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The Retrograde Cardioplegia Cannula with Duratio Treatment is indicated for use in the delivery of blood or cardioplegic solution intraoperatively.

Extracorporeal circuit components with the Duraflo treatment are indicated for use in cardiopulmonary surgery when a heparin-treated blood path is desired.

This device is for short-term use only (< 6 h).

The Baxter Research Medical Retrograde Cardioplegia Cannula with Duratio Treatment is a dual lumen cannula. The distal tip contains multiple infusion holes and an opening into the separate pressure monitoring lumen. A soft, low-pressure, self-inflating balloon surrounds the distal body (proximal to the flow holes). Inflation is accomplished via the differential pressure that occurs within the cannula during influsion. The balloon will deflate spontaneously when flow is stopped. The cannula is furnished with an introducer stylet. Each device is Individually packaged sterile and non-pyrogenic in a sealed, peed-type pouch.

The device is treated with Baxter Healthcare Corporation's proprietary Heparin coating, Duraflo.

Here's an analysis of the provided text regarding the Retrograde Cardioplegia Cannula with Duraflo Treatment, focusing on acceptance criteria and supporting studies.

It's important to note that the provided 510(k) summary (K991170) does not contain the detailed information typically associated with acceptance criteria and studies demonstrating device performance against those criteria as would be expected for an AI/ML or diagnostic device. This document is for a physical medical device (a catheter) and relies on substantial equivalence to predicate devices, rather than primary performance studies in the way you might be expecting.

Therefore, I will interpret your request within the context of what information is available in this 510(k) submission for a non-AI device.

Acceptance Criteria and Study for Retrograde Cardioplegia Cannula with Duraflo Treatment (K991170)

Given that this 510(k) is for a physical medical device (a cannula) rather than a software or diagnostic device, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" is framed differently. The primary mechanism for clearance in this case is demonstrating substantial equivalence to existing legally marketed predicate devices. The "performance" being evaluated is whether the new device functions similarly and is as safe and effective as the predicates.

1. Table of Acceptance Criteria and Reported Device Performance

Study Description (Basis for Clearance): A Comparison to Predicate Devices

The "study" that proves this device meets its acceptance criteria is a comparison to predicate devices to establish substantial equivalence.

• Description: The submission argues that the proposed device is substantially equivalent to two predicate devices:

  • Predicate Device A: Retroplegia Cannula, RC-014 (K880103) from Baxter Research Medical, Inc.
  • Predicate Device B: Extracorporeal Circuit with Duraflo II Heparin Treatment (K932208) from Baxter Healthcare Corporation.

  The argument is that the proposed device is Predicate Device A, but with the Duraflo treatment that is the subject of Predicate Device B. This combines an existing cannula design with an existing, cleared heparin coating technology. The core "proof" is that the individual components (the cannula design and the Duraflo treatment) have both been previously deemed safe and effective by the FDA.

Detailed Breakdown of Your Specific Questions (within the context of this 510(k)):

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: Not applicable. This 510(k) does not describe a performance study with a "test set" in the sense of patient data or algorithm testing. The evaluation is based on comparison to legally marketed predicate devices and their established performance/safety profiles.
   • Data Provenance: Not applicable for a new study. The provenance for the predicate devices' data would be from their original clearance submissions, which are not detailed here.

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. There was no "ground truth" to establish for a test set in the context of this 510(k) for a physical device. FDA regulators review the submission and make a determination of substantial equivalence based on the provided technical and comparative information.

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

   • Not applicable. No test set requiring expert adjudication was described. The FDA's review process acts as the "adjudication" of the substantial equivalence claim.

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 is not an AI or diagnostic device, so MRMC studies are irrelevant.

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

   • Not applicable. This is not an AI algorithm.

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

   • Ground Truth: The "ground truth" in this context is the FDA's prior determination of safety and effectiveness for the predicate devices. The new device is deemed substantially equivalent based on its shared characteristics with these already cleared devices. No new clinical "ground truth" was generated or used in this specific submission.

8. The sample size for the training set:

   • Not applicable. This is not an AI or machine learning device and therefore does not have a "training set."

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

   • Not applicable. There is no training set for this device.

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