(29 days)
The MeDioStar laser system is intended for surgical, aesthetic applications in the medical specialties of general and plastic surgery and dermatology.
The MeDioStar laser system is intended for the treatment of benign vascular lesions.
The MeDioStar laser system is intended for the treatment of benign pigmented lesions.
The MeDioStar laser system is intended for hair reduction defined as reduced hair growth with or without maintenance when measured at 6, 9 and 12 months ..
The modified MeDioStar is a pulsed diode laser emitting a wavelength of 755 - 1060 nm that is operated with a handpiece in contact with the skin. The system comprises a main console unit, a handpiece and is triggered by means of a footswitch. There are several handpieces, the user can choose from. Moreover, a specific software controls the device functions and allows the user selections through the touchscreen display.
The provided text describes modifications to an existing laser system, the "MeDioStar," focusing on an expanded wavelength range. However, it does not contain information about acceptance criteria or a study proving that the device meets specific performance metrics for its stated indications for use (e.g., hair reduction, treatment of vascular/pigmented lesions).
The document primarily focuses on:
- Regulatory Clearance (510(k) summary): Confirming that the modified device is substantially equivalent to a predicate device.
- Device Description: Outlining the technical specifications and modifications from the previous version.
- Performance Standards (Non-clinical): Listing the electrical safety, electromagnetic compatibility, software, usability, risk management, and laser-specific safety standards that the device passed. These standards ensure the device is safe and functions correctly from an engineering perspective, but not necessarily its clinical efficacy for its stated indications.
Therefore, for your specific request, most of the information is not present in the provided document. I can only report on what is available.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document lists performance standards the device passed, which are primarily related to safety and engineering aspects, not clinical efficacy or specific acceptance criteria for its intended uses (hair reduction, lesion treatment). Therefore, a table for clinical performance criteria and results cannot be generated from this text.
The document states:
- "MeDioStar passed all the required testing and is in compliance will all applicable sections of the abovementioned performance standards."
The performance standards mentioned are:
- ISO 60601-1: Medical electrical equipment Part 1: General requirements for safety and essential performance
- ISO 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests
- IEC 62304: Medical Device Software – Software life cycle processes
- IEC 62366-1: Medical devices Application of usability engineering to medical devices
- IEC 60601-2-22: Medical electrical equipment – Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment
- ISO 14971: Medical devices – Application of risk management to medical devices
- Software verification and validation testing (according to FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices").
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not provided. The document does not describe any clinical test sets or studies related to the device's efficacy for its intended uses.
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 provided. There is no mention of clinical experts or ground truth establishment for clinical performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not provided.
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 provided. This is a laser device, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not provided. This is a laser device, not an AI algorithm performing a standalone task.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not provided. No clinical ground truth is discussed.
8. The sample size for the training set
Not provided. No training set for an algorithm is mentioned.
9. How the ground truth for the training set was established
Not provided. No training set or ground truth for it is mentioned.
In summary: The provided FDA 510(k) clearance letter and summary primarily address the safety and engineering compliance of a modified medical laser device (MeDioStar) compared to its predicate. It confirms that the device meets various international and FDA standards for electrical safety, software, usability, and risk management. However, it does not include information about clinical performance studies, efficacy acceptance criteria, or any data related to how well the device performs for its stated indications (e.g., hair reduction, treatment of lesions). Such clinical data, if required for a 510(k), would typically be referenced or summarized, but none appears in this document.
§ 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.