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INSPIRE 6M: Hollow Fiber Oxygenator
INSPIRE 6M is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. INSPIRE 6M is intended to be used for 6 hours or less.

INSPIRE HVR DUAL: Hardshell Venous/Cardiotomy Reservoir
INSPIRE HVR DUAL is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It collects, defoams and filters venous blood and suction blood. INSPIRE HVR DUAL can be used postoperatively for chest drainage. INSPIRE HVR DUAL is intended to be used for 6 hours or less.

INSPIRE 6F M: Hollow Fiber Oxygenator
The INSPIRE 6F M is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. INSPIRE 6F M integrated arterial filter provides additional protection against air and solid emboli. INSPIRE 6F M is intended to be used for 6 hours or less.

INSPIRE HVR DUAL: Hardshell Venous/Cardiotomy Reservoir
INSPIRE HVR DUAL is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It collects, defoams and filters venous blood and suction blood. INSPIRE HVR DUAL can be used postoperatively for chest drainage. INSPIRE HVR DUAL is intended to be used for 6 hours or less.

The INSPIRE 6 DUAL and INSPIRE 6F DUAL are high efficiency microporous hollow fiber membrane oxygenators integrated with heat exchanger (INSPIRE 6M and INSPIRE 6F M, respectively) and connected to a hardshell venous/cardiotomy reservoir (INSPIRE HVR DUAL). A molded fitting joint connects the oxygenator to the reservoir. As compared to the INSPIRE 6 DUAL, the INSPIRE 6F DUAL oxygenating module is also integrated with an arterial filter.

The device can be operated at flow rates up to 6 liters per minute (I/min).

The hollow fiber membrane oxygenator provides oxygenation and carbon dioxide removal from venous blood or suctioned blood. The integrated heat exchanger controls blood temperature and allows the use of hypothermia or aids in the maintenance of normothermia during surgery. The integrated arterial filter provides additional protection against air and solid emboli and the integrated hardshell reservoir collects, defoams, filters venous and suctioned blood, and can be used post-operatively for chest drainage. The INSPIRE 6 DUAL and INSPIRE 6F DUAL are a modified version of the currently marketed INSPIRE 6 and INSPIRE 6F integrated oxygenator/hardshell venous cardiotomy reservoir systems.

The INSPIRE 6 DUAL and INSPIRE 6F DUAL integrated devices will be provided with a dual chamber venous/cardiotomy reservoir (INSPIRE HVR DUAL) rather than a single chamber venous/cardiotomy reservoir (INSPIRE HVR) as for the INSPIRE 6 and INSPIRE 6F unmodified devices.

No change to the oxygenating modules has been made as a result of this modification. The INSPIRE 6 DUAL and INSPIRE 6F DUAL modified devices are provided with oxygenating modules identical with respect to the unmodified devices.

This is a 510(k) summary for a medical device modification, not a clinical study involving AI or human reader performance. Therefore, many of the requested categories are not applicable.

Here's the breakdown of the information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists tests conducted and states that "The INSPIRE 6 DUAL and INSPIRE 6F DUAL successfully met all acceptance criteria for each test." However, the specific numerical acceptance criteria for each test are not provided in this summary. Only the test titles are listed.

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

• Sample Size: The document does not specify the sample size (number of devices) used for the in vitro tests.
• Data Provenance: The tests were "in vitro," implying laboratory testing. The document states testing was conducted "in accordance with the requirements of ISO 10993-1 and the FDA May 1st, 1995 Memorandum on the use of the ISO 10993 standard for biocompatibility testing of materials" and "relevant requirements of 'Guidance for Extracorporeal Blood Circuit Defoamer 510(k) Submissions; Final Guidance for Industry and FDA' issued on November 29, 2000; ISO 15674, 'Cardiovascular implants and artificial organs — Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags'." This indicates compliance with established international and FDA standards for medical device testing. The origin is Sorin Group Italia. It is a retrospective study in the sense that it evaluates a modified device against established standards and previously approved predicate devices, not a prospective clinical trial.

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

• This is not applicable as this is a device performance test, not an AI or diagnostic imaging study requiring expert human interpretation for ground truth establishment. The "ground truth" here is determined by the physical and functional performance of the device against predefined engineering and biocompatibility standards.

4. Adjudication Method for the Test Set

• Not applicable for device performance testing. Performance is measured against objective standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not done. This is a 510(k) submission for a device modification, focused on demonstrating substantial equivalence through in vitro testing.
• Effect Size: Not applicable.

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

• This is not an algorithm, but a physical medical device. Therefore, this question is not applicable.

7. The Type of Ground Truth Used

• The "ground truth" used for this device performance testing is based on pre-defined technical specifications, performance metrics, and compliance with recognized industry standards (ISO 10993-1, ISO 15674, FDA Guidance) for extracorporeal blood circuits. These standards dictate acceptable ranges for various physical, mechanical, and functional characteristics of the oxygenator and reservoir systems (e.g., integrity, fluid volumes, filtration efficiency, pressure drops, blood compatibility, etc.).

8. The Sample Size for the Training Set

• This is not an AI or machine learning study, so there is no "training set."

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

• Not applicable (see point 8).

Summary of the Study:

The study described is an in vitro performance and biocompatibility evaluation conducted to support a Special 510(k) submission for the INSPIRE 6 DUAL and INSPIRE 6F DUAL hollow fiber oxygenators. The purpose was to demonstrate substantial equivalence to previously cleared predicate devices (INSPIRE 6 and INSPIRE 6F) after a modification (changing from a single-chamber to a dual-chamber venous/cardiotomy reservoir).

The study involved a series of 16 tests covering physical/mechanical integrity and functional/performance aspects of the device, as well as biocompatibility. These tests were conducted in accordance with established international and FDA guidance documents and standards for such devices. The document explicitly states that "The INSPIRE 6 DUAL and INSPIRE 6F DUAL successfully met all acceptance criteria for each test," thereby proving that the device meets the acceptance criteria as defined by those standards.

The document emphasizes that no changes were made to the oxygenating modules, and therefore, performance data for those aspects (e.g., gas transfer, heat exchange) cross-referenced previously submitted data for the unmodified devices. The focus of this specific 510(k) was on the modified reservoir and the integrated system as a whole.

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