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The Fibers are indicated for use in general surgical applications for incision, vaporization, ablation, hemostasis or coagulation of soft tissue. It is also indicated for use in open or closed endoscopic applications including excision,tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated.

The Adler MicroMed Laser Surgery Fibers have a wavelength range of 450 nm to 2100 nm, can be used in contact and non-contact mode and are indicated for use in general surgery, urology, gastroenterology, gynecology, gynecology, drmnology, vascular surgery, neurosurgery, plastic surgery, ENT and endovenous occlusion of the greater saphenous veni in the patient with superficial vein reflux and laser assisted lipolysis with a cleared compatible laser marketed for the mononed intended uses and using an SMA 905 connector.

The Adler MicroMed Laser Surgery Fibers are single use laser delivery devices provided sterile and intended for medical applications in various fields of laser surgerv.

The devices are based on a silica quartz glass core, have a length range of 6.5 feet (2 meters) to 9.8 feet (3 meters) and a wavelength range between 450 and 2100nm. The proximal end of the fibers is connected to a cleared laser system via an SMA 905 connector, while the distal end delivers the laser energy to the target tissue inn pulsed and continuous wave mode.

The distal end may have a rounded or conical silica cap, or non-capped tips, which may be flat, spherical, ball, conical or bended for the various intended uses and effects.

The Adler MicroMed Laser Surgery Fibers are medical devices designed for various surgical applications. The provided document, a 510(k) summary, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove a device meets specific acceptance criteria based on performance metrics such as accuracy or efficacy in diagnosing conditions.

Therefore, many of the requested details about acceptance criteria, test set characteristics, expert involvement, and statistical comparisons (like MRMC studies) are not applicable or extractable from this document. The document describes non-clinical performance data conducted to establish that the device is as safe and effective as a predicate device, which is a different type of evaluation.

Here's an attempt to answer the questions based on the provided text, indicating when information is not available:

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

The document does not specify quantitative acceptance criteria or reported device performance in the typical sense of a clinical study measuring diagnostic accuracy or treatment efficacy against a predefined benchmark. Instead, it lists non-clinical performance tests conducted to demonstrate equivalence to a predicate device. The "performance" here refers to meeting safety and functional requirements rather than medical outcome metrics.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The listed "performance tests" are non-clinical (e.g., lab tests for sterilization, packaging, shelf-life, biocompatibility, and functional aspects). No "test set" in the context of patient data for a clinical performance study is mentioned.

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. The document does not describe a clinical study where experts would establish ground truth for a test set.

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

Not applicable. No clinical test set or adjudication method is mentioned.

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 device is a laser surgery fiber, not an AI-assisted diagnostic tool. No MRMC comparative effectiveness study was performed or is relevant to this type of device based on the provided document.

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

Not applicable. This device is a laser surgery fiber and does not involve algorithms or human-in-the-loop performance in the context of diagnostic or interpretive tasks. The "functional" performance tests likely assessed the physical and operational characteristics of the fibers themselves.

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

Not applicable. The non-clinical performance tests for this device rely on established industry standards and methods for validating sterilization, packaging, shelf-life, biocompatibility, and functional energy transmission, rather than "ground truth" derived from patient outcomes or expert consensus in a clinical diagnostic setting.

8. The sample size for the training set

Not applicable. No training set is mentioned as this is not a machine learning or AI-based device.

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

Not applicable. There is no training set for this device.

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