Search Results

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.

Ask a specific question about this device