(56 days)
ICOONE Laser med (also referred to as ICOONE Medical laser) is indicated for the relief of minor muscle aches and pain, relief of muscle spasms, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.
Icoone Medical Laser (also referred to as Icoone Lase med) is Therapeutic Massager machine attached to pivoting wheels, connected to a rolling stand, with a series of hand pieces equipped with motorized rollers, which are the core of the technology and that, opportunely guided by an operator, are applied to the patient's body. The combined synergistic action between the micro-stimulators (rollers) and a negative pressure (vacuum) created within the hand pieces grasp the skin tissues allowing to achieve the same effects of kneading tissue by hand. Applications are pre-set by the machine or the operator in relation to intensity, frequency, length of session, degree of tissue suctioning, and allow to address the issues of each individual in an absolutely targeted manner. Icoone Medical Laser (model ref 650EC24) (also referred to as Icoone Laser med) is also equipped with two light sources inside the Robosolo hand piece, each with the following wave lengths: - Led @ 650mm (50mW) - Laser @ 915mm (1W) Through the display, the light sources can be fully deactivated, or only LED activated. The sources are neither adjustable in intensity (always output at nominal value, as per specifications) nor in frequency (always continuous - CW). Once selected, by turning on the Robosolo hand piece, both suctioning and light emission are activated at the same time. The light is emitted via laser diodes or LEDs controlled by a dedicated power driver.
The provided text is a 510(k) summary for the ICOONE Laser med device. It details the device's substantial equivalency to a predicate device, its indications for use, technological characteristics, and performance data related to electrical safety, EMC, and software validation.
However, the document does not contain information about a study that proves the device meets specific performance acceptance criteria related to its clinical efficacy (e.g., reduction in cellulite, relief of muscle aches). Instead, the performance data presented focuses on safety and technical compliance standards.
Therefore, I cannot fulfill all parts of your request based on the provided text. I will address the parts that are extractable and clearly state when the information is not present.
Here's the breakdown based on the provided document:
Acceptance Criteria and Device Performance Study (as per document context)
The document primarily focuses on establishing substantial equivalence to a predicate device based on similar indications for use, technological characteristics, and compliance with safety and technical standards, rather than proving direct clinical performance against specific numerical acceptance criteria for its claimed therapeutic effects (e.g., a measured reduction in cellulite appearance, or pain relief scores).
The "Performance Data" section specifically lists compliance with electrical safety, EMC, and software verification/validation standards. It does not present data from studies measuring the device's efficacy for its stated indications (e.g., a clinical trial demonstrating cellulite reduction or pain relief).
1. Table of Acceptance Criteria and Reported Device Performance
Based on the document's content, the "acceptance criteria" are compliance with relevant safety and technical standards, and the "performance" tabulated is demonstrating that compliance. There are no clinical efficacy metrics or associated acceptance thresholds provided.
| Standard Category | Acceptance Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Electrical Safety | EN 60601-1:2006/A11: 2011/A1: 2013/A2: 2014 | Gap testing provided, demonstrating conformance to FDA-recognized standard (AAMI/ANSI ES60601-1:2005(R) 2012 and A1:2012). |
| EMC | EN 60601-1-2:2015 | Compliance with this standard. |
| Software V&V | FDA guidance: "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" | Software verification and validation testing conducted; documentation provided as recommended. |
| Laser Safety | IEC 60601-2-22 (Edition 3.1 2012-10) | Compliance with this standard. |
| Laser Product Safety | IEC 60825-1 (Edition 2.0 2007-03) | Compliance with this standard. |
| Biocompatibility | ISO10993-10:2010, 10993-5:2009 and 10993-12:2012 | Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization / Biological Evaluation Of Medical Device - Part 5: Test for cytotoxicity - According to the specified ISO standards. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not present in the provided document. The document describes technical testing (electrical safety, EMC, software, biocompatibility), which typically does not involve "sample sizes" in the sense of clinical study participants. No clinical efficacy study data is described.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not present in the provided document. As no clinical efficacy study is described, there's no mention of experts establishing ground truth for such a test.
4. Adjudication Method for the Test Set
This information is not present in the provided document. Since no clinical efficacy test set is detailed, no adjudication method is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
This information is not present in the provided document. The document does not describe any MRMC study or any study comparing human readers with and without AI assistance, as this is a physical device, not an AI diagnostic tool.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
This information is not applicable to the device described. The ICOONE Laser med is a physical therapeutic massager with laser and vacuum functions, operated by a human. It's not an algorithm or AI system for which standalone performance would be measured.
7. The Type of Ground Truth Used
Based on the document, the "ground truth" demonstrated is compliance with established international safety and performance standards for medical electrical equipment, laser products, and biocompatibility. For instance, the ground truth for electrical safety is that the device passes specific tests under EN 60601-1. There is no mention of clinical outcome data, pathology, or expert consensus being used as a ground truth for efficacy.
8. The Sample Size for the Training Set
This information is not applicable and not present in the document. The device is not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not present in the document. The device is not an AI/ML model that requires a training set.
In summary, the provided FDA 510(k) summary focuses on demonstrating that the ICOONE Laser med device is substantially equivalent to a predicate device primarily through adherence to established safety and performance standards (electrical, EMC, software, laser, biocompatibility), rather than through a clinical study demonstrating its efficacy against specific, quantitative acceptance criteria for its indications for use.
§ 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.