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The Medtronic CSS™ Cardioplegia Safety System is intended for use as a cardioplegia delivery system which controls, monitors, and delivers oxygenated blood and/or asanguineous solutions during cardiopulmonary bypass procedures.

The Medtronic CSS Cardioplegia Safety System Model 990 consists of an electro-mechanical instrument and disposable Cardioplegia Sets. The instrument delivers cardioplegia solution through dual peristaltic independently operated pumps (one for blood, one for crystalloid). It monitors volume delivered, flow rate (adjustable from 0 - 990 ml/min), and pressure (line and external). It also includes temperature monitoring capabilities, gross air detection using ultrasonic technology, and two independent elapsed timers. The instrument has a color central information display and a two-stage alert-alarm process. It has battery backup for 60 minutes of "On" time and 15 minutes of pumping time. The disposable sets are single use, sterile, and nonpyrogenic, designed to mix arterial blood and asanguineous cardioplegia solution at various ratios. The sets include silicone tubing and polycarbonate connectors and are available in four configurations, with or without a heat exchanger and with standard or dual lumen patient lines.

The Medtronic CSS Cardioplegia Safety System Model 990 is intended for use as a cardioplegia delivery system which controls, monitors, and delivers oxygenated blood and/or asanguineous solutions during cardiopulmonary bypass procedures. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than fully detailing a study against specific acceptance criteria for novel performance claims. However, it does present performance data for various features of the device as part of the substantial equivalence argument, which can be interpreted as meeting certain "acceptance criteria" by comparing them to predicate devices or manufacturer's specifications.

Here's an analysis of the acceptance criteria and the study as presented:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a comparative table where the Medtronic CSS's features and performance specifications are listed alongside those of predicate devices (Sorin BCC, Quest MPS, Sarns 9000). While it doesn't explicitly state "acceptance criteria" as pass/fail thresholds for clinical claims, the comparison table implicitly defines the acceptable performance range by demonstrating equivalence to already cleared devices or meeting internal specifications.

* "Based on customer input this accuracy is sufficient for this application"

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

The document describes "In-Vitro Bench Testing" and "Biocompatibility Testing."

• Test Set Sample Size: Not explicitly stated for any of the individual bench tests. The document only lists the types of tests conducted. For biocompatibility, it states "these devices were tested," implying a sample was used but no number is provided.
• Data Provenance: The tests described are "In-Vitro Bench Testing" and "Biocompatibility Testing." This indicates the data is from retrospective laboratory experiments conducted by the manufacturer, Medtronic Bio-Medicus, Inc. There is no mention of human subject data or data from specific countries of origin beyond the company's location in Eden Prairie, MN, USA.

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

Not applicable. This device is a cardioplegia delivery system, and the studies performed are bench tests and biocompatibility tests. There is no diagnostic component requiring human expert ground truth for interpretation of medical images or patient conditions. The "ground truth" for these tests would be the established engineering specifications, chemical/biological standards, and physical measurements.

4. Adjudication Method for the Test Set

Not applicable, as expert adjudication is not relevant for bench or biocompatibility testing. The "adjudication" would involve comparing test results against predefined engineering specifications and regulatory standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case comparative effectiveness study was not done. This type of study is typically performed for diagnostic or screening devices where human readers (e.g., radiologists) interpret images or data, and their performance with and without AI assistance is compared. The Medtronic CSS Cardioplegia Safety System is a therapeutic delivery system with monitoring capabilities, so an MRMC study is not relevant to its function and claims.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, the "In-Vitro Bench Testing" and "Biocompatibility Testing" can be considered standalone performance evaluations. These tests assess the device's intrinsic mechanical, electrical, and material properties and performance against specifications without direct human-in-the-loop interaction for the specific performance endpoint being measured (e.g., pump flow accuracy, pressure detection, air bubble detection). The control system (microprocessor, software) within the instrument operates autonomously during these tests to fulfill its functions.

7. Type of Ground Truth Used

The ground truth for the various tests appears to be:

• Engineering Specifications: For parameters like flow accuracy, pressure accuracy, temperature accuracy, timer accuracy, and constant pressure mode performance, the ground truth is the device's designed operational specifications and performance limits. These are then compared to the measured performance.
• Physical Measurements: Directly measured flow rates, pressures, temperatures, and times.
• Biological/Chemical Standards: For biocompatibility, the ground truth is established by recognized international standards (ISO 10993-1, USP XXIII) and FDA guidelines. For EtO residuals, it's ANSI/AAMI/ISO 10993-7:1995. For pyrogen testing, it's FDA guidelines.
• Visual/Physical Detection: For gross air detection, the ground truth would be the presence of a known air bubble of a specified size.

8. Sample Size for the Training Set

Not explicitly stated. As this is a 510(k) for a hardware device with embedded software (not a machine learning/AI diagnostic system generating models from data), the concept of a "training set" in the context of statistical modeling or AI development is not directly applicable in the way it is for imaging algorithms. Any "training" or calibration would likely refer to internal iterative development and testing against specifications, rather than data-driven model training.

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

Not applicable in the typical AI/ML sense. For hardware and embedded software development, the "ground truth" during development (if we were to loosely interpret "training set" as development data) would be established by engineering design specifications, safety standards, and performance targets derived from clinical requirements and predicate device performance. This would involve rigorous internal testing, debugging, and verification to ensure the device performs as designed.

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