(112 days)
The Visualase Thermal Therapy System is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy under magnetic resonance imaging (MRI) guidance in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, orthopedics, pulmonology, radiology, and urology, for wavelengths 800nm through 1064nm.
When therapy is performed under MRI guidance, and when data from compatible MRI sequences is available, the Visualase system can process images to determine relative changes in tissue temperature during therapy. The image data may be manipulated and viewed in a number of different ways, and the values of data at certain selected points may be monitored and/or displayed over time.
When interpreted by a trained physician, this device provides information that may be useful in the determination or assessment of thermal therapy. Patient management decisions should not be made solely on the basis of Visualase analysis.
The Visualase Thermal Therapy System comprises four devices: a laser energy source, a cooled laser applicator, a pump for circulating coolant through the applicator, and a computer workstation with magnetic resonance imaging (MRI) analysis software for determination and visualization of relative changes in tissue temperature during therapy.
The four components have themselves been previously cleared for marketing via 510(k) notifications with the new device bringing these four components into a single portable cart for use in MR-guided laser thermal therapy procedures. In practice, all of the devices are used according to their approved indications for use. That is, the laser applicator is introduced into the tissue to be destroyed and connected to both the laser energy source and the cooling pump. The cooling pump and laser are operated as normal to deliver energy and cause tissue ablation. Since the laser applicator is MR-compatible, the laser ablation procedure may be carried out inside of an MRI magnet. In this case, appropriate MR imaging can be performed during the treatment, and the MR analysis software can be used to evaluate the thermal changes in the target tissue.
The provided text does not contain detailed information about specific acceptance criteria, a study proving the device meets those criteria, or the methodology typically associated with evaluating AI/software performance as requested in the prompt.
The document K071328 is a 510(k) summary for the Visualase® Thermal Therapy System, describing it as a combination of four previously cleared devices: a laser energy source, a cooled laser applicator, a pump, and MRI analysis software. The summary focuses on the substantial equivalence of this combined system to its predicate devices, emphasizing that the individual components' functions and performance remain unchanged.
Therefore, many of the requested fields cannot be filled based on the provided text.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not specify quantitative acceptance criteria or detailed performance metrics. It rather states that "Performance and technical data for each of the components of the Visualase Thermal Therapy System are unchanged from those listed in the original submissions." This implies that the individual components met their respective acceptance criteria in prior 510(k) clearances, and the combination as a system is not introducing new performance parameters that require a new set of criteria.
2. Sample size used for the test set and the data provenance:
Not applicable. The submission is a 510(k) for a system combination, not a new device requiring a performance study with a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No new test set or ground truth establishment is described for this 510(k).
4. Adjudication method for the test set:
Not applicable.
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:
Not applicable. This device predates the common application of AI in this context and is a combination of existing cleared components. The MR analysis software provides "passive monitoring" and "information that may be useful," but explicitly states "Patient management decisions should not be made solely on the basis of Visualase analysis," indicating it's not designed for standalone diagnostic or decision-making. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The document indicates the Visualase MRI analysis software is for "passive monitoring" and processing "images to determine relative changes in tissue temperature during therapy." It provides "information that may be useful in the determination or assessment of thermal therapy" but explicitly states "Patient management decisions should not be made solely on the basis of Visualase analysis." This suggests it is not intended for standalone decision-making, and no standalone performance study is mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. There is no new performance study described in this 510(k) that would require establishing a ground truth for a test set. The individual components would have had their own validation data during their initial clearances.
8. The sample size for the training set:
Not applicable. The document describes a combination of existing cleared devices. There is no mention of a new "training set" for the MRI analysis software in this context. The software processes images based on physical principles (proton resonance-frequency shift analysis), not machine learning requiring a training set in the modern sense.
9. How the ground truth for the training set was established:
Not applicable. See point 8.
§ 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.