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510(k) Data Aggregation
(51 days)
COLLINS MEDICAL, INC.
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.
| Component / Parameter | Acceptance Criteria (Stated Performance) | Reported Device Performance (Same as criteria as these are specifications) |
|---|---|---|
| Spirometer | ||
| Pneumotach Resistance |
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(30 days)
COLLINS MEDICAL, INC.
The GEM 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 GEM is indicated for use in: pulmonary function testing.
The Collins GEM (Gas Exchange Module) is a Pulmonary Function Test System. is intended as a configurable, non-invasive pulmonary function tester (PFT). These tests are suitable for both pediatric and adult patient testing. Compatible with the Collins' Body Plethysmograph as an optional module.
The GEM (Gas Exchange Module) is a configurable, non-invasive pulmonary function tester (PFT) testing system. It includes a spirometer (pneumotach), gas analyzers (infrared for CO, CO2, CH4 and electrochemical for O2), and associated electronics.
The Collins GEM (Gas Exchange Module) is a diagnostic spirometer intended for use in pulmonary function testing.
Here is a summary of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature/Parameter | Acceptance Criteria (Standard/Reference) | Reported Device Performance |
|---|---|---|
| Spirometer Metrics | ||
| Resistance (Pneumotach) |
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(380 days)
COLLINS MEDICAL, INC.
Ask a specific question about this device
(28 days)
COLLINS MEDICAL, INC.
The Collins CPL Pulmonary Function Test System is intended as a configurable, noninvasive pulmonary function testing (PFT), and exercise/nutritional/metabolic testing system. Complete plethysmography capabilities are an optional module. These tests are suitable for both pediatric and adult patient testing.
Not Found
The provided text is a 510(k) premarket notification summary for the Collins CPL Pulmonary Function Test System. It contains information related to the device's intended use and FDA clearance but does not include any details about acceptance criteria, specific performance studies, sample sizes, or ground truth establishment.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: This information is not present.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method: Not mentioned.
- Multi-reader multi-case (MRMC) comparative effectiveness study information: Not mentioned.
- Standalone performance study information: Not mentioned.
- Type of ground truth used: Not mentioned.
- Sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
The document is a clearance letter and intended use statement, asserting substantial equivalence to a predicate device (GS Modular Pulmonary Function Test System, 510(k) K925459), rather than a detailed study report. To get the requested information, you would typically need to refer to the full 510(k) submission, which is often not publicly available in its entirety, or more specifically, to the performance testing section within that submission.
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