(70 days)
The VISULAS 532s Laser System with the VITE option is intended for use in retinal, panretinal, focal and grid photocoagulation of ocular tissues in the treatment of diseases of the eye including:
- Proliferative and non-proliferative diabetic retinopathy .
- Macular edema ◆
- Branch and central retinal vein occlusion .
- Lattice degeneration .
- Retinal tears and detachments .
The VISULAS 532s Laser System with the VITE option is an ophthalmic surgical laser intended for use in photocoagulating ocular tissues in treatment of diseases of the eye. As with the predicate device, laser energy for the proposed device is delivered via transpupillary delivery or intraocular endoprobe delivery. The VISULAS 532s Laser System with the VITE option includes an optional new laser slit lamp (the LSL 532s VITE) that features a multispot treatment cascade delivery option.
This is a 510(k) premarket notification for a medical device (VISULAS 532s Laser System with the VITE option). It establishes substantial equivalence by demonstrating that the new device has "the same intended use and technological characteristics as a predicate device," rather than by comparing it with specific acceptance criteria that must be met in a clinical study. Therefore, the requested information (performance table, sample sizes, expert qualifications, adjudication method, MRMC study, standalone performance, ground truth types, and training set details) is largely not applicable in the context of this 510(k) summary.
The document states:
- "The determination of substantial equivalence is based on the comparison between the results of performance data conducted using the VISULAS 532s with the VITE option and the predicate device. These results demonstrate the ability of the proposed device to produce photocoagulation of ocular tissues that is comparable to the photocoagulation produced by the predicate device."
- "The VISULAS 532s Laser System with the VITE option is substantially equivalent to the predicate device, the VISULAS 532s Laser System (K013402)."
This indicates that the study performed was a nonclinical performance study comparing the new device against a predicate device, focusing on producing comparable photocoagulation, rather than meeting specific quantifiable performance metrics.
Here is a summary of what can be extracted from the provided text, while noting the limitations due to the nature of a 510(k) submission based on substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: The primary "acceptance criterion" for this 510(k) submission is that the VISULAS 532s Laser System with the VITE option is substantially equivalent to the predicate device (VISULAS 532s Laser System, K013402) in terms of its ability to perform photocoagulation of ocular tissues. Specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy) are not provided or required for this type of submission.
- Reported Device Performance: "These results demonstrate the ability of the proposed device to produce photocoagulation of ocular tissues that is comparable to the photocoagulation produced by the predicate device." No specific numerical performance values are given.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Substantial Equivalence to predicate device (VISULAS 532s Laser System, K013402) based on comparable photocoagulation of ocular tissues. | The device demonstrates the ability to "produce photocoagulation of ocular tissues that is comparable to the photocoagulation produced by the predicate device." It is deemed "substantially equivalent." |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified, but given the nonclinical nature, it would likely involve experimental setups rather than human patient data from a specific country. The study was a "Brief Summary of Nonclinical Tests & Results."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts/Qualifications: Not applicable for a nonclinical study comparing device output.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. The "study" refers to nonclinical performance data comparing the device's output to a predicate, not to an assessment of diagnostic or clinical accuracy requiring expert adjudication.
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
- MRMC Study: No. This is a nonclinical submission for a laser surgical system, not an AI-assisted diagnostic or therapeutic device. No human readers or AI assistance are mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. The device is a surgical laser system, not an algorithm. Its performance is inherent to its physical operation, with a human surgeon always in the loop.
7. The type of ground truth used
- Type of Ground Truth: For the nonclinical performance data, the "ground truth" would implicitly be the established performance characteristics and outputs of the predicate device. The new device's output was compared for comparability.
8. The sample size for the training set
- Sample Size (Training Set): Not applicable. This device is not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth (Training Set) Establishment: Not applicable.
§ 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.