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The CAPIOX® RX Hardshell Reservoir is a hardshell reservoir used to store blood during extracorporeal circulation from both the venous line and the cardiotomy line. The reservoir contains filters to remove particulate matter and defoamers to facilitate air bubble removal.

The Hardshell Reservoir is also used for post-operative chest drainage and autotransfusion procedures to aseptically return blood to the patient for blood volume replacement.

The Hardshell Reservoir is also used with the vacuum-assisted venous return technique during cardiopulmonary bypass.

The Hardshell Reservoir contains X-Coating, which is intended to reduce platelet adhesion on the surfaces of the device.

The device may be used for procedures lasting up to 6 hours.

The design of the CAPIOX® RX Reservoir consist of a hard casing reservoir. It has a rotatable venous blood inlet port that permits minimizing tubing lengths, which could result in lower circuit priming volumes. The total capacity of the reservoir is 4000 mL.

The CAPIOX® RX Hardshell Reservoir contains a defoamer and a screen filter in the venous blood inlet section. The defoamer resides in the upper part of the reservoir, thus permitting blood to reside in the lower section of the reservoir.

The cardiotomy section of the RX reservoir contains a defoamer and a filter to facilitate air removal and the removal of particulates from suctioned blood entering the reservoir.

The generic materials used in the CAPIOX® RX Hardshell Reservoir are polycarbonate, polypropylene, PET, polyvinyl chloride, polyurethane, nylon, stainless steel and ceramic. The device also contains Terumo's X-Coating polymer solution.

This device is a CAPIOX® RX Hardshell Reservoir, classified as a Class II device (Blood Reservoir). The provided text describes a 510(k) premarket notification for demonstrating substantial equivalence to a predicate device, the CAPIOX® SX Hardshell Reservoir (K002238).

The acceptance criteria provided are not quantitative performance metrics for a diagnostic or AI device, but rather a set of functional and safety demonstrations for a medical device. The "study that proves the device meets the acceptance criteria" refers to the performance evaluations conducted to demonstrate substantial equivalence to the predicate device.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

   Acceptance Criterion (Performance Evaluation Conducted)	Reported Device Performance
   Filter Defoaming - Venous Section	Demonstrated equivalence to predicate device.
   Filter Defoaming - Cardiotomy Section	Demonstrated equivalence to predicate device.
   Pressure Drop/Flow Rate Testing - Venous Section	Demonstrated equivalence to predicate device.
   Pressure Drop - Cardiotomy Section	Demonstrated equivalence to predicate device.
   Filtration Efficiency - Cardiotomy Section	Demonstrated equivalence to predicate device.
   Effects Upon Cellular Blood Components	Demonstrated equivalence to predicate device.
   Pressure Integrity Testing	Demonstrated equivalence to predicate device.
   Tubing Connection Strength	Demonstrated equivalence to predicate device.
   Sterilization (SAL of 10-6)	Validated in accordance with AAMI guidelines.
   Ethylene Oxide Residues	Will not exceed maximum residue limits.
   Biocompatibility (ISO 10993)	Blood contacting materials found to be biocompatible.
   Polymer Coating (in-vivo animal study)	No adverse conditions noted.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
   The document does not specify sample sizes for any of the performance tests. The data provenance is not mentioned, and it is likely from internal laboratory testing rather than clinical data.

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. The "ground truth" for this type of device (a blood reservoir) is based on engineering and material performance standards and physical measurements, not expert diagnostic assessments.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
   Not applicable, as this is not a diagnostic device involving expert adjudication of findings.

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 imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
   Not applicable. This is not an AI or algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
   The ground truth for this device's performance evaluations would be derived from:

   • Engineering specifications and regulatory standards: For tests like pressure integrity, tubing connection strength, and acceptable pressure drop/flow rates.
   • Material science standards: Biocompatibility following ISO 10993.
   • Validated testing protocols: For defoaming efficiency and filtration efficiency.
   • Chemical analysis standards: For ethylene oxide residues.
   • Biological/physiological measurements: For effects on cellular blood components (e.g., hemolysis, platelet activation) and in-vivo animal study (for coating).

8. The sample size for the training set
   Not applicable. This is not a machine learning or AI device. The term "training set" is not relevant here.

9. How the ground truth for the training set was established
   Not applicable. As above, there is no "training set" for this type of medical device's performance evaluation.

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