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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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Stryker SwitchPoint Infinity® 3 Control Systern is intended to be a central point of control and integration of ancillary compatible equipment, audio, video, and data routing, as well as teleconferencing for medical personnel.

This submission describes the Stryker SwitchPoint Infinity® 3 Control System intended for use as a central point of control and integration of ancillary compatible equipment, audio, video, and data routing, as well as and teleconferencing for medical personnel. The system provides a user interface through which to centrally control and provide visual status of various compatible devices including surgical devices, such as through the Stryker SIDNE™ system, as well as other devices, such as audio/video equipment used by medical personnel. It also functions as a matrix router capable of dynamically routing an array of audio, video, or other data sources to an array of audio, video or other data destinations. The routing capability is used to integrate local audio/video sources and destinations within a room. The SPI3 system provides an interface to facilitate audio/video communications to other rooms within the hospital campus, as well as off-site.

The provided document is a 510(k) premarket notification for the Stryker SwitchPoint Infinity® 3 Control System. This device is described as a "central point of control and integration of ancillary compatible equipment, audio, video, and data routing, as well as teleconferencing for medical personnel."

It's important to understand that a 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and standalone AI performance as typically found in submissions for AI/ML-driven diagnostic devices.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance of an algorithm, and training set details are not applicable to this type of regulatory submission for this specific device.

Based on the provided text, here's what can be extracted and what cannot:

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

This information is not provided in the document. The submission focuses on demonstrating substantial equivalence to predicate devices rather than meeting specific performance 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 submission details engineering and design comparisons, not a clinical performance study with a test set of data.

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 there is no mention of a clinical test set requiring expert ground truth.

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

This information is not provided as there is no mention of a clinical test set.

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 provided. This device is an integration and control system, not an AI-driven diagnostic or assistive tool, so an MRMC study is not relevant to its stated purpose.

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

This information is not provided. The device is an integration system and not an algorithm with standalone performance metrics.

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

This information is not provided as there is no mention of a clinical test set requiring ground truth.

8. The sample size for the training set:

This information is not provided as the device is not described as an AI/ML system that undergoes a training phase with a dataset.

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

This information is not provided as there is no mention of a training set.

Summary of Device and Regulatory Approach as per the Document:

• Device Name: Stryker SwitchPoint Infinity® 3 Control System (SPI3)
• Intended Use: "A central point of control and integration of ancillary compatible equipment, audio, video, and data routing, as well as teleconferencing for medical personnel." It provides a user interface to centrally control compatible devices, acts as a matrix router for audio/video/data, and facilitates audio/video communications within and outside the hospital.
• Regulatory Basis: 510(k) Premarket Notification based on demonstrating substantial equivalence to legally marketed predicate devices.
• Predicate Devices:
  • Stryker SwitchPoint Infinity Control System (K033132)
  • Olympus EndoALPHA Integrated Endosurgery System (K051613)
  • KSEA Storz Communication Bus (SCB) Media Control (K020640)
• Claim of Equivalence: The submission states that "The minor differences between the Stryker SwitchPoint Infinity® 3 Control System and the predicate device raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or general intended use of the device." The conclusion is that it "does not raise any new safety or efficacy issues" based on "applicable testing and the equivalence information presented." (The details of this "applicable testing" are not provided in the excerpt, but typically include device verification and validation activities showing it meets its own design specifications and functions as intended, not a comparative clinical study).

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The intended use of the Stryker Visum™ LED Surgical Lighting System is to illuminate the operative site during surgical procedures with high intensity light.

The Stryker Visum™ LED Surgical Lighting System is intended to illuminate the operative site during surgical procedures. Light functions can be controlled from within the sterile field, from a wall mounted control panel, or through the Stryker SIDNE™ device (K022393). The Stryker Visum™ LED Surgical Lighting System will be used in indications the same as other surgical lights currently offered for commercial distribution in the United States.

The Stryker Visum™ LED Surgical Lighting System is suitable for all major and minor surgical procedures throughout the hospital. The light moves via an easy to move pivoting suspension and has a completely sealed lighthead for safety and hygiene. Intensity is variable from 50,000 Lux to 160,000 Lux and each lighthead has redundant light sources that are not affected by individual source failure. The light quality is based upon a multiple reflector design combined with a heat removing conductive path to provide shadow free, cool light.

All systems are ceiling, wall, or mobile mounted lights and each provides sufficient illumination for all types of surgical procedures. The ceiling mounted lights are available in single, dual, and triple configurations and may also be combined with a separate arm to hold a viewing monitor.

The provided text, K060802, describes a 510(k) premarket notification for the Stryker Visum™ LED Surgical Lighting System. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed study with specific acceptance criteria and detailed performance data. Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment are not present in this type of regulatory submission.

However, based on the information provided, here's a breakdown of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the device "meets the requirements set forth in FDA Guidance for Surgical Lamps, as well as electrical safety standards IEC 60601-1 and IEC 60601-2-41." It also mentions meeting "the sterility requirements of AAMI ST37 to achieve a SAL of 10^-6." The primary performance claim is its ability to "illuminate the operative site during surgical procedures with high intensity light."

While specific, quantifiable acceptance criteria are not presented in a table form in this document, the following can be inferred:

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

This document does not describe a clinical study with a "test set" in the context of an AI/algorithm-driven device. It's a 510(k) submission for a physical medical device (surgical lighting system). Therefore, information on sample size and data provenance for a test set is not applicable or provided.

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

Not applicable, as this is not a study requiring expert ground truth for an AI algorithm. The device's performance is likely evaluated against engineering specifications, standards, and comparative testing to predicate devices, rather than expert-established ground truth on a dataset.

4. Adjudication Method:

Not applicable for a 510(k) submission for a physical device.

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

No, an MRMC comparative effectiveness study is not mentioned or implied, as this is not an AI-assisted diagnostic or interpretive device.

6. Standalone (Algorithm Only) Performance Study:

No, a standalone algorithm performance study was not done. This device is a physical surgical lighting system, not an algorithm.

7. Type of Ground Truth Used:

The "ground truth" for this device's acceptance would be based on:

• Engineering Specifications: Adherence to design criteria for light intensity, color temperature, heat dissipation, maneuverability, etc.
• Regulatory Standards: Compliance with IEC 60601-1, IEC 60601-2-41, and AAMI ST37.
• Comparative Performance Data: Showing equivalence in performance characteristics to the predicate devices (K031068 and K042382).
• Safety Testing: Verifying electrical safety, sterility, and other physical safety parameters.

8. Sample Size for the Training Set:

Not applicable, as this is not an AI/machine learning device. The "training" for a physical device would involve design, prototyping, and iterative testing, not the use of a "training set" in the computational sense.

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

Not applicable, as there is no "training set" in this context. The "ground truth" for the device's design and development comes from established engineering principles, international performance standards, and the performance characteristics of existing, legally marketed predicate devices.

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The Switchpoint Infinity™ Control System is a medical device that is designed to allow direct control of the state, selection, and settings of room equipment, and audio/video equipment and indirect control through the Stryker Endoscopy Sidne™ System of the state, selection, and settings of surgical equipment in the operating room. The Switchpoint Infinity™ Control System is also an integrated voice, video, and data router and teleconferencing interface for the operating room. The intent of the Switchpoint Infinity™ Control System is to allow operating room personnel a center point for controlling all equipment and communication in surgery.

The Stryker Switchpoint Infinity™ Control System is indicated for use with the Stryker Endoscopy Sidne™ System [510(k) # K022393] and Sidne™ compatible endoscopic and general surgery devices. The users of Switchpoint Infinity™ Control System are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons, urologists, and any other surgeon whom requires the use of voice, video, or control in the operating room or a teleconferencing interface.

The Switchpoint Infinity™ Control System is a medical device that is designed to allow direct control of the state, selection, and settings of room equipment, and audio/video equipment and indirect control through the Stryker Endoscopy Sidne™ System of the state, selection, and settings of surgical equipment in the operating room. The Switchpoint Infinity™ Control System is also an integrated voice, video, and data router and teleconferencing interface for the operating room.

The provided text is a 510(k) summary for the Stryker Switchpoint Infinity™ Control System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria, a specific study proving device performance against those criteria, or details regarding ground truth, expert adjudication, or sample sizes related to performance evaluation.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed performance study data in the way a clinical trial or a standalone AI algorithm validation would.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria and performance study details from the provided text.

The document states:

"The technological differences between the Stryker Switchpoint Infinity™ Control System and the predicate devices (Sidne™ System, Nurse's Assistant OR Control System, Switchpoint™ III, and KSEA Storz Communication Bus (SCB) Media Control™) do not raise new issues of safety and efficacy. Therefore, the Stryker Switchpoint Infinity™ Control System is substantially equivalent to the currently marketed Sidne™ System, Nurse's Assistant OR Control System, Switchpoint™ III, and KSEA Storz Communication Bus (SCB) Media Control™."

This declaration of substantial equivalence, along with conformity to voluntary standards (UL 60601-1, EN 60601-1-2), is the "proof" the device meets the safety and effectiveness requirements for 510(k) clearance, as opposed to a specific performance study with acceptance criteria.

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