(66 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Total Cell Recovery | Ranged from 79% to 88% |
| Washout Efficiency of Contaminants | Ranged from 95% to 100% |
| Rate of processing of salvaged blood and fluid | Less than or equal to two liters per hour |
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.
§ 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).