Search Results

The Sony IP Converter's (IPC) intended use is to distribute patient images acquired from modalities within a hospital or clinical environment in almost real-time.

The IPC can send audio visuals and medical images to various commercially available products such as displays or recording devices commonly used in a medical procedure room or operating room.

The IPC allows for the switching of images easily among devices connected to an IPC in the operating room or throughout a healthcare campus.

The Sony IP Converter NU-IP40S is intended to transmit 4K or HD video and audio signals from endoscope system or other modalities equipped with 3G/HD-SDI video output via a high-speed optical fiber network with minimal delay.

Connecting multiple IP Converters via a network switch can construct a network video transmission system for medical procedures.

The provided document is a 510(k) summary for the Sony IP Converter NU-IP40S. This device is an "IP Converter" used for distributing patient images and audio-visuals within a hospital or clinical environment. It is classified as an "Endoscope and accessories" under regulation 21 CFR 876.1500.

The document states that no clinical study was included in the submission. Therefore, it is not possible to describe acceptance criteria or a study proving device performance in the context of clinical outcomes or human reader improvement, as this device primarily deals with technical image and audio-visual distribution.

However, the document does report on non-clinical performance data, which demonstrates the device's conformance to recognized technical safety and electromagnetic compatibility standards. These standards serve as the "acceptance criteria" for the non-clinical performance aspects of this device.

Here's a breakdown of the requested information based on the provided document:

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

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 specify a "test set" in the context of clinical samples or data. The testing mentioned relates to non-clinical performance (conformance to standards). For such testing, a sample size typically refers to the number of device units tested, but this detail is not provided. Data provenance is also not applicable in this context as it refers to technical performance rather than 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)

Not applicable. The non-clinical performance data involves testing against established technical standards, not expert-derived ground truth on clinical images.

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

Not applicable, as no clinical test set or adjudication process is described.

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: "No clinical study is included in this submission." This device is an IP converter for image/audio distribution, not an AI-powered diagnostic tool, so such a study would not be relevant.

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

Not applicable. This device is a hardware IP converter for signal distribution, not an algorithm.

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

Not applicable. For non-clinical performance testing against technical standards, the "ground truth" is the specifications and requirements defined by those standards.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI/machine learning device.

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

Not applicable. There is no training set.

Ask a specific question about this device