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The Magma Spark Pro system intended use is for non-invasive aesthetic and cosmetic treatments.

The Magma Spark Pro system has connection capability with the following available treatment hand pieces, for multiapplication treatment options. All hand pieces are designed for aesthetic and dermatological skin procedure applications, as follows:

· Magma Spark Pro system with ALD/LLD Laser hand piece is indicated for:

o Hair removal

• o Permanent hair reduction * in skin type I-VI
  o Pseudofolliculitis Barbae (PFB)

· Magma Spark Pro system with Intense Pulsed Light (IPL) Hand pieces (5 different Applicators) with a spectrum of 430-1100nm is intended for:

o Magma Spark Pro system with L-650 (650-1100nm) IPL hand piece is indicated for:

" Removal of unwanted hair from all skin types, and to effect stable long term. or permanent hair reduction * in skin types

I-V through selective targeting of melanin in hair follicles.

" Benign epidermal lesions, including dyschromia, hyperpigmentation

o Magma Spark Pro system with S-590 (590-1100nm) IPL hand piece is indicated for:

▪ Removal of unwanted hair from all skin types, and to effect stable long term, or permanent hair recuction * in skin types I-IV through selective targeting of melanin in hair follicles.

· Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma and ephelides (freckles)

· Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial truncal and leg telangiectasias,

erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins, venous malformations.

o Magma Spark Pro system with L-530 (530-1100nm) IPL hand piece is indicated for:

· Benign epidermal lesions, including dyschromia, hyperpigmentation, ephelides (freckles)

• · Cutaneous lesions, including warts, scars and striae
  · Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial truncal and leg telangiectasias,

erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.

o Magma Spark Pro system with S-530 (530-1100nm) IPL hand piece is indicated for:

· Mild to moderate inflammatory Acne (Acne vulgaris)

· Benign epidermal lesions, including dyschromia, hyperpigmentation, ephelides (freckles)

• · Cutaneous lesions, including warts, scars and striae
  · Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial truncal and leg telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations

o Magma Spark Pro system with S-430 (430-1100nm) IPL hand piece is indicated for:

= Mild to moderate inflammatory Acne (Acne vulgaris)

Note * 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 Magma Spark Pro device is a computerized, multi-application, compatible system platform designed to provide laser and intense pulsed light (IPL) optical energies for noninvasive aesthetic dermatology procedures.

The Magma Spark Pro is a relatively small tabletop device (portable version is also available). The device is compatible with two diode laser applicators (ALD and LLD) at nominal 808 nm wavelength and five IPL applicators: S-430, S-530, S-590, L-530 and L-650 at a wavelength range of 430-1100 nm. The system platform includes an AC/DC safety approved power supply, a CPU board, a Laser driver board, a charging board, a simmer board, an LCD display, Wires connectors and control components (inlet with On/Off switch and fuses, Emergency button), footswitch panel, water based cooling system for IPL and Laser applicators cooling and a touch screen module. The operator of Magma Spark Pro chooses and monitors the mode and intensity of the treatment from a digital control panel on the front of the device. Melanin meter is provided as an accessory tool for skin type determination.

The provided document is a 510(k) summary for the Magma Spark Pro device. It details various aspects of the device, including its intended use, specifications, and comparison to predicate devices, but it does not contain a study that proves the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy.

Instead, the document states: "Therefore, apart to the performance testing conducted in adherence with the aforementioned recognized consensus standards, no additional testing was performed to sustain device safety and effectiveness." and "Clinical Performance Data: Not Applicable."

This implies that the device's safety and effectiveness for its stated indications for use are established through adherence to recognized consensus standards and by demonstrating substantial equivalence to previously cleared predicate devices, rather than through new clinical performance studies with specific acceptance criteria.

Therefore, many of the requested sections about acceptance criteria, clinical studies, sample sizes, ground truth, experts, and adjudication methods are not applicable based on the provided text.

Here's a breakdown of what can be extracted based on the document:

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

No explicit acceptance criteria or reported device performance in terms of clinical outcomes (e.g., hair reduction percentage, lesion clearance rate) are provided. The "performance" discussed in the document refers to technical specifications and adherence to safety standards.

The document does mention compliance with several performance standards (e.g., IEC 60601-1 for basic safety, IEC 60825-1 for laser product safety), which are technical and safety-related, not clinical efficacy or diagnostic accuracy criteria.

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, as no clinical performance study with a test set is described.

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 no clinical performance study with a test set and ground truth established by experts is described.

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

Not applicable, as no clinical performance study with a test set requiring adjudication is described.

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 device is a laser/IPL system for aesthetic treatments, not an AI or diagnostic imaging device that would involve human readers or MRMC studies.

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

Not applicable. The device is a physical medical device, not an algorithm.

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

Not applicable, as no clinical performance study requiring ground truth is described. The approval is based on substantial equivalence to predicate devices and adherence to technical safety standards.

8. The sample size for the training set

Not applicable, as no machine learning or AI algorithm requiring a training set is described.

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

Not applicable.

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Magma Spark device is indicated for use in aesthetic applications in dermatology.

Magma Spark device has connection capability with the follo\ving available treatment hand-pieces (applicators), for multiapplication treatment options. All hand-pieces are designed for aesthetic demlatologic procedure applications. Magma Spark device \vith ALD or LLD diode laser applicators is indicated for hair removal, pennanent hair reduction* in skin types I-VI and for the treatment of pseudofolliculitis barbae (PFB).

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

The Magma Spark device is a computerized multi-application platform intended for non-invasive aesthetic applications utilizing laser optical power.

Magma Spark is a relatively small tabletop device that provided with melanin meter and two diode laser applicators (ALD and LLD) at nominal 808 nm wavelength. The system platform includes AC/DC power supply unit, water based cooling system, CPU main card and user interface including an LCD display and touch screen module. The operator of Magma Spark chooses and monitors the mode and intensity of the treatment from a digital control panel on the front of the device.

This document is a 510(k) Summary for the Magma Spark device, a laser system for aesthetic applications in dermatology. It claims substantial equivalence to a predicate device, Magma. The document does not contain the kind of detailed study information (acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance data) that would typically be associated with a device proving it meets acceptance criteria, especially for a new or significantly modified device.

Instead, the document details a Special 510(k) Summary, which is used when a modification to a previously cleared device does not affect its safety and effectiveness. The core argument for substantial equivalence is that the Magma Spark device is essentially the same as its predicate device (Magma K153566), particularly for diode laser applications, and any changes are minor.

Therefore, many of the requested data points are explicitly stated as "Not Applicable" or are addressed by referring to the predicate device's prior clearance.

Here's a breakdown based on the provided text, highlighting what is and isn't available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with quantitative "reported device performance" in the way one might expect for a de novo submission or a device with new clinical claims. Instead, the "performance" is implicitly deemed equivalent to the predicate device, especially regarding safety and efficacy for the specified indications.

The key "performance" claimed is the ability to perform the stated Indications for Use: hair removal, permanent hair reduction in skin types I-VI, and treatment of pseudofolliculitis barbae (PFB). The definition of permanent hair reduction is provided: "long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after completion of treatment regime." However, no new study data is provided in this document to demonstrate Magma Spark meets these criteria specifically. The implicit acceptance criterion is that its performance is equivalent to the predicate device.

• AAMI/ANSI 60601-1 (2012)
• IEC 60601-1-2 (Edition 3.0, 2007)
• IEC 60825-1 (Edition 2.0, 2007)
• IEC 60601-2-22 (Edition 3.0, 2007 & Edition 3.1 2012) |
  | Software functionality, hardware interfaces, performance, load test, download procedure, integrity, recovery, and usability. | "Comprehensive software-system test plan and results report covers the full system test of the Magma Spark." (No detailed results provided in this summary). |

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

• Test Set Sample Size: Not applicable. No new clinical or animal studies were conducted for this 510(k) submission to generate a "test set" in the traditional sense for evaluating new performance data. The submission relies on the substantial equivalence to the predicate device.
• Data Provenance: Not applicable for new performance data. The device's substantial equivalence is based on its similarity to the predicate device, which would have undergone its own studies. The only new data mentioned relates to software testing.

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

• Not applicable. No new clinical studies are detailed in this document that would require experts to establish ground truth for a test set.

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

• Not applicable. No new clinical studies are detailed in this document requiring 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

• Not applicable. This device is a laser system, not an AI or imaging diagnostic device that would typically involve human "readers" or MRMC studies.

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

• Not applicable. This is a laser treatment device, not an algorithm, so "standalone" performance in this context is irrelevant. The device is intended for use by a human operator. The document does mention "Comprehensive software-system test plan and results report covers the full system test of the Magma Spark. It includes operation and user procedures, as well as programs. In addition to comprehensively testing firmware functionality, hardware interfaces, performance, load test, download procedure, integrity, recovery and usability." This describes internal software verification and validation, but not "standalone" clinical performance.

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

• Not applicable for this submission. Any "ground truth" for the efficacy of hair removal or PFB treatment would typically come from clinical trials that measure hair count reduction or clinical improvement, but these were presumably done for the predicate device, not for this specific 510(k).

8. The sample size for the training set

• Not applicable. The document discusses a physical medical device (laser system), not a machine learning algorithm that would have a "training set."

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

• Not applicable. As above, this is not a machine learning algorithm.

Summary of Approach based on Document:

The acceptance criteria for the Magma Spark device in this 510(k) are primarily based on demonstrating substantial equivalence to a predicate device (Magma K153566). The "study" that proves the device meets (these implied) acceptance criteria is not a new clinical trial, but rather a comparative analysis of the Magma Spark to its predicate, highlighting:

• Similar Technology and Principle of Operation: The underlying technology (diode laser at 808 nm) and mechanism of operation are "essential the same."
• Equivalent Intended Use: The Magma Spark, with its diode laser applicators, has the same indications for use (hair removal, permanent hair reduction in skin types I-VI, and PFB) as the predicate's diode laser applications.
• Compliance with Standards: Both devices comply with the same recognized consensus standards for safety and electromagnetic compatibility.
• Software Verification and Validation: A comprehensive software system test was executed to ensure the functionality, performance, and safety of the Magma Spark's internal software. This is a bench test, not a clinical study.
• No New Clinical or Animal Studies: The document explicitly states "Clinical Performance Data: Not Applicable" and "Pre-Clinical (Animal Study) Performance Data: Not Applicable."

In essence, the "proof" is that the device is not significantly different from an already cleared device, and thus its safety and effectiveness are presumed to be upheld.

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The Forma System and Forma Light System** are indicated for use in aesthetic applications in dermatology. The Forma System and Forma Light System** have connection capability with the following available treatment handpieces, for multi application treatment options. All handpieces are designed for aesthetic and dermatological skin procedure applications, as follows:

1. The Forma System and Forma Light System** with the Intense Pulsed Light (IPL) Handpieces (10 different Applicators) with a spectrum of 430-1100nm are indicated for:

HR*, F-HR*, B-HR* Applicators (650-1100nm):

· Removal of unwanted hair from all skin types, and to effect stable long term, or permanent hair reduction* in skin types I-V through selective targeting of melanin in hair follicles.

HR, F-HR, B-HR Applicators (590-1100nm):

· Removal of unwanted hair from skin types I-IV, and to effect stable long term, or permanent hair reduction* in skin types I-IV through selective targeting of melanin in hair follicles.

SR, F-SR, B-SR Applicators (530-1100nm):

• · Benign epidermal lesions, including dyschromia, hyperpigmentation, ephelides (freckles)
• · Cutaneous lesions, including striae

· Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. F-AC Applicator (430-1100nm):

· Mild to moderate inflammatory Acne (Acne vulgaris)

2. The Forma System with the ST Handpiece (Radio Frequency) is indicated for the treatment of relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation.

3. The Forma System with the PLG Handpiece (Microdermabrasion Applicator) is indicated for skin dermabrasion.

The Forma System is a multi-application, multi-technology platform, intended for noninvasive aesthetic applications utilizing Radio Frequency (RF) and Intense Pulsed Light (IPL) technologies.

The system platform includes an AC/DC power supply unit, an RF Generator, a CPU main card and user interface including a LCD display and touch screen module. In addition to the system platform, the Forma System is provided with 12 applicators according to the following technology related sub-categories:

• . ST Applicator (Radiofrequency) for the treatment of relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation.
• Ten Intense Pulsed Light (IPL) Applicators divided into four sub-categories: o
  • o HR*, F-HR* & B-HR* (650-1100nm) Applicators for hair removal treatments (skin types I-V).
  • HR, F-HR & B-HR (590-1100nm) Applicators for hair removal o treatments (skin types I-IV).
  • o SR, F-SR & B-SR (530-1100nm) Applicators for the treatment of pigmented and vascular lesions.
  • o F-AC (430-1100nm) Applicator for acne treatments.
• PLG Applicator (Diamond ring) is indicated for skin dermabrasion. ●

The operator chooses and monitors the mode and intensity of the treatment from a digital control panel located on the front panel of the Forma System. The Forma System has three applicator ports; one for IPL based applicators, one for RF applicator and one for the skin dermabrasion applicator. The ports must be simultaneously connected with all there applicators for the system to operate.

The Forma Light System is a model of the Forma System employing only IPL technology.

The provided document is a 510(k) summary for the Forma System and Forma Light System, which are multi-application, multi-technology platforms for aesthetic applications in dermatology. The device uses Radio Frequency (RF) and Intense Pulsed Light (IPL) technologies.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The document doesn't explicitly state "acceptance criteria" in a quantitative, performance-metric sense. Instead, it details adherence to recognized consensus standards and performance testing to verify design requirement specifications, ensuring safety and effectiveness compared to predicate devices. The "acceptance criteria" can therefore be inferred as compliance with these standards and functional performance as designed.

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

The document explicitly states "Clinical Performance Data: Not Applicable" and focuses solely on "Non-Clinical Performance Data." Therefore, there is no patient-based "test set" for which sample size or data provenance would be relevant in the context of clinical studies. The testing described is bench testing, software validation, and electrical/mechanical safety testing.

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 no clinical test set or ground truth established by experts is described in this non-clinical submission. The "ground truth" for the non-clinical tests would have been the design specifications and recognized international safety standards.

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

Not applicable, as there is no clinical test set or human interpretation requiring adjudication.

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 aesthetic medical device (IPL and RF platform), not an AI-driven diagnostic or assistive tool for human readers. No MRMC study was conducted or is relevant to this submission.

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

Not applicable. This device does not involve an "algorithm" in the sense of AI or image analysis. It is a physical medical device that delivers energy. Its "standalone performance" is assessed through its compliance with safety standards and its ability to consistently output energy as designed, which was evaluated via the non-clinical performance and bench tests.

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

For the non-clinical performance data, the "ground truth" was:

• Design requirements/specifications: For evaluating the output power accuracy of the ST Applicator and the overall system functionality.
• Recognized consensus standards: AAMI/ANSI 60601-1, IEC 60601-1-2, IEC 60601-2-57, and IEC 60601-2-2, which define the safety and essential performance requirements for medical electrical equipment, including specific types of energy-delivering devices.
• Predicate device specifications: Used for comparison to demonstrate substantial equivalence, particularly for RF output power accuracy and overall technological characteristics.

8. The sample size for the training set

Not applicable. There is no mention of machine learning or an "AI" component that would require a training set. The device is a hardware-based system.

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

Not applicable, as no training set for a machine learning model is mentioned.

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The Magma System is indicated for use in aesthetic applications in dermatology.

The Magma System has connection capability with the following available treatment handpieces, for multi application treatment options. All handpieces are designed for aesthetic and dermatological skin procedure applications, as follows:

1. The Magma System with ALD/LLD Laser Handpiece is indicated for hair removal, permanent hair reduction* in skin types I-VI and for the treatment of Pseudofolliculitis Barbae (PFB).

2. The Magma System with Nd: Y AG Laser Handpiece (ND) with a wavelength of 1064 nm (Multi-Spot Nd: Y AG) is indicated for:

· The coagulation and hemostasis of vascular lesions and soft tissue, including the treatment of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1 - 4.0 mm. diameter) of the leg

· The removal of unwanted hair from all skin types, and to effect stable long term, or permanent hair reduction® in skin types I-V through selective targeting of melanin in hair follicles.

• The non-ablative treatment of facial wrinkles

3. The Magma System with the Intense Pulsed Light (IPL) Handpieces (10 different Applicators) with a spectrum of 430-1100nm is indicated for:

HR*, F-HR*, B-HR* Applicators (650-1100nm):

· Removal of unwanted hair from all skin types, and to effect stable long term, or permanent hair reduction* in skin types I-V through selective targeting of melanin in hair follicles.

HR, F-HR, B-HR Applicators (590-1100nm):

• Removal of unwanted hair from skin types I-IV, and to effect stable long term, or permanent hair reduction* in skin types I-IV through selective targeting of melanin in hair follicles.

SR, F-SR, B-SR Applicators (530-1100nm):

· Benign epidermal lesions, including dyschromia, hyperpigmentation, ephelides (freckles)

· Cutaneous lesions, including striae

· Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. F-AC Applicator (430-1100nm):

T-AC Applicator (+50-1100mm).

· Mild to moderate inflammatory Acne (Acne vulgaris) *Note

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 Magma System is a computerized multi-application, multi-technology platform, intended for non-invasive aesthetic applications utilizing laser and Intense Pulsed Light (IPL) optical power.

The system platform includes AC/DC power supply unit, water based cooling system, CPU main card and user interface including a LCD display and touch screen module. Apart from the system platform the Magma System is provided with 13 applicators divided into three technology related sub-categories:

• ALD & LLD Diode laser (808nm) Applicators for hair removal treatments.
• Multi-spot Nd:YAG laser (1064nm) Applicator for coagulation and hemostasis of vascular lesions and soft tissue, hair removal treatments and non-ablative treatment of facial wrinkles.
• Ten Intense Pulsed Light (IPL) Applicators divided into four sub-categories:
  • o HR*, F-HR* & B-HR* (650-1100nm) Applicators for hair removal treatments (skin types I-V).
  • o HR, F-HR & B-HR (590-1100nm) Applicators for hair removal treatments (skin types I-IV).
  • o SR. F-SR & B-SR (530-1100mm) Applicators for the treatment of pigmented and vascular lesions.
  • o F-AC (430-1100nm) Applicator for acne treatments.

The operator chooses and monitors the mode and intensity of the treatment from a digital control panel on the front of the Magma System. The Magma System has two applicator ports; one for IPL based applicators and one for Laser applicators. The ports must be simultaneously connected with both laser and IPL applicators for the system to operate.

The provided text is a 510(k) summary for the Magma System, a multi-application aesthetic device utilizing laser and Intense Pulsed Light (IPL) technology. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report for novel performance claims.

Here's a breakdown based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria for clinical performance (e.g., specific percentages for hair reduction, lesion clearance). Instead, it relies on demonstrating that its design and components are similar to already cleared predicate devices and that its functionality and mechanism of operation are similar.

Reported Device Performance (based on similarity to predicate devices and general claims):

• Hair Removal/Permanent Hair Reduction:
  • ALD/LLD Laser Handpiece: Skin types I-VI.
  • Nd:YAG Laser Handpiece: Skin types I-V.
  • IPL HR*, F-HR*, B-HR* (650-1100nm) Applicators: Skin types I-V.
  • IPL HR, F-HR, B-HR (590-1100nm) Applicators: Skin types I-IV.
  • Note: Permanent hair reduction defined as long-term, stable reduction measured at 6, 9, and 12 months post-treatment.
• Vascular Lesions/Soft Tissue Coagulation and Hemostasis:
  • Nd:YAG Laser Handpiece: Superficial and deep telangiectasias (venulectasias) and reticular veins (0.1 - 4.0 mm diameter) of the leg.
• Non-ablative treatment of facial wrinkles:
  • Nd:YAG Laser Handpiece.
• Benign Epidermal Lesions:
  • IPL SR, F-SR, B-SR (530-1100nm) Applicators: Dyschromia, hyperpigmentation, ephelides (freckles).
• Cutaneous Lesions:
  • IPL SR, F-SR, B-SR (530-1100nm) Applicators: Striae.
• Benign Cutaneous Vascular Lesions:
  • IPL SR, F-SR, B-SR (530-1100nm) Applicators: Port wine stains, hemangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
• Mild to moderate inflammatory Acne (Acne vulgaris):
  • IPL F-AC Applicator (430-1100nm).

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

The document explicitly states: "Clinical Performance Data: Not Applicable". This indicates that a separate clinical study with a test set was not conducted or presented for this 510(k) submission. The submission relies on establishing substantial equivalence to predicate devices which have already demonstrated clinical effectiveness.

Therefore, details regarding sample size, country of origin, or retrospective/prospective nature of a clinical test set are not provided.

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

Not applicable, as no clinical test set with human-established ground truth was presented.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring adjudication was presented.

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 Magma System is an aesthetic laser/IPL device for direct treatment, not an AI-based diagnostic tool that would typically involve human readers or MRMC studies.

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

Not applicable. The Magma System is a physical medical device (laser/IPL system) operated by a human, not a standalone algorithm.

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

Not applicable for a clinical performance study. The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices based on their prior clearances and the scientific literature supporting the principles of laser and IPL technology for the stated indications.

8. The sample size for the training set:

Not applicable. The document describes a medical device, not an AI algorithm requiring a training set in the conventional sense. The "training" for such a device would be the extensive research and development in laser and IPL technology, manufacturing, and engineering specific to the device's design, which is validated through non-clinical performance tests.

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

Not applicable. As above, this is not an AI algorithm submission with a distinct training set and ground truth establishment methodology. The "ground truth" for the device's functionality is demonstrated through compliance with recognized consensus standards (e.g., AAMI/ANSI 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22, IEC 60601-2-57) and non-clinical performance tests verifying hardware and software functionality and safety. The clinical efficacy is substantially equivalent to predicate devices.

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