(243 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Total Cell Recovery | 79% to 88% |
| Washout Efficiency of Contaminants | 95% to 100% |
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.
§ 868.5830 Autotransfusion apparatus.
(a)
Identification. An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.(b)
Classification. Class II (performance standards).