(37 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied by SE claim) |
|---|---|
| Safety and Efficacy for hair removal, permanent hair reduction, and PFB in skin types I-VI, equivalent to predicate device (Magma K153566). | Magma Spark device is "substantially equivalent" to the predicate Magma device for the mentioned indication for use (hair removal, permanent hair reduction, PFB with diode laser applicators). The underlying technology and principle of operation are "essential the same." It has similar safety features and complies with the same relevant consensus standards as the predicate device. |
| Compliance with recognized consensus standards (for safety and electromagnetic compatibility). | Complies with: |
- 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.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.