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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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