(289 days)
The MedicalCV SOLAR™ Surgical Ablation System is indicated for delivery of 810nm or 1064nm laser light to soft tissue, under direct visualization, during surgical procedures. Indications include the ablation, or coagulation of soft tissue.
The Solar™ Surgical Ablation System consists of a Laser Energy Generator, a Reciprocator Control unit, a fluid delivery tubing set and a flexible surgical ablation track. The Solar™ Orbital Track is an intraoperative, sterile, single-use device designed to apply laser energy to tissue. The fluid delivery tubing set is a single-use device having a sterile fluid path designed for the delivery of sterile saline solution to the ablation catheter. The Reciprocator Control unit is a motion generating device housing the fluid delivery pump and provides the means of monitoring the ablation process parameters. The laser energy Generator and Reciprocator Control Unit are sold separately. The Solar™ Orbital Track includes a ridged metallic shaft, a flexible track, and a guide lead and is equipped with a 905 SMA connector cable which attaches to the laser energy generator output connector. The emitted laser energy is directed toward the target tissue from the end of the optical fiber which rides within the flexible track.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Solar™ Surgical Ablation System:
The provided text focuses on demonstrating "substantial equivalence" of the Solar™ Surgical Ablation System to predicate devices rather than defining specific, quantifiable acceptance criteria for novel performance claims. The "study" described is primarily focused on demonstrating this equivalence through adherence to manufacturing specifications and qualitative/histological assessment of tissue lesions.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance to manufacturing specifications for Power Output | "Testing demonstrated that adherence to specifications was demonstrated..." |
| Compliance to manufacturing specifications for Fluid Flow | "Testing demonstrated that adherence to specifications was demonstrated..." |
| Visual and histology evaluation of lesions obtained on cardiac tissue compared to predicate device (Atrilaze™) to demonstrate substantial equivalence | "...the lesions obtained using the Solar™ flexible Orbital Trac are substantially equivalent to those obtained with the currently cleared Atrilaze™ Surgical Ablation System, which is to be expected since the energy source, the optical fiber, and application method used in both systems are identical." |
| Biocompatibility: Materials are non-toxic, non-hemolytic, non-pyrogenic | "The results of biocompatibility testing conducted on the disposable fiber optic delivery system and tubing set support that the materials used in the manufacture of the disposables are non-toxic, non-hemolytic, and non-pyrogenic." Consistent with predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The text mentions "lesions obtained on cardiac tissue" for visual and histology evaluation, but the number of tissue samples or experiments is not provided.
- Data Provenance: Not explicitly stated. The testing appears to be primarily laboratory-based ("biocompatibility testing," "Performance testing...included compliance to manufacturing specifications...along with visual and histology evaluation"). No mention of country of origin or whether it's retrospective or prospective human data. Given the context of a 510(k) submission and the nature of the testing, it's highly likely to be pre-clinical, laboratory-based testing rather than human study data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The "histology evaluation" implies evaluation by a histologist or pathologist, but no details are given.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/not specified. The testing described appears to be objective (manufacturing specifications) or qualitative/comparative (visual and histology) without indicating a need for expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence to predicate devices, not on comparing the system's effectiveness with and without AI assistance or between different human readers. The device itself is a surgical ablation system, not a diagnostic imaging AI tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a surgical system that delivers laser energy, not an algorithm. The "performance testing" described is for the physical device's specifications and its ability to create tissue lesions, which inherently involves human operation and observation.
7. The Type of Ground Truth Used
- Manufacturing Specifications: For power output and fluid flow.
- Histology/Visual Evaluation: For assessing the characteristics of the lesions on cardiac tissue. This would be considered a form of expert assessment or pathology ground truth, though the details of the assessment are limited.
- Biocompatibility Standards: For the disposable components.
8. The Sample Size for the Training Set
- Not applicable. This device is a physical surgical tool and does not employ AI/machine learning, therefore there is no "training set" in the context of AI.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there is no training set.
§ 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.