy study was conducted for the 510(k) submission. The acceptance criteria are derived from the usability study's goals.

• How to install the device.
• Perform the Light Sensitivity Test.
• Operate the device.
• Clean & disinfect the device.
  An overall subject score of 100% was achieved. |

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

• Sample Size for Usability Test Set: 45 end-users.
  • 15 participants with mild inflammatory acne.
  • 15 participants with moderate inflammatory acne.
  • 15 participants with periorbital wrinkles.
• Data Provenance: Prospective study conducted in America (AD Precision Health storefront and office, Carrollton, TX).

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

This information is not provided in the document. The usability study ground truth was based on participants' ability to understand and operate the device correctly, rather than on expert medical assessment of outcomes.

4. Adjudication Method for the Test Set

This information is not provided in the document. For the usability study, the "ground truth" (correctness of answers/demonstrations) would likely have been predefined by the study protocol, and scoring conducted against these predefined correct responses/actions. There's no indication of an adjudication panel.

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 MRMC comparative effectiveness study was not done. This device is an LED therapy device, not an AI-powered diagnostic or assistive tool for human readers. No AI components are mentioned in the submission.

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

N/A. This is an LED therapy device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the usability study was based on:

• Correct responses to a questionnaire: Assessing user comprehension of instructions, risks, warnings, etc.
• Successful demonstration of predefined operational tasks: Such as installation, light sensitivity test, operation, cleaning, and disinfection.

For the substantial equivalence determination, the ground truth was also established by comparing the device's technical specifications and safety standards compliance to those of legally marketed predicate devices.

8. The Sample Size for the Training Set

There is no training set in the context of an AI/ML algorithm, as this is a physical LED therapy device. The non-clinical tests (biocompatibility, electrical safety, EMC, photobiological safety) would have been performed on a sample of the manufactured devices, but this is not a "training set" in the AI sense.

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

N/A, as there is no training set for an AI/ML algorithm. For the non-clinical tests, the ground truth was established by internationally recognized standards (e.g., ISO, IEC) against which the device's performance was measured.

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The ND YAG Q-switch Laser Therapy Machine is indicated for the treatment of: benign cutaneous lesions, such as Warts, Scars, Striae and Psoriasis; benign pigmented lesions, such as Lentigines, nevus, and birthmark; and the removal of black or blue tattoos.

The ND YAG Q-switch Laser Therapy Machine is laser system which delivers laser at a wavelength 1064nm or 532nm.

There are 3 models included, FG 2010, FG 2010-B, FG 2010-C, the three models have same intended use, mechanism of action, principle and specification, only differences are the configurations.

The provided text describes a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting novel acceptance criteria or comprehensive study results for a new AI/software system. Therefore, much of the requested information regarding AI-specific criteria, studies, and ground truth establishment is not applicable or available in this document.

However, I can extract the relevant information from the provided text as it pertains to the device's performance claims and the studies conducted to support its substantial equivalence.

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

The document does not explicitly state acceptance criteria in the typical sense for a new AI/software device. Instead, it compares the proposed device's specifications and performance to a predicate device to demonstrate "substantial equivalence" (SE). The "reported device performance" is essentially the detailed specifications of the proposed device as presented for comparison.

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The Diode Laser Therapy Machine is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

The proposed device, Diode Laser Therapy System, is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI);

There are 4 models included, FG 2000, FG 2000-B, FG 2000-C and FG 2000-D, the four models have same intended use, mechanism of action, principle and specification, only difference is the configuration.

The main components of proposed device shown as following: Handpiece, Touchscreen, Emergency Switch, Key Switch, Connector, Indicator Lamp, Foot Switch.

The proposed system provides 36 working modes, which are six modes for men and six modes for women, the men or women mode includes face, armpit, arm, body, bikini, leg mode respectively for different treatment part, and each particular treat mode includes three submode as mode 1, mode 2 and mode 3.

The difference for each mode is only the default parameters for each mode can be adjustable in the parameter range.

The treatment can be applied on different Fitzpatrick skin type, including I (White), II (White with pigment), III (Yellow), IV (Yellow with pigment), V (Brown) and VI (Black);

The provided text is related to a 510(k) premarket notification for a Diode Laser Therapy Machine, a device intended for hair removal and permanent hair reduction.

1. Table of acceptance criteria and the reported device performance:

The document describes the device's technical specifications and how they compare to predicate devices, rather than explicit acceptance criteria and performance for clinical outcomes. The "acceptance criteria" here are essentially the standards and safety requirements met, and the "reported device performance" is its adherence to those standards and its technical parameters.

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

The submission explicitly states: "No clinical study is included in this submission." Therefore, there is no test set or related data provenance from a clinical study to report. The evaluation relies on non-clinical tests and substantial equivalence to predicate devices.

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 study or test set requiring expert ground truth was included.

4. Adjudication method for the test set:

Not applicable, as no clinical study or test set was conducted.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, an MRMC comparative effectiveness study was not done. The submission states, "No clinical study is included in this submission."

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

Not applicable. This device is a hardware-based medical laser system, not an algorithm.

7. The type of ground truth used:

Not applicable for clinical performance. For the non-clinical tests (e.g., biocompatibility guidance, electrical safety, EMC, laser safety), the "ground truth" is defined by the technical standards themselves (e.g., IEC, ISO standards).

8. The sample size for the training set:

Not applicable, as no clinical study or artificial intelligence/machine learning algorithm requiring a training set was used or described.

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

Not applicable, as no training set was used or described.

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The CO2 Laser Therapy Machine is used for human tissue vaporization in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.

The CO2 Laser Therapy Machine is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.

The CO2 Laser Therapy Machine is a carbon dioxide laser used in medical and aesthetic industry for treatment of such skin conditions as fine and coarse wrinkles, scars of various origin, uneven pigmentation and dilated pores. Due to the CO2 laser's high absorption of water, its high-energy beam of laser light interacts with the skin's surface causing the upper layer to peel off and use photothermolysis to stimulate deep cell regeneration and then achieve the target of skin improvement.

The proposed device is mainly used for human tissue vaporization, carbonization, coagulation and exposure to achieve the purpose of treatment.

The CO2 Laser Therapy Machine includes three models in this submission, FG 900, FG 900-B and FG 900-C, all three models have same principle, software, operation etc., only differences are appearance.

The proposed device includes the following components: Surgery tip, Surgery tip Arm, Touchscreen, Emergency Switch, Key Switch, Goggles for Patient, Goggles for Doctor, Foot Switch.

The provided document is a 510(k) Summary for a CO2 Laser Therapy Machine. It describes the device, its intended use, and a comparison to a predicate device to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study information based on the provided text:

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

The document presents a comparison of the proposed device against a predicate device across various parameters. It doesn't explicitly state "acceptance criteria" for each parameter with numeric thresholds, but rather lists characteristics that are considered "Substantially Equivalent (SE)" if they match or are comparable to the predicate. The performance is reported as the proposed device's specifications.

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The VE2000 device is indicated for use in surgical, aesthetic applications in permanent hair reduction of benign pigmented lesions and benign vascular lesions.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen

The VE2000 device are intense pulsed light system which delivers intense pulsed light at a wavelength ranging from 480nm-1200nm. Intense Pulsed Light (IPL) systems work on the principles of selective thermolysis. That is, causing thermal damage to target chromophores by using light of appropriate wavelength in pulses that exceeds the chromophores' thermal relaxation time but sparing normal skin by limiting the pulse width below the thermal relaxation time for skin.

IPL Systems are different from lasers in that they deliver many wavelengths in each pulse of light instead of just one wavelength. Generally, IPL enhances penetration without using excessive energy levels and enables targeting of specific chromophores.

Based on this,The VE2000 device (inclusive of the handpiece used to deliver pulsed-light energy) are indicated for use in surgical, aesthetic and cosmetic applications in permanent hair removal, reduction of pigmented lesions and vascular lesions.

The provided document outlines the substantial equivalence (SE) determination for the VE2000 IPL Therapy Machine (K161286) to a predicate device (Intense Pulsed Light (IPL) Systems, K122995).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present "acceptance criteria" for clinical performance. Instead, it demonstrates substantial equivalence by comparing the proposed VE2000 device's performance parameters and intended uses to those of a legally marketed predicate device. The underlying "acceptance criteria" are therefore implied to be that the proposed device performs comparably to the predicate device for its stated indications.

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

The document explicitly states: "No clinical study is included in this submission."

Therefore, there is no test set sample size or data provenance related to clinical performance described. The safety and effectiveness determination is based on non-clinical testing and comparison to a predicate device.

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

Since no clinical study was conducted and no clinical test set was used for performance evaluation, this information is not applicable and is not provided in the document.

4. Adjudication Method 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

No, an MRMC comparative effectiveness study was not done. The submission relies on non-clinical testing and substantial equivalence to a predicate device, without involving human readers or AI assistance in a comparative effectiveness study.

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

Not applicable. The device is an IPL Therapy Machine, not an algorithm, and its performance evaluation for substantial equivalence was based on non-clinical testing and comparison to a physical predicate device, not standalone algorithmic performance.

7. The Type of Ground Truth Used

The "ground truth" for the substantial equivalence determination for this device is primarily established by:

• Compliance with recognized electrical safety and EMC standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57.
• Biocompatibility testing: ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization).
• Direct functional and parametric comparison to a legally marketed predicate device (K122995) for intended use, light source, wavelength, energy density, pulse characteristics, and spot size. The predicate device itself has presumably been accepted by the FDA based on its own evidence of safety and effectiveness.

8. The Sample Size for the Training Set

Not applicable. This device is an IPL therapy machine, not an AI/ML algorithm that requires a training set.

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

Not applicable, as there is no training set for this type of device.

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