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The Rinspirator is intended to infuse physician specified fluid and remove/aspirate fluid, fresh, soft emboli and thrombi from the coronary and peripheral vasculature.

The Rinspirator consists of a catheter and a hand-held unit with accessories. The Rinspirator Catheter is a multi-lumen, rail configuration catheter to dispense an infusible fluid. The central lumen of the catheter is used for aspiration. The Rinspirator is provided sterile for single-use. The system is sterilized by Ethylene Oxide (ANSI/AAMI/ISO 11135), including limits for Ethylene Oxide residuals and validated to a sterility assurance level (SAL) of 106. The device is biocompatible per ISO-10993-1.

The provided documents describe the "Rinspirator" device, an embolectomy catheter, and its 510(k) summary for substantial equivalence. However, the documents do not contain information regarding detailed acceptance criteria, a specific study proving the device meets those criteria, or performance metrics like sensitivity, specificity, accuracy, or effect sizes for AI assistance.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (The Rinspiration Catheter System K062275), primarily noting a change in the lubricious coating on the catheter shaft. It states that "The subject device was shown to have substantially equivalent performance when compared to the predicate device." This implies that the device likely met performance criteria comparable to the predicate, but the specific metrics are not detailed in these documents.

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

Here's a breakdown of what can be extracted and what is missing:

1. Table of acceptance criteria and reported device performance:

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

• Sample size: Not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The 510(k) summary mentions "Special 510(k) safety and effectiveness" but doesn't detail any specific clinical study data beyond claiming substantial equivalence.

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

• Not applicable/Not specified, as no specific test set or ground truth establishment process is described for device performance evaluation in these documents.

4. Adjudication method for the test set:

• Not applicable/Not specified.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:

• No. The device is an embolectomy catheter, not an AI or imaging diagnostic device that would typically involve an MRMC study with human readers and AI assistance.

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

• No. This is a physical medical device (catheter), not an algorithm or AI.

7. The type of ground truth used:

• Not applicable/Not specified for performance evaluation data in these documents. The comparison is primarily based on the functional equivalence due to a coating change to a predicate device already on the market.

8. The sample size for the training set:

• Not applicable/Not specified. This is a physical medical device, not an AI model requiring a training set.

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

• Not applicable/Not specified.

Summary from the documents:

The documents confirm the regulatory clearance of "The Rinspirator" embolectomy catheter. The basis for clearance was a 510(k) submission demonstrating substantial equivalence to an existing predicate device (The Rinspiration Catheter System K062275). The only significant change noted was the type of lubricious coating on the catheter shaft (from silicone-based to hydrophilic). The 510(k) summary explicitly states: "With the exception of the coating, The Rinspirator is substantially equivalent in materials of construction, design, intended use, and safety and efficacy to the predicate device. The subject device was shown to have substantially equivalent performance when compared to the predicate device." This implies that testing (likely non-clinical, such as bench testing for lubricity, biocompatibility, and functionality) was conducted to ensure the coating change did not negatively impact performance, but the specific details of these tests, acceptance criteria, and quantitative results are not provided in the publicly available 510(k) summary.

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