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The Mallinckrodt Peripheral Dilatation Catheter is intended for use in Percutaneous Transluminal Angioplasty (PTA) of the peripheral vasculature system, such as the renal, iliac, femoral, popliteal, peroneal, and profunda arteries.

The Mallinckrodt PTA Catheter is intended for single patient use and is disposable, sterile and non-pyrogenic. This dilatation catheter is a coaxial double lumen catheter with a balloon mounted near the distal tip. The balloon is designed to inflate to a known diameter and length at pressures stated on the label (nominal inflation). The outer lumen is used for inflation of the balloon while the inner lumen permits (1) the use of a guide wire to facilitate catheter advancement to and through the stenosis to be dilated, and (2) low flow administration of contrast media to aid in correct positioning of the balloon. The lumens bifurcate from the catheter shaft to two molded hubs (proximal end of catheter), one for the inflation lumen and one for the guide wire lumen. The hubs are labeled for easy identification. The bifurcation is supported by a strain relief sleeve at the catheter end. Two radiopaque markers, within the balloon segment of the catheter, delineate the working length of the balloon for proper balloon orientation within a stenosis. The catheter tip is a highly radiopaque, soft, atraumatic material.

The Mallinckrodt PTA Catheter is available in two shaft diameters (4 and 5 Fr) and several shaft lengths (4 Fr - 90, 135 cm and S Fr - 45, 75, 125 cm). The catheter has a range of balloon sizes from 3 mm to 12 mm in inflated diameter and from 2 to 10 cm in length. (Note: Neither the 4 nor 5 Fr catheter with 12 min balloon is available in 8 and 10 cm length.) The catheters will be available with or without a hydrophilic coating.

Here's a summary of the acceptance criteria and the study details for the Mallinckrodt PTA Catheter, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the nature of the tests conducted and the statement that "The results of each test were found to be acceptable." Since specific numerical targets for acceptability are not provided, we infer that the device's performance in these tests met internal specifications or industry standards for similar predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify the exact sample size for each test. It states that "Finished PTA Catheters including both 4 and 5 Fr catheters with hydrophilic coating were tested" for biocompatibility and that "Bench testing was conducted for the following characteristics." This implies multiple units were tested, but the precise number is not given.
• Data Provenance: The tests were conducted internally by Mallinckrodt Inc. as part of their 510(k) submission. Therefore, the data provenance is from internal bench testing and biocompatibility testing. The country of origin of the data is implicitly the USA, where Mallinckrodt Inc. is located. The data is prospective in the sense that the tests were specifically performed to support this submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

• Number of Experts: Not applicable. The "ground truth" for these performance and biocompatibility tests is based on objective measurements and established scientific protocols (e.g., ISO 10993 for biocompatibility) rather than expert opinion on clinical findings.
• Qualifications of Experts: Not applicable for establishing ground truth in this context. The experts involved would be technical staff, engineers, and scientists specialized in medical device testing and biocompatibility, whose qualifications are inherent in conducting such tests according to regulatory standards.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. As the tests are objective measurements of physical and chemical properties, there is no need for an adjudication method based on subjective expert review. The results are either within acceptance limits or not.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? No. This document describes bench testing and biocompatibility testing for a medical device (a PTA catheter). MRMC studies are typically used for diagnostic devices (e.g., AI in radiology) to evaluate the performance of human readers with and without AI assistance on various cases. This device is an interventional therapeutic device, not a diagnostic one.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

• Was a standalone study done? Yes, in a manner of speaking, but not in the context of an algorithm. The entire study described comprises standalone performance tests of the device itself (e.g., balloon burst strength, biocompatibility), independent of human operators beyond the standard operating procedures for such devices. There is no AI or algorithm involved in the device's function as described.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the performance tests consists of objective physical measurements (e.g., pressure, diameter, strength, flow rates) compared against predefined specifications. For biocompatibility, the ground truth is established by conformance to recognized standards (ISO 10993) and the absence of adverse biological reactions (e.g., sensitization, cytotoxicity, hemolysis) as measured by standard laboratory assays.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This refers to the training of an AI algorithm, which is not relevant to this device's testing. The device itself is a physical medical instrument, not a software algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable, as there is no AI algorithm or training set involved.

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