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Acute central venous catheters are indicated to provide short-term access (

A family of power injectable central venous catheters constructed of medical grade polyurethane and is designed for insertion into the central venous system. BD power injectable acute central lines are radiopaque, and have a soft tip that is more pliable than the catheter body. Each catheter is provided in a sterile package with applicable insertion kit accessories.

The provided text describes the BD Acute Central Line, a medical device, and its substantial equivalence to a predicate device, the Arrow Central Venous Catheter (K071538). The document outlines various performance tests conducted to establish this equivalence, along with the criteria used.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly provide a table listing "acceptance criteria" alongside "reported device performance" with specific numerical results for each test. Instead, it states that "All testing passed the predetermined acceptance criteria." The acceptance criteria are implicitly defined by the standards and the purpose of each test.

Here’s a summary of the tests performed and their implied acceptance criteria:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the specific sample sizes used for each of the performance tests. It mentions that testing was conducted "by or for BAS per guidance documents and standards in conjunction with in-house protocols." The data provenance (country of origin, retrospective/prospective) is also not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable. The device is a physical medical device (central venous catheter), not an AI or diagnostic imaging device that typically requires expert-established ground truth for performance evaluation in the context of diagnostic accuracy. The "ground truth" for this device's performance is established through physical and material property testing against engineering specifications and industry standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable for a physical medical device. Performance is determined by objective measurements against established standards, not by agreement among adjudicators.

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

This is not applicable. The BD Acute Central Line is a physical medical device and not an AI or diagnostic imaging device for which MRMC comparative effectiveness studies with human readers would be performed.

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

This is not applicable. The device is a physical medical device and does not involve algorithms or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the BD Acute Central Line's performance is based on established industry consensus standards and in-house protocols for performance testing of medical devices, specifically intravascular catheters. This includes physical, chemical, and biological testing as outlined in standards like ISO 10993-1, ISO 10555, ASTM F640-12, USP , and FDA guidance documents. The acceptance criteria for these tests serve as the "ground truth" against which the device's performance is measured.

8. The sample size for the training set

This is not applicable. The device is a physical medical device, not an AI model that requires a training set.

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

This is not applicable as there is no training set for a physical medical device.

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