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The Dideco ATS Autotransfusion Cardiotomy Reservoir is an accessory to an autotransfusion device and is intended for the sterile collection and filtration of recovered blood for subsequent processing for autotransfusion.

The Dideco ATS Autotransfusion Cardiotomy Reservoir (Dideco ATS) is a modification of the Dideco-Shiley ACR-40 Autotransfusion Reservoir (ACR-40) (K884872). The Dideco ATS is identical in intended use and fundamental technology to the previously cleared autotransfusion reservoir. Both the proposed and predicate devices consist of a reservoir with an internal filter system. The proposed device is available with two different means of removing fluids from the reservoir. The "draw tube configuration" has a draw tube attached to a fluid outlet port in the reservoir cover. Fluids may also be drained from this version of the reservoir via a piercable connector at the bottom of the reservoir housing. In the second form of the device, the "bottom outlet" version, the fluid outlet port is located on the bottom of the housing. In both configurations of the device, fluids enter the reservoir through an inlet port in the reservoir cover which is connected to the internal filter system. There is also a Luer lock connector on the reservoir cover which bypasses the filter system. Both versions of the reservoir also contain an overflow valve to prevent the volume of fluid in the reservoir from exceeding the maximum holding capacity.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance for Dideco ATS Autotransfusion Cardiotomy Reservoir

This 510(k) summary describes a device that is a modification of a previously cleared autotransfusion reservoir. The study presented aims to demonstrate substantial equivalence to the predicate device (Dideco-Shiley ACR-40) rather than establishing de novo performance targets. Therefore, the "acceptance criteria" are implicitly that the new device performs comparably or acceptably to the predicate device for key functional and safety aspects.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) summary for a modified device, the acceptance criteria are not explicitly stated as numerical thresholds but rather as maintaining comparable performance or successful completion of safety tests.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample sizes used for any of the performance tests. It also does not explicitly state the provenance of the data (e.g., country of origin, retrospective or prospective). Given the nature of a 510(k) for a physical medical device (autotransfusion reservoir), the testing would typically involve in-vitro laboratory studies using blood samples, and potentially animal models for some biocompatibility aspects, rather than human patient data in the way an AI diagnostic device would.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable to this type of device and study. The "ground truth" for the performance characteristics (e.g., filtration efficiency, housing integrity, hemolysis) would be established through established scientific methods and laboratory measurements, not through expert consensus on diagnostic images or clinical assessments.

4. Adjudication Method for the Test Set

This information is not applicable to this type of device and study. Adjudication methods like "2+1" or "3+1" are relevant for establishing ground truth in clinical or diagnostic studies, particularly those involving human readers or interpretations. The tests conducted here are laboratory-based performance and safety evaluations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is primarily relevant for diagnostic devices, especially those involving human interpretation of medical images, where the AI system assists or replaces human readers. The Dideco ATS Autotransfusion Cardiotomy Reservoir is a physical medical device used for blood collection and filtration, not a diagnostic AI system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable to this device. The Dideco ATS is a physical medical device (reservoir) and does not involve any algorithms or AI for standalone performance evaluation in the way a software-based diagnostic device would. All performance tests are inherently "standalone" in the sense that they evaluate the device itself, but not in the context of an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is derived from:

• Established scientific methods and laboratory measurements: For tests like hemolysis, cell depletion, reservoir integrity, breakthrough time, residual volume, filtration efficiency, and connector pull strength, the ground truth is objective measurement against specified physical or biological parameters.
• International standards: Biocompatibility is assessed against ISO 10993-1.
• Predicate device comparison: For several metrics (hemolysis, cell depletion, breakthrough time, residual volume, filtration efficiency), the ground truth for "acceptability" is similarity or comparability to the performance of the legally marketed predicate device (Dideco-Shiley ACR-40).

8. The Sample Size for the Training Set

This information is not applicable. This device is a physical medical device, not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for this physical device.

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