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Hemodialysis with an ELISIO™-H hemodialyzer is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs.

The device is for prescription use only.

This product is intended for single use only. The performance properties of reused dialyzers have not been established.

The ELISIO-H hemodialyzers are medical devices used as an artificial kidney system for the treatment of patients with renal failure. During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment.

The ELISIO-H dialyzers are composed of polyethersulfone fiber and are available in various sizes, which are differentiated by membrane surface area.

The provided text describes a 510(k) summary for the ELISIO™-H Hemodialyzer, a medical device. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive details about a clinical study with acceptance criteria for device performance in the same way one might for a novel AI/software diagnostic device.

Therefore, many of the requested elements are not applicable or cannot be extracted from this document, as it pertains to a hemodialysis system and not an AI or imaging diagnostic device.

Here's an analysis based on the provided text, addressing the applicable points:

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

The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, or specific physical parameters with defined thresholds) or present a table of reported device performance against such criteria. The "Conclusion" states: "Testing performed on the ELISIO-H dialyzers indicates that they are safe, effective and perform as well as the legally marketed device models, when used in accordance with the instructions for use." This is a qualitative statement of efficacy in the context of substantial equivalence, not a detailed performance report.

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

This information is not provided. The document mentions "testing performed" but does not detail the nature of these tests (e.g., in vitro, animal, or human clinical trials), sample sizes, or data provenance.

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

This is not applicable to this type of device and submission. The ground truth for a hemodialyzer's performance would primarily be established through physical and chemical testing (e.g., clearance rates, ultrafiltration rates, biocompatibility) rather than expert interpretation of medical data from a test set.

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

Not applicable. This concept is typically relevant for studies involving human interpretation of data, where multiple experts might be used to resolve discrepancies in diagnoses or 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 is a hemodialysis system, not an AI or imaging device that would typically involve human readers being assisted by AI.

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

Not applicable. The device is a physical medical device (hemodialyzer), not a standalone algorithm.

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

The "ground truth" for a hemodialyzer's performance would be established through engineering and biological testing (e.g., direct measurement of solute clearance, ultrafiltration, pressure drops, blood-material interactions, and possibly in vivo biocompatibility or animal studies to simulate real-world conditions). The document does not detail these specific methods or outcomes. The basis for the substantial equivalence is the ELISIO™-H Hemodialyzer's composition and function being "safe, effective and perform as well as the legally marketed device models," implying that the performance metrics of the predicate devices serve as an implicit benchmark.

8. The sample size for the training set

Not applicable. The ELISIO™-H Hemodialyzer is a physical device, not an algorithm that requires a training set.

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

Not applicable.

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Hemodialysis with an ELISIO™-H or an ELISIO™-M hemodialyzer is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs.

The device is for prescription use only. This product is intended for single use only. The performance properties of reused dialyzers have not been established.

The ELISIO-H and ELISIO-M hemodialyzers are medical devices used as an artificial kidney system for the treatment of patients with renal failure. During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment.

The ELISIO-H and ELISIO-M dialyzers are composed of polyethersulfone fiber and are available in various sizes, which are differentiated by membrane surface area.

The provided text describes a 510(k) summary for Nipro ELISIO™-H and ELISIO™-M Hemodialyzers, which are medical devices used for hemodialysis in patients with renal failure.

Based on the provided text, there is no information related to acceptance criteria, device performance tables, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or training set details.

The document is a regulatory submission (510(k) summary) and primarily focuses on:

• Device Identification: Trade names, classification, common name.
• Device Description: What the device is, how it works, and its components (polyethersulfone fiber membrane, polypropylene casing).
• Intended Use: Conditions for which the device is indicated (acute or chronic renal failure, drug/poison intoxication).
• Technological Aspects and Substantial Equivalence: Comparison to predicate devices, noting the membrane composition is identical and the modification is a change in casing material from polycarbonate to polypropylene. It mentions non-clinical studies for biocompatibility demonstrating substantial equivalence.
• Conclusion: States that testing indicates the ELISIO™-H and ELISIO™-M dialyzers are safe, effective, and perform as well as predicate devices.
• FDA Communication: Formal letter from the FDA granting substantial equivalence.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, or ground truth establishment as it is not present in the provided text. The document focuses on regulatory approval based on demonstrating equivalence to an existing predicate device, primarily through material changes and biocompatibility testing, rather than detailed performance metrics against specific acceptance criteria.

Ask a specific question about this device

Hemodialysis with an ELISIO™-H hemodialyzer is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs.

The device is for prescription use only. This product is intended for single use only. The performance properties of reused dialyzers have not been established.

The ELISIO-H hemodialyzers are medical devices used as an artificial kidney system for the treatment of patients with renal failure. During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment.

The ELISIO-H dialyzers are composed of polyethersulfone fiber and are available in various sizes, which are differentiated by membrane surface area.

ELISIO™-H Hemodialyzer Acceptance Criteria and Study Details

The provided document describes the ELISIO™-H Hemodialyzer, which is an artificial kidney system for treating patients with renal failure. The submission (K131381) focuses on the inclusion of two additional family members (-90H and -250H) to the existing ELISIO-H product line. The primary method of demonstrating substantial equivalence to predicate devices (K122347, K002761, K926005, K082414) was through non-clinical bench studies.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative table format with pass/fail thresholds. Instead, it refers to performance "as well as" or "substantially equivalent" to legally marketed predicate devices. The "reported device performance" is a qualitative summary of non-clinical testing results.

Note: The acceptance criteria are inferred from the statement "Results of bench studies establish substantial equivalence to Fresenius hemodialyzer performance" and "Testing performed on the ELISIO-H dialyzers indicates that they are safe, effective and perform as well as the legally marketed device models." No specific numerical thresholds are provided for "substantially equivalent" or "as well as."

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

• Sample Size: The document does not specify the exact sample size for the non-clinical bench tests (e.g., number of dialyzer units tested for each parameter). It broadly states "non-clinical studies included those for analyte clearance...".
• Data Provenance: The studies were non-clinical bench tests, meaning they were conducted in a laboratory setting, not on human subjects. The country of origin for the data is not specified, but the submitter (Nipro Medical Corporation) is located in Miami, FL, USA. The studies are prospective in nature, as they were conducted to evaluate the performance of the ELISIO™-H hemodialyzer.

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

This question is not applicable. For non-clinical bench studies of this nature, "ground truth" is established through standardized laboratory measurement techniques and scientific principles, not through expert consensus on interpretation of data. The performance metrics are objectively measured.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human readers/interpreters where there can be inter-observer variability in establishing ground truth (e.g., image interpretation). For non-clinical, objective bench tests, adjudication is not performed in this manner.

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

No, an MRMC comparative effectiveness study was not done. The study was a non-clinical bench study, not a clinical study involving human readers or interpretation of cases. Therefore, no effect size for human readers improving with AI assistance is applicable or reported.

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

Yes, the studies conducted were standalone "device only" performance tests. The performance of the ELISIO™-H hemodialyzer itself (e.g., its ability to clear analytes, ultrafiltration coefficient) was measured directly. This is implicitly a "standalone" assessment of the device's physical and functional properties.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests was established through objective laboratory measurements of physical and chemical parameters based on established scientific methods. For example:

• Analyte Clearance: Measured concentrations of urea, creatinine, etc., before and after passage through the dialyzer, under controlled conditions.
• Ultrafiltration Coefficient: Direct measurement of fluid removal under a given transmembrane pressure.
• Pressure Drop: Direct measurement of pressure difference across the dialyzer.

These are not pathology, expert consensus, or outcomes data, but rather direct measurements of the device's functional performance.

8. The Sample Size for the Training Set

This question is not applicable. There is no mention of machine learning or AI algorithms being developed or "trained" for this device. The ELISIO™-H hemodialyzer is a physical medical device, not a software algorithm that requires training data.

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

This question is not applicable, as no training set was used for an AI/ML algorithm.

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