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Peripherally inserted central venous (PICC) and midline catheters placed for venous access or prolonged intravenous therapy.

Peripherally inserted central venous (PICC) and midline catheters placed for venous access or prolonged intravenous therapy. Method of insertion is through an introducer sheath. The optimal catheter tip location for the PICC catheter is in the superior vena cava of the heart. The recommended tip location for the midline catheter is below the shoulder, at the level of the axilla. The products will be available in single and dual lumen configurations; with and without a flushable guidewire; and as sterile individual units or in insertion kits containing the components used for insertion of the device.

This document is a Summary of Safety and Effectiveness Information for medical devices (PICC and Midline Catheters). It does not describe an AI/ML powered device, therefore, the information requested in your prompt (e.g., acceptance criteria for an algorithm, sample sizes for test/training sets, expert consensus for ground truth, MRMC studies) are not applicable to the provided text.

The document focuses on the safety and effectiveness of a physical medical device (catheter) based on engineering and biocompatibility tests, not on the performance of a software algorithm.

Here's a breakdown of what the document does provide in relation to traditional medical device testing:

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

The document provides a table of tests and their conclusions, which implicitly refer to meeting acceptance criteria for each physical test. The column "Conclusion" being "Passed" indicates that the device met the pre-defined acceptance criteria for that specific test.

The remaining points (2-9) are not applicable to this physical device submission. This document details the physical and biological performance of a catheter, not an AI system.

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Peripherally inserted catheter for venous access or intravenous therapy. Method of insertion is through an introducer. The optimal catheter tip location is below the shoulder at the level of the axilla.

Peripherally inserted catheter for venous access or intravenous therapy. Method of insertion is through an introducer. The optimal catheter tip location is below the shoulder at the level of the axilla. The products will be available in single and dual lumen configurations, as sterile individual units or in trays along with the components used for insertion.

The provided text describes a medical device, the MIDMARK™ Midline Catheter, and its summary of safety and effectiveness information for FDA clearance (K951620). However, it does not contain any information about acceptance criteria, device performance, sample sizes, expert ground truth, or any clinical studies.

The document focuses on:

• Device identification: Classification name, common name, proprietary name.
• Regulatory information: Establishment registration, classification, substantially equivalent devices.
• Device description: Function, insertion method, optimal tip location, configurations.
• Component specifications: Identical to a previously cleared device (Centermark K920828).
• Performance standards: States "No performance standards have been established by the FDA."
• Packaging and sterilization: Methods used.
• Biocompatibility testing: LAL procedure for non-pyrogenicity.

Therefore, I cannot fulfill your request for: a table of acceptance criteria and reported device performance, sample sizes, data provenance, expert ground truth details, adjudication methods, multi-reader multi-case studies, standalone performance, types of ground truth, or training set information.

This document is a regulatory submission summary primarily focused on establishing substantial equivalence to previously cleared devices, not a scientific study report detailing performance data against specific acceptance criteria.

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