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POLYFLUX R is indicated for use in hemodialysis for the treatment of chronic or acute renal failure. The choice of the filter is the responsibility of the physician. Special attention must be paid in connection with pediatric use. CAUTION! If POLYFLUX R is reused, the procedure and disinfection specified in the RENATRON INSTRUCTION MANUAL must be followed. The POLYFLUX R may be reprocessed for reuse on the same patient.

The Gambro Polyflux 17R and 21R, Capillary Dialyzers/Filters labeled for multiple use (reuse) are identical in construction in function to Gambro Polyflux 17S and 21S Hemodialyzers / Hemofilters labeled for single use which are currently marketed in the United States and have been previously cleared by the FDA under 510(k) Notification K981414. Only the product designation "R" has been changed from "S" to designate that they are labeled for multiple use (reuse). These devices are intended for use in hemodialysis for the treatment of acute and chronic renal failure and for certain types of intoxications for both single when reprocessed for reuse for a maximum of 15 reprocessing reuse cycles on the same patient. If reprocessing and reuse is practiced, it is recommended that the reuse be done under the conditions as existed in the in vitro and confirmatory clinical studies undertaken by Gambro and presented in the labeling for this device. It may also be used in cases of acute fluid overload for the removal of plasma water. The membrane used in these devices is polyethersulfone (PES) which is identical to the membrane utilized in the Gambro Polyflux 17S and 21S Hemodialyzers / Hemofitters for labeled for single use which have been previously approved for marketing in the United States under a 510K Notification (K982414). Blood enters a blood inlet port where it is distributed to polyethersulfone hollow fibers. Each hollow fiber has an inner diameter of approximately 215 microns (wet hollow fiber internal diameter) and a wall thickness of 50 microns. The number of polyethersulfone hollow fibers in each hemodialyzer / hemofilter is 10,000 for the Polyflux 17R and 12,500 for the 21R. These dialyzers have an effective membrane length of 250 mm. The effective membrane surface area is 1.7 square meters for the 17R and 2.1 square meters for the 21R. The housing and end caps of these hemodialyzers / hemofiters are made of polycarbonate. The fibers used in the Gambro Polyflux 17R and 21R are identical in design and materials to the previously approved Gambro Polyflux 17S and 21S Hemodialyzers / Hemofilters for labeled for single use (K982414). 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 polyethersulfone membrane, plasma water along with certain lower molecular weight solutes of plasma water pass through the membrane and into the dialysate or filtrate compartment of the device. 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 polyethersulfone membrane and into the counter current flowing dialysis solution during hemodialysis. The dialysate exits the devices via a dialysate outlet port.

This document describes the 510(k) Notification for the Gambro Polyflux 17R & 21R Capillary Dialyzers/Filters, labeled for multiple use. This submission seeks clearance for the multiple-use labeling of these devices, which are identical in construction and function to the previously cleared single-use Gambro Polyflux 17S & 21S Hemodialyzers/Hemofilters (K981414).

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states that the proposed devices (Polyflux 17R & 21R for multiple use) are identical in construction and function to the predicate devices (Polyflux 17S & 21S for single use), with the only difference being the labeling for multiple use. Therefore, the acceptance criteria are implicitly linked to demonstrating that the reprocessing for reuse does not compromise the device's original performance, safety, and effectiveness.

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

• Sample Size for Test Set: The document simply states that "Clinical data was collected according to the FDA Guidance for Hemodialyzer Reuse Labeling," and refers to "confirmatory clinical studies undertaken by Gambro." However, no specific sample sizes (number of devices or patients) for the clinical test set are provided within the excerpt.
• Data Provenance: The country of origin of the data is not explicitly stated. The nature of the studies ("confirmatory clinical studies undertaken by Gambro") suggests they were prospective studies, as they were conducted to support the multiple-use claim.

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 given excerpts. For medical devices like dialyzers, ground truth often relates to measurable clinical and laboratory parameters (e.g., solute clearance, ultrafiltration rates, patient outcomes), rather than interpretation by a panel of experts in the same way an imaging study would.

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

This information is not applicable/provided for this type of device and study. Adjudication methods like 2+1 or 3+1 are typically used in imaging studies where subjective interpretation is involved. For a hemodialyzer, the performance is assessed through objective measurements.

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 excerpt describes a 510(k) submission for a medical device (hemodialyzer) for multiple use, not an AI or imaging diagnostic device. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is entirely irrelevant to this submission.

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

Not applicable. This is a hardware medical device, not an algorithm or AI system.

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

Based on the nature of the device (hemodialyzer), the ground truth for performance and safety would have been established through a combination of:

• In vitro performance criteria: Objective measurements of device function (e.g., solvent removal, solute clearance, fiber integrity, pressure drop, biocompatibility measures like membrane integrity after reprocessing challenges).
• Clinical outcomes data: Patient safety data and clinical effectiveness parameters (e.g., maintaining patient electrolyte balance, fluid removal, absence of adverse events related to reprocessing) over the course of multiple reuse cycles. The document refers to "in vitro and confirmatory clinical studies."

8. The sample size for the training set:

Not applicable. As this is a medical device, not an AI algorithm, there is no "training set" in the computational learning sense. The "training" for the device's design and manufacturing would come from extensive engineering design, material science, and manufacturing process validation, which are not detailed in this excerpt.

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

Not applicable. As there is no "training set" for an AI algorithm, this question does not apply. The "ground truth" for the device's initial design and subsequent multiple-use validation is based on established engineering principles, regulatory standards (like the FDA Guidance for Hemodialyzer Reuse Labeling), and clinical guidelines for hemodialysis treatment.

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The Gambro Dialysis Quality Monitor DQM 200 is to act as a clinical tool aiding the physician to establish a dialysis dose of treatment of the patient. The DQM 200 performs a continuous measurement of the spent dialysate flow from a dialysis machine. From this measured data together with patient and treatment data provided by the operator, the DQM 200 derives clinical parameters helpful to the physician in evaluating the dialysis dose.

The Gambro DOM 200 measures the urea concentration in the dialysis solution leaving the waste outlet of a dialysis machine. Measurements obtained by this device are used in the treatment of certain renal diseases for patients on hemodialysis. The purpose of the Gambro DQM 200is to act as a clinical tool aiding the physician to evaluate the dialysis dose of a treatment. The DQM 200 performs a continuous urea measurement of the spent dialysate flow from a Cobe C3 machine, A Gambro AK 10 Machine, a Gambro AK 100/200 or a Gambro AK 100/200 ULTRA machine. From this measured data together with patient and treatment data provided by the operator of the DOM 200 derives clinical parameters to help define the dialysis dose. The urea measurement is achieved by catalyzing urea with the urease enzyme, with carbon dioxide gas present into ammonium ions and bicarbonate ions. The produced ions cause an increase in the electrical conductivity in proportion to the urea concentration.

Here's a breakdown of the acceptance criteria and the study information for the Gambro Dialysis Quality Monitor DQM 200, based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device seeking clearance, not a detailed scientific study report. As such, it will not contain the in-depth information typically found in a full study publication, such as detailed sample sizes, expert qualifications, or specific statistical efficacy metrics. The primary purpose of a 510(k) is to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document implies the acceptance criteria are that the device performs "as intended and labeled" and is "substantially equivalent" to the predicate. Specific numerical targets for accuracy, precision, or other performance metrics are not explicitly stated in this summary.

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

• Sample Size for Test Set: Not specified in the provided document. The text only states "In Vitro testing" and "Clinical testing" were performed.
• Data Provenance: Not specified. It is not mentioned where the data was collected (e.g., country of origin) or if the studies were retrospective or prospective.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. Given the nature of a device measuring urea concentration, the ground truth would likely be established through a reference laboratory method rather than expert adjudication of images or clinical outcomes.

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

• Was an MRMC study done? No, an MRMC comparative effectiveness study is not mentioned as part of the submission. The device is a diagnostic tool (urea monitor), not an image interpretation or decision-support AI tool that would typically undergo MRMC studies to assess human reader improvement with AI assistance.
• Effect size of human reader improvement: Not applicable, as no such study was conducted.

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

• Was a standalone study done? Yes, the "In Vitro testing" and "Clinical testing" describe the performance of the device itself (the "algorithm only," if we consider the device's measurement and calculation functions as an algorithm) in laboratory and clinical settings. These tests evaluate the device's ability to accurately measure urea and derive parameters. No human "in-the-loop" performance is described in these validation aspects, though the device aids a physician.

7. Type of Ground Truth Used

• Type of Ground Truth: The document does not explicitly state the specific methods used for ground truth. However, for a device measuring urea concentration, the ground truth would almost certainly be established by:
  • Reference Laboratory Methods: During in-vitro and clinical testing, the DQM 200's measurements and calculated parameters would be compared against results obtained from established, highly accurate laboratory methods for urea concentration, such as enzymatic assays or isotope dilution mass spectrometry.
  • Validated Formulas: The clinical parameters derived by the DQM 200 would be based on established and validated mathematical formulas (e.g., for urea kinetic modeling).

8. Sample Size for the Training Set

• Sample Size for Training Set: Not specified. The document does not detail any "training set" in the context of machine learning model development. This device appears to be based on established chemical principles and formulas rather than a data-driven machine learning model that requires a discrete training phase with a labeled dataset. Its "training" would likely refer to calibration and optimization during its development, not a separate data training set.

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

• How Ground Truth for Training Set Was Established: Not applicable in the context of a machine learning training set as described above. If "training set" refers to calibration or development data, the ground truth would have been established using precise chemical standards and reference measurement techniques to ensure the device's accuracy across its operational range.

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The. Cobe Arylane Hemodialyzers/Filters H1, H4, H9 are intended for use in hemodialysis and hemofiltration and associated modalities for the treatment of chronic renal failure.

The size, weight, state of uremia, cardiac status and general physical condition of the patient must be evaluated by the prescribing physician before each treatment. The choice of the appropriate heomdialyzer/filter and associated equipment as well as the treatment operating parameters are the sole responsibility of the physician.

The Hospal Cobe Arylane H1, H4, H6 & H9 Hemodialyzers/filters are identical in construction in function to other hemodialyzers currently marketed in the United States. These devices are intended for use in hemodialysis and hemofiltration for the treatment of acute and chronic renal failure and for certain types of intoxications. They may also be used in cases of acute fluid overload for the removal of plasma water. The membrane used in this device is polyarylethersulfone (polyethersulfone) (PES) which is identical to the membrane utilized in the Cobe Centrysystem 14 PES hemodialyzer which has been previously approved for marketing in the United States under a 510K Notification (K95-5592).

Blood enters a blood inlet port where it is distributed to polyarylethersulfone hollow fibers. Each hollow fiber has an inner diameter of approximately 215 microns (wet hollow fiber internal diameter) and a wall thickness of 50 microns. The number of polyarvlethersulfone hollow fibers in each hemodialyzer are 6400 for the H1, 8300 for the H4, 8300 for the H6, and 10600 for the H9. These dialyzers have effective membrane lengths of either 240mm (H1 & H4) or 280 mm (H6 & H9). In the Cobe Arylane H1 hemodialyzers/filter solid polyester filaments are interspersed in between the polyarylethersulfone hollow fibers and act as spacers to accommodate fewer numbers of fibers in the same housing used for the Cobe Arylane H4 hemodialyzer/filter. These same polyester spacing filaments have been used previously in other Cobe hemodialyzers for the same purpose. The effective membrane surface areas are 1.04 m2 for the H1, 1.35 m2 for the H4, 1.57 m2 for the H6, and 2.01 m2 for the H9. At either end of the device, the hollow fibers (and polyester filaments in the Cobe Arylane HI only) are potted in polyurethane to isolate the blood compartment from the filtrate compartment. The housing of this hemodialyzer is also made of polycarbonate. The fibers used in this device are identical in design and materials to the previously approved Cobe Centrysystem 14 PES (K95 5592) 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 polyarylethersulfone membrane, plasma water along with certain lower molecular weight solutes of plasma water pass through the membrane and into the dialysate or filtrate compartment of the device. 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 polyarylethersulfone membrane and into the counter current flowing dialysis solution during hemodialysis. The dialysate exits the devices via a dialysate outlet port.

The provided text describes a 510(k) notification for the Cobe Arylane H1, H4, H6, and H9 Hemodialyzers/filters. The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. No clinical study information, acceptance criteria for an AI device, or performance data for an AI device are present in the provided text.

Therefore, I cannot fulfill the request as it pertains to an AI device's acceptance criteria and studies. The document describes a medical device approval process for hemodialyzers, not an AI device.

However, I can provide a summary of the non-clinical tests performed for the hemodialyzers, which are analogous to how a non-AI medical device would be evaluated for substantial equivalence.

Summary of Non-Clinical Tests (for the hemodialyzers):

Regarding the requested points for an AI device, based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not applicable, as this is a non-AI medical device. The table above summarizes the non-clinical tests performed.
2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to the in vitro tests conducted on the physical hemodialyzer units. The number of units tested is not specified. Data provenance is not applicable in the context of a software algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for the hemodialyzer performance is established through laboratory measurements and established analytical methods, not expert consensus.
4. Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used: For the hemodialyzer performance, the ground truth would be the direct measurement of physical and functional properties in a laboratory setting (e.g., precise volume measurements, flow rate measurements, chemical analysis for clearance).
8. The sample size for the training set: Not applicable. This is for a physical device, not an AI algorithm.
9. How the ground truth for the training set was established: Not applicable.

Conclusion stated in the document for the hemodialyzers:

"Testing performed on the Cobe Arylane Hemodialyzers indicates that they are safe, effective, and perform as well as the predicate device, when used in accordance with the instructions for use." This statement implies that the non-clinical tests' results met the criteria established for substantial equivalence to the predicate device (Cobe Centrysystem 14 PES hemodialyzer, K95-5592). The specific numerical acceptance criteria themselves are not detailed in the summary.

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The Gambro Polyflux 11S, 14S, 17S, and 21S hemodialyzers / filters can be used whenever hemodialysis or hemofiltration is indicated. These can be used for acute or chronic hemodialysis or hemofiltration. In these therapies, monitoring of patient vital signs, the therapy delivery system, heparin administration and clotting times should be performed under the supervision / direction of a physician.

The Gambro Polyflux 11S, 14S, & 21S Hemodialyzers/Hemofiters are identical in construction in function to other hemodialyzers/filters currently marketed in the United States. These devices are intended for use in hemodialysis and hemofiltration for the treatment of acute and chronic renal failure and for certain types of intoxications. They may also be used in cases of acute fluid overload for the removal of plasma water. The membrane used in this device is polyarylether sulfone (polyethersulfone) (PES) which is identical to the membrane utilized in the Cobe Centrysystem 14 PES hemodialyzer which has been previously approved for marketing in the United States under a 510K Notification (K95-5592).

Blood enters a blood inlet port where it is distributed to polyarylethersulfone hollow fibers. Each hollow fiber has an inner diameter of approximately 215 microns (wet hollow fiber internal diameter) and a wall thickness of 50 microns. The number of polyarylethersulfone hollow fibers in each hemodialyzer / hemofilter are 8000 for the 11S. 10000 for the 14S, 10000 for the 17S, and 12500 for the 21S. These dialyzers have effective membrane lengths of either 210mm (11S & 14S) or 250 mm (17S & 21S). The effective membrane surface areas are 1.1 m2 for the 11S, 1.4 m2 for the 14S, 1.7 m2 for the 17S, and 2.1 m2 for the 21S. The housing of this hemodialyzer is also made of polycarbonate. The fibers used in this device are identical in design and materials to the previously approved Cobe Centrysystem 14 PES (K95 5592). 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 polyarylethersulfone membrane, plasma water along with certain lower molecular weight solutes of plasma water pass through the membrane and into the dialysate or filtrate compartment of the device. 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 polyarylethersulfone membrane and into the counter current flowing dialysis solution during hemodialysis. The dialysate exits the devices via a dialysate outlet port.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Gambro Polyflux 11S, 14S, 17S, and 21S Hemodialyzers/Filters:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a pass/fail format. Instead, it relies on demonstrating substantial equivalence to a predicate device (Cobe Centrysystem 14 PES Hemodialyzer) across several functional and material parameters. The "reported device performance" in this context refers to the results of in vitro testing and the overall conclusion of substantial equivalence.

• Polyarylethersulfone (PES) hollow fiber membrane
• Polycarbonate housing and header
• Polyurethane potting material | "The membrane used in this device is polyarylether sulfone (polyethersulfone) (PES) which is identical to the membrane utilized in the Cobe Centrysystem 14 PES hemodialyzer."
  "The fibers used in this device are identical in design and materials to the previously approved Cobe Centrysystem 14 PES (K95 5592)."
  "Both the proposed and predicate devices use polycerbonate for the housing and header material and polyurethane for the membrane potting material." |
  | Blood side priming volume | Not explicitly stated, implied to be comparable to predicate. | Substantially equivalent to predicate device. | "The results of these tests confirmed that the proposed device is substantially equivalent to the proposed device for these parameters." |
  | Dialysate side priming volume | Not explicitly stated, implied to be comparable to predicate. | Substantially equivalent to predicate device. | "The results of these tests confirmed that the proposed device is substantially equivalent to the proposed device for these parameters." |
  | Dialysate flow resistance | Not explicitly stated, implied to be comparable to predicate. | Substantially equivalent to predicate device. | "The results of these tests confirmed that the proposed device is substantially equivalent to the proposed device for these parameters." |
  | Blood flow resistance | Not explicitly stated, implied to be comparable to predicate. | Substantially equivalent to predicate device. | "The results of these tests confirmed that the proposed device is substantially equivalent to the proposed device for these parameters." |
  | Ultrafiltration coefficient | Not explicitly stated, implied to be comparable to predicate. | Substantially equivalent to predicate device. | "The results of these tests confirmed that the proposed device is substantially equivalent to the proposed device for these parameters." |
  | Urea clearance | Not explicitly stated, implied to be comparable to predicate. | Substantially equivalent to predicate device. | "The results of these tests confirmed that the proposed device is substantially equivalent to the proposed device for these parameters." |
  | Vitamin B12 clearance | Not explicitly stated, implied to be comparable to predicate. | Substantially equivalent to predicate device. | "The results of these tests confirmed that the proposed device is substantially equivalent to the proposed device for these parameters." |
  | Overall Safety & Effectiveness | Implied by predicate device approval (K95-5592) | Safe, effective, and performs as well as the predicate device. | "Testing performed on the Gambro Polyflux 11S, 14S, 17S, and 21S indicates that they are safe, effective, and perform as well as the predicate device, when used in accordance the instructions for use." |

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

• The document states: "In vitro testing was performed on the Gambro Polyflux 11S, 14S, 17S, and 21S hemodialyzers/hemofilter..."
• It does not specify the sample size (N) for the in vitro tests (e.g., how many units of each model were tested).
• Data Provenance: The data is from in vitro testing. No country of origin is specified for the testing itself, but the submission is for the US market. The study is prospective in the sense that the sponsor performed these tests to support the 510(k) submission.

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

• This information is not applicable to this submission. The "ground truth" for this medical device (hemodialyzer) is established through measurable physical and chemical performance parameters (e.g., flow resistance, clearance rates) and direct comparison to a predicate device's established performance based on its 510(k) approval. It does not involve expert consensus on interpreting data in the way a diagnostic AI might.

4. Adjudication Method for the Test Set

• This is not applicable. The data presented relies on objective measurements from in vitro tests, not expert interpretation requiring adjudication.

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

• No, an MRMC comparative effectiveness study was not done. Such studies are typically for diagnostic devices where human readers interpret medical images or data, and AI assists them. This document is for a therapeutic device (hemodialyzer).

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

• This question is not applicable as the device is a hemodialyzer, not an algorithm or AI. The in vitro testing performed is inherently "standalone" in that it measures the device's physical performance directly.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is established by objective, measurable physical and chemical characteristics obtained through in vitro testing, combined with the successful approval and marketing history of the predicate device (Cobe Centrysystem 14 PES Hemodialyzer, K95-5592). The data itself (e.g., clearance rates, flow resistance) constitutes the ground truth for performance, and the comparison to the predicate device validates its clinical relevance.

8. The Sample Size for the Training Set

• This information is not applicable. Hemodialyzers are not "trained" like AI algorithms. Their performance is inherent in their design and materials.

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

• This information is not applicable for the same reason as point 8.

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The Hospal Multiflow 100 and Multiflow 100 Kits A0 (A0/B A0 and A0/0 ) and Multiflow 100 Kits B22 (B22, B22B, & B22/0) can be used whenever continuous arterio-venous or veno-venous hemofiltration, ultrafiltration or hemodialysis is indicated. This can be used for acute hemodialysis, hemofiltration or continuous ultrafiltration. In these therapies, monitoring of patient vital signs, the therapy delivery system, heparin administration, and clotting times should be performed under the direction of a physician

The Hospal Multiflow 100, Multiflow 100 Kit A0, Multiflow 100 Kit B22 are identical in construction in function to other hemofilters currently marketed in the United States. These devices are intended for use in continuous pump assisted veno-venous The membrane used in this device is Acrylonitrile and sodium hemofiltration and. methallyl sulfonate copolymer (AN69) which is identical to the membrane utilized in the Kit Multiflow 60P which have been previously approved for marketing in the United States under a 510K Notification (K884365).

Blood enters a blood inlet port where it is distributed to Acrylonitrile and sodium methallyl sulfonate copolymer (AN69) hollow fibers. Each hollow fiber has an inner diameter of approximately 240 microns (wet hollow fiber internal diameter) and a wall thickness of 50 microns. There are 6,000 Acrylonitrile and sodium methallyl sulfonate copolymer (AN69) hollow fibers having an effective length of 27 cm. The effective membrane surface area of the Multiflow 100 hemofilter is 0.90 m2. At either end of the device the hollow fibers are potted in polyurethane to isolate the blood compartment from the filtrate compartment. Each end of the hemofilter is sealed using a silicone O-ring and polycarbonate end cap. The housing of this hemofilter is also made of polycarbonate. The fibers used in this device are identical in design and materials to the previously approved Hospal Kit Multiflow 60P. 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 Acrylonitrile and sodium methallyl sulfonate copolymer (AN69) membrane, plasma water along with certain lower molecular weight solutes of plasma water pass through the membrane and into the dialysate or filtrate compartment of the device. 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 Acrylonitrile and sodium methallyl sulfonate copolymer (AN69) membrane and into the counter current flowing dialysis solution during CVVHD. During CVVH, no dialysis solution is perfused through the filtrate compartment in which case removal of plasma water and uremic toxins is accomplished by means of convection alone. The dialysate exits the devices via a dialysate outlet port. Schematic drawings of the Hospal Multiflow 100, Multiflow 100 Kit A0, and Multiflow 100 Kit B22 are included in this Section.

• The Multiflow 100 Kit A0 (A0, A0/B and A0/0) and Multiflow 100 Kit B22 (B22, ● B22/B, & B22/0) are an extracorporeal blood circuit with the Multiflow 100 , Hemofilter and are intended to be used with a variety of equipment for pump assisted The Multiflow 100 Kit B22 consists of the Multiflow 100 CVVH, and CVVHD. Hemofilter pre-attached to blood tubing. The Multiflow 100 Kits A0 (A0, A0/B and A0/0) and Multiflow 100 Kits B22 (B22/B22/B/B22/0) can be used for continuous veno-venous hemodialysis (CVVHD), continuous veno-venous hemofiltration (CVVH). These kits are designed to operate with pump-assisted blood circulation. An ultrafiltrate / dialysate collection and measurement set is also included with these kits.
• The component parts of the Multiflow Kits 100 B22/B22/0 are: .
• A Multiflow 100 Hemofilter 1.
• A arterial blood line 2.
• 3. A venous blood line
• 4. An ultrafiltrate line
• 5. A ultrafiltrate/dialysate measuring container (not in the B22/0 Kit)
• A 5 liter ultrafiltrate/dialysate collection container (included in only the B22Kit) 6.
• 7. A priming adaptor
• A reinfusion line 8.
• The component parts of the Multiflow Kits 100 A0. A0/B and A0/0 are:
• A Multiflow 100 Hemofilter 1.
• 2. An ultrafiltrate line
• A ultrafiltrate/dialysate measuring container (included in only the A0 Kit) 3.
• A 5 liter ultrafiltrate/dialysate collection container (included in only the A0/B Kit) ব:
• 5. A priming adaptor

The provided text describes a 510(k) premarket notification for the Hospal Multiflow 100, Multiflow 100 Kit A0, and Multiflow 100 Kit B22. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials as would be required for a novel device. Therefore, the information typically requested for acceptance criteria and studies (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance with metrics like sensitivity/specificity, and specific effect sizes) is not present in this document.

However, based on the provided text, we can extract details about the non-clinical tests performed to demonstrate substantial equivalence to the predicate device.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" with numerical targets in the way one might expect for a new device's performance study. Instead, it relies on demonstrating substantial equivalence to a predicate device. The "performance" is implicitly deemed acceptable if it is "substantially equivalent" to the predicate.

Note on "Acceptance Criteria": For a 510(k) submission, the primary acceptance criterion is substantial equivalence to a predicate device. The in vitro tests were designed to demonstrate this equivalence across key performance parameters. The specific numerical thresholds for "substantial equivalence" are not detailed in this summary but would have been defined by comparison to the predicate device's known performance.

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

The document states: "In vitro testing was performed on the Multiflow 100 to determine the following..." It does not specify the sample size for these in vitro tests (e.g., number of devices tested, number of replicates).

• Sample Size for Test Set: Not specified.
• Data Provenance: In vitro laboratory testing. The country of origin of the data is not explicitly stated, but it would presumably be the testing facilities associated with Gambro Healthcare (formerly Cobe Renal Care, Inc.) in Lakewood, CO, USA, or the manufacturer Hospal Industrie. The data is retrospective in the sense that it's generated for a submission of a device already developed, not from an ongoing prospective clinical trial.

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

This information is not applicable to the type of testing described. The "ground truth" for in vitro performance tests is typically established through validated analytical methods and measurements, not expert consensus. These are objective physical and chemical measurements.

4. Adjudication Method for the Test Set

This is not applicable as the tests are in vitro measurements, not subjective evaluations requiring adjudication.

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

No. The document explicitly states: "Clinical testing was not performed." Therefore, an MRMC study comparing human readers with and without AI assistance was not conducted. This is not an AI device.

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

Not applicable. This device is a medical device (hemofilter), not an AI algorithm. Its performance is intrinsic to its physical design and materials, not an algorithm's output.

7. The Type of Ground Truth Used

For the in vitro tests, the ground truth was based on objective physical and chemical measurements of device parameters (e.g., priming volumes, flow resistances, sieving coefficients) using established laboratory methods.

8. The Sample Size for the Training Set

Not applicable. This is not an AI device, so there is no "training set."

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

Not applicable. As this is not an AI device, there is no training set or associated ground truth establishment method.

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The COBE C Hemodialysis Delivery System is indicated for patients in acute or chronic renal failure and when the physician prescribes hemodialysis or ultrafiltration. The COBE® Cx System may be used with both high permeability and low permeability (conventional) dialyzers. The COBE® Cartridge Set is intended for use with the COBE Centrysystem 3 Hemodialysis Delivery System, or the COBE C* Hemodialysis Delivery System only.

COBE® Model Cx™ Hemodialysis Delivery System and COBE® Cartridge Blood Tubing Set

The provided document is a 510(k) clearance letter from the FDA for the COBE® Cx™ Hemodialysis Delivery System and COBE Cartridge® Blood Tubing Set. This letter indicates that the device has been found substantially equivalent to a predicate device, allowing it to be marketed.

However, the document does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.

Specifically, the document lacks all of the following information:

1. A table of acceptance criteria and the reported device performance: This letter only states that the device is "substantially equivalent" to a predicate device. It does not provide any specific performance metrics or acceptance criteria that were met by the device itself.
2. Sample size used for the test set and the data provenance: No information about a test set, its size, or its origin is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: There is no mention of experts or ground truth establishment.
4. Adjudication method for the test set: Not applicable as no test set details are provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: This type of study is not mentioned in the clearance letter.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This device is a hemodialysis delivery system and blood tubing set, not an AI algorithm. Therefore, a standalone algorithm performance study is not relevant.
7. The type of ground truth used: Not applicable as ground truth is not mentioned.
8. The sample size for the training set: There is no mention of a training set.
9. How the ground truth for the training set was established: Not applicable as no training set details are provided.

In summary, this document is a regulatory clearance letter, not a study report. To find the requested information, one would typically need to refer to the 510(k) submission itself (K982760), which would contain the technical data and studies demonstrating substantial equivalence to the predicate device.

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TIPSTOP is intended to be used as a sterile compression dressing for puncture of the vascular access site.

The Hospal TIPSTOP is a compressive dressing made of polyamide compressive element covered with alginate, which is placed on an adhesive film. TIPSTOP has been specially designed to stop bleeding after venipuncture in a manner similar to other compression dressings. The action mechanism consists of prolonging the manual compression with a mechanical compression carried out by the compressive element. TIPSTOP is sterilized by gamma irradiation.

1. Acceptance Criteria and Reported Device Performance

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

No dedicated test set of patient data or clinical samples was used. The evaluation of the device relied on in vitro testing for biocompatibility and a comparison to the predicate device (Hospal TIPSTOP, K896068).

• Test Set Sample Size: Not applicable, as no clinical testing or patient data set was used.
• Data Provenance: Not applicable for a clinical test set. The "data" primarily comes from in vitro laboratory tests performed on the new alginate material, and a comparison of the device's design to its predicate.

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

Not applicable. No ground truth based on expert consensus was established for a clinical test set, as clinical testing was not performed.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication was used.

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 medical dressing, not an AI-powered diagnostic or assistive technology. No MRMC study was conducted.

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

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

7. The Type of Ground Truth Used

The "ground truth" for this submission was primarily based on:

• Biocompatibility Standards: The in vitro tests for the alginate material would have been assessed against established biocompatibility standards for medical devices.
• Predicate Device Performance: The underlying assumption is that the predicate device (Hospal TIPSTOP with bovine collagen) had an established safety and effectiveness profile, and the new device was deemed "substantially equivalent" if it performed similarly for its intended use, with the only significant change being the compression material.

8. The Sample Size for the Training Set

Not applicable. This submission does not describe a machine learning or AI model, so there is no "training set."

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

Not applicable. There was no training set for a machine learning model.

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The Gambro Central Water Treatment System CWP 100 – WRO H is designed to produce water of adquate quality for hemodialysis, both chemically and microbiologically with an adequate flow, provided that the feed water complies with the existing standards for drinking water and has been properly pre-treated.

The Gambro Central Water Treatment System CWP 100 - WRO H is designed to produce water of adquate quality for hemodialysis, both chemically and microbiologically with an adequate flow, provided that the feed water complies with the existing standards for drinking water and has been properly pre-treated. The WRO or the base unit of the CWP system, operates under the principle of reverse osmosis (RO) which is the preferred method for the purificationof water for hemodialysis. This system removes at least 95% of the total dissolved salts (based on conductivity measurements) and more than 99% of the bacteria and endotoxins from the inlet water. The WRO H also include a heat disinfection unit for disinfection of the distribution system which utilizes hot water to minimize any form of microbial growth and biofilf formation. With this system, dialysis machines can be included in this heat disinfection cycle, provided that they have heat disinfection capability. This procedure is called integrated heat disinfection.

In order to ensure that the microbiological quality will be maintained, this system has:

• an automated disinfection procedure to keep the membrane surfaces clean and to . minimize bacterial growth;
• a hygenic design with smooth surfaces and a minimum of stagnant zones; .
• automatic flushing programs at preset intervals when the system is not in use ●

In addition, the WRO H has been designed to reduce water consumption by automatically regulating the pump speed to the actual demand of pure water.

After pretreatment (i.e. sediment filter, water softener, charcoal filter, etc.) the water enters an inlet tank (please refer to position 4 on the following diagram) via a solenoid valve (1). The inlet water tank (4) has a float valve (5) and an air gap to help isolate the flowpath from the municipal water system. The main pump (33) then creates a pressure of up to 20 bar that is required for the reverse osmosis process.

Pure water from the WRO unit is distributed directly to the distribution system in the hemodialysis unit via solenoid valves (48), (103), and (105). Excess pure water that has not been used in the hemodialysis unit is recirculated back to the inlet water tank (4) via solenoid valve (106).

In order to reduce water consumption, the speed of the pump is automatically adjusted so that the return flow of water is kept constant. Part of the reject water is recirculated back to the sucking side of the main pump via valve (71) to help minimize water consumption and to maintain a high flow velocity over the membrane surface. The rest of the reject water is, however, continuously sent to the drain via a needle valve (41).

The WRO unit utilizes a proportioning pump (45) and solution container (46) to proportion disinfectant during the disinfection cycle. The proportioning pump is disconnected from the flow path during normal operation.

The pure water line has a solenoid valve (36) for automatic flushing to drain at the start up, in conductivity alarm situations, every two hours, when the unit is in stand-by mode and at rinse during disinfection. The pure water line also has a solenoid valve arrangement to isolate the system from the distribution system during disinfection. The WRO unit has an overflow valve (64) on the pure water side to control pressure and to relieve pressure peaks.

The provided document describes the Gambro Central Water Treatment System CWP 100 – WRO H, a water purification system for hemodialysis. This device was cleared through the 510(k) pathway, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than de novo clinical efficacy studies. Therefore, the document does not contain typical clinical study data with acceptance criteria based on patient outcomes or expert reviews. Instead, the "acceptance criteria" are implied by the performance characteristics demonstrated to establish substantial equivalence.

Here's an analysis of the available information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "test set" in the traditional sense of a clinical study with a defined sample size of patients or images. The testing was primarily in vitro performance testing on the device itself.

• Sample Size: Not applicable in terms of "test set" for clinical data. The testing involved multiple runs or configurations of the Gambro Central Water Treatment System.
• Data Provenance: The studies were non-clinical (in vitro performance testing) conducted by Gambro Healthcare. The location of these tests or the specific country of origin for the "data" is not explicitly stated beyond Gambro Healthcare's location in Lakewood, CO. The testing is retrospective, in the sense that it was completed prior to the 510(k) submission.

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

• Not applicable. This was a non-clinical performance study on a water treatment system, not a diagnostic or clinical decision-making device. Ground truth in this context would be established by validated analytical methods (e.g., chemical assays, microbiological cultures, flow measurements) rather than expert consensus.

4. Adjudication Method for the Test Set

• Not applicable. As described above, there was no "test set" requiring expert adjudication. Performance was measured objectively using instrumentation and analytical methods.

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

• No. An MRMC study is relevant for diagnostic devices where human readers interpret medical images or data. This device is a water treatment system, not a diagnostic tool.

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

• Yes, implicitly. The "in vitro performance testing" described is essentially a standalone evaluation of the device's capabilities without human intervention influencing its core function (i.e., water purification). The device's automated features (disinfection, flushing, pump regulation) operate independently. While an operator initiates the heat disinfection cycle, the performance data (e.g., % salt rejection, % bacteria removal, flow rates) represents the machine's intrinsic capabilities.

7. Type of Ground Truth Used

The ground truth for the device's performance was established through objective laboratory measurements and analytical validated methods for:

• Conductivity (for dissolved salts rejection)
• Microbiological assays (for bacteria and endotoxins removal)
• Flow rate measurements
• Temperature measurements (for heat disinfection)
• Material compatibility testing

These methods serve as the "ground truth" to verify the device's output against established standards for water quality.

8. Sample Size for the Training Set

• Not applicable. This device is a physical water treatment system, not an AI/ML algorithm that requires a "training set" of data. Its design and operational parameters are based on engineering principles and established reverse osmosis technology, not machine learning.

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

• Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant to the described device.

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The PRISMA™ System is indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. All treatments administered via the PRISMA System must be prescribed by a physician.

Not Found

I am sorry, but based on the limited information provided from the document, I cannot fulfill your request. The documents are a 510(k) clearance letter and an "Indications For Use" statement for the PRISMA™ Continuous Fluid Management System.

These documents confirm the device's regulatory clearance and its intended use. However, they do not contain any information regarding acceptance criteria, study details, sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies. These details are typically found in the premarket notification submission itself, which is not provided here.

Therefore, I cannot generate the requested table and answer the specific questions about the device's performance study based solely on the provided text.

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The Gambro® Water Treatment System is intended to be used by hemodialysis clinics for the purification of water to be used for the dilution of dialysate concentrate and in the reprocessing of dialyzers for reuse.

Not Found

The provided text describes an FDA 510(k) clearance letter for the Gambro® Water Purification System. This document is a regulatory approval, not a scientific study describing device performance against acceptance criteria in the way a clinical trial or AI algorithm validation would.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or expert involvement, because these details are not present in the provided FDA clearance letter. This type of document confirms regulatory compliance and substantial equivalence, not the results of a detailed performance study.

The document only states the "Indications for Use" for the device, which are:

• Purification of water to be used for the dilution of dialysate concentrate by hemodialysis clinics.
• Purification of water to be used in the reprocessing of dialyzers for reuse by hemodialysis clinics.

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