(30 days)
INSPIRE 8F 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 8F M integrated arterial filter provides additional protection against air and solid emboli. INSPIRE 8F M is intended to be used for 6 hours or less.
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 post-operatively for chest drainage. INSPIRE HVR DUAL is intended to be used for 6 hours or less.
The INSPIRE 8F DUAL is a high efficiency microporous hollow fiber membrane oxygenator integrated with an arterial filter and a heat exchanger (INSPIRE 8F M) and connected to a hardshell venous/cardiotomy reservoir (INSPIRE HVR DUAL). A molded fitting joint connects the oxygenator to the reservoir.
The device can be operated at flow rates up to 8 liters per minute (I/min).
The hollow fiber membrane oxygenator provides oxygenation and carbon dioxide removal from venous blood or suction 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 suction blood, and can be used post-operatively for chest drainage.
The INSPIRE 8F DUAL is a modified version of the currently marketed INSPIRE 8F integrated oxygenator/hardshell venous cardiotomy reservoir system.
The provided document is a 510(k) summary for a medical device, the INSPIRE 8F DUAL hollow fiber oxygenator. It details the device description, indications for use, technological characteristics, and non-clinical test results conducted to demonstrate substantial equivalence to a predicate device.
Based on the nature of this document (a 510(k) for a physical medical device, specifically an oxygenator used in cardiopulmonary bypass), the "study" referred to is a series of in vitro performance and physical/mechanical integrity tests, not a clinical study involving human patients or analysis of imaging data with expert readers. Therefore, many of the typical elements associated with AI/imaging device studies (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details) are not applicable in this context.
The document explicitly states that the "study" involved "in vitro testing" and lists various performance and physical/mechanical integrity tests.
Here's how the provided information maps to your request:
1. A table of acceptance criteria and the reported device performance
The document provides a list of tests conducted and states that "The INSPIRE 8F DUAL successfully met all acceptance criteria for each test." However, the specific numerical acceptance criteria for each test and the explicit numerical reported performance values are not detailed within this 510(k) summary. The table below lists the tests performed, and the performance is reported as meeting "all acceptance criteria."
| TEST | TEST CLASSIFICATION | TEST TITLE | Reported Device Performance (as stated in document) |
|---|---|---|---|
| 1 | Physical/Mechanical | Structural integrity | Successfully met all acceptance criteria |
| 2 | Physical/Mechanical | Blood pathway integrity | Successfully met all acceptance criteria |
| 3 | Functional/Performance | Blood rest volume | Successfully met all acceptance criteria |
| 4 | Functional/Performance | Air handling | Successfully met all acceptance criteria |
| 5 | Functional/Performance | Break-through time and volume | Successfully met all acceptance criteria |
| 6 | Functional/Performance | Defoaming efficiency | Successfully met all acceptance criteria |
| 7 | Functional/Performance | Dynamic priming volume / Hold-up | Successfully met all acceptance criteria |
| 8 | Functional/Performance | Filtration efficiency - venous section | Successfully met all acceptance criteria |
| 9 | Functional/Performance | Filtration efficiency - cardiotomy section | Successfully met all acceptance criteria |
| 10 | Functional/Performance | Flow rate capacity | Successfully met all acceptance criteria |
| 11 | Functional/Performance | Pressure drop | Successfully met all acceptance criteria |
| 12 | Functional/Performance | Hemolysis | Successfully met all acceptance criteria |
| 13 | Functional/Performance | Blood compatibility | Successfully met all acceptance criteria |
| 14 | Functional/Performance | Leaching of coating | Successfully met all acceptance criteria |
| 15 | Functional/Performance | Flaking of coating | Successfully met all acceptance criteria |
| 16 | Functional/Performance | Uniformity of coating | Successfully met all acceptance criteria |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The sample sizes for each specific in vitro test are not provided in this summary. These are typically detailed in the full test reports, which are part of the detailed 510(k) submission, but not summarized here.
- Data Provenance: The tests were "in vitro," meaning they were conducted in a laboratory setting, not on patient data. The manufacturer is Sorin Group Italia S.r.I., located in Italy. The tests would have been performed in a controlled laboratory environment. The methods followed "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'."
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)
- This is not applicable as the "ground truth" for in vitro physical/performance tests is established by adhering to widely accepted engineering, chemical, and biological testing standards and protocols (e.g., ISO standards, FDA guidance documents) and measurements obtained from calibrated equipment. There are no "experts" in the sense of clinical readers establishing ground truth for image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This is not applicable for in vitro performance testing. Performance is measured against predefined engineering specifications and standards.
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
- This is not applicable. This device is a physical medical device (an oxygenator), not an AI/imaging diagnostic tool. No human reader studies (MRMC or otherwise) were conducted or are relevant for its approval.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable. There is no AI algorithm involved with this device. The "standalone" performance here refers to the device's own physical and functional characteristics measured in a lab setting, which were indeed tested ("in vitro test results").
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance tests is based on engineering specifications, industry standards (e.g., ISO 15674), and regulatory guidance documents (e.g., FDA guidance for defoamer submissions). The device's measured performance during in vitro testing must fall within pre-defined acceptable ranges specified by these standards.
8. The sample size for the training set
- This is not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- This is not applicable for the same reason as above.
§ 870.4350 Cardiopulmonary bypass oxygenator.
(a)
Identification. A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.”