Search Results

The Preassembled Surgical Wash Set is intended for use with specific Autotransfusion machines which are identified on the primary label. It contains the basic components necessary to process blood collected during open heart or other surgical procedures for autotransfusion.

The Preassembled Surgical Wash Set is sterile, non-pyrogenic device designed for blood collection from the operating field or from the extracorporeal circuit, washing, concentrating and reinfusion of the blood products to the patient. The Preassembled Surgical Wash Set is composed of a rotary separation chamber (i.e. bowl) and bags connected with the appropriate the a connectors to fit the intended autotransfusion equipment.

The device may be offered in different configurations based on the specific autotransfusion machine for which it is designed. The basic components and the intended use remain the same.

The device is a modified version of the unmodified device, Preassembled Surgical Wash Set.

The provided document describes a 510(k) submission for a modified "Preassembled Surgical Wash Set." The study conducted is a non-clinical in vitro test comparing the modified device to the unmodified predicate device to demonstrate substantial equivalence, rather than a study defining acceptance criteria for a new AI or diagnostic device based on performance metrics like sensitivity or specificity.

Therefore, many of the requested categories (like number of experts, adjudication methods, MRMC studies, standalone performance for AI, and specific ground truth types) are not applicable to this type of device and study. The information provided focuses on the physical and functional characteristics of a medical device used for blood processing.

Here's an attempt to answer the questions based on the available information, noting when a question is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a table with specific quantitative acceptance criteria or performance metrics directly. Instead, the "acceptance criterion" essentially was that the modified device would perform "in a manner substantially equivalent to the unmodified Preassembled Surgical Wash Set with respect to biocompatibility and the functional parameters." The reported performance is that the "results of these tests met established specifications" and the device "performs in a manner substantially equivalent to the unmodified Preassembled Surgical Wash Set."

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify a numerical sample size for the in vitro tests. It mentions that "all the tests were performed on sterile wash sets where only the bowl was aged (accelerated aging up to 3 + 1 years)." It also states that "For comparative purpose the modified and unmodified Preassembled Surgical Wash Sets were compared." This implies at least one modified set and one unmodified set were tested for each scenario, but a specific quantity is not given.
• Data Provenance: The study was conducted in-house by the manufacturer ("internal methods developed by the manufacturer"). The country of origin would be Italy (where Sorin Group Italia is located). It is an in vitro study, not a human-data-based study (prospective or retrospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• Not applicable. This study is a non-clinical, in vitro comparison of a physical medical device. Ground truth, in the context of expert review for diagnostic or AI devices, is not relevant here. The "ground truth" is established by the physical and chemical properties and functional performance of the devices as measured by internal test methods.

4. Adjudication Method for the Test Set

• Not applicable. See explanation for #3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• Not applicable. This study is for a physical medical device (wash set), not an AI or diagnostic tool involving human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

• Not applicable. This pertains to an AI algorithm; the device being studied is a physical wash set.

7. The Type of Ground Truth Used

• The "ground truth" for this engineering and functional performance study is implicitly the established specifications and performance of the predicate (unmodified) device, against which the modified device was compared. This is based on in vitro measurements and comparisons of physical properties, biocompatibility, and functional operation (blood processing).

8. The Sample Size for the Training Set

• Not applicable. This is not a machine learning or AI study; therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

• Not applicable. See explanation for #8.

Ask a specific question about this device