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The Isopure Sodium Bicarbonate Mixing and Distribution System is intended to be used in Hemodialysis facilities for the mixing, storage and distribution of Bicarb liquid concentrate to be used in the treatment of Hemodialysis patients.

The Isopure Sodium Bicarbonate Mixing and Distribution System is designed to mix sodium bicarbonate powder into a liquid solution based on the recommended mixing procedures from the powder manufacturers. Once the powder is mixed into a liquid solution and verified for content accuracy, the solution is transferred to an independent distribution tank for transfer through a loop to the individual dialysis machines or to fill jugs which then can be transported to the individual dialysis machines when no distribution loop exists. The Isopure Sodium Bicarbonate Mixing and Distribution System features the patented SOLUBILIZER™, which utilizes a large volume of water spinning in a vortex manner to dissolve dry powder into a liquid solution that is drawn into a mix tank. The solution is mixed with AAMI quality water according to specifications outlined by the manufactures for the bicarbonate powder. Once the solution has been dissolved and mixed, the solution can be transferred from the mixing tank to the storage delivery tank for distribution to the loop or jugs. The tanks and the SOLUBILIZER™ are sealed to reduce microbial contamination. The sealed design also facilitates CO2 recovery and gassing off of CO2 during the mixing procedure. The entire system is controlled by programmable control logic (PLC), which operates the system. The PLC will control the mixing, the delivery and disinfection of the complete system. The system PLC is operated through an HMI touch screen which displays the critical aspects of the system. including the operational stages, real-time indication of various steps, and alarm conditions.

The provided text describes a 510(k) premarket notification for the Isopure Sodium Bicarbonate Mixing and Distribution System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive de novo clinical trials. Therefore, the information typically requested in your prompt (e.g., acceptance criteria with reported device performance in a table, sample sizes for test/training sets, number and qualifications of experts for ground truth, MRMC studies, standalone performance, type of ground truth) is not explicitly present in the provided document.

The document primarily focuses on comparing the technological characteristics of the new device to its predicate and outlining non-clinical testing performed to establish equivalence.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a table with explicit acceptance criteria and corresponding reported device performance metrics in the format typically used for performance studies. Instead, it states that the system "was tested repeatedly for proper operation" and "each mix batch was tested for the target conductivity of the solution to confirm the correct mixture."

The implied acceptance criterion is:

• Target conductivity of the solution: The mixed sodium bicarbonate solution must achieve the "target conductivity" to confirm correct mixture.

The reported device performance is:

• "each mix batch was tested for the target conductivity of the solution to confirm the correct mixture, and then transferred to the Distribution Tank."
• "The distribution function was then tested to ensure that circulation of the solution through the loop occurred as expected."
• "The system has undergone 100% testing to ensure substantial equivalence to the Pure Water, Inc. predicate device. Both systems are fully capable of meeting the mix requirements specified for a suitable sodium bicarbonate solution."

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

• Sample Size: The document does not specify a numerical sample size for the test set. It states the system "was tested repeatedly" and "each mix batch was tested for the target conductivity." This suggests multiple batches were tested for each selectable volume.
• Data Provenance: The testing was non-clinical. The "testing area consists of all components of a water room that would normally be present at a dialysis clinic." It utilized "the same brand of bicarbonate typically used in an operating clinic." This implies the testing environment and materials were representative of real-world use within a dialysis facility. The country of origin for the data is implicitly the US, as the submitter is an American company and the approval is from the US FDA. The testing was prospective within the context of the device development and validation.

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

• Experts: Not applicable. The "ground truth" for the device's function (correct mixing and distribution) was established through objective measurements (conductivity) and functional assessments (circulation). This is a technical performance verification, not a clinical interpretation requiring expert consensus.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. The "ground truth" (correct mixture via conductivity, proper circulation) was determined by direct measurement and observation, not expert review or adjudication.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a medical equipment system for mixing and distributing solutions, not an imaging or diagnostic device that would involve human readers interpreting cases.

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

• Standalone Performance: Not applicable in the context of typical AI/algorithm standalone performance. The device itself is an automated system controlled by a PLC, and its performance was assessed directly. There isn't a separate "algorithm" for human-in-the-loop interaction in the way AI diagnostics are often evaluated. The testing described focuses on the machine's ability to execute its programmed functions (mixing, distribution) correctly and automatically.

7. The Type of Ground Truth Used:

• Type of Ground Truth: The ground truth was based on objective technical measurements and functional verification. Specifically:
  • Conductivity Readings: To confirm the correct mixture of the sodium bicarbonate solution (compared against a target conductivity).
  • Functional Assessment: To ensure proper circulation of the solution through the distribution loop.
  • Compliance with Manufacturer Recommendations and Standards: Adherence to powder manufacturers' recommendations and AAMI RD52-2004 requirements for mixing procedures.

8. The Sample Size for the Training Set:

• Training Set Sample Size: Not applicable. This device is not an AI/machine learning model in the conventional sense that would require a "training set" of data to learn from. Its operation is governed by pre-programmed logic (PLC) and engineering design, not statistical learning from a dataset.

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

• Training Set Ground Truth: Not applicable, as there is no training set for this type of device. The operating parameters and expected performance are established through engineering specifications, manufacturer guidelines, and relevant industry standards (like AAMI RD52-2004).

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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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