(189 days)
The Ceralas D 980 is intended for delivery of laser light to soft tissue in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers, or catheters. The Ceralas D 980 is generally indicated for incision, excision, vaporization, ablation, hemostasis, or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, and cardiothoracic surgery. This Ceralas D 980 is specifically indicated for hemostasis and coagulation of soft tissue (including cardiac tissue).
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The provided text describes a 510(k) submission for the Ceralas D 980 Diode Laser System. This document focuses on demonstrating substantial equivalence to predicate devices rather than conducting a de novo study to establish new acceptance criteria and prove performance against them.
Therefore, many of the requested elements for a study proving a device meets acceptance criteria are not directly applicable or available in this submission.
Here's a breakdown of the available information and how it relates to your request:
Acceptance Criteria and Device Performance
Since this is a substantial equivalence submission, the "acceptance criteria" are primarily established by the performance characteristics of the predicate devices and relevant voluntary consensus standards. The device performance is demonstrated by showing that it meets these standards and has comparable characteristics to the predicates.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| Intended Use/Indication for Use (Same as predicates) | The Ceralas D 980 has the same intended use as the previously cleared Ceralas D 980 and its predicate devices, including incision, excision, vaporization, ablation, hemostasis, or coagulation of soft tissue in various surgical specialties, specifically for hemostasis and coagulation of soft tissue (including cardiac tissue). |
| Technological Characteristics (Same or comparable to predicates) | The Ceralas D 980 has the exact same technological characteristics as the previously cleared Ceralas D 980 (with an exception of a handpiece modification) and similar characteristics to the CardioFocus, Inc.'s Diode Laser System (a 980 nm diode laser). |
| Compliance with Voluntary Consensus Standards | The device complies with 21 C.F.R., IEC 601-1; IEC 601-2-22; and EN 60825-1. |
Summary of Device Performance: The primary "proof" of meeting acceptance criteria for a 510(k) submission like this is arguing that the device is "substantially equivalent" to legally marketed predicate devices. This means it has the same intended use and similar technological characteristics, and any differences do not raise new questions of safety and effectiveness.
Study Details (Not Applicable for this 510(k) Submission)
The 510(k) submission for the Ceralas D 980 Diode Laser System is focused on demonstrating substantial equivalence to predicate devices, and as such, it does not include a new clinical study or performance study in the way you've outlined for proving a device meets acceptance criteria. Information regarding test sets, ground truth establishment, expert adjudication, or MRMC studies for this specific device's performance is not provided because it's not typically required for a substantial equivalence claim for a laser system of this nature.
Here's why many of your questions cannot be answered from the provided text:
- Sample size used for the test set and the data provenance: Not applicable. This submission doesn't present a test set to validate a new algorithm or performance metric.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a test set is not established in this type of submission.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 is not an AI-based device, and no MRMC study is mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a surgical laser, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of proving new performance data. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices.
- The sample size for the training set: Not applicable. There is no algorithm being trained.
- How the ground truth for the training set was established: Not applicable.
In essence, this 510(k) is a regulatory argument of "this device is like these other devices that are already on the market and proven safe and effective," rather than a detailed report of a new performance study. The performance data mentioned (compliance with standards) is about the technical specifications and safety of the laser itself, not its clinical efficacy against a new set of criteria measured in a specific clinical study.
§ 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.