FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The device is a dual lumen percutaneously inserted Intra-Aortic IAB catheter, 8Fr. in size, with two independent non-communicating lumens. The outer 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. The IAB is timed to inflate in the aorta 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.
The catheter is available in an 8Fr. 30cc and 40cc sizes, and is identical in appearance and function to the predicate devices.

AI/ML Overview

This submission is a 510(k) premarket notification for the Arrow Ultra 8 Intra-Aortic Balloon Catheters (IAB) 8 Fr 30cc and 40cc Universal. As such, it is a notification claiming substantial equivalence to a predicate device, rather than a de novo submission or a PMA which would typically include detailed clinical study data with acceptance criteria for novel devices.

Therefore, the information you're requesting regarding acceptance criteria, specific study details (sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone performance), and training set information is not present in this 510(k) summary document.

Here's what can be extracted and inferred:

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

Acceptance Criteria	Reported Device Performance
Not explicit in document. The primary "acceptance criteria" for a 510(k) is demonstrating substantial equivalence to a legally marketed predicate device.	"The results of the laboratory tests demonstrate that the device is substantially equivalent to the legally marketed predicate devices." (Implied to meet all relevant performance characteristics for an IAB catheter as demonstrated by the predicate.)

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

Not explicitly stated. The document mentions "laboratory tests" were performed, but no details about sample size (number of catheters tested, number of simulated cycles, etc.) or data provenance are provided. This is typical for a 510(k) where detailed test reports are submitted separately and referenced.

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/Not stated. This type of information is typically relevant for studies involving diagnostic image interpretation or clinical outcomes adjudicated by specialists. Given that this is a balloon catheter, the "tests" would likely involve engineering performance (e.g., inflation/deflation times, material integrity, guidewire compatibility) rather than expert-adjudicated clinical data in the form you describe.

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

Not applicable/Not stated. See point 3.

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

No. This is a medical device (intra-aortic balloon catheter), not an AI diagnostic tool or software. Therefore, an MRMC study is not relevant.

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)

Inferred: The "ground truth" for demonstrating substantial equivalence for this type of device would be established engineering and performance specifications, material standards, and clinical performance expectations for the predicate device. For example, balloon integrity might be tested against known pressure thresholds, or deployment characteristics against established clinical needs. However, the specific "type" is not detailed in terms of the categories you provided.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable. See point 8.

Summary of what the document does provide:

Predicate Device: The new device is substantially equivalent to the current legally marketed Arrow 8Fr. 30cc and 40cc Universal Intra-Aortic Balloon Catheter Kits.
Technological Characteristics: States the device has "similar technological characteristics as its predicates."
Performance Claim: "The results of the laboratory tests demonstrate that the device is substantially equivalent to the legally marketed predicate devices."

In essence, this 510(k) relies on the established safety and effectiveness of its predicate device, and the "study" demonstrating this involves "laboratory tests" proving the new device's performance is comparable to the predicate. The details of these lab tests (specific protocols, sample sizes, methods of evaluation) are not included in this public summary but would have been part of the full 510(k) submission to the FDA.

Summary

Regulation Number and Section

§ 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.