(240 days)
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
| Acceptance Criteria | Reported Device Performance (OrthoPAT™ System) |
|---|---|
| Total cell recovery | Ranged from 79% to 88% |
| Washout efficiency of contaminants | Ranged from 95% to 100% |
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.
§ 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).