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510(k) Data Aggregation
(270 days)
StatusFirst™ CHF (Congestive Heart Failure) NT-proBNP is a rapid test for the in vitro quantitative determination of N-terminal pro-Brain natriuretic peptide (NT-proBNP) in human EDTA plasma. The device is intended for use with the DXpress™ Reader to provide quantitative results as an aid in the diagnosis of CHF.
The StatusFirst™ CHF NT-proBNP test device utilizes biotin coupled anti-NTproBNP antibody/streptavidin solid-phase chromatographic immunoassay technology to quantitatively determine the concentration of NT-proBNP in human EDTA plasma. After a sample has been dispensed into the sample well, the StatusFirst™ CHF NTproBNP test device is placed in the DXpress™ Reader. The DXpress™ Reader displays the NT-proBNP concentration 15 minutes after sample addition. The DXpress™ Reader is programmed to automatically convert the intensity of the test band (as indicated by the "pBNP" line on the test device) into a concentration of NTproBNP by using lot specific calibration factors supplied with each box of 20 StatusFirst™ CHF NT-proBNP test devices. The NT-proBNP concentration in the sample correlates with the intensity of the test band.
The provided document describes a 510(k) premarket submission for the StatusFirst™ CHF NT-proBNP device, which measures NT-proBNP levels for aid in CHF diagnosis. The study described is a method comparison study intended to demonstrate substantial equivalence to a predicate device, the Roche Elecsys® proBNP Immunoassay.
Here's an analysis of the provided information according to your requested categories:
Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list "acceptance criteria" in a pass/fail format with specific thresholds. Instead, it presents the results of a method comparison study against a predicate device, aiming to demonstrate substantial equivalence. The "reported device performance" is primarily shown through the correlation between the StatusFirst™ device and the predicate.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (StatusFirst™ CHF NT-proBNP vs. Elecsys® proBNP) |
|---|---|
| Good correlation for CHF subjects (compared to predicate) | Spearman Rank correlation: 0.922 (n = 324) |
| Good correlation for non-CHF subjects (compared to predicate) | Spearman Rank correlation: 0.948 (n = 324) |
| Good correlation for all subjects combined (compared to predicate) | Spearman Rank correlation: 0.973 (n = 648) |
| Agreement in measuring range (though predicate has wider range, the functional range of the new device should be clinically useful and comparable) | StatusFirst™ Measuring Range: 20-5,000 pg/mL Elecsys® proBNP Measuring Range: 5-35,000 pg/mL (StatusFirst™ falls within a relevant clinical range) |
| Functional Sensitivity (comparable to predicate) | StatusFirst™ Functional Sensitivity: 20 pg/mL Elecsys® proBNP Functional Sensitivity: < 50 pg/mL (StatusFirst™ is superior or equal) |
| Limit of Detection (comparable to predicate) | StatusFirst™ Limit of Detection: 20 pg/mL Elecsys® proBNP Limit of Detection: 5 pg/mL (Predicate is more sensitive, but StatusFirst's LOD is within a clinically relevant range) |
| Precision (acceptable CV values) | StatusFirst™ Precision: Within run: 11.1-16.8%CV Total: 12.4-18.1%CV (at various concentrations) Elecsys® proBNP Precision: E170 Within run: 0.9-1.1%CV; E170 Total: 3.7-5.8%CV E1010/2010 Within run: 1.8-2.7%CV; E1010/2010 Total: 2.3-3.2%CV (StatusFirst™ shows higher CVs than predicate) |
| Minimal interference from common substances/drugs | StatusFirst™ Limitations: No interference from bilirubin (10.0 mg/dL), hemoglobin (100 mg/dL), triglycerides (1500 mg/dL), d-biotin (100 ng/mL), rheumatoid factors (2030 IU/mL), creatinine (20 µg/mL), human albumin (16 g/dL), 63 common pharmaceuticals. |
The study "proves" the device meets acceptance criteria by demonstrating good correlation and comparable performance characteristics to the legally marketed predicate device, forming the basis for the FDA's determination of substantial equivalence. The provided data suggests that while some performance metrics (like precision and limit of detection) differ, the overall performance, particularly the strong correlation, supports this claim.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set:
- CHF subjects: 355
- Non-CHF subjects: 333 (282 apparently healthy, 51 with diabetes, renal insufficiency, hypertension or chronic obstructive pulmonary disease)
- Total for correlation analysis (after exclusion): 648 (324 CHF + 324 non-CHF) – Note: the document states N=324 for CHF and N=324 for non-CHF for Spearman Rank correlation, implying some samples were out of range or excluded from this specific calculation.
- Data Provenance: The document does not explicitly state the country of origin. The study is retrospective as it involves "patient samples" that were measured with both devices, implying existing samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This study is a method comparison of a diagnostic test (NT-proBNP measurement) against a predicate device, not an interpretation of images or clinical data by experts to establish a "ground truth" diagnosis. The "truth" for this study is the measurement obtained by the predicate device. The classification of subjects as "CHF subjects" and "non-CHF subjects" would have been based on clinical diagnoses, but the process of how these initial diagnoses were established is not detailed in this submission.
4. Adjudication method for the test set
Not applicable. As noted above, this is a method comparison study for an in vitro diagnostic device, not a study where human interpretation of data requires adjudication. The comparison is between quantitative results produced by two different instruments.
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 is not an AI-based device or an imaging interpretation study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in a sense. The StatusFirst™ CHF NT-proBNP device is an in vitro diagnostic (IVD) test system. Its standalone performance refers to its ability to accurately measure NT-proBNP concentrations. The method comparison study directly evaluates this "standalone" performance by comparing its quantitative results against a predicate IVD device, independent of human interpretation or intervention in the measurement process itself, other than operating the device. The DXpress™ Reader automatically converts the test band intensity to a concentration.
7. The type of ground truth used
The "ground truth" for this method comparison study is the quantitative NT-proBNP concentration obtained from the Roche Elecsys® proBNP Immunoassay, which is the legally marketed predicate device. The study aims to show that the new device's measurements are highly correlated with and similar to those of the predicate.
8. The sample size for the training set
Not applicable. This medical device (immunoassay) is not based on a machine learning algorithm that requires a "training set" in the conventional sense. The device's calibration refers to internal manufacturer processes using clinical calibrators and a 5-parameter logistic curve fit, but this isn't analogous to training data for an AI model.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" as understood in machine learning. The calibration data used by the manufacturer is based on "clinical calibrators" and internal procedures, designed to accurately reflect NT-proBNP concentrations.
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