(113 days)
SMOOTHLIPO is intended for laser-assisted lipolysis
The SMQQTHLIPO is the medical laser device using a diode laser module with emission of a beam of coherent light at 970nm ± 10 nm at a maximum power of 25W. The laser module consists of laser diodes assembled in series and optically aligned in order to focus in an optical fiber with the core of 600um. The optical fiber is connected to the laser module via a SMA 905 connector. The SMOOTHLIPO laser includes power supply for the laser (50A, 2V) and a Peltier element built on a ventilated radiator for efficient functioning of the device.
In addition, functional electronics is provided to allow for laser parameter setting and the safe functioning of the device. The adjustments of parameters is achieved through a TFT (touch) screen and a tactile flagstone.
The provided text describes a 510(k) summary for the SMOOTHLIPO™ SYSTEM, a laser device intended for laser-assisted lipolysis. This summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone clinical study to prove the device meets specific acceptance criteria based on performance. As such, much of the requested information about acceptance criteria, study details, and ground truth establishment is not present in the document.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific performance metrics against pre-defined acceptance criteria for the SMOOTHLIPO™ system itself.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided. No specific test set or clinical study data is presented for the SMOOTHLIPO™ system. The submission relies on the substantial equivalence to a predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided. No test set requiring expert ground truth establishment is described.
4. Adjudication Method for the Test Set
This information is not provided. No test set is described.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
This information is not provided. No MRMC study is mentioned.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
This information is not applicable/not provided. The SMOOTHLIPO™ system is a physical laser device, not an algorithm, and the submission does not describe any standalone performance study.
7. The Type of Ground Truth Used
This information is not provided. As no clinical or performance study is detailed, no ground truth type is specified.
8. The Sample Size for the Training Set
This information is not provided. The device is a physical laser system, and the submission does not mention any "training set" in the context of an algorithm or AI.
9. How the Ground Truth for the Training Set Was Established
This information is not provided. As there's no mention of a training set, there's no ground truth establishment for it.
Summary of the Device's Approach to Meeting Acceptance Criteria (as per the document):
The document indicates that the SMOOTHLIPO™ SYSTEM meets regulatory requirements and is accepted for marketing based on demonstrating substantial equivalence to a legally marketed predicate device, the PHARAON LIPO by OSYRIS INC. (K073617).
The key points regarding this approach are:
- Conformance to Guidance: The SMOOTHLIPO™ conforms to "Guidance on the content and organization of a premarket notification for a medical laser (June 1995)" and "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 2005)." It also conforms to 21CFR part 1040.10 and 1040.11.
- Substantial Equivalence: The primary basis for acceptance is that the SMOOTHLIPO™ has the "same intended use, material design and function as predicate device PHARAON LIPO (K073617)."
- Identical Manufacturing and Performance (asserted): The submission explicitly states, "In essence, the SMOOTHLIPO which is manufactured by Osyris is identical to PHARAON LIPO 980 laser from Osyris in its manufacturing, performance, and indications." This implies that because it is identical to a device already deemed safe and effective, it inherently meets the necessary "acceptance criteria" through that equivalence.
Therefore, the "study" that proves the device meets acceptance criteria, in this context, is the Premarket Notification (510(k)) submission process itself, which successfully demonstrated substantial equivalence to a predicate device, rather than a specific clinical trial or performance study detailed within this summary.
§ 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.