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A-View® is intended for use in conjunction with TEE investigation of the upper mediastinum in anesthetized patients. They allow visibility of the distal ascending aorta by TEE and permit the condition of the ascending aorta to be evaluated before surgery. A-View® is limited for use in adult patients.

The A-View® is a catheter with an inflatable balloon that is inserted through an endotracheal tube of an anesthetized patient. Once inserted the balloon is inflated with saline. This inflated balloon is placed near the aortic arch so that when the clinician is performing a TEE (transesophageal echocardiography) procedure the saline filled balloon provides better contrast for an image.

The provided text describes the 510(k) premarket notification for the A-View® device, which is a diagnostic ultrasonic transducer. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove the device meets acceptance criteria through clinical performance testing. Therefore, much of the requested information regarding clinical studies, ground truth, expert adjudication, and comparative effectiveness studies is not included in this type of submission.

However, based on the non-clinical performance testing conducted, I can extract information related to acceptance criteria and performance for certain device characteristics.

Here's the breakdown of the available information:

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

The document details bench tests conducted and states that the A-View® met all performance requirements and specifications, supporting substantial equivalence to the predicate device. Specific acceptance criteria are not explicitly quantifiable values in the provided text (e.g., "leakage less than X ml/hr"), but rather a general statement of meeting requirements.

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

The document does not specify a "test set" in the context of clinical data. It discusses bench tests for device performance. Sample sizes for these non-clinical tests (e.g., number of devices tested for leakage) are not provided. There is no mention of country of origin for any clinical data because none was presented. The testing described is non-clinical/bench testing, not retrospective or prospective clinical studies.

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

This information is not applicable. No clinical "test set" with ground truth established by experts is mentioned or described in this 510(k) summary. The device performance was assessed via bench testing, not expert interpretation of clinical data.

4. Adjudication method for the test set

This information is not applicable as there was no clinical "test set" requiring expert adjudication.

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. The A-View® device is a physical diagnostic ultrasonic transducer, not an AI-powered diagnostic tool. No MRMC study was conducted or reported.

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

This information is not applicable as the A-View® device is not an algorithm.

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

For the non-clinical performance testing (bench tests), the "ground truth" would be established by the engineering and quality standards set for each test (e.g., a specific pressure maintained for a leak test, a measured force for a tensile test). These are objective physical measurements rather than clinical ground truth types like pathology or expert consensus.

8. The sample size for the training set

This information is not applicable. The A-View® is a physical medical device, not an AI or machine learning algorithm that requires a training set.

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

This information is not applicable for the same reason as above (not an AI/ML algorithm).

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A-View® catheters are intended for use in conjunction with TEE investigation of the upper mediastinum in anaesthetised patients. They allow visibility of the distal ascending aorta by TEE and permit the condition of the ascending aorta to be evaluated before surgery. A-View Catheters are limited for use in adult patients.

A-View Basic consists of only the catheter itself. The A-View catheter has three tubes connected by a Y-connector of which one holds a distal, large balloon, one holds a small, pilot balloon and the third holds a stop cock with two standard female luer connections. Both balloons are clear and colorless. On the main shaft a distance mark indicating 24 cm from the closest balloon shoulder is pointed out. A-View Plus consists of the catheter plus a standard 50 ml syringe with luer connector and a swivel Y-connector.

The provided text describes a medical device, the A-View® Basic and Plus Catheters, and its regulatory submission. It does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details typically associated with AI/ML device evaluations.

Instead, this document is a 510(k) summary for a physical medical device (a catheter) intended for use in conjunction with Transesophageal Echocardiography (TEE). The "Performance Data" section indicates that the device's performance was assessed against established standards for risk management, biocompatibility, sterilization, and packaging.

Therefore, I cannot provide the requested information. The text clearly states:

• Performance Data: "Data is contained within this 510(k) demonstrating A-View catheters meet the requirements of ISO 14971 (Risk Management), ISO 10993 (Biocompatibility), EN 550 (Sterilization), and EN 868 (Packaging)."

This is not an AI/ML device submission, and therefore the types of performance data and studies you are asking for (e.g., related to AI model accuracy, human-in-the-loop performance, ground truth establishment, training set details) are irrelevant to this specific device submission.

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