Search Results
Found 1 results
510(k) Data Aggregation
(117 days)
The Strive™ Dual Zone PFM is a monitoring device that measures Peak Expiratory Flow (PEF) generated by the patient during a forced exhalation maneuver. The device will monitor the PEF of patients whose doses of medication are dependent upon a measured obstruction in PEF.
The Strive™ Peak Flow Meter is designed for children five years or older and adults. The intended environments for use include home, hospitals and clinics.
The Strive™ Dual Zone Peak Flow Meter (PFM) is a hand-held monitoring device that measures Peak Expiratory Flow (PEF) generated by the patient during a forced exhalation mancuver. It can be used to objectively measure PEF by tracking day-to-day changes in breathing patterns.
The Strive™ PFM meets the Standards of Spirometry, 2005 revision, for portable peak flow meters as established by the American Thoracic Society and also meets ISO23747, First edition 2007-07-15, for Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans. The Strive™ PFM and product insert meets the educational guidelines recommended by the National Asthma Educational Prevention Program (NAEPP) of the National Institutes of Health.
The Strive™ PFM has two scale ranges to make the device suitable for both pediatric (+5 yrs) and adult patients who use a peak flow meter as part of their treatment program for respiratory conditions. A range selector is used to select the scale that best fits the patient's needs as determined by a healthcare provider. The device incorporates the NAEPP three zone color codes. The color-coded zone indicators on the side of the device adjust to define the patient's red, yellow and green zones. They can be readjusted as recommended by a healthcare provider.
The provided text describes a 510(k) summary for the Strive™ Dual Zone Peak Flow Meter (PFM). It focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove the device meets specific acceptance criteria through clinical trials. Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance and AI-specific metrics is not available in the provided document.
However, based on the non-clinical testing sections, we can infer the acceptance criteria for performance and the type of evaluation conducted.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Performance: | |
| - Conformance to ATS Standard of Spirometry: 2005 | The Strive™ Dual Zone PFM was tested for performance, including Functional testing per the American Thoracic Society (ATS) Standard of Spirometry: 2005. The Strive™ Dual Zone PFM meets the same ATS standard as the predicate device, the TruZone® PFM. |
| - Conformance to ISO 23747 International Standard (First edition 2007-07-15) for peak expiratory flow meters | The Strive™ Dual Zone PFM was tested for performance, including ISO 23747 International Standard for peak expiratory meter. The Strive™ PFM meets ISO23747, First edition 2007-07-15, for Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans. |
| - Improved accuracy at low flow-rates (compared to predicate) | The Strive™ PFM has improved accuracy at low flow-rates. (This is a design improvement, not a specific quantifiable acceptance criterion with a numerical value in the document, but it's stated as a characteristic.) |
| Environmental Performance: | Environmental Testing was conducted. (No specific results or acceptance criteria are detailed, but the conclusion states it "meets performance requirements.") |
| Operational Performance: | Operational Testing was conducted. (No specific results or acceptance criteria are detailed, but the conclusion states it "meets performance requirements.") |
| Mechanical Life Cycle: | Mechanical Life Cycle testing was conducted. (No specific results or acceptance criteria are detailed, but the conclusion states it "meets performance requirements.") |
| Comparison to Predicate Device (TruZone® PFM): | All other testing (beyond ATS standard) was found to be comparable to the TruZone® PFM. The Strive™ Dual Zone PFM has the same function and intended use as the predicate device, TruZone® PFM. The Strive™ Dual Zone PFM meets the same ATS standard as the predicate device, the TruZone® PFM. |
| Safety and Effectiveness: | The Strive™ Dual Zone PFM ... raises no new issues of safety or effectiveness. (This is the overarching conclusion required for 510(k) clearance, implying that all tests met criteria such that safety and effectiveness are maintained, and it is substantially equivalent to the predicate.) |
2. Sample size used for the test set and the data provenance
The document describes non-clinical performance and functional testing against established standards (ATS, ISO 23747). It does not mention a "test set" in the context of clinical data or patient samples. The testing would have involved physical units of the Strive™ Dual Zone PFM and potentially simulated exhalation profiles, as per the standards. Specific sample sizes of devices or simulated breath cycles for these non-clinical tests are not provided in this summary. There is no data provenance in terms of country of origin or retrospective/prospective for clinical data, as no clinical study was performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No clinical expert-based ground truth was established for a "test set" as no clinical study was conducted. The "ground truth" for the non-clinical tests would be the specifications and requirements defined by the ATS and ISO standards.
4. Adjudication method for the test set
Not applicable. No clinical test set requiring adjudication was used.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a physical medical device (peak flow meter) and does not involve AI or human readers for diagnostic interpretation. Therefore, no MRMC study or AI-assisted improvement analysis was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device and does not involve an algorithm for standalone performance evaluation in the context of AI. Its "standalone performance" is its accuracy and reliability in measuring PEF, which was evaluated against the ATS and ISO standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical and functional testing, the "ground truth" was established by recognized industry and medical standards: the American Thoracic Society (ATS) Standard of Spirometry: 2005 and ISO 23747 International Standard. These standards define the acceptable range of accuracy and performance for peak flow meters.
8. The sample size for the training set
Not applicable. This device is a physical medical device and does not involve machine learning or AI models, so there is no training set in that context.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for AI/machine learning, this question is not relevant.
Ask a specific question about this device
Page 1 of 1