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The Haemocell System 350 is an autologous transfusion system designed to collect blood during or after an elective or emergency surgical procedure, filter the blood, process as required by the physician, and reinfuse the autologous blood.

The Haemocell System 350 is designed to be used in accordance with the American Association of Blood Banks, Guidelines for Blood Salvage and Reinfusion in Surgery and Trauma (1993). No change to the intended use of the System 350 is proposed as compared to the predicate devices.

The Haemocell System 350 is a device designed for collecting and reinfusing a patient's own blood. It comprises an electromechanical system called a Filter Pump and a range of sterile, single use disposable products which when used in accordance with their operating instructions are safe and effective in various surgical procedures.

The single use disposables comprise:

Collection Sets: These are plastic, biocompatible reservoirs of 600 and 1 200ml capacity which are used to contain blood suctioned from the patient during or after surgery. In both cases a regulated vacuum is applied to the collection reservoir by means of the hospital or a portable vacuum system. During surgery, a suction catheter provided with the collection reservoir is used to collect blood, whereas collection after surgery is effected by connecting a tube provided in the set to drains located at the surgical site by the surgeon.

Filter Sets: These are plastic, biocompatible, preassembled membrane filters connected to tubing and flexible containers. The sets are designed to locate on the electromechanical processing system in such a way that there is no contact between the processing system and the fluid content of the filter set, thus preserving the sterility of the fluid.

Reinfusion blood bags are located within either the collection set or filter set depending on the function of the set. The reinfusion bag is connected to the output of the filter set when processing is required and is used to reinfuse the processed blood when processing has been completed. Reinfusion is carried out under gravity, no pump operated or pressurised reinfusion is provided nor recommended.

The electromechanical hardware comprises:

• . A mobile stand on which the Filter Pump is located for ease of movement and which provides the location for fluid reservoirs.
• . A mains powered Filter Pump which when fitted with the correct disposables and set up according to the instructions for use will automatically process collected blood if required and selected by the operator. The Filter Pump is not required to be connected to the patient at any time in the procedure and can be operated by a circulating nurse or operating department assistant remote from the patient.

Various reusable hardware components are used with the system, such as a . vacuum canister for use with the 1200ml sterile collection reservoir to facilitate suction.

The provided text describes modifications to an existing device, the Haemocell System 350, and asserts its substantial equivalence to predicate devices. However, the text does not contain a specific study designed to prove the device meets pre-defined acceptance criteria in terms of performance metrics like accuracy, sensitivity, specificity, or improvement in human reader performance with AI assistance.

Instead, the document details a series of non-clinical tests to confirm that the modified device maintains the safety and effectiveness of the predicate device, rather than establishing new performance benchmarks for a novel AI or diagnostic system.

Here's an analysis of the provided information based on your requested headings, highlighting what is present and what is missing:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., accuracy, sensitivity, specificity) for device performance. Instead, it relies on demonstrating substantial equivalence to a predicate device through various non-clinical tests.

The reported performance is qualitative: "in in vitro tests to perform in a substantially equivalent way to the predicate devices with clinically insignificant differences."

2. Sample size used for the test set and the data provenance

The document refers to "in vitro biological function testing" but does not specify the sample size used for these tests. It also does not mention "data provenance" in terms of country of origin or whether it was retrospective or prospective, as the testing described is primarily for mechanical and biological compatibility/function rather than diagnostic performance on patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. The document describes technical and biological tests, not studies requiring expert consensus for ground truth on disease diagnosis or similar clinical outcomes.

4. Adjudication method for the test set

This information is not provided. As no ground truth establishment by experts is described, no adjudication method would apply.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This device is an autotransfusion apparatus, not a diagnostic AI system, so the concept of human readers improving with AI assistance is not applicable here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device is an electromechanical system with disposables, not a software algorithm for diagnostic purposes. Therefore, the concept of "standalone performance" in the context of an algorithm is not applicable. The device's function is automated processing of blood, operated by a circulating nurse or operating department assistant.

7. The type of ground truth used

The concept of "ground truth" in the context of diagnostic accuracy (e.g., pathology, outcomes data) is not applicable to the described device. The "ground truth" in the reported non-clinical tests would have been established by engineering specifications, validated biological standards, and comparisons to the performance of the predicate devices. For example, electromechanical tests would compare against standards like BS EN 60601-1-1, BS EN 60601-1-2, UL 544. Biocompatibility testing would be against Tripartite Biocompatibility Guidance for Medical Devices.

8. The sample size for the training set

This information is not applicable as the device is not an AI/machine learning system that requires a "training set."

9. How the ground truth for the training set was established

This information is not applicable as the device is not an AI/machine learning system.

In summary: The provided document is a 510(k) summary for device modification, focusing on demonstrating substantial equivalence to a predicate device through non-clinical engineering and biological tests. It does not describe a clinical study of diagnostic performance or AI effectiveness. Therefore, many of your specific questions related to AI performance, reader studies, and ground truth establishment in a diagnostic context are not addressed by this document.

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