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K Number
K083795
Device Name
CYNOSURE SMARTLIPO MPX LASER
Manufacturer
CYNOSURE, INC.
Date Cleared
2009-01-21

(30 days)

Product Code
GEX
Regulation Number
878.4810
Type
Special
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Cynosure Smartlıpo MPX Laser is intended for the surgical incision, excision, vaporization, ablation, and coagulation of soft tissue Soft tissue includes skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartılage meniscus. mucous membrane, lymph vessels and nodes, organs and glands The Cynosure Smartlıpo MPX Laser is futher ındıcated for laser assısted lıpolysis

Device Description

The Cynosure Smartlipo MPX laser with SmartSense T Module is a Nd YAG laser, having a ND YAG crystal rod as a lasing medium It is a laser with a wavelength of 1064 nm and 1320 nm. Laser activation is by footswitch Overall weight of the laser is 285lbs, and the size is 41"x18"x32" (HxWxD). Electrical requirement is 220 VAC, 20A, 50-60 Hz, single phase.

AI/ML Overview

This document does not describe acceptance criteria for a device's performance or a study proving that the device meets such criteria. Instead, it is a 510(k) premarket notification summary and an FDA clearance letter for the Cynosure Smartlipo MPX Laser with SmartSense T Module.

The key information provided relates to the device's regulatory submission and substantial equivalence to a predicate device, rather than detailed performance study results.

Here's an analysis based on the provided text, addressing your questions where possible:

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

    • N/A. The document explicitly states "Nonclinical Performance Data: none" and "Clinical Performance Data: none." This indicates that no specific performance criteria or studies proving performance against those criteria were submitted or are reported in this document for the Smartlipo MPX Laser with SmartSense T Module. The clearance is based on substantial equivalence to a predicate device.

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

    • N/A. No test set data or clinical study information is provided.

  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):

    • N/A. No ground truth establishment is described as there are no performance studies reported.

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

    • N/A. No test set or adjudication method 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:

    • N/A. This device is a laser system, not an AI-assisted diagnostic or imaging tool. Therefore, an MRMC study related to human readers and AI assistance is not applicable.

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

    • N/A. This device does not appear to involve an algorithm or AI component for standalone performance evaluation.

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

    • N/A. No ground truth is mentioned as no performance studies are reported.

  8. The sample size for the training set:

    • N/A. No training set is mentioned as no algorithm or AI component is described.

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

    • N/A. No ground truth for a training set is relevant or described here.

Conclusion from the document:

The Cynosure Smartlipo MPX Laser with SmartSense T Module received FDA clearance (K083795) based on its substantial equivalence to predicate devices (specifically, the Cynosure YAG Family laser). The submission explicitly states "Nonclinical Performance Data: none" and "Clinical Performance Data: none." This means that the regulatory decision was made without new performance studies, relying instead on the established safety and effectiveness of the legally marketed predicate devices with the same indications for use, principle of operation, and laser parameters.

§ 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.