(26 days)
The QuadroStar 980 Laser System 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 QuadroStar 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 cardiothoracic surgery. This QuadroStar 980 is specifically indicated for hemostasis and coagulation of soft tissue (including cardiac tissue).
The QuadroStar 980 is a diode laser system emitting a laser beam at a wavelength of 980 nm with a maximum power of 25 W.
The provided text describes a 510(k) summary for the Asclepion Laser Technologies GmbH QuadroStar 980 Laser System. This submission focuses on establishing substantial equivalence to a predicate device rather than detailing a study with acceptance criteria for device performance. Therefore, many of the requested fields cannot be filled.
Here's the information that can be extracted:
Acceptance Criteria and Device Performance Study
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Predicate Device Comparison: Substantially equivalent to the predicate device (Ceralas D 980) based on: | The QuadroStar 980 has the same principles of operation, the same wavelength (980nm), and essentially the same power range (max 25W) as the predicate device. |
| - Principles of operation | Matches predicate device. |
| - Wavelength | Matches predicate device (980 nm). |
| - Power range | Essentially the same as predicate device (max 25 W). |
| - Indications for Use | Matches predicate device. |
| Safety and Effectiveness: Safe and effective for intended uses. | "The QuadroStar 980 Laser System is another safe and effective device..." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
No test set or clinical study data is reported for this device in the provided summary. The submission is based on substantial equivalence to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No ground truth establishment by experts for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring adjudication is described.
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 is a laser system, not an AI-assisted diagnostic device, and no MRMC study is described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This describes a medical device (laser system), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The basis for acceptance is substantial equivalence to a legally marketed predicate device, not a comparison to a defined ground truth derived from a specific study.
8. The sample size for the training set
Not applicable. This is a medical device, and the submission does not mention machine learning or a training set.
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 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.