Search Results

The Passio Pump Drainage System is indicated for intermittent drainage of recurrent and symptomatic malignant ascites. The catheter is intended for long-term access of the peritoneal cavity in order to relieve symptoms such as dyspnea or other symptoms associated with malignant ascites.

Not Found

I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, or any studies involving AI or ground truth. The document is an FDA 510(k) clearance letter for the "Passio Pump Drainage System," which is a medical device for draining malignant ascites, not an AI or software-based device. It confirms that the device is substantially equivalent to a legally marketed predicate device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

Ask a specific question about this device

The Passio Pump Drainage System is intermittent drainage of recurrent and symptomatic pleural effusions. The catheter is intended for long-term access to the pleural cavity in order to relieve symptoms such as dyspnes and chest discomfort associated with malignant pleural effusion and other recurrent effusions.

Not Found

I'm sorry, but this document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

The provided text is an FDA 510(k) clearance letter for the "Passio Pump Drainage System." This letter confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls. It details the device's indications for use (intermittent drainage of recurrent and symptomatic pleural effusions) and regulatory information.

However, it does not include any details on:

• Acceptance criteria: There's no table or description of specific performance thresholds for the device.
• Device performance data: No study results, metrics (e.g., accuracy, sensitivity, specificity, flow rate, pressure, durability), or reported performance numbers are present.
• Study design details: There's no information on sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Therefore, I cannot populate the table or answer the specific questions about the study that proves the device meets acceptance criteria, as that information is not in the provided text.

Ask a specific question about this device

The Passio Pump Drainage System is indicated for intermittent drainage of recurrent and symptomatic pleural effusions. The catheter is intended for long-term access to the pleural cavity in order to relieve symptoms such as dyspnea and chest discomfort associated with malignant pleural effusion and other recurrent effusions.

Not Found

The provided text is an FDA 510(k) clearance letter for the Passio Pump Drainage System. It grants clearance for a medical device used for draining pleural effusions.

Crucially, this document is a regulatory clearance letter and does NOT contain information about acceptance criteria or a study that proves the device meets those criteria, as typically found in a clinical study report or a pre-market submission summary for AI/ML-based devices.

The letter confirms substantial equivalence to a predicate device and discusses regulatory requirements, but it does not detail:

• Performance metrics (e.g., sensitivity, specificity, accuracy, precision).
• Sample sizes for test or training sets.
• Data provenance.
• Expert qualifications or adjudication methods for ground truth establishment.
• Multi-reader multi-case studies or standalone algorithm performance.
• The type of ground truth used.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details based on the provided text. This device is a physical pump drainage system, not an AI/ML-based diagnostic or assistive software, which is typically where the types of acceptance criteria and study designs you've listed would be relevant.

To answer your request, I would need a different type of document, such as a summary of safety and effectiveness data (SSED) or a clinical study report for an AI/ML-driven medical device, not a 510(k) clearance letter for a mechanical device.

Ask a specific question about this device