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The VIDA LED Surgical Lighting System, V series provide illumination for surgery or examination at operating room.

The VIDA LED Surgical Lighting System, V series provide illumination for surgery or examination at operating room.

VIDA LED Surgical Lighting System, V series uses high-efficacy light-emitting-diodes (LED) as light source which provides high brightness and no extra heat; the design of the optical mechanism gives a characteristic of less shadow which is significant to the surgeon during the operation. Given of its modular design, VIDA V provided many options for configurations and can be installed in an operating room with or without a laminar air flow system.

The features of VIDA LED Surgical Lighting System, V series are as followed:

• Prism-Based Light Delivery Technology: ConVida's patented optical system, that . combines an advanced refractive prism lens and innovative high-power LED technology, focuses light into an intense 110cm (43") focal cylinder, eliminating the need for refocusing when adjusting surgical table.
• . Consistent Illumination at Different Color Temperature Settings: VIDA V series lighthead's color temperature can be individually adjusted at any of the 5 settings (3500K, 4000K, 4250K, 4500K, 5000K) with a high CRI of 95, R9 94.
• . Optimal Brightness without Glare: Elegant, sophisticated optical system consists up to 2 types of high-power LEDs and multiple refractive prisms produces up to 160,000 lux of intensity without discomfort flare/glare.
• . VIDA V light gives the Surgeon Control: On the VIDA V, both lighthead focus and light intensity can easily be adjusted via turning the lighthead handle. They are also adjustable from the standard lighthead control or optional VIDA V Control Center on the wall.
• Long Lifetime: Under normal use, VIDA V LEDs enjoy an extremely long lifetime of . 50,000+ hours (70% lumen maintenance at 50,000 hours).
• . Two Types of Ambient Lights (Option): 5% central luminance (GUIDE lighting mode) c be configured through standard lighthead control. Guide lighting mode may ambient lighting for manipulating endoscopy instruments or lighting diagnos procedures. Green ambient light sheds low-level green light from the suspension hub
• Camera-Ready Lighthead is Built into the System: All VIDA V lightheads are pre-wired . with HD cabling for taking an optional HD 1080p Camera Handle. The HD 1080p Camera Handle is removable from one VIDA V lighthead to another providing superb flexibility for recording.
• Exceptional Maneuvering Flexibility: The exceptionally durable non-sterile handles allow easy positioning of all our lightheads. Each lighthead rotates a full 360°so that the system can be quickly and easily positioned for any surgical procedure. Individual lightheads can be lower to 810mm above the floor providing excellent low lateral illumination.
• . Sleek Non-Sterile Handle: The lighthead has is molded with a sleek all-around handle that facilitates easy repositioning and adds modern elegance to O.R. setting
• Easy-to-clean Compact Lighthead: Made of tough molded materials, the VIDA V series . lightheads are completely sealed which helps prevent biocontaminants from entering the operative site and lighthead itself, and facilitates cleaning.
• . HD Supported Suspensions: All VIDA V suspensions are prewired with video cables to deliver information users need within and without the surgical field. Images are in crisp and accurate HD format with no signal conversion necessary and no loss of video quality.
• Heavy Duty HD Flat Monitor Suspension: Flat Monitor Suspension Arms support single/dual monitors up to a total of 24 kg (53 lbs), making them ideal for surgical displays up to 32". Large display compatibility allows the surgical team to see more of the procedural area. Optional Medical Grade LCD Displays from SONY also offer uncompressed HD video at 1080p which shows true images from SD- and HD-endoscopes, ultrasound, C-arms and other equipment.
• Optimal HD Connectivity: The built-in fiber optic cable allows the suspension to support monitors featuring Full HD 1920 x 1080 video signals.
• . Low Profile Suspension: Low-profile cardinal lighthead suspension is offered for rooms with ceiling lower than 280mm.
• . Failsafe Design: The unit is protected against an electrical power failure, thus ensuring that all surgical procedures can continue without interruption.

The provided document is a 510(k) summary for the "VIDA LED Surgical Lighting System, V series." This product is a surgical lamp and, as such, is not a medical device that utilizes artificial intelligence or machine learning. Therefore, many of the requested categories related to AI development and validation, such as "Sample sized used for the test set," "Number of experts used to establish the ground truth," "Adjudication method," "MRMC comparative effectiveness study," "standalone performance," "sample size for the training set," and "how the ground truth for the training set was established," are not applicable.

The submission is for a Traditional 510(k) for a Class II medical device (Product Code FSY - Light, Surgical, Ceiling Mounted). The manufacturer, ConVida Healthcare & Systems Corporation, is seeking substantial equivalence to its predicate device, the VIDA LED Surgical Lighting System-X series (K132307).

1. Table of acceptance criteria and the reported device performance:

The document describes the device's performance characteristics through "Performance Summary" and a comparative table with the predicate device. The acceptance criteria essentially align with compliance to relevant IEC and ISO standards and demonstrating substantial equivalence to the predicate device in terms of performance specifications.

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

This information is not applicable to this type of device and submission. The testing conducted was bench testing as per IEC and ISO standards for medical electrical equipment, not clinical or image-based studies with test sets or specific data provenance in that context.

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. Ground truth as typically defined for AI/ML models (e.g., expert consensus on medical images) is not relevant for the performance evaluation of a surgical lighting system. Device performance was assessed against engineering and electrical safety standards.

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

Not applicable. Adjudication methods are typically used for disagreements among human readers/experts, which is not relevant for the bench testing of a surgical lighting system.

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. The device is a surgical lighting system, not an AI-assisted diagnostic or clinical decision support tool.

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

Not applicable. This device does not involve an algorithm.

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

Not applicable. The "ground truth" for this device's performance is defined by compliance with established international standards for medical electrical equipment, particularly IEC 60601-1, IEC 60601-2-41, and IEC 60601-1-2. These standards specify physical, electrical, and optical performance requirements for surgical luminaires.

8. The sample size for the training set

Not applicable. There is no training set for this type of device.

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

Not applicable. There is no training set for this type of device.

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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.

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