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· Evacuate air and/or fluid from the chest cavity or mediastinum.
· Help re-establish lung expansion and restore breathing dynamics.
Chest Drain Auto transfusion (ATS)
To facilitate collection of autologous blood from the patient's pleural cavity or mediastinal area for reinfusion purposes in postoperative and trauma blood loss management.

Atrium's Auto transfusion (ATS) Chest Drains are sterile, single use, disposable devices that mimic a traditional "3 Bottle Systems".

A closed thoracic drainage system (chest drain and catheter together) are used to restore the chest to a more normalized condition after surgery, trauma, or spontaneous need for air and/or fluid to be removed. The Auto transfusion (ATS) features of the drains facilitate postoperative collection and reinfusion of autologous blood from the patient's pleural cavity or mediastinal area.

This document describes a 510(k) premarket notification for Atrium Medical Corporation's Auto transfusion (ATS) Chest Drains, specifically the Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, and Express Dry Seal Chest Drain. The filing argues for substantial equivalence to previously cleared predicate devices (K043140 and K043582).

Here's an analysis of the acceptance criteria and study information provided (or absence thereof):

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of acceptance criteria with specific quantitative performance metrics. This 510(k) submission is focused on demonstrating substantial equivalence to predicate devices, rather than meeting novel performance criteria through new clinical trials.

The performance is implicitly described as being equivalent to the predicate devices and that the device "performs as well as the predicate devices."

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

• Test Set Sample Size: Not applicable. No dedicated "test set" in the context of clinical performance evaluation is mentioned for the modified device. The document states, "There were no clinical studies of the modified device."
• Data Provenance: Not applicable for a new clinical study. The submission relies on the established safety and performance of the predicate devices and extensive non-clinical testing of the modified devices.

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

Not applicable. No ground truth establishment by experts for a new clinical test set is mentioned.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set or adjudication method is mentioned.

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

Not applicable. This device is an auto transfusion chest drain, which is a physical medical device, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

Not applicable in the context of a new clinical performance study. The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices (K043140 and K043582), as well as compliance with relevant voluntary standards and successful completion of non-clinical tests.

8. The Sample Size for the Training Set

Not applicable. The device is not an AI/ML algorithm that requires a training set.

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

Not applicable. The device is not an AI/ML algorithm.

Summary of Acceptance Criteria and "Study" (Non-Clinical) Proving Equivalence:

The primary "acceptance criterion" for this 510(k) submission is substantial equivalence to existing legally marketed predicate devices. The "study" that proves this involves a comprehensive non-clinical assessment, outlined as follows:

Acceptance Criteria (Implied for Substantial Equivalence):

• Same Intended Use: The modified devices must have the same indications for use as the predicate devices.
• Similar Technological Characteristics: The modified devices must operate on the same fundamental scientific technology and have similar features. Any differences in technological characteristics must not raise new questions of safety or effectiveness.
• Similar Materials: The major materials of construction must be the same or demonstrably equivalent in terms of safety and biocompatibility.
• Performance: The modified devices must perform as well as the predicate devices.
• Safety: The risks associated with the intended use must be acceptable and compatible with a high level of protection of health and safety.

"Study" (Non-Clinical Testing) Proving Equivalence:

The document states that Atrium Medical's development process required the completion of the following non-clinical activities:

• Specification Review: Ensuring the designs meet predefined criteria.
• Performance Testing: Verifying the functional aspects of the device.
• Biocompatibility Testing: Evaluating the device's interaction with biological systems (e.g., ISO 10993 series).
• Sterility Testing: Confirming the device is sterile and maintains sterility.
• Stability Testing: Assessing the device's ability to maintain its properties over time (shelf life).
• Design Validation: Ensuring the device meets user needs and intended uses.

These non-clinical tests, along with compliance with voluntary standards (Section 9, though not provided in the excerpt), are the basis for demonstrating that the modified devices are safe and effective and perform as well as the predicate devices, thereby supporting the claim of substantial equivalence. The submission also relies on the low complaint rates and reportable events of the predicate devices over the last 5 years as evidence of acceptable clinical safety and performance.

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