(464 days)
The Access AccuTnl+3 Reagent for use on the UniCel Dxl Access Immunoassay Systems is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnl) levels in human serum and plasma using the UniCel Dx1 Acess Immunoassay Systems to aid in the diagnosis of myocardial infarction.
The Access AccuTnI+3 Calibrators for use on the UniCel DxI Access Immunoassay Systems are intended to calibrate the Access AccuTn1+3 Reagent for the quantitative determination of cardiac troponin I (cTnl) levels in human serum and plasma using the UniCel DxI Access Immunoassay Systems to aid in the diagnosis of myocardial infarction.
The UniCel DxI 800 Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
The Access AccuTnI+3 Reagents, AccuTn1+3 Calibrators and the UniCel Dx1 800 Access Immunoassay System compose the Access Immunoassay System for the quantitative determination of cardiac troponin I (cTnl) in human serum and plasma.
The Access AccuTnl+3 Reagent packs contain specific reagents for the in virro diagnostic measurement of cTnl including:
- Paramagnetic particles coated with mouse monoclonal anti-human cardiac troponin I (cTnl) suspended in TRIS buffered saline, with surfactant, bovine serum albumin (BSA) matrix.
Here's an analysis of the provided 510(k) summary, specifically focusing on the acceptance criteria and the study proving the device meets them:
Disclaimer: This response is based solely on the provided text. A full understanding of the device's performance would require reviewing the complete 510(k) submission and potentially additional studies. The document provided is a summary, meaning it may not contain all the detailed information typically found in a full study report.
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on comparing the new device (Access AccuTnI+3) to a predicate device (ADVIA Centaur® TnI-Ultra™). While it lists some characteristics for both, explicit "acceptance criteria" for the new device's performance that it must meet are not clearly delineated as pass/fail thresholds in a dedicated section. However, performance characteristics are reported in the comparison table, which implicitly act as the device's claimed performance.
For the purpose of this request, I will extract relevant performance characteristics from the "Differences between the Access AccuTnI+3 Reagent and Calibrator and the Predicate" table, as these are the new device's specific claims, and then discuss what can be inferred as "acceptance."
| Characteristic | Acceptance Criteria (Implied / Comparator) | Reported Device Performance (Access AccuTnI+3) |
|---|---|---|
| Analytical Measuring Range | Predicate: 0.008 ng/mL to 50 ng/mL (The new device is implicitly accepting that its range is adequate, whether narrower or wider, as long as it supports the intended use. In this case, the range is different but considered acceptable for the intended use of aiding in MI diagnosis.) | 0.03 ng/mL to 80 ng/mL (This is the stated measuring range of the Access AccuTnI+3.) |
| **Acute Myocardial Infarction | ||
| (AMI) Cutoff** | Predicate: 0.78 ng/mL per WHO-defined cutoff (The new device demonstrates a different cutoff, but implies it is clinically validated.) | 0.03 ng/mL based on clinical trial outcome (This is the specific AMI cutoff determined for the Access AccuTnI+3 through its clinical trial.) |
| **Expected Results (Upper | ||
| Reference Limit)** | Predicate: 99th percentile of 0.04 ng/mL; range of 0.02-0.06 ng/mL (The new device's URL is presented as its own derived value, implying it's acceptable for clinical use.) | 99th percentile upper reference limit (URL) is 0.075 ng/mL. SD ≤0.006 at concentrations ≤0.075 ng/mL (These are the stated precision characteristics for Access AccuTnI+3. The low end precision (SD) shows particular attention to the critical low-level measurements.) |
Study Proving Device Meets Acceptance Criteria:
The document states: "In addition, verification and validation testing, the clinical and analytical data, the clinical use of the product reflected in current MI diagnostic guidelines, and other scientific information provided in this submission demonstrate that the Access AccuTnI+3 Reagent, Access AccuTnI+3 Calibrators on the UniCel DxI Access Immunoassay Systems is as safe and effective as the predicate devices."
This statement indicates that a combination of verification and validation (V&V) testing, along with clinical and analytical data, was submitted to support the device's claims and its substantial equivalence to the predicate. The specific studies mentioned directly related to establishing the AMI cutoff and the 99th percentile URL are:
- "0.03 ng/mL based on clinical trial outcome" for the AMI Cutoff.
- "99th percentile upper reference limit (URL) is 0.075 ng/mL. SD ≤0.006 at concentrations ≤0.075 ng/mL" for Precision. This would be established through a precision study.
Missing Information: The summary does not provide granular details about the methodologies, specific sample sizes, or results of these individual studies beyond the final reported performance values. It states these data were "provided in this submission," implying they exist in the full 510(k) filing.
Detailed Information for Study That Proves the Device Meets Acceptance Criteria:
Based on the provided text, many details about the specific studies are not included in this 510(k) summary. The summary is a high-level overview.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated for any of the studies (e.g., clinical trial for AMI cutoff, reference interval study, precision study).
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). The mention of "clinical trial outcome" for the AMI cutoff implies a prospective study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: Not explicitly stated.
- Given this is an immunoassay for a biomarker (troponin I), the ground truth for clinical outcomes like Myocardial Infarction would typically be established by a panel of cardiologists or emergency physicians, using a comprehensive assessment including clinical presentation, ECG changes, and serial biomarker measurements (often the device under study itself or a comparator, combined with other clinical judgment). For analytical performance (e.g., precision), laboratory experts would define ground truth or test methods.
4. Adjudication Method for the Test Set:
- Adjudication methods (e.g., 2+1, 3+1) are typically relevant for studies where expert readers or clinicians interpret images or clinical data to determine a diagnosis. For a quantitative immunoassay, the "ground truth" for myocardial infarction would generally involve comprehensive clinical criteria, including expert diagnosis, but the document does not detail how this clinical ground truth was adjudicated.
- For analytical studies (e.g., precision, analytical measuring range), adjudication methods are not typically applicable.
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:
- No, an MRMC comparative effectiveness study was not done. This type of study is specific to imaging devices, often involving AI algorithms, where human readers interpret images. The device here is an immunoassay system for a biochemical marker (cardiac troponin I), not an imaging device with AI assistance for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Yes, the device's performance is inherently standalone. The Access AccuTnI+3 Reagent and UniCel DxI Access Immunoassay System produce a quantitative measurement of cTnI. The "performance" reported (analytical measuring range, AMI cutoff, 99th percentile URL, precision) are all standalone performance characteristics of the assay system itself. There isn't a "human-in-the-loop" component for the measurement of troponin I. The physician then uses this measurement, along with other clinical information, to make a diagnosis.
7. The Type of Ground Truth Used:
- For Analytical Performance (Analytical Measuring Range, Precision): Ground truth is typically established by reference methods or gravimetric/volumetric preparation of standards.
- For Clinical Performance (AMI Cutoff, Expected Results/99th percentile URL):
- AMI Cutoff: "0.03 ng/mL based on clinical trial outcome." This implies that the ground truth for "myocardial infarction" was based on clinical diagnosis following established guidelines (e.g., WHO or ESC/ACC definitions available at the time) in the patient population studied in the clinical trial. This diagnosis would involve expert clinical judgment based on a combination of symptoms, ECG findings, and serial cardiac biomarker measurements (potentially including confirmed MI by a different, reference assay or the device itself as part of a comprehensive clinical picture).
- Expected Results (99th percentile URL): This is established by measuring cTnI levels in a healthy reference population and determining the 99th percentile value.
8. The Sample Size for the Training Set:
- Not explicitly stated. The summary does not provide any details about a "training set" or "validation set" in the context of an algorithm. For an immunoassay, the concept of training set might refer to reagent formulation and calibration curve development, but specific sample sizes for these are not provided.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable in the context of a "training set" for an AI algorithm. As this is an immunoassay, the "ground truth" for developing the assay (e.g., calibrators) would be based on precisely characterized reference materials (e.g., recombinant cardiac troponin I complex at known concentrations, as mentioned in the device description).
§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.