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The EAGLE is intended to be used for diagnostic use in the treatment of pulmonary illnesses with an intended use and indication for use as a configurable, non-invasive pulmonary function tester (PFT) testing system. The EAGLE is indicated for use in: pulmonary function testing.
The Collins EAGLE (Diffusion Spirometer)is a Pulmonary Function Test System. is intended as a configurable, non-invasive pulmonary function tester (PFT) testing system. These tests are suitable for both pediatric and adult patient testing.

The EAGLE is a configurable, non-invasive pulmonary function tester (PFT) testing system. It includes a pneumotach (single-screen bi-directional device), commercially available pressure transducers, and gas analyzers (fast-response Infrared analyzer for CO, CO2, and CH4, and an electrochemical sensor for O2). It operates on 115-240 VAC 50-60 Hz.

The Collins Medical, Inc.'s EAGLE is a diffusion spirometer intended for diagnostic use in the treatment of pulmonary illnesses as a configurable, non-invasive pulmonary function tester (PFT) testing system for both pediatric and adult patients.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The given document does not explicitly present a table of acceptance criteria for the overall device directly alongside its performance. Instead, it lists performance specifications for key components and indicates conformity to recognized standards. I will extract these performance specifications for the core components that would typically have acceptance criteria.

2. Sample Size for the Test Set and Data Provenance

The provided document does not contain details about a specific clinical "test set" and its sample size for evaluating the EAGLE device. The submission relies on establishing substantial equivalence to predicate devices (Collins CPL - K992743 and Collins GEM - K030464) based on similar intended use, principle of operation, and technological characteristics.

The testing mentioned for component specifications (e.g., spirometer accuracy, gas analyzer performance) pertains to device verification/validation during development and manufacturing, not a clinical test set in the sense of patient data. For instance, the spirometer is calibrated using a "known volume displacement device 3-liter syringe as a standard." For gas analyzers, "step responses, linearity, noise, and drift parameters are monitored, and the pass/fail criteria are identical to that of the GEM" during production. This suggests internal testing against established engineering and performance standards, rather than a clinical study with patient data.

Therefore, there is no explicit sample size for a test set of patient data and no information on data provenance (e.g., country of origin, retrospective/prospective) for a dedicated clinical study for the EAGLE device in this document.

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

Since no specific clinical "test set" with patient data is detailed in the document, there is no information provided regarding experts used to establish ground truth for such a set. The regulatory pathway here is substantial equivalence to legally marketed predicate devices, which typically focuses on demonstrating that the new device is as safe and effective as the predicate without requiring extensive new clinical trials if the technological characteristics and indications for use are sufficiently similar.

4. Adjudication Method for the Test Set

As there is no clinical "test set" of patient data described, there is no adjudication method provided. The document describes internal testing and calibration methods that do not involve human adjudication in the context of interpreting patient results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

No MRMC study is mentioned or implied in this submission. The focus is on the device's technical specifications and substantial equivalence to predicates, not on comparing human reader performance with and without AI assistance.

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

The EAGLE is a pulmonary function testing system, not an AI-driven diagnostic algorithm. Its performance is inherent in its measurement capabilities. Therefore, the concept of "standalone performance" for an algorithm without human-in-the-loop is not applicable to this device as described. The performance metrics reported (e.g., accuracy, linearity, response time) are descriptive of the device's standalone operational capabilities.

7. The Type of Ground Truth Used

For the component performance, the ground truth used is based on:

• Known physical standards: For the spirometer, a "known volume displacement device 3-liter syringe as a standard" is used for calibration and accuracy verification.
• Known gas concentrations: For the gas analyzers, "known gas concentrations" are used for setting the span and ensuring accuracy.
• Engineering specifications and predicate device performance: For the gas analyzers, "pass/fail criteria are identical to that of the GEM," implying that the ground truth for acceptability is derived from the established performance of a predicate device.
• Recognized industry standards: Conformity to ATS (American Thoracic Society) standards implies adherence to clinically accepted performance benchmarks for spirometry and diffusing capacity measurements.

8. The Sample Size for the Training Set

The provided document does not describe any machine learning or AI components that would require a "training set" of data. The device's operation is based on established physical and chemical principles and therefore does not have a training set in the context of AI model development.

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

As there is no training set for an AI model, this question is not applicable.

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