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The OrthoPAT Perioperative Autotransfusion System is indicated for use to salvage 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 perioperative 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® system consists of a single-use disposable set and an electromechanical device. The patient's blood is contained within the disposable set, is used for both intraoperative and postoperative processing (concentration and washing) of shed blood. The concentrated red blood cells are deposited into a bag. The bag is removed from the OrthoPAT system prior to the blood being reinfused.

The electromechanical device controls the collection process, the separation and washing process and the flow of fluids through the disposable. It contains a centrifuge, a pneumatic system, a valve system, electronic circuitry, a rechargeable battery, software for monitoring and controlling the operation of the system, and a separately-mounted display panel with a control keypad.

The system is compact, light weight, can be mounted on an IV pole or bed frame, and is designed to follow the patient from the operating room, to the recovery room, and, if necessary, to the hospital floor. The on-board rechargeable battery provides power to the system to maintain suction while the patient is being transported. The system functions automatically without a dedicated operator.

The OrthoPAT® Perioperative Autotransfusion System is a medical device designed to salvage and process a patient's own blood lost during and after surgery, making it available for autologous transfusion.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states that "An in vitro simulation of use test of the OrthoPAT system demonstrated the quality of blood product produced by it." However, the specific sample size for this in vitro test is not explicitly mentioned in the provided text.

The data provenance is in vitro simulation of use. The country of origin is not specified, but the submission is to the U.S. Food and Drug Administration (FDA), implying the study might have been conducted or overseen according to U.S. regulatory standards. The study was prospective in the sense that it was a controlled in vitro simulation designed to assess performance.

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

The provided text does not mention the use of experts to establish ground truth for the in vitro simulation. Performance metrics like "Total cell recovery" and "Washout efficiency of contaminants" are typically determined through laboratory assays and measurements against established standards for blood product quality, rather than expert consensus on individual "cases."

4. Adjudication Method for the Test Set

The provided text does not mention any adjudication method as would be relevant for subjective assessments. The results appear to be objective measurements from an in vitro test.

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 typically for image-based diagnostic devices where human readers interpret images with and without AI assistance. The OrthoPAT system is an autotransfusion device, not a diagnostic imaging device.

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

The performance data presented ("Total cell recovery" and "Washout efficiency") are representative of the standalone performance of the OrthoPAT system itself. The device is described as functioning "automatically without a dedicated operator," which supports the idea that the reported performance metrics reflect the algorithm/system's capabilities without direct human intervention in the processing steps.

7. The Type of Ground Truth Used

The ground truth for the performance claims (Total Cell Recovery and Washout Efficiency) was likely established through:

• Laboratory assays and analytical techniques: For example, measuring hemoglobin concentration or red blood cell count to determine recovery, and measuring markers of contaminants (e.g., plasma proteins, free hemoglobin) to determine washout efficiency.
• Established scientific/medical standards: The quality of blood product is assessed against accepted standards for autologous transfusion, though these specific standards are not detailed in the document.

8. The Sample Size for the Training Set

The provided text does not mention a training set. This is consistent with the nature of the device. The OrthoPAT system is an electromechanical device with software that "monitoring and controlling the operation of the system." It's not an AI/ML device that requires a "training set" in the conventional sense to learn patterns. Its operation is likely based on pre-programmed algorithms and control logic derived from engineering principles and physiological requirements for blood processing.

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

As no training set is mentioned or relevant for this type of device, the concept of establishing ground truth for a training set does not apply here. The device's operational parameters and control logic would have been designed and validated through engineering principles and possibly pre-clinical testing, rather than an AI training process.

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The OrthoPAT Orthopedic Perioperative Autotransfusion system is indicated for use to salvage RBCs from blood lost intraoperatively and postoperatively during orthopedic surgery procedures. Appropriate orthopedic procedures include joint replacement (primary and revision), and spinal fusion and instrumentation. 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 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™ system consists of a single-use disposable set and an electromechanical device. The patient's blood is contained within the disposable set, is used for both intraoperative and postoperative processing (concentration and washing) of shed blood. The concentrated red blood cells are deposited into a bag. The bag is removed from the OrthoPAT system prior to the blood being reinfused.

The electromechanical device controls the collection process, the separation and washing process and the flow of fluids through the disposable. It contains a centrifuge, a pneumatic system, a valve system, electronic circuitry, a rechargeable battery, software for monitoring and controlling the operation of the system, and a separately-mounted display panel with a control keypad.

The system is compact, light weight, can be mounted on an IV pole or bed frame, and is designed to follow the patient from the operating room, to the recovery room, and, if necessary, to the hospital floor. The on-board rechargeable battery provides power to the system to maintain suction while the patient is being transported. The system functions automatically without a dedicated operator.

The acceptance criteria and study proving device performance are detailed below:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The study was an in vitro simulation of use test. The specific sample size for this test is not explicitly stated in the provided document. The data provenance is also not explicitly stated beyond being an "in vitro simulation," which implies a controlled laboratory setting rather than patient data from a specific country. Given the nature of a 510(k) submission, it is assumed to be prospective data collected for the purpose of demonstrating device performance for regulatory approval.

3. Number of Experts and their Qualifications for Ground Truth

The provided document does not mention using experts to establish ground truth or their qualifications for the in vitro simulation test. The performance metrics (total cell recovery and washout efficiency) are objective, quantitative measurements derived from the experimental simulation rather than expert interpretation.

4. Adjudication Method for the Test Set

The concept of an adjudication method (e.g., 2+1, 3+1) is typically relevant for studies involving subjective interpretations, such as image analysis by human readers. For the in vitro simulation of use test described, which measured objective performance metrics like cell recovery and washout efficiency, an adjudication method is not applicable and therefore not mentioned.

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

No MRMC comparative effectiveness study was done. The study described is an in vitro performance evaluation of the device itself, not a study assessing the impact of the device on human reader performance.

6. Standalone Performance Study

Yes, a standalone performance study was done. The "in vitro simulation of use test" directly assessed the performance of the OrthoPAT system in terms of total cell recovery and washout efficiency, independent of human operators beyond the execution of the simulation itself. This constitutes an algorithm-only (device-only in this context) performance evaluation.

7. Type of Ground Truth Used

The ground truth used was based on quantitative laboratory measurements from an in vitro simulation. This means the performance metrics (total cell recovery and washout efficiency) were derived from direct experimental measurements of the blood product produced by the OrthoPAT system under simulated conditions, rather than expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set

The provided document does not mention a training set sample size. The OrthoPAT system is a medical device, not an AI/ML algorithm that typically requires a training set. The performance data presented relates to the functionality of the electromechanical device and its disposable set.

9. How Ground Truth for the Training Set Was Established

As the device is not an AI/ML algorithm, a "training set" and its associated ground truth establishment methods are not applicable and therefore not mentioned in the document. The performance evaluation focuses on the in vitro functionality of the physical device.

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The OrthoPAT™ Orthopedic Perioperative Autotransfusion System is intended for use in major orthopedic surgical procedures, such as joint replacement or spinal fusion to salvage red blood cells lost during and after surgery. It processes the shed blood to separate and wash the red blood cells (RBCs) and make them available for autologous transfusion to the patient.

The OrthoPAT™ system consists of a single-use disposable set and an electromechanical device. The patient's blood is contained within the disposable set, is used for both intraoperative and postoperative processing (concentration and washing) of shed blood. The concentrated red blood cells are deposited into a bag. The bag is removed from the OrthoPAT system prior to the blood being reinfused.

The electromechanical device controls the collection process, the separation and washing process and the flow of fluids through the disposable. It contains a centrifige, a pneumatic system, a valve system, electronic circuitry, a rechargeable battery, software for monitoring and controlling the operation of the system, and a separately-mounted display panel with a control keypad.

The system is compact, light weight, can be mounted on an IV pole or bed frame, and is designed to follow the patient from the operating room, to the recovery room, and, if necessary, to the hospital floor. The on-board rechargeable battery provides power to the system to maintain suction while the patient is being transported. The system functions automatically without a dedicated operator.

The provided document is a 510(k) Summary of Safety and Effectiveness for the OrthoPAT™ Perioperative Autotransfusion System. It details the device's description, intended use, and claims of substantial equivalence to predicate devices, supported by performance data.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not explicitly state the sample size (number of runs or tests) used for the in vitro simulation. It refers to "an in vitro simulation of use test."
• Data Provenance: The study was an "in vitro simulation of use test," meaning it was conducted in a lab setting, not on human subjects. The country of origin of the data is not specified, but the submitter is based in Natick, MA, USA. The study is prospective in nature, as it simulates future use of the device.

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. For an in vitro simulation of a medical device, "ground truth" would typically be established by established laboratory measurement standards and protocols, not necessarily expert consensus from medical professionals in the same way it would be for diagnostic imaging.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. The performance data presented (total cell recovery, washout efficiency) are objective, quantitative measurements derived from the in vitro tests, not subjective interpretations requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence through in vitro performance data, not by comparing human reader performance with and without AI assistance.

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

Yes, the performance data provided is for the device operating in a standalone manner (in vitro simulation). The reported metrics (cell recovery, washout efficiency) reflect the device's inherent capability to process blood without direct human intervention impacting these specific performance parameters during the processing phase. The device is designed to function automatically without a dedicated operator.

7. The Type of Ground Truth Used

For the in vitro simulation, the ground truth would be based on:

• Established laboratory measurement standards: The percentage of total cell recovery and washout efficiency would be measured using validated analytical methods.
• Reference materials: Known concentrations of red blood cells and contaminants would be used in the simulated blood input, allowing for a precise calculation of recovery and removal rates.

8. The Sample Size for the Training Set

This information is not applicable. The OrthoPAT™ system is a mechanical and electromechanical device with software for control, not a machine learning or AI-based diagnostic tool that requires a "training set" in the conventional sense of supervised learning algorithms. Its design and performance are based on engineering principles and in vitro testing.

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

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

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