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The Storz Communication Bus/ValleyLabs Force FX Control is an interface control box between the SCB computer and the electrosurgical generator. It contains software to display ValleyLab Force FX electrosurgical generator's control parameters on a SCB computer and screen. The Interface Unit serves as a connector box from the Force FX unit to the SCB compatible computer. The unit's software does not perform calculations. It only relays Force FX functions and controls on the SCB monitor for the surgeon's convenient control.

The Karl Storz SCB/ValleyLab Force FX Control connects a Storz Communication Bus computer to the ValleyLab Force FX electrosurgical generator. It enables the SCB computer to display and control the FX's functions.

The provided text describes a 510(k) premarket notification for a medical device and its clearance by the FDA. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

The document is a regulatory submission for a device labeled "SCB/ValleyLab Force FX Interface Unit" and details its intended use, device description, and substantial equivalence to a predicate device. It confirms the FDA's clearance (K041912) for marketing.

Therefore, I cannot provide the requested information, which typically would be found in a clinical study report or a detailed performance validation section of a 510(k) submission.

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The CAPIOX® 308 Hollow Fiber Oxygenator is used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during cardiopulmonary bypass surgery. The integral heat exchanger is used to warm or cool the blood or perfusion fluid flowing through the device. The device is intended for use during extracorporeal circulation for up to 6 hours. This device is for use with neonatal and pediatric patients.

CAPIOX® 308 Hollow Fiber Oxygenator (CAPIOX 308) contains an integrated heat exchanger. The CAPIOX 308 oxygenator is a membrane oxygenator consisting of microporous polypropylene hollow fibers. Blood flows internal to the hollow fibers while gases flow outside the fibers. The heat exchanger consists of stainless steel pipes with blood flowing inside the pipes and water flowing outside the pipes. A thermistor probe is located near the outlet port of the oxygenator which can be connected to accessory temperature monitoring equipment if desired.

The CAPIOX® 308 Hollow Fiber Oxygenator with integral heat exchanger is a new device that was found to be substantially equivalent to the Avecor 0800 2A Oxygenator and Omnitherm Heat Exchanger. The substantial equivalence was established based on intended use, design and materials, technology/principles of operation, specifications, and performance.

Here's a breakdown of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria (Specifications) and Reported Device Performance:

The acceptance criteria for the CAPIOX® 308 were established by demonstrating substantial equivalence to the predicate device, the Avecor 0800 2A Oxygenator and Omnitherm Heat Exchanger. The "acceptance criteria" are effectively the specifications of the predicate device that the new device needed to match or surpass for critical parameters to be considered substantially equivalent.

Important Note: The document explicitly states: "Although some design dissimilarities exist, the performance s and and the the the there that these differences do not Although some design arsements that these differences do not testing results demonstrate that chose in the function and intended uses of the devices." This indicates that while some specifications varied, the overall functional performance was deemed equivalent. For instance, the lower blood flow rate for the CAPIOX® 308 is likely acceptable given its intended use for neonatal and pediatric patients, who require lower flow rates than adults. Similarly, a smaller priming volume is often an advantage.

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

The document does not specify a separate "test set" in the context of clinical trial data or patient samples. The "test results" refer to engineering and performance tests conducted to compare the CAPIOX® 308 with the predicate device. These tests would involve physical measurements and simulations, not patient data in the typical sense of a clinical trial.

• Sample Size: Not applicable in the context of human subjects or clinical data. The tests would involve multiple units of the device and the predicate device for various performance metrics. The exact number of units tested for each specific parameter (e.g., gas exchange, heat transfer, leak testing) is not provided in the summary.
• Data Provenance: The tests were likely conducted in a laboratory or manufacturing setting. The document does not specify the country of origin for the testing, but it was submitted by Terumo Medical Corporation, located in New Jersey, USA, and Elkton, Maryland, USA. The data would be considered prospective as it involves new testing of the device.

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

Not applicable. The ground truth for this medical device submission is established through engineering specifications, direct comparative performance testing against a legally marketed predicate device, and compliance with recognized standards. There is no mention of expert consensus derived from reviewing diagnostic outputs or images.

4. Adjudication Method for the Test Set:

Not applicable. This is not a study involving human interpretation of data where adjudication methods (like 2+1 for reaching consensus among experts) would be used. The "adjudication" in this context is the FDA's regulatory review process, which determined substantial equivalence based on the provided engineering and performance test data.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This type of study is typically conducted for diagnostic devices (e.g., AI algorithms for medical imaging) to assess the impact of AI assistance on human reader performance. The CAPIOX® 308 is a therapeutic device (oxygenator with heat exchanger) used during cardiopulmonary bypass, not a diagnostic imaging tool.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):

Yes, the "performance" section implicitly refers to standalone performance studies. The document states, "The test results indicated the CAPIOX 308 performs in a substantially equivalent manner to the Avecor 0800 2A and Omnitherm Heat Exchanger." These tests were conducted on the device itself, measuring its physical and functional characteristics (e.g., gas exchange efficiency, heat transfer rate, priming volume, pressure resistance) without human intervention in its primary function during the test.

7. Type of Ground Truth Used:

The ground truth used for demonstrating substantial equivalence was a combination of:

• Engineering specifications and performance data of the legally marketed predicate device (Avecor 0800 2A Oxygenator and Omnitherm Heat Exchanger).
• Direct comparative performance testing of the CAPIOX® 308 against the predicate device to show that the new device's performance aligned with, or was acceptably different from, the predicate's performance.
• Compliance with recognized standards for medical device safety and biocompatibility (e.g., pyrogen testing, sterilization validation to SAL of 10⁻⁵, ethylene oxide residuals, 100% performance and leak testing, ISO-10993 for blood-contacting materials).

8. Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a "training set" of data.

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

Not applicable. As there is no training set, there is no ground truth established for one.

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