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The Automatic Continuous Effusion Shunt (ACES) System is indicated for use in adult (>21 years of age) patients with • chylothorax • intractable aseptic pleural effusion

The ACES System is an implanted pleural-peritoneal shunt system intended to palliate symptoms of recurrent pleural effusion, an accumulation of fluid in the cavity around the lungs. The ACES System comprises a pump that is, generally, a resilient flexible bulb having an inlet and an outlet. The inlet is attached to a first fenestrated barium striped tube that extends from the inlet valve to the patient's pleural cavity. The outlet is connected to a second fenestrated barium striped tube that extends from the outlet valve to the patient's peritoneal cavity. Each one-way valve is connected to a single pump chamber with an internal automatic pump extension and external manual compression and an integrated implant securement flange for suture fixation in the muscular facia. Internal (intercostal) automatic (passive) pump extension is placed between adjacent ribs in the external (subdermal) manual compression (active) pump extension is positioned under the skin and external to the ribs. Using a patient's own respiration, the internal automatic pump extension operates by being successively compressed and decompressed between adjacent ribs, as the patient breathes, whereby pumping the fluid from the pleural cavity to the peritoneal cavity, where it is naturally reabsorbed by the external manual compression pump extension allows for intraprocedural priming of the pump chamber as well as manual compression by the patient, post procedurally, at will or as directed by their physician for movement of fluid from the pleural cavity to the peritoneal cavity.

Here's a breakdown of the acceptance criteria and study information for the Automatic Continuous Effusion Shunt (ACES) System, based on the provided FDA 510(k) summary:

This device is a Class II medical device (Peritoneo-venous shunt), product code KPM. Its primary function is to move fluid from the pleural cavity to the peritoneal cavity in adult patients with chylothorax or intractable aseptic pleural effusion.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document primarily details non-clinical performance and biocompatibility testing. It doesn't present specific numerical acceptance criteria (e.g., "flow rate must be X mL/day") with corresponding numerical performance results. Instead, for most tests, the acceptance criterion is implied as "Pass" and the reported performance is simply "All samples passed the acceptance criteria."

Note: The document states that the biocompatibility evaluation supports an implant duration of 12 months, beyond which removal is recommended, and that chronic toxicity and carcinogenicity were "Not evaluated".

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

The document does not explicitly state the numerical sample sizes for each test in the "Non-Clinical Performance Tests" or "Biocompatibility" sections. For most tests, it simply states "All samples passed the acceptance criteria."

• Test Set Sample Size: Not specified numerically for individual tests.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, given this is a 510(k) summary for a US FDA submission, the tests were likely conducted in accordance with recognized international standards (ISO, ASTM) and GLP (Good Laboratory Practice) guidelines, often performed by contract research organizations. The testing appears to be prospective bench and animal (biocompatibility) testing rather than human clinical data.

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

This information is not applicable as the studies described are non-clinical (bench and animal testing). There is no "ground truth" established by human experts in the context of diagnostic performance for these types of engineering and biological safety tests. The ground truth for these tests is defined by the objective measurement and standards outlined in the test methods.

4. Adjudication Method for the Test Set

This is not applicable for non-clinical performance and biocompatibility testing. Adjudication methods like 2+1 or 3+1 are used in clinical studies, especially for evaluating diagnostic performance where expert disagreement needs to be resolved.

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

No, a MRMC comparative effectiveness study was not done. The provided document details bench and biocompatibility testing for a medical device (a shunt system), not a diagnostic algorithm that requires human reader interpretation. No mention of AI assistance or human reader improvement appears in this summary.

6. If a Standalone Study Was Done (Algorithm Only Without Human-in-the-Loop Performance)

This is not applicable. The ACES System is a physical medical device, not a software algorithm or AI model.

7. The Type of Ground Truth Used

For the non-clinical performance tests, the "ground truth" is based on pre-defined engineering specifications, standard test methods (e.g., pressure thresholds, flow rates, tensile strength values), and visual inspection criteria.

For biocompatibility tests, the "ground truth" is based on established biological safety endpoints and accepted international standards (ISO, USP) for reactions in in-vitro assays and animal models. For example, "non-cytotoxic," "non-sensitizer," and "no systemic toxic effects" represent the ground truth for biological safety.

8. The Sample Size for the Training Set

This is not applicable. The ACES System is a physical medical device, not a machine learning model. There is no "training set."

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

This is not applicable as there is no training set for a physical medical device.

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