Search Results

The Diode Laser Handpiece is indicated for: The hair removal single (HRS) and hair removal moving (HRM) mode are intended for permanent reduction in hair regrowth defined as 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. Use on all skin types (Fitzpatrick I-VI) including tanned skin. The IPL Handpiece has various filters to create different wavelengths. The various wavelengths are broken down by wavelength and applicable indication for use: Intended for use in aesthetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology. The IPL handpiece is indicated for: Indication for Use for the 430-980nm wavelength . Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae. • Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas, and poikiloderma of Civatte. · For use on Fitzpatrick skin types (I-V) Indication for use for the 515-980mm wavelength . Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae. • Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas, poikiloderma of Civate and Lentigines. • For use on Fitzpatrick skin types (I-V) Indication for use for the 560-980mm wavelength • Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae. • Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas, poikiloderma of Civate and Lentigines. • The removal of unwanted hair to effect stable long-term or permanent hair reduction • For use on Fitzpatrick skin types (I-V) Indication for use for the 585-980mm wavelength • Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae. • Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas, and poikiloderma of Civatte. • The removal of unwanted hair to effect stable long-term or permanent hair reduction • For use on Fitzpatrick skin types Indication for use for the 640-980mm wavelength . Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae. • Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas, and poikiloderma of Civatte. • The removal of unwanted hair to effect stable long-term or permanent hair reduction • For use on Fitzpatrick skin types (I-V) Indication for use for the 700-980nm wavelength • The removal of unwanted hair and to effect stable long-term or permanent hair reduction. Permanent reduction in hair regrowth is defined as the 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 regime • For use on Fitzpatrick skin types (I-V) RF Microneedling Handpiece The RF MicroNeedling Handpiece is indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis Thermal RF Handpiece The Thermal RF Handpiece is indicated for 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 Darwin is a Class II Medical Device that combines multiple technologies into one platform for use in dermatologic and aesthetic procedures. The system is comprised of a micro-processor-controlled and userfriendly console that houses the power supply, the electronics and the user interface. It has 4 handpieces that are attached to the console, which can be selected for use in treatment through the user interface. There are 4 separate handpieces. Each handpiece has its own indication for use. - . Diode Laser Handpiece - IPL Handpiece - RF Microneedling Handpiece . - Thermal RF The Diode Laser handpiece uses laser light in the 808nm wavelength for hair removal. The laser removes hair, employing a method knows as selective photothermolysis. This involves raising the temperature of the hair follicle without damaging the epidermis and the surrounding tissue. Delivering pulsed light using a coherent light source of 808nm wavelength, the diode laser handpiece is intended for hair removal and permanent hair reduction on skin types (Fitzpatrick skin types I - V). The user can choose from two modes: hair removal shot (HRS) and hair removal moving (HRM) when using the Diode laser handpiece. The IPL Handpiece produces light pulses with a specific duration, intensity, and spectral distribution allowing for a controlled and confined energy delivery into tissue. IPL use in dermatology relies on the basis that certain targets for energy absorption (chromophores) are capable of absorbing energy from this broad spectrum of light wavelength (absorptive band) without exclusively being targeted by their highest absorption peak. The IPL Handpiece has various filters to create different wavelengths. The handpiece is Intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology. Each wavelength has its own indications for use, which are listed in the tables below. Filters for the non-invasive IPL handpiece include 430nm, 515nm, 560nm, 585, 640nm, and 700nm. The user can select two treatment modes: ST (Skin Type) and HR (Hair Removal) when using the IPL handpiece. The RF Microneedling handpiece operates using sterile, single-use, multi-needle tips (10 pin and 25 pin) and is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis. The RF Microneedling handpiece generates radiofrequency (RF) energy by means of bipolar RF at 2 MHz. The RF handpiece penetrates micro needles directly into the skin and delivers high frequency energy. This energy flows through the electrode to the tissue and uses heat generated by load or contact resistance to induce coagulation. The RF energy is delivered through the skin into the target tissue via a handpiece equipped with an electrode tip. As the RF energy passes through the tissue, it generates an electrothermal reaction which is capable of coagulating the tissue. The RF Microneedling Handpiece has a single use sterile disposable cartridge. This is the only sterile component on the device. The RF Microneedling handpieces are not intended to be sterilized or disinfected by the end user. The Thermal RF Handpiece is indicated for 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 provided document is a 510(k) summary for the Darwin device, which includes several handpieces (Diode Laser, IPL, RF Microneedling, Thermal RF). The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.

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

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

The document does not explicitly state "acceptance criteria" for performance in the typical sense of a target value. Instead, it demonstrates performance by showing technical specifications that are either identical or considered similar/a subset of predicate devices. The entire document is essentially a comparison study against predicate devices to establish substantial equivalence.

Therefore, the "acceptance criteria" are implicitly met by demonstrating these technical equivalences.

Study that proves the device meets the acceptance criteria:

The provided text focuses on demonstrating substantial equivalence to predicate devices rather than reporting on a de novo clinical trial with specific performance metrics and their achievement. The "study" here is a comparison to legally marketed predicate devices based on their indications for use and technical specifications.

The document lists the following performance data provided in support of the substantial equivalence determination:

• IEC 60601-1: General Requirements for basic safety and essential performance of medical electrical equipment.
• IEC 60601-1-2: General Requirements for basic safety and essential performance: electromagnetic compatibility.
• IEC 60601-2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic, and diagnostic laser equipment.
• IEC 60601-2-2: Particular requirements for the basic safety and essential performance of high-frequency surgical equipment and high-frequency surgical accessories.
• ISO 10993-1: Biological Evaluation of Medical Devices.

These are international consensus standards related to electrical safety, electromagnetic compatibility, and biocompatibility, which verify the device's fundamental safety and performance aspects. The successful completion of these tests demonstrates that the Darwin device meets recognized safety and effectiveness benchmarks, aligning with the performance of its predicate devices.

2. Sample size used for the test set and the data provenance:
The document does not describe a test set or test subjects in the context of a clinical performance study. The evaluation relies on comparison to predicate devices and adherence to international safety standards. Therefore, information regarding "sample size" for a comparative clinical test set or data provenance (country of origin, retrospective/prospective) is not applicable or provided here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable or provided. The ground truth is established by the existing regulatory clearance of the predicate devices and the technical specifications required to meet IEC and ISO standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable or provided. There is no described "test set" in the context of human interpretation or diagnostic evaluation that would require an adjudication method.

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:
This information is not applicable or provided. The Darwin device is not described as an AI-assisted diagnostic tool for human readers. It is a physical device for dermatologic and surgical procedures.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable or provided. As mentioned, the Darwin device is a physical therapeutic/surgical instrument, not a diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" in this context is established by:

• Regulatory Clearance of Predicate Devices: The FDA has already determined the predicate devices to be safe and effective for their stated indications.
• International Consensus Standards: Adherence to standards like IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60601-2-2, and ISO 10993-1 provides the ground truth for electrical safety, electromagnetic compatibility, and biocompatibility.

8. The sample size for the training set:
This information is not applicable or provided. There is no mention of an AI model or training set in this submission.

9. How the ground truth for the training set was established:
This information is not applicable or provided for the same reason as above.

Ask a specific question about this device

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 Thermal RF System is a Class II Medical Device that utilizes monopolar RF energy for the purpose of elevating tissue temperature for selected medical conditions. The system is comprised of a micro-processor-controlled and user-friendly console that houses the power supply, the electronics and the user interface. It then has a handpiece that is attached to the console, and through the user interface can be selected for administering the treatment.

The provided text describes a 510(k) premarket notification for a medical device called the "RF Thermal System" and includes information about its performance data and substantial equivalence to a predicate device. However, it does not describe:

• Acceptance criteria expressed as specific quantitative metrics (e.g., sensitivity, specificity, accuracy thresholds).
• A study using a test set with expert-established ground truth for performance evaluation of a diagnostic or AI-based device.
• Sample sizes for test sets in the context of diagnostic accuracy.
• Data provenance (country of origin, retrospective/prospective) for a test set.
• Number of experts or their qualifications for ground truth establishment.
• Adjudication methods for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or human reader improvement with AI.
• Standalone algorithm performance.
• Type of ground truth used in the context of diagnostic accuracy (e.g., pathology, outcomes data).
• Sample size for a training set or how ground truth for a training set was established.

This document focuses on the safety and basic performance of a therapeutic device (RF Thermal System) which uses heat to relieve pain, muscle spasms, and increase local circulation. The "performance data" refers to technical safety standards (IEC, ISO) and the device's ability to raise and maintain tissue temperature within a therapeutic range, not diagnostic accuracy metrics.

Therefore, based solely on the provided text, it is not possible to answer the detailed questions about acceptance criteria, test sets, ground truth, experts, or AI-specific study designs as they relate to a diagnostic or AI-driven device. The device in question is a therapeutic RF system, and its "performance" is assessed through engineering and biocompatibility tests, and its ability to achieve a therapeutic temperature, not through diagnostic accuracy metrics.

The only "performance data" provided relates to:

• IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2: Standards for general safety, electromagnetic compatibility, and high-frequency surgical equipment.
• ISO 10993-1, -12, -5, -10: Biocompatibility evaluation for medical devices.
• ASTM D 4169: Package validation testing.
• Thermal Testing: "Results showed that the Thermal RF system is capable of raising the temperature to 40°C and then maintain the temperate between 40°C – 44°C for 10 minutes, which meets the requirements for a therapeutic treatment."
• Mechanical performance: "output accuracy of the TRF TIP, all results demonstrate accuracy within ±20%."
• Temperature sensor testing: "tested successfully to demonstrate the device meets design specifications and performance requirements."

There are no details on "acceptance criteria" in the sense of accuracy metrics for a diagnostic device, nor any study design related to AI or human interpretation of images/data. The "study" mentioned is primarily engineering and bio-compatibility testing, along with a small-scale in vivo thermal test.

Ask a specific question about this device

The Diode Laser Handpiece is indicated for:
The hair removal single (HRS) and hair removal moving (HRM) mode are intended for permanent reduction in hair regrowth defined as 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. Use on all skin types (Fitzpatrick I-VI) including tanned skin

The IPL Handpieces are indicated for:
Intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology.
Indication for Use for the 430-980nm wavelength . Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae. • Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas, and poikiloderma of Civatte. · For use on Fitzpatrick skin types (I-V)
Indication for use for the 515-980mm wavelength • Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae. • Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas, poikiloderma of Civate and Lentigines. • For use on Fitzpatrick skin types (I-V)
Indication for use for the 560-980nm wavelength . Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae. • Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas, poikiloderma of Civate and Lentigines. • The removal of unwanted hair to effect stable long-term or permanent hair reduction • For use on Fitzpatrick skin types (I-V)
Indication for use for the 585-980mm wavelength . Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae. • Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas and spider angiomas, and poikiloderma of Civatte. • The removal of unwanted hair to effect stable long-term or permanent hair reduction • For use on Fitzpatrick skin types
Indication for use for the 640-980mm wavelength . Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae. • Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas, and poikiloderma of Civatte. • The removal of unwanted hair to effect stable long-term or permanent hair reduction • For use on Fitzpatrick skin types (I-V)
Indication for use for the 700-980m wavelength · The removal of unwanted hair and to effect stable long-term or permanent hair reduction. Permanent reduction in hair regrowth is defined as the 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 regime • For use on Fitzpatrick skin types (I-V)

The RF MicroNeedling Handpiece is indicated for:
Use in dermatologic and general surgical procedures for electro-coagulation and hemostasis

The Darwin is a Class II Medical Device that combines multiple technologies into one platform for use in dermatologic and aesthetic procedures. The system is comprised of a micro-processor-controlled and user-friendly console that houses the power supply, the electronics, and the user interface. It then has 3 handpieces that are attached to the console, and through the user interface can be selected for use in the treatments.
There are 3 separate handpieces. Each handpiece has its own indication for use.

• Diode Laser Handpiece
• IPL Handpiece
• RF Microneedling Handpiece ●

The Diode Laser handpiece uses laser light in the 808nm wavelength for hair removal. The laser eliminates hair, employing a method knows as selective photothermolysis. This involves disabling hair regrowth mechanism by raising the temperature of the hair follicle high enough to irreversibly damage the follicle's germinative cells without damaging the epidermis and the surrounding tissue. The germinative root resides inside the follicle but is located to the outer follicles sheath. Therefore, the complete follicle volume must be heated above 70° C to accomplish permanent destruction of all stem cell.
Delivering a pulsed light using a coherent light source of 808nm wavelength, the diode laser handpiece is intended for hair removal and permanent hair reduction on skin types (Fitzpatrick skin types I - V). The user can choose from two modes: hair removal shot (HRS) and hair removal moving (HRM) when using the Diode laser handpiece.

The IPL Handpiece produces light pulses with a specific duration, intensity, and spectral distribution allowing for a controlled and confined energy delivery into tissue. IPL use in dermatology relies on the basis that certain targets for energy absorption (chromophores) are capable of absorbing energy from this broad spectrum of light wavelength (absorptive band) without exclusively being targeted by their highest absorption peak.
The IPL Handpiece has various filters to create different wavelengths. The handpiece is Intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology. Each wavelength has its own indications for use, which are listed in the tables below.
Filters for the non-invasive IPL handpiece include 430nm, 515nm, 560nm, 585, 640nm, and 700nm. The user can select two treatment modes: ST (Skin Type) and HR (Hair Removal) when using the IPL handpiece.

The Needle RF handpiece operates using sterile, single-use, multi-needle tips (10 pin and 25 pin) and is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis. The RF Microneedling handpiece generates radiofrequency (RF) energy by means of bipolar RF at 2 MHz.
The RF handpieces penetrates micro needles directly into the skin and delivers high frequency energy. This energy flows through the electrode to the tissue and uses heat generated by load or contact resistance to induce coagulation. The RF energy is delivered through the skin into the target tissue via a handpiece equipped with an electrode tip. As the RF energy passes through the tissue, it generates an electrothermal reaction which is capable of coagulating the tissue.
The RF Microneedling Handpiece has a single use sterile disposable cartridge. This is the only sterile component on the device. No handpieces or accessories are intended to be sterilized or disinfect by the end user. There are no components of the Darwin that are reusable.

This document, a 510(k) premarket notification for the Darwin device, primarily focuses on demonstrating substantial equivalence to predicate devices based on comparable technological characteristics and safety standards. It does not contain information about a study proving the device meets specific acceptance criteria related to its performance in terms of accuracy, sensitivity, or specificity, which would typically be seen for AI/ML-based medical devices.

The "Performance Data" section (VIII) describes electrical safety and electromagnetic compatibility testing, as well as thermal testing for the RF Microneedling handpiece. This type of performance data is focused on the device's physical and functional safety and effectiveness, rather than clinical efficacy or diagnostic accuracy as might be evaluated for an AI algorithm.

Therefore, I cannot provide the requested information for acceptance criteria and a study that proves the device meets those criteria in the context of an AI/ML algorithm's performance. The document describes a device that is intended for aesthetic and surgical procedures using laser, IPL, and RF microneedling technologies, not an AI or algorithm-driven device that would have metrics like sensitivity, specificity, or human reader improvement with AI assistance.

To directly answer your request based on the provided text, but noting the absence of AI/ML performance metrics:

1. A table of acceptance criteria and the reported device performance:
   The document focuses on demonstrating substantial equivalence to predicate devices rather than listing specific, quantitative performance acceptance criteria for clinical outcomes like an AI/ML system would. The "Performance Data" section primarily addresses safety and functional performance testing.

   Acceptance Criteria (Inferred from testing)	Reported Device Performance (Summary)
   IEC 60601-1 (Basic Safety & Essential Performance)	Performed, demonstrating compliance.
   IEC 60601-1-2 (Electromagnetic Compatibility)	Performed, demonstrating compliance.
   IEC 60601-2-22 (Laser Equipment Safety & Performance)	Performed, demonstrating compliance.
   IEC 60601-2-2 (HF Surgical Equipment Safety & Performance)	Performed, demonstrating compliance.
   RF Microneedling Thermal Performance	Demonstrated "consistent formation of measurable thermal lesions for medium and highest energy level settings in the treatment of in vivo pig skin and in vitro liver and kidney tissues at a temperature close to physiological," leading to the conclusion that "treatment by this device at the appropriate testing settings will result in a desirable clinical treatment effect."

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

   • Sample Size: Not specified quantitatively for any human subjects or patients. For the thermal testing, "in vivo pig skin and in vitro liver and kidney tissues" were used, but specific numbers of subjects/samples are not provided.
   • Data Provenance: Not applicable in the context of clinical patient data for AI validation. The testing described is laboratory/benchtop testing and animal model (pig skin) testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable. This device is not an AI/ML diagnostic or prognostic tool that requires expert-established ground truth from images or data. Ground truth in this context would relate to the physical effects of the device (e.g., thermal lesion formation), not interpretations by human experts.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   Not applicable. This is not an AI/ML device requiring human annotation for ground truth establishment.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
   Not applicable. The Darwin device is not an AI-assisted diagnostic or prognostic tool. No human-in-the-loop study comparing human performance with and without AI assistance was described.

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 algorithm that would be tested for its performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For the thermal testing, the ground truth was the direct observation and measurement of thermal lesions in biological tissues (pig skin, liver, kidney). This is an objective physical outcome.

8. The sample size for the training set:
   Not applicable. This device is not an AI/ML system that undergoes a "training set" phase.

9. How the ground truth for the training set was established:
   Not applicable, as there is no training set for an AI/ML algorithm described in this submission.

Ask a specific question about this device

The hair removal single (HRS) and hair removal moving (HRM) mode are intended for permanent reduction in hair regrowth defined as 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. Use on all skin types (Fitzpatrick I-VI) including tanned skin.

The Bare : 808 Laser is a microprocessor-controlled, user friendly, sealed diode laser system that produces a wavelength of 808nm with a maximum energy of 120Jcm2. The system incorporates a diode laser within each hand piece, and the energy is delivered from the hand piece directly to the desired target. The Bare: 808 Laser consists of a console, a touch screen user interface, a footswitch and 1 handpiece.

This document is a 510(k) Summary for the Bare: 808 Laser System (K193446), a device intended for permanent hair reduction.

Here's an analysis of the provided text regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states that a human clinical study was not required because the device is considered substantially equivalent to predicate devices. Therefore, there is no direct table of acceptance criteria for diagnostic/performance metrics (e.g., sensitivity, specificity) derived from a clinical study for the Bare: 808 device itself.

Instead, the "Performance Data" section lists compliance with relevant IEC (International Electrotechnical Commission) standards for electrical safety and electromagnetic compatibility as the acceptance criteria for these aspects. The reported performance is that the device was tested and complied with these standards.

For its intended use and indications for use, the acceptance criterion implicitly is substantial equivalence to the predicate device (Soprano Ice K140009), meaning it performs as safely and effectively. The document provides a comparison table of technical specifications between the Bare: 808 and the predicate device to demonstrate this equivalence, rather than a direct performance metric.

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

• No clinical test set was used for the K193446 submission. The document states: "A human clinical study was not required as the device is substantially equivalent to the predicate devices."
• Data provenance for a clinical test set is therefore not applicable to this submission. The performance data provided is related to engineering and safety standards compliance.

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 was required or used.

4. Adjudication method for the test set:

• Not applicable, as no clinical test set was required or 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:

• No MRMC study was done, as this device is a laser system for hair removal, not an AI-assisted diagnostic device.

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

• Not applicable, as this device is a laser system, not an algorithm.

7. The type of ground truth used:

• The "ground truth" for this submission primarily relies on compliance with established international safety and performance standards (IEC) for medical electrical equipment and laser devices, as well as the technical specifications and intended use of a legally marketed predicate device to establish substantial equivalence.

8. The sample size for the training set:

• Not applicable, as this is a hardware laser device, not a machine learning algorithm that requires a training set in the typical sense. Any internal development or testing would relate to engineering validation, not an AI training set.

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

• Not applicable, as it's not an AI/ML device requiring a training set with established ground truth.

Ask a specific question about this device

The Lucent : IPL is Intended for use in aesthetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology.

Indication for Use for the 430-980nm wavelength
· Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae.
· Benign cutaneous vascular lesions, including port wine stains, facial and truncal telangiectasias, angiomas and spider angiomas, and poikiloderma of Civatte.
· For use on Fitzpatrick skin types (I-V)

Indication for use for the 515-980nm wavelength
· Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles). and striae.
· Benign cutaneous vascular lesions, including port wine stains, facial and truncal telangiectasias, angiomas and spider angiomas, poikiloderma of Civatte and Lentigines.
· For use on Fitzpatrick skin types (I-V)

Indication for use for the 560-980nm wavelength
· Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae.
· Benign cutaneous vascular lesions, including port wine stains, facial and truncal telangiectasias, angiomas and spider angiomas, poikiloderma of Civatte and Lentigines.
· The removal of unwanted hair to effect stable long-term or permanent hair reduction
· For use on Fitzpatrick skin types (I-V)

Indication for use for the 585-980nm wavelength
· Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae.
· Benign cutaneous vascular lesions, including port wine stains, facial and truncal telangiectasias, angiomas and spider angiomas, and poikiloderma of Civatte.
· The removal of unwanted hair to effect stable long-term or permanent hair reduction
· For use on Fitzpatrick skin types (I-V)

Indication for use for the 640-980nm wavelength
· Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae.

• · Benign cutaneous vascular lesions, including port wine stains, facial and truncal telangiectasias, angiomas and spider angiomas, and poikiloderma of Civatte.
• · The removal of unwanted hair to effect stable long-term or permanent hair reduction
• · For use on Fitzpatrick skin types (I-V)

Indication for use for the 700-980nm wavelength
• The removal of unwanted hair and to effect stable long-term or permanent hair reduction. Permanent reduction in hair regrowth is defined as the 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 regime
· For use on Fitzpatrick skin types (I-V)

The LUVO Medical Technologies, Inc. Lucent : IPL is a multi-wavelength non-invasive system for IPL skin treatments, treatment of vascular and pigmented lesions, and hair removal using multiple filters reflecting a wavelength range of 430nm to 980nm. The Lucent : IPL system consists of a system console, electronics and software, cooling system, and handpiece with six filters

The provided text is a 510(k) premarket notification summary for the Lucent : IPL device. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are explicitly stated as not applicable or not required in this type of submission.

Here's a breakdown based on the provided document:

Acceptance Criteria and Device Performance for Lucent : IPL

The device, Lucent : IPL, did not undergo a de novo clinical study with specific acceptance criteria in the typical sense for this 510(k) submission. Instead, its performance and safety are established by demonstrating substantial equivalence to legally marketed predicate devices. The "acceptance criteria" here are implicitly linked to showing that its technical specifications and indications for use fall within the established range or scope of the predicates, and that any differences do not raise new questions of safety or effectiveness.

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

Since no specific performance metrics with predefined acceptance criteria from a de novo study are presented, the "acceptance criteria" are the ranges and types of indications provided by the predicate devices. The "reported device performance" is the Lucent : IPL's own specifications.

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

• Sample Size: Not applicable. A human clinical study (test set) was explicitly not required for this 510(k) submission, as stated in the document ("Results of Clinical Study: A human clinical study was not required as the device is substantially equivalent to the predicate devices.").
• Data Provenance: Not applicable, as no clinical study was performed.

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 was performed and no "ground truth" for a test set was established.

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

• Not applicable, as no clinical study was performed and no "ground truth" for a test set was established.

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 an IPL system, 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 medical device for treatment, not an AI algorithm.

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

• Not applicable. The basis for clearance is substantial equivalence to existing legally marketed predicate devices, meaning that the device's technical specifications and indications for use are similar enough not to raise new safety or effectiveness concerns. The "ground truth" in this context is the FDA's prior clearance of the predicate devices based on their established safety and effectiveness.

8. The sample size for the training set:

• Not applicable. This refers to AI/ML development, which is not relevant to this type of device and submission.

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

• Not applicable. This refers to AI/ML development, which is not relevant to this type of device and submission.

Summary of the Study Proving Device Meets Acceptance Criteria:

The "study" proving the Lucent : IPL meets acceptance criteria is the 510(k) premarket notification review process, which involved:

• Comparison to Predicate Devices: The submission meticulously compares the Lucent : IPL's technical specifications (wavelength, intended use, indications for use, pulse width, energy density, spot size) to two predicate devices:
  • Alma Harmony XL Multi-Application Platform (K072564)
  • Lumenis M22 System (K142860)
• Performance Testing (Non-Clinical): The document states that the following performance data was provided:
  • ES60601-1:2005/(R)2012 and A1:2012 Test for Medical Electrical equipment (General Requirements for basic safety and essential performance)
  • IEC 60601-1-2 Edition 4.0 2014-02 Test for Medical Equipment (General Requirements for basic safety and essential performance: electromagnetic compatibility)
  • IEC 60601-2-57 Edition 1.0 2011-01 (Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use)

The conclusion, explicitly stated in the document, is: "The Lucent : IPL's intended use, indications for use and technical specifications are substantially equivalent to the Harmony XL Multi-Application Platform and the M22 System." This "substantial equivalence" is the "proof" accepted by the FDA for clearance in this case, rather than a de novo clinical study with specific performance metrics.

Ask a specific question about this device