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The EndoPur Endotoxin 10" Filter Flat is intended to filter water used in hemodialysis devices. It assists in providing hemodialysis quality water. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (Reverse Osmosis, Deionization, etc.).

The EndoPur Endotoxin 10" Filter Flat is a hollow fiber ultrafilter that retains bacteria, viruses, endotoxin and particulate from water used in hemodialysis.

The document provided describes a 510(k) premarket notification for a medical device called the "EndoPur Endotoxin 10" Filter Flat." This device is a water purification filter for hemodialysis. The information primarily focuses on establishing substantial equivalence to a predicate device through non-clinical performance data.

Here's an analysis based on your request, highlighting what is and isn't available in the provided text:

1. Table of acceptance criteria and the reported device performance

The document doesn't explicitly present a formal table of acceptance criteria with corresponding performance results in a structured format. However, it lists the types of tests performed and implies that the results were "acceptable" or demonstrated "substantial equivalence."

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

• Sample Size for Test Set: The document does not specify the sample sizes used for each of the performance tests (Flow Rate, Pyrogen Removal, Virus Challenge, Bacteria Challenge, Disinfection Compatibility, Biocompatibility).
• Data Provenance: The study was conducted by Nephros, Inc. (the device manufacturer) for regulatory submission to the FDA. The country of origin of the data is implicitly the USA, as Nephros, Inc. is located in River Edge, NJ. The data is retrospective in the sense that it was generated as part of a premarket notification for an existing device design.

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

The concept of "ground truth" as typically applied to diagnostic algorithms (e.g., expert consensus on clinical images) is not directly applicable here as this is a physical filter device. For the biocompatibility testing, a toxicologist was used to evaluate the exhaustive extractable and leach testing results and found them to be safe. The number of toxicologists is not specified (e.g., "a toxicologist" usually implies one unless otherwise stated).

4. Adjudication method for the test set

Not applicable. The tests performed are objective laboratory and engineering tests for device performance, not subjective assessments requiring adjudication like clinical image interpretation.

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-powered diagnostic device, and no MRMC studies or human-in-the-loop performance evaluations were conducted or are relevant.

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

Not applicable. This device is not an algorithm. The "standalone performance" refers to the filter's ability to perform its function (e.g., removing contaminants) independently, which is what the "Assessment of Non-clinical Performance Data" describes.

7. The type of ground truth used

For the performance tests:

• Pyrogen Removal, Virus Challenge, Bacteria Challenge: The "ground truth" would be established by validated laboratory assays and measurement techniques for detecting and quantifying these biological contaminants (e.g., using known concentrations of pyrogens, viruses, or bacteria and measuring the reduction after filtration).
• Biocompatibility: The "ground truth" is established by standard toxicological assessment methods and guidelines (e.g., AAMI/ISO standards) which evaluate the potential for adverse biological reactions. The outcome is assessed by a toxicologist.
• Residual Levels: The "ground truth" is established by chemical analytical methods to quantify residual levels against pre-defined acceptable limits (e.g., as per ANSI/AAMI 13959).

8. The sample size for the training set

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

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

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

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The HydraGuard 10" UltraFilter is intended to be used to filter EPA quality drinking water. The filter retains bacteria, viruses and endotoxin. By providing ultrapure water for patient washing and drinking, the filter aids in infection control. The filter produces water that is suitable for patient wound cleaning of equipment used in medical procedures and washing of surgeon's hands. Medical: The filter is not intended to provide water that can be used as a substitute for USP sterile water.

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The provided document is a 510(k) clearance letter for the HydraGuard 10" UltraFilter. It does not contain information about acceptance criteria for device performance or a study demonstrating the device meets such criteria in terms of clinical or diagnostic accuracy. Instead, it describes the indications for use and the regulatory classification of the device as a water purification system.

The "Indications for Use" section (page 2) describes what the device is intended for:

• To filter EPA quality drinking water.
• To retain bacteria, viruses, and endotoxin.
• To provide ultrapure water for patient washing and drinking, aiding in infection control.
• To produce water suitable for patient wound cleaning, cleaning of equipment used in medical procedures, and washing of surgeon's hands.

It explicitly states, "The filter is not intended to provide water that can be used as a substitute for USP sterile water."

Based on the provided text, the specific details regarding acceptance criteria, device performance metrics (other than the qualitative statements above), and information about a "study that proves the device meets the acceptance criteria" in the context of clinical effectiveness or diagnostic accuracy are not available. The document focuses on regulatory clearance based on substantial equivalence to a predicate device, not on a detailed performance study with specific quantitative acceptance criteria as would be found for a diagnostic or AI-driven device.

Therefore, I cannot populate the table or answer the specific questions about sample sizes, expert involvement, adjudication, MRMC studies, or ground truth establishment based solely on the text provided. This document is a regulatory approval letter, not a clinical study report.

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The S100 Point of Use Filter is intended to be used to filter EPA quality drinking water. The filter retains bacteria. By retaining bacteria in water for washing and drinking, the filter may aid in infection control. The filter produces water that is suitable for cleaning of equipment used in medical procedures and washing of surgeon's hands. The filter is not intended to provide water that can be used as a substitute for USP sterile water.

The S100 Point of Use Filter is a hollow fiber microfilter that retains bacteria from water used for washing and drinking.

Here's a breakdown of the acceptance criteria and study information for the Nephros S100 Point of Use Filter, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document directly compares the S100 filter to the DSU-H and SSU-H Ultrafilters (K141731) as predicate devices. The "Acceptance Criteria" here are derived from the performance specifications of these predicate devices as presented in the "SUBJECT TO PREDCATE DEVICE COMPARISON TABLE." The S100's performance is considered "substantially equivalent" to these predicates.

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

The document does not explicitly state the sample size for the test set (number of S100 filters tested for performance). It only mentions "The S100 Point of Use Filter has been tested for performance."

The data provenance (country of origin, retrospective/prospective) is not specified in the provided text.

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

This information is not provided in the document. The testing described for the filter's performance (Flow Rate, Simulated Use Life, Bacteria Challenge, Biocompatibility) are typically lab-based tests with objective measurements, not requiring expert consensus for "ground truth" in the way a clinical study for diagnosis might.

4. Adjudication Method for the Test Set

This information is not applicable/provided as the performance tests described are objective, laboratory-based measurements rather than subjective assessments 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

An MRMC study is not applicable to this type of device. The S100 Point of Use Filter is a physical water filter, not an AI-powered diagnostic tool. The document describes performance testing for filtration capabilities.

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

This is not applicable to this device. As mentioned, the S100 Point of Use Filter is a physical filter, not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth for the performance testing (e.g., bacteria removal, flow rate) would be established through laboratory-based measurements and validated testing methods. For example:

• Bacteria Removal: Direct enumeration of bacteria in the influent and effluent water (e.g., colony-forming units, turbidity measurements) using standard microbiological laboratory practices.
• Flow Rate: Direct measurement of water volume passed over time at a given pressure.
• Use Life: Controlled flow and pressure conditions over an extended period, with periodic performance checks for bacteria removal and flow.

8. The Sample Size for the Training Set

This is not applicable/provided. As the S100 Point of Use Filter is a physical device and not an AI/machine learning model, there is no "training set" in the computational sense.

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

This is not applicable as there is no training set for this type of device.

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The DSU-H and SSU-H Ultrafilters are intended to be used to filter EPA quality drinking water. The filters retain bacteria, viruses and endotoxin. By providing ultrapure water for patient washing and drinking, the filters aid in infection control. The filters produce water that is suitable for wound cleansing, cleaning of equipment used in medical procedures and washing of surgeon's hands. The filters are not intended to provide water that can be used as a substitute for USP sterile water.

The DSU-H and SSU-H Ultrafilters are hollow fiber ultrafilters that retain bacteria, viruses, endotoxin and particulate from water used for washing and drinking.

The provided text describes a medical device, the DSU-H and SSU-H Ultrafilters, but it does not include information about AI algorithms, reader studies, ground truth establishment for AI, or training/test sets for AI. Therefore, I cannot fulfill most of your request regarding acceptance criteria and studies that prove the AI device meets acceptance criteria.

However, I can extract the acceptance criteria for the Ultrafilters themselves as stated in the submission documents, which are based on their filtration performance.

Here's what I can provide based on the given information:

1. Table of Acceptance Criteria and Reported Device Performance (for the Ultrafilters)

The document primarily performs a substantial equivalence comparison to a predicate device (MainStream™ Water Purification Device – K012716) and refers to its own reference device (DSU and SSU Filters – K110285). The "acceptance criteria" can be inferred from the "Retention" section of the comparison table, where the device must demonstrate at least equivalent or superior reductions for various contaminants.

Explanation of Inference:
The submission states "Based on non-clinical performance testing, the DSU-H and SSU-H Ultrafilters have been found to be substantially equivalent to the predicate PrisMedical MainStream Filter (K012716)." For the characteristics where the subject device also performs, it must meet or exceed the predicate's performance. Furthermore, the subject device's performance aligns with its own reference device (K110285), which indicates its expected retention capabilities.

The following points cannot be answered as the provided text pertains to a physical water purification device and does not involve AI or a diagnostic algorithm evaluated through an AI specific study:

2. Sample size used for the test set and the data provenance: Not applicable. This is for a physical filter, not an AI algorithm. The performance data would come from laboratory testing of the filter medium with controlled contaminant challenges.
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 a physical filter's performance is established through standard microbiological and chemical testing, not expert consensus on medical images or diagnoses.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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.
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 (expert consensus, pathology, outcomes data, etc.): For the performance data presented (bacteria, virus, endotoxin reduction), the ground truth would be established by quantitative laboratory analysis of contaminant levels before and after filtration, using validated assays (e.g., CFU counts for bacteria, TCID50 for viruses, LAL test for endotoxin).
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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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 DSU, MSU, SSU Filters are intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. The DSU, MSU, SSU Filters assist in providing hemodialysis quality water or bicarbonate concentrate. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore, it must be used in conjunction with other water treatment equipment (i.e., RO, DI, etc.).

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The provided text is a 510(k) summary letter from the FDA regarding a medical device called the "Nephros Inc. DSU, MSU, SSU Filter." This document is a regulatory approval letter and an "Indications for Use" statement.

Based on the content, it's clear that this document concerns a water purification system for hemodialysis and is not an AI/ML medical device. Therefore, the concepts of acceptance criteria, test sets, ground truth, experts, adjudication, MRMC studies, standalone performance, and training sets as typically applied to AI/ML device evaluations are not applicable to this submission.

The document discusses substantial equivalence to predicate devices, regulatory compliance, and general controls, which are standard for traditional medical devices. There is no information about algorithms, software performance, or diagnostic/prognostic capabilities that would necessitate the metrics and study designs you've asked about.

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The DSU Dual Stage Ultrafilter is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. The DSU Ultrafilter assists in providing hemodialysis quality water or bicarbonate concentrate. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore, it must be used in conjunction with other water treatment equipment (i.e., RO, DI, etc.).

The DSU Dual Stage Ultrafilter is a hollow fiber filter that removes bacteria, viruses, endotoxin and particulate from water and bicarbonate concentrate used in hemodialysis.

The provided text describes the DSU Dual Stage Ultrafilter, a device intended to filter water or bicarbonate concentrate used in hemodialysis. The information primarily focuses on its regulatory submission and equivalence to a predicate device. While it mentions various tests conducted, it does not provide detailed acceptance criteria with numerical thresholds or specific performance results in a comparative table format. Therefore, some information requested cannot be fully extracted from the provided text.

Here's the information that can be extracted, and an indication of what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The document mentions that the DSU Dual Stage Ultrafilter "has been tested for performance." However, it does not specify the sample size used for the test set for any of the mentioned tests (Flow Rate, Bicarbonate Composition, Pyrogen Removal, Virus Challenge, Bacteria Challenge, Chemical Compatibility).

The data provenance is also not explicitly stated. It's a regulatory submission to the FDA (USA), implying the testing was conducted by the manufacturer (Nephros Inc. in River Edge, NJ, USA). It does not indicate if the data is retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This device is a physical filter, not an AI/software device that relies on expert interpretation for ground truth. Therefore, this information is not applicable to this type of medical device submission. The performance is assessed through laboratory testing against physical and biological contaminants.

4. Adjudication Method for the Test Set

As this is a physical device with laboratory performance testing, adjudication methods typically used for human interpretation of medical images or data are not applicable. Test results would be objectively measured.

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

This is not applicable as the device is a physical filter, not an AI-assisted diagnostic tool involving human readers.

6. Standalone Performance Study

Yes, the studies mentioned (Flow Rate, Bicarbonate Composition Effect, Pyrogen Removal, Virus Challenge Test, Bacteria Challenge Test, and Chemical Compatibility) represent standalone performance testing of the DSU Dual Stage Ultrafilter. The text states: "The DSU Dual Stage Ultra Filter has been tested for performance." This indicates that the algorithm (in this case, the device's physical mechanism) was evaluated directly without human intervention to complete its primary function.

7. Type of Ground Truth Used

The ground truth for the stated tests would be based on objective laboratory measurements and established scientific standards for water purification and filtration efficacy (e.g., bacterial count reduction, virus removal, pyrogen levels, flow rate consistency). For example, for the "Virus Challenge Test" and "Bacteria Challenge Test," the ground truth would be the known concentration of viruses or bacteria in the input water and the measured concentration in the output water after filtration, adhering to specific test protocols.

8. Sample Size for the Training Set

This information is not applicable as this is a physical medical device, not an AI/machine learning algorithm that requires a training set.

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

This information is not applicable as this is a physical medical device, not an AI/machine learning algorithm.

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The OLpūr™ HD 190 Dialyzer is indicated for hemodialysis and hemodiafiltration of patients with acute or chronic renal failure.

The OLpur"M HD 190 Dialyzer is a sterile, non-pyrogenic, single use, high permeability hemodialyzer intended to be used in providing hemodiafiltration to patients with acute or chronic renal failure. This dialyzer is designed for use only with UF controlled dialysis equipment and is compatible with all models of this generic type of equipment currently in use in the US. The individual dialyzers are packaged in a pouch constructed of Polyamide/Polyethylene film and a Tyvek® backing. The individually packaged dialyzers are packaged twelve to a carton and thirty-six to a shipping container. The dialyzer membranes used in this device consist of polyethersulfone (PES). The hollow fiber membranes are potted in a polyurethane compound at each end within a polycarbonate dialyzer casing to form a tubesheet. A polycarbonate blood inlet header attached to the end of the casing directs the incoming blood into the hollow fibers. The blood then flows through the inside of the hollow fibers and exits out through the polycarbonate blood outlet header attached to the other end of the casing. Inlet and outlet dialysate (Hansen) ports on the dialyzer casing allow for the flow of dialysate around the outside of the hollow fibers counter-current to the blood flow. Uremic toxins and excess plasma water are removed from the blood across the semi-permeable hollow fibers. A combination of diffusion, due to the concentration differences between the blood and dialysate, and convection, due to the transmembrane pressure differential across the hollow fibers, leads to the toxin removal. The spent dialysate exits the device via the dialysate outlet port. As received by the customer, the dialyzer's blood and dialysate ports are covered with polyethylene sterility caps. Silicone o-rings are included in the connections between the headers and the dialyzer tubesheet at each end of the dialyzer to provide a fluid-tight seal between the headers and the tubesheet.

The provided text is a 510(k) summary for the Nephros OLpūr™ HD 190 Dialyzer. It focuses on demonstrating substantial equivalence to predicate devices based on nonclinical testing (biocompatibility, sterility, pyrogenicity, shelf life, and in vitro performance).

Crucially, this document does not contain information about a study proving the device meets acceptance criteria related to a specific performance metric like diagnostic accuracy with human readers or a standalone algorithm performance. It describes a medical device (a dialyzer), not an AI/ML-driven diagnostic or image analysis tool.

Therefore, I cannot fulfill most of your request regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, or MRMC comparative effectiveness, as these concepts are not applicable to the information provided in this 510(k) summary.

However, I can extract information relevant to the device's performance based on the nonclinical testing described:

1. Table of Acceptance Criteria and Reported Device Performance

The rest of the requested information cannot be provided from the given document:

• Sample sizes for test set and data provenance: Not applicable/not provided. The "test set" here refers to the dialyzer units themselves used for nonclinical testing, not patient data for an AI algorithm.
• Number of experts and qualifications for ground truth: Not applicable. Ground truth for a dialyzer involves lab measurements and existing standards, not expert clinical interpretation as would be for an AI diagnostic.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This is for AI-assisted human performance in diagnostic tasks.
• Standalone (algorithm only) performance: Not applicable. This is a medical device, not an algorithm.
• Type of ground truth used: For in vitro performance, the ground truth would be established by controlled laboratory measurements and standard test methods for dialyzers, compared against the specifications or performance of predicate devices. For biocompatibility/sterility/pyrogenicity, it would be based on established international standards and test protocols.
• Sample size for the training set: Not applicable. This is not an AI/ML model.
• How the ground truth for the training set was established: Not applicable.

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