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VIDA LED Surgical Lighting System - X series provide illumination for surgery or examination at operating room.

The VIDA LED Surgical Lighting System-X series provide illumination for surgery or examination at operating room. The VIDA LED Surgical Lighting System-X series (VIDA X) use high-efficacy light-emitting diodes (LED) for surgical operations and diagnostic purposes. LEDs provide bright and shadow reduced light. Thanks to its modular design. VIDA X also offers many options for configurations and can be installed in operating rooms with or without laminar air flow systems. A lighthead to the main spindle can be rotated horizontally with 360°. the spring arms can be rotated horizontally with 360° and moved vertically with 45° downwards and 30° upwards. The VIDA LED Surgical Lighting System-X series consists of Mounting Module, Horizontal Arm module, Suspension Device Module, sterile handle cover and Optional Accessories.

The provided document describes a 510(k) submission for the "VIDA LED Surgical Lighting System-X series," a surgical lamp. The submission focuses on demonstrating substantial equivalence to a predicate device, the "Mach LED SC," rather than presenting a study where acceptance criteria are directly defined and proven for the device's performance in a clinical setting.

Therefore, the document does not contain information for many of the requested categories because it's a regulatory submission based on substantial equivalence to an existing device, not a de novo clinical trial proving novel performance against predefined acceptance criteria.

Here's an attempt to extract relevant information and explain why other information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

For this specific device (a surgical lighting system), "acceptance criteria" are primarily established by conformity to recognized medical device standards and demonstrating performance comparable to a predicate device, rather than patient-centric clinical outcomes. The performance metrics are generally technical specifications.

Note: The document compares two models for the subject device (X70 and X50) and two for the predicate (5sc and 3sc). For the table above, the most comparable models have been selected to illustrate the comparison. The differences in specific values between the subject and predicate devices are noted in the original document but are deemed not to raise new issues of safety or effectiveness.

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

This information is not provided in the document. The submission relies on "bench testing" and compliance with standards rather than human clinical test sets in the traditional sense for evaluating diagnostic or therapeutic accuracy.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided and is not applicable to this type of device submission. There is no "ground truth" to establish through expert consensus for a surgical lamp in the way there would be for a diagnostic AI device.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size.

No, a MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret medical images with or without AI assistance. A surgical lighting system does not fit this category.

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

No, this study type is not applicable. The device is a physical surgical lighting system, not an algorithm.

7. The Type of Ground Truth Used

This information is not provided and is not applicable in the typical sense. For this device, "ground truth" is effectively defined by the performance specifications outlined in recognized standards (e.g., IEC 60601-2-41 for surgical luminaires) and the demonstrated performance of the legally marketed predicate device. The "study" proving the device meets the criteria is the comparison to these standards and the predicate.

8. The Sample Size for the Training Set

This information is not provided and is not applicable. The device is a physical product, not a machine learning algorithm that requires a training set.

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

This information is not provided and is not applicable.

Summary of the "Study" Proving Acceptance Criteria:

The "study" proving the device meets acceptance criteria, as presented in this 510(k) submission, is fundamentally a non-clinical performance testing and substantial equivalence comparison.

• Acceptance Criteria Basis: The implicit acceptance criteria are derived from:
  • Compliance with international standards for medical electrical equipment (IEC 60601-1, IEC 60601-2-41, IEC 60601-1-2, IEC 62304, ISO 14971, ISO 15223-1, ISO 17664).
  • Demonstrating technical performance specifications that are comparable to (or in some cases, exceed) those of the legally marketed predicate device (Mach LED SC).
  • The predicate device itself serving as a benchmark for what constitutes a safe and effective surgical lamp.
• Proving Acceptance: The document states:
  • "Performance testings were conducted to verify that the VIDA LED Surgical Lighting System-X series meet the requirements for Medical Electrical Equipment as defined in IEC 60601-1, IEC 60601-2-42, and IEC 60601-1-2." (Section 5.12)
  • "The result of bench testing indicates that the new device is as safe and effective as the predicate device." (Section 5.10)
  • The detailed comparison table (Section 5.11) highlights the similarities and differences, concluding that "Any difference that exists between the Mach LED SC and the predicate device has no negative effect on safety or effectiveness and actually enhances the usefulness in the chosen application."
  • "No clinical testing is required for this device classification submission." (Section 5.13)
  • The ultimate conclusion is substantial equivalence to the predicate, meaning it is considered as safe and effective as the already marketed device.

In essence, the "study" is a collection of engineering tests and a comparison of specifications to established benchmarks and a predicate device, rather than a clinical trial with patient data.

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