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The Haemonetics® Cardiovascular Perioperative Autotransfusion System (cardioPAT™) is indicated for use to salvage red blood cells from blood lost intraoperatively and postoperatively during cardiovascular surgical procedures, where the expected rate of processing of salvaged blood and fluid aspirated from the surgical site is less than or equal to two liters per hour.

Autotransfusion is indicated for patients who meet at least one of the following criteria:

• The patient is expected to lose sufficient blood in the perioperative period, so as to require red blood cell transfusion, and autotransfusion will likely reduce or eliminate the need for allogeneic blood transfusion.
• Religious beliefs cause the patient to refuse allogeneic transfusion, but accept autologous transfusion.
• Compatible allogeneic blood is not available.
• The patient is unable to donate sufficient quantities of autologous blood prior to surgery to adequately cover the anticipated transfusion requirement.
• The patient or physician prefers perioperative autotransfusion rather than preoperative autologous donation or transfusion of allogeneic blood.

The cardioPAT system is designed to provide perioperative autotransfusion for patients undergoing cardiovascular surgery. The system consists of an electromechanical device and a sterile single-use disposable set, which together collect and process red blood cells (RBCs) lost during and after surgery. It is a small portable system which mounts on an IV pole. It is designed to be used in the operating room to recycle blood lost during cardiovascular surgical procedures and in the recovery room to recycle blood lost after surgery, where the expected rate of processing of salvaged blood and fluid aspirated from the surgical site is less than or equal to two liters per hour.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Haemonetics® Cardiovascular Perioperative Autotransfusion System (cardioPAT™):

The provided document describes a 510(k) submission for a medical device (cardioPAT™), which is for autotransfusion. The study presented here is a comparative study to demonstrate substantial equivalence to a predicate device (OrthoPAT®), rather than a standalone clinical trial establishing new efficacy. The "acceptance criteria" are implied by the comparison to the predicate device's performance.

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

The acceptance criteria are implicitly defined by acceptable deviations from the predicate device's performance, specifically less than 2% difference in washout values and less than 3% difference in red blood cell (RBC) recovery.

Reported cardioPAT™ Performance Summary (from Table 1):

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 document mentions "pools of different hematocrit blood" processed. It does not specify the exact number of samples or "runs" for the cardioPAT system, but it presents mean values across these pools. For the predicate device (OrthoPAT®), it refers to "previously obtained, using similar pools of blood."
• Data Provenance: The study appears to be a laboratory-based performance test ("processed under simulated use conditions"). There is no mention of country of origin of data or whether it was retrospective or prospective in a clinical sense. It's a technical performance validation.

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. This is a technical performance study measuring physical properties (washout, RBC recovery) of blood, not a diagnostic or interpretative study requiring human expert ground truth.

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

Not applicable. This is a technical performance study based on direct laboratory measurements.

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/diagnostic device and does not involve human readers interpreting data or assisting in a clinical decision.

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

This refers to a "standalone" performance of the device itself in processing blood. The data presented in Table 1 represents the "standalone" performance of the cardioPAT™ system under simulated use conditions.

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

The "ground truth" in this context refers to the measured physical and chemical properties of the processed red blood cells, specifically:

• Concentration of Supernate Heparin
• Concentration of Supernate Albumin
• Concentration of Supernatant Hemoglobin
• Red Blood Cell Recovery

These are objective measurements performed in a laboratory setting.

8. The sample size for the training set

Not applicable. This device is an electromechanical system for physical processing of blood, not an AI/machine learning algorithm that requires a "training set."

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

Not applicable. See point 8.

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