(168 days)
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:
- 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) - 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).
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Electrical Safety | Conformance to ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012 | Pass |
| Electromagnetic Compatibility (EMC) | Conformance to IEC 60601-1-2:2014 | Pass |
| Software Validation & Verification | Conformance to IEC 62304:2015 | Pass |
| Usability | Conformance to IEC 62366-1:2015 | Pass |
| Performance – Bench | Conformance to device input specifications, user needs, and intended uses | Pass |
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.
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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).
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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.
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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.
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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.
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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.
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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.
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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.
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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.
§ 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.