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

The ATS Suction Line is a suction line to aspirate and anticoagulate blood from the surgical field into an autotransfusion reservoir with ¼" suction port connected to a vacuum source.

The ATY Y-Adapter is a Y-Adapter to connect two autotransfusion reservoirs with 1/4´´ female outlet connector to an autotransfusion device.

The ATO Oxygenator Line is a tubing system to connect an oxygenator with 1/4´´ male connector to an autotransfusion device: - via a Y-adapter connected to an autotransfusion reservoir; or

• directly to the autotransfusion device accepting a 1/4´´ female connector; or

• via an autotransfusion reservoir.

The ATS Suction Line consists of a double lumen tubing set for collection and anticoagulation of shed blood in surgery or trauma. The large tubing is used for aspiration of the shed blood. The small tubing welded to the large tubing provides anticoagulation. The large suction tube and small anticoagulation tube meet at the Yankauer adapter, to provide anticoagulation immediately after collection of blood. The suction line is connected to the appropriate collection reservoir by a ¼´´ female connector. The anticoagulant line is spiked to a anticoagulant container. Anticoagulant dosage is controlled by a roller clamp and regulates the drip rate of the anticoagulant into the drip chamber. The Yankauer adapter is designed to adapt to suction tips from 6.5 to 9.5 mm outer diameters.

The ATY Y-Adapter is a disposable tubing set used to connect two autotransfusion reservoirs to an autotransfusion disposable set prior to processing. Each branch of the Y-Adapter may be attached to the blood outlet port of two reservoirs by 2 stepped ¼´´ adapters. Each branch connecting to the reservoirs has a pinch clamp to control flow to the autotransfusion device. The Y-Adapter outlet line has a universal adapter fitting for ¼´ male connectors or 3/8´´ female connectors. Alternatively, the ATY Y-Adapter can be used to connect one autotransfusion reservoir and one oxygenator line to an autotransfusion device.

The ATO oxygenator line is a disposable tubing set for the collection or transfer of shed blood from the extracorporeal circulation (ECC) in cardiac surgery to an autotransfusion reservoir or to an autotransfusion device prior to processing. The is connected to the coronary perfusion port of an oxygenator prior to priming ECC. After conclusion of ECC, it may be connected to the free branch of a Y-adapter attached to an autotransfusion reservoir outlet, or directly to the blood inlet line of an autotransfusion device for direct processing. Alternatively it may be connected to a ¼" inlet connector of an autotransfusion reservoir to empty the oxygenator content into the reservoir prior to processing.

All three devices are for single patient use, sterilized using ethylene oxide gas, and the fluid paths are non-pyrogenic.

Acceptance Criteria and Device Performance Study for Fresenius C.A.T.S Autotransfusion Accessories

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance:

The document does not explicitly state the numerical sample sizes for each specific test (e.g., number of devices tested for structural integrity or biocompatibility). However, it implies testing was conducted on a sufficient number of devices to demonstrate compliance.

The data provenance is not explicitly stated in terms of country of origin. The studies appear to be retrospective in the sense that they were performed on manufactured devices to validate their properties and then submitted for regulatory approval.

3. Number of Experts and Qualifications for Ground Truth:

This document does not describe a study involving human experts to establish ground truth in the way one might for diagnostic imaging devices. The "ground truth" here is compliance with established engineering and biocompatibility standards. The experts involved would have been the internal Fresenius Hemotechnology, Inc. engineers, scientists, and regulatory affairs personnel responsible for designing, testing, and validating the devices against these predefined standards. Their qualifications would likely include expertise in biomaterials, medical device design, manufacturing, and regulatory compliance.

4. Adjudication Method:

Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or evaluations where human readers interpret data to establish ground truth (e.g., radiologists reading images). This type of adjudication is not applicable to the technical and performance testing described in this document for the autotransfusion accessories. The compliance was determined by direct measurement and analysis against predefined technical specifications and standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study assesses how human readers perform with and without AI assistance, which is irrelevant for these autotransfusion accessories as they are not AI-powered diagnostic or assistive devices requiring human interpretation.

6. Standalone Performance Study:

Yes, a standalone performance study was done in the sense that the devices themselves were tested against technical specifications and standards (e.g., biocompatibility testing, structural integrity testing, shelf-life studies). This testing focused solely on the inherent performance characteristics of the devices without human interaction other than setting up and operating the testing equipment. The goal was to prove the devices' ability to function as intended and safely under specified conditions.

7. Type of Ground Truth Used:

The ground truth used was based on established industry standards and regulatory requirements. Specifically:

• Biocompatibility: Applicable standards for cytotoxicity, sensitization, intracutaneous toxicity, systemic toxicity, hemocompatibility (hemolysis), genotoxicity, and pyrogenicity.
• Structural Integrity: Requirements to withstand twice the flow capacity and negative/positive pressures associated with autotransfusion device use.
• Packaging and Sterility: Requirements for protecting devices, maintaining sterility, and demonstrating a one-year shelf-life.
• Overall Suitability: Compliance with AAMI/ANSI standards for autotransfusion devices.

8. Sample Size for the Training Set:

This question is not applicable. These are medical devices (tubing sets, adapters) and not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The "training" in this context refers to the design and refinement process of the physical device, which typically involves iterations of prototypes and bench testing, but not a formally defined "training set" like in AI development.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no "training set" for these physical medical devices. The design and manufacturing process would be guided by engineering principles, material science, and regulatory requirements, with validation against the "ground truth" of established standards as described in point 7.

Ask a specific question about this device