(120 days)
The XTRA Autotransfusion System is indicated for intraoperative recovery of blood, washing of blood collected in the postoperative period, and preoperative sequestration (with indirect patient connection). Typical clinical applications of autotransfusion include the following surgical specialties:
- Cardiovascular
- Orthopedics
- Thoracic
- Transplant Surgery
- Emergency (Trauma)
- Neurosurgery
- Obstetrics and gynecology
- Urology
XTRA Autotransfusion System consists of hardware and disposables. It is the next generation of the Sorin autotransfusion device family. The main elements of the hardware include the centrifuge, blood pump, automatic clamps, control and monitoring sensors, and an user interface (display panel and keyboard). The main modifications to the disposables are the elimination of the bowl snap on bayonet fitting system to fix the device into the centrifuge, the elimination of the silcone bayon inting bystem to and the newly designed system that allows the set up of the disposable set to simplify the installation of disposable.
Here's a breakdown of the acceptance criteria and study information for the XTRA Autotransfusion System, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state quantitative acceptance criteria for performance metrics. Instead, the basis for equivalence is primarily a comparison to a predicate device (Dideco ELECTA) and compliance with general safety standards.
| Criterion Type | Acceptance Criteria (Not explicitly quantitative in this document) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1 and FDA May 1, 1995 Memorandum for raw materials. Testing for Hemolysis, Hemocompatibility, Cytotoxicity, Intracutaneous Reactivity, Sensitization, Acute Systemic Toxicity, Mutagenicity, Sterility, Pyrogenicity, ETO residuals, and package integrity. Established specifications in each category met. | "The results of the testing met established specifications." (Implies individual tests passed their respective criteria, although specific values/limits are not provided). |
| In Vitro Performance | Compliance with performance specifications for electrical testing, electromagnetic compatibility testing, and general performance testing. Substantial equivalence to the predicate device (Dideco ELECTA). | "Testing supplied... includes electrical testing, electromagnetic compatibility testing, and performance testing that demonstrate compliance with performance specifications. The results of the study showed the device characteristics between XTRA Autotransfusion System and Dideco ELECTA were comparable." |
| Safety & Effectiveness | Substantial equivalence to the predicate device (Dideco ELECTA) in terms of safety and effectiveness. | "The results of in vitro studies demonstrate that the XTRA Autotransfusion System is substantially equivalent to the predicate device in terms of safety and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify the sample size for the "in vitro test results." It generally refers to "testing" and "the study."
- Data Provenance: The studies were in vitro (laboratory-based testing). The country of origin for the data is not explicitly stated, but the submitter is Sorin Group Italia S.r.l., suggesting the tests were likely conducted in Italy or a contracted facility. The studies appear to be prospective in nature, as they were conducted to support the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to the provided document. The studies described are in vitro performance tests and biocompatibility tests, not studies that would require human expert interpretation of device output to establish ground truth in the way a diagnostic imaging device might. Ground truth was established through validated laboratory testing procedures against established specifications and comparison to the predicate device's known characteristics.
4. Adjudication Method for the Test Set
This is not applicable. Since the device is an autotransfusion system and the testing described is primarily in vitro performance and biocompatibility, there is no "adjudication method" in the context of human interpretation of results (e.g., as in a clinical trial or image reading study). The results were likely assessed against pre-defined engineering and safety specifications by qualified testing personnel.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not mentioned or performed. This type of study is typically relevant for diagnostic devices where human readers interpret output (e.g., images), and the AI's impact on reader performance is evaluated. The XTRA Autotransfusion System is a therapeutic/surgical support device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the "in vitro test results" and biocompatibility tests can be considered standalone performance assessments. These tests evaluate the device's inherent characteristics and functionality (electrical, electromagnetic, performance specifications, and material interactions) without specific "human-in-the-loop" interaction directly influencing the measured outcomes for these particular tests. The device is a piece of medical equipment, and its performance is assessed based on engineering specifications and biological safety.
7. The Type of Ground Truth Used
The ground truth used for these studies consisted of:
- Established Specifications: For biocompatibility (e.g., limits for hemolysis, cytotoxicity) and engineering performance (electrical, electromagnetic, mechanical parameters).
- Predicate Device Characteristics: For the in vitro performance study, the Dideco ELECTA's characteristics served as the comparative "ground truth" or benchmark for demonstrating substantial equivalence.
8. The Sample Size for the Training Set
This information is not applicable. The XTRA Autotransfusion System is a physical medical device, not an AI/machine learning algorithm that requires a "training set" in the computational sense. The device's design, engineering, and manufacturing would be based on established principles and prior experience, but not a data-driven training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as 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).