(299 days)
The Smith & Nephew Control Digital Operating Room System is indicated for use with compatible endoscopic and surgical equipment for centralized control of these devices and display of device status. The control system provides centralized touch panel and voice control of medical devices for use by the surgeon and O.R. staff.
The proposed Smith & Nephew Control Digital Operating Room System is a computer based system that enables centralized status display and control of multiple medical and non-medical devices through touch panel activation or through an optional voice recognition feature. The primary system consists of a Medical Device Controller, Medical Device Hub, Primary Touch Panel Interface (TPI-P), Surgical Touch Panel Interface (TPI-S), Ethernet Router and AVB network hub and AVB Power Supply. Optional components include: speech recognition engine, a wireless microphone for speech recognition, a wireless touch screen interface that can be bagged and placed in the sterile field, a display controller which allows device settings and conditions to be displayed on the surgeon's monitor.
Here's an analysis of the provided text regarding the Smith & Nephew Control Digital Operating Room System, addressing the requested information:
1. Table of Acceptance Criteria & Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance | Study Proving Performance |
|---|---|---|---|
| Safety | IEC 60601-1 (1988) + Amd 1 (1991) + Amd 2 (1995) (UL 2601-1) | Conforms to standard | Performance testing (general statement) |
| IEC 60601-1-1 (1992) + Amd 1 (1995), (2000) | Conforms to standard | Performance testing (general statement) | |
| UL 60601-1 (2003) | Conforms to standard | Performance testing (general statement) | |
| CAN/CSA 22.2 No. 601.1 (1990) + Supp 1-94 (1994) | Conforms to standard | Performance testing (general statement) | |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 (2001-09) 2nd Edition | Conforms to standard | Performance testing (general statement) |
| Functional Equivalence | Centralized and remote control of medical devices in the O.R. equivalent to predicate devices. | Demonstrates substantial equivalence to Olympus EndoALPHA, HERMES, and Sidne™ systems. | Summary Performance Data (general statement) |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The submission references "performance testing" but does not detail the methodology, sample sizes, or data provenance (e.g., country of origin, retrospective/prospective nature) for any specific tests performed beyond adherence to general safety and EMC standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The submission focuses on substantial equivalence to predicate devices and adherence to regulatory standards, not on clinical-performance-based ground truth established by experts.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given the nature of the device (a control system for existing medical devices) and the focus on substantial equivalence to predicate devices and adherence to regulatory standards, a formal adjudication method for a "test set" in the sense of clinical image or data interpretation is unlikely to have been a primary component of this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not provided and is not applicable to this device. The Smith & Nephew Control Digital Operating Room System is a control system for medical devices, not an AI-powered diagnostic or interpretive tool that would involve "human readers" or "AI assistance" in the typical MRMC study context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
This information is not provided and is not entirely applicable in the context of an algorithm's interpretive performance. The device itself is a standalone system for controlling other medical devices. Its "performance" would be assessed in terms of its ability to correctly send commands and display status, which is inherent in its function. No separate "algorithm-only" study examining diagnostic accuracy (as typically implied by this question) would be relevant here.
7. The Type of Ground Truth Used
The "ground truth" used for this submission appears to be:
- Adherence to recognized voluntary standards: IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, UL 60601-1, CAN/CSA 22.2 No. 601.1 regarding safety and EMC.
- Functional equivalence to predicate devices: The ability of the system to provide "centralized and remote control of medical devices in the O.R." in a manner deemed equivalent to existing, legally marketed systems (Olympus EndoALPHA, HERMES, Sidne™). This implies that the accepted functionality of the predicate devices serves as a benchmark for "ground truth" performance.
No pathology, expert consensus on diagnostic outcomes, or patient outcomes data is mentioned as ground truth.
8. The Sample Size for the Training Set
This information is not provided in the document. As this is a control system for operational devices rather than a machine learning algorithm that is "trained" on data to perform a specific task (e.g., image classification), the concept of a "training set" in the context of AI/ML is not applicable here. Its development would involve software engineering and hardware testing, not a data-driven training process.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable for the reasons stated in point 8.
§ 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.