Search Results

The Nurse's Assistant® O.R. Control System, 1.8 is a programmable electrical medical system that is intended to provide trained staff with a centralized user interface from which to route audio and video signals, and to perform auxiliary control functions for activating, adjusting and monitoring certain settings of compatible medical and non-medical equipment.

The Nurse's Assistant® O.R. Control System, 1.8 is Indicated for use in an operating room for video assisted surgery during minimally invasive and traditional open procedures in all surgical specialities. The System is also used as an adjunct display of interventional techniques and provides teleconferencing capability through an optional interface.

The Nurse's Assistant® O.R. Control System, 1.8, is a modification of an existing device that is composed of off-the-shelf audio/video hardware components, proprietary software that runs on a non-Windows based operating system and a touch panel interface with an intuitive graphical user interface. The Nurse's Assistant® System 1.8 communicates with interconnected devices through standard data communication protocols which allows the adjustment of equipment settings and routing of audio/video signals from one location in the operating room.

The provided document is a 510(k) summary for the ConMed Integrated Systems Nurse's Assistant® O.R. Control System, 1.8. It focuses on demonstrating substantial equivalence to predicate devices based on intended use and technological characteristics.

Crucially, this document does not contain information about acceptance criteria, device performance metrics, sample sizes, expert ground truth establishment, or any comparative effectiveness studies (MRMC or standalone).

The document explicitly states: "Clinical testing is not required for this device." This indicates that the regulatory submission was based on non-clinical performance (e.g., electrical safety, electromagnetic compatibility) and a comparison of technological characteristics and intended use to previously cleared devices, rather than a study involving patient data or human readers.

Therefore, most of the requested information cannot be extracted from this document.

Here's what can be stated based on the provided text:

1. A table of acceptance criteria and the reported device performance:

• Not available. The document does not specify performance acceptance criteria or report device performance in terms of clinical metrics (e.g., sensitivity, specificity, accuracy). Its focus is on demonstrating safety and efficacy through equivalence to predicate devices and compliance with non-clinical standards.

2. Sample size used for the test set and the data provenance:

• Not applicable. Clinical testing with a test set of data (patients/images) was not conducted or required for this device according to the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. As no clinical testing was performed, there was no need for experts to establish ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. No clinical test set was used.

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. The document explicitly states "Clinical testing is not required for this device." An MRMC study would fall under clinical testing. Furthermore, this device is an O.R. control system, not an AI-powered diagnostic, so the concept of human readers improving with AI assistance is not relevant to its function.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• No. The device is an O.R. Control System; it's not an "algorithm" in the sense of an AI diagnostic. The document focuses on hardware, proprietary software, and its ability to route signals and control medical equipment.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not applicable. No clinical ground truth data was used as clinical testing was not conducted. The assessment relied on a comparison of technical specifications and intended use against predicate devices.

8. The sample size for the training set:

• Not applicable. This device is not an AI/ML algorithm that would typically be 'trained' on a dataset in the way a diagnostic AI is. Its software is proprietary, but its development would follow standard software engineering practices rather than machine learning training.

9. How the ground truth for the training set was established:

• Not applicable. As above, the concept of a 'training set' and 'ground truth' for training is not relevant to this type of device according to the provided documentation.

In summary, the provided FDA 510(k) summary focuses entirely on demonstrating substantial equivalence through non-clinical means (technical specifications, intended use comparison, and compliance with general safety standards), explicitly stating that clinical testing was not required for this device.

Ask a specific question about this device

The Nurse's Assistant® 1.7 O.R. Control System is a computerized control system that is intended to provide operating room (OR) staff with a simple, centralized user interface from which to activate, adjust and monitor certain settings of equipment located in the OR and to route audio and video from multiple sources to multiple destinations.

The Nurse's Assistant® 1.7 O.R. Control System is indicated for use in an operating room for video assisted surgery. This includes minimally invasive procedures in all surgical specialties, as an adjunct display of interventional techniques and traditional open procedures.

The Nurse's Assistant® 1.7 O.R. Control System indicated for use with ConMed Linvatec IM3300 Endoscopic Camera, ConMed Linvatec LS7500 Xenon Light Source, ConMed Linvatec GS1002 40L Insufflator, ConMed Electrosurgery System 5000 Electrosurgery Unit (ESU), ConMed Linvatec VP-1500 Digital Capture Device, Getinge ALM Surgical Lamp Energix WPS, Getinge ALM PrismaVision PRV3 Surgical Light Camera, Berchtold Chromophare D-Series Surgical Lamps, Berchtold ChromoVision HR24 Surgical Light Camera, National Display Systems 15" & 18" Vector III and 19" & 32" Radiance flat panel displays, Sony LMD-2140MD 21" flat panel display, Sony UP-51MD or Sony UP-51MDU video printers, Sony SVO-9500MD VCR, ProVation™ procedure documentation device, Skytron Stellar Series Surgical Lights, optional Surgeon's Assistant™ accessory touch panel and an audio/video conferencing interface.

The Nurse's Assistant® 1.7 O.R. Control System is indicated for use in general, cardiovascular, ENT, gastroenterology, urology, plastic, obstetrics, gynecology, and orthopedic surgery, and general thoracoscopy, general cardiothoracic surgery, general laparoscopy, arthroscopy, laparoscopy, nasopharynqoscopy, ear endoscopy and sinusoscopy.

The Nurse's Assistant® 1.7 O.R. Control System is a computerized control system that is intended to provide operating room (OR) staff with a simple, centralized user interface from which to activate, adjust and monitor certain settings of equipment located in the OR and to route audio and video from multiple sources to multiple destinations.

The provided text describes a 510(k) submission for a medical device called the "Nurse's Assistant® 1.7 O.R. Control System (1.7C)". This submission is for a modification to an existing device, and its primary purpose is to demonstrate substantial equivalence to previously marketed predicate devices.

Crucially, the document does NOT contain information about specific acceptance criteria or performance studies in the way one would typically find for a new artificial intelligence or diagnostic device. Instead, the "study" mentioned refers to the testing performed to demonstrate substantial equivalence to predicate devices rather than meeting specific performance metrics against a defined ground truth.

Here's an breakdown based on the information available:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly defined in terms of measurable performance metrics (e.g., sensitivity, specificity, accuracy). The implicit "acceptance criteria" is demonstrating substantial equivalence to predicate devices, meaning it operates in a similar manner and has similar safety and effectiveness.
• Reported Device Performance: The document states: "Tests performed on the Modification to Nurse's Assistant® 1.7 O.R. Control System demonstrate substantial equivalence to the predicate devices listed above." No specific numerical performance results are provided.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• This information is not provided in the document. The type of testing done is focused on the control system's functionality and safety, not on diagnostic performance with a test set of patient data.

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/not provided. The device is a surgical control system, not an AI or diagnostic tool that requires expert-established ground truth for performance evaluation in the typical sense. The 'ground truth' for such a device would relate to its functional specifications and safe operation, which are evaluated through engineering tests and adherence to standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• This information is not applicable/not provided for the same reasons as point 3.

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. This type of study is not relevant to a surgical control system. The device's purpose is to act as a centralized user interface for OR equipment, not to assist human readers in interpreting images or data.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• The device itself is a "computerized control system" designed for "operating room (OR) staff with a simple, centralized user interface". It is inherently a human-in-the-loop system. While functional tests of its components would be done standalone, the overall system's purpose is to be used by humans. The document does not detail specific standalone vs. human-in-the-loop performance studies as one would typically see for AI-driven diagnostic devices.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For this type of device (a control system), the "ground truth" would be its adherence to engineering specifications, safety standards, and functional requirements. For example, does it correctly actuate the specified equipment settings? Does it route audio/video as intended? These are verified through engineering and functional testing, not typically through pathology or expert consensus on clinical cases.

8. The sample size for the training set

• This information is not provided and is generally not applicable to this type of device. The Nurse's Assistant 1.7 O.R. Control System is a hardware/software control system, not an AI model that undergoes "training" with a dataset in the machine learning sense.

9. How the ground truth for the training set was established

• This information is not applicable for the reasons stated in point 8.

Ask a specific question about this device

The Nurse's Assistant® 1.7 O.R. Control System is a computerized control system that is intended to provide operating room (OR) staff with a simple, centralized user interface from which to activate, adjust and monitor certain settings of equipment located in the OR and to route video from multiple sources to multiple destinations.

The Nurse's Assistant® 1.7 O.R. Control System is indicated for use in an operating room for video assisted surgery. This includes minimally invasive procedures in all surgical specialties, as an adjunct display of interventional techniques and traditional open procedures.

The Nurse's Assistant 1.7 O.R. Control System indicated for use with ConMed Linvatec IM3300 Endoscopic Camera, ConMed Linvatec LS7500 Xenon Light Source, ConMed Linvatec GS1002 40L Insufflator, ConMed Electrosurgery System 5000 Electrosurgery Unit (ESU), ConMed Linvatec VP-1500 Digital Capture Device, Getinge ALM Surgical Lamp Energix WPS, Getinge ALM PrismaVision PRV3 Surgical Light Camera, Berchtold Chromophare D-Series Surgical Lamps, Berchtold ChromoVision HR24 Surgical Light Camera, National Display Systems 15" & 18" Vector III and 19" Radiance flat panel displays, Sony LMD-2140MD 21" flat panel display, Sony UP-51MD or Sony UP-51MDU video printers, Sony SVO-9500MD VCR, and ProVation™ procedure documentation device.

The Nurse's Assistant® 1.7 O.R. Control System is indicated for use in general, cardiovascular, ENT, gastroenterology, urology, plastic, obstetrics, gynecology, and orthopedic surgery, and general thoracoscopy, general cardiothoracic surgery, general laparoscopy, arthroscopy, laparoscopy, nasopharyngoscopy, ear endoscopy and sinusoscopy.

The Nurse's Assistant® 1.7 O.R. Control System is a computerized control system that is intended to provide operating room (OR) staff with a simple, centralized user interface from which to activate, adjust and monitor certain settings of equipment located in the OR and to route video from multiple sources to multiple destinations.

This 510(k) summary describes a modification to an existing device, the Nurse's Assistant® 1.7 O.R. Control System, and focuses on demonstrating substantial equivalence to predicate devices rather than independent performance testing against acceptance criteria. Therefore, many of the requested categories related to a de novo device study or AI-specific performance evaluation cannot be directly extracted from the provided text.

Here is an analysis based on the available information:

Description of the Device and Study Focus:

The Nurse's Assistant® 1.7 O.R. Control System is a computerized control system designed to provide OR staff with a centralized user interface for activating, adjusting, and monitoring certain equipment settings, and for routing video within the OR. The submission (K052740) describes a modification to an existing Nurse's Assistant® 1.7 O.R. Control System (predicate K050829) and also references the HERMES O.R. Control Center (predicate K030240). The primary goal of this submission is to demonstrate substantial equivalence to these predicate devices.

This means the "study" described is primarily a comparative effectiveness study against established predicate devices, focusing on demonstrating that the modified device has the same intended use, similar indications for use, and equivalent technological characteristics, safety, effectiveness, and performance. This is not a standalone performance study in the typical sense of establishing de novo performance metrics for a novel device. There is no indication of AI involvement in this device from the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

As this K052740 submission is for a modification to an already cleared device and relies on substantial equivalence, explicit "acceptance criteria" for a new device's performance are not detailed in the provided text. Instead, the "acceptance criteria" implicitly revolve around demonstrating equivalence to the predicate devices in terms of:

Note: The document explicitly states "Tests performed on the Modification to Nurse's Assistant® 1.7 O.R. Control System demonstrate substantial equivalence." However, the specific details or results of these "tests" are not provided in the submitted summary.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the given text. As the submission is for a modification seeking substantial equivalence, it's likely the "tests" performed were focused on verifying the new components or software changes maintained compatibility and functionality consistent with the predicate, rather than an extensive new clinical trial with a large test set. The provenance of any data (e.g., country of origin, retrospective/prospective) is also not mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided and is generally not applicable to this type of 510(k) submission for a control system modification focusing on substantial equivalence. The "ground truth" here would be the established safe and effective operation of the predicate devices.

4. Adjudication Method for the Test Set

This information is not provided and is not typically relevant for a substantial equivalence submission for a modification to a control system.

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

• No Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done based on the provided document.
• AI is not mentioned in the context of this device or study. The device is described as a "computerized control system," which predates widespread clinical AI applications. Therefore, there is no discussion of human readers improving with or without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This device is a "computerized control system" designed to provide a "user interface" for "OR staff." It inherently involves human interaction and is not an algorithm-only standalone device in the sense of an AI-powered diagnostic tool.
• The nature of the device (a control system for OR equipment) means its performance is inextricably linked to human operation and integration within the surgical environment.

7. The Type of Ground Truth Used

The "ground truth" for this substantial equivalence submission is implicitly the established safety, effectiveness, and performance of the legally marketed predicate devices (K050829 and K030240). The tests performed were to ensure the modified device maintained this established performance. There is no mention of pathology, outcomes data, or expert consensus being used to establish a new ground truth for this modification.

8. The Sample Size for the Training Set

This information is not provided and is irrelevant for this type of device and submission. This is not a machine learning or AI-driven device that requires a training set in that context.

9. How the Ground Truth for the Training Set Was Established

This information is not provided and is irrelevant for this type of device and submission.

Ask a specific question about this device

The Nurse's Assistant® 1.7 is intended to be used to route video from multiple sources to multiple destinations, to be used to turn on and off power to specific 110 volt receptacles within the OR, and to be used to adjust specific operating parameters of video displays, analog or digital recording, communication and playback equipment, endoscopic cameras, endoscopic light sources, surgical lamps, observation cameras, surgical cameras and operating room lights.

The Nurse's Assistant® 1.7 is indicated for use in an operating room for video assisted surgery. This includes minimally invasive procedures in all surgical specialties, as an adjunct display of interventional techniques and traditional open procedures.

The Nurse's Assistant® 1.7 is indicated for use in general, cardiovascular, ENT, gastroenterology, urology, plastic, obstetrics, gynecology, and orthopedic surgery, and general thoracoscopy, general cardiothoracic surgery, general laparoscopy, arthroscopy, laparoscopy, nasopharyngoscopy, ear endoscopy and sinusoscopy.

The Nurse's Assistant® 1.7 O.R. Control System is a computerized control system that provides operating room (OR) staff with a simple touch panel interface from which to activate, adjust and monitor certain settings of equipment located in the OR.

The provided text is a 510(k) premarket notification for the Nurse's Assistant® 1.7 O.R. Control System. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical trials to prove safety and effectiveness from scratch. Therefore, the information typically requested in your query (e.g., sample sizes, ground truth establishment, MRMC studies, specific acceptance criteria with performance metrics) is not present in this document, as it is not required for a 510(k) submission that demonstrates equivalence to existing predicate devices.

Instead, the document focuses on comparing the new device's intended use, indications for use, and technological characteristics to those of predicate devices. The "study" in this context is the comparison itself, which concludes that the Nurse's Assistant® 1.7 is substantially equivalent.

Here's an organized breakdown based on the available information, with explanations for what is not present:

Acceptance Criteria and Study for Nurse's Assistant® 1.7 O.R. Control System

Device: Nurse's Assistant® 1.7 O.R. Control System

Approach: This 510(k) submission leverages the concept of substantial equivalence to predicate devices rather than proving de novo safety and effectiveness through clinical trials with specific performance metrics. Therefore, the "acceptance criteria" and "study" are framed around demonstrating equivalence to already approved devices.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: For a 510(k) submission, the "acceptance criteria" are primarily established by the regulatory requirement to demonstrate substantial equivalence to legally marketed predicate devices. Specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy, precision figures) and numerical acceptance thresholds for these metrics are typically not provided in a 510(k) summary when equivalence is established through comparison of design and intended use, rather than de novo performance testing. The "reported performance" here refers to the conclusion of equivalence based on the comparison and any verification/validation testing performed.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not applicable/Not mentioned. The document does not describe specific patient or image test sets in the typical sense of a clinical performance study. The "tests performed" refer to verification and validation activities to confirm the device operates as designed and is equivalent to predicates.
• Data Provenance: Not applicable/Not mentioned. The document does not refer to clinical data (e.g., from specific countries, retrospective/prospective studies) for performance evaluation.

3. Number of Experts and Qualifications for Ground Truth

• Not applicable/Not mentioned. The determination of substantial equivalence does not involve establishing ground truth from experts for a diagnostic output.

4. Adjudication Method for the Test Set

• Not applicable/Not mentioned. No clinical test set is described.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No. The document does not describe an MRMC study.
• Effect Size: Not applicable. An MRMC study was not conducted, so no effect size for human reader improvement with AI assistance is reported. This device is an OR control system, not a diagnostic AI tool.

6. Standalone Performance Study (Algorithm Only)

• Standalone Performance Study: No. This device is an O.R. Control System; it's an integrated hardware/software system to manage other medical equipment, not a standalone algorithm in the typical AI sense that would have an "algorithm only" performance study. The "tests performed" refer to engineering and functional verification to ensure the system operates correctly.

7. Type of Ground Truth Used

• Not applicable/Not mentioned. The concept of "ground truth" (e.g., pathology, outcomes data) is not relevant to this 510(k) submission, which focuses on functional equivalence of an OR control system, not diagnostic accuracy.

8. Sample Size for the Training Set

• Not applicable/Not mentioned. This device is a control system, not a machine learning model that would typically have a "training set" of data in the context of AI.

9. How Ground Truth for the Training Set Was Established

• Not applicable/Not mentioned. As there is no described training set, there is no ground truth establishment for it.

Conclusion from the Document:

The Nurse's Assistant® 1.7 O.R. Control System gained clearance based on demonstrating substantial equivalence to three predicate devices: Val Med Nurse's Assistant O.R. Control System (K010754), Olympus Integrated Endosurgery System EndoALPHA (K981993), and Karl Storz OR1 (KSEA SCB-ACC) (K023704). The "study" proving it meets "acceptance criteria" is the comprehensive comparison of its intended use, indications for use, and technological characteristics to these legally marketed devices, concluding that it is as safe and effective.

Ask a specific question about this device

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:

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."

Ask a specific question about this device