Search Results

The Haemonetics OrthoPAT advance (Orthopedic Perioperative Autotransfusion) System is indicated for use to salvage Red Blood Cells (RBCs) from blood lost intraoperatively and postoperatively during surgical procedures where the expected rate of processing of salvaged blood and fluid aspirated from the surgical site is less than or equal to 2 liters per hour. Autotransfusion is indicated for patients who meet at least one of the following criteria:

• The patient is expected to lose sufficient blood in the period so as to require RBC transfusion, and autotransfusion will likely reduce or eliminate the need for allogeneic blood transfusion.
• Religious beliefs cause the patient to refuse allogeneic transfusion, but accept autologous transfusion.
• Compatible allogeneic blood is not available.
• The patient is unable to donate sufficient quantities of autologous blood prior to surgery to adequately cover the anticipated transfusion requirement.
• The patient or physician prefers perioperative autotransfusion rather than preoperative autologous donation or transfusion of allogeneic blood.

The OrthoPAT advance Perioperative Autotransfusion System is an evolution of the previously cleared OrthoPAT Perioperative Autotransfusion System. The OrthoPAT advance System is designed to salvage Red Blood Cells (RBCs) from blood lost intraoperatively and postoperatively during surgical procedures where the expected rate of processing of salvaged blood and fluid aspirated from the surgical site is less than or equal to two liters per hour. Blood shed from the surgical site or wound drain is collected in the reservoir; processed in the Dynamic Disk® separation chamber to pack the RBCs; washed to remove the cell fragments, irrigation fluid, plasma, and other undesirable components that are found in the fluid portion of the shed blood; then transferred to a bag for gravity reinfusion to the patient. The OrthoPAT advance System consists of the following three parts that work together to collect and process the RBCs lost during and after surgery: OrthoPAT advance device: the electro-mechanical device and display screen. Disposable set: the single-use collection material including reservoir, processing set, A&A line, post-op line, and vacuum line. Solutions: solutions for collecting and processing salvaged blood (examples: anticoagulant and wash solutions).

Here's an analysis of the acceptance criteria and supporting study for the Haemonetics OrthoPAT advance Perioperative Autotransfusion System, based on the provided 510(k) summary:

The K122262 submission for the Haemonetics OrthoPAT advance Perioperative Autotransfusion System focuses on demonstrating substantial equivalence to a predicate device (Haemonetics OrthoPAT Perioperative Autotransfusion System, K992723). The "acceptance criteria" in this context are primarily established by showing that the new device performs at least as well as, or better than, the predicate device in relevant performance areas, and that any changes do not raise new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes "Non-Clinical Testing Summary" which serves as the evidence that the device meets the implied acceptance criteria for substantial equivalence, specifically focusing on the differences from the predicate device. The acceptance criteria are implicit in the "Test Intent" columns, signifying that the device must "Pass" these tests to be considered safe and effective, and substantially equivalent.

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

The provided document describes non-clinical bench testing. It does not specify sample sizes for these tests in terms of patient-derived data or a typical "test set" as one might expect in a clinical study for diagnostic AI. Instead, the tests are primarily engineering and material validation tests.

• Sample Size: Not specified in terms of patient counts or data points in the provided summary. The tests are focused on hardware, software, and material properties. For example, "Biocompatibility Testing" would involve material samples, and "Transportation & Aging Testing" would involve multiple reservoir units.
• Data Provenance: Not applicable in the context of patient data. These are bench testing results, meaning they were generated in a controlled laboratory environment by the manufacturer.

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

This information is not applicable (N/A) for this type of device and submission. The tests performed are engineering and material science evaluations (e.g., software validation, biocompatibility, electrical safety, EMC). They do not involve expert interpretation of medical images or patient data to establish a "ground truth" in the way an AI diagnostic device would.

4. Adjudication Method for the Test Set

This information is not applicable (N/A). Adjudication methods like 2+1 or 3+1 are used in clinical studies where multiple human readers interpret data, and their discrepancies need to be resolved to establish a definitive ground truth. Such a scenario is not described for the non-clinical bench tests reported here.

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

No, a MRMC comparative effectiveness study was not done or at least not described in this 510(k) summary. This type of study is relevant for diagnostic devices (especially those involving image interpretation by human readers) to assess how an AI system impacts human performance. The OrthoPAT advance is an automated autotransfusion system, not a diagnostic imaging device with human readers.

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

The document describes standalone performance of device components, particularly the software and hardware. For example, "Bench Testing for Software" validated the software's user interface and its display of Estimated Blood Loss (EBL) volume. The "Bench Testing for Electrical Hardware" demonstrated the electrical safety of the battery. These are effectively standalone tests of the device's functional components. However, this is not an "algorithm only" study in the sense of a machine learning algorithm detecting a condition, but rather a validation of the device's engineered functions.

7. Type of Ground Truth Used

The "ground truth" for the tests described is based on engineering specifications, regulatory standards, and material science properties.

• For software validation: The ground truth is the expected correct functionality and display of EBL volume according to design specifications.
• For biocompatibility: The ground truth is compliance with recognized biocompatibility standards (e.g., ISO 10993).
• For transportation & aging: The ground truth is maintaining specified package integrity and device stability over time.
• For electrical safety and EMC: The ground truth is compliance with relevant electrical safety and electromagnetic compatibility standards.

8. Sample Size for the Training Set

This information is not applicable (N/A). The Haemonetics OrthoPAT advance System is an automated blood processing device, not an AI/machine learning device that relies on a "training set" of data for algorithm development or learning. Any software development would follow traditional software engineering principles and verification/validation.

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

This information is not applicable (N/A), as there is no "training set" in the context of machine learning for this device. The software and hardware functionalities are designed and verified against established engineering requirements and safety standards.

Ask a specific question about this device

The Haemonetics Cell Saver® Elite™ Autotransfusion System and its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processed red cell product to either a bag for gravity reinfusion into the patient or to the arterial line of an extracorporeal circuit for reinfusion into the patient. The intended use of the Sequestration Protocol is to collect an autologous, preoperative, platelet rich plasma product for reinfusion to the same patient within 6 hours of collection.

The Cell Saver Elite Autotransfusion System is an evolution of the previously cleared Haemonetics Cell Saver Elite Autotransfusion System. The Cell Saver Elite System consists of a single use disposable equipment. One disposable set is used throughout an individual patient's surgical procedure and then discarded. The Cell Saver Elite System utilizes a unique bowl processing kit, but is compatible with Haemonetics standard reservoirs and A&A lines. The collected blood is processed through a centrifugal separation chamber (bowl) where RBCs are concentrated and then washed, removing unwanted substances such as hemolized cells, anticoagulant and irrigating fluids. The washed RBC product is available for return via a product bag to the patient. The Elite System is designed to perform plasma sequestration disposable in conjunction with an ancillary sequestration set prior to performing autotransfusion. The changes from the previously cleared Cell Saver Elite to the subject Cell Saver Elite system include a software change and a mechanical change to the pinch valve disposable sensor detection system.

The Haemonetics Cell Saver Elite Autotransfusion System is an autotransfusion apparatus. The data provided includes non-clinical performance testing which focuses on processing efficiency and product characteristics of blood products.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes (number of tests or units of blood) used for each in-house laboratory evaluation. It states "Test data demonstrates that the device and resultant blood products met all clinical and performance requirements". The data provenance is "In-house Laboratory Evaluation," implying the data was generated within Haemonetics Corporation and is retrospective for the purpose of this 510(k) submission, as it refers to testing submitted with a previous 510(k) in 2010.

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

This type of information is not applicable to the non-clinical performance studies described. The ground truth for these studies relies on instrumental measurements and validated laboratory protocols for determining blood product characteristics (e.g., hematocrit, concentration of substances, cell recovery). There is no mention of human expert evaluation for establishing ground truth in these technical performance tests.

4. Adjudication Method for the Test Set

Not applicable. As described above, the ground truth is based on laboratory measurements and established performance criteria, not on expert consensus or 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 an autotransfusion system, a medical device that processes blood. It is not an AI-powered diagnostic or imaging device that would involve human readers or AI assistance in interpretation.

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

The performance studies described ("In-house Laboratory Evaluation") are essentially standalone performance evaluations of the device's ability to process blood and achieve specific product characteristics. The device operates automatically based on programmed protocols.

7. The Type of Ground Truth Used

The ground truth for the performance studies was established through:

• Laboratory Measurements: Quantifiable parameters like hematocrit, heparin concentration, free hemoglobin concentration, and red blood cell recovery.
• Established Performance Criteria/Thresholds: Pre-defined numerical targets or ranges (e.g., hematocrit 40-60%, washout ≥95%) that the device's output should achieve.

8. The Sample Size for the Training Set

Not applicable. The device is a physical medical device (autotransfusion system) rather than an algorithm or AI model that requires a training set in the conventional sense. Its performance is based on engineering design and validated physical/chemical processes.

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

Not applicable, as there is no training set for this type of medical device. The "ground truth" for its operation is the set of physical and biochemical principles it utilizes for blood processing.

Ask a specific question about this device

The Haemonetics Cell Saver® Elite™ Autotransfusion System and its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processed red cell product to either a bag for gravity reinfusion into the patient or to the arterial line of an extracorporeal circuit for reinfusion into the patient. The intended use of the Sequestration Protocol is to collect an autologous, preoperative, platelet rich plasma product for reinfusion to the same patient within 6 hours of collection.

The Cell Saver Elite Autotransfusion System is an evolution of the Haemonetics Cell Saver 5 Autologous Blood Recovery System. The Cell Saver Elite System consists of a single use disposable equipment. One disposable set is used throughout an individual patient's surgical procedure and then discarded. The Cell Saver Elite System utilizes a unique bowl processing kit, but is compatible with Haemonetics standard reservoirs and A&A lines. The collected blood is processed through a centrifygal separation chamber (bowl) where RBCs are concentrated and then washed, removing unwanted substances such as hemolized cells, anticoagulant and irrigating fluids. The washed RBC product is available for return via a product bag to the patient. The Elite System is designed to perform plasma sequestration disposable in conjunction with an ancillary sequestration set prior to performing autotransfusion. The Cell Saver Elite system is designed to perform the same types of procedures as the Cell Saver 5 system, utilizing very similar disposable sets. The primary changes from the Cell Saver 5 to the Cell Saver Elite systems include a modernized graphical user interface with a touch screen display, barcode data capture capability to simplify data entry, and the integration of an onboard vacuum system to provide regulated vacuum to the collection reservoir.

Here's an analysis of the acceptance criteria and supporting studies for the Haemonetics Cell Saver Elite Autotransfusion System, based on the provided document:

Acceptance Criteria and Device Performance Study for Haemonetics Cell Saver Elite Autotransfusion System

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not explicitly state the sample sizes used for the test sets in the non-clinical laboratory studies (TR-CLN-100177, TR-CLN-100201, TR-CLN-100049).

The data provenance is internal in-house laboratory evaluations. There is no information regarding the country of origin of the data beyond "in-house laboratory" or whether it was retrospective or prospective. Given it is laboratory testing for performance characterization, it would typically be prospective testing conducted for the purpose of the submission.

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 studies are described as "in-house laboratory evaluations" characterizing device performance, not assessments based on expert-derived ground truth from a clinical data set. The ground truth for these tests would be the measured properties of the processed blood products (e.g., hematocrit, washout percentages), which are quantifiable laboratory values.

4. Adjudication Method for the Test Set

The concept of an "adjudication method" (like 2+1 or 3+1) is typically relevant for studies where subjective expert assessment is used to establish ground truth or evaluate a device's diagnostic output. Since these are laboratory performance studies measuring objective parameters of blood processing, an adjudication method is not applicable and therefore not mentioned. The "ground truth" for these studies is the direct measurement of the physical and chemical properties of the blood components.

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

There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The document describes non-clinical laboratory performance testing of the device itself and a comparison of its characteristics to a predicate device. It does not involve human readers evaluating output or comparing human performance with and without AI assistance.

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

The studies described are standalone performance studies of the device (Haemonetics Cell Saver Elite system) itself, focusing on its ability to process blood and produce a specific output (e.g., washed red blood cells, platelet-rich plasma). The device itself operates autonomously in its processing functions, so its performance is inherently "algorithm only" or "device only" in terms of its processing capabilities. There is no human interaction during the blood processing and characterization that would alter the device's fundamental performance metrics.

7. Type of Ground Truth Used

The ground truth used for these performance studies is objective, quantitative laboratory measurements of the processed blood products. This includes:

• Final product hematocrit
• Heparin Washout percentage
• Free Hemoglobin Washout percentage
• Red Blood Cell Recovery percentage
• Platelet count in platelet-rich plasma

These are direct physical and chemical measurements rather than subjective expert consensus, pathology reports, or patient outcomes.

8. Sample Size for the Training Set

This information is not applicable and therefore not provided. The Haemonetics Cell Saver Elite Autotransfusion System is a medical device that performs physical blood processing through centrifugation and washing. It is not an AI/ML-based diagnostic or prognostic algorithm that requires a "training set" in the computational sense. Its design and performance are established through engineering, physics, and validation testing, not machine learning training.

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

This information is not applicable. As stated above, the device does not use a training set as it is not an AI/ML system. Its "ground truth" for development and validation is based on established principles of blood processing, and performance is verified through rigorous laboratory testing against predefined specifications.

Ask a specific question about this device

The SmartSuction Solo device is an AC-powered, stand-alone device designed to be used as a suction source to replace wall suction in the operating room to remove fluids and debris from the surgical field during surgical procedures. The SmartSuction Solo device is intended for use by trained personnel under the direction of the physician.

The SmartSuction Solo device is not intended for endotracheal suction. The SmartSuction Solo device automatically adjusts suction up to 150 mmHg negative pressure when the suction tip is occluded. Do not use SmartSuction Solo device as a suction source in any procedure where 150 mmHg of suction could damage underlying tissue.

This device is intended for use by trained personnel under the direction of a physician. The attending physician is responsible for the proper use of these devices. Therefore, the device is to be used as a prescription medical device, which is indicated in the labeling as "Rx only".

Haemonetics® SmartSuction Solo™ (HSS) is a product line extension from the SmartSuction HARMONY™ device, which was cleared by FDA under K052626 in October 2005. The SmartSuction Solo device is an AC-powered, stand-alone device designed to be used as a suction source to replace wall suction in the operating room to remove fluids and debris from the surgical field during surgical procedures. The SmartSuction Solo device is intended for use by trained personnel under the direction of the physician. The attending physician is responsible for the proper use of these devices. Therefore, both these devices are to be used as a prescription medical device, which is indicated in the labeling as "Rx only".

Both electromechanical devices are the same and consist of a vacuum pump and control circuitry.

The provided text describes a 510(k) premarket notification for the Haemonetics® SmartSuction Solo™ device. It establishes substantial equivalence to a predicate device, the SmartSuction HARMONY™. However, the document does not contain specific acceptance criteria or a detailed study proving the device meets acceptance criteria in the format explicitly requested.

The document states: "Performance Testing - Bench Haemonetics has conducted testing to verify the electrical safety and performance characteristics as described in the Operation Manual. A detailed list of testing is provided with test protocols and reports." This indicates that performance testing was conducted, but the specifics of what those characteristics were, what the acceptance criteria for them were, and the results of those tests are not included in the provided text.

Therefore, I cannot fully complete the requested table and answer all questions directly from the provided input. However, I can extract the available information and highlight what is missing.

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information:

• Specific quantitative acceptance criteria (e.g., maximum allowable leakage current, minimum/maximum flow rates, precise suction pressure ranges beyond "up to 150 mmHg").
• Detailed test results for each of the performance characteristics.

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

The document does not specify a "test set" in the context of a clinical study with patients or human subjects. The performance testing mentioned is "Bench testing." Therefore, information on sample size for a test set and data provenance (country of origin, retrospective/prospective) for a clinical study is not provided.

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 as the document describes bench testing, not a study involving expert-established ground truth for a test set of data.

4. Adjudication method for the test set

This information is not applicable as the document describes bench testing, not a study requiring adjudication of a test set.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. The device is an AC-powered suction device, not an AI-assisted diagnostic tool.

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

This information is not applicable. The device is a physical medical device, not an algorithm. Bench testing constitutes a "standalone" evaluation of the device's technical performance.

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

For the bench testing, the "ground truth" would be established by engineering specifications, industry standards, and the predicate device's performance characteristics. The document states, "Haemonetics has conducted testing to verify the electrical safety and performance characteristics as described in the Operation Manual." This implies the operational manual and internal specifications serve as the "ground truth" against which the device's performance was measured.

8. The sample size for the training set

This information is not applicable. The document describes a physical medical device and bench testing, not a machine learning model requiring a training set.

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

This information is not applicable. The document describes a physical medical device and bench testing, not a machine learning model requiring a training set.

Ask a specific question about this device

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.

Ask a specific question about this device

The Haemonetics® Cardiovascular Perioperative Autotransfusion System (cardioPAT™) is indicated for use to salvage red blood cells from blood lost intraoperatively and postoperatively during cardiovascular surgical procedures, where the expected rate of processing of salvaged blood and fluid aspirated from the surgical site is less than or equal to two liters per hour. Autotransfusion is indicated for patients who meet at least one of the following criteria: The patient is expected to lose sufficient blood in the perioperative period, so as to require red blood cell transfusion, and autotransfusion will likely reduce or eliminate the need for allogeneic blood transfusion. Religious beliefs cause the patient to refuse allogeneic transfusion, but accept autologous transfusion. Compatible allogeneic blood is not available. The patient is unable to donate sufficient quantities of autologous blood prior to surgery to adequately cover the anticipated transfusion requirement. The patient or physician prefers perioperative autotransfusion rather than preoperative autologous donation or transfusion of allogeneic blood.

The cardioPAT system is designed to provide perioperative autotransfusion for patients undergoing cardiovascular surgery. The system consists of an electromechanical device and a sterile single-use disposable set, which together collect and process red blood cells lost during or after surgery. It is designed to be used in the operating room to recycle blood lost during cardiovascular surgical procedures and in the recovery room to recycle blood lost after surgery, where the expected rate of processing of salvaged blood and fluid aspirated from the surgical site is less than or equal to two liters per hour. It is a small portable system which mounts on an IV pole.

Here's a breakdown 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

Note: The document states, "The quality of salvaged red blood cells returned to the donor during autotransfusion procedures with both the current cardioPAT and modified cardioPAT system is acceptable with respect to measured markers." While specific numeric acceptance criteria are not explicitly given, the presentation of these mean values, with the accompanying statement of acceptability, implies these are the performance targets or within acceptable ranges determined by the manufacturer.

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

• Test Set Sample Size: The document does not explicitly state the total number of samples or "pools of different hematocrit blood" tested. It lists results for 5%, 15%, and 40% hematocrit levels, implying at least three distinct test conditions.
• Data Provenance: The study was conducted under "simulated use conditions." There is no information regarding the country of origin of the data or whether it was retrospective or prospective. The reference "From TP- & TR-DIS-02028" suggests an internal company test report.

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

This information is not provided in the document. The study appears to be a laboratory performance test measuring objective criteria (washout percentages, recovery percentage) rather than requiring expert assessment for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided, as the study involves objective measurements rather than subjective expert consensus.

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 information is not applicable as the device is an autotransfusion system, not a diagnostic AI system that would assist human readers in interpretation.

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

This information is not applicable as the device is an electromechanical autotransfusion system, not an algorithm, and its performance relies on its mechanical and operational function, not an algorithm's interpretation.

7. The Type of Ground Truth Used

The ground truth for this device's performance is based on objective laboratory measurements of:

• Supernatant concentrations of Heparin, Albumin, and Hemoglobin (used to calculate washout percentages).
• Red blood cell recovery percentage.

These are direct measurements of the physical properties and efficacy of the device's processing function.

8. The Sample Size for the Training Set

This information is not applicable as the device is an electromechanical system, not an AI/machine learning algorithm that requires a training set.

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

This information is not applicable for the same reason as above.

Ask a specific question about this device

The SmartSuction HARMONY device is an AC-powered suction device intended to be used as a suction source to replace wall suction in the hospital operating room to remove fluids and debris from the surgical field during surgical procedures.

The SmartSuction HARMONY device is not intended for endotracheal suction. The SmartSuction HARMONY device automatically adjusts suction up to 150 mmHg negative pressure when the suction tip is occluded. Do not use SmartSuction HARMONY device as a suction source in any procedure where 150 mmHg of suction could damage underlying tissue.

The SmartSuction HARMONY" device is an AC-powered, stand-alone device, designed to be used as a suction source to replace wall suction in the hospital operating room to remove fluids and debris from the surgical field during surgical procedures. The SmartSuction HARMONY device is designed to be used intra-operatively by trained operating room personnel under the direction of a physician. Therefore, it is to be used as a prescription medical device, which is indicated in the labeling as "Rx only".

The provided text describes a 510(k) summary for the Haemonetics SmartSuction HARMONY device. It outlines the device's intended use and performance testing. However, it does not contain detailed information regarding specific acceptance criteria, the methodology of a study proving those criteria, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC comparative effectiveness studies. The primary focus of the document is on establishing substantial equivalence to a predicate device based on similar technological characteristics and intended use, supported by "bench" performance testing.

Here's a summary of the requested information based only on the provided text, acknowledging what is missing:

Acceptance Criteria and Device Performance

The document states that "Haemonetics has conducted testing to verify the electrical safety and performance characteristics as described in the Operation Manual." However, the specific acceptance criteria and the reported performance values are not detailed in the provided text.

Note: The document asserts that "Verification and validation testing has been completed on the SmartSuction HARMONY and provide valid scientific evidence to demonstrate the devices are functionally equivalent" to the predicate device. This implies the device met its internal performance and safety criteria, but these criteria themselves are not listed.

Study Details

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

   • Sample Size: Not specified in the provided text.
   • Data Provenance: The testing is referred to as "Performance Testing - Bench." This suggests laboratory or bench-top testing, not clinical data from patients. No country of origin is specified for data. The testing is implicitly prospective, as it's for a new product verification, but this is not explicitly stated.

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

   • Number of Experts: Not applicable/Not specified. The testing described is "bench" performance testing, implying measurements against technical specifications rather than interpretations requiring expert consensus.
   • Qualifications of Experts: Not applicable/Not specified.

3. Adjudication method for the test set:

   • Adjudication Method: Not applicable/Not specified. The nature of "bench" testing typically involves objective measurements rather than subjective assessments requiring adjudication.

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

   • MRMC Study: No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence through "bench" performance testing and comparison of technological characteristics with a predicate device, not on assessing human reader performance with or without AI assistance.

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

   • Standalone Performance: Not applicable. The SmartSuction HARMONY is an AC-powered suction device, not an AI algorithm. Its performance is inherent to its electromechanical function.

6. The type of ground truth used:

   • Ground Truth: Not explicitly stated as "ground truth." For "bench" performance testing, the ground truth would typically be the established engineering specifications, safety standards, and functional requirements for the device. The device's ability to "automatically adjust suction up to 150 mmHg negative pressure when the suction tip is occluded" is a performance characteristic verified against a defined standard.

7. The sample size for the training set:

   • Sample Size: Not applicable. This is a hardware device, not an AI/machine learning algorithm that requires a training set.

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

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

Ask a specific question about this device

The Haemonetics® Cardiovascular Perioperative Autotransfusion System (cardioPAT™) is indicated for use to salvage red blood cells from blood lost intraoperatively and postoperatively during cardiovascular surgical procedures, where the expected rate of processing of salvaged blood and fluid aspirated from the surgical site is less than or equal to two liters per hour.

Autotransfusion is indicated for patients who meet at least one of the following criteria:

• The patient is expected to lose sufficient blood in the perioperative period, so as to require red blood cell transfusion, and autotransfusion will likely reduce or eliminate the need for allogeneic blood transfusion.
• Religious beliefs cause the patient to refuse allogeneic transfusion, but accept autologous transfusion.
• Compatible allogeneic blood is not available.
• The patient is unable to donate sufficient quantities of autologous blood prior to surgery to adequately cover the anticipated transfusion requirement.
• The patient or physician prefers perioperative autotransfusion rather than preoperative autologous donation or transfusion of allogeneic blood.

The cardioPAT system is designed to provide perioperative autotransfusion for patients undergoing cardiovascular surgery. The system consists of an electromechanical device and a sterile single-use disposable set, which together collect and process red blood cells (RBCs) lost during and after surgery. It is a small portable system which mounts on an IV pole. It is designed to be used in the operating room to recycle blood lost during cardiovascular surgical procedures and in the recovery room to recycle blood lost after surgery, where the expected rate of processing of salvaged blood and fluid aspirated from the surgical site is less than or equal to two liters per hour.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Haemonetics® Cardiovascular Perioperative Autotransfusion System (cardioPAT™):

The provided document describes a 510(k) submission for a medical device (cardioPAT™), which is for autotransfusion. The study presented here is a comparative study to demonstrate substantial equivalence to a predicate device (OrthoPAT®), rather than a standalone clinical trial establishing new efficacy. The "acceptance criteria" are implied by the comparison to the predicate device's performance.

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

The acceptance criteria are implicitly defined by acceptable deviations from the predicate device's performance, specifically less than 2% difference in washout values and less than 3% difference in red blood cell (RBC) recovery.

Reported cardioPAT™ Performance Summary (from Table 1):

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: The document mentions "pools of different hematocrit blood" processed. It does not specify the exact number of samples or "runs" for the cardioPAT system, but it presents mean values across these pools. For the predicate device (OrthoPAT®), it refers to "previously obtained, using similar pools of blood."
• Data Provenance: The study appears to be a laboratory-based performance test ("processed under simulated use conditions"). There is no mention of country of origin of data or whether it was retrospective or prospective in a clinical sense. It's a technical performance validation.

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

Not applicable. This is a technical performance study measuring physical properties (washout, RBC recovery) of blood, not a diagnostic or interpretative study requiring human expert ground truth.

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

Not applicable. This is a technical performance study based on direct laboratory measurements.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/diagnostic device and does not involve human readers interpreting data or assisting in a clinical decision.

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

This refers to a "standalone" performance of the device itself in processing blood. The data presented in Table 1 represents the "standalone" performance of the cardioPAT™ system under simulated use conditions.

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

The "ground truth" in this context refers to the measured physical and chemical properties of the processed red blood cells, specifically:

• Concentration of Supernate Heparin
• Concentration of Supernate Albumin
• Concentration of Supernatant Hemoglobin
• Red Blood Cell Recovery

These are objective measurements performed in a laboratory setting.

8. The sample size for the training set

Not applicable. This device is an electromechanical system for physical processing of blood, not an AI/machine learning algorithm that requires a "training set."

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

Not applicable. See point 8.

Ask a specific question about this device

The Cell Saver 5 Autologous Blood Recovery System is intended for use as an autotransfusion apparatus in conjunction with the Cell Salvage and Sequestration Protocols and single use sterile disposable sets. The Cell Saver 5 Autologous Blood Recovery System is intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processed red cell product to either a bag for gravity reinfusion into the patient or to the arterial line of an extracorporeal circuit for reinfusion into the patient. The intended use of the Sequestration Protocol is to collect an autologous preoperative platelet rich plasma product.

LN291A Haemonetics Basic Mini Volume (70mL) Cell Saver 5 Bowl Set is a functionally closed systems intended to be used to perform cell salvage using the CS5 Autologous Blood Recovery Svstem.

LN242 10L Waste Bag is intended to be used as an alternate waste bag with the CS5 Autologous Blood Recovery System.

This Special 510(k) premarket notification describes a modification to Haemonetics' currently legally marketed CELL SAVER 5 SYSTEM and the Cell Saver 5 Protocols and associated disposable sets. The proposed modifications involve the addition of a new smaller volume, blow molded bowl disposable set, the LN291A Basic Mini Volume (70mL) Cell Saver 5 Bowl Set and the associated software and hardware changes required to accommodate the smaller volume set. It also includes the addition of an alternate 10L waste bag, LN242. The intended use of the modified device is the same as for the predicate device and has not changed as result of the changes in software for the Cell Salvage and Sequestration Protocols.

Additionally, the design configuration, material composition, manufacturing methods and operational principles for the changed device are equivalent to those of the predicate device.

This document is a 510(k) premarket notification for a modification to an existing medical device, the Haemonetics Cell Saver 5 Autologous Blood Recovery System. The modification involves adding a new, smaller volume bowl disposable set (LN291A) and an alternate waste bag (LN242), along with associated software and hardware changes.

Therefore, the submission is focused on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and reported performance metrics in the way a novel device might. The document explicitly states: "These changes do not affect the intended use or alter the fundamental scientific technology of the device."

Given this context, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, MRMC study, how ground truth for training set was established) are not applicable because the submission is about demonstrating equivalence of a modified, existing device, not a de novo clearance requiring extensive clinical performance studies.

Here's an attempt to answer the questions based on the provided text, while acknowledging the limitations of the document's purpose:

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

The document does not explicitly state quantitative acceptance criteria or detailed reported device performance metrics in a table format. The basis for acceptance is a demonstration of substantial equivalence to the predicate device. The "performance" assessment is qualitative, focusing on whether the modifications adversely affect performance.

The key claim relating to performance is:

• "Verification testing has been performed and demonstrated that the performance of the modified device is not adversely affected by the software changes." (Section: DESIGN CONTROL ACTIVITIES)
• "The Cell Saver 5 Autologous Blood Recovery System, the Cell Saver 5 Protocols, software revision K, and its associated disposable set LN291A are substantially equivalent to legally marketed devices." (Section: CONCLUSION)

There are no specified numerical targets (e.g., specific recovery rates, wash efficiencies, or platelet counts) or measurements presented for the modified device to compare against. The "acceptance criteria" can be inferred as maintaining the established performance characteristics of the predicate device, which is considered satisfied by the "substantial equivalence" determination.

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

The document does not specify a "test set" in the context of a clinical study or data-driven performance evaluation. The "verification testing" mentioned is likely internal engineering and quality assurance testing related to the software and hardware changes, rather than a clinical trial. Therefore, sample size, data provenance (country of origin), and retrospective/prospective nature are not described.

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

Not Applicable. The submission does not detail a study involving expert-established ground truth. The assessment is based on design control activities and verification testing to ensure the modified device functions as intended and is equivalent to the predicate.

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

Not Applicable. There is no "test set" or adjudication process described for clinical performance.

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 an autotransfusion apparatus, not an AI-driven diagnostic or imaging device used with human readers.

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

Not Applicable. This is a hardware and software modification to a medical device, not an algorithm being evaluated in isolation. The "software changes" are integrated into the device's operation.

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

Not Applicable. The submission focuses on substantial equivalence based on engineering and performance characteristics relative to a predicate device, not on specific clinical endpoints validated by ground truth methods like pathology or expert consensus. The "ground truth" (if one could even apply the term loosely) would be the established performance and safety profile of the predicate device.

8. The sample size for the training set

Not Applicable. This document describes a modification to an existing device, not the development of a machine learning model that requires a training set.

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

Not Applicable. As per point 8, there is no training set mentioned or implied in this 510(k) submission.

Ask a specific question about this device

To be used with the Haemonetics Cell Saver HaemoLite 2 family of autologous blood recovery systems to collect, concentrate, and wash red blood cells from diluted intraoperative and post-operative shed blood for autotransfusion.

This Special 510(k) premarket notification describes a modification to Haemonetics' currently legally marketed autotransfusion disposable set LN163. The modifications are dimensional changes to 1) the centrifugal processing bowl, and the Final Product Bag and Waste Bag incorporated in the LN163 disposable set, and 2) the disposable thermoformed tub used for packaging of the LN163 disposable set. The intended use of the modified disposable set (the "LN193") is the same as for the LN163 disposable set and has not changed as result of the change in centrifugal blood processing bowl. Additionally, the design configuration, material composition, manufacturing methods and operational principles for the LN193 disposable set are equivalent to those of the LN163 disposable set.

Device Acceptance Criteria and Performance Study

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria or detailed performance metrics for the LN193 disposable set. Instead, the primary acceptance criterion is described as "substantial equivalence" to the predicate device (LN163).

However, the summary indicates that "Verification testing has been performed and demonstrated that the performance of the modified LN163 Disposable Set is not adversely affected by the listed changes." This implies that the device successfully met the intended performance standards, which are assumed to be consistent with the predicate device.

Given the information, the table is structured to reflect this focus on substantial equivalence rather than explicit numerical acceptance criteria.

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

The document does not specify a sample size for any test set. The term "verification testing" is used, but details on the number of units tested, the types of tests performed, or the data collected are not provided.

The data provenance is not explicitly stated. However, given it's a 510(k) submission from Haemonetics Corporation (Braintree, MA, USA), the testing would likely have been conducted in the United States or at facilities overseen by the company. It is a retrospective analysis in the sense that the data being submitted is from testing already completed, though the specific nature of the data (e.g., patient data, lab testing) is not detailed.

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

This information is not applicable and not provided for this type of device submission. The device is a disposable set for blood processing, not a diagnostic or screening tool requiring expert interpretation of results. The "ground truth" would be established by objective measurements and functional performance tests rather than expert consensus on diagnostic images or clinical findings.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods are typically used in studies where human interpretation or consensus is required, such as when establishing ground truth for medical imaging analysis. For a manufacturing change to a disposable blood processing set, verification testing would involve objective measurements and comparisons against specifications, not an adjudication process.

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 information is not applicable and not provided. The device is a disposable set for autotransfusion, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this submission.

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

This information is not applicable and not provided. The device is a physical disposable medical product, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The document does not explicitly define "ground truth" in a way that aligns with typical diagnostic or AI performance studies. For this device, "ground truth" would implicitly refer to the established performance specifications and functional requirements of the predicate device (LN163). The verification testing would have aimed to demonstrate that the modified LN193 met these same objective performance criteria related to:

• Red blood cell collection, concentration, and washing efficacy.
• Sterility and biocompatibility.
• Integrity and function of the physical components (bowl, bags, tubing).
• Compatibility with the HaemoLite 2 system.

These would be verified through engineering tests, material compliance, and functional performance assessments, not through expert consensus, pathology, or outcomes data in the typical sense.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The device is a physical product, not a machine learning model, so there is no concept of a "training set" in the context of this 510(k) submission.

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

This information is not applicable and not provided for the same reasons as #8.

Ask a specific question about this device