(115 days)
The Barco Nexxis OR system is designed to allow transfer, selection and distribution of A/V signals and medical images from various commercially available instruments that are commonly used in a medical procedure laboratory or operating room.
The Barco Nexxis OR system is also designed for transfer, selection and distribution of human interface signals and control signals of non-medical room equipment,
The Barco Nexxis OR system allows control and selection of these signals from a central point.
The Barco Nexxis OR system is not intended to be used for remote or robotically assisted surgery,
The Barco Nexxis OR system is not intended to be used in the vicinity of MRI or other devices that use strong magnetic fields.
The Nexxis OR system is a solution for video distribution in operating rooms and medical procedure laboratories. The Nexxis OR can consist of any possible combination of the Nexxis encoders/decoders that transfer video signals from various available devices to one or more output devices (displays). Additionally the Nexxis components can transfer audio signals and USB signals. The USB communication is intended only for keyboard and mouse control and control signals for non-medical room equipment. The selection of sources and output devices is done by control software (NMS API). The Nexxis OR system can also contain, optionally, the MNC-180 compositor device, a MDSC-8258 MNA display and/or the touch user interface MUIP-2112. The Nexxis OR system may now consist of any combination of the following components: a) Nexxis OR components (Medical network adaptors) b) Nexxis Compositor with NCS composition software (MNC-180) c) Nexxis Management Suite (NMS). d) A 58-inch large screen LCD monitor: Barco MDSC-8258 MNA.(optional) e) touch user interface MUIP-2112 (optional) f) Cables g) Documentation
The provided document is a 510(k) premarket notification for the Barco Nexxis OR system, which is a video distribution solution for operating rooms. The document focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study to prove meeting those criteria in the context of diagnostic performance.
Therefore, many of the requested elements for a diagnostic device's acceptance criteria and study cannot be extracted from this document.
Here's what can be gathered and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria in the sense of specific performance metrics (e.g., sensitivity, specificity, accuracy) for a diagnostic output. Instead, the "acceptance criteria" can be inferred as demonstration of similar characteristics in terms of safety and effectiveness compared to the predicate device.
| Acceptance Criteria (Inferred from regulatory context) | Reported Device Performance (from "Performance testing" section) |
|---|---|
| Similar characteristics to predicate device | "The tests showed that the device has similar characteristics compared to the predicate device and did not reveal new issues of safety and effectiveness." |
| No new issues of safety and effectiveness | "The tests showed that the device... did not reveal new issues of safety and effectiveness." |
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 testing described ("Display bench tests," "Display validation tests," "Nexxis OR qualification tests," "System tests") appears to be engineering and system validation rather than clinical performance testing with a "test set" of medical images or 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 video distribution system, not a diagnostic algorithm that relies on expert interpretation of output.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided.
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
This information is not applicable/not provided. This is not a diagnostic device with an AI component for image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable/not provided. This is a system for distributing video signals, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable/not provided. Ground truth in a clinical sense would not be relevant for the device itself, though the medical images it transmits would have their own ground truth established outside the scope of this device.
8. The sample size for the training set
This information is not applicable/not provided. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable/not provided.
Summary based on information provided in the document:
The Barco Nexxis OR system is a medical video distribution system. The study to demonstrate its performance and meet acceptance criteria primarily consisted of bench tests and system qualification tests. These tests aimed to show that the device has similar characteristics to its predicate device (Nexxis OR cleared under K170537) and did not reveal new issues of safety and effectiveness. The document explicitly states that "Animal or clinical testing have not been performed," indicating that the "study" was not a clinical trial in the traditional sense, but rather engineering and functional validation.
§ 870.2450 Medical cathode-ray tube display.
(a)
Identification. A medical cathode-ray tube display is a device designed primarily to display selected biological signals. This device often incorporates special display features unique to a specific biological signal.(b)
Classification. Class II (performance standards).