(474 days)
The MultiPulse HoPLUS Laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic, to perform incision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and use in medical specialties including: Urology, Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery.
The MultiPulse HoPLUS Laser system and its fiber optic delivery system is a laser Class IV, pulsed, solid state Holmium-YAG, which emits laser radiation with a wavelength of approximately 2100 nm with a pulse with between 150-850 microseconds. The laser power up to 110 Watts is transmitted to the tissue through different optical fibers. The laser system consists of: Laser system including control panel (user interface) Foot switch
This document is a 510(k) summary for the ASCLEPION LASER TECHNOLOGIES GmbH MultiPulse HoPLUS, a laser surgical instrument. It details the device's intended use, comparison to predicate devices, and a list of performance testing standards. However, it does not contain specific acceptance criteria or the results of a study that directly compares the device's performance against numerical acceptance criteria.
The document states that the MultiPulse HoPLUS laser system is tested according to various ISO and DIN EN standards, and that it complies with the European Medical Device Directive. These standards are general safety and performance standards for medical devices and lasers, not specific performance metrics for the device's indicated uses in surgery.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: This information is not present in the provided text. The document lists the standards the device complies with, but not quantifiable acceptance criteria or performance metrics derived from those standards specific to the device's surgical capabilities (e.g., ablation rate, coagulation depth, precision of incision).
- Sample size used for the test set and the data provenance: Not specified. Performance testing is mentioned generally, but no details on specific studies, sample sizes, or data provenance (e.g., country of origin, retrospective/prospective) are provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified. There is no mention of expert-established ground truth for performance testing.
- Adjudication method for the test set: Not specified.
- 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 device is a surgical laser, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reading improvement with AI is not applicable and not mentioned.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: This pertains to AI algorithms, which is not what this device is.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not specified.
- The sample size for the training set: Not applicable for this type of device (a laser surgical instrument).
- How the ground truth for the training set was established: Not applicable for this type of device.
In summary, the provided text confirms that the MultiPulse HoPLUS laser system has undergone performance testing against general medical device and laser safety standards, and is deemed substantially equivalent to predicate devices based on its intended use and functional features. However, it does not provide detailed information about specific performance acceptance criteria or the results of studies directly demonstrating the device's performance against such criteria for its numerous surgical indications.
§ 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.