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Intended to relieve or mitigate overhydration in patients undergoing cardiopulmonary procedures and to increase the concentration of cells and proteins in the blood.

The Low Volume Hemoconcentrator is similar to the F Series F400 Hemoconcentrator. Both hemoconcentrators are hollow fiber-type filters and will be provided with and without a tubing set. The Low Volume Hemoconcentrator has an active membrane surface area of 0.35M2 and a priming volume of 27 ml.

The provided text describes a 510(k) submission for a device modification, specifically the Fresenius F Series Low Volume Hemoconcentrator. This document is a regulatory submission for a medical device whose performance is characterized by physical specifications and in-vitro performance rather than clinical outcomes or diagnostic accuracy. Therefore, many standard AI/ML evaluation metrics like sensitivity, specificity, or AUC, and ground truth establishment methods typically associated with clinical studies, are not applicable here.

The "acceptance criteria" and "device performance" are presented as a comparison table between the modified device and its predicate device, demonstrating that the new device meets the necessary physical and performance characteristics to be considered substantially equivalent.

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

The acceptance criteria for this device are implicitly defined by its substantial equivalence to the predicate device (F400 Hemoconcentrator, K974584), meaning its specifications and performance characteristics must be comparable or within acceptable ranges relative to the predicate. The reported device performance for the new "Low Volume Hemoconcentrator" is shown in the table below, alongside the predicate device's data for comparison.

Note: For parameters like Active Membrane Surface, Priming Volume, Number of Fibers, Max. Blood Flow, Pressure Drop, and Ultrafiltration Rate, changes are expected due to the "Low Volume" nature of the device modification. The "Met?" column indicates whether the new device's characteristic is identical to the predicate (Yes) or if it's a designed difference due to the modification (N/A – meaning it's not expected to be identical but aligns with the intended modification and is presumed acceptable by the FDA for substantial equivalence).

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

The document does not detail specific "test set" sample sizes in the context of clinical or performance data collection on multiple units. The data presented is for the design specifications and nominal performance characteristics of the device itself.

• Sample Size: Not explicitly stated as this is a device modification submission based on technical specifications and in-vitro performance, not a clinical trial. The performance characteristics (e.g., pressure drop, ultrafiltration rate) are likely derived from bench testing or engineering calculations based on the design, rather than a "test set" of many devices.
• Data Provenance: Not specified, but generally, such technical specifications and in-vitro test data would be generated within the manufacturing and R&D facilities of Fresenius Hemotechnology Inc. (location: Concord, CA). The data is not derived from human subjects, thus "retrospective or prospective" is not applicable in the typical clinical sense.

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 is not applicable to this type of device submission. There is no "ground truth" established by experts in the sense of clinical diagnoses or interpretations for this mechanical device. The "truth" lies in the engineering specifications and in-vitro performance data, which are verified through standard engineering and laboratory testing protocols.

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

Not applicable. This is not a study involving human interpretation or clinical adjudication.

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 hemoconcentrator, not an AI/ML-enabled diagnostic or therapeutic device that would involve human readers or AI assistance.

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

Not applicable. This device is a physical medical device, not an algorithm or software.

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

The "ground truth" for this device modification is the verified engineering specifications, material properties, and in-vitro performance measurements (e.g., pressure drop, ultrafiltration rates) obtained through standardized laboratory testing and quality control processes. This is analogous to "bench testing" or "design verification" rather than clinical "ground truth."

8. The sample size for the training set

Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set."

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

Not applicable, as there is no training set for this device.

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Hemoflow dialyzers are designed for use in acute or chronic hemodialysis therapies as either single use or multiple use.

Fresenius Polysulfone Hemodialyzers

The provided documents are a letter from the FDA regarding a 510(k) premarket notification and an "Indications for Use" statement for Fresenius Polysulfone Hemodialyzers. These documents are from 1998 and pertain to medical devices (dialyzers), not an AI-powered diagnostic device.

Therefore, the information required to describe the acceptance criteria and the study proving an AI device meets those criteria (such as detailed performance metrics, sample sizes, expert qualifications, ground truth methods, or MRMC studies) is not present in the provided text.

The documents confirm that the specified Fresenius Hemoflow Dialyzers were found "substantially equivalent" to predicate devices for use in acute or chronic hemodialysis. This substantial equivalence determination by the FDA is the "acceptance criteria" in this context, rather than specific performance metrics detailed in a study report for an AI device.

To answer your specific questions:

1. A table of acceptance criteria and the reported device performance: Not applicable/not provided. The acceptance was based on substantial equivalence to predicate devices, not on specific performance metrics of an AI model against predefined acceptance criteria.
2. Sample size used for the test set and the data provenance: Not applicable/not provided. This is a medical device approval based on substantial equivalence, not an AI model validation study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided. Ground truth for an AI model is not relevant here.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/not provided.
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/not provided. This is not an AI device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable/not provided. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/not provided.
8. The sample size for the training set: Not applicable/not provided.
9. How the ground truth for the training set was established: Not applicable/not provided.

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The Fresenius F Series Hemoconcentrators are indicated to relieve or mitigate overhydration in patients undergoing cardiopulmonary procedures and to increase the concentration of cells and proteins in the blood.

The Fresenius Hemoflow Series Dialyzer, the same product as the F Series Hemoconcentrators, is a hollow fiber-type filter. Fresenius-produced polysulfone capillary fibers are bundled and potted with polyurethane into an artificial kidney jacket manufactured from polyurethane. Screw-type end caps, manufactured from polyurethane, have twist lock connectors for the connection of venous and arterial blood lines. Two filtrate ports are located on the filter adjacent to the filtrate chambers. The ports have Hansen-type fittings for connection of filtrate tubing. For hemoconcentration, only the filtrate port on the venous end of the filter is used; the other port on the arterial end is capped. There are four (4) models within the F Series Hemoconcentrators family. The difference between the four models in the F Series Hemoconcentrators is the number of fibers contained within the artificial kidney jacket. As the number of fibers contained in the filter increases, the diameter of the filter and the filtration capacity increases proportionally. Each model will be manufactured with a tubing set (F400TS, F500TS, F700TS, F800TS); other models will be manufactured with tubing adapter, only (F400, F500, F700, F800).

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 a specific numerical sample size for the test set. However, it indicates that "Comparative in vitro testing" was performed on the Fresenius F40, F50, F70, and F80 hemoconcentrators. This suggests a test set comprising various models of the subject device.

The data provenance is in vitro testing. The country of origin of the data is not explicitly stated, but given that Fresenius USA submitted the 510(k), it is likely the testing was conducted in the US or by a facility associated with Fresenius USA. The testing was prospective as it was conducted to characterize the performance of the new devices.

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

This information is not provided in the document. The study focuses on in vitro performance comparison, which typically relies on established laboratory measurement techniques and standards rather than expert human interpretation for raw data.

4. Adjudication Method for the Test Set

This information is not applicable/provided. As explained above, the study involved in vitro testing and performance measurements, not expert human assessment that would require an adjudication method.

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

No, an MRMC comparative effectiveness study was not done. The study described is an in vitro performance comparison of the device itself, not an evaluation of human readers (clinicians) using the device with or without AI assistance.

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

N/A. The device is a medical apparatus (hemoconcentrator), not an AI algorithm. Therefore, the concept of "standalone algorithm performance" is not applicable in this context. The study did evaluate the standalone performance of the device in vitro.

7. The Type of Ground Truth Used

The ground truth used was established laboratory measurements and scientific principles. Specifically, performance characteristics were measured against:

• Draft specifications for the products.
• A recognized international standard, EN 1283, Haemodialyzers, Haemodiafilters, Haemoconcentrators and Their Extracorporeal Circuits.
• Performance of legally marketed predicate devices (F40, F60, Bard HC40, Amicon Diafilter 30, Minntech Hemocor HPH 1000, Baxter Bentley Quick Prime HQ 7000, Research Medical Biofilter 140) under similar operating conditions.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical device, not an AI algorithm that requires a training set. The term "training set" doesn't apply to the development or evaluation of this type of product.

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

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

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The C.A.T.S (Continuous Autotransfusion Svstem) by Frescruus is an autotransfusion device indicated for the processing of autologous shed blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion. Additionally, it can be used for perioperative separation of blood into Packed Red Cells (PRC), Plasma (PLS) and Platelet Rich Plasma (PRP).

The Fresenius C.A.T.S is a continuous autotransfusion system working on the principle of a continuous flow centrifuge. In this continuous system, the blood to be processed passes through a separation chamber that can be divided into several compartments in which different steps of the autotransfusion process (i.e.; plasma separation, resuspension with saline and reconcentration) are performed simultaneously, creating a continuous flow of blood through the system. The C.A.T.S device is comprised of two major components: Reusable Autotransfusion Device (electromechanical microprocessor controlled device) and Disposable AT1 Autotransfusion Set.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Fresenius C.A.T.S Autotransfusion System Plasma Sequestration-Direct Draw Program and PSQ Set (Direct Draw).

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than a full clinical study report designed to prove novel efficacy or safety with predefined criteria and detailed performance metrics. As such, some of the requested information (like specific effect sizes for MRMC studies, number of training set samples, or direct performance statistics for clinical outcomes) is not explicitly present.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not presented in a quantitative, pass/fail table as might be seen for a new device claiming specific performance metrics. Instead, the "acceptance criteria" are implied by demonstrating that the new components (PSQ Set (DD) and the direct draw software module) meet established standards and operate equivalently to predicate devices and the existing C.A.T.S system.

Study Details

Based on the provided K973378 510(k) Summary, here's what can be inferred about the "study" (which consists of multiple tests to support substantial equivalence):

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

   • Sample Size: Not explicitly stated in terms of patient numbers or blood samples. The testing appears to be primarily in vitro or bench testing on the device itself and its components (biocompatibility, structural integrity, software testing).
   • Data Provenance: Not specified. Given the nature of the tests (biocompatibility, structural integrity, software), it would likely be laboratory or bench test data, not necessarily country-specific clinical data. It is a retrospective compilation of test results.

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

   • Number of Experts: Not applicable or not specified. This document describes testing against engineering standards (AAMI/ANSI) and internal software requirements, and biocompatibility standards (FDA/ISO). Ground truth, in the sense of clinical expert consensus for diagnosis or interpretation, is not relevant here as the device processes blood, it doesn't make clinical diagnoses.
   • Qualifications of Experts: The experts involved would be those performing the biocompatibility, materials, structural, and software engineering tests. Their specific titles or experience are not detailed.

3. Adjudication Method for the Test Set:

   • Method: Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies where human readers interpret medical images or data against a consensus ground truth. Here, the "test set" involves measurable physical and software performance against defined standards.

4. 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:

   • MRMC Study: No. This is not an AI/imaging device and an MRMC study is not relevant to its purpose. The device is an autotransfusion system, not an interpretive diagnostic tool.

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

   • Standalone Performance: The "standalone" performance here refers to the device's operational capabilities without direct human intervention once started. The software testing confirms the automated functions of the plasma sequestration direct draw program module meet requirements without human-in-the-loop comparison for efficacy. However, the device itself is an automated system for blood processing, so "standalone" performance in the AI context isn't directly applicable.

6. The Type of Ground Truth Used:

   • Ground Truth: The "ground truth" for the tests described are:
     • Biocompatibility: Compliance with FDA's modified ISO standards for biological evaluation of medical devices.
     • Structural Integrity: Compliance with AAMI/ANSI standards for autotransfusion devices.
     • Software Functionality: Meeting the requirements as set forth in the internal "Software Requirements Specification."
     • Shelf-life: Maintenance of biocompatibility, structural integrity, packaging integrity, and sterility over time, as tested according to internal protocols often based on industry standards.

7. The Sample Size for the Training Set:

   • Training Set Sample Size: Not applicable. This device is not an AI/machine learning device that requires a "training set" in the conventional sense. The "development" and "validation" would refer to engineering design, manufacturing, and testing processes.

8. How the Ground Truth for the Training Set Was Established:

   • Training Set Ground Truth: Not applicable, as there is no "training set" for an AI model. The "ground truth" for the device's engineering and performance validation comes from established engineering standards, material science principles, and software development best practices.

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The Fresenius On Line Clearance Monitor is a module that is incorporated into the Fresenius 2008H hemodialysis equipment to be used during a dialysis treatment to determine dialyzer clearance efficiency using changes in conductivity of the dialysate solution.

The Fresenius On Line Clearance Monitor is intended to be used as a module with the Fresenius 2008H hemodialysis machine for determination of dialysis treatment urea clearance efficiency using Sodium conductivity as the surrogate solute marker.

The Fresenius On Line Clearance Monitor (OLC) is a module that is incorporated into the Fresenius 2008H hemodialysis equipment. The OLC consists of hardware modifications to the 2008H dialysate fluid circuit which includes a second conductivity probe in the effluent dialysate line and software. The dialyzer clearance determination is made using changes in dialysate conductivity (Sodium concentration). The software either increases or decreases the dialysate conductivity. This change in conductivity causes a sodium concentration gradient to be formed between the blood and dialysate sides of the dialyzer. Sodium is then either diffused into the blood or out of the blood depending whether the dialysate conductivity is high or low. Accurate conductivity readings of the inlet and outlet dialysate solution can be used to calculate the flux of sodium (or change in conductivity because of changes in sodium concentration) in the dialysate. This value can then be used to calculate the dialyzer clearance of sodium. The clearance of sodium has been used as a surrogate dialyzer performance solute since the beginning of dialysis since urea and Sodium (from NaCl) pass through the dialysis membrane at essentially the same rate.

The use of the On Line Clearance Monitor is non invasive and is performed automatically by the hemodialysis equipment with no effect to the patient or action of the operator and minimizes the need for blood based urea analysis and dialyzer performance determination.

The provided text does not contain a specific table of acceptance criteria or details of a study designed to explicitly meet quantitatively defined acceptance criteria for the Fresenius On Line Clearance Monitor.

However, based on the information provided, we can infer the acceptance criteria and study as follows:

Inferred Acceptance Criteria and Reported Device Performance

• Equivalence to equipment adaptors using conductivity for dialyzer performance (K830190, K841153)
• Equivalence to manual invasive blood urea determinations. | Non-Clinical Testing: Statistically significant correlation between clearance values obtained using Sodium (conductivity) as a marker and urea.
  Clinical Testing: No difference in clearance determinations between the OLC (using Sodium conductivity) and identical blood-side urea measurements. |
  | Operational Impact: Non-invasive, automatic operation with no effect on the patient or operator, minimizing the need for blood-based urea analysis. | The On Line Clearance Monitor is non-invasive and performed automatically by the hemodialysis equipment with no effect to the patient or action of the operator. |
  | Mechanism: Utilize conductivity (Sodium concentration) to calculate dialyzer clearance. | The OLC accurately measures inlet and outlet dialysate conductivity to calculate sodium flux, which is then used to calculate dialyzer clearance. |

Study Information

1. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated. The non-clinical testing involved "a number of different dialyzer membranes." The clinical testing used "a modified 2008H hemodialysis machine... clinically to evaluate dialyzer performance during dialysis." Specific patient or case numbers are not provided.
   • Data Provenance: Not specified for non-clinical. For clinical testing, it was likely conducted in a clinical setting ("clinically to evaluate dialyzer performance during dialysis"), implying prospective or retrospective data collection from patients undergoing dialysis. Country of origin is not mentioned but can be inferred to be the USA, given the applicant's address.

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

   • Not specified. The ground truth was established by comparing the OLC's performance to "identical blood side urea measurements" and "blood urea determinations," which are established clinical methods. It is implied that standard clinical laboratory practices and medical professionals would be involved in obtaining and interpreting these ground truth measurements, but no specific number or qualifications of experts are given for establishing the ground truth for the test set.

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

   • No adjudication method is described. The comparison relies on direct measurements from the OLC versus established clinical methods (blood urea measurements).

4. 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. The device (OLC) is an automated monitor, not a diagnostic aid requiring human interpretation of output in the traditional sense of an MRMC study.

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

   • Yes, a standalone study was primarily done. The OLC is described as functioning "automatically by the hemodialysis equipment with no effect to the patient or action of the operator." The reported "statistically significant correlation" and "no difference in the clearance determinations" are evaluations of the device's performance directly against established methods.

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

   • The ground truth used was established clinical measurements of dialyzer performance, specifically:
     • Urea clearance: Measured through blood urea determinations.
     • Conductivity-based clearance: From predicate devices (K830190, K841153).

7. The sample size for the training set:

   • Not specified. The document does not describe a distinct "training set" in the context of machine learning model development. This device appears to be based on an algorithmic calculation from physical measurements rather than a machine learning model that would require a distinct training phase.

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

   • As there's no mention of a traditional machine learning training set, the concept of establishing ground truth for it is not applicable here. The device's underlying principles are based on established physiological and engineering principles (sodium/urea diffusion and conductivity).

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Ask a specific question about this device

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