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The inflation device is intended for single use while performing urological balloon dilation procedures to inflate the balloon, monitor the pressure within the balloon and deflate the balloon.

The Ryder Urological Balloon Catheter Inflation Device consists of a plastic syringe with a screw-type plunger and a locking lever and rotating palm grip that control the plunger, a manometer to measure pressure and a high pressure connecting tube. The Device has a fluid capacity of 20 cc and an operating pressure range of vacuum to 20 atm.

This document is a 510(k) summary for a medical device (Ryder Urological Balloon Catheter Inflation Device) and does not contain detailed information about a clinical study with acceptance criteria, sample sizes, expert involvement, or adjudication methods in the way a diagnostic AI study would. Instead, it focuses on demonstrating substantial equivalence to a predicate device through technological characteristics and safety testing.

Therefore, many of the requested fields cannot be directly extracted from the provided text.

Based on the information given, here's what can be inferred and what cannot:

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not applicable. This document describes a new device submission, not a study involving a "test set" in the context of clinical performance data. The device's safety was assessed through materials testing and comparison to a predicate.
• Data Provenance: Not applicable.

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. No "ground truth" establishment in a diagnostic sense is described.

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 not an AI-assisted diagnostic tool.

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

• Not applicable. This is a physical medical device, not an algorithm.

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

• For the safety testing, the "ground truth" was adherence to USP guidelines for biocompatibility of materials.

8. The sample size for the training set

• Not applicable. No "training set" in the context of machine learning or clinical trials is mentioned.

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

• Not applicable.

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The Ryder Lacrimal Intubation set is valuable in the reconstruction of the lacrimal outflow system and also useful in canaliculus repair, lacrimal obstruction and complicated and uncomplicated dacryocystorhinostomy procedures.

The Lacrimal Intubation Set consists of two malleable stainless steel probes (to facilitate insertion) securely attached to a flexible silicone tube of varying thickness. The intubation set is a single-use product, sterilized by gamma radiation.

The provided text is a summary of safety and effectiveness for a medical device (Ryder Lacrimal Intubation Set) and a subsequent correction letter from the FDA. It does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it detail any performance data, sample sizes, expert involvement, or ground truth methodologies typically associated with clinical studies or AI/algorithm performance evaluations.

The document explicitly states: "Based on the 510(k) "Substantial Equivalence" decision-making process and the information provided herein, we conclude that the new device is substantially equivalent to the predicate device under the Federal Food, Drug and Cosmetic Act." This indicates that the device was approved based on its similarity to a previously approved predicate device, not through a study demonstrating it meets specific performance acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and a study proving the device meets them from the provided text.

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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.

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