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The Lasemar 800, Lasemar 1000, Lasemar 1500 (and the fiber delivery systems and accessories used to deliver laser energy), are indicated for :surgical applications requiring the vaporization, incision, excition, cutting and hemostation, cutting and hemostasis, or specialistion of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracio Surgery, Plastic Surgery and Dermatology, Aesthetics including vascular lesions and hair removal, General Surgery, Ophthalmology, Orthopedias, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Spinel Radiology, Endovascular coagulation, Oral Surgery, Dental procedures and Laser Assisted Linolysis Assisted Lipolysis.

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The provided document is a 510(k) clearance letter from the FDA for the Lasemar 800, 1000, and 1500 devices. This type of document does not typically contain the detailed information about acceptance criteria and specific studies that would be necessary to answer your request fully.

510(k) clearance is based on demonstrating substantial equivalence to a legally marketed predicate device, not necessarily on meeting quantitative performance acceptance criteria in the same way a PMA (Premarket Approval) would require. The letter confirms the device's substantial equivalence for its stated "Indications for Use," which are listed.

Therefore, I cannot extract the requested information from this document. To answer your questions, you would typically need to refer to the original 510(k) submission summary or a separate clinical/performance study report for the device, which is not provided here.

However, based on the information not present in the document, I can state the following:

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

• Not available in the provided document. The document does not specify quantitative acceptance criteria or detailed performance metrics.

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

• Not available in the provided document. No details about a specific test set, its size, or provenance are 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 available in the provided document. No information on ground truth establishment or experts is provided.

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

• Not available in the provided document. No 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 available in the provided document. This document pre-dates widespread AI integration in such devices and focuses on laser surgical technology. No MRMC study details or AI assistance are mentioned.

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

• Not available in the provided document. This device is a laser surgical instrument operated by a human, not an algorithm, so "standalone performance" in the AI sense is not applicable.

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

• Not available in the provided document. Ground truth for any performance studies is not mentioned.

8. The sample size for the training set:

• Not available in the provided document. No training set for an algorithm is mentioned as this is a physical device, not an AI/algorithm-driven one.

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

• Not available in the provided document. Not applicable for this type of device and submission.

The document primarily states the device's "Indications for Use" and confirms its substantial equivalence to predicate devices for these applications, which involve "surgical applications requiring the vaporization, incision, excition, cutting and hemostasis, or coagulation of soft tissue" across various medical specialties. The FDA's decision is based on comparing the device's technical characteristics and intended use to existing legally marketed devices, rather than on detailed performance metrics against specific acceptance criteria presented in this specific letter.

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