(38 days)
The Intra-Aortic Balloon (IAB) is clinically indicated for the following conditions:
a. Acute Coronary Syndrome
b. Cardiac and Non-Cardiac Surgery
c. Complications of Heart Failure
IAB's are designed to provide cardiac assist therapy. The devices are dual lumen percutaneously inserted Intra-Aortic IAB catheters, with two independent non-communicating lumen is comprised of an inflatable bladder connected to the catheter distal tip and to the IAB tip outer surface. The inner lumen is comprised of a luer adapter connected to the proximal end of the inner lumen and to the IAB tip inner surface. The IAB inner lumen is used for placement of the device with a guidewire and the outer lumen is used to shuttle helium gas to and from the inflatable bladder. IABs are timed to inflate within the aota during the diastolic relaxation of the heart and deflate during the systolic contraction of the heart, resulting in increased blood supply to the heart muscle and decreased work load for the left ventricle.
This appears to be a 510(k) summary for an Intra-Aortic Balloon (IAB) device. The document does not describe a study involving an AI component or a specific algorithm. Instead, it focuses on demonstrating substantial equivalence to predicate devices, which is common for medical device clearances that are not novel AI/ML devices.
Therefore, most of the requested information about acceptance criteria, study design, and AI performance metrics is not applicable to this document. The document primarily focuses on the device description, indications for use, and a list of predicate devices used to establish substantial equivalence.
Here's an attempt to answer the questions based on the provided text, acknowledging that many fields will be "Not Applicable" or "Not Provided" given the nature of the document:
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A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as quantifiable metrics in the manner typically seen for AI/ML performance. The document implies the acceptance criterion is "substantial equivalence" to predicate devices based on technological characteristics and intended use.
- Reported Device Performance: The document states, "The results of the laboratory tests demonstrate that the device is substantially equivalent." No specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy) are provided, as this is not a study reporting on diagnostic or predictive output.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not provided. The document refers to "laboratory tests" but does not detail the sample size or provenance of data used in those tests, as it's a submission for an IAB device, not an AI study.
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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/Not provided. Ground truth establishment by experts is not relevant in this context, as it's about the physical and functional characteristics of an IAB device.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided.
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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 is not an AI/ML device, and no MRMC study is mentioned.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device does not involve an algorithm with standalone performance.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. For a substantial equivalence claim for an IAB, ground truth would relate to its physical and functional specifications meeting design requirements and performance similar to predicate devices, rather than a diagnostic 'truth'.
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The sample size for the training set
- Not applicable/Not provided. There is no AI training set for this device.
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How the ground truth for the training set was established
- Not applicable/Not provided.
§ 870.3535 Intra-aortic balloon and control system.
(a)
Identification. An intra-aortic balloon and control system is a prescription device that consists of an inflatable balloon, which is placed in the aorta to improve cardiovascular functioning during certain life-threatening emergencies, and a control system for regulating the inflation and deflation of the balloon. The control system, which monitors and is synchronized with the electrocardiogram, provides a means for setting the inflation and deflation of the balloon with the cardiac cycle.(b)
Classification. (1) Class II (special controls) when the device is indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure. The special controls for this device are:(i) Appropriate analysis and non-clinical testing must be conducted to validate electromagnetic compatibility and electrical safety of the device;
(ii) Software verification, validation, and hazard analysis must be performed;
(iii) The device must be demonstrated to be biocompatible;
(iv) Sterility and shelf-life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components;
(v) Non-clinical performance evaluation of the device must demonstrate mechanical integrity, durability, and reliability to support its intended purpose; and
(vi) Labeling must include a detailed summary of the device- and procedure-related complications pertinent to use of the device.
(2) Class III (premarket approval) when the device is indicated for septic shock and pulsatile flow generation.
(c)
Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before March 31, 2014, for any intra-aortic balloon and control system indicated for septic shock or pulsatile flow generation that was in commercial distribution before May 28, 1976, or that has, on or before March 31, 2014, been found to be substantially equivalent to any intra-aortic balloon and control system indicated for septic shock or pulsatile flow generation that was in commercial distribution before May 28, 1976. Any other intra-aortic balloon and control system indicated for septic shock or pulsatile flow generation shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.