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FX CorAL HD dialyzers are intended for hemodialysis (HD), hemodiafiltration (HDF), hemofiltration (HF), and isolated ultrafiltration in patients, including pediatric patients, with acute kidney injury or chronic kidney disease when conservative therapy is judged to be inadequate.

Consider body and dialyzer surface area, blood flow, body weight and extracorporeal blood volume when selecting dialyzers for use with pediatric patients.

The FX CorAL dialyzers are high-flux, single-use, steam-sterilized hemodialyzers. The dialyzers are provided blood pathway sterile and non-pyrogenic. The dialyzers allow for the transfer of water and solutes between blood and dialysate using semipermeable, hollow fiber membranes.

The FX CorAL dialyzers are high-flux, sterile devices designed for single-use acute and chronic hemodialysis. The dialyzers are configured to connect to a bloodline set which connects to a patient's vascular access system when used with a hemodialysis machine equipped with ultrafiltration control. During hemodialysis, blood is pumped from the patient's body through an extracorporeal circuit, one component of which is the dialyzers contain semipermeable membranes that allow for diffusion and/or ultrafiltration to transport toxins and excess fluid from the blood compartment (fiber lumen) to the dialysate compartment. Dialyzers utilize a counter-current flow in which dialysate and blood flow in opposite directions in the dialyzer. The counter-current flow maintains the concentration gradient across the membrane for waste and fluid removal.

The document describes the FX CorAL 40 and FX CorAL 50 dialyzers and their substantial equivalence to predicate devices, focusing on performance, materials, and intended use. There is no information provided in the document regarding acceptance criteria or performance of an AI/ML device.

The provided text describes a medical device clearance (K242053) for FX CorAL 40 and FX CorAL 50 dialyzers, which are high permeability hemodialysis systems. While the request asks about acceptance criteria and study details for an AI/ML device, the document focuses on the performance data of these physical medical devices. Therefore, much of the requested information regarding AI/ML specifics (like effect size of AI assistance, standalone algorithm performance, training set details, expert qualifications for ground truth) is not applicable to this submission.

However, I can extract the relevant information pertaining to the tests conducted for these dialyzers, which function as "acceptance criteria" for a physical device.

Here's a breakdown based on the provided document:

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

The document lists performance tests conducted and states that "All testing met predetermined acceptance criteria." It does not explicitly list numerical acceptance criteria values for each test but provides typical performance results for urea clearance.

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

• Performance Testing (in vitro): Sample size for each specific in vitro test (e.g., clearance, integrity) is not explicitly stated, but it's implied that multiple samples were tested to generate the "typical" values and ensure criteria were met.
• Clinical Studies (retrospective):
  • Sample Size: Fourteen (14) pediatric ESRD patients
  • Data Provenance: Retrospective clinical data analysis. The country of origin is not specified.

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 the document describes a physical medical device (dialyzer), not an AI/ML diagnostic tool requiring expert interpretation for ground truth establishment. The "ground truth" for the dialyzer's performance is established through well-defined physical and chemical measurements following international standards (e.g., ISO 8637-1).

4. Adjudication method for the test set:

Not applicable. For physical device performance, the results are typically quantitative measurements against defined specifications, not subjective interpretations requiring 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, as this is not an AI-assisted diagnostic device.

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

Not applicable, as this is not an AI/ML device.

7. The type of ground truth used:

• In vitro Performance Tests: Ground truth is based on established physical and chemical measurement standards (e.g., ISO 8637-1 First Edition 2017-11) and direct laboratory measurements of parameters like clearances, sieving coefficients, ultrafiltration rates, and pressure drops.
• Biocompatibility Testing: Ground truth is established through standardized biological evaluation tests as per FDA guidance and ISO 10993-1.
• Clinical Studies: "Adequate clearance" (demonstrated by spKt/V values) and patient tolerance serve as clinical outcomes demonstrating the device's effectiveness in a real-world setting.

8. The sample size for the training set:

Not applicable, as this is not an AI/ML device and thus does not have a "training set" in that context.

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

Not applicable.

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The Hemoflow F3 and F4 dialyzers are intended for hemodialysis of patients, including pediatric patients, with acute or chronic renal failure when conservative therapy is judged to be inadequate. Consider body and dialyzer surface area, blood flow, body weight, and extracorporeal blood volume when selecting dialyzers for use with pediatric patients.

The Hemoflow F3 and F4 dialyzers are low-flux, single-use, ethylene oxide (EO) sterilized hemodialyzers. The dialyzers are provided blood pathway sterile and non-pyrogenic. The membrane surface areas of the F3 and the F4 dialyzers are 0.3 m2 and 0.7 m2, respectively.

The Hemoflow F3 and F4 dialyzers are low-flux, sterile devices designed for single-use acute and chronic hemodialysis. The dialyzers are configured to connect to a bloodline set which connects to a patient's vascular access system when used with a hemodialysis machine equipped with ultrafiltration control. During hemodialysis, blood is pumped from the patient's body through an extracorporeal circuit, one component of which is the dialyzers contain a semi-permeable membrane that allows for diffusion and/or ultrafiltration to transport toxins and excess fluid from the blood compartment (fiber lumen) to the dialysate compartment. Dialyzers utilize a counter-current flow in which dialysate and blood flow in opposite directions in the dialyzer. The counter-current flow maintains the concentration gradient across the membrane for waste and fluid removal.

The provided text is related to a 510(k) premarket notification for Hemoflow F3 and F4 Dialyzers, not a study describing acceptance criteria and device performance in the context of AI or software. Therefore, much of the requested information (like sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) is not applicable or present in this document.

However, I can extract the relevant performance data and highlight the acceptance criteria as stated for the dialyzers themselves and the summary of compliance.

Here's an attempt to structure the available information, noting where information is not present as per your request related to an "AI device":

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

For medical devices like dialyzers, performance is typically demonstrated through various tests meeting established standards. While specific numerical acceptance criteria (e.e.g. "urea clearance must be >X") are not explicitly listed in easily interpretable tables for each test, the text states the ultimate acceptance: "All testing met predetermined acceptance criteria." and "Results of the proposed devices' design verification tests met the requirements and demonstrated that, like the predicate device, the Hemoflow F3 and F4 dialyzers are safe and effective for their intended use."

The key performance characteristic highlighted and its reported value are:

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 mentions "A retrospective data analysis performed on the Hemoflow F3 and F4 dialyzers included 10 pediatric ESRD patients on HD treated for 12 consecutive weeks." This appears to be a clinical "test set" for the clinical effectiveness aspect (adequate clearance), not for the engineering performance tests.

• Sample Size (Clinical): 10 pediatric ESRD patients
• Data Provenance (Clinical): Retrospective. Country of origin not specified.

For the engineering performance tests listed in Table 2, the sample size of dialyzers tested is not explicitly stated.

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)

Not applicable. This document describes a medical device (dialyzers), not an AI device that relies on expert human interpretation for ground truth.

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

Not applicable. This document describes a medical device, not a diagnostic or AI system requiring adjudication of expert interpretations.

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 document is for a medical device (dialyzers), not an AI-assisted diagnostic tool.

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

Not applicable. This document is for a medical device (dialyzers), not an AI algorithm.

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

For the clinical study mentioned: "adequate clearance" with a mean spKt/V of 1.78 (F3) and 2.18 (F4) served as the "ground truth" or outcome measure for the clinical effectiveness aspect. This is outcomes data (clinical efficacy in terms of clearance).
For the engineering performance tests, the "ground truth" is typically established by physical measurements and adherence to established engineering standards (e.g., ISO 8637:2010) and regulatory guidance.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI device.

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

Not applicable. There is no mention of a training set as this is not an AI device.

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The 800 series RAPIDO BLS HOLLOW-FIBRE DIAL YZERS are single-use devices intended for hemodialysis (HD), hemofiltration (HF), and hemodiafiltration (HDF) to treat conditions of acute or chronic renal failure when conservative therapy is judged to be inadequate. They are also indicated in the treatment intoxicated with poisons or drugs.

The above mentioned devices are dialyzers consisting of a cylindrical polycarbonate transparent body containing a bundle of microporous hollow fibers in highly-permeable polyethersulfone (Diapes® HF) secured to the ends by means of hot-melt polyurethane resin.

The provided text is a 510(k) Premarket Notification for the RAPIDO BLS HOLLOW-FIBRE DIALYZER. It describes the device, its intended use, and comparative testing against predicate devices to demonstrate substantial equivalence, rather than a study proving the device meets specific acceptance criteria in the context of an AI/algorithm-based medical device.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of regulatory submission and device.

However, I can extract the relevant information regarding the acceptance criteria and the study type used for this medical device, which is an in-vitro performance study.

Here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "The results of these tests met established specifications." However, the specific numerical acceptance criteria for each performance parameter are not provided in this summary. The reported performance is implicitly that the device performs substantially equivalently to the predicate devices.

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

• Sample Size: Not specified in the document. The testing mentioned is "in vitro test results" and refers to "the device" (singular) implying testing on a sample, but the specific number of units tested is not given.
• Data Provenance: In vitro test results. The device manufacturer is Bellco Srl, located in Mirandola (MO), Italy. The tests were conducted internally or by a contracted lab. The document describes these as "non-clinical" and "in vitro" tests, not involving human data.

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

• Not Applicable. This is an in-vitro performance study for a physical medical device, not an AI/algorithm-based device relying on expert-annotated ground truth.

4. Adjudication method for the test set

• Not Applicable. See point 3.

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 an AI-assisted device.

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

• Not Applicable. This is not an AI/algorithm. However, the performance described is of the device itself (standalone), not in conjunction with a human operator making clinical decisions based on its output (beyond operating the dialysis machine it connects to).

7. The type of ground truth used

• Established Specifications/Predicate Device Performance: The "ground truth" or reference for evaluating the RAPIDO BLS was its ability to meet established specifications for various performance parameters and to demonstrate substantial equivalence to legally marketed predicate devices (Xenium Dialyzer, Syntra, and Polyflux 6H). This relied on comparing the numerical values obtained from the in-vitro tests against these benchmarks.

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning device; there is no "training set."

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

• Not Applicable. See point 8.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study was an in vitro and non-clinical performance evaluation comparing the RAPIDO BLS HOLLOW-FIBRE DIALYZER to existing predicate devices (Xenium Dialyzer, Syntra, and Polyflux 6H).

The testing included:

• Biocompatibility testing: Conducted in accordance with ISO 10993-1.
• Sterility, pyrogenicity, EtO residual, and package integrity testing.
• In vitro functional performance testing:
  • Mechanical integrity
  • Priming volume
  • Blood side pressure drop
  • Ultrafiltration rate
  • Sieving coefficient
  • Hemolysis

For comparative purposes, the same in-vitro functional performance tests were also conducted on the predicate devices where applicable.

Conclusion of the Study:
The document concludes that the results from these in vitro studies demonstrate that the RAPIDO BLS performs in a manner substantially equivalent to the predicate devices and that it is biocompatible and safely manufactured (sterile, non-pyrogenic). All tests "met established specifications." This substantial equivalence argument is the basis for FDA clearance.

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