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The Light Handle Adapters are permanent replacements to the original OEM handle provided by the light manufacturer in the event that the customer wishes to use a disposable light handle cover. This will eliminate the cleaning and resterilizing of the original OEM reusable light handle. The customer will need to replace the original OEM handle, with the light handle adapter that Litex Manufacturing, Inc. will provide the facility, through the light companies and other distributors.

The Litex Manufacturing, Inc. Light Handle Adapter is a permanent replacement for the light manufacture's OEM reusable handle and it is designed to be permanently attached to the surgical light.

This document is a 510(k) premarket notification for the "Light Handle Adapters" manufactured by Litex Manufacturing Incorporated. It states that no non-clinical or clinical tests were performed. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria and study results.

The document asserts substantial equivalence to a predicate device (American Medical MFG., Inc. Plastic Disposable Surgical Light Handle Cover & Adapters, K915068) based on technological characteristics and function. However, this is a regulatory argument for market clearance, not a report of performance testing against specific acceptance criteria.

In summary, none of the requested information (acceptance criteria, device performance, sample size, ground truth, expert qualifications, adjudication, MRMC, standalone performance, training set details) is available in this document.

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A device intended to be used as a disposable barrier for a surgical lighting system and which allows a surgical team member to manually adjust the lighting system. This is a single-use device

The Surgical Light Handle Cover is a polycarbonate injection molded device shaped to fit a surgical light that has release buttons protruding from the surgical light handle. The Surgical Light Handle Cover has apertures located at the end of the device, proximal to the surgical light, which correspond to the release buttons on the surgical light handle. When the Surgical Light Handle Cover is attached to the light, the release buttons will interface with the apertures to secure the Surgical Light Handle Cover to the light handle.

The Surgical Light Handle Cover is hollow in the center, with transparent polycarbonate located near the distal end. The transparent end permits the use of a recording device, which may be mounted onto the surgical light. The transparent end allows light to pass through for the purpose of recording images, it does not provide image enhancement or magnification.

The provided text describes the acceptance criteria and the study results for the "Surgical Light Handle Cover" device (K133554).

The study did not involve AI assistance, human readers, or the establishment of ground truth by experts in the context of diagnostic accuracy. This device is a physical medical accessory, and its performance evaluation focuses on manufacturing, sterility, biocompatibility, and physical functionality rather than diagnostic capabilities.

Here's a breakdown of the requested information based on the provided text, with clarifications where the questions are not directly applicable to this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for each test listed in the "Performance Data Summary." For tests like "Simulated Distribution Test" (ASTM D4169), "Dye Migration Test" (ASTM F1929), "Seal Peel Test" (ASTM F88), "Sterility" (ISO 11135-1), "EO/ECH Residuals" (ISO 10993-7), "Cytotoxicity" (ISO Elution), and "Material Leachables" (USP Physical-Chemical Analysis), the sample sizes would typically be determined by the specific ASTM/ISO standards referenced, but they are not detailed in this summary.

For the functional requirements ("Product must be easily installed and removed" and "Product must not interfere with the functionality of surgical light"), the test method indicates empirical assessment on a surgical light, but no specific number of trials or devices tested is provided.

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective/prospective, but given that it's a 510(k) submission for a medical device manufacturer, the testing would have been conducted by or for Microtek Medical Inc., an Ecolab Company, likely in a controlled laboratory setting.

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

This question is not applicable to the evaluation of this device. The "ground truth" for this type of medical accessory is not established by clinical expert interpretation or diagnostic accuracy. Instead, it's based on objective engineering specifications, regulatory standards (ASTM, ISO), and functional performance against predefined criteria. For example:

• Sterility: Achieved if the Sterility Assurance Level (SAL) meets 10^-6 as per ISO 11135-1.
• Packaging: Pass/fail based on meeting the requirements of ASTM standards.
• Functionality: Pass/fail based on whether the device can be attached/detached and doesn't impede light movement or clarity.

No clinical experts or radiologists were involved in establishing "ground truth" for these performance metrics.

4. Adjudication method for the test set

This question is not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving interpretation of medical images or patient data where there might be inter-reader variability. For this device, the tests are objective: either a package seal passes ASTM F88 or it doesn't; either an item is sterile to the specified SAL or it isn't. Discrepancies would be resolved by re-testing or reviewing the test methodology rather than expert consensus on an interpretation.

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. This device is a physical surgical light handle cover, not an AI-powered diagnostic or assistive tool. Therefore, there is no AI component, no human reader performance to improve, and no effect size to report in this context.

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

No, a standalone (algorithm only) performance evaluation was not done. This device is a physical product and does not involve any algorithms or AI for standalone performance assessment.

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

As discussed in point 3, the concept of "ground truth" as typically applied to diagnostic AI is not relevant here. The "ground truth" for this device's performance is defined by:

• Adherence to established international standards (e.g., ASTM, ISO) for material properties, sterility, and packaging integrity.
• Meeting predefined functional specifications (e.g., ease of installation, non-interference with light function).
• Compliance with biocompatibility requirements for medical devices.

8. The sample size for the training set

This question is not applicable. This device is not an AI algorithm, and therefore there is no "training set" in the machine learning sense. The device is manufactured based on a design and then tested against the criteria outlined above.

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

This question is not applicable. As there is no training set for an AI algorithm, there is no "ground truth" to establish for such a set.

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IDSS SLC allows the control of surgical lighting during a surgical procedure from the IDSS, which is a centralized interface for voice, video, audio, observational camera and teleconferencing for the operating room.

IDSS SLC is an additional function of the IDSS, which is an integrated operating room system that controls video displays, observation cameras, audio video equipment, teleconferencing and the routing of videos and images from multiple sources to multiple destination via touch screen interface.

This document, a 510(k) Summary for the IDSS SLC device, does not contain a study proving the device meets acceptance criteria as typically understood for AI/ML medical devices.

The IDSS SLC is described as an additional function of an integrated operating room system that controls surgical lighting, video displays, observation cameras, audio/video equipment, and teleconferencing. Its primary function is to allow control of surgical lighting during a procedure from a centralized interface.

Instead of a typical performance study with acceptance criteria for an AI/ML diagnostic or prognostic device, this document describes a summary of nonclinical testing focused on the device's functional integrity, safety, and equivalence to predicate devices.

Here's a breakdown of the information that can be extracted, and what is not applicable (N/A) given the nature of this device and document:

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

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

• N/A. This document describes nonclinical engineering and safety testing of a control system, not a study involving patient data or a test set in the traditional sense for AI/ML performance evaluation. The "test set" would be the device itself and its components undergoing various engineering validation tests.

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)

• N/A. Ground truth for clinical interpretation or diagnostic accuracy is not relevant here. The "ground truth" for this device's performance would be whether it accurately implements its programmed controls, adheres to safety standards, and functions reliably. This would be established by qualified engineers and testers.

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

• N/A. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers in interpreting clinical data. This is not relevant for the type of 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

• N/A. The IDSS SLC is a control system for surgical lights and other OR equipment. It is not an AI-assisted diagnostic or interpretative device that would be subject to an MRMC study.

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

• N/A. Not an AI algorithm in the context of clinical interpretation. The "standalone" performance would refer to the IDSS SLC system's ability to operate its functions as designed, which is covered by the validation testing.

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

• The "ground truth" for this device's performance is its conformance to engineering specifications, functional requirements, and established safety standards (e.g., EN 60601-1). This ground truth is based on predefined technical standards and the expected behavior of a physical control system.

8. The sample size for the training set

• N/A. This device does not use a training set for machine learning. The "training" for such a system would involve software development, component testing, and integration testing, which are distinct from AI model training.

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

• N/A. As there is no training set mentioned in the context of AI/ML, this question is not applicable.

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The OASYS Surgical Light Controller Software allows the control of surgical lights during a procedure from the OASYS View user interface touch panel. It displays the status of the surgical light and controls the operation of the surgical light.

The OASYS Surgical Light Controller allows the control of surgical lights from the OASYS View user interface touch panel. It displays the status of the surgical light and controls the operation of the surgical light. It works with surgical lights from many vendors.

The OASYS Surgical Light Controller communicates with the target surgical light using serial or Ethernet communications. All communications include error and exception handling. The safety features and controls of the surgical light take precedence over these communications.

This software controlling the Surgical Light is written with C# and XML data structures that run on Windows Embedded 7. The software is an optional module to the OASYS View OR Control application. OASYS View is a medical control application that allows for simple and streamlined management of an operating room. The software allows users to:

• Enable video routing from any source device to any destination device
• Preview selected sources on-screen
• Adjust image settings for video sources
• Change picture-in-picture capabilities on supported displays
• Control camera settings including:
• Panning & tilting
• Zooming
• Focusing
• Presets
• Operate medical-grade video recorders
• Select and listen to audio from an iPod or external audio device
• Engage in video conference calls

The software communicates with the light over a serial connection (RS485). Parameters are passed over a socket. The software manages the send and receive buffers to ensure effective communications. Data transmission is verified through the use of checksums and status commands.

The software allows for the Surgical Light to be initialized at run time. Default settings, such as brightness, are initialised on the Surgical Light. During normal operation, commands are passed back and forth based upon operator interaction with the graphical user interface. There are no patient contacting components.

The provided text describes functionality and technical specifications rather than diagnostic performance, therefore it does not fit the typical format for AI/ML device performance analysis. However, based on the provided text, I can infer the "acceptance criteria" relate to the functional operation of the OASYS Surgical Light Controller and the "study" is the performance testing conducted to confirm these functions.

Here's an adaptation of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document specifies "Performance Testing" was carried out, but it does not mention the sample size for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of data). This is a software and hardware control system, not a diagnostic AI/ML device, so the concept of "data provenance" in the usual sense (e.g., patient data) does not apply. The testing would have involved the physical device and a surgical light.

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

The document does not mention using experts to establish ground truth. For a control system like this, the "ground truth" would be defined by the functional specifications (e.g., is the light brighter when the "increase brightness" button is pressed?). Testing would likely be performed by engineers or quality assurance personnel against these predefined functional requirements.

4. Adjudication method for the test set

The document does not mention an adjudication method. For functional testing of a control system, formal adjudication by experts is typically not performed in the same way it would be for a diagnostic AI/ML device.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size

Not applicable. This device is a surgical light controller, not an AI/ML diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers with and without AI assistance is not relevant or described.

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

The performance testing described is inherently "standalone" in function, as it tests the capability of the software to control the surgical light as designed. The software itself is the "algorithm only" aspect, performing its control functions based on user input. The document describes the software communicating with the light and managing operations.

7. The type of ground truth used

The ground truth for this device would be defined by engineering specifications and user requirements for the control of a surgical light. For example, "increasing brightness" means the software sends the correct command and the light responds by becoming brighter. This is a functional truth rather than a clinical ground truth (like a pathology report).

8. The sample size for the training set

Not applicable. This is not an AI/ML device in the sense of requiring a training set for model development. The software is programmed with explicit logic and rules for controlling surgical lights, not "trained" on data.

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

Not applicable. As this is not an AI/ML device requiring a training set, the concept of establishing ground truth for a training set does not apply.

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EasySuite™ Surgical Light Control (ESLC) allows the control of surgical lighting during a surgical procedure from the EasySuite™ touch panel user interface.

The EasySuite™ Surgical Light Control (ESLC) is an optional function in the EasySuite™, which is an integrated operating room system for configurable communication of images from sources to displays within the operating room for management of audio systems, and for control of devices such as room lights. The ESLC function allows control of surgical lights from the EasySuite™ touch panel user interface.

This document describes the EasySuite™ Surgical Light Control (ESLC), a software application that allows control of surgical lights from the EasySuite™ touch panel user interface.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not contain explicit quantitative acceptance criteria or detailed performance metrics. The device is a "Surgical Light Accessory" and its function is to control surgical lights. The primary claim for performance is its substantial equivalence to a predicate device.

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

The document states that "Verification and validation testing was performed by Image Stream personnel." However, it does not specify the sample size used for the test set (e.g., number of test cases, scenarios, or a defined testing protocol with associated metrics).

The data provenance is internal to the manufacturer ("Image Stream personnel"). No information is given regarding the country of origin of the data, and it implies a prospective validation/verification process rather than retrospective data analysis.

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

This information is not provided in the document. As this is a control system for surgical lights, ground truth might relate to correct operation or functionality rather than diagnostic accuracy.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the device (a control system), a formal adjudication method (like 2+1 or 3+1 for diagnostic tasks) is unlikely to be directly applicable. Testing would likely involve functional checks against specified requirements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed, nor is it applicable to this device. This device is a surgical light control system, not an AI-powered diagnostic or assistive tool for human readers.

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

The device itself is a software application designed to control hardware (surgical lights) via a human-machine interface (touch panel). Therefore, the concept of "standalone algorithm performance without human-in-the-loop" as typically understood in AI/diagnostic contexts does not directly apply. The "algorithm" (software) is inherently designed to be interacted with by a human operator to control a physical device. The verification and validation testing would have focused on the software's ability to execute commands and control the lights as intended.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The document does not explicitly state the "type of ground truth." For a device like this, ground truth would likely be established empirically through:

• Functional Verification: Confirming that the system correctly sends commands to the surgical lights and that the lights respond as expected (e.g., turn on/off, adjust intensity).
• Requirements Traceability: Ensuring that all specified functional and performance requirements are met by the implemented software.
• Predicate Device Comparison: Demonstrating that the new device functions similarly to the cleared predicate device in its control capabilities.

8. The Sample Size for the Training Set

This information is not provided and is largely not applicable in the context of this device. The ESLC is described as a software application, not a machine learning or AI algorithm that would typically require a "training set" of data to learn from. Its functionality is deterministically programmed based on specified requirements.

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

This information is not applicable as there is no indication that this device uses a training set or machine learning model in the conventional sense.

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MainStream® OR Surgical Light Control (MSLC) allows the control of surgical lights from the Mainstream® OR touch panel user interface. It does not perform calculations. It displays surgical light status on the MainStream® OR display and allows control of the surgical lights. The safety features and controls of the surgical light system take precedence over the MainStream® OR surgical light control.

MSLC is an optional function in the MainStream® OR integrated operating room system. (The MainStream® OR system includes a touch panel user interface for quick routing of surgical images to displays within the operating room and for convenient control of room video cameras, surgical cameras, ambient lighting, and surgical lights. MainStream® OR also includes an audio management system and a single point of entry for querying surgical charts and image archives.)

The MainStream® OR Surgical Light Control (MSLC) is an optional function in the MainStream ® OR, which is an integrated operating room system for configurable communication of images from sources to displays within the operating room, for management of audio systems, and for control of devices such as room lights.

The MSLC function allows control of surgical lights from the MainStream® OR touch panel user interface.

The provided text does not contain information about acceptance criteria and a study to prove the device meets those criteria. This device, the MainStream® OR Surgical Light Control (MSLC), is a surgical light accessory that enables control of surgical lights from an integrated operating room system's touch panel. The submission primarily focuses on establishing substantial equivalence to a predicate device (SCB/Steris OR-Light Interface Box) based on functional similarities and safety principles rather than performance metrics.

The document states that the MSLC does not perform calculations and that the safety features and controls of the surgical light system take precedence over the MSLC. This implies that the MSLC's function is primarily an interface and control mechanism, and its safety is intrinsically linked to the underlying surgical lighting system it controls.

Therefore, I cannot provide a table of acceptance criteria or details about a study as requested. The available information describes the device's function and its classification, but not specific performance testing or clinical studies.

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The disposable Light Handle Cover is a single use sterile product. Its intended use is as a cover for surgical light handles. It is to be placed over the light handle prior to the start of a surgical procedure to provide the nurse or surgeon with a sterile protective cover to enable them to move the light during the procedure without compromising the sterility of their hands. This product does not come in contact with the patient.

The disposable Light Guard Light Handle Cover is made from a plastic material and is a single use item used to cover the handle of a surgical light. This device fits over the handle of a surgical light to provide a sterile barrier between sterile personnel and the non-sterile light handle.

The provided text does not contain information regarding acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for a medical device (Light Guard Light Handle Cover) which focuses on demonstrating substantial equivalence to a predicate device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide information for the specific points you've listed (sample size, experts, adjudication, MRMC, standalone, ground truth, training set size).

The document states: "Xodus Medical Inc.'s Light Guard Light Handle Cover has the same physical characteristics, material and design as the predicate device. They are both designed to slide over a surgical light handle. Both the predicate device and Xodus Medical's device are used to provide a sterile barrier between the sterile personnel and the non-sterile light handle." This indicates that the regulatory approval was based on substantial equivalence, implying that the new device performs similarly to the already approved predicate device, rather than requiring a new clinical study to establish performance against specific acceptance criteria.

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The Storz Communication Bus/STERIS OR-Light Interface device is an interface box that is use to connect the Karl Storz's SCB computer and the STERIS Harmony LA OR-Lighting Control System. This interface box allows SCB computer to control/monitor the STERIS Harmony LA Surgical Lighting System, a room camera and various ambient light settings. It contains software to display the STERIS Harmony LA OR-Lighting System's control parameter on a SCB computer screen. The interface box software does not perform calculations. It only relays STERIS Harmony LA Surgical Lighting System functions and controls on the SCB computer monitor for the surgeon's convenient control. The safety features of Harmony LA system will remain intact and take precedence over the SCB controls.

The Karl Storz SCB/STERIS OR-Light Interface Box connects the Storz Communication Bus computer to the STERIS Harmony OR-Light Control System. It enables the SCB computer to display and control the Harmony's functions.

This document describes a 510(k) summary for the KARL STORZ Endoscopy - America, Inc. SCB/STERIS OR-Light Interface Box.

Here's an analysis of the provided text in relation to your request about acceptance criteria and a study:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not contain any specific acceptance criteria or performance metrics for the device itself. Instead, it focuses on demonstrating substantial equivalence to a predicate device. This is a common approach for 510(k) submissions, where the main "acceptance criterion" is that the new device is as safe and effective as a legally marketed predicate device.

The "reported device performance" is implicitly that it functions as intended by allowing the SCB computer to "control/monitor" the STERIS Harmony LA Surgical Lighting System, a room camera, and various ambient light settings. The key assertion is: "The interface box software does not perform calculations. It only relays STERIS Harmony LA Surgical Lighting System functions and controls on the SCB computer monitor for the surgeon's convenient control. The safety features of Harmony LA system will remain intact and take precedence over the SCB controls."

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

The document does not describe any specific test set, sample size, or data provenance related to performance testing of the device. This is because the device's function is an interface for control, and its safety and effectiveness are established through substantial equivalence to a predicate device with similar functionalities, rather than through
a clinical or performance study with a test set.

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

Not applicable. No ground truth was established through expert consensus for this device notification as no specific performance study beyond substantial equivalence was provided.

4. Adjudication Method for the Test Set:

Not applicable. No adjudication method is mentioned as there was no test set or study described in the provided document.

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

Not applicable. No MRMC study was conducted or described. This type of study is more relevant for diagnostic or image-interpretation devices, not for an interface box that relays controls.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. The device is a hardware interface with software that relays controls; it is always "human-in-the-loop" as it is controlled by a surgeon via a monitor. The concept of "standalone algorithm performance" doesn't apply here.

7. Type of Ground Truth Used:

Not applicable. As no performance study requiring ground truth was described, there is no mention of ground truth established through expert consensus, pathology, or outcomes data. The "truth" for this submission is the established safety and effectiveness of the predicate device and the claim that the new device operates similarly and introduces no new safety or effectiveness concerns.

8. Sample Size for the Training Set:

Not applicable. There is no mention of a "training set" as this device is not an AI/ML algorithm that requires training data.

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

Not applicable. As there is no training set, there is no ground truth establishment for it.

Summary of the Document's Approach to Acceptance:

The submission relies entirely on Substantial Equivalence to establish the device's "acceptance."

• Predicate Device: SCB/ValleyLabs Force FX Interface Box (K041912)
• Argument for Equivalence: "The Karl Storz SCB/STERIS OR-Light Interface Box is substantially equivalent to the predicate device SCB/ValleyLabs Force FX Interface Box (K041912) since the basic features and intended uses are the same. The minor differences between the Karl Storz SCB/STERIS OR-Light Interface Unit and the predicate device raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices."

In essence, the "study" proving the device meets "acceptance criteria" is the comparison to the predicate device, demonstrating that the new device performs similarly for its intended use, without introducing new risks. This is a regulatory pathway, not a performance study in the traditional sense of medical device evaluation for diagnostic or therapeutic efficacy.

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The KSEA SCB ACC Control provides remote control for overhead and surgical lights, cameras, video devices, telephones, air-conditioning and teleconference equipment in the operating room.

The Karl Storz SCB ACC Control is an interface device to provide remote control via a touch screen panel.

The provided text is a 510(k) summary for the Karl Storz SCB ACC Control, which is a remote control interface device. The document primarily focuses on establishing substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results for the device itself.

Therefore, most of the requested information cannot be extracted from this document, as a typical performance study as requested for AI/ML devices or diagnostic tools is not present. The device described is a remote control for operating room equipment, and its safety and effectiveness are primarily supported by its functional equivalence to existing devices, not by a study with ground truth and expert consensus.

Here's what can be extracted based on the provided text, and where the information is not available:

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

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

• Sample Size: Not applicable. The document does not describe a performance study with a test set of data.
• Data Provenance: Not applicable.

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)

• Number of Experts: Not applicable. Ground truth establishment is not relevant for this device's regulatory submission as described.
• Qualifications of Experts: Not applicable.

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

• Not applicable. There is no test set or adjudication method 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 remote control, not an AI/ML-driven diagnostic or assistive device that would involve human readers or MRMC studies.

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

• Not applicable. This device is not an algorithm.

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

• Not applicable. Ground truth is not a concept applied in this 510(k) submission for this type of device.

8. The sample size for the training set

• Not applicable. There is no training set mentioned, as this is not an AI/ML device.

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

• Not applicable.

Summary:

The provided document is a 510(k) summary for a remote control device (KSEA SCB ACC Control). Its regulatory pathway is based on demonstrating substantial equivalence to a legally marketed predicate device, not on presenting a performance study with acceptance criteria, ground truth, and expert evaluations typical of AI/ML or diagnostic devices. Therefore, most of the requested information regarding performance studies, sample sizes, expert involvement, and ground truth is not applicable to this submission. The "study" referenced in the prompt (if interpreted as the documentation within the 510(k)) primarily consists of a comparison to a predicate device, asserting that "minor differences...have no effect on the performance, function or general intended use of these devices."

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