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The Diacap Pro Dialyzer is designed for single use in acute and chronic hemodialysis.

The Diacap Pro dialyzer is a polysulfone high flux dialyzer with the surface areas 1.3 sqm, 1.6 sqm, 1.9 sqm. It is designed for single use in acute and chronic hemodialysis. The dialyzer is gamma sterilized, with a non pyrogenic fluid path, and does not contain natural rubber latex.

This document is a 510(k) summary for the Diacap Pro Dialyzer. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a study with a defined ground truth, a common practice for AI/ML devices. Therefore, a direct response to your request, specifically sections 1-9 as they apply to AI/ML device studies, cannot be fully provided from the given text.

However, I can extract the relevant performance testing that was done and the comparison to the predicate device to illustrate how equivalence was demonstrated for this medical device, which is a key part of its acceptance for market.

Here's a breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a non-AI/ML device, the "acceptance criteria" are generally related to demonstrating substantial equivalence to a predicate device through functional and performance testing, rather than a specific numeric threshold for an AI model's output. The "reported device performance" is a comparison of the proposed device's characteristics and performance to the predicate device.

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

The document mentions "functional and performance testing" and "comparative testing" on "the proposed Diacap Pro dialyzers" and "the proposed and predicate device." It also states "The following in-vitro testing was performed on the proposed device..." and "The following comparative testing was performed on the proposed and predicate device..." and "The following clinical testing was performed on the proposed device..."

However, specific sample sizes for these tests (e.g., number of dialyzers tested for each model) are not explicitly provided in this 510(k) summary. The summary refers to the methods in FDA Guidance and ISO 8637, implying that standard testing protocols were followed, which would include appropriate sample sizes.

Data provenance: Not specified, but likely laboratory testing conducted by the manufacturer or a contracted lab. This is not retrospective or prospective patient data in the context of an AI/ML study, but rather in vitro and in vivo (clinical) testing of the physical device.

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

This concept is not applicable here as this is not an AI/ML device study. Performance is assessed through physical and chemical measurements (e.g., ultrafiltration rate, clearances, pressure drops, hemolysis) and clinical testing, not human expert interpretation of an AI output.

4. Adjudication method for the test set

Not applicable as this is not an AI/ML device study requiring expert adjudication of results.

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. No AI component is described in this device.

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

Not applicable. No AI component is described in this device.

7. The type of ground truth used

For the functional and performance testing, the "ground truth" would be the:

• Physical measurements and chemical analyses: e.g., precisely measured ultrafiltration rates, clearance values, pressure drops, and assessment of hemolysis, according to established scientific and engineering standards (e.g., ISO 8637).
• Clinical data: for in-vivo ultrafiltration coefficient.

This is fundamentally different from a human-labeled ground truth for an AI/ML algorithm.

8. The sample size for the training set

Not applicable. As this is not an AI/ML device, there is no "training set." The device is physically manufactured, not trained.

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

Not applicable. No AI/ML training set.

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The xevonta dialyzer is designed for single use in acute and chronic hemodialysis.

The xevonta dialyzer is a polysulfone high flux dialyzer with the surface areas 1.2 m², 1.5 m2, 1.8 m2, 2.0 m2, 2.3 m2. It is designed for single use in acute and chronic hemodialysis. The dialyzer is gamma sterilized, with a non pyrogenic fluid path, and does not contain natural rubber latex.

The polysulfone hollow fiber (membrane) is housed within a plastic cylinder containing four ports: two ports for blood compartment access and two ports for dialysate access.

This document is a 510(k) premarket notification for the "xevonta dialyzer". It describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to previously marketed predicate devices.

Here's an analysis of the provided information concerning acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table with formal acceptance criteria against which numerical performance metrics are directly compared for the new device. Instead, it states that the testing aimed to demonstrate equivalence with the predicate devices. This implies that the performance of the xevonta dialyzer was expected to be comparable to, or within an acceptable range of, the predicate devices for each tested parameter.

Below is a table summarizing the tested parameters and the general conclusion regarding performance, as direct numerical targets for acceptance criteria are not provided.

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

The document does not specify the exact sample sizes used for the "test set" in any of the described studies (biocompatibility, in vitro performance, clinical testing). It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective.

Given the nature of the device (dialyzer) and the types of tests mentioned, it is highly probable that:

• Biocompatibility testing would have used standard laboratory samples according to ISO 10993.
• In vitro performance testing would involve a set number of dialyzers for each model and surface area, tested under controlled laboratory conditions.
• Clinical testing (comparison of in-vitro and in-vivo ultrafiltration coefficient) would have been performed on a cohort of human subjects undergoing hemodialysis. This would most likely be a prospective study, though its location is not specified.

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

This information is not applicable to the studies described. The "ground truth" concept, often used in AI/ML performance evaluation (e.g., for image interpretation), does not directly apply here. The studies involve objective measurements of physical and chemical properties of the dialyzer and their performance in a clinical setting, rather than subjective interpretations by experts.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the studies involve objective measurements, not subjective evaluations requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging devices or AI systems that assist human readers in making diagnoses. The xevonta dialyzer is a medical device (a high permeability hemodialysis system) for which performance is assessed through biophysical and clinical parameters, not human interpretation of data.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. The xevonta dialyzer is a passive medical device, not an algorithm or AI system. Its performance is inherent in its physical and chemical properties and how it functions during hemodialysis. "Standalone performance" in this context refers to the device's function independent of human interaction beyond its setup and monitoring during use. The in-vitro tests represent this form of standalone performance.

7. Type of Ground Truth Used

The "ground truth" for the performance evaluation comes from:

• Established scientific and regulatory standards: For biocompatibility (ISO 10993-1).
• Instrumental measurements: For in-vitro performance parameters like ultrafiltration rate, pressure drop, and clearances.
• Clinical measurements: For in-vivo ultrafiltration coefficient, which would be measured directly from patients.
• Predicate device performance: The performance of the legally marketed predicate devices provided the benchmark for "substantial equivalence."

8. Sample Size for the Training Set

Not applicable. The xevonta dialyzer is a manufactured medical device, not an AI/ML algorithm that requires a "training set."

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

Not applicable, as there is no training set for this type of device.

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Solcart B Powder Dialysis Concentrate is intended for use in bicarbonate hemodialysis for acute and chronic renal failure, or acute intoxication with dialyzable substances.

Solcart B consists of a powder concentrate used to prepare bicarbonate concentrate solution for use in hemodialysis. Solcart B is a non-refillable polypropylene cartridge containing dry sodium bicarbonate [in compliance with European Pharmacopoeia (Ph. Eur.) and United States Pharmacopoeia (USP)] for hemodialysis. It must be used together with a suitable acid concentrate and water meeting the requirements of the Association for the Advancement of Medical Instrumentation (AAMI). The Solcart B cartridge is designed to fit into cartridge holder adapters affixed to the hemodialysis machine. The 1100g cartridge may only be used with B. Braun hemodialysis machines for which the use of powder bicarbonate cartridges is a stated option and the machine is equipped with a holder for the bicarbonate cartridge.

This document describes the Solcart B Sodium Bicarbonate Powder Dialysis Concentrate, 1100g Cartridge, and its acceptance criteria for market clearance.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for the package/ship tests, performance tests, or stability tests. It generally states that "The proposed device was subjected to package and ship tests" and "performance testing was conducted," and "stability testing conducted."

• Data Provenance: The studies were conducted by B. Braun Avitum AG (Germany) and B. Braun Medical Inc. (USA). The nature of these tests (e.g., in-house testing, third-party validation) typically implies a prospective design for these specific engineering and performance evaluations.

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

This type of information (number and qualifications of experts) is not typically relevant or disclosed for this type of device (sodium bicarbonate powder for hemodialysis). The "ground truth" for this device's performance would be established by objective measurements against predefined chemical, physical, and functional specifications, rather than expert interpretation of complex data like medical images.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Adjudication methods like 2+1 or 3+1 are used for studies involving subjective reader interpretations (e.g., medical imaging). For hardware/material testing of a hemodialysis concentrate, such methods are not applicable. The device performance is assessed through direct physical and chemical measurements.

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 MRMC comparative effectiveness study was conducted or is applicable for this device. This is a material component (sodium bicarbonate powder) for a hemodialysis system, not an AI-powered diagnostic or assistive tool for human readers.

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

This question is not applicable. The device is a physical product (sodium bicarbonate powder cartridge), not an algorithm or software. It does not have a "standalone" or "human-in-the-loop" performance in the context of AI or software.

7. The Type of Ground Truth Used

The ground truth for this device's performance is based on predefined specifications for:

• Chemical composition and purity of sodium bicarbonate.
• Physical properties (e.g., concentration upon dissolution).
• Compatibility with B. Braun hemodialysis machines (functional performance).
• Stability over time.
• Integrity of packaging and shipping.

These specifications would be derived from industry standards (e.g., European Pharmacopoeia, United States Pharmacopoeia, AAMI) and internal product requirements.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" in the context of machine learning or AI involved with this device. Performance is validated through standard engineering and pharmacological testing, not through training an algorithm.

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

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

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The Diacap® Polysulfone HiFlo 23 Hemodialyzer is designed for single use in acute and chronic hemodialysis.

The Diacap® Polysulfone HiFlo 23 Hemodialyzer is a high permeability dialyzer intended to be used in acute and chronic hemodialysis. It is composed of polysulfone hollow fiber capillary membranes in a polycarbonate housing with a polyurethane potting resin and a silicone O-ring. The proposed Diacap HiFlo 23 hemodialyzer will be available in one model, the 23, which represents the effective surface area of 2.3m². The dialyzer is intended for single use and is provided sterile.

The provided text is a 510(k) summary for the B. Braun Avitum AG Diacap Polysulfone HiFlo 23 Hemodialyzer. It focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about specific acceptance criteria, device performance metrics, or a study that quantitatively proves the device meets those criteria in the way typically expected for AI/ML device evaluations.

Instead, the document states:

"Verification and validation testing for the proposed dialyzer have been completed and all acceptance criteria have been met. The testing demonstrated that there are no differences between the predicate and the proposed device that raise new issues of safety or effectiveness."

This indicates that internal testing was conducted, and the results satisfied predefined acceptance criteria. However, the document does not provide a table of these criteria, the reported device performance, or details about the study design that would allow for a comprehensive answer to your request in the context of an AI/ML device.

Therefore, I cannot provide the requested information regarding sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details because this information is not present in the provided document.

The document focuses on the regulatory approval process for a medical device based on substantial equivalence, rather than a detailed scientific study proving performance against specific quantitative metrics for an AI/ML algorithm.

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This dialysis machine can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a physician.

The following types of renal replacement therapy can be carried out with the Dialog+ System:

Hemodialysis (HD) with or without phases of pure ultrafiltration -

• . High flux hemodialysis
• 트 Low flux hemodialysis

The Adimea option to the Dialog* Hemodialysis System provides an alternate means of obtaining effectiveness information on the patient's hemodialysis treatment during a double-needle procedure by continuously measuring the UV absorption in the spent dialysate line. This optional feature includes controlling software, ancillary hardware (a double-beam spectrophotometer) and electronics to operate the Adimea function. Adimea software provides the Kt/V calculation, an online measure of dialysis treatment effectiveness.

This document (K083460) is a 510(k) Premarket Notification for the Dialog+ Hemodialysis System with Adimea Option. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria, study details, or performance data for the Adimea option's ability to measure hemodialysis effectiveness.

The document primarily focuses on establishing substantial equivalence based on the Adimea option being an "alternate means of obtaining effectiveness information" that "does not have a significant affect upon the fundamental technology" of the Dialog+ System. It mentions "Software requirements specifications for Adimea have been met and verification and validation testing is complete," but does not provide any details about these tests, the acceptance criteria used, or the results.

Therefore, based solely on the provided text, I cannot fill out the requested table and answer the study-related questions for the Adimea option's performance. The information required for those sections is typically found in a separate performance study report or verification and validation documentation, which is not included in this 510(k) summary.

Here's what I can extract from the provided text, and where I identify missing information:

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

• Acceptance Criteria: Not provided in this document. The document states "Software requirements specifications for Adimea have been met," implying criteria existed, but they are not detailed.
• Reported Device Performance: Not provided in this document. The document states "verification and validation testing is complete," but no performance results are presented.

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 provided.
• Data Provenance: Not provided.

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

• Not Applicable / Not provided. The Adimea option measures UV absorption for Kt/V calculation, which is a quantitative measurement, not typically relying on expert interpretation for ground truth establishment in this context. If "ground truth" refers to the accuracy of the Kt/V calculation against a gold standard, that information is missing.

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

• Not Applicable / Not provided. Adjudication methods are typically used for subjective assessments or when multiple human readers interpret data. This device performs automated measurements.

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, an MRMC study was not described or implied. The Adimea option is described as an "alternate means of obtaining effectiveness information," implying it provides direct measurements rather than assisting human readers in interpreting clinical images or data.

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

• Yes, implied. The description of the Adimea option suggests it operates as a "discreet component / function" that "continuously measuring the UV absorption" and provides a "Kt/V calculation." This indicates a standalone algorithmic function. However, no performance data for this standalone operation is presented.

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

• Not explicitly stated, but likely a reference method for Kt/V. For a device measuring Kt/V, the "ground truth" would typically be established by a well-accepted, highly accurate reference method for measuring dialysis adequacy (e.g., blood urea nitrogen sampling and calculation, or comparison to an established device known to be accurate). This is not detailed in the document.

8. The sample size for the training set

• Not applicable / Not provided. While the Adimea option includes "controlling software," it is not described as a machine learning or AI algorithm that requires a "training set" in the typical sense. It appears to be based on spectral analysis and calculation. If there was any calibration or model development data, it's not referred to as a "training set" here and its size is not provided.

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

• Not applicable / Not provided. (See point 8).

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