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The OPTIMUS 0.035" PTA Balloon Dilatation Catheter is intended to dilate stenoses in the Illiac, Femoral, Popliteal and Renal arteries.

The OPTIMUS 0.035" PTA Balloon Dilatation Catheter is a two lumen catheter with a distal inflatable balloon. One lumen is used for inflation of the balloon with contrast medium; the other lumen permits the use of a guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. Two radiopaque marker bands indicate the dilatating section of the balloon and aid in the balloon placement. The marker bands also indicate the stated nominal length of the balloon. The catheter tip is designed to ease entry into the indicated arteries and to facilitate the crossing of tight stenoses.

The provided text describes the OPTIMUS 0.035" PTA Balloon Dilatation Catheter and its clearance. However, it does not include details about acceptance criteria, device performance tables, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices based on non-clinical design verification/validation tests. It does not present a clinical study with detailed performance metrics as one might find for a novel device or AI-driven system.

Here's what can be extracted based on the provided text, and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated in terms of performance metrics (e.g., sensitivity, specificity, accuracy). The document focuses on "substantial equivalence" to predicate devices.
• Reported Device Performance: The document states: "Substantial equivalence of the OPTIMUS 0.035" PTA Balloon Dilatation Catheter to the predicate device has been demonstrated through data collected from non-clinical design verification/ validation tests and analyses. The device has been tested according to ISO 10993 Part 1 and was determined to be biocompatible."
  • Specific performance numbers (e.g., balloon burst pressure, inflation/deflation times, guidewire trackability, etc.) for non-clinical tests are not included in this summary.

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

• Not applicable / Not provided. The summary describes non-clinical design verification/validation tests, not a clinical study with a "test set" of patient data in the context of an AI/algorithm-driven device.

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

• Not applicable / Not provided. This information pertains to studies validating AI or diagnostic devices against expert consensus, which is not described here.

4. Adjudication method for the test set

• Not applicable / Not provided. This information pertains to studies validating AI or diagnostic devices against expert consensus, which is not described here.

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. This is a medical device (balloon catheter), not an AI-driven diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.

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

• No. This is a medical device, not an algorithm.

7. The type of ground truth used

• Not applicable / Not provided in the context of clinical "ground truth." The "ground truth" for this device's validation appears to be engineering specifications and standards for device performance, and biocompatibility testing against ISO standards.

8. The sample size for the training set

• Not applicable / Not provided. This device does not involve a "training set" in the machine learning sense.

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

• Not applicable / Not provided. This device does not involve a "training set."

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