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The intended use of the modified LX-20 is identical to that of the LX-20, namely the vaporization, incision, excision, ablation, or photocoagulation of soft tissue in the listed surgical specialties of:

• · Gynecology
• · Laparoscopic Surgery including GYN laparoscopy
• · Dermatology
• · Dental and oral surgery
• · Orthopedic
• · General Surgery
• · Otorhinolaryngology
• · Podiatry

No new indications were sought in the premarket notification and no clinical data were presented.

The Luxar modified LX-20 surgical laser system produces laser (infrared) energy at a wavelength of 10.6 microns which is directed to soft tissue through a knuckled beam delivery assembly, hollow fiber waveguides, handpieces, and sterile delivery tips.

This document describes a 510(k) summary for a modified CO2 surgical laser system (Luxar modified LX-20). The submission focuses on demonstrating substantial equivalence to a predicate device (Luxar LX-20 CO2 Surgical Laser System, K953074) and explicitly states that no new indications were sought and no clinical data were presented.

Therefore, there is no information available within this document to address the requested points about acceptance criteria and a study proving device performance as they would typically apply to a new or significantly modified device that requires clinical data. The submission relies solely on comparing technological characteristics to the predicate device to establish safety and effectiveness.

Here's how the provided information relates to your request:

1. A table of acceptance criteria and the reported device performance: This information is not present. The submission focuses on technological equivalence, not performance against specific acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as no clinical data or test set was used for performance evaluation.
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 test set requiring expert ground truth was utilized.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set requiring adjudication was utilized.
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 surgical laser device, not an AI or diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a surgical laser device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No clinical data or ground truth was established for this submission.
8. The sample size for the training set: Not applicable. No training set was used as no AI/machine learning component is described.
9. How the ground truth for the training set was established: Not applicable. No training set was used.

In summary, this 510(k) submission is for a modification to an existing device where the intended use, laser output characteristics, and core components are identical to the predicate. The changes are minor (addition of an accessory patterning handpiece, cabling, and control software/electronics) and are stated to "not raise any new issues of safety and effectiveness." Therefore, a detailed performance study with acceptance criteria, test sets, and expert evaluations was not deemed necessary and was not included in this summary.

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