(243 days)
Core.nova (core.browser, core.connect with driver, IR Transceiver, core.media, and core.portal) are components used for the central control of integrated medical devices and accessories in one central location within the operating room. In particular core.nova is used for the control of connected compatible OR equipment, like OR-lamp, OR-camera, ORtable, insufflator, or video- and documentation system intended for diagnostic and therapeutic medical conditions. The connected devices (Richard Wolf or third party) can be control terminals (with touch screen), or the control mechanism on actual device.
The core nova (complete operating room endoscopy nova) by Richard Wolf is a networkbased integrated operating room accessory that provides central control to various Richard Wolf devices and third party devices. This control allows the user to control device settings from the sterile area. Richard Wolf's core nova is comprised of core.browser, core.connect with driver, IR Transceiver, an optional core.media, and an optional server core.portal.
The provided document is a 510(k) premarket notification for the "core nova Complete Operating Room Endoscopy" system by Richard Wolf. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed device performance metrics in the way one might expect for a diagnostic or therapeutic algorithm.
Therefore, the requested information, particularly regarding acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, and standalone performance related to diagnostic or therapeutic effectiveness, is not present in this document. The device in question, an endoscopic central control unit, is a system for managing and controlling other medical devices in an operating room, rather than a device that directly yields a diagnostic output or performs a direct therapeutic action that would typically require such performance studies.
However, I can extract information related to the device's validation based on the document's content:
1. Table of Acceptance Criteria and Reported Device Performance
As noted, the document doesn't provide acceptance criteria and performance in the typical sense for a diagnostic device (e.g., sensitivity, specificity). The "performance" described here relates to compliance with regulatory standards for medical electrical equipment and software.
| Acceptance Criteria (Standards Adherence) | Reported Device Performance (Compliance) |
|---|---|
| Electrical safety (IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007)) | Complies with IEC 60601-1 (3rd edition) |
| Electrical safety (ANSI/AAMI ES60601-1) | Complies with ANSI/AAMI ES60601-1, C1: 2009, Amendment 2: 2010 |
| Electromagnetic compatibility (EMC) (IEC 60601-1-2 Edition 3: 2007-03) | Complies with IEC 60601-1-2 |
| Electromagnetic compatibility (EMC) (EN 61000-3-2/ EN 61000-3-3 for harmonics/flicker limit class A) | Complies with EN 61000-3-2/ EN 61000-3-3 |
| Software safety and functionality (FDA Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices") | Software verification and validation testing were conducted, and documentation was provided as recommended by FDA guidance. |
2. Sample size used for the test set and the data provenance:
- Sample size: Not applicable/Not provided. The validation described is compliance with electrical and software standards, not performance on a dataset of patient data.
- Data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- Not applicable. The "ground truth" here is compliance with established engineering and software safety standards, assessed through testing, not expert interpretation of medical data.
4. Adjudication method for the test set:
- Not applicable.
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:
- No MRMC study was done. This device is not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is an operating room control system, not a standalone diagnostic or therapeutic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" in this context is the adherence of the device to established international and national electrical safety and electromagnetic compatibility (EMC) standards and compliance with FDA software validation guidelines. This is verified through engineering tests and software verification documentation, not medical ground truth like pathology.
8. The sample size for the training set:
- Not applicable. This device is not a machine learning or AI algorithm that requires a training set in the conventional sense.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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.