(153 days)
The SOLAR™ Surgical Ablation System is indicated for delivery of 810nm, 1064nm, or 1083nm laser light to soft tissue, under visualization, during surgical procedures Indications include the ablation, or coagulation of soft tissue.
The SOLAR™ Surgical Ablation System Accessories are intended for use in the support of the delivery of laser light to soft tissue during surgical procedures.
The SOLAR Surgical Ablation System consists of a Cart, Laser Energy Generator (Laser Generator), Controller, an infusion set and a Track is an intraoperative, sterile, single-use device designed to apply laser energy to tissue The infusion set is a single-use device having a sterile fluid path designed for the delivery of sterile salıne solution to the Track laser tup The Track includes a rigid metallic shaft, a flexible track, and an introducer (guiding obturator) The Track further includes a laser compatible optical fiber which attaches to the Laser Generator The emitted laser energy is directed toward the targeted tissue from the end of the optical fiber which rides within the flexible Track The position of the optical fiber in relation to the target tissue is maintained constant by the method of mounting the fiber within the fiber optic housing and the design of the flexible Track itself The black markers on the Track indicate the area of tissue to be ablated and are used to set the positioning of the fiber optic housing within a given area of tissue The lines of ablation are created by independently activating the laser energy between two numbered segments, which are predetermined by the physician when positioning the flexible Track against the targeted tissue.
The provided text describes a 510(k) premarket notification for the SOLAR™ Surgical Ablation System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving the device meets those criteria.
Therefore, many of the requested sections about specific acceptance criteria, study methodologies, and performance metrics for a novel AI device are not present in the provided document.
Here's an analysis based on the available information:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or a performance report for the SOLAR™ Surgical Ablation System against such criteria. The "Testing" section broadly states:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Adherence to specifications | "demonstrated that adherence to specifications was demonstrated" |
| Substantial equivalence to predicate device | "the lessons obtained using the SOLAR system with 1083nm laser light are substantially equivalent to those obtained with the currently cleared ATRILAZE Surgical Ablation System wavelengths" |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of device performance evaluation. The "Testing" section mentions "lessons obtained using the SOLAR system with 1083nm laser light" but does not provide details on sample size, data provenance (country of origin, retrospective/prospective), or the nature of these "lessons."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The submission focuses on substantial equivalence based on technical comparisons, not on human-expert based ground truth validation for a novel AI or diagnostic device.
4. Adjudication method for the test set
This information is not provided in the document.
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
An MRMC comparative effectiveness study is not mentioned in the document. This type of study is typically performed for AI-assisted diagnostic devices to measure human reader improvement, which is not the nature of the SOLAR™ Surgical Ablation System.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to the SOLAR™ Surgical Ablation System, as it is a surgical laser instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document does not describe the establishment of a "ground truth" in the context of a diagnostic or AI performance evaluation. The evaluation is focused on technical specifications and functional equivalence to predicate devices.
8. The sample size for the training set
The concept of a "training set" is not applicable to this 510(k) submission, as it concerns a physical medical device (surgical laser) and not a machine learning algorithm.
9. How the ground truth for the training set was established
As there is no training set for an AI algorithm discussed, this information is not provided.
§ 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.