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Gambro FH 22H Fiber Hemofilter

This document is a 510(k) clearance letter from the FDA for a medical device (Gambro FH 22H Fiber Hemofilter). It primarily states that the device has been found substantially equivalent to a predicate device and can be marketed.

However, the provided text does not contain any information regarding acceptance criteria or a study that proves the device meets those criteria, nor any of the specific details requested in your prompt (e.g., sample size, expert qualifications, adjudication methods, MRMC study, standalone performance, ground truth, training set information).

This type of FDA letter confirms regulatory clearance based on substantial equivalence, but it typically summarizes the outcome of the review process, not the detailed performance data or study specifics submitted by the manufacturer. The detailed studies and data would be part of the original 510(k) submission, which is not included here.

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The Centrysystem 14 PES Gamma can be used whenever hemodialysis is indicated. This dialyzer can be used for long term chronic hemodialysis as well as for acute hemodialysis. In hemodialysis therapy, monitoring of patient vital signs, the dialysate delivery system, heparin administration, and clotting times should be performed under the direction of a physician.

The membrane used in this device is polyether sulfone which is substantially equivalent to the polysulfone membrane utilized in the Fresenius F80A dialyzers and the polyether sulfone membrane utilized in the Gambro HC 14 R Hemoconcentrators. Both devices have been previously approved for marketing in the United States under 510K Notifications. The polyether sulfone membrane is manufactured by Gambro.

Blood enters a blood inlet port where it is distributed to polyether sulfone hollow fiber has an inner diameter of approximately 215 microns and a wall thickness of 50 microns. The effective length of the fibers is 267 mm. The fibers used in this device are substantially equivalent in design to the previously approved Gambro HC 14R Hemoconcentrator. The patient's blood traverses the inside of the hollow fibers and exits the device via a blood exit port.

By means of a hydrostatic pressure or transmembrane pressure which is created by a combination of positive and negative pressures across the Polyether sulfone membrane, plasma water along with certain lower molecular weight solutes of plasma water pass through the membrane and into the dialysate Removal of uremic toxins and waste products are removed from the compartment of the devices. patient's blood in this device by means of both diffusion and convection through the Polyether sufone membrane into the counter current flowing dialysis solution. The dialysate exits the devices via a dialysate outlet port.

The provided text describes a 510K Notification for a medical device, the Cobe Centrysystem 14 PES Gamma hemodialyzer. This document details the device's characteristics, intended use, and a comparison to predicate devices, along with summaries of non-clinical and clinical tests. However, it does not contain the specific information required to complete the detailed table and answer all the questions about acceptance criteria and a study proving the device meets them, particularly in the context of an AI/algorithm-based device.

The document discusses performance criteria for a hemodialyzer, which are physical and physiological measurements, not typical "acceptance criteria" for an AI model's performance. The "study" described is a clinical test of a physical medical device, not a study validating an algorithm's performance.

Therefore, I can only extract limited information, mainly regarding the clinical test performed.

Here's a breakdown based on the provided text and the limitations:

Acceptance Criteria and Reported Device Performance (as far as can be inferred for a physical device):

The document states: "It can be concluded from the results of the investigation that the Cobe Centrysystem 14 PES Gamma Hemodialyzer fulfills the performance criteria stated by Gambro." However, the specific numerical acceptance criteria and the corresponding reported performance values are not explicitly listed in a table format with thresholds. Instead, it lists parameters that were studied.

Detailed Information about the Study:

The document describes a clinical test for a physical medical device. It does not describe a study for an AI/algorithm. Therefore, many of the requested points are not applicable or cannot be answered from the provided text.

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

   • Sample Size: 24 Cobe Centrysystem 14 PES Hemodialyzers used in six patients.
   • Data Provenance: Not specified (e.g., country of origin, specific demographics), but it's a clinical test performed on human subjects with the device. It is a prospective clinical test, as indicated by "Clinical testing was performed utilizing... in six patients."

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

   • This is not applicable to a physical device clinical study determining physiological parameters. "Ground truth" here would be the actual measurements and observed patient outcomes, not expert labeling of data. The "direction of a physician" is mentioned for monitoring vital signs, heparin, etc., but not for establishing ground truth of the device's physical performance parameters.

3. Adjudication method for the test set:

   • Not applicable for a physical device performance study in this context. The study is measuring physical parameters directly.

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. This is a study of a physical hemodialyzer, not an AI-assisted diagnostic tool.

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

   • No. This is a study of a physical hemodialyzer, not an algorithm.

6. The type of ground truth used:

   • For the physical device, the "ground truth" implicitly refers to physiological measurements and clinical observations (e.g., actual ultrafiltration rates, clearance values, pressure drops, observed safety, and handling).

7. The sample size for the training set:

   • Not applicable. This is a physical device, not an AI algorithm requiring a training set.

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

   • Not applicable. This is a physical device, not an AI algorithm.

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The Gambro Polyflux 14, 17, and 21 hemodialyzers can be used whenever hemodialysis is indicated. This dialyzer can be used for long term chronic hemodialysis as well as for acute hemodialysis. In hemodialysis therapy, monitoring of patient vital signs, the dialysate delivery system, heparin administration, and clotting times should be performed under the direction of a physician.

The membrane used in these devices is Polyamide which is identical to the polyamide membrane utilized in the Gambro Polyflux 11 dialyzers which have been previously approved for marketing in the United States under a 510K Notification (K933818). This membranes is manufactured by Gambro Dialysatoren of Germany.

Blood enters a blood inlet port where it is distributed to polyamide hollow fibers. Each hollow fiber has an inner diameter of approximately 220 microns and a wall thickness of 50 microns. The effective length of the fibers is 210 mm for the Polyflux 14 and 250 mm for the Polyflux 17 and 21. The fibers used in this device are substantially equivalent in design to the previously approved Gambro Polyflux 11 hemodialyzers. The patient's blood traverses the inside of the hollow fibers and exits the device via a blood exit port.

By means of a hydrostatic pressure or transmembrane pressure which is created by a combination of positive and negative pressures across the Polyamide membrane, plasma water along with certain lower molecular weight solutes of plasma water pass through the membrane and into the dialysate compartment of the devices. Removal of uremic toxins and waste products are removed from the patient's blood in this device by means of both diffusion and convection through the Polyamide membrane into the counter current flowing dialysis solution. The dialysate exits the devices via a dialysate outlet port.

This 510(k) notification describes a medical device, not an AI/ML powered device, therefore, the requested information about acceptance criteria and study details for an AI/ML device is not applicable.

The document discusses the substantial equivalence of the Gambro Polyflux 14, 17, and 21 Hemodialyzers to a predicate device (Gambro Polyflux 11 Hemodialyzer) based on technological characteristics and non-clinical in vitro testing.

Here's a breakdown of the relevant information provided:

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

The document doesn't explicitly state "acceptance criteria" in a quantitative table format as one might find for an AI/ML performance study. Instead, it relies on demonstrating substantial equivalence to a predicate device. The performance is assessed through in vitro testing to ensure that certain parameters are comparable or within acceptable ranges relative to the predicate device.

The "acceptance criteria" here is implicitly that the in vitro test results for the proposed devices demonstrate performance that is "substantially equivalent" to the previously approved predicate device (Gambro Polyflux 11).

Regarding the other requested points (2-9), these are not applicable to the provided document as it describes a traditional medical device, not an AI/ML system.

Here's why each point is not applicable:

• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set in the context of AI/ML data is used. The "testing" refers to non-clinical in vitro performance evaluations of the physical device.
• 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): No ground truth established by experts in this context. The "ground truth" is based on the measurable physical and chemical performance of the device in a lab setting, compared to a known predicate device.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for non-clinical in vitro device 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: Not applicable. This is for AI/ML diagnostic or assistive devices, not hemodialyzers.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" is the established performance characteristics of the predicate device and the physical measurements from the in vitro tests of the new devices.
• 8. The sample size for the training set: Not applicable; there is no AI/ML model to train.
• 9. How the ground truth for the training set was established: Not applicable; there is no AI/ML model to train.

In summary, the document demonstrates substantial equivalence through a comparison of technological characteristics and non-clinical in vitro performance data, rather than through AI/ML specific validation studies. The key "study" here is the series of in vitro tests performed on the proposed devices, comparing their performance against the established predicate device.

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The Centrysystem 600 HG can be used whenever hemodialysis is indicated. This dialyzer can be used for long term chronic hemodialysis as well as for acute hemodialysis. In hemodialysis therapy, monitoring of patient vital signs, the dialysate delivery system, heparin administration, and clotting times should be performed under the direction of a physician.

The membrane used in this device is Hemophane which is substantially equivalent to the Hemophane membrane utilized in the Gambro GFS Plus 20 dialyzers which have been previously approved for marketing in the United States under a 510K Notification (K902481). Both of these membranes are manufactured by Akzo (Enka) of Germany.

Blood enters a blood inlet port where it is distributed to Hemophane hollow fibers. Each hollow fiber has an inner diameter of approximately 200 microns and a wall thickness of 6.5 microns. The effective length of the fibers is 267 mm. The fibers used in this device are substantially equivalent in design to the previously approved Gambro GFS Plus hemodialyzers. The patient's blood traverses the inside of the hollow fibers and exits the device via a blood exit port.

By means of a hydrostatic pressure or transmembrane pressure which is created by a combination of positive and negative pressures across the Hemophane membrane, plasma water along with certain lower molecular weight solutes of plasma water pass through the membrane and into the dialysate compartment of the devices. Removal of uremic toxins and waste products are removed from the patient's blood in this device by means of both diffusion and convection through the Hemophane membrane into the counter current flowing dialysis solution. The dialysate exits the devices via a dialysate outlet port.

The provided 510K K960474 notification describes a hemodialyzer, the Cobe Centrysystem 600 HG. This submission is for a medical device that performs a physical function (blood filtration) rather than a diagnostic function (e.g., image analysis or disease detection). Therefore, many of the requested categories in the prompt (e.g., 'number of experts', 'adjudication method', 'MRMC study', 'standalone performance', 'training set sample size') are not applicable to this type of device and its regulatory submission.

Here's an analysis based on the provided text, focusing on applicable points and noting where the information is not relevant to this specific device:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state "acceptance criteria" in a tabular format as might be seen for a diagnostic algorithm. Instead, it relies on demonstrating substantial equivalence to a predicate device through non-clinical in vitro testing. The performance is "accepted" if it is shown to be substantially equivalent.

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

The document refers to "in vitro testing" to determine various parameters. It does not specify the sample size (e.g., number of devices tested) for these in vitro tests. Data provenance (country of origin, retrospective/prospective) is not applicable or specified for in vitro device performance tests.

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

This is not applicable as this is a physical medical device and its performance is evaluated through measurable physical characteristics in an in vitro setting, not by human expert assessment of a "ground truth" like in diagnostic imaging.

4. Adjudication method for the test set

Not applicable for in vitro physical device 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

Not applicable. This is not a diagnostic AI device requiring human reader interaction.

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

Not applicable. This is a physical medical device, not an algorithm. The in vitro testing represents the "standalone" performance of the device without patient involvement.

7. The type of ground truth used

The "ground truth" in this context is the established, measurable physical and chemical properties of the device and its performance in a controlled in vitro environment. For example, "urea clearance" is measured directly, rather than being an expert consensus or pathology finding. The established performance of the predicate device serves as the benchmark for "substantial equivalence."

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning.

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

Not applicable. There is no training set for this type of device.

Study Proving Acceptance Criteria are Met:

The study proving the acceptance criteria are met is the "Summary of Non-Clinical Tests".

• Study Design: This was an in vitro test series.
• Purpose: To determine the blood side priming volume, dialysate side priming volume, dialysate and blood flow resistance, ultrafiltration coefficient, and clearances for urea, creatinine, phosphate, and vitamin B12 at varying blood flows, as well as residual blood volume.
• Methodology: The specific tests performed were standard in vitro measurements for hemodialyzers. The document mentions "varying blood flows" for clearance measurements, indicating different operational conditions were tested.
• Results/Conclusion: "The results of these tests confirmed that the proposed device is substantially equivalent to the proposed device for these parameters." This statement indicates that for all the measured parameters, the Cobe Centrysystem 600 HG performed comparably to the predicate device, the Gambro GFS Plus 20 Hemodialyzer.

Key Takeaway: The entire submission for the Cobe Centrysystem 600 HG relies on demonstrating substantial equivalence to an already approved predicate device (Gambro GFS Plus 20). This is a common pathway for physical medical devices, where the "acceptance criteria" are implicitly met if the new device performs within acceptable bounds of the predicate device's established performance for critical functional parameters. Clinical testing was explicitly not performed, further solidifying the reliance on in vitro evidence of equivalence.

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