Search Results

The Imaging Jet System provides physicians with a three dimensional image of an endoscope inside a patient.

The Imaging Jet is an endoscopic accessory that provides a spatial view of an endoscope inside a patient. When in use, the sensor catheter is inserted into the biopsy channel of an endoscope inside a patient. The sensor catheter measures the shape of a scope and sends sensory signals to a computer for calculating and displaying the image on the computer screen. A complete Imaging Jet system consists of the following major components: (1). a computer which governs the operation of the whole system, calculates the scope spatial image and displays the image; (2). a signal processing unit which acquires and processes the sensory signals and supplies them to the computer for image calculation; (3). a sensor catheter which is a long flexible rod with sensors embedded inside in its head portion; (4). a sensor catheter transport unit which is used to insert and withdraw sensor catheter into and from the biopsy channel of a scope; and (5). a mobile stand for transporting the whole system.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

The provided text describes a laboratory test to evaluate the performance of the Imaging Jet system.

1. Table of Acceptance Criteria and Reported Device Performance: See the table above.

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

   • Sample Size: The document does not explicitly state a numerical sample size. It refers to using "a colonoscope to form different shapes" and then presenting "five actual scope images and the measured images using Imaging Jet." This suggests a small, qualitative visual comparison rather than a statistically robust sample. The images shown are (a) spiral, (b) two intersecting loops, (c) single loop, (d) large curve with loop, (e) wave-like curve, and (f) S-shape (top and side views).
   • Data Provenance: The data was generated in a "laboratory test." No country of origin is mentioned, but the company address is in Ypsilanti, Michigan, USA. The study appears to be prospective as it involves creating shapes and then measuring them with the device.

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

   • The document does not mention the use of experts to establish a ground truth for the test set. The "actual scope image" (ground truth) was presumably generated by physically shaping the colonoscope, and its accuracy is implied rather than expert-validated.

4. Adjudication method for the test set:

   • No adjudication method is mentioned or implied. The comparison is visual, between the "actual scope image" and the "measured image using Imaging Jet."

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 MRMC study was conducted. The device is a "Spatial Imaging Sensor for Endoscopy" providing a 3D image of the endoscope's shape within the patient. It is not an AI-assisted diagnostic tool that humans would use to improve their reading of medical images.

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

   • Yes, the performance evaluation described appears to be a standalone (algorithm only) assessment. The system measures the shapes and displays them; there is no human interpretation or interaction described as part of the performance evaluation.

7. The type of ground truth used:

   • The ground truth used was the "actual scope image", meaning the physical shape the colonoscope was formed into during the laboratory test. This is an objective, physically defined ground truth rather than expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

   • The document does not mention a training set or machine learning aspects for this device. The phrase "effectiveness of this device is established through thorough mathematical analysis" suggests models and algorithms derived from mathematical principles rather than a data-driven machine learning approach requiring a training set.

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

   • Not applicable, as no training set is mentioned.

Ask a specific question about this device