Search Results

The CritiView Device is indicated for in-vivo monitoring of changes in NADH redox state and microvascular perfusion in tissue. Changes in the measured parameters--blood flow change, blood volume change, and NADH concentration change-- provide information on tissue metabolic activity.

Tissues which may be monitored are: brain, liver, kidney, intestine, testis, skin, and urethra. Note that heart may not be used as the heart beating motion may not provide a reliable probe contact surface.

The CritiView device carries out certain in-vivo, spectroscopic measurements and displays them as a trend. The parameters measured are blood flow change, blood volume change, and NADH concentration change. It is a multi-parametric monitoring device intended for the measurement of tissue metabolic state. The Criti View device consists of NADH Fluorometer and Doppler Flowmeter. The CritiView (CRV3) device is a modification of the predicate, CritiView, K051145. Measurements are made with the use of optical probes, i.e. pencil type for direct tissue contact and Foley catheter for measurement on the urethral wall tissue.

The provided text is a 510(k) Non-Confidential Summary of Safety and Effectiveness for the CritiView Model CRV3 device. This type of document is primarily focused on demonstrating substantial equivalence to a predicate device and includes details about the device's intended use, technical specifications, and comparison to existing devices. It does not contain information about acceptance criteria or specific study results that prove the device meets performance criteria in the way a clinical trial report or a dedicated validation study would.

Therefore, many of the requested items (acceptance criteria, reported device performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance, etc.) cannot be extracted from this document.

The document states: "There are no significant differences between the CritiView (CRV3) and the predicate --CritiView, K051145 and between the CritiView Foley catheter probe accessory and the predicate Foley catheter, Mallinckrodt - Foley with temperature - K923538." This implies that the device is considered safe and effective based on its substantial equivalence to previously cleared devices, rather than through a new, comprehensive performance study outlined in this summary.

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

• Acceptance criteria and reported device performance: Not explicitly stated in this document. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific performance metrics against pre-defined acceptance criteria.
• Sample size used for the test set and the data provenance: Not mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
• Adjudication method for the test set: Not mentioned.
• 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 mentioned. This device is not described as an AI-assisted diagnostic tool.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a medical device for direct measurement, not an algorithm.
• The type of ground truth used: Not mentioned.
• The sample size for the training set: Not mentioned.
• How the ground truth for the training set was established: Not mentioned.

Ask a specific question about this device

CritiView is indicated for in-vivo monitoring of changes in NADH redox state and microvascular perfusion in tissue. Changes in the measured parameters, blood flow change, blood volume change, and NADH concentration change provide information on tissue metabolic activity. The CritiView uses a pencil style probe which is in contact with the tissue(s) to be measured / monitored. The device may be used for up to eight (8) hours per twenty-four (24) hour period. Tissues which may be monitored are: brain, liver, kidney, intestine, testis, skin. Note that heart may not be used, as the heart beating motion may not provide a reliable probe contact surface. Environment of use include - hospital - OR, ICU, Emergency Departments, High Dependency Units Institutions

The CritiView device carries out certain in-vivo, spectroscopic measurements and displays them as a trend. The parameters measured are blood flow change, blood volume change, and NADH concentration change. It is a multi-parametric monitoring device intended for the measurement of tissue metabolic state. The CritiView device consists of NADH Fluorometer and Doppler Flowmeter. The CritiView device is a modification of the predicate, Tissue Spectroscope (K992529).

The provided text is a 510(k) summary for the CritiView device, which is a cardiovascular blood flowmeter intended for in-vivo monitoring of changes in NADH redox state and microvascular perfusion in tissue.

It does not provide information on acceptance criteria or the specific study that proves the device meets acceptance criteria.

The document primarily focuses on:

• Device Description: What the CritiView is and what it measures.
• Indications for Use: How the device is intended to be used.
• Patient Population: The types of patients for whom the device is intended.
• Summary of Specifications: Technical details and operational parameters.
• Predicate Device Comparison: Stating that there are no significant differences between CritiView and its predicate device (Tissue Spectroscope, K992529).
• FDA Clearance Letter: Confirmation of substantial equivalence to a legally marketed predicate device.

Since the document explicitly states "There are no significant differences between the CritiView and the predicate – Tissue Spectroscope, K992529", it implies that the basis for clearance is substantial equivalence to the predicate device, rather than a new standalone clinical performance study with predefined acceptance criteria for the CritiView itself.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert adjudication, or MRMC studies for the CritiView device is not available in the provided text. The 510(k) summary relies on the substantial equivalence to a predicate device, meaning that the predicate device would have undergone testing and had its performance established.

Ask a specific question about this device