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The intra-aortic balloon is placed in the descending aorta just below the subclavian artery and is intended to improve cardiovascular functioning during the following situations:

Refractory ventricular failure
Cardiogenic shock
Unstable refractory angina
Impending infarction
Mechanical complications due to acute myocardial infarction
Ischemic related intractable ventricular arrhythmias
Cardiac support for high risk surgical patients and coronary angiography or angioplasty patients
Septic shock
Weaning from cardiopulmonary bypass
Interoperative pulsatile flow generation
Support for failed angioplasty and valvuloplasty

The intra-aortic balloon is placed in the descending aorta just below the subclavian artery and is intended to improve cardiovascular functioning during the following situations:

Refractory ventricular failure
Cardiogenic shock
Unstable refractory angina
Impending infarction
Mechanical complications due to acute myocardial infarction
Ischemic related intractable ventricular arrhythmias
Cardiac support for high risk surgical patients and coronary angiography or angioplasty patients
Septic shock
Weaning from cardiopulmonary bypass
Interoperative pulsatile flow generation
Support for failed angioplasty and valvuloplasty

The submitted text is a 510(k) premarket notification for a medical device, specifically an Intra-Aortic Balloon (IAB). This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than establishing new safety and effectiveness through extensive clinical trials as would be required for a Class III device requiring PMA. As such, the information typically requested in your prompt (acceptance criteria, study details, human reader performance, training sets, etc.) is not present in this document because it's not relevant to a 510(k) submission for this type of device.

Here's an analysis based on the provided text:

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

• Acceptance Criteria: The document does not explicitly state specific quantitative acceptance criteria for the device's performance. The primary acceptance criterion for a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device. This is a regulatory standard, not a performance metric in the way you might define it for a diagnostic algorithm.
• Reported Device Performance: The document states that "The results of in-vitro tests conducted demonstrate that the functionality and performance characteristics of the device are comparable to the currently marketed devices." However, no specific performance metrics or quantitative results from these in-vitro tests are provided.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. No clinical test set data is described in this document. The device did not undergo clinical evaluation in the U.S. in this submission pathway.

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)

• Not Applicable. No clinical test set requiring expert ground truth is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. No clinical test set requiring adjudication is described.

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

• Not Applicable. This device is an Intra-Aortic Balloon (IAB), a physical medical device. It is not an AI diagnostic algorithm, and therefore, MRMC studies or human reader improvement with AI assistance are not relevant to its evaluation.

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

• Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not Applicable. No clinical data requiring "ground truth" establishment in this manner was used for this 510(k) submission. The equivalence was based on technological characteristics and in-vitro testing.

8. The sample size for the training set

• Not Applicable. This submission is not for an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

• Not Applicable. This submission is not for an AI/ML algorithm that requires a training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" that proves the device meets the acceptance criteria for a 510(k) submission is the demonstration of substantial equivalence to predicate devices through:

• Technological Comparison: The company asserted that "Datascope's Percor STAT-DL® 9.5Fr. IAB is substantially equivalent to the predicate devices with regard to its indications for use." The only stated technological difference was "material grade and chemical composition of the membrane material," which they claimed "has been demonstrated not to affect safety or efficacy of the device."
• Non-Clinical (In-vitro) Tests: "The results of in-vitro tests conducted demonstrate that the functionality and performance characteristics of the device are comparable to the currently marketed devices." These tests are not detailed in the provided summary.
• Lack of Clinical Tests: Explicitly stated, "There has been no clinical evaluation of the new device in the U.S."

The FDA's acceptance of the 510(k) notification (K980780) means they concurred that, based on the provided information, the device is substantially equivalent to legally marketed predicate devices, and therefore can be marketed.

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