Search Results

The Ryder device is intended for single use inflating of a balloon catheter, monitoring the pressure within the catheter and deflating the balloon catheter during angioplasty procedures.

The Ryder Balloon Catheter Inflation Device consists of a plastic syringe with a screen-type plunger and a locking lever and rotating pairn grip that control the plunger, a manometer to measure pressure and a high pressure connecting tube.

The Ryder Device has a fluid capacity of 20 cc. and an operating pressure range of vacuum to 30 bars.

The provided text describes a medical device, the "Ryder Balloon Catheter Inflation Syringe," and a summary of its safety testing. However, it does not contain any information regarding acceptance criteria, device performance metrics (like sensitivity, specificity, accuracy), or any studies that would typically be described with the questions posed in the request.

Here's a breakdown of why each question cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document mentions "USP guidelines" for material testing but doesn't detail performance criteria or results beyond "product is safe for its intended use."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No information about a test set for performance evaluation is provided. The safety testing mentioned refers to material compatibility rather than device performance in a clinical or simulated clinical setting.
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): Not applicable, as there's no test set described for performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 mechanical syringe, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a mechanical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no performance study is described.
8. The sample size for the training set: Not applicable, as this is a mechanical device, not a machine learning algorithm.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document focuses on the description, intended use, and material safety testing of a physical medical device (a syringe), not on the performance characteristics or clinical efficacy studies typically associated with "acceptance criteria" for AI-powered or diagnostic devices as implied by the detailed questions.

Ask a specific question about this device