(90 days)
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.
| Acceptance Criteria (Implied from Test Intent) | Reported Device Performance |
|---|---|
| Software User Interface (EBL Display) | Passed |
| Validate update to software user interface with display of Estimated Blood Loss (EBL) volume. | Passed |
| Biocompatibility of New Reservoir Materials | Passed |
| Demonstrate the biocompatibility of the new reservoir, containing materials different from the predicate device. | Passed |
| Transportation & Aging Testing for Reservoir (Package Integrity & Device Stability) | Passed |
| Demonstrate the package integrity and device stability of the new reservoir, up to a six-month shelf life. | Passed |
| Electrical Hardware (Increased-Capacity Battery Safety) | Passed |
| Demonstrate the electrical safety of the increased-capacity battery. | Passed |
| EMC (Modified Device Compliance) | Passed |
| Demonstrate the EMC compliance of the modified device. | Passed |
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.
§ 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).