(90 days)
The Evolve HPD 980/ 1470nm Multiwavelength Diode Laser (Evolve Dual) (and its delivery accessories used to deliver optical energy) are indicated for use in general surgical applications for incision, excision, ablation, cutting, vaporization, hemostasis, and coagulation of soft tissue contact or non-contact, open or closed endoscopic applications where incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue vaporization, hemostasis and/or coagulation may be indicated.
The device is intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures including via endoscopes. The Evolve HPD Multiwavelength 980/ 1470 Diode Laser is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, cardiothoracic surgery, dental applications, and endovenous occlusion of the saphenous veins in patients with superficial vein reflux. The Multiwavelength laser is further indicated for laser assisted lipolysis.
The device is specifically indicated for use as follows:
Ear, Nose and Throat and Oral Surgery (Otolaryngology)
Arthroscopy
Gastroenterology
General Surgery, Dermatology, Plastic Surgery and Podiatry
Urology
Gynecology
Neurosurgery
Cardiac Surgery
Pulmonary Surgery
Dental Applications
The Biolitec Medical Device, Inc. Evolve HPD 980/ 1470nm Multiwavelength Diode Laser contains the same identical components as the cleared Biolitec, Inc. Evolve HPD 980/ 1470nm Multiwavelength Diode Laser (K112013).
The provided document is a 510(k) summary for the Evolve® HPD 980/ 1470nm Multiwavelength Diode Laser. It explicitly states that the device is determined to be substantially equivalent to a predicate device (K112013).
In the context of 510(k) submissions, the acceptance criteria for a new device are typically met by demonstrating that it is as safe and effective as a legally marketed predicate device. This is primarily done by showing identical or highly similar technological characteristics, intended use, indications for use, and principles of operation, and by demonstrating compliance with relevant voluntary consensus standards.
Therefore, the "study that proves the device meets the acceptance criteria" in this case is the substantial equivalence determination by the FDA, based on a comparison to the predicate device and compliance with established standards. There is no clinical study, comparative effectiveness study, or standalone algorithm performance study described in these documents that would provide information on sensitivity, specificity, or other performance metrics typically associated with AI/software devices.
Here's the breakdown of why certain requested information cannot be provided from this document:
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A table of acceptance criteria and the reported device performance
- Acceptance Criteria (Implied by Substantial Equivalence): The device must be "as safe and effective" as the predicate device (Evolve HPD 980/ 1470nm Multiwavelength Diode Laser, K112013). This implicitly means it must perform within the same safety and effectiveness parameters as the predicate.
- Reported Device Performance: The document states, "The Evolve HPD 980/ 1470mm Multiwavelength Diode Laser is as safe and effective for these Indication for Use as the cleared predicate device." and "The Evolve HPD 980/ 1470nm Multiwavelength Diode Laser has the identical same intended uses, indications, technological characteristics, and principles of operation as its predicate device." No specific quantitative performance metrics (e.g., accuracy, sensitivity, specificity, or other clinical outcomes) are provided for either device.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided: No test set or clinical study data is described in this 510(k) summary. The submission relies on demonstrating substantial equivalence to a predicate device through technological and intended use comparisons, and compliance with recognized standards.
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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)
- Not applicable / Not provided: No test set or ground truth establishment is described.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided: No test set or adjudication process is described.
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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
- No: No MRMC study was done, nor is this device an AI-assisted device. The device is a multiwavelength diode laser for general surgical applications.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No: This is a physical medical device (laser), not an algorithm or software. Therefore, a standalone performance assessment in the sense of an algorithm is not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided: No ground truth used for a performance study is described as no performance study was conducted for this 510(k). The "ground truth" for this submission is the established safety and effectiveness of the existing predicate device.
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The sample size for the training set
- Not applicable / Not provided: This is not a machine learning or AI device. No training set is involved.
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How the ground truth for the training set was established
- Not applicable / Not provided: No training set is involved.
In summary, this 510(k) submission for the Evolve® HPD 980/ 1470nm Multiwavelength Diode Laser is based on demonstrating substantial equivalence to a predicate device and compliance with relevant voluntary consensus standards. It does not involve performance studies in the context of diagnostic or AI devices, and therefore, most of the requested information regarding independent performance testing, sample sizes, and ground truth is not present in the provided text.
§ 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.