Search Results

Connected OR Hub with Device and Voice Control:
The use of the Connected OR Hub with Device and Voice Control is to allow for voice control and remote control of medical device settings by surgeons or operating room personnel, thereby eliminating the need to manually operate those devices compatible with the Connected OR Hub with Device and Voice Control or to rely on verbal communication between the surgeon and other operating room personnel in order to adjust the surgical equipment. It also has additional digital documentation functionality to electronically capture, transfer, store and display medical device data (non-medical device function), which is independent of the functions or parameters of any attached Stryker device.

SDC4K Information Management System with Device and Voice Control:
The use of the SDC4K Information Management System with Device and Voice Control is to allow for voice control and remote control of medical device settings by surgeons or operating room personnel, thereby eliminating the need to manually operate those devices compatible with the SDC4K Information Management System with Device and Voice Control or to rely on verbal communication between the surgeon and other operating room personnel in order to adjust the surgical equipment. It also has additional digital documentation functionality to electronically capture, transfer, store and display medical device data (non-medical device function), which is independent of the functions or parameters of any attached Stryker device.

The Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control are network compatible hardware platforms that carry out Medical Device Data System (MDDS) functionalities and allows the user to control the state, selection, and settings of compatible connected devices both wired and wirelessly.

The Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control consists of the following components:

• 1. Base Console which includes:
  • a) Medical Device Data System (MDDS) functionalities
  • b) Optional Device Control feature
  • c) Optional Voice Control feature
  • d) Optional Video Image Processing (VIP) feature
• 2. Device Control Package (software activation USB dongle and a handheld Infrared (IR) remote control)
• 3. Voice Control Package (software activation USB dongle and a wireless headset and base station)
• 4. Video Image Processing package (software activation USB dongle)
• 5. Connected OR Spoke (MDDS)

The provided FDA 510(k) summary for the Stryker Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control describes the acceptance criteria and the study that proves the device meets them. However, it does not involve an AI system for diagnostic or prognostic purposes, but rather a control system for medical devices. Therefore, some of the requested information regarding AI-specific criteria (like effect size of AI assistance for human readers, ground truth type for training, etc.) is not applicable.

Here's an analysis based on the available information:

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

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

The document does not specify a "test set" in the context of a dataset for an AI model. Instead, it refers to various engineering and validation tests. The "Performance - Bench" tests would have involved specific test cases and scenarios, but the sample size (number of tests, number of voice commands, etc.) is not explicitly detailed. The provenance is internal to Stryker's development and validation processes. Given the nature of software and hardware validation, these tests are typically conducted in a controlled environment as part of the manufacturing and R&D process.

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

This information is not explicitly provided in the document. For non-AI device validation, "ground truth" is typically established by engineering specifications, recognized standards (e.g., IEC, AAMI), and user needs. The validation process would involve qualified engineers and testers to confirm the device performs according to these pre-defined specifications. For "Usability," expert users (e.g., surgeons, OR personnel) or human factors engineers would likely be involved, but their number and specific qualifications are not detailed.

4. Adjudication method for the test set

The document does not describe an adjudication method in the context of multiple observers or interpretations for a test set, as would be common for AI performance evaluation. For the various "Pass" results, internal validation protocols and test reports would have been followed, likely involving engineering review and sign-off based on predefined success criteria for each test.

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, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done. This device is a control system (voice and remote control) for other medical devices and not an AI diagnostic or prognostic tool that assists human readers in interpreting medical images or data.

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

The device's core functionality involves control of medical devices, including "voice control of medical device settings." While this incorporates voice recognition, it's not a standalone AI algorithm for medical diagnosis or interpretation. The "Voice Recognition Performance" was tested, implying a standalone evaluation of this component, but it's part of a human-in-the-loop control system. The other listed tests (Electrical Safety, EMC, etc.) are inherent to the device's standalone hardware and software performance.

7. The type of ground truth used

The ground truth for this device's validation is based on:

• Recognized Standards: e.g., IEC 60601-1 for electrical safety, IEC 60601-1-2 for EMC, AAMI TIR69 for wireless technology, IEC 62304 for software, IEC 62366-1 for usability.
• Device Input Specifications: Internal engineering requirements for video compatibility, environmental robustness, voice recognition accuracy, and overall system design.
• User Needs and Intended Uses: The device must meet the functional requirements for surgeons and operating room personnel to control medical devices effectively and safely.

8. The sample size for the training set

This information is not provided. For the voice recognition component, a training set would have been used to develop the voice models. However, the document does not specify its size or characteristics, as it's not the primary focus of the 510(k) summary for this type of device.

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

Not explicitly stated. For the voice recognition feature, the ground truth for training would typically involve a large dataset of spoken commands, explicitly transcribed and labeled, to train the voice recognition model to accurately identify the intended commands. This process is standard for developing speech recognition systems.

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Connected OR Hub with Device and Voice Control:

The use of the Connected OR Hub with Device and Voice Control is to allow for voice control and remote control of medical device settings by surgeons or operating room personnel, thereby eliminating the need to manually operate those devices compatible with the Connected OR Hub with Device and Voice Control or to rely on verbal communication between the surgeon and other operating room personnel in order to adjust the surgical equipment. It also has additional digital documentation functionality to electronically capture, transfer, store and display medical device data (non-medical device function), which is independent of the functions or parameters of any attached Stryker device.

SDC4K Information Management System with Device and Voice Control

The use of the SDC4K Information Management System with Device and Voice Control is to allow for voice control and remote control of medical device settings by surgeons or operating room personnel, thereby eliminating the need to manually operate those devices compatible with the SDC4K Information Management System with Device and Voice Control or to rely on verbal communication between the surgeon and other operating room personnel in order to adjust the surgical equipment. It also has additional digital documentation functionality to electronically capture, transfer, store and display medical device data (non-medical device function), which is independent of the functions or parameters of any attached Stryker device.

The Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control are network compatible hardware platforms that carry out Medical Device Data System (MDDS) functionalities and allows the user to control the state, selection, and settings of comected endoscopic and general surgery devices both wired and wirelessly.

The Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control consists of the following components:

1. Base Console which includes:

a) Medical Device Data System (MDDS) functionalities

b) Optional Device Control feature

d) Optional Video Image Processing (VIP) feature

2. Device Control Package (software activation USB dongle and a handheld Infrared (IR) remote control)

3. Voice Control Package (software activation USB dongle and a wireless headset and base station)

4. Video Image Processing package (software activation USB dongle)

5. Connected OR Spoke (MDDS)

The Connected OR Hub and SDC4K consoles carry out the Medical Device Data System (MDDS) functionalities (i.e. Non-medical function) and can be marketed as standalone devices. When upgraded with the Device Control package, the consoles extend their functionalities to control compatible devices from their touchscreen graphical user interface (GU), spoken commands via headset (voice control input), and an IR remote control or directional keypad from a camera head (device control input). The received user commands are then processed and communicated with the connected controllable devices, allowing the user to control the state, selection, and settings of those devices.

In addition, the Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control provide compatibility with the Connected OR Spoke (also referred to as "Spoke") which is a standalone Medical Device Data System. Once the Connected OR Hub with Device and Voice Control or SDC4K Information Management System with Device and Voice Control is connected to the Spoke, Device Control can be extended to compatible devices which are directly connected to the Spoke.

When upgraded with the Video Image Processing (VIP) package, the Connected OR Hub automates an image enhancing algorithm, and removal of surgical smoke through a compatible insufflator.

This FDA 510(k) summary for the Stryker Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control does not contain the detailed information required to fill out a table of acceptance criteria and reported device performance related to diagnostic accuracy or clinical effectiveness measures for AI/ML performance.

Instead, this document focuses on non-clinical testing to establish the safety and performance of the device's voice and remote control functionalities and its compliance with relevant medical device standards. This device appears to be an enabling technology for controlling medical devices, rather than a diagnostic or prognostic AI/ML system that would typically have the kind of performance metrics you've requested.

Therefore, many of your requested items, such as expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and sample sizes for training sets, are not applicable (N/A) in the context of this specific device's submission summary.

Here's a breakdown of what can be extracted and what cannot:

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

This information is not provided in a format that allows for a table of "acceptance criteria" and "reported device performance" in terms of diagnostic or clinical metrics. The document instead describes compliance with engineering and safety standards and successful verification and validation testing for its functionalities.

• Acceptance Criteria (General): Conformity with recognized safety standards, design input specifications, user needs, and intended uses.
• Reported Device Performance (General): Verification and validation testing successfully completed demonstrated that the device conforms with these requirements.

Without a specific performance metric (like accuracy, sensitivity, or specificity for a diagnostic task), a direct "performance" table cannot be constructed.

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. The document discusses "software function testing" and "verification and validation testing," but these are engineering tests, not clinical performance studies on patient data. There is no mention of a "test set" in the context of diagnostic or clinical data in this summary.

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. As this is not a diagnostic device using AI for interpretation, there's no "ground truth" established by medical experts for a test set.

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

• N/A. Not applicable, as there is no test set for clinical ground truth.

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 document explicitly states: "The subject devices do not require clinical studies to support the determination of substantial equivalence." This confirms no MRMC study was conducted or required. The device's function is to control other medical devices via voice/remote, not to assist in interpretation.

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

• N/A. This is not an AI algorithm for diagnostic interpretation in that sense. Its "intelligence" is in processing voice commands and mapping them to device controls. Its performance would be evaluated on the accuracy of carrying out those commands, not on a diagnosis.

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

• N/A. The "ground truth" for this device's performance would relate to whether it accurately executes commands (e.g., "increase insufflator pressure" results in the correct pressure change) and whether it adheres to safety protocols. This is confirmed through engineering and software testing, not medical ground truth types.

8. The sample size for the training set

• N/A. In the context of a diagnostic AI/ML device, this refers to the data used to train the model. This device's capabilities (voice control, device control) would involve training data for speech recognition models, but the 510(k) summary does not detail the specifics of such training or sample sizes for that purpose. It focuses on the validation of the system as a whole.

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

• N/A. Similar to point 8, this level of detail is not provided for speech recognition components, given the nature of this 510(k) submission.

In summary, this document is for a medical device that provides control and information management functionalities, rather than an AI/ML-driven diagnostic or prognostic tool. Therefore, the typical metrics and study designs for evaluating AI/ML performance in clinical decision-making are not present here.

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Connected OR Hub with Device and Voice Control:
The use of the Connected OR Hub with Device and Voice Control is to allow for voice control and remote control of medical device settings by surgeons or operating room personnel, thereby eliminating the need to manually operate those devices compatible with the Connected OR Hub or to rely on verbal communication between the surgeon and other operating room personnel in order to adjust the surgical equipment. It also has additional digital documentation functionality to electronically capture, transfer, store and display medical device data (non-medical device function), which is independent of the functions or parameters of any attached Stryker device.

SDC4K Information Management System with Device and Voice Control:
The use of the SDC4K Information Management System with Device and Voice Control is to allow for voice control and remote control of medical device settings by surgeons or operating room personnel, thereby eliminating the need to manually operate those devices compatible with the SDC4K Information Management System with Device and Voice Control or to rely on verbal communication between the surgeon and other operating room personnel in order to adjust the surgical equipment. It also has additional digital documentation functionality to electronically capture, transfer, store and display medical device data (non-medical device function), which is independent of the functions or parameters of any attached Stryker device.

The Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control are network compatible hardware platforms that carry out Medical Device Data System (MDDS) functionalities and allows the user to control the state, selection, and settings of compatible connected endoscopic and general surgery devices both wired and wirelessly.

The Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control consists of the following components:

• 1. Base Console which includes:
  • a) Class I Medical Device Data System (MDDS) functionalities
  • b) Optional Device Control feature
  • c) Optional Voice Control feature
  • d) Optional Video Image Processing (VIP) feature
• 2. Device Control Package (software activation USB dongle and a handheld Infrared (IR) remote control)
• 3. Voice Control Package (software activation USB dongle and a wireless headset and base station)
• 4. Video Image Processing package (software activation USB dongle)
• 5. Connected OR Spoke (Class I MDDS)

The Connected OR Hub and SDC4K consoles carry out the Medical Device Data System (MDDS) functionalities (i.e. Class I device function or Non-medical function) and can be marketed as standalone devices. When upgraded with the Device Control and/or Voice Control package, the consoles extend their functionalities to control compatible devices from their touchscreen graphical user interface (GUI), spoken commands via headset (voice control input), and an IR remote control or directional keypad from a camera head (device control input). The received user commands are then processed and communicated with the connected controllable devices, allowing the user to control the state, selection, and settings of those devices.

In addition, the Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Control provide compatibility with the Connected OR Spoke (also referred to as "Spoke") which is a standalone Class I Medical Device Data System. Once the Connected OR Hub with Device and Voice Control or SDC4K Information Management System with Device and Voice Control is connected to the Spoke, Device Control can be extended to compatible devices which are directly connected to the Spoke.

When upgraded with the Video Image Processing (VIP) package, the Connected OR Hub automates an image enhancing algorithm, and removal of surgical smoke through a compatible insufflator.

The provided text is a 510(k) Pre-market Notification from the FDA for a medical device called "Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control."

Based on the document, here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines performance testing but does not explicitly state quantitative acceptance criteria with corresponding performance metrics in a clear table format for device functionality as requested in the prompt. Instead, it reports broad "Pass" results for various tests.

Important Note: The document focuses on demonstrating substantial equivalence to a predicate device (K222079), which is the same device. This implies that the acceptance criteria are largely aligned with the predicate's established safety and effectiveness. The "Performance Data" section primarily addresses non-clinical testing for software functionality, network security, and memory profiling. It does not provide detailed quantitative acceptance criteria for aspects like voice recognition accuracy or remote control latency, which would be crucial for a novel device. Given that the predicate device is essentially the same, this submission likely relies on the previous clearance for demonstrating the core performance characteristics.

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

The document does not explicitly state the sample size used for the test set in terms of specific number of voice commands, remote control actions, or network transactions. It refers to "Software functional verification," "Network Security," and "Memory Profiling and Performance" tests.

• Sample Size: Not specified in terms of trials or data points. The "tests" are described generically.
• Data Provenance: Not explicitly stated (e.g., country of origin). Since it's a 510(k) submission for a device from Stryker Endoscopy (based in San Jose, California), the testing was likely conducted internally by the manufacturer in the USA.
• Retrospective/Prospective: The testing described ("Software functional verification," "Network Security," "Memory Profiling and Performance") would typically be prospective controlled engineering and software validation tests conducted internally by the manufacturer.

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

This information is not provided in the document. The document primarily describes engineering and software-level verification and validation. For a device like this, "ground truth" would relate to the successful execution of commands (voice or remote). It's implied that technical experts (e.g., software engineers, test engineers) would verify the functionality, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set:

This information is not provided in the document. Given the nature of the tests (software functional verification, network security, memory profiling), a formal adjudication method by independent experts, as might be seen in clinical image-based AI studies, is not typically described in such 510(k) summaries for device control systems. The "Pass" results imply internal verification protocols.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of human readers improving with AI vs. without AI assistance:

No. The document explicitly states: "The Connected OR Hub and SDC4K Information Management Systems with Device and Voice Control Packages do not require clinical studies to support the determination of substantial equivalence." This device is a medical device data system (MDDS) and a control system for other medical devices; it's not an AI diagnostic tool that would typically undergo an MRMC study.

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

The device's core functionality is to process human input (voice commands, remote control) and translate it into control signals for other medical devices. Therefore, the "algorithm" is inherently integrated with human interaction. The "Performance Data" section describes validation of the software (algorithm) itself, which implicitly includes its ability to correctly interpret and execute commands. However, it doesn't describe a separate "standalone" performance evaluation in the sense of a diagnostic AI system without human involvement. The "functional verification" tests would confirm the algorithm's correctness.

7. The Type of Ground Truth Used:

The ground truth for the "Performance Data" section is primarily functional correctness and adherence to technical specifications. For example:

• Software Functional Verification: Ground truth is whether a given command (voice or IR remote) correctly triggers the intended action on a compatible device and whether all defined functionalities operate as designed.
• Network Security: Ground truth involves verifying the system's resistance to known vulnerabilities and secure data transfer, based on established security protocols and testing methodologies.
• Memory Profiling and Performance: Ground truth relates to meeting predefined engineering benchmarks for resource utilization and responsiveness.

This is not "expert consensus," "pathology," or "outcomes data" in the typical sense of a diagnostic or therapeutic medical device.

8. The Sample Size for the Training Set:

This information is not applicable and therefore not provided. This device is a control system, not a machine learning or AI model that would typically have a "training set" in the context of learning from data (e.g., for image recognition or predictive analytics). Its functionality is rule-based and pre-programmed, not learned.

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

This information is not applicable as there is no "training set" for this type of device. The "ground truth" for the device's development (pre-market validation) would be based on engineering specifications, software requirements, and functional design.

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Connected OR Hub with Device and Voice Control:
The use of the Connected OR Hub with Device and Voice Control is to allow for voice control and remote control of medical device settings by surgeons or operating room personnel, thereby eliminating the need to manually operate those devices compatible with the Connected OR Hub with Device and Voice Control or to rely on verbal communication between the surgeon and other opersonnel in order to adjust the surgical equipment. It also has additional digital documentation functionality to electronically capture, transfer, store and display medical device data (non-medical device function), which is independent of the functions or parameters of any attached Stryker device.

SDC4K Information Management System with Device and Voice Control:
The use of the SDC4K Information Management System with Device and Voice Control is to allow for voice control and remote control of medical device settings by surgeons or operating room personnel, thereby eliminating the need to manually operate those devices compatible with the SDC4K Information Management System with Device and Voice Control or to rely on verbal communication between the surgeon and other operating room personnel in order to adjust the surgical equipment. It also has additional documentation functionality to electronically capture, transfer, store and display medical device data (non-medical device function), which is independent of the functions or parameters of any attached Stryker device.

The Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control are network compatible hardware platforms that carry out Medical Device Data System (MDDS) functionalities and allows the user to control the state, selection, and settings of compatible connected endoscopic and general surgery devices both wired and wirelessly.

The Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Control consists of the following components:

• 1. Base Console which includes:
  • a) Class I Medical Device Data System (MDDS) functionalities
  • b) Optional Device Control feature
  • c) Optional Voice Control feature
  • d) Optional Video Image Processing (VIP) feature
• 2. Device Control Package (software activation USB dongle and a handheld Infrared (IR) remote control)
• 3. Voice Control Package (software activation USB dongle and a wireless headset and base station)
• 4. Video Image Processing package (software activation USB dongle)
• 5. Connected OR Spoke (Class I MDDS)

The Connected OR Hub and SDC4K consoles carry out the Medical Device Data System (MDDS) functionalities (i.e. Class I device function or Non-medical function) and can be marketed as standalone devices. When upgraded with the Device Control and/or Voice Control package, the consoles extend their functionalities to control compatible devices from their touchscreen graphical user interface (GUI), spoken commands via headset (voice control input), and an IR remote control or directional keypad from a camera head (device control input). The received user commands are then processed and communicated with the connected controllable devices, allowing the user to control the state, selection, and settings of those devices.

In addition, the Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control also provide compatibility with the Connected OR Spoke (also referred to as "Spoke") which is a standalone Class I Medical Device Data System. Once the Connected OR Hub with Device and Voice Control or SDC4K Information Management System with Device and Voice Control is connected to the Spoke, Device Control can be extended to compatible devices which are directly connected to the Spoke.

When upgraded with the Video Image Processing (VIP) package, the Connected OR Hub automates an image enhancing algorithm, and removal of surgical smoke through a compatible insufflator.

The provided text describes a 510(k) premarket notification for the "Connected OR Hub with Device and Voice Control" and "SDC4K Information Management System with Device and Voice Control." This submission asserts substantial equivalence to predicate devices and focuses on performance data derived from bench testing and adherence to various standards. However, the document does not contain the level of detail typically found in a clinical study report regarding acceptance criteria for diagnostic accuracy, sample size of a test set, expert qualifications for ground truth, adjudication methods, MRMC studies, or specific training set information.

Based on the provided information, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria in terms of diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) for an AI or imaging device, as this device primarily focuses on device control and information management rather than diagnostic interpretation. The "Performance - Bench" criterion is qualitative.

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

The document indicates that the devices underwent "Performance - Bench" testing. However, it does not specify a numeric sample size for a test set, nor does it detail the provenance of any data used (e.g., country of origin, retrospective or prospective). This is expected given the nature of the device as a control and information management system, rather than an AI-enabled diagnostic imaging device that processes patient data.

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 the involvement of experts to establish ground truth. As the device functions relate to controlling medical equipment and managing data, and not to diagnostic interpretation of medical images or patient conditions, such an expert-based ground truth assessment would not be applicable or expected. The "Pass" results for the listed tests (Electrical Safety, EMC, Software Validation, Usability, Bench Performance) imply that the device met pre-defined engineering and functional requirements, which are typically verified by engineers and quality assurance personnel against specifications, rather than by medical experts establishing diagnostic ground truth.

4. Adjudication method for the test set

No adjudication method is mentioned, as there is no expert-driven ground truth establishment described for a 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

No MRMC comparative effectiveness study was conducted or mentioned in this submission. The device is not an AI-assisted diagnostic tool that would typically warrant such a study. Its function is to facilitate device control and information management in the operating room.

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

The document describes "Software Validation & Verification" (IEC 62304:2015) and "Performance - Bench" tests. These tests would involve evaluation of the device's functions, including its algorithms for device/voice control and data management, in a standalone manner without human intervention for diagnostic interpretation. The reported result for these tests is "Pass," indicating that the algorithms and system components performed as specified. However, it's not a standalone performance for diagnostic purposes.

7. The type of ground truth used

The concept of "ground truth" in the diagnostic sense (e.g., pathology, outcomes data) is not applicable or stated. For the types of tests described (Electrical Safety, EMC, Software, Usability, Bench Performance), the "ground truth" would be defined by engineering specifications, regulatory standards, and predefined functional requirements. A "Pass" result indicates compliance with these established criteria.

8. The sample size for the training set

The document does not provide any information about a training set size. This is because the device described is not an AI/ML-driven diagnostic or predictive model that typically undergoes a training phase with a distinct dataset. Its functionalities are primarily based on deterministic software logic for control and data management.

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

As no training set is mentioned or applicable in the context of this device's functionalities, there is no information on how ground truth for a training set was established.

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The use of the Connected OR Hub with Device and Voice Control system is to allow for voice control and remote control of medical device settings by surgeons or operating room personnel, thereby eliminating the need to manually operate those devices compatible with the Connected OR Hub with Device and Voice Control or to rely on verbal communication between the surgeon and other opersonnel in order to adjust the surgical equipment. It also has additional digital documentation functionality to electronically capture, transfer, store and display medical device data (non-medical device function), which is independent of the functions or parameters of any attached Stryker device.

The Connected OR Hub with Device and Voice Control is a network compatible hardware platform that carries out Medical Device Data System (MDDS) functionalities and allows the user to control the state, selection, and settings of compatible connected endoscopic and general surgery devices both wired and wirelessly.

The Connected OR Hub with Device and Voice Control consists of the following components:

1. The Connected OR Hub Console which includes:
   a. Class I Medical Device Data System (MDDS) functionality
   b. Device Control package (optional software feature and a handheld Infrared (IR) remote control)
   c. Voice Control package (optional software feature and a headset and base station)
   d. Video Imaging Process (VIP) package (optional software feature)
2. Connected OR Spoke (Class I MDDS)

The Connected OR Hub console carries out the Medical Device Data System (MDDS) functionalities (i.e. Class I device function or Non-medical function) and can be marketed as a standalone device. When upgraded with the Device Control and/or Voice Control package, the Connected OR Hub Console extends its functionality to control compatible devices from its touchscreen graphical user interface (GUI), spoke commands via headset (voice control input), and an IR remote control or directional keypad from a camera head (device control input). In addition, the Device and Voice Control package also provide compatibility with the Connected OR Spoke which is a standalone Class I Medical Device Data System. Once the Connected OR Hub is connected to the Spoke, Device Control can be extended to compatible devices connected directly to the Spoke. When upgraded with the Video Image Processing package, the Connected OR Hub automates an enhanced image algorithm and removal of surgical smoke through a compatible insufflator.

Here's an analysis of the provided FDA 510(k) summary regarding the Connected OR Hub with Voice Control, focusing on acceptance criteria and study data:

Acceptance Criteria and Device Performance (Table)

The document does not provide a specific table of quantitative acceptance criteria for performance metrics (e.g., accuracy, precision, latency) alongside reported device performance. Instead, it lists the types of tests conducted and indicates that the device "Passed" them. The acceptance criteria for these tests are implicitly the standards themselves (e.g., meeting all requirements of ANSI/AAMI ES60601-1 for electrical safety).

Study Details for Acceptance Criteria

The document uses a predicate device comparison for substantial equivalence. The "studies" conducted are primarily engineering verification and validation tests rather than clinical trials or statistically powered performance studies in the traditional sense.

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

   • The document does not specify sample sizes for any of the tests.
   • The data provenance is not explicitly stated, but given it's a submission to the FDA, it is expected to be from controlled laboratory or simulated environments, primarily prospective testing conducted by the manufacturer (Stryker Endoscopy).

2. 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 in the document. The tests described (electrical safety, EMC, software, usability, bench performance) typically rely on engineering specifications and standard compliance, not expert "ground truth" derived from clinical judgment.

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

   • This information is not applicable and therefore not provided. The tests are based on objective engineering standards and specifications, not subjective interpretation requiring adjudication among experts.

4. 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 MRMC comparative effectiveness study was done or mentioned. The device described is a control system for medical devices (including voice control), not an AI-assisted diagnostic or interpretative tool that would typically involve human readers.

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

   • The device's core function involves controlling other medical devices via voice or remote input, with a human user (surgeon or OR personnel) always in the loop. Therefore, a "standalone algorithm only" performance study in a diagnostic sense is not applicable. The "Performance – Bench" test would evaluate the system's ability to interpret commands and control connected devices as intended, representing its standalone functional performance without human "interpretation" of device outputs.

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

   • The "ground truth" for the tests performed is primarily defined by engineering specifications, international safety standards (electrical safety, EMC), and software development/usability standards. For the "Performance – Bench" test, the ground truth would be the expected and correct execution of commands and functionalities as per the device's design and user needs.

7. The sample size for the training set:

   • This information is not provided and likely not applicable in the context of this device. The Connected OR Hub with Voice Control is a rule-based control system with voice recognition, not a machine learning model that typically requires a distinct training set for diagnostic or predictive tasks. If voice recognition involves ML, the training data for that component is not specified.

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

   • This information is not provided and likely not applicable for the reasons mentioned above.

Additional Notes from the Document:

• Non-Clinical Nature: The document explicitly states: "The Connected OR Hub with Device and Voice Control does not require clinical studies to support the determination of substantial equivalence." This is critical as it indicates the FDA considered the substantial equivalence claim justifiable based on non-clinical data, primarily engineering and performance testing against standards.
• Predicate Device Comparison: The claim of substantial equivalence is heavily based on the comparison to previously cleared predicate devices (K201434, K192172, K181258). The subject device shares many technological characteristics, principles of operation, and intended uses with its predicate, suggesting that the established safety and effectiveness of the predicate extend to the new device once its engineering performance is verified.

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The use of the Connected OR Hub with Device and Voice Control system is to allow for voice control and remote control of medical device settings by surgeons or operating room personnel, thereby eliminating the need to manually operate those devices compatible with the Connected OR Hub with Device and Voice Control or to rely on verbal communication between the surgeon and other operating room personnel in order to adjust the surgical equipment. It also has additional digital documentation functionality to electronically capture, transfer, store and display medical device data (non-medical device function), which is independent of the functions or parameters of any attached Stryker device.

The Connected OR Hub with Device and Voice Control is a medical device that allows the surgeon to control the state, selection, and settings of any compatible device attached to it. It also has operating room documentation functionalities (Class I device function) to electronically capture, transfer, store and display medical device data independently of the functions or parameters of the connected medical device. The Connected OR Hub with Device and Voice Control consists of the following: a. A Connected OR Hub console (MDDS device) b. A Device control package (contains an optional software upgrade and a handheld Infrared (IR) remote control) - Class II c. A Voice control package (contains an optional software upgrade and a headset and base station) - Class II

The provided document is a 510(k) premarket notification for a medical device called "Connected OR Hub with Device and Voice Control." It does not contain any performance study data or acceptance criteria related to AI or algorithm performance.

The document primarily focuses on establishing substantial equivalence to a predicate device (Stryker Connected OR Hub with Device and Voice Control, K181258). It highlights that the proposed device has "no significant design changes" and that a "risk analysis of the indications for use change concluded that the change in indication for use does not raise new issues of safety and effectiveness." Therefore, the document explicitly states: "Therefore, performance data are not necessary to evaluate the change in indications to a tool type indication."

As a result, I cannot provide the information requested in your prompt regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details. This information is absent from the provided text.

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