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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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The water treatment system and its components consisting of; pretreatment, reverse osmosis machine, and the product water distribution components, are designed to remove microbiological, organic, and inorganic contaminants from the tap water to supply dialysis machines for the preparation of dialysate solutions for hemodialysis treatments.

NOTE: Federal Law restricts this device to sale by or on the order of a physician for use as a water treatment device for hemodialysis.

The water treatment system and its components consisting of; pre-treatment, reverse osmosis machine, and the product water distribution components, are designed to remove microbiological, organic, and inorganic contaminants from the tap water to supply dialysis machines for the preparation of dialysate solutions for hemodialysis treatments.

Pretreatment components can include a tap water boosting system, blending valve, sediment filtration, carbon removal system, blomaing vars, and all the necessary interconnecting nlumbing. The purpose of this part of the system is to ensure that properly conditioned water is supplied to the reverse osmosis machine to ensure its safe and trouble free operation. The blending valve ensures that the water is at the proper temperature when entering the reverse osmosis machine. The tap water booster system helps ensure that the reverse osmosis machine has adequate water pressure and volume so it can produce the desired amount of water. The sediment filters can be in the form of an automatic backwashing filter (such as a multi-media depth filter), or as a replaceable filter cartridge. The carbon filters are installed primarily to remove the amount of chlorine and chloramines from the water to meet the necessary water quality standards and can be in the form of automatic backwashing tanks, or portable exchange tanks. The water softener(s) are in place to remove the hardness from the tap water to both meet water quality standards, and to protect the reverse osmosis membranes from scaling and therefore not performing to specifications.

After the tap water has been pre-treated, it then enters the R.O. (reverse osmosis), where total dissolved solids are removed to pertinent water quality standards. This is accomplished by utilizing a membrane separation process, whereby the incoming water is separated into a product stream, and a concentrate stream. The molecular weight cut-off determines what and how many contaminants are passed through into the product stream. R.O.s used for this application typically remove 95-99% of all total dissolved solids and bacteria.

The product water distribution part of the system is in place to store, provide additional purification if needed, and deliver the purified water to wherever needed. These components can include such things as a storage tank, deionization tanks, final filters (for bacteria and endotoxins), and delivery pumps and controls. Some systems can also utilize an ultraviolet light for additional sterilization properties. The distribution piping encompasses the piping and related fittings to deliver the dialysis water from the water treatment system to the use points (dialysis machines) and return the unused portion of water back to the water treatment system.

The provided text describes the Dialysis Services Water Treatment & Distribution System, a water purification system for hemodialysis. This document is a 510(k) premarket notification and primarily focuses on establishing substantial equivalence to a predicate device and demonstrating compliance with relevant standards.

Here's an analysis based on the information provided and the questions you've asked:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the acceptance criterion for the device is:

• "The Dialysis Services Water Treatment System produces product water which is in compliance with the standard issued by the Association for the Advancement of Medical Instrumentation, AAMI RD62-2001."

The reported device performance is:

• "The Dialysis Services Water Treatment System produces product water which is in compliance with the standard issued by the Association for the Advancement of Medical Instrumentation, AAMI RD62-2001."

2. Sample size used for the test set and the data provenance:

• Sample size: Not specified. The document only states that "The Dialysis Services Water Treatment System produces product water which is in compliance..." It doesn't detail the testing methodology, number of tests, or amount of water sampled.
• Data provenance: Not specified. It's likely from internal testing by Dialysis Services, Inc., but no details on country of origin or whether it was retrospective/prospective are provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not provided in the document. The general nature of water quality testing against a standard typically does not involve human experts establishing a "ground truth" in the way a medical image diagnosis might. The ground truth here is the AAMI RD62-2001 standard itself, and measurements are taken against that standard using calibrated instruments.

4. Adjudication method for the test set:

• Not applicable/Not provided. Water quality testing against a standard generally relies on objective measurements rather than adjudication by multiple human experts.

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:

• No. This device is a water treatment system, not an AI-assisted diagnostic tool or imaging device that would involve human readers or MRMC studies.

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

• Not applicable/No. This is a physical water treatment system, not a software algorithm.

7. The type of ground truth used:

• The "ground truth" used is the AAMI RD62-2001 standard for water purification systems for hemodialysis. Device performance is measured against the specifications outlined in this standard.

8. The sample size for the training set:

• Not applicable/Not provided. This is a hardware device, not a machine learning model, so there is no concept of a "training set" in this context.

9. How the ground truth for the training set was established:

• Not applicable/Not provided. As there is no training set, this question is not relevant.

Summary of the Study:

The "study" referenced in the document is a non-clinical performance evaluation to demonstrate that the Dialysis Services Water Treatment System produces product water that complies with the AAMI RD62-2001 standard. This type of evaluation typically involves testing the system's output water against various chemical, physical, and microbiological parameters specified in the standard (e.g., levels of total dissolved solids, chlorine, chloramines, hardness, bacteria, endotoxins). The document does not provide specifics about the experimental design, sample sizes, or the individual results of these tests, only a summary statement of compliance. The FDA reviewed this claim of compliance as part of the 510(k) submission to determine substantial equivalence to a predicate device.

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