(70 days)
Coagulation, vaporization, ablation or cutting of soft tissue in dermatology and plastic surgery, general surgery, podiatry and otorhinolaryngology.
The LS-40 CO2 Laser System is a microprocessor- controlled CO2 laser system using a sealed CO2 laser tube providing 40 watts maximum power. The system incorporates a CO2 laser tube within the main cabinet, an articulated arm beam delivery system and attachable laser accessories. The unit is activated for laser emission by a footswitch.
The provided text describes a 510(k) summary for the LS-40 CO2 Laser System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical studies with specific performance metrics for acceptance criteria.
Therefore, most of the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment is not present in the provided document. The document primarily highlights the device's intended use and equivalence to a predicate device.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria or report specific device performance metrics in the way one would expect for a diagnostic or AI-driven device. Clinical performance is not detailed, as the submission relies on substantial equivalence.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
2. Sample size used for the test set and the data provenance
Not applicable. The document describes a laser system, not an AI or diagnostic device that would typically involve a "test set" in the context of clinical data. The performance evaluation is based on engineering and safety standards, and equivalence to a predicate device, not a data-driven test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth establishment with experts is not relevant for this type of device submission based on substantial equivalence to a predicate laser system.
4. Adjudication method for the test set
Not applicable. There is no test set or adjudication process 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 surgical system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
Not applicable. Clinical ground truth (pathology, expert consensus, outcomes data) is typically used for diagnostic devices. For a surgical laser, ground truth would relate to its physical properties, safety, and functionality, which are assessed through engineering tests and comparison to a predicate device.
8. The sample size for the training set
Not applicable. This device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI algorithm.
Conclusion from the provided information:
The LS-40 CO2 Laser System gained 510(k) clearance based on its substantial equivalence to the previously cleared LS-25 Family of CO2 Laser Systems (K040563). The submission primarily focuses on the device's technical specifications and intended use, demonstrating that it functions similarly and for the same indications as a legally marketed predicate device. This approach generally does not require new clinical studies demonstrating performance against specific acceptance criteria with clinical data, but rather relies on non-clinical performance data (e.g., electrical safety, electromagnetic compatibility, laser safety standards) and comparison to the predicate.
The "Performance Data: Results of Clinical Study:" section in the 510(k) summary (Attachment V) is empty, strongly suggesting that a clinical study with detailed performance metrics was not performed or was not necessary for clearance under the substantial equivalence pathway.
§ 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.