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The Venofer Pump is an optional accessory for use with the Fresenius 2008 Series Hemodialysis Machines and is intended to administer Venofer® to treat iron deficiency anemia in patients with chronic kidney disease undergoing hemodialysis, where Venofer®, in conjunction with hemodialysis, is prescribed by a physician.

The Venofer Pump is an optional module for use on Fresenius 2008 Series Hemodialysis Machines and is designed to administer Venofer® during dialysis treatments and consists of a control panel, vial holder, fluid detector, and a peristaltic pump. The module is a self contained microprocessor controlled device that receives its power from the Fresenius 2008 Hemodialysis machine.

The provided text describes the Venofer Pump Version 1.3, an optional accessory for hemodialysis machines. This submission is a "Special 510(k)" for modifications to support the use of an additional blood tubing set. The document focuses on demonstrating substantial equivalence to a previously cleared device (K103564) and confirming that the modifications do not raise new questions of safety or effectiveness.

Here's an analysis of the acceptance criteria and study information based on the provided text:

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 for any of the verification activities (functional, safety, or software).
The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective. The studies described are non-clinical (verification) testing, not clinical trials on human subjects.

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. Given that the studies are non-clinical verification tests, the "ground truth" would likely be established by engineering specifications, regulatory standards, or consensus standards, rather than expert clinical judgment in the traditional sense for medical imaging or diagnostic devices.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving human readers/interpreters, not for non-clinical device verification testing.

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 MRMC comparative effectiveness study was done. This device is a pump for administering medication, not an AI-powered diagnostic or assistive device for human readers.

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

No standalone algorithm performance study was done in the context of AI. The "standalone" performance described would be the functional performance of the pump itself, which was tested during "Venofer Pump Performance Testing." The device is a physical pump, not a diagnostic algorithm.

7. The Type of Ground Truth Used

For the non-clinical verification testing described:

• Performance Testing: The "ground truth" would be the device's design specifications and expected functional behavior.
• Safety Testing: The "ground truth" would be established by FDA Consensus Standards (e.g., IEC 60601-1-2 for EMC, AAMI / ANSI / ISO 10993-1 for biocompatibility).
• Software Testing: The "ground truth" would be the software design input requirements and functional specifications.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. The Venofer Pump is a physical medical device, not an AI/machine learning algorithm that requires a training set.

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

This information is not applicable and therefore not provided. As mentioned above, the device is not an AI/machine learning algorithm.

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The 2008 Sorbent System is intended for adult acute and chronic uremic patients in the presence of a healthcare practitioner where hemodialysis is prescribed on the order of a physician.

The 2008 Sorbent System is intended for adult acute and chronic uremic patients in the presence of a healthcare practitioner where hemodialysis is prescribed on the order of a physician. The 2008 Sorbent System operates in a similar manner to standard hemodialysis systems currently approved for use; it is substantially equivalent to the Fresenius 2008T hemodialysis machine (K080964) and the Renal Solutions Allient® Sorbent Hemodialysis System (K070739). The significant difference between the 2008 Sorbent System and standard single-pass hemodialysis machines is that the 2008 Sorbent System utilizes a sorbent cartridge to purify dialysate made from potable tap water and then regenerates fresh dialysate from spent dialysate (like the Allient Sorbent Hemodialysis System). The 2008 Sorbent System consists of two distinct components: the 2008 Machine, and the SORB™ Module. The SORB Module is a sorbent dialysate regenerative system that attaches to the 2008 Machine and replaces the machine's existing single-pass dialysate delivery system. During treatment, used dialysate is chemically reprocessed into fresh, new dialysate and sent back to the dialyzer instead of being sent down a drain. By recirculating and regenerating the dialysate, the 2008 Sorbent System uses less than 15 liters of potable tap water per treatment compared to a standard single-pass system that uses at least 120 liters of purified water during a standard 4-hour dialysis treatment.

The provided text describes the 2008 Sorbent Hemodialysis System, focusing on its substantial equivalence to predicate devices and the verification testing performed. However, it does not include the specific details required to fully answer your request regarding acceptance criteria and a study proving the device meets those criteria, particularly for an AI-powered medical device.

The document is a 510(k) summary for a Sorbent Hemodialysis System, which is a medical device for dialysate delivery, not an AI or software-intensive diagnostic device in the sense your questions imply (e.g., test sets, ground truth, expert consensus, MRMC studies). The "software testing" mentioned is to ensure the device's control software meets its design input requirements, not for evaluating an AI algorithm's diagnostic or predictive performance.

Therefore, many of your requested items cannot be extracted from this document as they are not relevant to the type of device being described.

However, I can extract what is available:

1. A table of acceptance criteria and the reported device performance:

The document outlines categories of testing and general objectives, implying acceptance criteria were defined for each. However, it does not explicitly state the quantitative acceptance criteria or the specific numerical performance results. Instead, it refers to "pre-defined acceptance or pass/fail criteria" and states that testing "demonstrates the device meets its performance specifications."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the given text. The testing described is non-clinical verification testing of a physical medical device, not a study involving patient data in the context of AI performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/provided. The ground truth for this type of device (a hemodialysis system) is established through engineering and performance specifications, adherence to standards, and risk analysis, not expert consensus on diagnostic interpretations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/provided. Adjudication methods like 2+1 are typically used in clinical studies involving multiple readers or interpretations, which is not what is described here.

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

An MRMC comparative effectiveness study was not done, as this device is a hemodialysis system and not an AI-assisted diagnostic tool for human readers.

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

This information is not applicable/provided. The "software testing" refers to the control software of the device, not a standalone diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device is based on engineering specifications, regulatory standards (e.g., IEC, ISO), and performance requirements related to the physical and functional operation of the hemodialysis system. The document lists "pre-defined acceptance or pass/fail criteria" as part of the test protocols.

8. The sample size for the training set

This information is not applicable/provided. This device is a physical medical device, not an AI model trained on a dataset.

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

This information is not applicable/provided. As above, there is no AI model or training set in the context of this device.

In summary, the provided document describes a 510(k) submission for a Sorbent Hemodialysis System, focusing on its functional, safety, and software verification to demonstrate substantial equivalence to predicate devices. It does not contain the detailed information typically associated with the evaluation of AI-powered diagnostic or predictive medical devices.

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Fresenius Model 2008T Hemodialysis Machine is indicated for acute and chronic dialysis therapy.

The Venofer® Pump Module is an optional accessory for use on Fresenius 2008T Hemodialysis Machines and is intended to administer Venofer®, an iron sucrose, to treat iron deficiency anemia in patients with chronic kidney disease undergoing hemodialysis, where Venofer®, in conjunction with hemodialysis, is prescribed by a physician.

The Venofer Pump Module is an optional module for use on Fresenius 2008T Hemodialysis Machines. The module is designed to administer Venofer, an iron sucrose supplement, during dialysis treatments. The Venofer Pump Module is to be used in accordance with the approved Venofer Indications for Use and the physician's prescription.

The Venofer Pump Module is intended to provide ease and consistent delivery of Venofer, an iron sucrose supplement, indicated for the treatment of iron deficiency anemia for Hemodialysis dependent-chronic kidney disease patients. Anemia commonly occurs in patients with chronic kidney disease undergoing Hemodialysis and effective anemia management is recognized as an important factor in improving the outcomes of these patients. Iron deficiency is a frequent contributing factor which complicates the treatment of anemia in chronic kidney disease patients. Iron sucrose is commonly delivered to improve iron status in patients who have chronic kidney disease. Venofer is an injectable iron preparation drug approved for treatment of iron deficiency and is the most commonly used drug to treat iron deficiency anemia in dialysis patients. Renal Solutions has developed the Venofer Pump Module that provides the means to deliver Venofer when undergoing Hemodialysis on a Fresenius 2008T Dialysis System.

The Venofer Pump Module fits into the module compartment of existing Fresenius 2008T Machines and consists of a control panel, vial holder, fluid detector, and a peristaltic pump.

The provided text describes a 510(k) premarket notification for the "Fresenius Model 2008T Hemodialysis Machine with Venofer Pump Module." This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study with acceptance criteria and performance data for a novel device. Therefore, much of the requested information regarding acceptance criteria, sample sizes, expert ground truth, adjudication methods, and comparative effectiveness studies is not available in the provided text.

Based on the information given, here's what can be extracted:

1. A table of acceptance criteria and the reported device performance:

This information is not provided in the document. The submission is for a medical device accessory and states that non-clinical testing was performed, but it doesn't detail specific acceptance criteria or quantitative performance results in a table format. It generally claims the device is "as safe, as effective, and performs at least as safely and effectively as the legally marketed devices identified as predicate devices."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not provided in the document. The text mentions "non-clinical testing" but does not specify sample sizes or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not provided in the document. The nature of the device (a pump for administering medication during hemodialysis) suggests that ground truth would likely be established through engineering and medical performance standards, rather than expert-derived ground truth in the way a diagnostic imaging AI might.

4. Adjudication method (e.g. 2+1, 3+1, none) 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, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable and not provided in the document. The Venofer Pump Module is an accessory for a hemodialysis machine, administering medication. It is not an AI-assisted diagnostic tool that would typically involve human "readers" or an MRMC study.

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

This information is not applicable in the context of an AI algorithm. The device is a physical pump module. The document states, "Like the Heparin Pump, the Venofer Pump Module is not a stand alone device. The Venofer Pump Module cannot operate unless it is connected to the 2008T Hemodialysis Machine." This refers to its operational dependency on the larger hemodialysis machine, not a standalone AI performance evaluation.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

This information is not explicitly stated in the document. Given the device's function, ground truth for its performance would likely be established through engineering specifications, flow rate accuracy, absence of adverse events, and efficacy of drug delivery as measured by standard medical parameters (e.g., successful iron administration without pump-related complications), rather than categorical labels like pathology or expert consensus on image interpretation. The submission relies on "verification, safety, performance and software testing."

8. The sample size for the training set:

This information is not provided in the document. The device is a physical pump, not an AI algorithm that undergoes a "training set" in the machine learning sense.

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

This information is not provided in the document, as it's not an AI device with a training set.

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The Allient Sorbent Hemodialysis System, including the SORB™ series and HISORB™ series of cartridges is to be used for the treatment of acute and chronic uremic patients where hemodialysis is prescribed by the physician.

Not Found

This document is a 510(k) clearance letter for the Allient Sorbent Hemodialysis System. It does not contain information on the acceptance criteria or a study that proves the device meets specific acceptance criteria in the format requested. The letter confirms that the device is substantially equivalent to legally marketed predicate devices, but it does not detail the technical performance data that led to this determination.

Therefore, I cannot provide the requested table or information based on the content of this document.

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