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Hospira Advanced Sensor Catheters:

Indicated for the assessment of the hemodynamic status of a patient, including but not restricted to the following: Venous Pressures, Cardiac Output. Oxyhemoglobin Saturation, and Venous Blood Sampling. A secondary indication is for the therapeutic infusion of solutions.

Hospira Critical Care Catheters;

Indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients including the following : acute heart failure; differentiating ruptured ventricular septum form mitral regurgitation; diagnosis of tamponate; severe hypovolemia; complex circulatory situations (e.g., fluid management with acute burn patients); medical emergencies; adult respiratory distress syndrome; gram negative sepsis; drug intoxication; acute renal failure; hemorrhagic pancreatitis; intra- and postoperative management of high risk patients; history of pulmonary or cardiac disease; fluid shifts (such as extensive intra-abdominal operations); management of high risk obstetrical patients; known cardiac disease; toxemia; premature separation of the placenta; cardiac output determination by thermodilution method; and blood sampling.

Additional indication for Hospira Critical Care Pacing Lead Catheters:

Indicated for temporary transluminal ventricular pacing using a temporary ventricular lead.

The Hospira Critical Care and Advanced Sensor Catheters have multi-lumens that incorporate some or all of the following components and features: a distal balloon for positioning the catheter tip via blood flow within the pulmonary artery, a heater coil for determining continuous cardiac output, a thermistor for monitoring core temperature and cardiac output, fiber optics for monitoring mixed venous oxygen saturation (SvQ2), and access ports for drug delivery or blood sampling. In addition, the Hospira Critical Care Pacing Lead Catheters include an access port for use with Transluminal Right Ventricular Pacing Leads. The catheters also incorporate insertion distance markings and are provided with a syringe for inflating the balloon.

The provided document is a 510(k) summary for Hospira Critical Care and Advanced Sensor Catheters. It describes the device, its intended use, and a comparison to a predicate device.

However, it does not contain detailed information about specific acceptance criteria and the comprehensive study results that would typically prove a device meets those criteria.

The document states:
"The Hospira Critical Care and Advanced Sensor Catheters have been tested for biocompatibility and for expansion symmetry, over inflation, multiple inflations, deflation time, and burst strength and have passed all of the acceptance criteria." (page 2)

This is a high-level summary and does not provide the quantitative acceptance criteria or the reported device performance in a table format, nor does it detail the specifics of the study, such as sample sizes, data provenance, ground truth establishment, or expert involvement.

Therefore, I cannot fully complete the requested table and study details based solely on the provided text. The following is extracted from the available information, with specific limitations noted for the missing data.

1. Table of Acceptance Criteria and Reported Device Performance

Limitations: The document provides a high-level statement that tests were passed but does not specify quantitative acceptance criteria or detailed reported device performance for each test.

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

• Sample Size for Test Set: Not specified in the provided text.
• Data Provenance: Not specified, but generally, medical device testing for regulatory submission like this would be conducted in a controlled lab or manufacturing environment. It is not patient or country-specific data in the clinical sense. This type of testing is typically prospective for engineering and material performance.

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

• Number of Experts: Not applicable. These tests appear to be engineering and material performance tests, not clinical evaluations requiring expert interpretation of results like medical imaging. The "ground truth" would be established by the physical/chemical properties and design specifications of the device.
• Qualifications of Experts: Not applicable for the type of testing described (biocompatibility, mechanical performance). These tests are typically performed by engineers, quality control specialists, and lab technicians.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The tests described (biocompatibility, mechanical tests) yield objective pass/fail results based on predefined engineering or regulatory standards, rather than requiring subjective adjudication of interpretations.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence based on manufacturing methods, materials, and functional performance tests of the device itself, not on the interpretation of results by human readers with or without AI assistance. This device is a catheter, not an AI diagnostic tool.
• Effect Size of Human Readers with/without AI: Not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: No, a standalone (algorithm only) performance study was not done. This device is a physical medical catheter, not an algorithm or AI product.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for this device's performance relies on engineering and material specifications, and validated test methods. For example, the burst strength is compared against a pre-defined safety margin derived from engineering principles and regulatory guidelines for medical devices. Biocompatibility would be assessed against ISO standards (e.g., ISO 10993).

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This document describes a physical medical device, not a machine learning model, so there is no "training set" in the context of AI.

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

• How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for an AI model. For the device itself, the "ground truth" for its design and manufacturing is established through design specifications, material characterization, and adherence to quality systems and regulatory standards (e.g., Good Manufacturing Practices).

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