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The Xcela Power Injectable PICC is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administrations and nutrients, the sampling of blood, and for power injection of contrast media.

The Xcela PICC with PASV Valve technology is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administrations and nutrients, the sampling of blood, and for power injection of contrast media.

The Xcela Hybrid PICC with PASY Valve technology is indicated for short or long-term access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media. Non-valved lumens are indicated for central venous pressure monitoring. The maximum power injection flow rate is 6 mL/sec.

The proposed device has identical technological characteristics and performance as the predicate intravascular catheters. Both the proposed and predicate devices are, in brief, intended for short- or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, and power injection of contrast media. available in single and multi-lumen configurations in a wide range of sizes from 3F to 6 F outside catheter diameter; rated for maximum power injector settings up to 325 psi rated for maximum power injection flow rate up to 6 ml/second based on model; and available kitted with a range of procedural accessories for user convenience. The only difference compared to the current Xcela Power Injectable PICC, Xcela PICC with PASV Valve and Xcela Hybrid PICC with PASV Valve catheters cleared via K093366, K111906 and K150527 is a change of the catheter shaft, luer and suture wing print ink.

Here's an analysis of the provided text regarding acceptance criteria and the study that proves device performance. It's important to note that this document is a 510(k) summary for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria in the way one might for a novel AI device. Therefore, some of the requested categories (especially those related to AI algorithm performance) will not be applicable or directly found in this type of document.

Summary of Acceptance Criteria and Device Performance:

The document describes the Xcela Power Injectable PICC, Xcela PICC with PASV Valve Technology, and Xcela Hybrid PICC with PASV Valve Technology. The core premise for this 510(k) submission is that the only difference compared to previously cleared predicate devices (K093366, K111906, and K150527) is a change in the catheter shaft, luer, and suture wing print ink. Therefore, the "acceptance criteria" and "device performance" largely refer to the established performance characteristics of the predicate devices, which the modified device is expected to meet due to the minor nature of the change.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) for a minor modification and not a de novo device, explicit numerical acceptance criteria for each test are not listed in this summary. Instead, the document states that the modified device has "identical technological characteristics and performance as the predicate intravascular catheters." The performance aspects are implied by the types of tests performed.

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The Xcela Power Injectable PICC is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administrations and nutrients, the sampling of blood, and for power injection of contrast media. Maximum power injection flow rate:

4F Single Lumen, 45 cm - 4 mL/sec

4F Single Lumen, 55 cm - 3.5 mL/sec

5F Single Lumen, 55 cm - 5 mL/sec

5F Dual Lumen, 45 cm - 5 mL/sec

5F Dual Lumen, 55 cm - 4 mL/sec

6F Dual Lumen, 55 cm - 5 mL/sec

The Xcela Power Injectable PICC is a peripherally inserted central catheter. It is available in single and multi-lumen configurations in a wide range of sized from 4F to 6F outside catheter diameter. It is rated for maximum power injector settings up to 325 psi and rated for maximum power injection flow rate up to 5 ml/second based on model. It is available kitted with a range of procedural accessories for user convenience. Changes from the predicate device include the addition of an oversleeve to the extension tube, a new non-valved luer design, and inclusion of maximum flow rates into the indication statement.

The provided document is a 510(k) Summary for a medical device called "Xcela Power Injectable PICC." It focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and performance data. The document does not contain information about acceptance criteria or specific studies in the context of AI/ML device performance as requested in the prompt.

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

Here's an attempt to answer based only on the provided text, indicating where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) for an AI/ML device. Instead, it refers to equivalence based on technological characteristics and non-clinical tests.

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

• Sample Size: Not applicable. The document describes non-clinical "performance evaluation" and "non-clinical tests" but does not specify a "test set" in the context of AI/ML validation (e.g., a dataset of images or patient cases). The tests are for the physical device.
• Data Provenance: Not applicable.

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

• Not applicable. This is not an AI/ML device validation.

4. Adjudication method 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 is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

7. The type of ground truth used

• Not applicable in the AI/ML sense. The "ground truth" for this device would be established by physical and chemical testing against defined specifications and standards, confirming material properties, dimensional accuracy, flow rates, pressure resistance, and biological safety (e.g., biocompatibility testing, not detailed here but implied by compliance with standards).

8. The sample size for the training set

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

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