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The Haemonetics 40μ RBC Filter Bag is intended for use for perioperative autologous transfusion to hold washed red blood cells from a Haemonetics cell salvage device and filter the RBCs for microaggregates greater than 40 microns. It is intended to eliminate the need for a discrete 40 micron filter often used to filter autotransfusion blood prior to reinfusion.

The Haemonetics 40µ RBC Filter Bag is described as a blood transfusion microfilter with FDA Product Code CAK in the FDA Guidance Document for Intravascular Administration Sets 510(k)s dated April 15, 2005. It is defined as a Class II medical device in 21 CFR 880.5440 and is included as a component for an Intravascular Administration Set.

The provided text describes a 510(k) submission for the Haemonetics® 40µ RBC Filter Bag. While it states that performance testing was conducted, it does not provide specific acceptance criteria or details about the study that proves the device meets them in the format requested.

Here's an breakdown of the information that is available and what is missing:

The document confirms that "Haemonetics has conducted testing to verify the safety and performance of the 40u RBC Filter Bag. A detailed list with summaries of testing is provided with the test protocols and reports." However, these detailed lists, summaries, protocols, and reports are not included in the provided text.

Therefore, many of the requested details cannot be extracted from the given input.

Here's what can be gathered and what is missing based on your request:

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

• Acceptance Criteria: Not explicitly stated in the provided text. The text mentions the filter is for "microaggregates greater than 40 microns," which implies a filtration efficiency criterion, but no specific percentage or threshold is given.
• Reported Device Performance: Not explicitly stated in the provided text beyond the general statement of testing for "safety and performance."

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

• Sample Size: Not provided.
• Data Provenance: Not provided (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 not provided. The device is a filter, and its performance would likely be assessed through laboratory testing (e.g., particle counting, flow rates) rather than expert review of images or clinical cases that require ground truth from human experts.

4. Adjudication method for the test set

• Not applicable/not provided. See 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

• Not applicable. This device is a physical filter, not an AI-assisted diagnostic tool.

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

• Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used

• Since the device filters particles greater than 40 microns, the ground truth would likely be established through physical measurements of particle size and count before and after filtration, using methods like microscopy or automated particle counters. However, the specific type of ground truth used is not specified in the provided text.

8. The sample size for the training set

• Not applicable. This device is a physical filter. It does not use a "training set" in the context of machine learning or AI. Testing would involve a specific number of filter units tested under defined conditions. This number is not provided.

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

• Not applicable (see point 8).

In summary, the provided document is a 510(k) summary focused on establishing substantial equivalence to a predicate device for regulatory approval. It mentions that performance testing was conducted, but it does not include the details of those tests, such as specific acceptance criteria or the study results, that would fulfill your request. These details would typically be found in the accompanying test protocols and reports referenced within the document but not included in your input.

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The Summit Medical Transfusion Filter is intended for the filtration of up to one unit of intra-operative or post-operative salvaged blood, for the reduction of lipid particles, anaphylatoxin C3a, microaggregates and leucocytes. It is indicated for the reinfusion of blood derived from the surgical site or post-operative wound drainage.

The Transfusion Filter device consists of a sterile, single wrapped package, containing a filter assembly, with or without an administration set. The administration set is fitted with a drip chamber and roller clamp. The filter unit is connected to a flexible bag containing the blood to be reinfused via a spike port in the bag. The filter is primed by holding the bag inverted, with the filter above the bag, then squeezing the bag to force blood through the filter medium and to the desired level within the drip chamber. The roller clamp is then closed, and the system hung on a drip stand ready for use. The administration line can then be primed and connected to the patient according to clinical practice, and the rate of blood flow to the patient requlated by adjusting the roller clamp.

The provided text describes the Summit Medical Transfusion Filter and its substantial equivalence to a predicate device. It outlines performance testing conducted to demonstrate safety and effectiveness, but it does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria in the way typically associated with clinical or AI/software validation studies.

Instead, the document focuses on demonstrating that the device is substantially equivalent to a legally marketed predicate device (Pall Biomedical Products Co. SQ40 Blood Transfusion Filter, K960993) by showing it has the "same design principles, made of the same materials, and have the same indications and contraindications for use."

The performance testing mentioned is primarily related to manufacturing quality, biocompatibility, and sterility, which are standard for medical devices.

Therefore, I cannot populate the requested table and answer many of the questions as the specific details are not present in the provided document.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that "The test results achieved demonstrate that the device meets the applicable standards, is biocompatible, and performs in accordance with design specifications." However, it does not provide the specific quantitative acceptance limits or thresholds for each of these tests.

Information Not Found in the Provided Text:

• Sample sizes used for the test set and data provenance: The document mentions "performance testing" and "biocompatibility testing" but does not specify sample sizes for these tests, nor the origin or nature (retrospective/prospective) of any data beyond indicating it was performed on the device itself.
• Number of experts used to establish ground truth for the test set and their qualifications: This type of information is relevant for studies involving human interpretation or clinical endpoints. As this is a physical filter, such an expert panel for "ground truth" establishment in a diagnostic sense is not applicable to the reported tests.
• Adjudication method for the test set: Not applicable based on the type of testing described.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable to a physical transfusion filter. MRMC studies are typically for evaluating diagnostic software or imaging modalities where human readers interpret results.
• Standalone (algorithm only without human-in-the-loop performance): Not applicable, as this is a physical device, not an algorithm.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the tests described are the established scientific and regulatory standards (e.g., ISO standards) for material properties, sterility, and biocompatibility.
• Sample size for the training set: Not applicable, as this is a physical device, not a machine learning model requiring training data.
• How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) summary demonstrating substantial equivalence primarily through a comparison of design, materials, and indications for use with a predicate device, supported by standard medical device performance, biocompatibility, and sterility testing. It does not contain evidence of a study designed to validate performance against specific clinical acceptance criteria in a way that would require expert-established ground truth, human reader performance analysis, or AI/algorithm metrics.

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Single use device for the removal of microaggregate and particulate debris from whole blood and red blood cells (RBCs) during infusion.

40 micron filter offered both as a stand alone device and as an integral component of a Y-Blood Administration Set.

The provided text describes the 510(k) submission for the Charter Medical, Ltd. 40 Micron Filter (Code MP450). It details the comparison of the new device to a predicate device to establish substantial equivalence.

Based on the provided information, here's a breakdown of the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance

Study Details:

The information provided describes a comparative study to demonstrate substantial equivalence to a predicate device. It is not a clinical study involving patients or a study with human readers assessing AI performance in a diagnostic context.

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 for Test Set: Not explicitly stated. The document refers to "comparative studies" and "physical testing" but does not provide specific sample sizes for these tests.
• Data Provenance: Not explicitly stated. It's implied these are laboratory or bench testing results conducted by Charter Medical, Ltd. (USA), but the specific location of the tests or if any external data was used is not mentioned. They are likely prospective tests conducted for the submission.

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 device approval revolves around objective measurements of performance characteristics (flow rate, blood constituent impact, hold-up volume, biocompatibility, physical integrity) against a predicate device and established standards. It does not involve expert interpretation or consensus on a diagnostic outcome.

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

• Adjudication Method: Not applicable. This is not an image-based or diagnostic study requiring adjudication of expert opinions. The assessment relies on direct measurement and comparison of 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

• MRMC Comparative Effectiveness Study: No. This is a medical device (filter) submission, not an AI-based diagnostic tool. Therefore, an MRMC study assessing human reader performance with or without AI assistance is not relevant and was not conducted.

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

• Standalone Performance: Not applicable in the context of an AI algorithm. The "standalone performance" of the device in this case refers to its functional characteristics (filtration, flow rate, biocompatibility) as measured in the comparative studies and physical tests. These are inherent to the device itself, without human intervention as part of its primary function, other than its proper installation and operation.

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

• Type of Ground Truth: The ground truth is primarily based on:
  • Objective measurements: Of device characteristics like flow rate, hold-up volume, white blood count, red blood count, hemoglobin, hematocrit.
  • Established standards: ISO Standard 10993-1 for biocompatibility.
  • Comparison to a predicate device: The performance of the predicate device (PALL Biomedical Products Company SQ™40S 40-Micron Screen Filter) serves as a benchmark for substantial equivalence.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is a medical device (filter) submission, not a machine learning model. There is no concept of a "training set" in this context.

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

• How Ground Truth for Training Set was Established: Not applicable, as there is no training set for this type of device submission.

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The Fenwal® 20 Micron Pediatric Transfusion Filter is indicated for the removal of microaggregate particles from whole blood and red blood cells.

Baxter's Fenwal® 20 Micron Pediatric Transfusion Filter is a depth-type filter which traps microaggregates composed of degenerating platelets, leukocytes, fibrin strands and other particles which form in blood after storage. The filter consists of a fiber pad supported by a screen contained in a housing. The subject of this submission is a change in the fiber composition of the filter pad. The filter pad is currently comprised of five types of fiber strands. The supplier of one of the fibers has discontinued production. We are proposing to eliminate two of the five fibers used in construction of the filter pad and increase the percentage composition of the remaining three sizes. This change will make the composition of the 20 micron pediatric filter pad identical to the composition of the pad in the Fenwal® 20 Micron High Capacity Transfusion Filter covered by K830057.

The provided text describes a 510(k) Premarket Notification for a modified Fenwal® 20 Micron Pediatric Transfusion Filter (K982822). The submission focuses on a change in the fiber composition of the filter pad, rather than a new AI-powered diagnostic device. Therefore, the specific questions regarding acceptance criteria and studies for AI performance (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies) are not directly applicable to this document.

However, I can extract the relevant information regarding the performance of this medical device:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that "Performance testing indicates that the modified device meets or exceeds all functional requirements and supports its suitability for use." While specific numerical acceptance criteria are not detailed in the provided summary, the key performance aspects evaluated were:

Study Proving Device Meets Acceptance Criteria:

The study conducted was a nonclinical performance comparison of the proposed modified filter with the current Fenwal® 20 Micron Pediatric Transfusion Filter.

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

• Sample Size: Not explicitly stated in the provided text. The document only mentions "Test data has been generated comparing the performance... using packed red blood cells."
• Data Provenance: The tests were nonclinical (laboratory-based) and used "packed red blood cells." The country of origin for the data is not specified, but given Baxter Healthcare Corporation's location in Round Lake, IL, USA, it is highly likely the testing was conducted in the USA. The data is prospective in the sense that it was generated specifically for this 510(k) submission to demonstrate equivalence of the new filter design.

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

This question is not applicable. This is a medical device performance study, not an AI diagnostic study requiring expert consensus for ground truth. The "ground truth" here refers to the measured physical performance characteristics of the filter (e.g., actual microaggregate removal percentage, actual hemolysis percentage) in a controlled laboratory setting.

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

This question is not applicable. Adjudication methods are relevant for human interpretation or AI output reviews, not for direct physical performance measurements of a medical device.

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 question is not applicable. This device is a passive filtration device, not an AI system.

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

This question is not applicable. This device is not an algorithm.

7. The type of ground truth used:

The ground truth used was empirical measurement of physical performance characteristics (e.g., filter efficiency, hemolysis, red blood count, filter capacity) of the filter, likely against established industry standards or internal specifications for the existing predicate device.

8. The sample size for the training set:

This question is not applicable. There is no AI model or "training set" for this physical device.

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

This question is not applicable.

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The 40 Micron Transfusion Filter is indicated for removal of microaggregate particles from whole blood and red blood cells and for transfusion of platelets.

Baxter is currently marketing a 40 Micron Transfusion Filter indicated for the removal of microaggregates from whole blood and red blood cells and for the transfusion of platelets. The filter consists of a fiber pad supported by a single layer screen contained in a housing. The subject of this submission is a change in the fiber composition of the filter pad. Fibers which comprise approximately 50% of the current filter pad are being discontinued by the supplier. These fibers are being replaced with fibers from another supplier which differ in size and material formulation.

The provided text describes a 510(k) premarket notification for a modified 40 Micron Transfusion Filter. The submission focuses on a change in the fiber composition of the filter pad from the predicate device and a change in sterilization method from ETO to gamma.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly listed with numerical targets. Instead, the submission states that the modified device "meets or exceeds all functional requirements." The functional performance studies cover various aspects, and the reported outcome is that the device is suitable for its intended use.

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

The document does not specify the sample sizes used for any of the functional performance tests. It also does not mention the provenance (country of origin, retrospective or prospective) of the data. The studies are described as "Data regarding the functional performance...have been generated," implying prospective testing conducted in a laboratory setting, but this is not explicitly stated.

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

This information is not applicable to this type of device and study. The testing for a blood transfusion filter involves objective measurements of physical and chemical properties (e.g., flow rate, filtration efficiency, hemolysis, cell counts, pH) rather than subjective expert interpretation or "ground truth" derived from expert consensus.

4. Adjudication Method for the Test Set

This is not applicable for the reasons stated above. The functional performance tests involve direct measurements and comparisons, not subjective interpretations requiring adjudication.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed, nor would it be relevant for this type of device. An MRMC study is typically used for diagnostic devices where human readers interpret medical images or data. This submission is for a physical filtration device.

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

This is not applicable as the device is a physical filter, not an algorithm. The performance described is inherently standalone, as it's the filter's performance in laboratory tests.

7. Type of Ground Truth Used

The ground truth for the performance tests is based on objective laboratory measurements and established scientific/biological methodologies. For example, filtration efficiency is determined by measuring microaggregate removal, hemolysis by quantifying red blood cell lysis, and WBC removal by counting cells. This is not "expert consensus," "pathology," or "outcomes data" in the conventional sense, but rather direct empirical evidence from controlled experiments.

8. Sample Size for the Training Set

This device does not involve a "training set" in the context of machine learning or AI models. Therefore, the sample size for a training set is not applicable. The studies described are testing the performance of a physical product.

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

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

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The intended use of the Alpha Micron®-20/40 Microaggregate Filter is for filtering microaggregate debris from plasma derivative products to prevent pulmonary embolization.

The Alpha Micron®-20/40 Microaggregate Filter is a filter used for the filtration of microaggregate debris from plasma derivative products in order to aid in the prevention of pulmonary embolization. The device is designed to be utilized in either of two applications; by syringe, or by administration set. The syringe is inserted into the exposed inlet of the filter while the spike end is inserted into the bottle (or bag) of the plasma derivative. The blood plasma derivative is aspirated through the filter into the syringe resulting in filtration. The administration set is placed into the exposed inlet of the filter while the spike end is attached to an infusion set. The plasma derivative is drawn through the filter during administration resulting in filtration.

The provided text is a 510(k) summary for a medical device (Alpha Micron®-20/40 Microaggregate Filter) and does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way typically associated with AI/ML devices or diagnostic accuracy studies.

The document describes the device, its intended use, and claims substantial equivalence to previously marketed devices. Substantial equivalence for this type of device typically relies on demonstrating that the new device has the same intended use, technological characteristics, and safety and effectiveness as the predicate device. This is often achieved through comparison of materials, design, manufacturing processes, and performance specifications rather than a clinical study with acceptance criteria in the context of diagnostic accuracy.

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from the provided text because it describes a hardware microaggregate filter, not a device requiring such detailed performance evaluation.

The provided text does not contain the information requested for the following reasons:

• Type of Device: The device described is a physical "Microaggregate Filter" for blood products, not a diagnostic or AI/ML-driven device that would typically involve acceptance criteria and studies related to diagnostic accuracy, such as those involving radiologists or pathology.
• Study Design: The document outlines the device's description, intended use, and claim of "substantial equivalence" to predicate devices. Substantial equivalence for this type of device is usually demonstrated through comparative technical specifications and performance data (e.g., flow rate, filtration efficiency) rather than clinical studies with "ground truth" established by experts in the diagnostic sense.
• Missing Information: There is no mention of acceptance criteria formulated as performance metrics (e.g., sensitivity, specificity, accuracy), sample sizes for test sets, expert involvement, adjudication methods, MRMC studies, standalone algorithm performance, or details about training sets.

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