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The Leo Minor is intended to provide visible illumination of the surgical field and the patient during surgical and non surgical procedures.

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I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets any specific criteria.

The document is a 510(k) clearance letter from the FDA for a surgical lamp called "Leo Minor." It confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls. The letter also includes the "Indications for Use" for the device, stating it is "intended to provide visible illumination of the surgical field and the patient during surgical and non-surgical procedures."

This type of document does not typically include detailed performance data, acceptance criteria, or study results. This information would usually be found in a separate submission document or a scientific publication.

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The Claveguard Freedom Surgical Light is designed to illuminate the surgical site in Operating theatres

The ClaveGuard Freedom surgical lights are suitable for all types of surgical procedures in operating rooms. The light is based on Light Emitting Diodes (LEDs) in combination with adaptive focus and shadow free illumination. It operates at a distance of 70-140cm from the surgical site. A light system may consist of 1 to 3 light heads supported by pivoting suspension system that is mounted to Healthcare facility's ceiling. The system may include optional monitor extension arms, monitor mounts, and in-light video camera.

This document describes the ClaveGuard Freedom Surgical Light, a surgical lamp designed to illuminate surgical sites. The information provided is for regulatory clearance (510(k)) and focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive study for establishing acceptance criteria for a new AI/ML device.

However, based on the provided text, we can infer the "acceptance criteria" relate to performance specifications defined by recognized international standards, and the "study" is the nonclinical testing conducted in accordance with those standards.

Here's an attempt to structure the information as requested, understanding that the context is a medical device for illumination, not an AI/ML diagnostic tool:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a number of devices. The "test set" refers to the ClaveGuard Freedom Surgical Light device itself, which was subjected to a series of nonclinical tests to assess its compliance with international standards. It's implied that a representative sample of the device, or the device itself, underwent these tests.
• Data Provenance: The testing was conducted in accordance with international standards (IEC standards). The location of testing is not specified, but the manufacturer is ClaveGuard Pty Ltd, based in Australia. The document does not specify "retrospective or prospective" as this type of testing is typically prospective, involving specific performance measurements on the device.

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

This section is not applicable in the context of this document. The "ground truth" for a surgical light's performance is established by objective measurements against engineering and safety standards (e.g., light intensity, color rendering, shadow reduction, electrical safety, EMC). These are typically performed by accredited test laboratories and engineers, not by medical experts in the way ground truth is established for AI/ML diagnostic studies.

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human reviewers (e.g., radiologists) in AI/ML performance studies. Here, compliance is determined by objective measurements against predefined standard requirements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. The ClaveGuard Freedom Surgical Light is an illumination device, not a diagnostic tool requiring interpretation by human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone (algorithm only) performance study was not done. This concept is specific to AI/ML algorithms. The ClaveGuard Freedom Surgical Light is a physical medical device, and its performance is evaluated through direct physical and electrical testing.

7. The Type of Ground Truth Used

The "ground truth" for the ClaveGuard Freedom Surgical Light's performance is based on objective measurements and validation against recognized international performance, safety, and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-2-41, IEC 60601-1-2, IEC 60601-1-4) and the product's own design specifications.

8. The Sample Size for the Training Set

This section is not applicable. The device is an electro-mechanical surgical light, not an AI/ML system that requires a "training set."

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

This section is not applicable for the same reason as point 8.

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The MI-750 is a fixed pattern / three level intensity procedural/minor surgical light designed to provide visible illumination of the surgical field and the patient during minor surgical and non-surgical procedures.

The proposed MI-750 is a first generation fix pattern / three level intensity procedural/minor surgical light designed to provide visible illumination of the surgical field and the patient during minor surgical and non-surgical procedures.

This document is a 510(k) summary for the Medical Illumination International MI-750 Minor Surgical Light. It contains information related to the regulation, intended use, and substantial equivalence to predicate devices, but it does not contain a study that proves the device meets specific acceptance criteria in the context of diagnostic or AI performance.

Instead, the "Performance Testing" section states: "Performance testing was conducted to verify that the MI-750 meets the requirements for Medical Electrical Equipment as defined in CEI / IEC 60601-1 and IEC 60601-2-41." These are general safety and performance standards for medical electrical equipment and surgical luminaires, not performance metrics like sensitivity, specificity, or reader improvement typically seen in studies for AI/diagnostic devices.

Therefore, many of the requested points in the prompt (e.g., sample size for test set, number of experts, MRMC study, standalone performance) are not applicable or cannot be answered from the provided text, as this document is not reporting on such a study.

However, I can extract the relevant information about the acceptance criteria and how "performance" was assessed based on the provided text.

1. A table of acceptance criteria and the reported device performance

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 provided in the document. The performance testing refers to compliance with safety standards for medical electrical equipment, not a study involving human subjects or data sets in the typical sense of AI/diagnostic device evaluation.

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)

This information is not provided as the document describes a safety and performance compliance testing for a medical light, not a study evaluating human interpretation or diagnostic accuracy where expert ground truth would be established.

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

This information is not provided as it's not relevant to the type of compliance testing 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

No, an MRMC comparative effectiveness study was not done as this device is a surgical light, not an AI or diagnostic tool designed to assist human readers.

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

This is not applicable. The device is a surgical light, not an algorithm.

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

This is not applicable. The "ground truth" for compliance testing of a surgical light would be the specifications and requirements outlined in the CEI/IEC 60601 standards.

8. The sample size for the training set

This is not applicable. The device is a surgical light, not an AI model requiring a training set.

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

This is not applicable. The device is a surgical light, not an AI model.

In summary, the provided document is a 510(k) premarket notification for a medical device (a surgical light). The "study" mentioned refers to performance testing against established international electrical safety and performance standards (CEI/IEC 60601-1 and IEC 60601-2-41) for medical electrical equipment, rather than a clinical trial or AI performance study typically associated with the detailed criteria requested in your prompt.

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The Shadowless Operation Light ZF 720 is intended to be used to provide visible illumination of the surgical area or the patient with high intensity and shadow free light during surgical procedures.

The Surgical Light ZF 720 is applicable for Open surgery, Endoscope surgery or other surgical procedures. With ceiling, wall and floor versions, the Surgical Light ZF 720 Systems are well-suited for various operating rooms. The device can be adjusted the color temperature, light intensity and light focus in accordance with the different visual habit by the users. And it is workable to connect to the monitor, video or other expansion devices with the requirements of the surgical environment. The Surgical Light ZF 720 consists of base assembly, pendent system and light head assembly integrated into one system. The Surgical Light ZF 720 provides optimum shadow resolution and ease of maneuverability. And the extension arm on the central block possesses the movement mechanism which enables the light heads swivel in all directions. With ceiling, wall and floor versions, the Surgical Light ZF 720 is well-suited for various operating rooms. It is also available in single, dual and triple configurations in compliance with users' requirements. The software is equipped in the device. Dispense with training before using the device.

The provided text describes a 510(k) premarket notification for a surgical light, the Umbel Corporation ZF 720. However, the details regarding clinical study design, specific acceptance criteria for performance metrics (e.g., lux levels, color temperature, shadow resolution), sample sizes for test and training sets, expert composition, adjudication methods, MRMC studies, or the method of ground truth establishment are not present in the provided document.

Instead, the performance data section states:

• "The Hazard Analysis of the device is in accordance with ISO 14971 Medical Application of Risk Management to Medical Devices."
• "The performance of product has been tested and verified by users."
• "Performance testing was conducted to verify the Surgical Light ZF 720 meets the requirements for Medical Electrical Equipment as defined in IEC 60601-1 and IEC 60601-2-41."

This indicates that the device's performance was evaluated against engineering and safety standards (IEC 60601-1 and IEC 60601-2-41), and general user verification, rather than detailed clinical performance metrics derived from a study involving image analysis, AI assistance, or human reader performance. The device is a surgical lamp, not an AI/imaging diagnostic device, so the typical criteria associated with AI algorithms (e.g., sensitivity, specificity, AUC, human reader improvement with AI) are not applicable or expected for this type of submission.

Therefore, I will present what acceptance criteria and performance are stated or implied in the provided text, along with the limitations of the information for the questions asked.

Acceptance Criteria and Device Performance for Umbel Corporation ZF 720 Surgical Light

The provided documentation details the regulatory submission for a surgical light (ZF 720), which is a medical device for illumination during surgery. The performance evaluation for such a device typically focuses on meeting established electrical, safety, and functional standards, rather than diagnostic accuracy or human interpretation metrics common for AI-driven imaging devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Information Not Provided: The document does not specify test set sample sizes for any performance evaluations (e.g., number of units tested, number of users involved in verification).
• Data Provenance: Not explicitly stated, but the submission is from a US-based company (Umbel Corporation, Diamond Bar, CA), suggesting testing was likely conducted in a relevant controlled environment or lab setting conforming to international standards. The nature of the device (surgical lamp) means "retrospective or prospective" data is not applicable in the typical clinical study sense.

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

• Information Not Provided: This question is more relevant to diagnostic devices where expert consensus forms ground truth. For a surgical light, "ground truth" is measured against engineering specifications (e.g., lux meters, colorimeters) and user feedback on functional aspects rather than "expert interpretation of images." The "users" who verified performance are not detailed in terms of number or specific qualifications.

4. Adjudication Method for the Test Set

• Information Not Provided/Not Applicable: Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies with multiple readers interpreting data where discrepancies need resolution to establish ground truth. This concept does not apply to the performance testing of a surgical light against technical standards or general user verification.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, not applicable: An MRMC study is designed to assess the performance of diagnostic imaging (or AI-assisted diagnostic) systems by comparing the accuracy of multiple human readers across multiple cases, often with and without AI assistance. The ZF 720 is a surgical illumination device, not a diagnostic imaging or AI system. Therefore, an MRMC study was not conducted nor would it be relevant for its intended use and regulatory pathway. The concept of "human readers improving with AI vs. without AI assistance" does not apply here.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No, not applicable: Similar to the MRMC study, this concept relates to the performance of artificial intelligence algorithms in a standalone diagnostic capacity. The ZF 720 is a physical surgical light, not an algorithm. Its performance is inherent to its physical design and measured through engineering standards and user feedback.

7. The Type of Ground Truth Used

• Engineering Standards and User Verification: The "ground truth" for the ZF 720's performance is established by:
  • Compliance with IEC 60601-1 (General requirements for basic safety and essential performance of medical electrical equipment)
  • Compliance with IEC 60601-2-41 (Particular requirements for basic safety and essential performance of surgical luminaires and luminaires for diagnosis)
  • User verification of functional aspects like "high intensity and shadow free light."

8. The Sample Size for the Training Set

• Not Applicable: "Training set" refers to data used to train machine learning models. As the ZF 720 is a physical device and not an AI algorithm, there is no "training set" in this context. The design and development process for a physical device involves engineering design, prototyping, and testing, not data-driven model training.

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

• Not Applicable: Since there is no training set for this type of device, the concept of establishing ground truth for it does not apply.

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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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The surgical light Mach LED 2SC is intended to illuminate the surgical field and the patient.

The surgical light Mach LED 2SC is intended to illuminate the surgical field and the patient.

The Mach LED 2SC consists of lamp housing, LED modules, optical -/electrical and mechanical components, one sterilizable handle sleeve as well as the cables.

One LED-module consists of one white LED.

The light system can be added to the ceiling mounted suspension system supporting the horizontal arms and spring arms. The horizontal arms can be rotated horizontally with 360°, the spring arms can be rotated horizontally with 360° and moved vertically with 50° downwards and 45° upwards.

The light system is operated by a kevpad on the lamp head or, by special request of the customer, by a keypad on the wall.

The surgical light Mach LED 2SC will be marketed with merging of light fields and light intensity control. Color temperature adjustment will not be available.

Available accessories for the Mach LED 2SC lighting systems are as follows:

• Camera module .
• Remote control of camera module .
• Remote control with network interface for camera module .
• Single monitor yoke for flat panel monitors .
• Double monitor yoke for flat panel monitors .
• Instrument trays .
• Trays for CRT monitors
• 24V DC battery backup support .
• . Low profile wall control unit
• Integrated laser pointer .
• Sterilizable handle sleeves

The provided document is a 510(k) summary for the Mach LED 2SC surgical lamp, which is a medical device for illuminating surgical fields. The information requested in the prompt is typically found in studies specifically designed to validate the performance of AI/ML or diagnostic devices against certain criteria. This document, however, focuses on demonstrating substantial equivalence to a predicate device for regulatory approval, rather than detailing the design and results of such performance validation studies.

Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not available in this specific regulatory submission for a surgical lamp.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

The document speaks to "performance testing" to meet requirements for "Medical Electrical Equipment as defined in the relevant standards for Medical electrical equipment and the EN 61000 group." However, specific acceptance criteria and detailed reported device performance in a tabular format are not explicitly provided in this summary. The comparison table focuses on technological characteristics rather than performance metrics against acceptance criteria.

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 provided. The document mentions "performance testing" but does not detail the sample sizes or data provenance for such tests. This is a physical device, not an AI/diagnostic software, so the concept of "data provenance" in the context of image data or patient records is not directly relevant here. The manufacturing location is Ebersberg, Germany.

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)

This information is not applicable/not provided. The device is a surgical lamp, which does not require "ground truth" established by experts in the way an AI diagnostic tool would. Performance is typically measured using physical instruments and standardized testing procedures.

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

This information is not applicable/not provided. Adjudication methods are relevant for subjective assessments or disagreement resolution in diagnostic studies, which is not the case for a surgical lamp's technical performance.

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

This information is not applicable/not provided. MRMC studies are specific to diagnostic tools, especially those involving human interpretation (e.g., radiologists interpreting images). This device is a surgical lamp and does not involve "human readers" in a diagnostic context or AI assistance.

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

This information is not applicable/not provided. This device is a physical surgical lamp, not an algorithm, so the concept of "standalone performance" in this context is irrelevant.

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

This information is not applicable/not provided. Ground truth, as typically understood in AI/diagnostic studies, is not relevant for the performance testing of a surgical lamp. Its performance is measured against technical specifications and safety standards.

8. The sample size for the training set

This information is not applicable/not provided. This device is a physical product and does not involve a "training set" in the context of machine learning or AI.

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

This information is not applicable/not provided. As above, there is no "training set" for this physical device.

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The surgical light Mach LED 2MC is intended to illuminate the on the patient's body with a high intensity, shadow-free and "cold" light.
The Mach LED 2MC lighting system is designed for illuminating an examination area and surgical field at the hospital and doctor's practice.

The surgical light Mach LED 2MC is intended to illuminate the operation site on the patient's body with a high intensity, shadow free and "cold" light.
The Mach LED 2MC consists of lamp housing, LED modules, optical, electrical and mechanical components, one sterilizable handle sleeve as well as the cables.
One LED-module consists of 4 different-colored LEDs: warm white, cold white, green and red. The four different colors are merged inside the lamp head by a computercalculated optical system with light guide and facetted lenses.
The light system can be added to the ceiling mounted suspension system supporting the horizontal arms and spring arms. The horizontal arms can be rotated horizontally with 360°, the spring arms can be rotated horizontally with 360° and moved vertically with 50° downwards and 45° upwards.
The light system is operated by a keypad on the lamp head or, by special request of the customer, by a keypad on the wall.
The surgical light Mach LED 2MC will be marketed with merging of light fields, light intensity control, color temperature adjustment and integrated laser pointer.

The provided text is a 510(k) summary for the Mach LED 2MC surgical lamp. It does not contain information about acceptance criteria, device performance, or study results in the format requested. The document primarily focuses on establishing substantial equivalence to a predicate device based on technological characteristics and non-clinical data. It explicitly states that "No clinical data is required for this device classification submission."

Therefore, I cannot provide the requested information from the given text.

Here's why each point cannot be fulfilled:

1. A table of acceptance criteria and the reported device performance: The document only lists "Technical Parameter" for the new device and predicate devices (Number of LEDs, which is a design characteristic, not a performance metric like illuminance or color temperature), and states that "Performance testing was conducted to verify that Mach LED 2MC meet the requirements for Medical Electrical Equipment as defined in the relevant standards for Medical electrical equipment and the EN 61000 group." However, it does not provide the specific acceptance criteria or the actual performance results in a table.
2. Sample sized used for the test set and the data provenance: No specific test set or data provenance is mentioned beyond general performance testing against standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment by experts is not applicable as no clinical or interpretative study is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable; no such study 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 lamp, 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 device is a physical surgical lamp, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable; no clinical study or ground truth for diagnostic purposes is mentioned.
8. The sample size for the training set: Not applicable; there is no AI or machine learning component mentioned that would require a training set.
9. How the ground truth for the training set was established: Not applicable for the same reason as above.

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The Visum Blade LED Surgical Light is intended to illuminate the operative site during surgical procedures with high intensity light.

The Visum Blade LED Surgical Light System is indicated to be used with various mounting configurations in operating rooms, examination rooms, emergency rooms, and all other health care facilities where the need for additional illumination exists.

The Visum Blade LED Surgical Light System (Blade) is suitable for all major and minor surgical procedures in operating rooms and all other healthcare facilities where the need for illumination exists. The light intensity is variable up to 160,000 Lux. The light quality is based upon high quality LED's to provide cool light with reduced shadow resolution.

A system consists of 1 - 4 light heads supported by a pivoting suspension system that is attached to the heath care facility's super structure by a mounting plate. The system requires at least one of the following: a power supply box, ceiling cover, drop tube, central axis and spring arm. The system may include optional end effectors such as but not limited to monitor mounts. The mounting plates may be configured to accommodate a single or tandem mount suspension system.

Independent, control of each light's intensity is via the light handle. An optional electronic wall control panel may be installed in the operating room for control by non-sterile users. Blade allows for an in-light camera option that may be added to a light head. This option requires a wall control for camera operation.

Based on the provided text, the "Visum Blade LED Surgical Light System" is a medical device, and the document describes its 510(k) submission. This is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device, rather than a study proving the device meets clinical acceptance criteria with specific performance metrics like sensitivity or specificity.

Therefore, the requested information regarding acceptance criteria for device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types and training set details cannot be fully extracted as such studies are not typically part of a 510(k) summary for this type of device. The focus here is on demonstrating substantial equivalence to existing devices, primarily through technological comparison and bench testing that shows no new questions of safety or effectiveness.

Here's a breakdown of what can be inferred or directly stated from the provided text, in relation to your request, with the understanding that typical AI/ML-related performance metrics are not applicable here:

1. A table of acceptance criteria and the reported device performance

For a surgical light system, "performance" relates to its physical characteristics and operational safety, not diagnostic accuracy. The document states:

2. Sample size used for the test set and the data provenance

• Not applicable (N/A): This is a hardware device (surgical light), not one that processes data or requires a test set in the traditional sense of AI/ML or diagnostic devices. Performance is assessed through engineering specifications, bench testing, and comparison to predicate devices, not through a "test set" of clinical cases or data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable (N/A): See point 2. There is no "ground truth" in the diagnostic sense for a surgical light system. The device's functionality is verified against engineering standards and comparison to similar devices.

4. Adjudication method for the test set

• Not applicable (N/A): See point 2.

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 (N/A): This is not an AI-assisted diagnostic device. It's a surgical light system.

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

• Not applicable (N/A): This is a hardware device; there is no "algorithm only" performance.

7. The type of ground truth used

• Not applicable (N/A): For this type of device, "ground truth" would relate to validated engineering specifications, safety standards, and the performance characteristics of its predicate devices, rather than clinical outcomes or pathological findings.

8. The sample size for the training set

• Not applicable (N/A): This device does not use an AI/ML model that requires a training set.

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

• Not applicable (N/A): This device does not use an AI/ML model that requires a training set or associated ground truth.

Summary from the provided text for a 510(k) submission:

The "study" or assessment for the Visum Blade LED Surgical Light System is a substantial equivalence demonstration to predicate devices (Burton's AIM 200 OR Major Surgical Light and Stryker's Visum LED Surgical Light System).

• Methodology: The substantial equivalence was established through:
  • Technological Comparison: Comparing intended use, design, energy used/delivered, materials, performance, safety, effectiveness, and labeling to the predicate devices.
  • Bench Testing: As indicated by "Performance Testing: See Section 18, Performance, Bench." (though Section 18 details are not provided in this excerpt). This bench testing would verify the physical and electrical characteristics of the device against relevant engineering standards and performance claims (e.g., light intensity, color temperature, safety).
• Conclusion: "The submitted information in this premarket notification shows that Blade raises no new questions of safety and effectiveness and the performance can be considered equivalent to the predicate devices."
• Approval: The FDA granted the 510(k) clearance (K132747) based on this demonstration of substantial equivalence.

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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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The intended use of the Amico iCE LED series surgical lights are to provide high intensity, shadow free illumination to the patient surgical field during surgical procedures.

The intended use of the Amico Mira LED series minor surgery lights is to provide high intensity, shadow free illumination to the patient surgical field during minor surgery procedures.

Amico iCE series consists of 3 models - iCE-30-6, iCE-25-6, & iCE-25-3. These are major surgical luminaires that provide illumination in a surgical suite allowing doctors to operate on a patient.. The device comes with several built-in fail safe's preventing any single fault from creating a hazardous situation. These lamps are a Class 2 device (under FDA) providing max illumination of 160,000 lx, 160.0001x, and 130.000 Ix respectively. These surgical lights are coupled with ceiling mounted suspension systems supporting horizontally articulating extensions arms and horizontally and vertically articulating spring arms. Both arms can rotate either 340 degree (with stop) or infinitely without a stop. The spring arms vertically articulate 50° downwards and 45° upwards. This allows for ease of movement of the lamp head to any given position. The lamp housing is made of high quality plastic wrapped around an aluminum structure. The front clear glass is made of high quality polycarbonate material. The yoke connecting the lamp head to the spring arms is made of steel. The lamps also have a built-in mechanical focusing system that is controlled using the center Aluminum and/or plastic handle. Rotating this handle allows the user to expand and contract the lighted field as per the user's requirement. The lamps can also be sold with an optional in-light camera that doubles as a focusing handle. This provides the user with the option to record/display small areas of a surgical site on a large display allowing for greater detail and accuracy during surgeries. A separate remote control is used to control the various functions of the camera.

Amico Mira LED series consists of 3 models - Mira LED 90, Mira LED 65 & Mira LED 50. These are minor surgical luminaires that provide illumination in a surgical suite allowing doctors to perform minor surgical procedures on a patient. These lamps are a Class 2 device (under FDA) providing max illumination of 90.000 1x. 65.000 Ix, and 50.000 Ix respectively. These surgical lights are coupled with ceiling mounted suspension systems supporting horizontally articulating extensions arms and horizontally and vertically articulating spring arms. Both arms can rotate either 340 degree (with stop) or infinitely without a stop. The spring arms vertically articulate 50° downwards and 45° upwards. This allows for ease of movement of the lamp head to any given position. The lamp housing is made of high quality plastic which connects to the front clear glass is made of high quality polycarbonate material. The yoke connecting the lamp head to the spring arms is made of steel. The lamps also have a built-in electronic focusing system that is controlled using the center Aluminum/plastic handle. Rotating this handle allows the user to expand and contract the lighted field as per the user's requirement.

This K131893 submission is for surgical lights (Amico iCE LED Series and Amico Mira LED Series Minor Surgical Lights). The study provided is non-clinical performance testing. Therefore, many of the typical categories for AI/algorithm-based medical devices are not applicable.

Here's an analysis based on the provided document:

Acceptance Criteria and Device Performance (Non-Clinical)

The acceptance criteria for these surgical lights are based on meeting established electrical safety and performance standards for medical electrical equipment and surgical luminaires. The reported device performance indicates that the devices passed these tests.

Study Details for Device Acceptance

It's important to note that this submission describes non-clinical performance testing for surgical lights, not a clinical study involving patients or an algorithm-based device. Therefore, many of the typical questions for AI/ML device studies are not applicable.

1. Sample size used for the test set and the data provenance: Not applicable. This was testing of the physical device's electrical safety and performance, not a test on a dataset.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for electrical and performance standards is established by the specifications in the international standards, not by expert consensus in the context of an algorithm. The testing would be conducted by qualified engineers/technicians in an accredited lab.
3. Adjudication method for the test set: Not applicable. The testing involves objective measurements against predefined thresholds within the standards.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this was not an MRMC study. This device is a surgical lamp, not an AI or imaging device that would typically undergo such a study.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.
6. The type of ground truth used: The "ground truth" for this type of device and testing is defined by the requirements and thresholds set forth in the international electrical safety and performance standards (IEC 60601-1, IEC 60601-2-41, IEC 60601-1-2).
7. The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
8. How the ground truth for the training set was established: Not applicable.

Conclusion from Non-Clinical Testing:

The electrical safety testing concludes that the Amico Clinical Solutions Corp. iCE LED Series and Amico Lights Corp. - Mira LED Series Minor Surgical Lights have been proven to be safe and effective and pose no foreseen hazards, having passed all specified IEC standards tests.

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