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The VPOD™ Intrathoracic Pressure Regulator is indicated for the temporary decrease in intrathoracic pressure to increase blood circulation, as prescribed by a physician, licensed practitioner, or qualified technician. Recommended duration of use is up to four hours.

The proposed VPOD Intrathoracic Pressure Regulator (ITPR) is also intended to be used with patients who would benefit from increased venous return back to the heart for treatment of a number of different clinical conditions associated with severe hypotension but generates its own vacuum via the VPOD Motor and connects with a positive pressure source such as a separate ventilator or manual resuscitator bag.

The provided text is a 510(k) summary for the VPOD™ Intrathoracic Pressure Regulator. It describes the device, its indications for use, and its comparison to a predicate device (CirQlator™). The document outlines various tests conducted to demonstrate substantial equivalence but does not explicitly provide a table of acceptance criteria with reported device performance in the format requested.

However, based on the non-clinical testing and comparative performance sections, we can infer some of the performance aspects and the studies that support them.

Here's an attempt to structure the information as requested, though some details like specific numerical acceptance criteria are not explicitly stated in the document.

Acceptance Criteria and Study Details for VPOD™ Intrathoracic Pressure Regulator

The provided document, a 510(k) summary for the VPOD™ Intrathoracic Pressure Regulator (K172388), describes various tests and comparisons to establish substantial equivalence with its predicate device, the CirQlator™ (K070490). While explicit numerical acceptance criteria are not tabulated, the document details performance characteristics that were compared and found to be equivalent or superior.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Animal Study: The document explicitly mentions an "Animal Study" was conducted comparing the subject device to the predicate.

  • Sample Size: Not explicitly stated.
  • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). It is a "comparative performance" study.

• Bench Performance: No explicit sample sizes are provided for the various bench tests listed (e.g., Accuracy – airway pressure, flow rates, vacuum accuracy, etc.). These tests are presumed to be conducted in a laboratory setting.

  • Sample Size: Not explicitly stated.
  • Data Provenance: Laboratory testing.

• Biocompatibility: Tests were performed on materials.

  • Sample Size: Not explicitly stated for each specific test, but representative material samples would have been used.
  • Data Provenance: Laboratory testing.

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

This information is not provided in the document. The studies described are primarily technical performance tests (bench and animal), not clinical studies requiring expert ground truth for interpretation of outcomes from patient-derived data (e.g., image interpretation).

4. Adjudication Method for the Test Set:

This information is not applicable as the described tests are technical performance evaluations (bench and animal studies), not studies involving human interpretation or adjudication of diagnostic findings.

5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not conducted. The studies described are an animal study comparing device performance and various bench tests.

• Effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is neither an AI device nor a human reader study.

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

This question is not directly applicable as the VPOD™ Intrathoracic Pressure Regulator is a medical device, not an AI algorithm. Its standalone performance was evaluated through bench testing and, presumably, the animal study where its intrinsic function was assessed without human intervention in the mechanism of action. The device itself is designed to be "standalone" in its vacuum generation, while still being used with assisted ventilation by a clinician.

7. The Type of Ground Truth Used:

• Biocompatibility: Laboratory standard tests for cytotoxicity, irritation, sensitization, etc., against established ISO standards.
• Bench Performance: Engineering specifications, physical measurements, and compliance with relevant IEC/AAMI standards.
• Animal Study: Physiological parameters (e.g., mean arterial pressure, airway pressure measurements) directly measured in an animal model of compromised circulation, compared against predicate device performance.

8. The Sample Size for the Training Set:

This information is not applicable. The VPOD™ is a hardware medical device with integrated microprocessor control, not a machine learning model that requires a "training set" of data in the typical sense.

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

This information is not applicable for the same reason as #8. The device's control system and operational parameters would be based on engineering design, physiological principles, and iterative testing rather than a data training set.

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