Search Results

The NxStage System One is indicated for treatment of renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration. All treatments must be administered by a health care provider, under physician's prescription.

The NxStage System One consists of the NxStage Cycler and the NxStage Cartridge Extracorporeal Blood and Fluid Circuit. The NxStage Cycler is an electro-mechanical device that interfaces with the NxStage Cartridge. The NxStage Cartridge is a single-use extracorporeal blood circuit and fluid management device that mounts integrally within the NxStage Cycler. The NxStage Cartridge Express is a single-use extracorporeal blood circuit and fluid management device with a pre-attached high flux (permeability) hollowfiber filter.

The provided text describes the NxStage System One with Cartridge Express, a device intended for the treatment of renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration. However, the document does not contain the detailed information necessary to complete all sections of the request, particularly regarding specific acceptance criteria, a dedicated study proving performance against those criteria, sample sizes for test and training sets, expert qualifications, or details about comparative effectiveness studies.

Here's a summary of the information that can be extracted and a note on what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific numerical acceptance criteria or detail the reported device performance against such criteria. It generally states that "Performance testing was conducted to characterize the performance of the NxStage Cartridge Express during hemodialysis to provide a basis of comparison to the predicate devices. Results of the performance testing have documented that the NxStage Cartridge Express is substantially equivalent to the predicate devices and is suitable for the labeled indication for use."

Therefore, a table cannot be constructed with specific criteria or performance metrics from the provided text.

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

The document mentions "Performance testing" but does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective or prospective nature).

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

This information is not provided in the document.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

The document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it quantify any effect size of human readers improving with or without AI assistance. The device in question is a medical device (dialyzer system), not an AI-assisted diagnostic tool.

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

The device is an electro-mechanical system for treating renal conditions, not an algorithm. Therefore, the concept of "standalone (algorithm only)" performance is not applicable to this device described in the document.

7. The Type of Ground Truth Used

The document indicates that performance testing was conducted to demonstrate "substantial equivalence to the predicate devices" and "suitability for the labeled indication for use." This implies that the "ground truth" or reference for evaluating the device's performance was based on the performance characteristics of its predicate devices, rather than an independent gold standard like pathology or long-term outcomes data, as would be typical for a diagnostic device.

8. The Sample Size for the Training Set

The document does not mention a training set, as the device is not an AI/machine learning model that undergoes a training phase.

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

As there is no mention of a training set, this information is not applicable or provided.

Ask a specific question about this device

The Baxter Accura System is indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. The Baxter Accura System may also be used in Therapeutic Plasma Exchange (TPE) therapies.

The Accura System hardware consists of blood pumps, scales and various monitoring detectors and alarms designed for Continuous Renal Replacement Therapy (CRRT) and Therapeutic Plasma Exchange Therapy. This device was developed to provide pump assisted Slow Continuous Ultrafiltration (SCUF), Continuous Veno-Venous Hemofiltration (CVVH), Continuous Veno-Venous Hemodialysis (CVVHD) and Continuous Veno-Venous Hemodiafiltration (CVVHDF); four modalities used for treating acute renal failure and/or fluid overload. Additionally, the Accura System was developed to provide the pump assisted Therapeutic Plasma Exchange (TPE) therapy.

The Baxter Accura System is a medical device for Continuous Renal Replacement Therapy (CRRT) and Therapeutic Plasma Exchange (TPE) therapies. The provided summary states "All functions of the Baxter Accura System were tested and validated according to design specifications. Based on the validation results, all functions meet their respective required specifications." However, specific numerical acceptance criteria and reported device performance metrics are not detailed in the provided document.

Therefore, the table below will reflect the general statement of compliance rather than explicit numbers.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the "sample size used for the test set" in terms of patient data or the number of units tested.
The validation was conducted on the "functions of the Baxter Accura System" and "components of the disposable tubing set," implying laboratory or engineering testing rather than human subject data.

Data Provenance: Not applicable as no clinical (human subject) data was used for performance validation. The validation appears to be entirely technical/engineering in nature.

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

Not applicable. The validation was based on engineering design specifications, biological requirements (ISO 10993-1), and sterilization standards (ANSI/AAMI/ISO 11135), and safety standards (IEC 60601), not on expert consensus regarding clinical ground truth.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of an adjudication process as the validation was against predefined technical specifications and standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document explicitly states "Clinical Data: N/A". This device validation did not involve human readers or a comparative effectiveness study with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a medical system for physical therapies (CRRT, TPE) and does not involve an algorithm with standalone performance metrics in the way an AI-driven diagnostic tool would. Its performance is related to its mechanical and electrical functions and compliance with safety standards.

7. Type of Ground Truth Used

The "ground truth" for this device's validation were:

• Design Specifications: All functions were tested and validated against their specific design requirements.
• International Standards:
  • Biological requirements per ISO 10993-1.
  • Sterilization cycle validation per ANSI/AAMI/ISO 11135:1994.
  • Electrical safety and general standards per IEC 60601 series.

8. Sample Size for the Training Set

Not applicable. This product is a physical medical device (hardware and disposable tubing set) and its validation did not involve a "training set" in the context of machine learning or AI algorithms. The testing was for compliance with engineering specifications and regulatory standards.

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

Not applicable, as there was no training set in the context of machine learning or AI. The "ground truth" for the device's development and validation was established through engineering design, international standards, and regulatory requirements.

Ask a specific question about this device