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The HemoSonic™ 200 can be used to observe, diagnose, evaluate, and monitor at-risk patients from 15 to 150 kg by providing hemodynamic information for determining therapeutic actions and maintaining cardiovascular stability.

The probe jacket contains the acoustic gel into which the ultrasound crystals are placed. It consists of a plug rod, tip cap, hub, body, acoustic gel and tip.

This 510(k) submission describes a "Probe Jacket for the HemoSonic™ 200 Hemodynamic Monitor," which is an accessory to an existing hemodynamic monitor. Based on the provided information, the submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with specific performance metrics against defined acceptance criteria for clinical diagnostic performance.

Therefore, many of the requested categories regarding clinical study design, ground truth establishment, expert adjudication, and comparative effectiveness are not applicable or not explicitly detailed in this type of submission. This 510(k) is about a device component whose safety and effectiveness are established through physical and material property testing, rather than a diagnostic algorithm.

Here's the breakdown of what can be extracted from the provided text according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document states, "Tests were performed to demonstrate substantial equivalence in the following areas: • tensile strength, • acoustic properties, • simulated insertion, and • biocompatibility." It doesn't list specific numerical acceptance criteria or performance values. The conclusion is that "The results of the laboratory tests demonstrate that the device is as safe and effective as the legally marketed predicate devices," implying successful meeting of internal criteria designed to show equivalence.

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

This information is not provided in the given 510(k) summary. The "tests" mentioned are laboratory tests, not clinical studies with patient data.

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

This information is not applicable/not provided. The ground truth for laboratory tests like tensile strength or acoustic properties is based on established engineering and materials science standards, not expert adjudication of clinical data.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are used for clinical diagnostic studies where expert consensus on interpretations is needed. For mechanical and material properties, standardized test methods are followed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is for evaluating the impact of a diagnostic device (often AI-assisted) on human reader performance, typically in interpreting medical images or data. The "Probe Jacket" is a physical accessory and not a diagnostic algorithm.

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

No, a standalone algorithm performance study was not done. This device is a physical accessory, not a standalone algorithm.

7. The Type of Ground Truth Used

The ground truth used for the performance tests (tensile strength, acoustic properties, simulated insertion, biocompatibility) would be based on engineering standards, material specifications, and established biocompatibility testing protocols. It is not clinical "expert consensus," "pathology," or "outcomes data" in the diagnostic sense.

8. The Sample Size for the Training Set

This information is not applicable/not provided. This device does not involve a "training set" in the context of machine learning or AI algorithms. The "training" for such devices would involve manufacturing process controls and quality assurance, not data training.

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

This information is not applicable/not provided. As there is no training set in the AI sense, this question is not relevant to this device submission.

In summary: The K040802 submission for the "Probe Jacket for the HemoSonic™ 200 Hemodynamic Monitor" is a 510(k) for an accessory device. The evaluation of its safety and effectiveness relied on demonstrating substantial equivalence through laboratory tests of its physical and material properties, rather than clinical efficacy studies often associated with diagnostic devices or AI algorithms. Therefore, much of the requested information pertinent to clinical study design and AI validation is not applicable to this particular submission.

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