(29 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 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:
- Base Console which includes:
a) Medical Device Data System (MDDS) functionalities
b) Optional Device Control feature
d) Optional Video Image Processing (VIP) feature
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Device Control Package (software activation USB dongle and a handheld Infrared (IR) remote control)
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Voice Control Package (software activation USB dongle and a wireless headset and base station)
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Video Image Processing package (software activation USB dongle)
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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.
§ 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.