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Bicarby™ Dialysate solutions are indicated for use as a dialysis fluid for adult patients in acute care settings, requiring Kidney Replacement Therapies (KRT).

Ci-Ca Dialysate solutions are indicated for use as a dialysis fluid for adult patients in acute care settings, requiring Kidney Replacement Therapies (KRT).

The Bicarby and Ci-Ca solutions are single-use, sterile, ready-to-use dialysis solutions consisting of sodium chloride, potassium chloride, magnesium chloride, calcium chloride (select solutions), sodium bicarbonate, and glucose. The calcium-containing solutions are available in five (5) formulations, while the calcium-free solutions are available in three (3) formulations. The Bicarby and Ci-Ca solutions are single-use, steam sterilized dialysis solutions for use in Kidney Replacement Therapy (KRT). The solutions are each provided in a 2-compartment bag. One compartment contains 4.75 L of a slightly alkaline bicarbonate solution and the other compartment contains 0.25 L of an acidic electrolyte, glucose solution. The 2 solutions are mixed before use by opening the peel seam between the compartments, yielding 5 L of a ready-to-use sterile solution. The dialysate bags are made of a gas barrier foil, a material manufactured without PVC, latex, or plasticizer. The calcium-containing solutions are designed for modalities using heparin anticoagulation, while the calcium-free solutions are intended for modalities using regional citrate anticoagulation (RCA). The calcium-free solutions sustain the anticoagulatory effect of citrate in the filter. Therefore, a separate infusion of calcium is mandatory when using these solutions.

The provided FDA 510(k) clearance letter (K243786) is for Bicarby and Ci-Ca Dialysate solutions, which are dialysis fluids. This type of device is classified as a Class II medical device (Hemodialysis system and accessories, product code KPO).

The provided documentation describes the acceptance criteria and supporting studies for these dialysate solutions, not for a software algorithm or AI-powered medical device that would have performance metrics like sensitivity, specificity, or AUC. The studies conducted are primarily focused on the physical, chemical, and biological safety and performance of the solution and its container system, rather than an AI device's diagnostic or predictive capabilities.

Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth types, training set sample size, ground truth for training set) are not applicable to this type of device and the information provided in the 510(k) summary.

Below is a summary of the available information relevant to acceptance criteria and supporting studies for the Bicarby and Ci-Ca Dialysate solutions:

Acceptance Criteria and Device Performance (Not Applicable in the traditional sense for an AI device)

For this type of device (dialysis solutions), "acceptance criteria" relate to meeting specifications for chemical composition, sterility, packaging integrity, and biocompatibility rather than diagnostic performance metrics. The document details the key performance specifications for the chemical components.

Table of Acceptance Criteria (Key Performance Specifications) and Reported Device Performance

Note: The document states these are the "Key Performance Specifications," meaning the solutions are manufactured to these specific ionic contributions. The "Reported Device Performance" is implied to meet these specifications as part of the manufacturing and quality control process, which are regulated under GMP but specific quantified "performance" results are not provided in this 510(k) summary.

Study Information (as applicable to a dialysis solution):

A. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
* Not Applicable in the context of an AI device's test set. The studies conducted are primarily engineering, chemical, and biological evaluations, not data-driven performance assessments.
* For Biocompatibility, "testing was conducted to evaluate the material changes in accordance with ISO 10993-1:2018 and FDA guidance document...". This implies lab-based testing.
* For Human Factors Validation Testing, it was stated that "The Bicarby and Ci-Ca solutions were found to be safe and effective for their intended users, uses, and use environments." The sample size for this human factors study is not provided in the summary.

B. 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. No "ground truth" establishment by medical experts for a test set of images/data is relevant here. The ground truth for chemical composition is defined by the formula and analytical testing. Biocompatibility experts would assess the results of the specific biological tests.

C. Adjudication method (e.g. 2+1, 3+1, none) for the test set
* Not Applicable. This concept is for clinical or diagnostic studies involving human readers, not for chemical solutions or their packaging.

D. 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. This is a dialysis solution, not an AI diagnostic system.

E. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
* Not Applicable. This is a medical device (dialysate solution), not an algorithm.

F. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
* For chemical composition: Defined chemical formula and analytical testing standards.
* For physical properties (e.g., shipping, connector integrity): Engineering specifications and test standards.
* For biocompatibility: Reference to international standards (ISO 10993-1:2018) and established biological endpoints (Cytotoxicity, Sensitization, Irritation, Material Mediated Pyrogenicity, Hemocompatibility, Genotoxicity) with a toxicological risk assessment.

G. The sample size for the training set
* Not Applicable. This is a manufactured product, not a machine learning model.

H. How the ground truth for the training set was established
* Not Applicable. This is a manufactured product, not a machine learning model.

Summary of Performance Data Conducted:

The device's substantial equivalence to predicate devices was supported by the following performance data:

1. Shipping and Distribution Testing: Demonstrated "the integrity and robustness of the bag system packaging within the distribution environment."
2. HF-Connector Testing:
   • Evaluated torque for removing protective cap and male/female connector torque.
   • Evaluated breaking strength of the cone.
   • Evaluated leakage and tightness of connectors.
   • Evaluated pull-out force of connectors and injection ports.
3. Biocompatibility Testing: Conducted in accordance with ISO 10993-1:2018 and FDA guidance. Assessed endpoints including Chemical Characterization, Cytotoxicity, Sensitization, Irritation, Material Mediated Pyrogenicity, Hemocompatibility, and Genotoxicity. A toxicological risk assessment was also performed. These tests confirm the safety of the materials used in the container closure system.
4. Human Factors Validation Testing: Concluded the solutions were "safe and effective for their intended users, uses, and use environments."
5. Not Applicable for this device type: Electrical Safety and Electromagnetic Compatibility (EMC), Software Verification and Validation Testing, Animal Studies, Clinical Studies.

Conclusion:

The 510(k) summary concludes that the Bicarby and Ci-Ca solutions are substantially equivalent to the predicate devices and are safe and effective for their intended use, based on the non-clinical performance testing summarized above, primarily focusing on materials, packaging integrity, and chemical specifications.

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The HemoCare Bicarbonate Concentrate Set (BCS) is indicated for use in the preparation of dialysate in a 3-stream proportioning hemodialysis machine with a compatible mechanical interface, such as the HemoCare Hemodialysis System. The BCS is intended for extracorporeal bicarbonate hemodialysis for chronic renal failure, according to a physician's prescription.

The HemoCare Bicarbonate Concentrate Set (BCS) is the Subject Device of this submission. It consists of powdered sodium bicarbonate in a single use cartridge with an integrated tubing assembly for interfacing with hemodialysis systems with compatible three-stream proportioning connector ports such as the HemoCare Hemodialysis System. The HemoCare System uses the bicarbonate concentrate in 3-stream, 45x proportioning to generate dialysate for bicarbonate hemodialysis therapy.

This document is a 510(k) summary for the HemoCare Bicarbonate Concentrate Set (BCS). It outlines the device, its intended use, comparison to a predicate device, and performance data. However, it does not describe a study involving an AI/Machine Learning (ML) device.

Therefore, I cannot provide information on acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details as they pertain to an AI/ML device.

The document focuses on the HemoCare Bicarbonate Concentrate Set, which is a medical accessory for hemodialysis, and its performance data relates to biocompatibility and bench testing to verify specified performance, not the performance of an AI/ML algorithm.

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pureFLOW solutions are indicated for use as a dialysate in Continuous Renal Replacement Therapy.

pureFLOW solutions are single-use, sterile, ready-to-use dialysis solutions consisting of sodium chloride, potassium chloride, magnesium chloride, sodium bicarbonate, and glucose. The pureFLOW dialysis are available in four (4) formulations which differ in potassium chloride concentration.

The provided text does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/human reader study or standalone AI performance.

The document is a 510(k) summary for a medical device called "pureFLOW" solutions, which are dialysate solutions used in Continuous Renal Replacement Therapy (CRRT). The entire summary focuses on demonstrating substantial equivalence of the new pureFLOW solutions (manufactured in Mexico) to a predicate pureFLOW device (manufactured in Germany).

The performance data section (1.8 Performance Data) does detail various tests conducted to support substantial equivalence. However, these are engineering and chemical tests related to the physical properties and stability of the product and its packaging, not diagnostic performance of an AI or human readers.

Specifically, the "Performance Data" section discusses:

• 5 L Bag Hanging: Stability of eyelets.
• Shipping and Distribution: Integrity and robustness of packaging.
• Injection Port: Integrity and penetration force of septum and injection port.
• Temperature and Pressure Resistance: Performance of the bag under varying temperature and pressure.
• Gas Barrier: Integrity of the bag as a CO2 barrier.
• Biocompatibility Testing: Chemical characterization, cytotoxicity, sensitization, irritation, material mediated pyrogenicity, hemocompatibility, genotoxicity.
• Human Factors Validation Testing: Found safe and effective for intended users, uses, and environments (no specific details on methodology or metrics provided in this summary).
• Electrical Safety and Electromagnetic Compatibility (EMC): Not applicable.
• Software Verification and Validation Testing: Not applicable.
• Animal Studies: None performed.
• Clinical Studies: None performed.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving a device meets them in the context of AI performance, human reader performance, MRMC studies, or related ground truth establishment, as this information is not present in the provided document. The device in question is a medical solution, not a software device that would involve such studies.

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NxStage PureFlow Solution is indicated for use with NxStage renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis for chronic care patients.

The NxStage PureFlow Solution is a family of premixed dialysate solution formulations which are sterile, non-pyrogenic, fully constituted dialysate solutions provided in 5L single use flexible bags.

The provided text describes the 510(k) premarket notification for the NxStage PureFlow Solution, a pre-mixed dialysate for hemodialysis. However, the document does not contain information about a study involving an AI/Machine Learning device or a Multi-Reader Multi-Case (MRMC) comparative effectiveness study.

The document discusses performance testing for the NxStage PureFlow Solution, which is a physical medical device (a liquid solution in a bag), not a software or AI-driven diagnostic device. Therefore, the acceptance criteria and study details requested in the prompt (e.g., sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance) are not applicable to the content of this document.

The performance data mentioned in the document for the NxStage PureFlow Solution are related to:

• Analytical testing: per device specifications and applicable sections of USP and EP.
• Physical testing of container (bag): per device specifications.
• Container closure integrity testing: per ISO 11607-1.
• Temperature excursion testing: per device specifications.
• Stability/Shelf-life testing: per ICH Q1A to support a 24-month shelf life.
• Ship testing: per ASTM D4169-22.
• Biocompatibility testing: in accordance with ISO 10993-1 and FDA guidance, including chemical characterization, toxicological risk assessment, cytotoxicity, sensitization, irritation, pyrogenicity, hemocompatibility, and systemic toxicity.
• Human Factors Validation Testing: in accordance with FDA guidance and AAMI/ANSI/EC 62366-1.
• Electrical Safety and EMC: Not Applicable (the device has no electronic features).
• Software Verification and Validation Testing: Not Applicable (the device has no software features).
• Animal Studies: Not Applicable.
• Clinical Studies: Not Applicable.

The conclusion states that "Verification and validation was conducted to characterize the proposed device and the predetermined acceptance criteria were met." However, the document does not enumerate specific quantitative acceptance criteria or the specific performance metrics achieved in these tests, only the types of tests conducted.

Therefore, I cannot provide the requested information about AI acceptance criteria and study details based on the provided document.

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pureFLOW solutions are indicated for use as a dialysate in Continuous Renal Replacement Therapy.

The pureFLOW solutions are single-use, sterile, ready-to-use dialysis solutions consisting of sodium chloride, potassium chloride, magnesium chloride, calcium chloride (400 series only), sodium bicarbonate, and glucose. The pureFLOW dialysis solutions containing calcium are available in four (4) formulations which differ in potassium chloride concentration. The calcium-free pureFLOW dialysis solutions are available in two (2) formulations which differ in potassium chloride concentration. pureFLOW solutions are single-use, steam sterilized dialysis solutions for use in Continuous Renal Replacement Therapy (CRRT). The pureFLOW solutions are each provided in a 2-compartment bag. One compartment contains 4.75 L of a slightly alkaline bicarbonate solution and the other compartment contains 0.25 L of an acidic electrolyte, glucose solution. The 2 solutions are mixed before use by opening the peel seam between the compartments, yielding 5 L of a ready-to-use sterile solution. The dialysate bags are made of a gas barrier foil, a material manufactured without PVC, latex, or plasticizer. The calcium-containing pureFLOW 400 series solutions are used for treatment modalities using heparin anticoagulation while the calcium-free pureFLOW 500 series solutions are used for treatment modalities using regional citrate anticoagulation.

The provided document, K233159, is an FDA 510(k) summary for the pureFLOW dialysis solutions. This document primarily describes the device, its intended use, and the performance testing conducted to demonstrate substantial equivalence to a predicate device. It does not contain information related to software-based AI/ML device performance or clinical studies using human readers.

Therefore, I cannot fulfill most of the requested points as the information is not present in the provided text. The document explicitly states:

• 5.8.4. Software Verification and Validation Testing: "Not applicable. The pureFLOW solutions do not contain software."
• 5.8.6. Clinical Studies: "No clinical studies were performed."

Given this, there is no information on:

• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Acceptance criteria for AI/ML performance.
• Study design for AI/ML performance, including sample sizes, data provenance, expert qualifications, or adjudication methods for ground truth.
• Effect size of human reader improvement with AI assistance.
• Training set details for AI/ML models.

However, I can extract information regarding the general performance testing and the context of the device:

Device: pureFLOW dialysis solutions (pureFLOW 402, 400, 406, 401, 502, 504)
Intended Use: As a dialysate in Continuous Renal Replacement Therapy (CRRT).

Here's what can be extracted:

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

Based on the provided document, the "performance" is demonstrated through various physical, chemical, and biological tests to ensure the product's quality, safety, and functionality as a sterile dialysis solution and its container system. The document lists "Key Performance Specifications/Characteristics" for the chemical components of the solutions. It also details the various "Performance Testing" conducted. While these are not acceptance criteria in the sense of AI/ML metrics (like sensitivity, specificity), they are the performance criteria for this physical device.

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

• The document does not specify exact sample sizes for each of the performance tests (e.g., how many bags were tested for hanging, welding, etc.).
• Data provenance (country of origin, retrospective/prospective) is not applicable or provided, as these are primarily laboratory/engineering tests on manufactured product, not clinical data sets.

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 as the device is not an AI/ML product for which expert-annotated ground truth is required. Performance is demonstrated through physical, chemical, and biological testing.

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

• Not applicable for the reasons stated above.

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. The document explicitly states: "No clinical studies were performed." and "The pureFLOW solutions do not contain software." Therefore, no MRMC study was conducted, and this question is not relevant to the described device.

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

• No. The device does not contain software or an algorithm.

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

• For this type of medical device (physical product, dialysate solution), "ground truth" is established by adherence to predefined engineering specifications, chemical composition limits, sterility requirements, and biocompatibility standards, validated through laboratory testing, rather than clinical outcomes or expert consensus on diagnostic images.

8. The sample size for the training set:

• Not applicable. The device does not involve a "training set" in the context of AI/ML.

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

• Not applicable.

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For LC+100 Series: This acid concentrate is formulated for use in acute and chronic hemodialysis, and is to be used in conjunction with Nipro MedicaLyte™ bicarbonate concentrate, or an equivalent bicarbonate concentrate of the same composition, in a 36.83X proportioning three-stream hemodialysis machine.

For LC+200 Series: This acid concentrate is formulated for use in acute and chronic hemodialysis, and is to be used in conjunction with Nipro MedicaLyte™ bicarbonate concentrate, or an equivalent bicarbonate concentrate of the same composition, in a 45X proportioning three-stream hemodialysis machine.

The Citric Complete™ Liquid Citric Acid Concentrate products are single-use, non-sterile devices intended for use in hemodialysis therapy for acute and chronic renal failure. These products are designed to be used as one (1) component in the preparation of dialysate in a three (3)-stream proportioning hemodialysis machine according to a physician's prescription.

The subject devices are formulated to be compatible with 36.83X proportioning (proposed LC+100 series devices), as well as 45X proportioning (proposed LC+200 series devices) hemodialysis machines, in which bicarbonate concentrate is proportioned into one stream, this Citric Complete™ Liquid Acid Concentrate is proportioned into a second stream, and RO water is proportioned into third stream. These three streams are then mixed by the hemodialysis machine in distinctly specific ratios to prepared hemodialysis solution, or final dialysate.

The Citric Complete™ Liquid Citric Acid Concentrate products are comprised of:
USP grade sodium chloride,
USP grade magnesium chloride,
USP grade calcium chloride,
USP grade potassium chloride,
USP grade dextrose, and
USP grade citric acid.

The final dialysate solution is pumped to the dialysis system, known as the dialyzer or hemodialyzer, through which the patient's blood also flows in the opposite direction. The dialysate is separated from the patient's blood by semi-permeable membranes in the hemodialyzer, which passage of waste and toxins from the circulating blood into the hemodialysis solution. The used dialysate is disposed, while the patient blood is recirculated back into the patient with acute and end-stage renal failure can effectively have their blood filtered of wastes and toxins without the proper functioning of his or her kidneys.

The provided text describes a medical device called "Citric Complete™ Liquid Citric Acid Concentrate" and its FDA 510(k) clearance (K223431). However, the document is a 510(k) summary and does not contain detailed information about specific acceptance criteria and a study proving those criteria are met for AI/ML devices.

The document states:
"Internal verification and validation testing confirms that the Citric Acid Concentrate meets specifications equivalent in design and technological characteristics to the predicate devices. The subject device complies with all applicable voluntary consensus standards for performance, package integrity and biocompatibility. There are no significant differences with respect to any of the above presented predicate devices, and therefore a finding of substantial equivalence is deemed appropriate for the proposed Citric Complete™ Liquid Citric Acid Concentrate."

And:
"Testing was accomplished by formulating the dialysis liquid concentrate pursuant to the instructions on the device labels and measuring the concentrations of all components to ensure that by following the label instructions, end users can generate a final dialysate consistent with the values as specified on the Citric Acid Concentrate label. All testing was conducted pursuant to ANSI/AAMI/ISO 23500-4:2019. All requirements were met. All samples from all batches of each device tested were within acceptable limits for that product, as set by ANSI/AAMI/ISO 23500-4:2019."

This indicates that the device is a liquid concentrate, not an AI/ML powered device. The "acceptance criteria" and "study" described are chemical and performance specifications for the concentrate itself, and the study involves chemical analysis to ensure the concentrate produces a final dialysate consistent with specifications.

Therefore, most of the information requested in your prompt (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth types, training set size) is not applicable to this type of device and is not present in the provided text.

Based on the available information from the text, here's what can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated, but implied to be "All samples from all batches of each device tested". This suggests multiple batches and multiple samples per batch were tested. The exact number of samples is not provided.
• Data Provenance: The testing was "internal verification and validation testing" conducted by the manufacturer, Nipro Renal Solutions USA, Corp. The country of origin of the data is not specified beyond being generated internally by this US-based company. The study is prospective, as it involves testing newly manufactured product batches.

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

• Not applicable. The ground truth is based on chemical specifications (target concentrations of components in the final dialysate) and compliance with international standards (ANSI/AAMI/ISO 23500-4:2019), not expert interpretation of data.

4. Adjudication method for the test set:

• Not applicable. The "ground truth" is determined by established chemical specifications and compliance with standards, not discretionary human judgment 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. This is not an AI/ML device, nor does it involve human readers or image interpretation.

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

• Not applicable. This is not an AI/ML device.

7. The type of ground truth used:

• Chemical specifications (target concentrations of active ingredients in the final dialysate) and compliance with established international standards (ANSI/AAMI/ISO 23500-4:2019).

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable.

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The NikkiCart cartridge is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute renal failure, chronic renal failure, or acute intoxication with dialyzable substances. The NikkiCart cartridge is intended to be used as one component in the preparation of dialysate according to a physician's prescription in a 3-stream proportioning machine on the Nikkiso DBB-06 dialysis system equipped with a compatible bicarbonate cartridge holder.

The NikkiCart is a single use polypropylene (PP) cartridge containing dry sodium bicarbonate powder, which enables on-line preparation of saturated Sodium Bicarbonate solution that, in conjunction with appropriate acid concentrate solution and dialysis water, creates a bicarbonate -based dialysis fluid that meets the Association for the Advancement of Medical Instrumentation (AAMI) guidelines.

When the NikkiCart is attached to the Nikkiso DBB-06 dialysis machine with a compatible bicarbonate cartridge holder, water is drawn by the dialysis machine through the cartridge, producing a saturated solution of sodium bicarbonate. The dialysis machine mixes the sodium bicarbonate solution with water and the acid concentrate to produce a bicarbonate-based dialysis fluid. The acid concentrate must have a dilution ratio of 1:44 also known as 45X to be used with the NikkiCart Sodium Bicarbonate cartridge.

The provided text does not contain typical acceptance criteria and study details for an AI-medical device in the format requested. Instead, it describes a 510(k) submission for a medical device called "Nikkicart," which is a single-use polypropylene cartridge containing dry sodium bicarbonate powder for hemodialysis. The submission focuses on demonstrating substantial equivalence to a predicate device (GAMBRO BiCart®) by comparing their characteristics and performance data.

Therefore, many of the requested fields cannot be directly extracted from the provided document. However, I can summarize the performance data that was presented to support the safety and effectiveness of the Nikkicart, which can be seen as meeting the criteria for device functionality and safety.

Here's a breakdown of the available information:

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

The document doesn't explicitly list "acceptance criteria" in a quantitative sense as might be typical for AI performance. Instead, it details various performance data categories that were assessed to support the device's safety and effectiveness and its substantial equivalence to the predicate. The "reported device performance" is a statement that these tests were conducted and their results support the claims.

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 does not specify sample sizes for the various tests (e.g., how many cartridges were tested for stability or biocompatibility). It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective, although stability and shipping tests imply a prospective element.

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 applicable and not provided. The Nikkicart is a hardware and chemical product, not an AI-driven diagnostic device requiring expert interpretation for ground truth establishment. The "ground truth" for this device would be established by laboratory measurements and chemical analyses, not expert consensus on medical images or patient data.

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

This information is not applicable and not provided, as the device doesn't involve subjective interpretation that would necessitate an adjudication method.

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 was not done. This is not an AI-assisted device, and the concept of human readers improving with AI assistance is not relevant to this product.

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

This is not applicable as the device is not an algorithm. Performance tests were conducted on the physical cartridge and its components.

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

The "ground truth" for this device's performance is based on laboratory measurements, chemical analysis, physical testing, and established standards (e.g., AAMI guidelines for dialysate fluid, USP & European Pharmacopeia for sodium bicarbonate grade, ASTM D4169-16 for shipping).

8. The sample size for the training set

This is not applicable. The Nikkicart is not an AI/ML device that requires a "training set."

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 medical device.

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The Di-Chem Inc. Hemo-Lyte C cartridge is indicated for use in bicarbonate hemodialysis for acute and chronic renal failure, or intoxication with dialyzable substances.

The Di-Chem Hemo-Lyte C sodium bicarbonate cartridge for hemodialysis is a dry powder concentrate used to prepare sodium bicarbonate concentrate solution for use in conventional hemodialysis. The Hemo-Lyte C cartridge is a single use/non-refillable polypropylene cartridge containing a measured amount of sodium bicarbonate (USP Hemodialysis grade) which enables the online preparation of bicarbonate hemodialysis solution on commercially available hemodialysis machines/monitors equipped for use with bicarbonate cartridges.

The provided text describes a 510(k) premarket notification for the Di-Chem Hemo-Lyte C Cartridge, a dry powder sodium bicarbonate concentrate for hemodialysis. The submission demonstrates substantial equivalence to predicate devices through non-clinical testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

It appears there are multiple test sets for different aspects of the device.

• In vitro Chemical Composition: The sample size for this specific test is not explicitly stated. The text mentions "Testing was performed in accordance with our standard operating procedures utilizing validated equipment and analytical methods." The data provenance is internal testing by Di-Chem, Inc. (retrospective).
• Transportation Testing: The sample size is not explicitly stated, but it was performed on "the proposed Hemo-Lyte C cartridge." Data provenance is internal testing by Di-Chem, Inc. (retrospective).
• Biocompatibility Testing: The sample size for each specific ISO 10993 test is not detailed. Data provenance is internal testing by Di-Chem, Inc. (retrospective).
• Shelf-Life Verification: The sample size is not explicitly stated, but it involved "aged product." Data provenance is internal testing by Di-Chem, Inc. (retrospective).
• Bench Testing (Nipro SURDIAL DX compatibility): "12 total cartridges consisting of 3 samples from each of the proposed weight sizes were tested." This would be (3 samples/weight size * 5 weight sizes) = 15 cartridges, not 12, or 12 cartridges distributed among the weight sizes. The text says "3 samples from each of the proposed weight sizes were tested" and later "12 total cartridges". It is unclear if these are referring to the same thing, or if 12 are a subset of the 15. Assuming it refers to the 12 total, the provenance is internal testing by Di-Chem, Inc. (retrospective).
• Endotoxin Analysis: "60 total test samples comprised of three different lots of sodium bicarbonate. 30 samples from the pre-stability performance testing and 30 samples from the conclusion of the shelf-life study were tested." Data provenance is internal testing by Di-Chem, Inc. (retrospective).

The data provenance for all tests is from internal testing conducted by Di-Chem, Inc. and is retrospective in nature, as it refers to performance testing completed before the 510(k) submission. No specific country of origin for the data is mentioned beyond the manufacturing company's location in the US.

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

The concept of "experts" and "ground truth" in the traditional sense (e.g., medical diagnoses for AI algorithms) does not directly apply here. This is a medical device for preparing a dialysate solution, and the "ground truth" is defined by established engineering and chemical standards (ANSI/AAMI 13958:2014, ASTM D4169-16, ISO 10993). The "experts" would be the engineers, chemists, and quality control personnel within Di-Chem, Inc. responsible for conducting and interpreting the tests according to these standards, but their specific number and qualifications (e.g., "radiologist with 10 years of experience") are not detailed.

4. Adjudication Method for the Test Set

Not applicable for this type of device and testing. Adjudication (e.g., 2+1, 3+1) is typically used in clinical studies involving multiple human readers to establish a reconciled ground truth for diagnostic accuracy, which is not the nature of these non-clinical, bench, and chemical tests. The results are compared against defined numerical specifications from recognized standards.

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

No, an MRMC comparative effectiveness study was not done. This type of study would be relevant for diagnostic imaging devices where human readers interpret results, and it is not applicable to a hemodialysis cartridge that involves chemical and physical performance verification.

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

This question is not applicable. The Hemo-Lyte C Cartridge is a physical medical device, not an AI algorithm. Its performance is inherent to its physical and chemical properties and interaction with a hemodialysis machine.

7. The Type of Ground Truth Used

The ground truth for all performance tests is based on established regulatory and industry standards, specifically:

• ANSI/AAMI 13958:2014 (Concentrates for Hemodialysis and Related Therapies) for chemical composition, shelf-life, and endotoxin limits.
• ASTM D4169-16 (Standard Practice for Performance Testing of Shipping Containers and Systems) for transportation durability.
• ISO 10993 (Biological evaluation of medical devices) for biocompatibility.

These standards define the acceptable range and performance characteristics of such devices.

8. The Sample Size for the Training Set

This question is not applicable. Training sets are relevant for machine learning algorithms. The Hemo-Lyte C Cartridge is a physical device, and its development and verification rely on traditional engineering and chemical testing, not machine learning or AI models that require training data.

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

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

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Citrasate® Liquid Acid Concentrate is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure. Citrasate® Liquid Acid Concentrate is intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine to a physician's prescription.

NaturaLyte® Liquid Acid Concentrate is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure. NaturaLyte® Liquid Acid Concentrate is intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine to a physician's prescription.

Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate products are single-use, non-sterile devices intended for use in hemodialysis therapy for acute and chronic renal failure. Both products consist of electrolytes (chloride salts of sodium, calcium, magnesium, and potassium), dextrose, and an organic acid source (citric acid in Citrasate and acetic acid in NaturaLyte). Citrasate also contains sodium acetate as a secondary pH adjuster.

All formulation components are mixed in a single solution with dialysis quality water and provided to the customer ready for use.

Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are each intended to be used as one (1) component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician's prescription. Both concentrates are formulated for use in 45X proportioning systems which proportion a nominal ratio of 1 : 1.72 : 42.28 (acid : bicarbonate : water) to generate dialysate. The dialysate is intended to be pumped through a dialyzer, creating an osmotic gradient across the dialyzer membrane to exchange solutes with blood during hemodialysis.

The proposed Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate 1-gallon bottles have a modified cap design with alternate raw materials. The proposed bottle cap is composed of high density polyethylene (HDPE). The tamper-evident cap has a grooved ring pull tab intended to provide a thread lock. Due to the difference in cap design, the bottle threads are modified to match the threads and dimensions of the proposed cap. Dimensional changes are limited to the threads and bottle termination area only and do not affect the main bottle dimensions. There is no change in wall thickness or material used to manufacture the Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate 1-gallon bottles.

This document, K212620, is a 510(k) premarket notification for Citrasate® Liquid Acid Concentrate and NaturaLyte® Liquid Acid Concentrate. These are liquid acid concentrates used in hemodialysis. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices (K192017) after a modification to the bottle cap design.

It is important to note that this document does not describe a study involving device performance for diagnostic accuracy, classification, or prediction, as would typically be seen for AI/ML devices. Instead, the "device" in this context refers to a medical consumable (liquid concentrates) and its packaging. Therefore, many of the requested criteria, which are geared towards evaluating the performance of AI/ML or diagnostic devices, are not applicable.

Here's an assessment based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the device (liquid concentrates with a packaging change), the "acceptance criteria" and "performance" are focused on safety, functionality, and manufacturing quality, not diagnostic accuracy.

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

• Sample Size for Test Set: Not explicitly stated in terms of number of units tested for each criterion. The testing would involve a representative sample of the modified bottles/caps and the liquid concentrates. The document refers to "Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate products" and "bottles" as the test subjects.
• Data Provenance: The studies were conducted by Fresenius Medical Care Renal Therapies Group, LLC, presumably within their R&D and quality control processes. No information is provided about the country of origin of the data or if it was retrospective or prospective, though it would be prospective for this type of verification.

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

• Experts and Qualifications: Not applicable in the context of this type of device. The "ground truth" here is adherence to recognized standards (e.g., ISO, ASTM, FDA guidance) and internal specifications, verified through laboratory testing and engineering assessments. The experts involved would be qualified engineers, chemists, and toxicologists conducting the testing and analysis according to their respective disciplines.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The "ground truth" is determined by objective measurements against predefined specifications and standards, not through consensus of human readers or adjudicators.

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

• MRMC Study: No, an MRMC study was not done. This type of study is relevant for diagnostic or AI-assisted interpretation devices, which is not what this submission is for.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: Not applicable. This device is a medical consumable, not an algorithm or AI system.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for this submission is based on:
  • Adherence to recognized standards: ASTM D4169-16 for shipping, ISO 10993-1:2018 for biocompatibility, FDA guidance for human factors.
  • Established product specifications: For chemical composition, shelf life, and functional performance (e.g., cap sealing integrity not impacting concentrate stability).
  • Substantial equivalence to predicate: Demonstrated by confirming that the modified device characteristics do not raise new questions of safety or effectiveness compared to the previously cleared predicate device.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device does not involve machine learning algorithms that require a training set.

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no training set.

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