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510(k) Data Aggregation
(51 days)
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 | < 1.4 cmH2O/L/Sec @ 14 L/Sec | < 1.4 cmH2O/L/Sec @ 14 L/Sec |
| Volume Accuracy | +/- 3% | +/- 3% |
| GEMtach | ||
| Linearity | 2% | 2% |
| Resistance | < 0.5 cmH2O/L/Sec @ 14 L/Sec | < 0.5 cmH2O/L/Sec @ 14 L/Sec |
| Accuracy | +/- 3% | +/- 3% |
| Flow Range | +/- 15 L/Sec | +/- 15 L/Sec |
| Multi-Gas (Infrared CO, CH4, CO2) | ||
| CO, CH4 Range | 0-3000 ppm | 0-3000 ppm |
| CO2 Range | 0-15% | 0-15% |
| Response | < 100 ms | < 100 ms |
| Sample Rate | 100 Hz | 100 Hz |
| Accuracy | 1% | 1% |
| Linearity | < 1% | < 1% |
| Noise | < 1% full scale | < 1% full scale |
| Oxygen Analyzer (Electrochemical) | ||
| Range | 0.1-100% O2 | 0.1-100% O2 |
| Accuracy | 1% | 1% |
| Response | 80 ms | 80 ms |
| Overall Performance Standards | ATS American Thoracic Society Standardization of Spirometry 1994 Update | Conforms to ATS standards |
| & | ATS American Thoracic Society Single-breath Carbon Monoxide Diffusing Capacity (Transfer Factor) Recommendations for a Standard Technique - 1995 Update | Conforms to ATS standards |
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.
Ask a specific question about this device
(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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(380 days)
Ask a specific question about this device
(28 days)
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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