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The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion and power injection of contrast media. The maximum pressure of power injector equipment used with the pressure injectable PICC may not exceed 300 psi.

The Pressure Injectable Peripherally Inserted Central Catheters have the following characteristics: Radiopaque polyurethane catheters 4 Fr single-lumen BlueFlex® Tip and non-BlueFlex® Tip 5 Fr double lumen BlueFlex® Tip and non-BlueFlex® Tip Usable length of 4 Fr catheters are 40cm to 60cm Usable length of 5 Fr catheters are 40cm to 60cm Catheters are provided in sterile kit configurations The 4 Fr BlueFlex® Tip, 4Fr non-BlueFlex® Tip and 5 Fr BlueFlex® Tip catheters are labeled for "4ml/sec, pressure injectable" on the Luer hub(s) to facilitate the proper use of the device The 5 Fr non-BlueFlex® Tip catheter is labeled for "5ml/sec, pressure injectable" on the Luer hubs to facilitate the proper use of the device

The provided text does not contain information about acceptance criteria for a medical device's performance that would typically be evaluated through clinical studies with human patients, algorithms, or expert ground truth. Instead, it describes a 510(k) submission for a Pressure Injectable Peripherally Inserted Central Catheter (PICC) and focuses on bench testing to demonstrate substantial equivalence to a predicate device.

Therefore, many of the requested categories in your prompt (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to the information given.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. The tests are bench tests, likely involving a representative number of device units.
• Data Provenance: Bench test data; not human clinical data. No country of origin is specified for these bench tests, but the company is based in Reading, PA, USA. The data is prospective, as these are tests conducted specifically for the 510(k) submission.

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

• Not Applicable. The "ground truth" for these engineering/performance tests is defined by established engineering standards, test methods, and the performance of the predicate device, not by expert medical opinion on a clinical outcome.

4. Adjudication Method for the Test Set

• Not Applicable. As these are bench tests against predetermined engineering criteria, an adjudication method in the sense of reviewing ambiguous clinical cases is not relevant. The pass/fail criteria for each test (e.g., burst pressure, flow rate) would be objectively measured.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. This is a device submission based on bench testing of physical properties, not a study evaluating human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not Applicable. This is a physical medical device (catheter), not an AI algorithm.

7. The Type of Ground Truth Used

• Engineering Performance Metrics: The ground truth for these tests is the performance of the device against predefined engineering specifications (e.g., flow rates, burst pressures) and comparison to the predicate device's established performance under similar test conditions.

8. The Sample Size for the Training Set

• Not Applicable. This submission is for a physical medical device, not an AI model that requires a training set.

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

• Not Applicable. As there is no AI model or training set, this question is not relevant.

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The Arrow Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.
The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion and power injection of contrast media. The maximum pressure of power injector equipment used with the pressure injectable PICC may not exceed 300 psi.

The Arrow PICC have the following characteristics: Radiopaque polyurethane catheters; 4 Fr Single Lumen, trimmable; 5 Fr Double Lumen, trimmable and BlueFlex® Tip; Usable lengths of 5 French catheter is 40 and 60 cm; Usable length of 4 French catheter is 60 cm; Catheters are provided sterile kit configurations. The catheter is labeled for "4cc/pressure injectable" on the catheter distal hub to facilitate the proper use of the device.

Here's a breakdown of the acceptance criteria and study information based on the provided text, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" in the context of clinical trials or AI/algorithm performance. The performance tests described ("Dynamic Flow Rate test," "Catheter whip test," "Repeat Injection Test") are bench tests conducted on the physical device itself. Therefore, sample sizes for these tests are not provided in terms of patient data, nor is data provenance like country of origin or retrospective/prospective mentioned, as these are not relevant to bench testing.

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

Not applicable. The "ground truth" for these bench tests would be the measured physical properties or performance characteristics of the device under specific test conditions, compared against established engineering standards or the performance of a predicate device. This doesn't involve expert human assessment in the way clinical ground truth does.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the tests are bench tests, not clinical evaluations that would require adjudication of human interpretation.

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, an MRMC comparative effectiveness study was not done. This device is a medical catheter, not an AI or imaging diagnostic tool that would involve human readers or AI assistance in interpretation.

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

No, a standalone algorithm performance study was not done. This device is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the performance tests would be based on objective measurements and engineering standards, compared directly to the performance of the legally marketed predicate devices (AngioDynamic's Morpheus™ CT PICC and Arrow International's existing PICC). The "Repeat Injection Test" specifically verifies the ability to withstand power injection of contrast media at a maximum pressure of 300 psi, which would be a measured performance characteristic.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical product, not an AI or machine learning model that requires a training set.

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

Not applicable, as no training set was used for this device.

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