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The OLPur H2H Hemodiafiltration (HDF) Module is indicated for use, with a UF controlled hemodialysis machine that provides ultrapure dialysate in accordance with current ANSI/AAMI/ISO standards, for treatment of patients with chronic renal failure as prescribed by a physician. The OLPur MD 220 Hemodiafilter is indicated for use for hemodiafiltration of patients with chronic renal failure. The OLPur MD 220 Hemodiafilter is only to be used with the OLpur H2H Hemodiafiltration Module. Selection of patients, as well as treatment operating parameters, are a medical decision and the responsibility of the prescribing physician.

The H₂H™ Hemodiafiltration Module is a programmable electro-mechanical medical device designed to work in conjunction with and in close proximity to a hemodialysis machine during patient treatments. Upon installation, the H₂H Module is placed next to the hemodialysis machine (which can be on either side depending upon type and model of the hemodialysis machine) and is connected to the clinic's water supply, drain, and electricity.

The H₂H Hemodiafiltration Module serves two basic functions. The Module's primary function is to generate on-line substitution fluid for hemodiafiltration. The H₂H Module does this by ultrafiltering dialysate, provided by the hemodialysis machine, through a reusable substitution filter. The secondary function of the H₂H Hemodiafiltration Module is to serve as a substitution filter reprocessing machine. These steps are performed when the H₂H Hemodiafiltration Module is not connected to the hemodialysis machine. More detailed descriptions of the device, its accessories and how the system functions can be found in Section 11 (Device Description) of this submission.

The provided text is a 510(k) summary for the Nephros OLpūr® H₂H H₂H Hemodiafiltration (HDF) Module and OLpūr MD 220 Hemodiafilter. It focuses on device description, intended use, and technological characteristics compared to predicate devices for substantial equivalence.

However, this document does not contain explicit acceptance criteria and a study proving the device meets those criteria in the typical format of a clinical trial report or performance study with detailed results against defined benchmarks. Instead, it refers to "Bench Analyses performed on the subject devices" in Section 18 and "clinical data supporting substantial equivalence" in Section 20 of the full application, which are not provided.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be extracted directly from the given 510(k) summary.

Here's what can be gathered and what is missing based on the provided text:

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

• Acceptance Criteria: Not explicitly stated in terms of specific performance metrics with numerical targets within this summary. Substantial equivalence is the overall goal, meaning the device performs as safely and effectively as predicate devices.
• Reported Device Performance: The summary states, "The proposed device has the same technological characteristics and is similar in design as compared to the predicate devices and already approved kidney dialysis therapy." This is a general statement of equivalency rather than specific performance numbers against acceptance criteria. The full submission's Section 18 and 20 would contain these details.

2. Sample sized 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: Not specified in this 510(k) summary.
• Data Provenance: Not specified in this 510(k) summary.

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 specified in this 510(k) summary.

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

• Not specified in this 510(k) summary.

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

• This device is a medical module and hemodiafilter, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human readers improving with AI is irrelevant and not mentioned.

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

• This device is a physical medical device (hemodiafiltration module and filter), not a software algorithm. Therefore, "standalone algorithm" performance is not applicable in this context. Its performance would be evaluated during its operation in conjunction with a hemodialysis machine.

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

• Not specified in this 510(k) summary. Given the nature of the device, ground truth would likely refer to performance metrics like filtration efficiency, ultrafiltration control accuracy, biocompatibility, and microbiological purity, established through bench testing and potentially in vivo studies (though clinical data reference focuses on substantial equivalence).

8. The sample size for the training set

• Not applicable/specified. This is a physical medical device, not an AI/machine learning model that typically has a "training set."

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

• Not applicable/specified for the same reasons as point 8.

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The DialGuard™ device is intended to be used for the reduction of endotoxin from:

1. Dialysate prior to entering the dialyser
2. Water prior to its use for preparation of dialysate
3. Water prior to use for regenerating dialysers.
   DialGuard™ is intended to be used on a regular preventative basis during hemodialysis treatments. Experimental data indicates that DialGuard TM will consistently reduce endotoxin levels to ≤ 0.05 EU/mL. (AAMI standard for water for dialysate is < 5.0 EU/mL. Currently, there are no standards set for dialysate).

DialGuard™ is a device used for the reduction of endotoxin from dialysate and water. It consists of a polysulfone housing filled with an affinity resin with polysulfone endcaps. The endcaps are fitted with Quick Connect couplings.

Here's an analysis of the provided text, outlining the acceptance criteria and the study used to demonstrate the device's performance, organized according to your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the DialGuard™ filter are primarily focused on its ability to reduce endotoxin levels. The performance is reported in the context of meeting or exceeding relevant standards.

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

• Sample Size: The document does not explicitly state the specific sample size for the "test set" used in the endotoxin reduction studies, flow rate, pressure, conductivity, ion composition, leachables, or biocompatibility tests. It only states that "Experimental data indicates..."
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given the context of a 510(k) summary, these would typically be internal testing conducted by the manufacturer (Clarigen, Inc.) to support the submission.

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

This information is not provided in the document. The studies described are laboratory-based performance tests (e.g., endotoxin reduction, flow rate, leachables) rather than studies that would typically require expert consensus for "ground truth" in the way a diagnostic imaging study would. The ground truth for these tests is established by objective measurements against known standards or controls.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used for studies where human readers or experts are interpreting results (e.g., medical images). The studies described here are direct performance measurements of a filter.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic AI applications involving human interpretation (e.g., radiology AI), not for a device like an endotoxin filter.

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

No, this concept is not applicable to the DialGuard™ filter. The device itself is a physical filter, not an algorithm. The "performance" being evaluated is its physical and chemical effectiveness in reducing endotoxin and maintaining dialysate properties.

7. The Type of Ground Truth Used

The ground truth used for relevant tests would be:

• Endotoxin Removal: Quantified endotoxin levels using standard assay methods (e.g., Limulus Amebocyte Lysate (LAL) test) in controlled experiments, with reference to established benchmarks like the AAMI standard for water for dialysate.
• Flow Rate/Pressure: Direct physical measurements.
• Conductivity/Ion Composition: Direct chemical measurements using calibrated instruments.
• Leachables: Chemical analysis (analytical chemistry techniques).
• Biocompatibility: Standardized in vitro and/or in vivo biocompatibility testing methods against recognized standards.

8. The Sample Size for the Training Set

This information is not provided and is not applicable to this type of device. The DialGuard™ filter is a physical device, not an AI algorithm, so there is no "training set" in the machine learning sense. The "training set" concept relates to data used to train an AI model.

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

This information is not provided and is not applicable for the same reason as point 8. There is no AI training set for this device.

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