(82 days)
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:
-
- 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
-
- Device Control Package (software activation USB dongle and a handheld Infrared (IR) remote control)
-
- Voice Control Package (software activation USB dongle and a wireless headset and base station)
-
- Video Image Processing package (software activation USB dongle)
-
- 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.
| Test Category | Acceptance Criteria (Explicit from document) | Reported Device Performance |
|---|---|---|
| Software | Successful functional verification | Pass |
| Network Security | Secure network operation | Pass |
| Memory Profiling and Performance | Acceptable memory usage and performance | Pass |
| Biocompatibility | Not patient contacting, therefore not required | N/A (Test not required) |
| Clinical Studies | Not required for substantial equivalence | N/A (Study not required) |
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.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.