Search Results

This medical monitor is intended to provide color video displays and images from medical equipment which include laparoscopy and endoscopy systems for surgery and various medical imaging systems.

27HS714S LCD monitor is intended to provide color video displays of images from surgical endoscope, laparoscopic camera system and other compatible medical imaging systems. This Medical Monitor has multiple video interface ports such as Display port, HDM, DVI and SDI. This monitor displays color video and images from medical equipment which include various medical imaging systems. This monitor can be covered over 99% of the sRGB spectrum.

This document, K243439, is a 510(k) premarket notification for a medical monitor (27HS714S). The information provided focuses on demonstrating substantial equivalence to a predicate device (K241402) rather than presenting a study proving the device meets specific acceptance criteria in the context of AI/ML performance.

Therefore, many of the requested elements regarding acceptance criteria for AI/ML performance, ground truth establishment, expert adjudication, and MRMC studies are not applicable or cannot be extracted from this document, as the device is a monitor, not an AI/ML-driven diagnostic tool.

However, I can extract information related to the device's functional performance and safety validations:

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

The document does not specify quantitative acceptance criteria for performance in the sense of diagnostic accuracy or output quality against a ground truth, as it is a display monitor. Instead, the acceptance criteria are implied by compliance with established medical device standards for electrical safety, electromagnetic compatibility, and software validation. The "reported device performance" is essentially that it met these standard requirements.

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

• Sample Size for Test Set: Not applicable. The document describes bench tests for electrical safety, EMC, and software validation, not a test set of clinical cases or data for AI/ML performance.
• Data Provenance: Not applicable for AI/ML data. The tests are laboratory/bench-based.

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

Not applicable. Ground truth as typically defined for AI/ML (e.g., disease presence/absence determined by experts) is not relevant for this device's validation. Validation was against technical standards.

4. Adjudication method for the test set

Not applicable. There was no expert adjudication of clinical cases.

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. This device is a medical monitor, not an AI-assisted diagnostic tool. No MRMC study was conducted or is relevant for its performance validation.

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

Not applicable. This is not an algorithm-only device. Its "performance" relates to its ability to display images accurately and safely, not to independently analyze data.

7. The type of ground truth used

The "ground truth" for this device's validation were the requirements of the specified international standards (IEC 60601-1, IEC 60601-1-2, IEC TR 60601-4-2, IEC 62304) and FDA guidance documents. Compliance with these standards served as the benchmark for acceptance.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set of data.

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

Not applicable.

Summary of the Device's Validation Study (as described in the document):

The study to prove the device (Medical Monitor 27HS714S) meets acceptance criteria primarily consists of bench tests and software validation.

• Purpose: To demonstrate the device's compliance with electrical safety, electromagnetic compatibility, and software development standards, and thus its substantial equivalence to the predicate device.
• Methodology:
  • Electrical Safety & EMC: Bench tests were conducted against harmonized standards: IEC60601-1 Edition 3.2 2020-08, IEC60601-1-2 Edition 4.1 2020-09, and IEC TR 60601-4-2 Edition 1.0 2016-05. These tests verify the device's safe operation and its ability to function correctly in its electromagnetic environment.
  • Software Validation: The software was designed, developed, verified, and validated according to IEC 62304, a standard for medical device software life cycle processes. Information was provided in accordance with FDA guidance "The content of premarket submissions for Device Software Functions (June 14, 2023)."
• Results: The tests demonstrated that the proposed device complies with all specified standards.
• Clinical Studies: None were considered necessary or conducted, as the device's function as a display monitor does not typically require clinical performance studies for safety and effectiveness demonstration in a 510(k) context, especially when demonstrating substantial equivalence. The document explicitly states: "No clinical studies were considered necessary, and therefore, none were conducted."

Ask a specific question about this device