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510(k) Data Aggregation
(84 days)
The Quantel Optimis II Q-Switched Nd:YAG Photodisruptor is indicated for posterior capsulotomy.
The Quantel Optimis II Q-Switched Nd:YAG Photodisruptor in a Nd:YAG laser which operates at a nano-second pulse rate. The laser energy is delivered to the treatment site using a provided Optimis II slit lamp.
The provided document is a 510(k) summary for the Quantel Optimis II Q-Switched Nd:YAG Photodisruptor, which is an ophthalmic laser.
Crucially, the document states "Performance Data: None required - comparison of indications and specifications/characteristics established the substantial equivalence of the Optimis II laser to predicates." This means that the device was not required to undergo a specific performance study to establish acceptance criteria or to prove that it meets such criteria in the context of this 510(k) submission. Instead, its substantial equivalence to previously marketed predicate devices was established through a comparison of their intended uses and technical specifications.
Therefore, many of the requested details about acceptance criteria, study design, and ground truth cannot be extracted from this document, as a performance study as typically understood was not conducted.
Here's a breakdown based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
| (No performance data was required or submitted for this 510(k) based on the "substantially equivalent" determination) | (The device was deemed substantially equivalent to predicate devices based on indications and specifications. No specific efficacy or safety performance metrics, such as sensitivity, specificity, accuracy, or other clinical outcomes, are provided or were assessed in a dedicated study for this submission.) |
2. Sample size used for the test set and the data provenance: Not applicable, as no dedicated performance study using a test set was required or conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no dedicated performance study requiring expert ground truth was conducted.
4. Adjudication method for the test set: Not applicable, as no dedicated performance study requiring adjudication was conducted.
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 is an ophthalmic laser, not an AI-assisted diagnostic tool for human readers. No MRMC study was mentioned or required.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a laser, not a standalone algorithm.
7. The type of ground truth used: Not applicable, as no dedicated performance study requiring ground truth was conducted. The "ground truth" for this submission was established by comparing the device's indications and specifications to those of legally marketed predicate devices.
8. The sample size for the training set: Not applicable, as no algorithm training was involved.
9. How the ground truth for the training set was established: Not applicable, as no algorithm training was involved.
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