(29 days)
The Nurse's Assistant® is a programmable controller operated through a touch screen GUI that offers professional O.R. staff a simplified remote user interface and a real time display of settings for the devices attached to the system thereby eliminating the necessity for using the various control panels on diverse surgical equipment.
The Nurse's Assistant® is intended to be used to turn on and off, and adjust certain settings of, endoscopic and surgical cameras, electrosurgical generators such as the ConMed System 5000 ESU, laparoscopic insufflators such as the Linvatec GS1002 Insufflator, surgical lamps, operating room ("O.R.") lights, and operate digital documentation products, VCR's, video monitors, video printers, radios and CD players.
The Nurse's Assistant® is indicated for use in general, cardiovascular, ENT, gastroenterology, urology, plastic, obstetrics, gynecology, and orthopedic surgery, and general thorascoscopy, general cardiothoracic surgery, general laparoscopy, nasopharyngoscopy, ear endoscopy, and sinuscopy. A few examples of the more common surgical procedures where this system could be used are laparoscopic cholecystectorny, laparoscopic hernia repair, laparoscopic appendectorny, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectorny, laparoscopic and thorascopic anteriorspinal fusion, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass, coronary artery bypass grafting where endoscopic visualization is indicated, examination of the evacuated cardiac chamber during performance of valve replacement, arthroscopic meniscus repair, anterior cruciate ligament repair and associated procedures.
The Nurse's Assistant is a programmable controller operated through a touch screen GUI that offers professional O.R. staff a simplified remote user interface and a real time display of settings for the devices attached to the system thereby eliminating the necessity for using the various control panels on diverse surgical equipment.
The document describes the ConMed Integrated Systems' Nurse's Assistant® O.R. Control System, a programmable controller that offers a simplified remote user interface and real-time display of settings for various surgical equipment. The device is intended to turn on, turn off, and adjust settings of endoscopic and surgical cameras, electrosurgical generators, laparoscopic insufflators, surgical lamps, operating room lights, and to operate digital documentation products, VCRs, video monitors, video printers, radios, and CD players.
Here's an analysis of the provided information, framed by your request for acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance
The provided document does not explicitly state specific quantitative acceptance criteria (e.g., performance metrics like accuracy, sensitivity, or specificity for a particular function) nor does it report the device's performance against such criteria in a clinical or analytical study.
Instead, the document focuses on compliance with safety standards as its primary method for demonstrating acceptable performance and substantial equivalence. The "acceptance criteria" can be inferred as the successful completion of these listed safety tests, which inherently imply the product is functioning as intended and safely.
If we interpret "acceptance criteria" as meeting safety standards and "reported device performance" as the successful completion of these tests, a table would look like this:
| Acceptance Criterion (Test Standard) | Reported Device Performance |
|---|---|
| IEC 601-1 | Tested to standard |
| IEC 601-1 Amendment 1 | Tested to standard |
| IEC 601-2-18 | Tested to standard |
| EN 60601-1 | Tested to standard |
| EN 60601-1-1 | Tested to standard |
| EN 60601-1-2 (2001) | Tested to standard |
| CAN/CSA C22.2 601.1-M90 | Tested to standard |
| UL 2601-1, 2nd Ed. | Tested to standard |
| EN 55011 (Conducted Emissions) | Tested to standard |
| EN 55011 (Radiated Emissions) | Tested to standard |
| IEC 61000-4-2 (Electrostatic Discharge) | Tested to standard |
| IEC 61000-4-3 (Radio Frequency Electromagnetic Fields) | Tested to standard |
| IEC 61000-4-4 (Fast Transients Common Mode) | Tested to standard |
| IEC 61000-4-5 (High Energy Surge) | Tested to standard |
| IEC 61000-4-6 (Conducted Immunity) | Tested to standard |
Explanation: The document explicitly states, "The Nurse's Assistant® O.R. Control System has been tested to the following standards:" followed by the list above. The implied "performance" is that the device successfully met the requirements of each standard.
2. 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 describe a clinical "test set" in the traditional sense of patient data. The testing performed was related to electrical safety and electromagnetic compatibility standards. Therefore, concepts like "sample size" for patient data, "country of origin," or "retrospective/prospective" are not applicable here. The testing was likely conducted in a laboratory environment on the device itself.
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)
This information is not applicable to the type of testing described (safety and EMC standards). "Ground truth" in this context would be whether the device passed or failed a specific engineering test, which is determined by test engineers and equipment, not by medical experts establishing a "ground truth" on patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used in clinical studies for interpretation of results by multiple experts. The testing described is against engineering standards.
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
Not applicable. The Nurse's Assistant® O.R. Control System is a control interface for surgical equipment, not an AI-powered diagnostic or assistive tool for human readers/clinicians, so an MRMC study comparing human readers with and without AI assistance is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an O.R. control system that relies on a "human-in-the-loop" (the O.R. staff) to operate it. It is not an autonomous algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context refers to the requirements and specifications defined by the various international and national safety and EMC standards (e.g., IEC 601-1, UL 2601-1, EN 55011). The device was tested to ensure it met these pre-defined engineering and safety "truths."
8. The sample size for the training set
Not applicable. The Nurse's Assistant® O.R. Control System is a hardware and software control system, not an AI/ML algorithm that requires a "training set" of data in the machine learning sense.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set."
§ 878.4580 Surgical lamp.
(a)
Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.(b)
Classification. Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.