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The bicarbonate mixing and distribution system and its components consisting of; tanks, pumps, piping, and controls, are designed to consistently, safely, and effectively mix and distribute bicarbonate solutions for hemodialysis treatments.

NOTE: Federal Law restricts this device to sale by or on the order of a physician for use as a bicarbonate mixing and distribution system for hemodialysis.

Device is designed to provide the user with a system for consistent and easy to use system by which they may be able to mix and distribute bicarbonate solution for use in a hemodialysis clinic.

The provided text describes a 510(k) submission for the TYPHOON Bicarb Mixing and Distribution System, focusing on its substantial equivalence to a predicate device. However, the document does not contain information on acceptance criteria or a study proving the device meets specific performance criteria in the manner expected for a typical medical device performance study.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (USFilter Bicarbonate Mixing and Dispensing System, K031502) by comparing technical specifications and intended use. The rationale is that since the TYPHOON system utilizes similar technology, components, and fluid contact materials as previously cleared devices, it is safe and effective.

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

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, explicit quantitative acceptance criteria and corresponding reported device performance values (e.g., accuracy, sensitivity, specificity) for a clinical or in-vitro performance study are not present in the provided document. The performance is assessed through a comparison of technical specifications and the assertion of similar technology and components to a predicate device.

The table below summarizes the comparison of technical specifications between the TYPHOON device and its predicate, which serves as the basis for demonstrating "performance" in this context of substantial equivalence.

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

• Sample Size: Not applicable. The submission does not describe a clinical or performance study with a test set of data points or cases. It relies on a comparison of device specifications to demonstrate substantial equivalence.
• Data Provenance: Not applicable. There is no test set data mentioned.

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

Not applicable. There was no test set or ground truth established by experts in the context of a performance study for this submission. The device is a physical system for mixing and distributing bicarbonate solution.

4. Adjudication Method for the Test Set

Not applicable, as there was no test set.

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 device is a mechanical system for mixing and distributing solutions; it does not involve AI or human readers for diagnostic interpretation.

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

Not applicable. This device is a mechanical system; it does not have an algorithm for standalone performance evaluation in the usual sense of AI/software devices.

7. The Type of Ground Truth Used

Not applicable. There is no concept of "ground truth" (e.g., pathology, outcomes data) in the context of this 510(k) submission, as it relates to a mechanical system rather than a diagnostic or interpretive device. The "truth" of its performance relies on its physical and functional specifications meeting the intended use and being similar to a predicate.

8. The Sample Size for the Training Set

Not applicable. The device is a mechanical system for which a "training set" in the context of machine learning or AI is not relevant.

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

Not applicable, as there is no training set.

Summary of the Study (or lack thereof) Proving Device Meets Acceptance Criteria:

The provided document indicates that the Dialysis Services, Inc. TYPHOON Bicarb Mixing and Distribution System relies on substantial equivalence to a predicate device (USFilter Bicarbonate Mixing and Dispensing System, K031502) rather than a novel performance study with explicit acceptance criteria.

The "study" to prove the device meets acceptance criteria consists of:

• Comparison of Technical Specifications: The submission provides a detailed table comparing the technical specifications and requirements of the TYPHOON system with those of its predicate device, demonstrating functional and material similarity (Section {2}).
• Similar Technology and Intended Use: The submitter explicitly states that both devices utilize "similar technology" and share the same "intended use" to consistently mix and distribute bicarbonate solution for hemodialysis (Sections {1} and {3}).
• Non-Clinical Performance Data: The document states that the TYPHOON system "utilizes similar components and fluid contact materials as other items currently cleared for use in hemodialysis" (Section {3}, 4.12).
• Biocompatibility Testing: The submitter certifies that most materials and components are "identical to those previously cleared and registered with the FDA," with additional testing provided in Section 9.0 (not included in the provided text snippet) (Section {3}, 4.14).
• Absence of Clinical Testing: The submission explicitly states "N/A" for clinical testing, indicating that such a study was not deemed necessary due to the substantial equivalence claim (Section {3}, 4.13).

In conclusion, the acceptance criteria are not quantitative performance metrics from a specific study, but rather the qualitative determination by the FDA that the device is substantially equivalent to a legally marketed predicate device based on its design, materials, and intended use, and therefore meets the safety and effectiveness requirements without the need for a separate clinical or detailed performance study beyond the comparison provided.

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