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The 800 Series Surgical Laser System (KTP Upgrade) and Accessories is intended to be used for all currently cleared Laserscope indications. These indications include applications in the following specialities:

KTP/532 nm Applications: Dermatology. Gastroenterology, General Surgery, Gynecology, Head and Neck/Otorhinolaryngology (ENT), Neurosurgery, Ophthalmology, Spinal Surgery, Plastic Surgery, Thoracic Surgery and Urology.

Nd:YAG/1064 Applications: Dermatology, Gastroenterology, General Surgery, Genecology, Head and Neck/Otorhinolaryngology (ENT), Hemostasis During Surgery, Neurosurgery, Oculoplastics, Orthopedics, Plastic Surgery, Pulmonary Surgery, Thoracic Surgery, Urology.

The Laserscope 800 Series Surgical Laser System is currently available in 8 configurations, 7 which have a KTP laser emitting light at 532 nm. This is achieved by passing the infrared beam produced by the Nd: Y A G source through a second crystal made from potassium titanyl phosphate (KTP). The process that converts the infrared light to the visible green light requires two photons of infrared light to produce one photon of ereen light. This conversion process halves the wavelength, or doubles the frequency, so the wavelength of the KTP beam is exactly half that of the Nd: Y AG beam.

The Laserscope 800 Series Surgical Laser Sytem (KTP Upgrade) is achieved by an upgraded, higher quality q-switch and driver; increasing the power supply; adding a water to water heat exchanger and utilizing silicone based titanium dioxide lamp reflectors. Four new configurations are available:

Model 833, 2XP: 50 watts KTP/532, 100 watts Nd:YAG/1064, Dual Port
Model 834, 2XP: 50 watts KTP/532, 100 watts Nd:YAG/1064, Single Port
Model 843, 3XP: 60 watts KTP/532, 100 watts Nd: YAG/1064, Dual Port
Model 843, 3XP: 60 watts KTP/532, 100 watts Nd:YAG/1064, Single Port

The provided document is a 510(k) summary for a medical device called the "800 Series Surgical Laser System (KTP Upgrade) and Accessories." This document is a regulatory submission to the FDA for market clearance, not a study report. Therefore, it does not contain the detailed information typically found in a clinical study used to "prove" a device meets acceptance criteria.

Instead, the document asserts substantial equivalence to a predicate device, which is the primary mechanism for 510(k) clearance. This means the manufacturer is claiming the new device is as safe and effective as a device already legally marketed, rather than providing new clinical data to prove a specific set of performance criteria.

Therefore, many of the requested details related to clinical study design, sample sizes, ground truth establishment, and multi-reader studies are not available in this type of regulatory submission.

However, I can extract the relevant information implied by a 510(k) submission regarding acceptance criteria generally and the comparison with the predicate device.

Description of Acceptance Criteria and the "Study" (Substantial Equivalence Claim)

The "acceptance criteria" for a 510(k) upgraded device relying on substantial equivalence are primarily centered around demonstrating that the modified device performs as safely and effectively as, and does not raise new questions of safety or effectiveness compared to, the predicate device. This is achieved by showing comparable indications for use, materials, method of operation, physical construction, and performance.

The "study" that proves the device meets these acceptance criteria, in this context, is the Premarket Notification (510(k)) submission itself. It details the device's characteristics and compares them explicitly to a legally marketed predicate device to establish substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) on an upgrade to an existing system, the "acceptance criteria" are implied by the requirements for substantial equivalence. The "reported device performance" is the assertion of equivalence to the predicate.

The remainder of the requested information pertains to clinical study design, which is not provided in this 510(k) summary. These types of submissions typically leverage existing data and the established safety and efficacy of a predicate device, rather than generating new, extensive clinical evidence.

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 provided. A formal "test set" from a clinical study is not described. The submission relies on establishing equivalence to a predicate device, which implies that the predicate's performance history and existing data (which are not detailed here) serve as the basis.

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 provided. No specific "ground truth" establishment by experts for a test set is mentioned.

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

• Not Applicable / Not provided. No clinical test set requiring adjudication 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 device is a surgical laser 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 hardware surgical device, not a standalone algorithm.

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

• Not Applicable / Implied by Predicate Device: The "ground truth" for demonstrating safety and effectiveness of the upgraded device is the established safety and effectiveness of the predicate device for its approved indications for use. No new ground truth data type is specified for the upgrade.

8. The sample size for the training set

• Not Applicable / Not provided. No training set for an algorithm is described.

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

• Not Applicable / Not provided. No training set for an algorithm is described.

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