(105 days)
PHARAON LIPO is intended for laser assisted lipolysis
The medical device PHARAON LIPO is based on the use of a laser module allowing the 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 of 600um. The optical fiber is screwed onto the SMA 905 connector of the laser module. The apparatus PHARAON LIPO includes the whole of the supplies necessary to supply the laser (50A, 2V) and to ensure its thermalisation using a Peltier element built on a ventilated radiator.
In addition PHARAON LIPO includes the whole of electronics and the functions allowing the parameter setting of the laser and the safe functioning of the device. The adjustments of the parameters are done using a TFT screen and a tactile flagstone.
The provided 510(k) K073617 for the PHARAON LIPO device is for a laser surgical instrument, not an AI/algorithm-driven device. Therefore, the information requested about acceptance criteria, study details, ground truth, and expert involvement (which are typically relevant for AI/algorithm performance evaluation) is not explicitly available in this type of submission.
510(k) submissions for devices like PHARAON LIPO primarily focus on demonstrating substantial equivalence to a legally marketed predicate device through engineering specifications, safety and performance testing against recognized standards, and functional comparison. They do not involve clinical studies with human readers, AI assistance, or the generation of ground truth in the same way an AI diagnostic or prognostic device would.
Based on the provided text, here’s what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance:
The document states that "Performance data demonstrate the safety and effectiveness of PHARAON LIPO for its intended use." However, it does not provide a table of specific quantitative acceptance criteria (e.g., power output tolerance, wavelength stability, thermal management metrics) nor detailed performance data against those criteria. It broadly states conformance to regulatory guidelines and standards.
- Acceptance Criteria (Implicit/General):
- Conformance to Guidance on the content and organization of a premarket notification for a medical laser (June 1995).
- Conformance to Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 2005).
- Conformance to 21CFR part 1040.10 and 1040.11 (Performance Standards for Laser Products).
- Demonstration of safety and effectiveness for laser-assisted lipolysis.
- Substantial equivalence to the predicate device SMARTLIPO (K062321) in terms of intended use, material design, and function.
- Reported Device Performance: The document only makes a general statement: "Performance data demonstrate the safety and effectiveness of PHARAON LIPO for its intended use." No specific quantitative performance metrics are provided in the summary.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not applicable/not provided in this 510(k) summary for a laser device. There is no "test set" in the context of an algorithm's performance on patient data. Performance evaluation for this type of device typically involves engineering tests, electrical safety tests, electromagnetic compatibility (EMC) tests, and biocompatibility tests, rather than clinical data sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable/not provided. Ground truth in the context of clinical images or patient data is not established for a laser device's mechanical or energy delivery performance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable/not provided. Adjudication methods are relevant for resolving discrepancies in expert interpretations of data, typically in AI performance studies.
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:
This information is not applicable/not provided. An MRMC study is designed for evaluating the impact of AI on human reader performance, which is not relevant for a standalone laser surgical instrument.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable/not provided. There is no "algorithm only" performance study relevant to this laser device in the context of AI. The device itself is the "standalone" entity whose physical and electrical performance is being evaluated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not applicable/not provided. "Ground truth" as understood in AI studies (e.g., pathology reports for image analysis) is not generated for evaluating the technical performance of a laser device. The "truth" for device performance lies in its adherence to engineering specifications and safety standards.
8. The sample size for the training set:
This information is not applicable/not provided. There is no "training set" for a laser surgical instrument in the context of machine learning.
9. How the ground truth for the training set was established:
This information is not applicable/not provided. As there is no training set, there is no ground truth established for it in this context.
§ 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.