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The LED Light Source is used to illuminate the site of surgery during minimally invasive surgical procedures in arthroscopy (orthopedic surgery), laparoscopy (general and gynecological surgery) and in Endoscopy (general, gastroenterological and ENT surgery). The light is transmitted from the light source through a fiber optic cable and a scope.

LED Light Source (LLS-050 LED Illuminator)

The provided text is a 510(k) summary for the Sunoptic Technologies® LED Light Source (LLS-050 LED Illuminator). This document establishes the substantial equivalence of the LLS-050 to a legally marketed predicate device (Stryker L9000 LED Light Source, K082813).

The information requested pertains to the acceptance criteria and the study that proves a device meets those criteria. However, the provided 510(k) summary does not contain details of specific performance acceptance criteria or a study designed to directly prove the device meets these criteria in the context of clinical accuracy or diagnostic performance.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device by stating: "The technological differences between the LED Light Source (LLS-050) and the Styker LED Light Source (L9000) do not raise new questions of safety or effectiveness." It also mentions that the device will conform to voluntary safety and performance standards (UL60601-1, CAN/CSA C22.2 No.601.1 (SUP1+AM2), Medical EMC Stds. EN 60601-1-2).

Therefore, I cannot populate the requested table and sections with specific details about acceptance criteria, device performance metrics (like sensitivity, specificity, accuracy), sample sizes for test/training sets, expert qualifications, or ground truth methods, because such information is not present in the provided 510(k) summary. This type of detail is typically found in clinical study reports or validation documents, which are not part of this 510(k) summary.

Based on the provided document, here is what can be inferred or stated as "not applicable" given the nature of a substantial equivalence submission for an LED light source:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size (Test Set): Not applicable, as this is a substantial equivalence submission for a light source, not a diagnostic device requiring a clinical test set for performance metrics like sensitivity/specificity. The evaluation focuses on engineering and safety comparisons.
• Data Provenance: Not applicable for a clinical test set. The submission is based on engineering design, performance specifications, and safety standard adherence.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Number of Experts: Not applicable. Ground truth establishment for a diagnostic test is not relevant for an LED light source substantial equivalence submission.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There was no clinical test set requiring adjudication in this 510(k) summary.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? No. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, which is not the function of an LED light source.
• Effect size of human reader improvement: Not applicable.

6. Standalone (Algorithm Only) Performance Study

• Was a standalone study done? No. This device is a hardware component (light source), not an algorithm or AI system.

7. Type of Ground Truth Used

• Type of Ground Truth: Not applicable for a diagnostic or algorithmic "ground truth." The "truth" in this context revolves around engineering specifications, safety standards compliance, and functional performance as an illuminator, which are evaluated against a predicate device.

8. Sample Size for the Training Set

• Sample Size (Training Set): Not applicable. This device is not an AI/ML algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable.

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