(125 days)
PHARAON 980 ENDO is indicated for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.
PHARAON 980 EXO is indicated for photocoagulation of teleangectasia of the legs.
The medical device PHARAON 980 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. PHARAON 980 includes the whole of the supplies necessary to supply the laser and to ensure its thermalisation using a Peltier element built on a ventilated radiator.
PHARAON 980 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.
PHARAON 980 is available for ENDO application (endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux) and EXO application (photocoagulation of teleangectasia of the legs).
PHARAON 980 EXO is supplied with CONTROL4+ HANDPIECE a dedicated handpiece including an auto-requlated cooling system and video allowing optimal mapping of the treatment area and screen display of the vessel on PHARAON 980.
The provided text is a 510(k) summary for the PHARAON 980 ENDO & EXO laser device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance metrics for the PHARAON 980 itself.
Therefore, the requested information for acceptance criteria and a study proving device conformance cannot be fully extracted from the provided document. The document states that the device "conform[s] to Guidance on the content and organization of a premarket notification for a medical laser (June 1995) and to Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 2005)" and "conform[s] to 21 CFR part 1040.10 and 1040.11," indicating compliance with regulatory standards, not performance against specific clinical acceptance criteria.
The 510(k) summary explicitly states: "Performance data demonstrate the safety and effectiveness of PHARAON ENDO /EXO for its intended use." However, it does not provide this performance data, acceptance criteria, or details of the study in the document itself. The basis for substantial equivalence is primarily the similarity in intended use, design, and function to the predicate device, CERALAS D 980 LASER SYSTEM.
Here's what can be stated based on the provided text, and what cannot be:
1. Table of acceptance criteria and reported device performance:
- Cannot be provided. The document does not list specific acceptance criteria (e.g., success rate, complication rate, accuracy, sensitivity, specificity) for the PHARAON 980 device's clinical performance. It also does not report specific device performance metrics against such criteria. The document states that "Performance data demonstrate the safety and effectiveness," but does not present the data itself.
2. Sample size used for the test set and data provenance:
- Cannot be provided. The document does not describe any specific clinical "test set" for the PHARAON 980 device. The performance claims are based on substantial equivalence to the predicate device, not on a new clinical study with a specified sample size or data provenance for the PHARAON 980.
3. Number of experts used to establish the ground truth for the test set and their qualifications:
- Cannot be provided. Since no specific clinical test set is described for the PHARAON 980 device, there's no mention of experts establishing ground truth for such a set.
4. Adjudication method for the test set:
- Cannot be provided. No test set is described.
5. Multi-reader multi-case (MRMC) comparative effectiveness study information:
- No, an MRMC comparative effectiveness study was not done according to the provided text. This device is a laser surgical instrument, and MRMC studies are typically for imaging or diagnostic devices where human readers interpret results, often with and without AI assistance. This document does not mention any human-in-the-loop performance or AI assistance.
6. Standalone (algorithm only without human-in-the-loop performance) study information:
- Not applicable in the context of this device. The PHARAON 980 is a laser surgical instrument; its "performance" is about its physical operation, safety, and effectiveness in delivering laser energy as intended, not about an algorithm's standalone diagnostic performance. The document mentions conformity to "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 2005)," which suggests software is involved, but not in a diagnostic or interpretive capacity that would typically warrant a "standalone" algorithm performance study as understood in AI/imaging contexts.
7. Type of ground truth used:
- Cannot be provided as no specific clinical study data for the PHARAON 980 is presented. For a laser device, "ground truth" (if a study were conducted) would likely relate to clinical outcomes (e.g., successful coagulation, absence of reflux, teleangectasia reduction, complication rates) rather than expert consensus on an image or pathology.
8. Sample size for the training set:
- Cannot be provided. This is not an AI/ML device in the sense of requiring a "training set" of data to learn from. Its safety and effectiveness are established through engineering design, adherence to standards, and substantial equivalence to a predicate device.
9. How the ground truth for the training set was established:
- Cannot be provided. Not applicable.
In summary: The provided 510(k) summary is typical for a medical device seeking clearance through substantial equivalence. It confirms compliance with relevant regulations and guidance documents and asserts that performance data exists to demonstrate safety and effectiveness. However, it does not present the detailed studies, acceptance criteria, or performance results that would answer the specific questions posed, as these details are usually contained within the full 510(k) submission and not summarized in this public document to the same level of granularity.
§ 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.