Search Results

The TEECAD System is intended to provide visualization during the placement of a Transesophageal Echocardiogram (TEE) probe in adults. Do not use this system for any purpose other than the intended use.

The Visura TEE Camera Assist Device (TEECAD) is an accessory that provides visualization for the physician during TEE probe placement. It consists of a very simple design that has two main components:

• Disposable Carrier a single-use carrier with an integrated camera .
• Viewing System a physician interface display unit .
  The TEECAD System is not a diagnostic or therapeutic device. The TEECAD Disposable Carrier acts as an accessory that attaches to the commercially available Philips X7-2t TEE transducer probe and is removed once the probe reaches its target location in the patient's esophagus to allow for normal ultrasound imaging of the heart.
  The TEECAD Disposable Carrier is a single use device, and is designed to be manufactured with commonly used medical device materials that are considered safe for body contact.
  The Viewing System includes software that allows the operator to view the endoscopic images during TEE probe placement. The software is installed by the manufacturer and cannot be accessed, modified or installed by the user.

The provided text does not contain specific acceptance criteria or details of a study that proves the device meets such criteria. It is an FDA 510(k) clearance letter and summary, which confirms the device's substantial equivalence to a predicate device based on non-clinical testing.

Here's what can be extracted based on the provided text, and what information is not available:

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

The document does not provide a table of acceptance criteria or specific reported device performance metrics in detail. It mentions that "the collective results of the non-clinical tests demonstrate that the TEECAD System meets the established specifications necessary for consistent performance for its intended use" and that "the TEECAD System is a safe and effective device." However, the 'established specifications' are not detailed, nor are the specific performance results in a quantifiable manner.

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 refers to "non-clinical tests" including "TEECAD Design Verification and Validation Studies," "Packaging Testing," "Biocompatibility Testing," "Cleaning Validation," "Software Verification and Validation," "Electrical safety, electromagnetic compatibility, and laser safety testing," and "TEECAD System GLP Animal Safety and Performance Report."

• Sample Size for Test Set: Not specified for any of the tests.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
  • The "GLP Animal Safety and Performance Report" implies animal testing, but specifics of the animal model, location, and study design are not given.

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 provided. The testing described is "non-clinical" and appears to involve engineering, material science, and animal studies rather than human clinical studies requiring expert ground truth establishment in the traditional sense of diagnostic accuracy.

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

Not applicable or not provided. The described tests are non-clinical and do not involve adjudication by experts for diagnostic or similar outcomes.

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

• MRMC Study: No, an MRMC study was not described. The device, TEECAD System, is an accessory for visualization during TEE probe placement, not an AI diagnostic tool requiring human reader improvement comparison.
• Effect Size: Not applicable.

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

• Standalone Performance: The TEECAD System's "Viewing System includes software that allows the operator to view the endoscopic images during TEE probe placement." The software is not described as an AI algorithm providing diagnostic or analytical output; rather, it facilitates live image viewing. Therefore, a standalone algorithm performance in the context of AI is not relevant or described. The non-clinical tests assess the device's functional and safety performance, which would include the performance of the imaging system itself.

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

Given the non-clinical nature of the studies (design verification, biocompatibility, animal safety), the concept of "ground truth" as typically applied in diagnostic imaging (e.g., pathology, expert consensus) is not directly applicable. The "ground truth" for these tests would be defined by the specified engineering standards, material properties, safety parameters, and physiological responses observed in animal models.

8. The sample size for the training set

Not applicable. The TEECAD System is described as a "very simple design" with hardware components (disposable carrier with integrated camera, viewing system) and software for image viewing. There is no mention of machine learning or an AI algorithm that would require a "training set."

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

Not applicable, as no training set for an AI algorithm appears to be involved.

Ask a specific question about this device