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Hemodialysis with Althin capillary dialyzers are indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.

The A-22 Hemodialyzer is a high permeability hemodialyzer that is used as an artificial kidney in a hemodialysis system to treat patients with acute or chronic renal failure. The blood from a patient flows through the arterial tubing of the extracorporeal blood circuit to the blood compartment of the hemodialyzer, then returns through the venous tubing of the extracorporeal blood system to the patient. The hemodialyzer has semipermeable hollow fibers which divide the device into two compartments. When the blood passes through the hollow fibers, water and toxic waste products from the blood pass through the semipermeable membrane into the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the hemodialyzer. A high permeability hemodialyzer has a semipermeable membrane that is more permeable to water than that of the conventional dialyzer. This device must be used in conjunction with a controlled dialysate delivery system that incorporates an ultrafiltration controller to prevent excessive loss of water from the patient's blood. This highly permeable, semipermeable membrane may also permit greater loss of high molecular weight substances from the blood, compared with the conventional hemodialyzer. Each A-22 Hemodialyzer is packaged in a plastic bag and 20 hemodialyzers are packed in a cardboard box. It is sterilized by gamma radiation and intended, and labeled, for single use only.

The Althin medical device, A-22 Hemodialyzer, does not have clear, distinct acceptance criteria and reported device performance values laid out in a table format within the provided text. The document states that "Functional testing has been conducted to evaluate the functional performance of the A-22 Hemodialyzer. Testing was based on the specification cleared for the predicate device and test results showed significant equivalence. Moreover, the results of the functional testing attest that the A-22 Hemodialyzer conforms to its specifications and has demonstrated that it is suitable for its intended use."

However, specific numerical acceptance criteria or performance metrics for clearance or ultrafiltration, for example, are not detailed in the summary. The core of the submission relies on demonstrating substantial equivalence to a legally marketed predicate device (Altra Nova 200 Hemodialyzer, K926379), rather than meeting a pre-defined set of quantitative acceptance criteria for de novo approval.

Therefore, I cannot generate the table as requested with distinct acceptance criteria and reported performance values.

Here's what can be extracted and inferred based on the provided text for the other requested information:

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

As explained above, specific numerical acceptance criteria and reported device performance values are not explicitly provided in the submitted text. The basis of the submission is "substantial equivalence" to a predicate device. The general statement is: "Testing was based on the specification cleared for the predicate device and test results showed significant equivalence."

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

• Sample Size for Test Set: Not explicitly stated. The text mentions "functional testing" and "biocompatibility testing" but does not give the number of devices or data points used in these tests.
• Data Provenance: Not explicitly stated. Given the company is "Althin Medical AB" in Sweden, it is reasonable to infer the testing was conducted internally or outsourced within a similar region. The text does not specify if the studies were retrospective or prospective, but functional and biocompatibility testing for a new device are typically prospective.

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

This is not applicable as the evaluation is for a physical medical device (hemodialyzer) based on functional and biocompatibility testing, not on interpretation of data requiring expert radiographic or clinical review.

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

This is not applicable for the same reason as point 3.

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 is not applicable. This is a submission for a physical medical device (hemodialyzer), 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 is not applicable. This is a submission for a physical medical device, not an algorithm.

7. The type of ground truth used:

The "ground truth" for the device's performance is established through:

• Functional Testing: Demonstrating the A-22 Hemodialyzer conforms to its specifications and is suitable for its intended use, likely by measuring parameters like ultrafiltration coefficient and clearance. These specifications are "based on the specification cleared for the predicate device."
• Biocompatibility Testing: Performed on the finished sterile device in accordance with ISO10993 to ensure safety when in contact with blood.

8. The sample size for the training set:

This is not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.

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

This is not applicable for the same reason as point 8.

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Hemodialysis with Althin capillary dialyzers are indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.

The AF-150 Hemodialyzer is a high permeability hemodialyzer that is used as an artificial kidney in a hemodialysis system to treat patients with acute or chronic renal failure. The blood from a patient flows through the arterial tubing of the extracorporeal blood circuit to the blood compartment of the hemodialyzer, then returns through the venous tubing of the extracorporeal blood system to the patient. The hemodialyzer has semipermeable hollow fibers which divide the device into two compartments. When the blood passes through the hollow fibers, water and toxic waste products from the blood pass through the semipermeable membrane into the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the hemodialyzer.

A high permeability hemodialyzer has a semipermeable membrane that is more permeable to water than that of the conventional dialyzer. This device must be used in conjunction with a controlled dialysate delivery system that incorporates an ultrafiltration controller to prevent excessive loss of water from the patient's blood. This highly permeable membrane may also permit greater loss of high molecular weight substances from the blood, compared with the conventional hemodialyzer.

Each AF-150 Hemodialyzer is packaged in a plastic bag and 20 hemodialyzers are packed in a cardboard box.

It is sterilized by gamma radiation and intended, and labeled, for single use only.

Here's a breakdown of the acceptance criteria and the study information for the Althin Medical AB AF-150 Hemodialyzer, based on the provided 510(k) summary:

This device submission does not involve Artificial Intelligence (AI). The submission is for a medical device (hemodialyzer) and the "study" referred to is functional testing and biocompatibility testing to demonstrate substantial equivalence to a predicate device. Therefore, many of the requested AI-specific details (such as sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types for AI models) are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary indicates that the AF-150 Hemodialyzer's performance was evaluated against the specifications cleared for its predicate device, the Altra Flux 140 Hemodialyzer (K945620). The key performance characteristics are related to its function as a high permeability hemodialyzer.

Note: Specific quantitative acceptance criteria (e.g., exact clearance rates, ultrafiltration coefficients) are not provided in this summary but are implied to be met in comparison to the predicate device's cleared specifications.

Regarding AI-Specific Information:

Since this is a traditional medical device (hemodialyzer) and not an AI/ML-based device, the following points are not applicable and cannot be answered from the provided text. The "study" here refers to standard medical device functional and biocompatibility testing, not an AI model's performance evaluation.

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

• Not Applicable (N/A) for AI/ML. For functional testing of a physical medical device, the "sample size" would refer to the number of devices tested. This information is not provided in the summary. Data provenance is also not relevant in the context of device functional testing described here.

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)

• N/A for AI/ML. Ground truth, in the context of AI, involves expert annotations or diagnoses. For a physical device, functional performance is measured objectively through testing (e.g., laboratory measurements for clearance, ultrafiltration) against defined specifications, not through expert consensus on a "test set."

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

• N/A for AI/ML. Adjudication methods are used in AI performance studies to resolve discrepancies in expert annotations for ground truth. This is not relevant for functional device testing.

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

• N/A. MRMC studies are specific to evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This device is a hemodialyzer.

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

• N/A. This refers to AI algorithm performance. The device is a physical hemodialyzer.

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

• N/A for AI/ML. The "ground truth" for the device's functional evaluation comprises objective measurements based on established test methodologies for hemodialyzers (e.g., measuring ultrafiltration coefficients, clearance rates, and confirmed biocompatibility according to ISO 10993).

8. The sample size for the training set

• N/A. This device does not use a training set as it is not an AI/ML algorithm.

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

• N/A. This device does not use a training set or ground truth in the AI context.

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Hemodialysis with Althin capillary dialyzers are indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.

The AF-220 Hemodialyzer is a high permeability hemodialyzer that is used as an artificial kidney in a hemodialysis system to treat patients with acute or chronic renal failure. The blood from a patient flows through the arterial tubing of the extracorporeal blood circuit to the blood compartment of the hemodialyzer, then returns through the venous tubing of the extracorporeal blood system to the patient. The hemodialyzer has semipermeable hollow fibers which divide the device into two compartments. When the blood passes through the hollow fibers, water and toxic waste products from the blood pass through the semipermeable membrane into the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the hemodialyzer. A high permeability hemodialyzer has a semipermeable membrane that is more permeable to water than that of the conventional dialyzer. This device must be used in conjunction with a controlled dialysate delivery system that incorporates an ultrafiltration controller to prevent excessive loss of water from the patient's blood. This highly permeable, semipermeable membrane may also permit greater loss of high molecular weight substances from the blood, compared with the conventional hemodialyzer. Each AF-220 Hemodialyzer is packaged in a plastic bag and 20 hemodialyzers are packed in a cardboard box. It is sterilized by gamma radiation and intended, and labeled, for single use only.

The provided text describes a 510(k) summary for the AF-220 Hemodialyzer, which is a medical device for treating renal failure. The submission focuses on demonstrating substantial equivalence to a legally marketed predicate device (Altra Flux 200 Hemodialyzer) rather than a study proving the device meets specific quantitative acceptance criteria using a new algorithm or AI.

Therefore, many of the requested sections (e.g., sample sizes for test/training sets, number of experts for ground truth, MRMC study, standalone performance) are not applicable or cannot be extracted from this type of regulatory submission. The information provided is primarily related to functional testing and biocompatibility, aimed at showing equivalence.

Here's a breakdown of what can be extracted and what cannot:

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

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

• Sample Size: Not specified. The document globally refers to "functional testing" and "biocompatibility testing" without providing specific sample counts for individual tests.
• Data Provenance: Not specified. The document does not indicate the country of origin of the data or whether the studies were retrospective or prospective.

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

• This is not applicable as the study described is not evaluating an AI/algorithm's performance against expert-defined ground truth, but rather the functional and biocompatibility characteristics of a physical device.

4. Adjudication method 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, a MRMC comparative effectiveness study was not done. This device is a physical hemodialyzer, not an AI or imaging diagnostic tool that would involve human readers.

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

• Not applicable as this is a physical medical device, not an algorithm.

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

• The "ground truth" or reference standards for the testing would have been based on established engineering specifications for functional performance (e.g., ultrafiltration coefficient, clearance rates, material integrity) and ISO 10993 standards for biocompatibility (e.g., cytotoxicity, sensitization, irritation tests). It is not expert consensus, pathology, or outcomes data in the context of diagnostic algorithms.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device.

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

• Not applicable. This is not an AI/machine learning device.

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Hemodialysis with Althin capillary dialyzers are indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.

The AF-180 Hemodialyzer is a high permeability hemodialyzer that is used as an artificial kidney in a hemodialysis system to treat patients with acute or chronic renal failure. The blood from a patient flows through the arterial tubing of the extracorporeal blood circuit to the blood compartment of the hemodialyzer, then returns through the venous tubing of the extracorporeal blood system to the patient. The hemodialyzer has semipermeable hollow fibers which divide the device into two compartments. When the blood passes through the hollow fibers, water and toxic waste products from the blood pass through the semipermeable membrane into the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the hemodialyzer. A high permeability hemodialyzer has a semipermeable membrane that is more permeable to water than that of the conventional dialyzer. This device must be used in conjunction with a controlled dialysate delivery system that incorporates an ultrafiltration controller to prevent excessive loss of water from the patient's blood. This highly permeable membrane may also permit greater loss of high molecular weight substances from the blood, compared with the conventional hemodialyzer. Each AF-180 Hemodialyzer is packaged in a plastic bag and 20 hemodialyzers are packed in a cardboard box. It is sterilized by gamma radiation and intended, and labeled, for single use only.

Here's an analysis of the provided text regarding the acceptance criteria and study for the AF-180 Hemodialyzer:

Summary of Acceptance Criteria and Device Performance:

Based on the provided 510(k) summary, the device is being cleared based on substantial equivalence to a predicate device, the Altra Flux 170 Hemodialyzer. This means the acceptance criteria are implicitly that the AF-180 Hemodialyzer performs similarly enough to the predicate device in terms of its functional characteristics and safety profile.

Detailed Study Information:

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

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

   • Sample Size: The document does not specify the sample size for the functional testing or biocompatibility testing. It only states that functional testing was "conducted."
   • Data Provenance: Not specified. It's likely the testing was conducted by Althin Medical AB in Sweden, but this is not explicitly stated. The document does not indicate if the data was retrospective or prospective.

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 provided in the summary. For a medical device like a hemodialyzer, "ground truth" would typically refer to established standards or validated methods for measuring performance parameters (e.g., clearance rates, ultrafiltration coefficients) and safety (biocompatibility). These would be established by engineers, toxicologists, and other relevant experts within the company or external labs, but the specific number or qualifications are not mentioned.

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

   • None described. The summary describes "functional testing" and "biocompatibility testing" but does not detail any adjudication methods, as this is not typically applicable to this type of device testing where objective measurements are primary.

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 device is a hemodialyzer, not an AI-assisted diagnostic or imaging device for human readers. Therefore, an MRMC study is not relevant.

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

   • Not applicable. This device is a physical medical device (hemodialyzer), not a software algorithm. The "standalone" performance would be its functional performance and biocompatibility as tested.

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

   • The "ground truth" for this device's performance would be:
     • Industry Standards and Predicate Device Specifications: Functional testing was "based on the specification cleared for the predicate device."
     • Validated Test Methods: Biocompatibility testing was performed "in accordance with ISO10993," which is an international standard for biocompatibility evaluation of medical devices.
     • Objective Measurements: Performance parameters like ultrafiltration coefficient and clearance would be measured using validated laboratory methods.

8. The sample size for the training set:

   • Not applicable. This device is a physical medical device, not an AI model that requires a training set.

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

   • Not applicable. As explained above, there is no AI training set for this device.

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The PS 150 Hemodialyzer is intended for hemodialysis in patients with acute or chronic renal failure, when conservative therapy is judged to be inadequate.

The PS 158 Hemodialyzer consists of approximately 13,000 polysulfone hollow fibers encapsulated in polyurethane resin with an outer housing and headers made of Polycarbonate. The device is packaged in a blister package composed of Glycol modified Polyethylene Terephtalate for the bottom web, and a foil laminater for the top web. The PS 15® Hemodialyzer has two compartments, the blood compartment and the dialysate compartment, separated by the polysulfone permeable membrane and and flows from the patient access site through the tubing of the extracorporeal. system and accessories to the blood compartment of the dialyzer. From the blood compartment, undesirable substances in the blood pass through the membrane into the dialysate compartment of the dialyzer. Circulation and monitoring of dialysate into flow through the dialysate compartment is controlled by the dialysate delivery system, while the ultrafiltration controller prevents excessive loss of yeater from the patient's blood.

This document describes the acceptance criteria and study that proves the PS 15® Hemodialyzer meets these criteria. The device is intended for hemodialysis in patients with acute or chronic renal failure.

1. Acceptance Criteria and Reported Device Performance

The PS 15® Hemodialyzer was evaluated against a predicate device, the Altrex 170 Hemodialyzer, and in some functional tests, also against the Fresenius F60 Polysulfone Dialyzer. The acceptance criteria are implicitly defined by demonstrating substantial equivalence to these legally marketed predicate devices through comparable functional and biocompatibility test results.

Table: Acceptance Criteria (as demonstrated by predicate device performance) and PS 15® Hemodialyzer Performance

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Hemodialysis with Althin capillary dialyzers are indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.

The A-15 Hemodialyzer is a conventional hemodialyzer that is used as an artificial kidney in a hemodialysis system to treat patients with acute or chronic renal failure. The blood from a patient flows through the arterial tubing of the extracorporeal blood circuit to the blood compartment of the hemodialyzer, then returns through the venous tubing of the extracorporeal blood system to the patient. The hemodialyzer has semipermeable hollow fibers which divide the device into two compartments. When the blood passes through the hollow fibers, water and toxic waste products from the blood pass through the semipermeable membrane into the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the hemodialyzer. Each A-15 Hemodialyzer is packaged in a plastic bag and 20 hemodialyzers are packed in a cardboard box. It is sterilized by gamma radiation and intended, and labeled, for single use only.

The provided text is a 510(k) summary for the Althin Medical AB A-15 Hemodialyzer, which is a medical device. This document does not describe a study involving performance metrics like accuracy, sensitivity, or specificity, which are typically associated with AI/ML model evaluations. Instead, it describes a
The acceptance criteria are that the device perform equivalently to the predicate device. The study performed that demonstrates that the A-15 Hemodialyzer meets this criteria is functional testing. The functional testing was based on the specifications of the predicate device, the Altra Nova 140 Hemodialyzer (K945625). The results of the functional testing showed "significant equivalence." Additionally, biocompatibility testing was performed in accordance with ISO 10993, and the device passed all indicated tests.

Here's a breakdown of the requested information based on the provided text. Please note that many of the categories you requested are typically relevant for AI/ML device evaluations and are not applicable to the traditional medical device submission described here.

1. Table of acceptance criteria and the reported device performance

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 the document. The testing involved "functional testing" and "biocompatibility testing," but the number of units tested is not provided.
• Data provenance: Not explicitly stated. The company, Althin Medical AB, is based in Sweden. The testing would have been conducted to support the 510(k) submission to the FDA in the USA.

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)

• Number of experts: Not applicable. The "ground truth" for this type of device is based on established engineering specifications and industry standards for functional and biocompatibility performance, not expert medical opinion on individual cases.

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

• Adjudication method: Not applicable. This does not involve interpretation of data by multiple experts.

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

• MRMC study: No. This is a traditional hemodialyzer, not an AI/ML device, so such a study is not relevant or described.

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

• Standalone performance: Not applicable. This is a physical medical device, not an algorithm.

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

• Type of ground truth: The ground truth for this device's performance is based on established engineering specifications for hemodialyzers (e.g., ultrafiltration coefficient, clearance) and the requirements of biocompatibility standards (ISO 10993). Performance is compared against the specifications of a legally marketed predicate device.

8. The sample size for the training set

• Sample size for training set: Not applicable. This is not a machine learning device and therefore does not have a "training set" in the context of AI/ML.

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

• Ground truth for training set: Not applicable, as there is no training set for this type of device.

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Hemodialysis with Althin capillary dialyzers are indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.

The A-18 Hemodialyzer is a conventional hemodialyzer that is used as an artificial kidney in a hemodialysis system to treat patients with acute or chronic renal failure. The blood from a patient flows through the arterial tubing of the extracorporeal blood circuit to the blood compartment of the hemodialyzer, then returns through the venous tubing of the extracorporeal blood system to the patient. The hemodialyzer has semipermeable hollow fibers which divide the device into two compartments. When the blood passes through the hollow fibers, water and toxic waste products from the blood pass through the semipermeable membrane into the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the hemodialyzer.

Each A-18 Hemodialyzer is packaged in a plastic bag and 20 hemodialyzers are packed in a cardboard box.

It is sterilized by gamma radiation and intended, and labeled, for single use only.

The Althin Medical AB A-18 Hemodialyzer is a conventional hemodialyzer used to treat patients with acute or chronic renal failure. The device was deemed substantially equivalent to the Althin Medical Inc Altra Nova 170 Hemodialyzer (K945621).

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the functional testing. It only mentions "functional testing has been conducted to evaluate the functional performance of the A-18 Hemodialyzer."
The data provenance is not specified regarding country of origin or whether it was retrospective or prospective.

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

This information is not provided in the document. The document refers to "specifications cleared for the predicate device" as the basis for testing, implying a comparison against established performance standards rather than expert-defined ground truth for specific cases.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported. The submission focuses on demonstrating substantial equivalence to a predicate device through functional and biocompatibility testing.

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

This question is not applicable as the device is a hemodialyzer, a physical medical device, not an algorithm or AI system. Therefore, standalone performance in the context of AI algorithms is not relevant. The "functional testing" described evaluates the device's physical performance.

7. The Type of Ground Truth Used

The ground truth for the functional testing appears to be based on the specifications and performance characteristics of the legally marketed predicate device (Altra Nova 170 Hemodialyzer), along with established industry standards for biocompatibility (ISO10993). This is a comparative "ground truth" rather than an expert consensus, pathology, or outcomes-based ground truth typical for diagnostic AI.

8. The Sample Size for the Training Set

This question is not applicable as the A-18 Hemodialyzer is a physical medical device and does not involve a training set in the context of machine learning or AI.

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

This question is not applicable for the same reason as point 8.

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The Althin Medical AB Altracart II is indicated for the preparation of sodium bicarbonate containing hemodialysis solutions for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine / monitor and acid concentrate solutions.

The Althin Medical AB Altracart II is a column, which contains sodium bicarbonate formulated and intended for use in hemodialysis when mixed or proportioned with the appropriate volume of purified water and acid concentrate solution. It is designed to fit into a holder with a connecting system where a spike punctures a membrane at the top and bottom of the cartridge/column which then permits water to flow through the column and mix with the sodium bicarbonate. The connections to the column are sealed by a standard 0-ring, which allows an internal positive or negative pressure to be created in the column. The Altracart II is fitted with a mesh filter to prevent the sodium bicarbonate powder from entering the dialysis machine before it is dissolved or placed in solution with water. The Altracart is supplied in the following 2 configurations: 750 and 1000 grams of sodium bicarbonate.

This document describes the Althin Medical AB Altracart II, a column containing sodium bicarbonate for use in hemodialysis. The submission focuses on demonstrating substantial equivalence to predicate devices rather than independent performance metrics.

Here's the breakdown of the acceptance criteria and study information:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by demonstrating substantial equivalence to the legally marketed predicate device, the Gambro BiCart Columns (K873155 and K940601). The "reported device performance" is essentially that the Altracart II performs "as well as the predicate device" in terms of chemical composition and intended use.

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

• Sample Size: The document does not specify a numerical sample size for the "in vitro testing." It only generally states that "in vitro testing was performed to determine the chemical composition and range of composition."
• Data Provenance: The document implies the data was generated by Althin Medical AB, a Swedish company. It is an "in vitro" study, meaning it was conducted in a controlled environment (e.g., laboratory) rather than a clinical setting. It is inherently prospective in the sense that the tests were specifically conducted to support this 510(k) submission.

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

N/A. This medical device primarily concerns chemical composition and compatibility, which are validated through instrumental analysis and engineering assessment rather than expert radiographic or clinical interpretation establishing "ground truth" in the diagnostic sense. The comparison is made against the established performance of predicate devices.

4. Adjudication Method for the Test Set

N/A. There was no expert adjudication process as would be typical for image-based diagnostic devices. The acceptance was based on direct comparison of chemical properties and functional equivalence to the predicate.

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

N/A. An MRMC study is not applicable as this is not a diagnostic device requiring human interpretation of results. The device is a component used in hemodialysis.

6. Standalone (Algorithm Only) Performance Study

N/A. This is not a software algorithm; it is a physical medical device (a column containing sodium bicarbonate). The "performance" is its ability to deliver the correct chemical composition for hemodialysis.

7. Type of Ground Truth Used

The "ground truth" for the Altracart II is the established chemical composition, intended use, and performance of the legally marketed predicate devices (Gambro BiCart Columns). The substantial equivalence argument relies on demonstrating that the Altracart II matches these characteristics. In-vitro testing (chemical analysis) serves as the basis for this comparison.

8. Sample Size for the Training Set

N/A. This submission primarily relies on substantial equivalence and in-vitro testing, not machine learning or AI models that require training sets.

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

N/A. As there is no training set for a machine learning model, this question is not applicable.

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Altra Fluxed 200 Heinodialyzers are intended for acule or chronic Hemodialysis. Hemodiatysis is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. The Altra Flux 200 Hemodialyzer is indicated for single use or multiple use with the same patient.

The Altra Flux® 200 multiple use hemodialyzer is the Altra Flux® 200 single use device with reuse labeling. Like the Altra Flux® 200 single use device, it is used as an artificial kidney in a hemodialysis system to treat patients with acute or chronic renal failure. The blood from a patient flows through the arterial tubing of the extracorporeal blood circuit to the blood compartment of the hemodialyzer, then returns through the venous tubing of the extracorporeal blood system to the patient. The hemodialyzer has semipermeable hollow fibers which divide the device into two compartments. When the blood passes through the hollow fibers, water and toxic waste products from the blood pass through the semipermeable membrane into the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the hemodialyzer. A high permeability hemodialyzer has a semipermeable membrane that is more permeable to water than that of the conventional dialyzer. This device must be used in conjunction with a controlled dialysate delivery system that incorporates an ultrafiltration controller to prevent excessive loss of water from the patient's blood. This highly permeable, semipermeable membrane may also permit greater loss of high molecular weight substances from the blood, compared with the conventional hemodialyzer.

The provided text describes the Altra Flux® 200 Hemodialyzer with multiple use labeling, focusing on its substantial equivalence to an already marketed single-use device and its validation for reuse. However, it does not explicitly detail specific quantitative acceptance criteria or the full study design with all the requested information for a device performance study.

Based on the information provided, here's what can be extracted and what is not available:

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

The document states that "Testing performed on reprocessed devices demonstrate that the Altra Nova® 200 multiple use hemodialyzer is as safe and effective as the currently marketed Altra Nova® 200 single use hemodialyzer." This implies the acceptance criterion was "as safe and effective as the predicate device" after reprocessing.

However, specific quantitative metrics (e.g., clearance rates, ultrafiltration rates, fiber bundle volume integrity) and their acceptable ranges are not provided in this summary. Therefore, a table cannot be fully completed.

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

The document does not specify the sample size used for the "testing performed on reprocessed devices." It also does not mention the data provenance (e.g., country of origin, retrospective or prospective).

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

This information is not applicable and hence not provided, as the study described is a performance validation of a medical device, not an AI or diagnostic tool requiring ground truth established by experts. The "ground truth" for a hemodialyzer's performance would be objective measurements of its function.

4. Adjudication method for the test set

This information is not applicable and hence not provided, as the study described is a performance validation of a medical device, not an AI or diagnostic tool requiring adjudication.

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 is typically used for diagnostic imaging devices or AI tools evaluated by multiple human readers. The Altra Flux® 200 Hemodialyzer is a therapeutic device.

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

This concept is not applicable to a hemodialyzer. The device itself performs its function (filtration), and its performance is measured directly, not through an algorithm or human interpretation.

7. The type of ground truth used

The "ground truth" for the performance of a hemodialyzer would be direct measurements of its functional parameters (e.g., clearance of waste products, ultrafiltration rates, integrity of the membrane). While not explicitly stated, these are typically measured in laboratory settings or in simulated clinical conditions. There is no mention of expert consensus, pathology, or outcomes data as "ground truth" in this context.

8. The sample size for the training set

This information is not applicable. The device is a physical medical device, not an AI model requiring a training set.

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

This information is not applicable, as there is no training set for a physical medical device.

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Altra Nova® 200 Hemodialyzers are intended for acute or chronic Hemodialysis. Hemodialysis is indicated for patients with acute or chronic result failure when conservative therapy is judged to be inadequate.
The Altra Nova 200 Hemodialyzer is indicated for single use or multiple use with the same patient.

The Altra Nova® 200 multiple use hemodialyzer is the Altra Nova® 200 single use device with reuse labeling. Like the Altra Nova® 200 single use device, it is used as an artificial kidney in a hemodialysis system to treat patients with acute or chronic renal failure. The blood from a patient flows through the arterial tubing of the extracorporeal blood circuit to the blood compartment of the hemodialyzer, then returns through the venous tubing of the extracorporeal blood system to the The hemodialyzer has semipermeable hollow fibers which divide the patient. device into two compartments. When the blood passes through the hollow fibers, water and toxic waste products from the blood pass through the semipermeable membrane into the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the hemodialyzer.

A high permeability hemodialyzer has a semipermeable membrane that is more permeable to water than that of the conventional dialyzer. This device must be used in conjunction with a controlled dialysate delivery system that incorporates an ultrafiltration controller to prevent excessive loss of water from the patient's blood. This highly permeable, semipermeable membrane may also permit greater loss of high molecular weight substances from the blood, compared with the conventional hemodialyzer.

The provided text describes a 510(k) summary for the Altra Nova® 200 Hemodialyzer with multiple-use labeling. It focuses on demonstrating equivalence to an existing single-use device rather than performing a typical clinical study with acceptance criteria and reported device performance in the way a new diagnostic or AI-driven device would.

Therefore, many of the requested categories (e.g., AI integration, expert consensus, MRMC studies, training set details) are not applicable to this type of submission. The document is a regulatory submission for a medical device (hemodialyzer) seeking clearance for reuse, not a study evaluating software performance or diagnostic accuracy.

Here's a breakdown based on the information available, highlighting what is applicable and what isn't:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a typical "acceptance criteria" table with performance metrics like sensitivity or specificity. Instead, the acceptance criteria for this device (a reusable hemodialyzer) revolve around demonstrating that the reprocessed device is as safe and effective as the single-use predicate device. The "performance" is implicitly tied to maintaining the original device's characteristics after reprocessing.

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

• Sample Size: Not explicitly stated in this 510(k) summary. The summary refers to "Testing performed on reprocessed devices," but the number of devices or cycles tested is not disclosed.
• Data Provenance: Not specified, but likely proprietary internal testing conducted by Althin Medical, Inc. (the manufacturer) in the USA. It would be retrospective in the sense that the testing was performed on devices that were then reprocessed according to a defined protocol.

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

• This is Not Applicable (N/A). This submission is for a physical medical device (hemodialyzer), not an AI-driven or diagnostic device requiring expert interpretation for ground truth.

4. Adjudication method for the test set:

• This is Not Applicable (N/A). No adjudication method is described because the testing doesn't involve subjective interpretations or expert consensus. It likely involved objective measurements of device performance parameters (e.g., clearance rates, ultrafiltration rates, material integrity) after reprocessing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• This is Not Applicable (N/A). This is a physical medical device, not an AI or diagnostic tool that would involve human readers.

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

• This is Not Applicable (N/A). This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• The "ground truth," in this context, is the original performance specifications and safety profile of the single-use Altra Nova® 200 Hemodialyzer. The study's goal was to demonstrate that the reprocessed device met these same predefined engineering and functional standards. This would involve objective measurements (e.g., chemical analysis, physical integrity tests, performance characteristics like solute clearance and ultrafiltration coefficient) against established benchmarks for the fresh device.

8. The sample size for the training set:

• This is Not Applicable (N/A). There is no AI or machine learning model involved, therefore no training set.

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

• This is Not Applicable (N/A). There is no AI or machine learning model involved, therefore no training set or ground truth establishment relevant to AI.

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