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510(k) Data Aggregation
(30 days)
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) | < 1.4 cmH2O/L/Sec @ 14 L/Sec | < 1.4 cmH2O/L/Sec @ 14 L/Sec (from pneumotach description) |
| Volume Accuracy | +/- 3% | +/- 3% |
| Resistance (GemTach - separate component) | < 0.5 cmH2O/L/Sec @ 14 L/Sec | < 0.5 cmH2O/L/Sec @ 14 L/Sec |
| Accuracy (GemTach) | +/- 3% | +/- 3% |
| Flow Range (GemTach) | Not explicitly stated as acceptance criteria, but given as specification | +/- 15 L/Sec |
| Gas Analyzers Metrics | ||
| Response (Multi-Gas: CO, CO2, CH4) | Not explicitly stated as acceptance criteria, but "fast-response" mentioned and monitored during production with pass/fail criteria identical to CPL | < 100 ms |
| Accuracy (Multi-Gas: CO, CO2, CH4) | Not explicitly stated as acceptance criteria, but monitored during production with pass/fail criteria identical to CPL | 1% |
| Linearity (Multi-Gas: CO, CO2, CH4) | Not explicitly stated as acceptance criteria, but monitored during production with pass/fail criteria identical to CPL | < 1% |
| Noise (Multi-Gas: CO, CO2, CH4) | Not explicitly stated as acceptance criteria, but monitored during production with pass/fail criteria identical to CPL | < 1% full scale |
| Response (Oxygen) | Not explicitly stated as acceptance criteria, but "fast-response" mentioned and monitored during production with pass/fail criteria identical to CPL | 80 ms |
| Accuracy (Oxygen) | Not explicitly stated as acceptance criteria, but monitored during production with pass/fail criteria identical to CPL | 1% |
| General Compliance/Performance | ||
| Electrical Safety | UL 2601-1, EN 60601-1, IEC 60601-1-1, CSA 22.2 No. 1 | Conforms as stated implicitly by listing standards |
| Emissions and Immunity | IEC 60601-1-2 | Conforms as stated implicitly by listing standards |
| Spirometry Performance | ATS American Thoracic Society Standardization of Spirometry 1994 Update | Conforms as stated implicitly by listing standards |
| Single-breath Carbon Monoxide Diffusing Capacity | ATS American Thoracic Society Recommendations for a Standard Technique - 1995 Update | Conforms as stated implicitly by listing standards |
2. Sample Size Used for the Test Set and Data Provenance:
The provided document describes the technical specifications and adherence to recognized standards for the Collins GEM device. It does not contain information about a specific "test set" in the context of a clinical performance study with human subjects or a defined dataset. The performance metrics listed are technical specifications that would be verified through engineering and calibration tests, not typically a clinical test set with patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The document does not describe a study involving expert-established ground truth for a test set. The validation appears to be based on adherence to engineering specifications and industry standards.
4. Adjudication Method for the Test Set:
Not applicable. The document does not describe a study involving adjudication of a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. This device is a diagnostic instrument, not an AI-based interpretation tool.
6. Standalone (Algorithm Only) Performance Study:
Yes, in the sense that the device's technical specifications and performance are evaluated independently against established standards and calibration procedures. The description mentions "production, step responses, linearity, noise, and drift parameters are monitored, and the pass/fail criteria are identical to that of the CPL." This implies standalone testing of the device's components against predefined thresholds.
7. Type of Ground Truth Used:
The "ground truth" for the device's technical specifications is rooted in:
- Industry Standards: Performance guidelines set by organizations like the American Thoracic Society (ATS) for spirometry and carbon monoxide diffusing capacity.
- Calibration Standards: Use of known volume displacement devices (e.g., 3-liter syringe) and known gas concentrations for calibration.
- Engineering Specifications: Internal design and performance thresholds for electrical, mechanical, and analytical components.
8. Sample Size for the Training Set:
Not applicable. This document describes a medical device, not an AI model, so there is no concept of a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As there is no training set for an AI model, this question is not relevant to the provided text.
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