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The Lumenis 1000 Integrated Slit Lamp laser delivery system is indicated for a variety of ophthalmic diagnostic and treatment uses including, but not limited to, the indications specified in the compatible laser's Operator Manuals. The Lumenis 1000 Integrated Slit Lamp may be used in the medical specialties or procedures that have been given market clearance by the Food and Drug Administration through the compatible laser systems. The Lumenis 1000 Integrated Slit Lamp is compatible with Lumenis lasers only.

The Lumenis 1000 Integrated Slit Lamp consists of an ophthalmic laser delivery system and an associated eye safety filter that has been integrated into a conventional slit lamp to provide the most efficient means to diagnose and treat ocular disease. The Lumenis 1000 Integrated Slit Lamp consists of: (1) a slit lamp with parallel binocular optics and fiveposition magnification, (2) SureSpot™ 1000 um laser delivery telescope, (3) laser aiming and treatment beam micromanipulator (4) an internal three-color ClearView™ laser eye safety filter, and (5) an electrically adjustable table with slit lamp power supply, elbow rest, laser mounting tray, and laser power outlets.

This 510(k) premarket notification for the "Lumenis 1000 Integrated Slit Lamp" does not contain information about specific acceptance criteria or a study designed to prove the device meets those criteria through performance metrics. Instead, it focuses on demonstrating substantial equivalence to predicate devices, which is a different regulatory pathway.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:
   The document does not specify any quantitative acceptance criteria or report specific performance metrics for the Lumenis 1000 Integrated Slit Lamp. The basis for substantial equivalence is "the same indications for use, similar technologies, and functional features" as the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance:
   No test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective) is mentioned, as a performance study demonstrating device efficacy or safety against specific criteria was not conducted for this 510(k). The regulatory submission relies on substantial equivalence.

3. Number of Experts Used to Establish Ground Truth and Qualifications:
   Not applicable. The submission does not involve a study with a test set requiring expert-established ground truth.

4. Adjudication Method:
   Not applicable. No expert adjudication process is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
   No MRMC comparative effectiveness study was performed. The document does not describe any human-in-the-loop performance evaluation or an assessment of how human readers improve with or without AI assistance, as the device is a laser delivery system integrated into a slit lamp, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance Study:
   No standalone performance study was conducted. The device is a physical medical instrument (laser delivery system) and not an algorithm or AI.

7. Type of Ground Truth Used:
   Not applicable. The submission does not refer to ground truth data as it's not a study evaluating diagnostic accuracy or a similar performance characteristic.

8. Sample Size for the Training Set:
   Not applicable. This device is a hardware product, not a machine learning model, so there is no concept of a "training set."

9. How Ground Truth for the Training Set Was Established:
   Not applicable, as there is no training set for this device.

Summary of the K052129 Submission:

The K052129 submission for the Lumenis 1000 Integrated Slit Lamp is a 510(k) substantial equivalence submission. This regulatory pathway does not typically require new clinical studies or detailed performance data against specific acceptance criteria if the device can be shown to be substantially equivalent to a legally marketed predicate device.

The rationale for substantial equivalence is based on the device sharing:

• "the same indications for use"
• "similar technologies"
• "functional features"

The document explicitly states: "There have been no significant changes or modifications from the predicate devices that affect the safety or effectiveness of the Lumenis 1000 Integrated Slit Lamp." This indicates that the safety and efficacy are largely presumed to be similar to the predicate devices (Lumenis (Coherent) LaserLink Z-1000 Slit Lamp Laser Delivery Adapter [K022181, K022327, K000498] and Lumenis (HGM) M140 Integrated Slit Lamp [K990174, K022327, K981952]).

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