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The primeMIDLINE™ Catheters are indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling and power injection of contrast media. These catheters are indicated for patients older than 28 days and that weigh more than 10 kg, with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The primeMIDLINE™ Catheters are suitable for use with power injectors.

The 4F DL primeMIDLINE™ Catheter is a peripherally placed midline catheter designed to provide access to the vascular system. The catheter lumen is an open-ended design comprised of radiopaque polyurethane. The 4F DL primeMIDLINE ™ Catheter is packaged sterile in a tray with the accessories necessary to establish short-term (less than 30 days) vascular access. The 4F DL primeMIDLINE Catheter is suitable for use with power injectors.

The provided text describes a 510(k) submission for a medical device (4F Dual Lumen primeMIDLINE™ Catheter) and focuses on demonstrating its substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria based on a study with a test set, expert ground truth, and statistical performance metrics commonly seen in studies for AI/ML-enabled devices.

Therefore, the requested information regarding a table of acceptance criteria and reported device performance, sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, and training set ground truth establishment is not present in the provided document.

This document details the regulatory pathway for a conventional medical device, emphasizing its similarity to a previously cleared predicate device through comparisons of intended use, technological characteristics, and performance testing (e.g., tensile strength, flow rate). These tests are typically engineering/bench tests rather than clinical studies with human "ground truth" and reader performance metrics.

Here's a breakdown of what is provided and why it doesn't fit the requested AI/ML study format:

1. Acceptance Criteria and Reported Device Performance: Instead of performance in terms of diagnostic accuracy or reader improvement, the document lists various non-clinical performance tests conducted on the device (e.g., Visual Inspection, Tensile Strength, Catheter Elongation, Radiopacity, Lifecycle Performance, Static Burst Pressure, Power Injection Flowrate, Biocompatibility tests). The acceptance criteria for these tests are stated as having been "met all predetermined acceptance criteria as defined in the referenced Standards, FDA Guidance Document or PFM Medical, Inc. Internal Standards." Specific numerical results are not provided in this summary but would be in the full submission.

2. Sample Size for Test Set and Data Provenance: Not applicable in the context of the reported performance testing. These are bench tests on manufactured units, not a dataset of patient cases.

3. Number of Experts & Qualifications for Ground Truth: Not applicable. Ground truth for these tests would be objective measurements (e.g., a caliper for dimensional characteristics, a flow meter for flow rate).

4. Adjudication Method: Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This is for evaluating changes in human reader performance, typically with AI assistance.

6. Standalone Performance: Not applicable. This device is a physical catheter, not an algorithm.

7. Type of Ground Truth Used: For non-clinical tests, "ground truth" refers to the objectively measured values compared against specifications derived from standards or internal requirements.

8. Sample Size for Training Set & How Ground Truth for Training Set was Established: Not applicable. This device does not involve machine learning or training a model.

In summary, the provided document describes the regulatory clearance of a physical medical device (a catheter) based on its substantial equivalence to an existing device and a series of engineering and biocompatibility tests. It does not contain information about an AI/ML-based device study with a "test set" in the diagnostic sense, expert ground truth, or human reader performance metrics.

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The primeMIDLINE™ Catheters are indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling and power injection of contrast media. These catheters are indicated for patients older than 28 days and that weigh more than 10kg, with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The primeMIDLINE™ Catheters are suitable for use with power injectors.

The primeMIDLINE™ Catheters are a family of peripherally placed midline catheters designed to provide access to the vascular system. These catheters are offered in 3F, 4F and 5F Single Lumen and 5F Dual Lumen configurations with 20cm lengths. The catheter lumen is an open-ended design comprised of radiopaque polyurethane. Each primeMIDLINE™ Catheter is packaged sterile in a tray with the accessories necessary to establish short-term (less than 30 days) vascular access. The primeMIDLINE™ Catheters are suitable for use with power injectors.

The document provided describes the primeMIDLINE™ Catheters and their substantial equivalence to a predicate device, PowerMidline Catheters. It outlines verification testing performed to demonstrate that the device performs as intended and meets established acceptance criteria.

However, the document does not contain information about a study comparing the device's performance against specific acceptance criteria in the format requested. While it lists various performance testing categories, it does not provide:

• A table of specific quantitative acceptance criteria for each test (e.g., "Tensile Strength should be > X N") and the reported device performance against those criteria.
• Details on sample sizes for a "test set" in the context of device performance, data provenance, or the number/qualifications of experts for ground truth.
• Information on adjudication methods, MRMC comparative effectiveness studies, or standalone algorithm performance, as these are typically relevant to AI/diagnostic imaging devices, not direct hardware performance.
• The type of ground truth used for performance validation.
• Training set sample size or how ground truth was established for a training set (again, this points more towards AI/ML studies).

Instead, the document states: "The subject devices met all predetermined acceptance criteria as defined in the referenced Standards, FDA Guidance Documents or PFM Medical, Inc. Internal Standards." This is a general statement that the device passed all tests, but without quantifying the criteria or the results.

Therefore, based on the provided text, I cannot complete the table or answer most of the requested questions because the specific data is not available.

Summary of available information:

• Device: primeMIDLINE™ Catheters
• Predicate Device: PowerMidline Catheters (K153393)

1. Table of Acceptance Criteria and Reported Device Performance:

Study Information (based on available text):

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

• Not specified. The document states "design verification testing" was conducted but does not provide sample sizes for individual tests or data provenance.

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):

• Not applicable/Not specified. The testing described is performance testing of a physical device against standards, not expert-adjudicated diagnostic performance.

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

• Not applicable/Not specified.

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 type of study is for diagnostic tools, typically AI-powered. The device is a physical catheter.

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

• No. This is not an algorithm.

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

• "Predetermined acceptance criteria as defined in the referenced Standards, FDA Guidance Documents or PFM Medical, Inc. Internal Standards." This refers to objective measurements against established engineering and safety standards.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable.

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