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The hemoconcentrators are intended for use in cardiopulmonary bypass circuits for hemoconcentration and consequent restoring of patient physiological hematocrit. The choice of hemoconcentrator depends on the protocol being used and required filtration speed. The device is intended to be used for six hours or less.

DHF and SH Hemoconcentrators are single-use, non-toxic and nonpyrogenic fluid path devices; they are supplied sterile and individually packaged. The devices are made of plastic materials and are recommended for use in cardiopulmonary bypass circuits for hemoconcentration and consequent restoring of patient's physiological hematocrit: The choice of hemoconcentrator depends on the protocol being used and required filtration rate. The device can be used up to 6 hours.

The DHF and SH hemoconcentrators are the modified version of the disposables currently marketed in the Dideco DHF hemoconcentrators (K021732) and the SH 14 hemoconcentrators (K081313).

The provided FDA 510(k) clearance letter for the DHF and SH Hemoconcentrators does not describe a study that proves the device meets specific acceptance criteria in the manner of an AI/ML algorithm or diagnostic device.

Instead, this document details a change to an existing, cleared medical device (hemoconcentrators used in cardiopulmonary bypass circuits). The core of the 510(k) submission is to demonstrate substantial equivalence to previously cleared predicate devices, not to establish performance against new, quantitative clinical acceptance criteria as one would find for a novel diagnostic or AI-powered system.

The "study" described here is a non-clinical performance evaluation focused on demonstrating that a material change (from Santoprene to Silicone for O-rings) does not introduce new questions of safety or effectiveness.

Therefore, many of the specific questions you've asked (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable to this type of device clearance.

Here's an analysis based on the provided document, highlighting what is (and isn't) present:

Analysis of Acceptance Criteria and Device Performance for DHF and SH Hemoconcentrators

The information provided describes a 510(k) clearance for hemoconcentrators, which are physical medical devices, not an AI/ML or diagnostic software. The "acceptance criteria" and "study" are therefore framed around demonstrating substantial equivalence to existing predicate devices, particularly after a material change to a component, rather than performance metrics for a diagnostic algorithm.

This document explicitly states: "No clinical testing was conducted in support of the DHF and SH hemoconcentrators, as the indications for use and technical characteristics are unchanged with respect to those of the predicate devices, which have been on the market for several years with proven safety and efficacy of use."

The "study" instead focuses on non-clinical performance data to ensure that the device still complies with applicable standards and performs as expected after the specified design change.

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device and submission, acceptance criteria are generally met through compliance with recognized standards and demonstrating that the device's fundamental characteristics and performance are maintained despite the change. The document does not list specific quantitative performance criteria in a table format, but rather states compliance.

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

• Test Set Sample Size: Not explicitly stated as a number of "cases" or "patients" because this was non-clinical performance testing (e.g., bench testing of prototypes or manufacturing samples), not a clinical study on patient data.
• Data Provenance: The testing was conducted by Sorin Group Italia S.R.L. and is "non-clinical," implying laboratory or bench testing. The country of origin would be Italy (where Sorin Group Italia S.R.L. is located). It is not retrospective or prospective in the sense of a clinical trial; it is product performance verification.

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

Not Applicable. This is a physical device, and the testing involved demonstrating compliance with engineering and safety standards, not establishing a "ground truth" for diagnostic purposes by human experts.

4. Adjudication Method for the Test Set

Not Applicable. There was no human adjudication process involved in assessing diagnostic performance. The evaluation was based on engineering and performance testing.

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

No, an MRMC study was NOT done. This type of study is relevant for diagnostic devices (especially imaging-based AI) to assess how human readers perform with and without AI assistance. This device is a hemoconcentrator, not an imaging or diagnostic AI system.

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

Not Applicable. This is not an algorithm. Performance was assessed for the physical device itself.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by engineering specifications, recognized national and international standards (e.g., for dialyzers), and performance parameters (e.g., filtration rates, material integrity, biocompatibility, sterility assurance). It is not based on expert consensus, pathology, or outcomes data from patients in the context of a new diagnostic claim. The "ground truth" is that the device, with the new material, still meets the same performance and safety requirements as the predicate device.

8. The Sample Size for the Training Set

Not Applicable. This device is not an AI/ML algorithm, so there is no concept of a "training set."

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

Not Applicable. As there is no AI/ML algorithm or training set, this question is not relevant.

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The Purema® H Hemoconcentrator is designed to remove excess fluid from the blood in order to maintain proper hematocrit and protein concentration during cardiopulmonary bypass and to enable reinfusion of blood remaining in the circuit after bypass.

It is intended to be used in a hospital setting, in connection with a suitable circuit for extracorporeal blood circulation and a pump that regulates its flow. There are no other accessories.

The Purema® H Hemoconcentrator Models DP07HC, DP09HC, and DP12HC are intended to be used for adult patients.

Purema® H hemoconcentrators are single use hemoconcentrators containing filters composed of a hollow fiber made of polyethersulfone (PUREMA® H). Purema® H hemoconcentrators are hemoconcentrators of various dimensions that can be used in treatments which require the removal of liquids that are in excess. Blood is pumped through a membrane that has high permeability, and the pressure gradient, through the membrane (TMP) determines the passage of water and molecules with a mechanism that is similar to glomerular filtration (convective mechanism). The fraction of filtrated liquid depends on the osmotic pressure, hydrostatic transmembrane pressure, the surface, membrane permeability and patient hematocrit. The Purema® H hemoconcentrators are designed to be used in a healthcare facility.

Purema® H hemoconcentrators can be sterilized using Ethlyene Oxide (EtO). The EtO sterilized Purema® H hemoconcentrators consist of hollow fiber made of polyethersulfone (PUREMA® H), cartridge, rings, connectors, potting (fiber closure seals), and O-rings.

The EtO sterilized Purema® H Hemoconcentrator is available in three models: DP07HC, and DP12HC. The main differences in these models are their total membrane surface areas.

The provided text describes a 510(k) premarket notification for the Purema® H Hemoconcentrator, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study where a device's performance is measured against predefined acceptance criteria for a new clinical claim. Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types is not applicable as this type of study was not performed.

The document states that the Purema® H Hemoconcentrator underwent various tests to demonstrate substantial equivalence to the predicate device, the Terumo Capiox Hemoconcentrator. These studies were focused on biological safety, mechanical characteristics, performance characteristics, and hemocompatibility.

Here's a summary of the types of tests performed, as provided in the document:

Studies Performed to Demonstrate Substantial Equivalence:

• Biological Safety:

  • In vitro sterility
  • Non pyrogenicity
  • Cytotoxicity (ISO 10993-5 (2009) and ISO 10993-11 (2017))
  • Acute systemic toxicity tests (ISO 10993-5 (2009) and ISO 10993-11 (2017))
  • Intracutaneous reactivity irritation (ISO 10993-12)
  • Guinea pig maximization sensitization (delayed hypersensitivity test) (ISO 10993-12)
  • Material-mediated pyrogen (USP )
  • Reverse Mutation Assay using Bacteria (ISO 10993-1; ISO 10993-3; ISO 10993-12; and ISO/TR 10993-33)
  • Mammalian Cell Gene Mutation Assay (ISO 10993-1; 10993-3; and 10993-12)
  • Sc5b-9 complement activation assay (FDA Biocompatibility Guidance and ISO 10993-4:2017)
  • Non-activated Partial Thromboplastin Time (PTT) assay (ASTM F2382-18)
  • Platelet and Leukocyte Count assay (ASTM F2888-19)

• Mechanical Characteristics:

  • Blood Compartment Integrity
  • Structural integrity
  • Hemoconcentrator blood and filtrate ports

• Performance Characteristics:

  • Solute clearance
  • Sieving coefficient (SC) for albumin
  • Ultrafiltration coefficient
  • Pressure drop of the blood compartment

• Hemocompatibility:

  • Plasma free Hemoglobin
  • White Blood Cells and Platelets counts
  • Blood Clotting at minimum flow rate

The document states, "All testing met predetermined testing criteria." However, the specific acceptance criteria for each test and the detailed reported device performance values are not provided in this excerpt. The excerpt also does not contain information about human reader studies, AI performance, or data provenance in the way one would expect for an AI/CADe device submission. It describes a conventional medical device's premarket notification.

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The MAQUET Hemoconcentrators are used to remove excess fluid from the blood or to concentrate highly diluted blood solutions. They are only intended for use for blood concentration during and/or following cardiopulmonary bypass procedures. The maximum duration of use is 6 hours. The physician in charge of treatment has sole responsibility for decisions concerning use of the hemoconcentrator.

BC 60 plus, BC 140 plus Hemoconcentrators are used to remove excess fluid from the blood during and/or following cardiopulmonary bypass procedures. Hemoconcentrators are ready for use after they have been filled and vented as the membrane contains no stabilizers. The type of Hemoconcentrator used is determined by the protocol used.

This document describes a 510(k) premarket notification for the MAQUET BC 60 plus and BC 140 plus Hemoconcentrators. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with detailed performance metrics.

Therefore, many of the requested items (e.g., acceptance criteria table with reported performance, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, specific training set details, and type of ground truth used) are not applicable or not provided in this type of regulatory submission.

Here's a breakdown of what can be extracted based on the provided text:

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

This information is not explicitly provided in the format of acceptance criteria and reported performance values. The submission states that the devices met the requirements of ISO standards and that evaluation and testing demonstrated substantial equivalence. However, the specific quantitative acceptance criteria or the reported performance data against those criteria are not detailed in this public FDA summary. The assessment revolves around equivalence to predicate devices, not the new establishment of performance criteria for this specific device.

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

This information is not provided. The submission states that "evaluation and testing on safety and effectiveness was executed" and lists general areas (Integrity, Performance, Biocompatibility, Sterility) that were tested/evaluated. However, details about sample sizes, study design (retrospective/prospective), or data provenance are absent.

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/not provided. This type of information is typically relevant for studies evaluating diagnostic or AI-driven devices where human expert consensus forms a "ground truth" for comparison. Hemoconcentrators are physical medical devices, and their performance is assessed through engineering and biological testing, not through expert interpretation of data points that require "ground truth" establishment in the way an image analysis algorithm might.

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

This is not applicable/not provided for the same reasons as item 3. Adjudication methods are used in studies involving human interpretation or subjective assessments to resolve discrepancies, which is not the primary method for evaluating the performance of a physical device like a hemoconcentrator.

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/not provided. MRMC studies are specific to diagnostic devices where human readers (e.g., radiologists) interpret images or data, and their performance is compared with and without AI assistance. This device is a hemoconcentrator, not a diagnostic imaging or AI system.

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

This is not applicable/not provided. This question pertains to AI algorithms. The MAQUET Hemoconcentrators are physical devices that perform a function and are not AI algorithms.

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

As noted previously, the concept of "ground truth" in the context of expert consensus or pathology is not directly applicable to the evaluation of a hemoconcentrator. The "truth" in this context would be the objective measurements of the device's technical performance and biological safety as defined by the relevant ISO standards and predicate device performance. For biocompatibility, established biological endpoints and validated testing methods would constitute the "ground truth."

8. The sample size for the training set

This is not applicable/not provided. This question applies to machine learning models. The MAQUET Hemoconcentrators are physical medical devices, not an AI algorithm that requires a training set.

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

This is not applicable/not provided for the same reason as item 8.

Summary of the Study and Device Evaluation:

The study proving the device meets criteria for substantial equivalence (which is the regulatory standard for this 510(k) submission) is based on non-clinical testing.

• Acceptance Criteria/Performance Standards: The devices were tested to and met the requirements of:

  • ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing. (This implies meeting established biocompatibility endpoints).
  • ISO 8637: Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators. (This implies meeting established performance and safety requirements for these types of devices).
  • The overall "acceptance criteria" were demonstrating substantial equivalence in safety and effectiveness to the predicate devices: Hemocor HPH® 700 (K983085) and Hemocor HPH® 1400 (K923139). This equivalence was assessed across the "principals of operation, performance and indications for use."

• Areas Tested/Evaluated:

  • Integrity
  • Performance
  • Biocompatibility
  • Sterility

Limitations of the provided text: This 510(k) summary is a high-level overview. It confirms that testing was done and standards were met, but it does not provide the detailed results, specific test protocols, or quantitative data that would fulfill many of the requested items (e.g., exact performance numbers, sample sizes, or specific ground truth methodologies for each test). The purpose of this summary is to demonstrate regulatory compliance through substantial equivalence, not to provide a detailed scientific publication of a study's methodology and results.

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The SH14 hemoconcentrator is intended for use in cardiopulmonary bypass circuits for hemoconcentration and consequent restoring of patient's physiological hematocrit. The choice of hemiconcentrator depends on the protocol being used and required filtration rate. The device is intended to be used for six hours of less.

The SH14 Hemoconcentrator is a hollow fiber type hemoconcentrator available for adult patients consisting of an external transparent housing with two filtrate ports on the cylindrical body and a fiber bundle. These fibers are bonded within the housing with polyurethane. A transparent blood header cap with a male Pos-Lock port is bonded to each end of the housing. Diluted blood is drawn, from the patient, inside the fibers of the plasma water is removed across the semi-permeable hollow fibers from the blood pathway to the filtrate side. The SH hemoconcentrator is ethylene oxide sterilized and has a nonpyrogenic fluid path. It is for single use only.

Here's an analysis of the acceptance criteria and supporting study for the SH14 Hemoconcentrator, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for each performance metric in a pass/fail format. Instead, it indicates that the results of the tests "met established specifications" or "met established specifications." For comparative purposes, it also states that data collected show that functional and biocompatibility parameters exhibited by the currently marketed predicate devices (Sorin Group USA HC1400 Maxi and DHF 0.6) apply to the SH14.

Therefore, the table below will list the tests performed and the general outcome as reported. The implication is that the performance of the SH14 was either equivalent to or within the established specifications of the predicate devices.

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

The document does not explicitly state the specific "sample size" for the in vitro tests (e.g., number of SH14 devices tested for priming volume). It generally states "a complete battery of tests were carried out" and "in vitro testing were carried out."

Regarding data provenance:

• Country of Origin: Not explicitly stated for each test, but the submitter is Sorin Group Italia S.r.I. (Italy).
• Retrospective or Prospective: These were laboratory "in vitro" tests, implying they were prospective tests conducted specifically for this submission. The biocompatibility tests were performed on the SH14, aged up to three years ("accelerated aging").

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

This information is not applicable and is not provided. The "ground truth" for device performance in this context is based on objective, measurable physical, chemical, and biological properties evaluated through standardized laboratory tests, not expert consensus on interpretations.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments (e.g., image interpretation by multiple readers) to establish a consensus ground truth. Here, the "truth" is derived directly from quantitative measurements in laboratory settings.

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 relevant for diagnostic devices where human readers interpret data, and the AI's impact on their performance is being evaluated. This device is a medical device for hemoconcentration, not a diagnostic AI.

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

Yes, the studies described are standalone performance studies of the device itself (not an algorithm in the typical AI sense). The "in vitro test results" and "biocompatibility test results" sections detail these standalone performance evaluations against established specifications and comparison with predicate devices.

7. The Type of Ground Truth Used

The "ground truth" in this context is the objective performance of the device as measured by established scientific and engineering methods, guided by:

• Standardized Test Methods: ISO 10993-1.1995 for biocompatibility and "Guidance for the content of premarket notifications for conventional and high permeability hemodyalizers, August 7, 1990" for in vitro functional performance.
• Predicate Device Performance: The functional and biocompatibility parameters of the Sorin Group USA HC1400 Maxi and DHF 0.6 served as a comparative benchmark, implying that the SH14's performance should be substantially equivalent to these legally marketed devices.

8. The Sample Size for the Training Set

This information is not applicable. This device is a physical medical device, not an AI or machine learning algorithm that requires a "training set" of data.

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 like the SH14 Hemoconcentrator in the context of AI.

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The HPH™ Junior Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution is employed. It is indicated for all patients (including all pediatric patients) according to physician assessment of the patient and the Instructions for Use. In pediatric patients this device must be used only as a part of a cardiopulmonary bypass or circulatory support circuit, with the circuit being connected to the patient.

The HPH Junior Hemoconcentrator consists of many individual polysulfone hollow fibers encapsulated into a polycarbonate case. The device has arterial and venous ports on opposite ends of the device. As the patient's blood enters the device through the arterial blood port, it passes through the fiber bundle and then exits the device through the venous blood port and is returned to the patient. As the blood passes through the fiber bundle, ultrafiltration occurs as a result of a hydrostatic pressure gradient that exists across the semipermeable membrane. The resulting hemoconcentration removes large quantities of plasma water, and small and medium sized solutes (such as IL-6, C3a and C5a) are removed from the vascular space thereby concentrating the red cell mass and the plasma proteins.

The provided text describes the HPH™ Junior High Performance Hemoconcentrator and its substantial equivalence to a predicate device, the HPH Mini. The study focuses on demonstrating this equivalence through functional and safety testing.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" with numerical targets for each parameter. Instead, it states that the performance characteristics of the HPH Junior are "substantially equivalent" to the predicate device, HPH Mini. The reported device performance is presented as a comparison to the HPH Mini.

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

The document does not explicitly state the sample sizes used for the testing. It mentions "functional and safety testing" performed on "both the HPH Junior and the HPH Mini for comparison purposes." This implies a retrospective comparison as the HPH Mini is an existing device.

The data provenance is not specified beyond being internal testing conducted by Minntech Corporation to support their 510(k) submission to the U.S. FDA. There is no information regarding the country of origin of the data.

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 testing appears to be functional and safety testing conducted in a laboratory setting, not involving expert interpretation of patient data or clinical outcomes.

4. Adjudication Method for the Test Set

This information is not applicable as the study did not involve human interpretation or subjective assessment that would require an adjudication method. The testing was objective, measuring physical and performance characteristics.

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 type of study is relevant for AI-powered diagnostic devices involving human interpretation, which is not the nature of this hemoconcentrator device.

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

This concept is not applicable to a mechanical medical device like a hemoconcentrator. The device itself performs its function (ultrafiltration) in a standalone manner, but there is no "algorithm" in the sense of AI or software processing data that would have a standalone performance.

7. The Type of Ground Truth Used

The "ground truth" for this study is based on objective measurements and engineering specifications as defined by relevant FDA guidances and ISO standards (specifically ISO 8637:2004E). The predicate device (HPH Mini) served as the benchmark for "substantially equivalent" performance.

8. The Sample Size for the Training Set

This information is not applicable as there is no "training set" in the context of this device. The study is a comparison of two physical devices based on their functional and safety characteristics, not a machine learning model.

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

This information is not applicable for the same reasons as in point 8.

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The Dideco DHF Hemoconcentrator is intended for use in cardiopulmonary bypass circuits for hemoconcentration and consequent restoring of patient's physiological hematocrit. The choice of hemconcentrator depends on the protocol being used and required filtration speed. The device is intended to be used for six hours or less.

The Dideco DHF Hemoconcentrator is a hollow fiber type hemoconcentrator consisting of an external transparent housing with two filtrate ports on the cylindrical body and a fiber bundle. These fibers are bonded within the housing with polyurethane. A transparent blood header cap with a male Pos-Lock port is bonded to each end of the housing.

The provided document is a 510(k) premarket notification for a medical device, the Dideco DHF Hemoconcentrator. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a full clinical study with specific acceptance criteria and detailed performance metrics as one might find for a novel AI/software medical device.

Therefore, many of the requested points regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies are not applicable or
not explicitly detailed in this type of submission. The 'acceptance criteria' here refer to the performance specifications the device must meet to be considered equivalent to existing devices and safe for its intended use.

Here's an analysis based on the provided text, addressing the applicable points:

Acceptance Criteria and Device Performance for Dideco DHF Hemoconcentrator

The Dideco DHF Hemoconcentrator underwent non-clinical and in vitro testing to demonstrate compliance with safety and effectiveness requirements and substantial equivalence to its predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with specific numerical values or ranges. Instead, it states that the results of the tests "met established specifications" and showed "comparable or even better performances" with respect to the predicate devices. The types of performance criteria evaluated are listed.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: The document does not specify the exact number of devices or repeat tests performed for each in vitro and non-clinical test. It states "The results of these tests carried out on the DHF 0.6 and DHF 0.2 Hemoconcentrators aged to 5 years met established specifications." This implies multiple units of each model were tested.
• Data Provenance: Not explicitly stated, but based on the submitter's location (Italy) and adherence to international (ISO, EN) and US (FDA) standards, the testing was likely conducted in a laboratory setting, potentially in Italy or a contracted facility. The data is retrospective in the sense that the tests were performed before the 510(k) submission.

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

N/A. This is a medical device (hardware) submission focused on physical and biological performance characteristics, not an AI/software device requiring expert interpretation for ground truth establishment. The "ground truth" here is determined by objective measurements and standardized test methods.

4. Adjudication Method for the Test Set

N/A. Adjudication methods like '2+1' or '3+1' are typically used for establishing ground truth in image interpretation or diagnostic studies, which is not applicable to the in vitro and non-clinical testing of a hemoconcentrator.

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

N/A. This type of study is relevant for AI-assisted diagnostic tools where human reader performance is a key metric. The Dideco DHF Hemoconcentrator is a physical device used during cardiopulmonary bypass; it is not an AI/software tool, and human interpretation of outputs in the clinical context is not evaluated in this way in this submission.

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

N/A. The device is a physical hemoconcentrator. The tests performed are "standalone" in the sense that they evaluate the device's inherent properties and performance without human interaction as part of the test itself (though a human operates the test equipment).

7. Type of Ground Truth Used

The "ground truth" for the performance characteristics was established through:

• Established Specifications/Standards: Reference to ISO 10993-1:1997, FDA May 1, 1995 Memorandum, FDA "Guidance for the Content of Premarket Notifications for Conventional and High permeability Hemodialyzers" (1998), and EN 1283:1996 when applicable. These documents define the accepted test methods and, implicitly or explicitly, the performance thresholds for safety and effectiveness.
• Predicate Device Performance: The primary comparative "ground truth" was the established performance of the legally marketed predicate devices (Cobe HC 700 Midi Hemoconcentrator (K003023) and Hemocor HPH 400 Hemoconcentrator (K923139)). The new device was deemed acceptable if its performance was "comparable or even better" than these predicates.
• Objective Measurements: Laboratory measurements of physical properties (priming volume, pressure drop, ultrafiltration rate, sieving coefficient, mechanical integrity) and biological indicators (plasma free hemoglobin, index of hemolysis) against predefined limits.

8. Sample Size for the Training Set

N/A. This submission does not involve a "training set" as it is not an AI/machine learning device. The tests are for device validation, not model training.

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

N/A. See point 8.

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Intended to relieve or mitigate overhydration in patients undergoing cardiopulmonary procedures and to increase the concentration of cells and proteins in the blood.

The Low Volume Hemoconcentrator is similar to the F Series F400 Hemoconcentrator. Both hemoconcentrators are hollow fiber-type filters and will be provided with and without a tubing set. The Low Volume Hemoconcentrator has an active membrane surface area of 0.35M2 and a priming volume of 27 ml.

The provided text describes a 510(k) submission for a device modification, specifically the Fresenius F Series Low Volume Hemoconcentrator. This document is a regulatory submission for a medical device whose performance is characterized by physical specifications and in-vitro performance rather than clinical outcomes or diagnostic accuracy. Therefore, many standard AI/ML evaluation metrics like sensitivity, specificity, or AUC, and ground truth establishment methods typically associated with clinical studies, are not applicable here.

The "acceptance criteria" and "device performance" are presented as a comparison table between the modified device and its predicate device, demonstrating that the new device meets the necessary physical and performance characteristics to be considered substantially equivalent.

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

The acceptance criteria for this device are implicitly defined by its substantial equivalence to the predicate device (F400 Hemoconcentrator, K974584), meaning its specifications and performance characteristics must be comparable or within acceptable ranges relative to the predicate. The reported device performance for the new "Low Volume Hemoconcentrator" is shown in the table below, alongside the predicate device's data for comparison.

Note: For parameters like Active Membrane Surface, Priming Volume, Number of Fibers, Max. Blood Flow, Pressure Drop, and Ultrafiltration Rate, changes are expected due to the "Low Volume" nature of the device modification. The "Met?" column indicates whether the new device's characteristic is identical to the predicate (Yes) or if it's a designed difference due to the modification (N/A – meaning it's not expected to be identical but aligns with the intended modification and is presumed acceptable by the FDA for substantial equivalence).

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 detail specific "test set" sample sizes in the context of clinical or performance data collection on multiple units. The data presented is for the design specifications and nominal performance characteristics of the device itself.

• Sample Size: Not explicitly stated as this is a device modification submission based on technical specifications and in-vitro performance, not a clinical trial. The performance characteristics (e.g., pressure drop, ultrafiltration rate) are likely derived from bench testing or engineering calculations based on the design, rather than a "test set" of many devices.
• Data Provenance: Not specified, but generally, such technical specifications and in-vitro test data would be generated within the manufacturing and R&D facilities of Fresenius Hemotechnology Inc. (location: Concord, CA). The data is not derived from human subjects, thus "retrospective or prospective" is not applicable in the typical clinical sense.

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 to this type of device submission. There is no "ground truth" established by experts in the sense of clinical diagnoses or interpretations for this mechanical device. The "truth" lies in the engineering specifications and in-vitro performance data, which are verified through standard engineering and laboratory testing protocols.

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

Not applicable. This is not a study involving human interpretation or clinical 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 device is a hemoconcentrator, not an AI/ML-enabled diagnostic or therapeutic device that would involve human readers or AI assistance.

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, not an algorithm or software.

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

The "ground truth" for this device modification is the verified engineering specifications, material properties, and in-vitro performance measurements (e.g., pressure drop, ultrafiltration rates) obtained through standardized laboratory testing and quality control processes. This is analogous to "bench testing" or "design verification" rather than clinical "ground truth."

8. The sample size for the training set

Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set."

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

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

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The Hemocor HPH® Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution has been employed.

The Minntech I lemocor HPI 700 Hemoconcentrator is made of glycerin-free, microporous, hollow fiber, polysulfone membrane encased in a polycarbonate chamber meroporous, notiow troot, porty and polycarbonate blood port header caps. The FIPE 700 TS device has attached PVC 1/4" tubing and accessory polycarbonate adapters for blood path connection. The no-rinse device feature provides versatility for inscrtion of the hemococentrator into the extracorporeal circuit.

Here's a breakdown of the acceptance criteria and study information for the Minntech Hemocor HPH® 700 Hemoconcentrator and Tubing Set, based on the provided 510(k) summary:

This device is not an AI/ML device, so many of the requested fields are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary for the Minntech Hemocor HPH® 700 Hemoconcentrator does not explicitly list "acceptance criteria" in the traditional sense of a pass/fail threshold for a performance metric. Instead, it presents a comparison of technological characteristics with a predicate device and outlines performance testing that was conducted to demonstrate device effectiveness and substantial equivalence.

Note on Acceptance Criteria: For legacy medical devices like this, especially for 510(k) submissions, "acceptance criteria" are often implicitly demonstrated by showing substantial equivalence to a legally marketed predicate device. The goal is to show the new device is as safe and effective as the predicate, not necessarily meet pre-defined numerical thresholds beyond what is necessary to support the same indications for use. The technological characteristics table serves as a primary source of this comparison. The performance testing further supports that the device performs as expected for a hemoconcentrator.

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

The 510(k) summary does not specify sample sizes for the performance testing conducted. It only states that testing was conducted. This is typical for 510(k) summaries where detailed pre-clinical test results are often kept in the full submission, not in the publicly available summary.

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). Given this is a device performance test, it likely refers to in vitro or ex vivo lab testing, rather than human clinical data.

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

This question is not applicable as the ground truth for mechanical device performance (like a hemoconcentrator) is established through technical testing and measurement against engineering specifications and industry standards, not expert clinical consensus.

4. Adjudication Method for the Test Set

This question is not applicable as the ground truth for mechanical device performance is established through technical testing and measurement, not consensus among experts.

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 done. This type of study is relevant for diagnostic imaging or clinical interpretation where human readers are involved. This submission is for a medical device (hemoconcentrator) and its physical performance.

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

The concept of "standalone performance" for an algorithm or AI is not applicable here. This is a physical medical device, not a software algorithm. The "performance testing" described (Ultrafiltration Rate, Pressure Drop, Protein Rejection, Blood Path Integrity) represents the "standalone" performance of the device in a laboratory setting.

7. The Type of Ground Truth Used

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

• Bench testing/Laboratory Measurements: Based on established engineering principles, fluid dynamics, membrane science, and medical device performance standards.
• Comparison to Predicate Device: The performance of the new device is compared to the known and accepted performance of the legally marketed predicate device (Hemocor HPH® 1000 Hemoconcentrator). Substantial equivalence means the new device performs at least as safely and effectively.

8. The Sample Size for the Training Set

This question is not applicable. This device is not an AI/ML system, so there is no concept of a "training set" for an algorithm.

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

This question is not applicable. As there is no AI/ML component, there is no "training set" or ground truth for such a set.

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The Fresenius F Series Hemoconcentrators are indicated to relieve or mitigate overhydration in patients undergoing cardiopulmonary procedures and to increase the concentration of cells and proteins in the blood.

The Fresenius Hemoflow Series Dialyzer, the same product as the F Series Hemoconcentrators, is a hollow fiber-type filter. Fresenius-produced polysulfone capillary fibers are bundled and potted with polyurethane into an artificial kidney jacket manufactured from polyurethane. Screw-type end caps, manufactured from polyurethane, have twist lock connectors for the connection of venous and arterial blood lines. Two filtrate ports are located on the filter adjacent to the filtrate chambers. The ports have Hansen-type fittings for connection of filtrate tubing. For hemoconcentration, only the filtrate port on the venous end of the filter is used; the other port on the arterial end is capped. There are four (4) models within the F Series Hemoconcentrators family. The difference between the four models in the F Series Hemoconcentrators is the number of fibers contained within the artificial kidney jacket. As the number of fibers contained in the filter increases, the diameter of the filter and the filtration capacity increases proportionally. Each model will be manufactured with a tubing set (F400TS, F500TS, F700TS, F800TS); other models will be manufactured with tubing adapter, only (F400, F500, F700, F800).

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 a specific numerical sample size for the test set. However, it indicates that "Comparative in vitro testing" was performed on the Fresenius F40, F50, F70, and F80 hemoconcentrators. This suggests a test set comprising various models of the subject device.

The data provenance is in vitro testing. The country of origin of the data is not explicitly stated, but given that Fresenius USA submitted the 510(k), it is likely the testing was conducted in the US or by a facility associated with Fresenius USA. The testing was prospective as it was conducted to characterize the performance of the new devices.

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

This information is not provided in the document. The study focuses on in vitro performance comparison, which typically relies on established laboratory measurement techniques and standards rather than expert human interpretation for raw data.

4. Adjudication Method for the Test Set

This information is not applicable/provided. As explained above, the study involved in vitro testing and performance measurements, not expert human assessment that would require an adjudication method.

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

No, an MRMC comparative effectiveness study was not done. The study described is an in vitro performance comparison of the device itself, not an evaluation of human readers (clinicians) using the device with or without AI assistance.

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

N/A. The device is a medical apparatus (hemoconcentrator), not an AI algorithm. Therefore, the concept of "standalone algorithm performance" is not applicable in this context. The study did evaluate the standalone performance of the device in vitro.

7. The Type of Ground Truth Used

The ground truth used was established laboratory measurements and scientific principles. Specifically, performance characteristics were measured against:

• Draft specifications for the products.
• A recognized international standard, EN 1283, Haemodialyzers, Haemodiafilters, Haemoconcentrators and Their Extracorporeal Circuits.
• Performance of legally marketed predicate devices (F40, F60, Bard HC40, Amicon Diafilter 30, Minntech Hemocor HPH 1000, Baxter Bentley Quick Prime HQ 7000, Research Medical Biofilter 140) under similar operating conditions.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical device, not an AI algorithm that requires a training set. The term "training set" doesn't apply to the development or evaluation of this type of product.

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

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

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