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System 100 is indicated for temorary (up to 8 hours) ultrafiltration treatment of patients with fluid overload.

System 100 consists of the:
• S-100 console
• UF 500 set
• Venous access catheters
• Catheter extension set
• Needless flushing port
• Catheter insertion kit

The provided text describes the "System 100" device, a high-permeability hemodialysis system, and its FDA 510(k) clearance. However, it does not contain specific acceptance criteria, detailed study designs, or quantitative results that would allow for a complete description of the device's performance against predefined metrics.

The text primarily focuses on the regulatory submission process and the determination of substantial equivalence to a predicate device.

Here's an analysis based on the information available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document states that "CHF Solutions, Inc. performed non-clinical testing on System 100 to demonstrate that the device met its functional and performance specification." and "Clinical data confirm that the device is safe and effective for its intended use." However, it does not explicitly define these "functional and performance specifications" as acceptance criteria, nor does it provide quantitative results or metrics against which performance was measured.

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

Explanation: The document mentions "Clinical data confirm that the device is safe and effective." However, it does not provide any details about the sample size of the clinical study, whether it was prospective or retrospective, or the country of origin of the data.

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

Explanation: This type of information is typically relevant for interpretative diagnostic devices where human experts establish ground truth for testing AI algorithms. The System 100 is a medical device for ultrafiltration, not an AI-powered diagnostic tool, so this concept does not directly apply.

4. Adjudication Method for the Test Set

Explanation: As with the previous point, adjudication methods are typically used for establishing ground truth from multiple expert interpretations, which is not relevant for this type of medical device's performance testing.

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

Explanation: An MRMC comparative effectiveness study is specific to evaluating the impact of AI assistance on human reader performance, usually in image-based diagnostics. The System 100 is a physical medical device, not an AI system, so this type of study would not be applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Explanation: "Standalone" performance refers to an algorithm's performance without human intervention, again, relevant for AI diagnostic systems. This device is not an AI algorithm.

7. The Type of Ground Truth Used

Explanation: While "Clinical data confirm that the device is safe and effective," the specific type of ground truth (e.g., patient outcomes, physiological measurements, laboratory results) used in these clinical studies to evaluate safety and effectiveness is not detailed. For a device like this, ground truth would likely involve measurements of fluid removal, patient vital signs, and adverse event reporting.

8. The Sample Size for the Training Set

Explanation: The concept of a "training set" is typically associated with machine learning or AI models. The System 100 is a physical medical device, not an AI algorithm, so it does not have a training set in this context.

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

Explanation: As stated above, there is no training set for this type of device.

In summary: The provided 510(k) summary focuses on the regulatory aspects of substantial equivalence. It confirms that non-clinical and clinical data were generated to demonstrate safety and effectiveness but does not provide the granular details requested regarding specific acceptance criteria, study methodologies, or quantitative performance metrics. Such details would typically be found in more comprehensive study reports or validation documentation, which are not part of this 510(k) summary.

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