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1. Warming transfusions, infusions, fluids.
2. Warming blood transfusions and return blood flow.

The ASTOFLO PLUS is a modified version of the ASTOFLO covered by K020060. The ASTOFLO uses the closed water circuit where the temperature of the closed water circuit is controlled by sensors. ASTOFLO PI.US uses dry heat warming and the control the sleeve temperature with integrated sensors.

The ASTOFLO PLUS blood warmer is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Stihler ASTOFLO 510(K) Number 020060 and Barkey Prismacomfort 510(K) Number K071909. The ASTOFLO PLUS blood warmer is used to warm the transfusions, infusions, fluids and also return blood flow in the medical field. The ASTOFLO PLUS warmer consists of one control unit and one sleeve warmer. The control unit (ASTOFLO PLUS) controls the sleeve warmer made by Stihler and displays alarm and status messages.

The ASTOFLO PLUS warmer warms blood, infusions, fluids and return blood flow by means of a silicon tube heat exchanger, which covers the fluid lines used in the medical field nearly complete. The heat is transferred by the contact of the resistance heating system to the inserted disposable lines need in the medical field. The nearly complete enclosure of the disposable lines used in the medical field to be warmed ensures that there is good warmth conduction to the fluids and there are no temperature losses to the surroundings. The warmth produced by the sleeve warmer is therefore transferred to the disposable lines used in the medical field and may be used with any therapy choices. when heat loss may cause undesirable cooling of the patient.

The sleeve warmer is powered with 22 VDC which is derived from 115 VAC (or where required 230 VAC), 50/60 Hz power supply and is controlled by an on-off switch on the front panel of the control unit Stihler ASTOFLO PLUS. Above the on-off switch is a display temperature monitor. The temperature of the sleeve warmer visual and audible alarms and other performance characteristic of the sleeve warmer are controlled electronically. Like the blood warmer Stihler ASTOFLO and the Barkey Prismacomfort, the sleeve warmer Stihler ASTOFLO PLUS is constructed as a slotted enclosed silicon tube, which can completely enclose inserted bluod return flow lines of up to 7.00 mm diameter. The ASTOFLO Plus weighs approx 3.0 kg and is equipped with a holder at the rear side of the control unit, which allows mounting on i.v. poles and medical rails. All three products, the Stihler ASTOFLO PLUS, Barkey Prismacomfort and the Sticker ASTOFI.O use sleeve warmers made of silicon. The flexibility of this material ensures a nearly complete enclosure of the disposable lines used in the medical field.

The provided text describes a 510(k) summary for a medical device called ASTOFLO PLUS, a blood and infusion warmer. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report with specific performance metrics for the new device.

Therefore, many of the requested categories cannot be fully addressed from the given document as it does not contain the specific information about detailed acceptance criteria, numerical performance results, sample sizes for test sets, expert involvement for ground truth, MRMC studies, or training set details that would typically be found in a detailed study report.

Here's an analysis based on the provided text, highlighting what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: Numerical acceptance thresholds for temperature, heating rates, alarm activation points, or other quantitative performance metrics are not provided in this summary.

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

• Sample Size: Not specified. The document states "the following tests were carried out successfully," but does not provide any information about the number of units tested, duration, or specific fluid volumes.
• Data Provenance: Not specified. No information about the country of origin of the data or whether the studies were retrospective or prospective is present.

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

• This information is not provided. The document outlines verification and validation activities related to engineering and safety standards, but not clinical studies involving expert interpretation or ground truth establishment in a clinical context.

4. Adjudication Method for the Test Set

• Not applicable/Not specified. There's no indication of a test set requiring adjudication in the context of clinical performance or interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. The document presents nonclinical tests and design control activities for substantial equivalence. It does not mention any MRMC studies comparing human readers with AI assistance. The device in question is a medical warmer, not an AI-assisted diagnostic tool.

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

• Yes, in a sense. The "tests were carried out successfully" to verify the system's ability to warm fluids and protect the patient. These are likely engineering and bench tests performed on the device itself without direct human interaction as part of the primary performance evaluation. However, the study details are not provided.

7. The Type of Ground Truth Used

• For the non-clinical tests mentioned, the "ground truth" would be established by engineering specifications, regulatory standards (e.g., DIN EN, ASTM, IEC), and predefined performance metrics for warming capabilities and safety mechanisms. For instance, a temperature sensor would provide the objective "ground truth" of the fluid temperature, measured against a specified target range. The document doesn't mention pathology, outcomes data, or expert consensus in relation to these tests.

8. The Sample Size for the Training Set

• Not applicable/Not specified. This device is an electromechanical warmer, not an AI/ML algorithm that requires a training set.

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

• Not applicable/Not specified, as it's not an AI/ML device requiring a training set.

Summary of Limitations from the Document:

The provided text is a 510(k) summary, which is designed to demonstrate "substantial equivalence" of a new device to existing legally marketed devices. It focuses on predicate device comparisons, safety standards compliance, and general functional verification, rather than detailed performance studies with granular data, statistical analyses, or human reader studies typically associated with AI/ML or complex diagnostic devices. Therefore, much of the requested information about specific acceptance criteria numerically, sample sizes, expert involvement, and reader studies is either not present or not applicable to this type of device and submission.

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