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The ECHOLASER X4 laser system is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, orthopedics, pulmonology, radiology, and urology, at a wavelength of 1064nm.

The ECHOLASER X4 is a medical device equipped with a diode laser source emitting at 1064nm wavelength in CW mode. The laser beam is transmitted via optical fibers . The operator can use 1 to 4 (or 1 to 2 in case of two channels model) fibers simultaneously, one independent from the other in both activation and power adjustment. Laser activation is controlled by footswitch.

This document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The document is a 510(k) premarket notification from the FDA for the ECHOLASER X4, which is a laser surgical instrument. It details the device's indications for use, its substantial equivalence to a predicate device (K181510), and the fact that the requested change is solely a language revision of the intended use, supported by a reference predicate (K181859).

Since the submission states that no other changes have been made to the existing ECHOLASER X4 and that the technical features, design, performance, and safety are unaffected, no new non-clinical or clinical testing was performed to demonstrate performance against acceptance criteria. The submission relies on the prior clearance of the predicate device.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, or details about studies, sample sizes, ground truth, experts, or adjudication methods, as this information is not present in the provided text.

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The ECHOLASER X4 laser system is intended for use in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, bronchoscopes, gastroscopes, cystoscopes and colonoscopies), in incision/excision, ablation and coagulation of soft tissue in contact and non-contact open surgery (with or without a handpiece), and in the treatment and/or removal of vascular lesions (tumors).

The ECHOLASER X4 is a medical device equipped with a diode laser source emitting at 1064nm wavelength in CW mode. The laser beam is transmitted via 1 to 4 optical fibres. The operator can use 1 to 4 fibres simultaneously, one independent from the other in both activation and power adjustment. Laser activation is controlled by footswitch.

The provided text describes a medical laser system, the ECHOLASER X4, and its substantial equivalence to a predicate device for the purpose of FDA 510(k) clearance. However, it does not include information about acceptance criteria or a study proving the device meets specific performance criteria in terms of clinical or algorithmic efficacy.

The document focuses on regulatory compliance and comparison with a predicate device (DORNIER MEDILAS D 1064 laser system) based on technical specifications and intended use.

Therefore, most of the requested information cannot be extracted from this document, as it pertains to clinical or algorithmic performance, which is not detailed here.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance:

• Cannot be fully provided. The document lists technical specifications of the device and compares them to a predicate device. It doesn't define explicit "acceptance criteria" in terms of clinical performance metrics (e.g., accuracy, sensitivity, specificity for a diagnostic device, or a specific outcome measure for a therapeutic device) or detailed "reported device performance" against such criteria. The performance shown is primarily technical parameters.

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 / Not mentioned. The document explicitly states "Clinical Performance Data: None" and "Non-Clinical Performance Data" only refers to conformance with electrical and laser safety standards. There was no clinical test set or data provenance mentioned 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 / Not mentioned. No clinical test set or ground truth establishment is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable / Not mentioned. No clinical test set or adjudication method 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 document describes a laser surgical instrument, not an AI-assisted diagnostic or therapeutic device that would involve human readers. No MRMC study was performed or mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is a hardware device (laser system), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not applicable / Not mentioned. No clinical ground truth was established as no clinical performance study was conducted or reported here.

8. The sample size for the training set:

• Not applicable / Not mentioned. No training set for an algorithm is relevant to this device description.

9. How the ground truth for the training set was established:

• Not applicable / Not mentioned. No training set or ground truth establishment is relevant to this device description.

In summary, the provided FDA document for the ECHOLASER X4 focuses solely on demonstrating substantial equivalence to a predicate device based on technical specifications and intended use, and conformance to electrical and laser safety standards. It does not contain information about clinical performance studies, test sets, ground truth, or expert involvement, as these were not required for this type of 510(k) submission based on the presented information.

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