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The device is intended to be used as components of a hemodialysis water purification system to remove organic and inorganic substances from water used to dilute dialysis concentrate to form dialysate, and to produce purified water for other purposes such as dialyzer reprocessing and equipment rinse and disinfection. Upon exhaustion, these tanks will be replaced with other Deionization Tanks containing newly regenerated resin or with new resin altogether, or in the case of Carbon Tanks, with tanks containing fresh virgin carbon.

BTI Filtration Deionizer and Carbon Tank Exchange Service for Hemodialysis includes carbon filtration for the removal of chlorine and chloramines and deionizer (DI) exchange tanks for the removal of contaminants from the water through an ion exchange process to provide AAMI quality water for hemodialysis applications.

The renal care facilities will supply their own water treatment system, which may consist of water softeners, sediment filters, ultra-filtration, reverse osmosis system, alarms, monitors, tanks, and pumps. BTI Filtration will only be providing the activated carbon and deionization components to their systems.

This document describes a 510(k) submission for the BTI Filtration Deionization and Carbon Exchange System, a water purification component for hemodialysis. The submission focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel performance criteria.

Here's an analysis of the provided text with respect to your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not provide specific, quantifiable acceptance criteria or detailed device performance metrics in a tabular format. Instead, it makes a general claim of substantial equivalence.

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

The submission does not specify a "test set" in the context of clinical or performance data with a defined sample size. The performance testing appears to be functional characterization of the system components.

• Sample Size: Not specified.
• Data Provenance: Not specified, but likely laboratory or bench testing on system components, not patient data. Retrospective or prospective is not applicable here as it's not a clinical study on patients.

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

This information is not provided in the document. The type of evaluation performed was not a clinical study involving expert interpretation of patient data to establish ground truth.

4. Adjudication Method for the Test Set

This information is not provided. As no clinical test set requiring expert interpretation or adjudication is mentioned, this is not applicable.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not conducted or reported. This type of study is typically done for diagnostic imaging devices where human readers interpret medical images. This device is a water purification system component.

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

This question is not applicable to this device. This is hardware (water purification components), not a software algorithm that would operate in a standalone manner. The device itself is designed to perform its function (water purification) autonomously once installed and operating.

7. The Type of Ground Truth Used

The ground truth or performance validation appears to be based on the physical and chemical characteristics of the purified water generated by the system, compared against established standards for hemodialysis water (e.g., AAMI quality water). The substantial equivalence claim is anchored on the device's technological characteristics and its ability to achieve these water quality standards, similar to the predicate devices. It is not based on expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set

This information is not applicable as this is not a device employing machine learning or AI that requires a training set.

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

This information is not applicable as there is no training set for this device.

Summary of Device and Performance Information from the Given Text:

The BTI Filtration Deionization and Carbon Exchange System is intended as a component of a hemodialysis water purification system. Its purpose is to remove organic and inorganic substances from water to produce AAMI quality water for hemodialysis applications.

The manufacturer claims substantial equivalence to predicate devices (AmeriWater Purification System for Hemodialysis (K991519) and US Filter Water Purification System for Hemodialysis (K980182)) based on:

• Technological Characteristics: The proposed device has the "same technological characteristics and is similar in design and configuration" to the predicate devices, using "components commonly found in the predicate devices."
• Performance Testing: "Performance testing was conducted to characterize performance... [and] demonstrated that the BTI Filtration Deionization and Carbon Exchange System is substantially equivalent to the predicate devices and is suitable for the labeled indications for use."

The submission focuses on the engineering and functional similarity to already cleared devices, rather than presenting a novel clinical study with explicit acceptance criteria for diagnostic performance or treatment outcomes. The "acceptance criteria" can be inferred as meeting the AAMI water quality standards, which the performance testing presumably verified, consistent with the predicates.

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