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510(k) Data Aggregation
(417 days)
The Access AccuTnl+3 Reagent is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnl) levels in human serum and plasma using the Access 2 Immunoassay System to aid in the diagnosis of myocardial infarction.
The Access AccuTnl+3 Calibrators are intended to calibrate the Access AccuTnl+3 Reagent for the quantitative determination of cardiac troponin I (cTnl) levels in human serum and plasma using the Access 2 Immunoassay System to aid in the diagnosis of myocardial infarction.
The Access 2 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 AccuTnl+3 reagents, AccuTnl+3 calibrators and the Access 2 Immunoassay System compose the Access Immunoassay System for the quantitative determination of cardiac troponin I (cTn!) in human serum and plasma.
The Access AccuTnI+3 reagent packs contain specific reagents for the in vitro diagnostic measurement of cTnI including:
- Paramagnetic particles coated with mouse monoclonal anti-human cardiac . troponin I suspended in TRIS buffered saline, with surfactant, bovine serum albumin (BSA) matrix. <0.1% sodium azide, and 0.1% ProClin® 300.
- 0.1N NaOH. .
- . TRIS buffered saline, surfactant, <0.1% sodium azide and 0.1% ProClin 300.
- Mouse monoclonal anti-human cTnI alkaline phosphatase conjugate . diluted in ACES buffered saline, with surfactant, BSA matrix, protein (bovine, goat, mouse), <0.1% sodium azide, and 0.25% ProClin 300.
The Access AccuTnl+3 Calibrator set contains multi-point calibrators for use with the Access AccuTnI+3 assay. Individual vials contain zero or approximately 0.3. 1.2, 5.0, 25 and 100 ng/mL (ug/L) of recombinant cardiac troponin I complex. respectively, in a buffered BSA matrix, with surfactant, <0.1% sodium azide, and 0.1% ProClin 300.
The Access 2 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 Reagent, AccuTnI+3 Calibrators, and Access 2 Immunoassay System constitute the Access Immunoassay System. This system aims to quantitatively determine cardiac troponin I (cTnI) in human serum and plasma to assist in diagnosing myocardial infarction.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document compares the new device (Access AccuTnI+3 Reagent and Calibrators) with a predicate device (ADVIA Centaur TnI-Ultra Assay) and the new Access 2 Immunoassay System with a predicate Access 2 Immunoassay System. The "acceptance criteria" are implied by the performance characteristics presented, demonstrating equivalence or improvements over the predicate devices.
Acceptance Criteria (Implied by Predicate Performance) and Reported Device Performance (New Device)
| Characteristic | Predicate Device (ADVIA Centaur® TnI-Ultra™) | New Device (Access AccuTnI+3 Reagent and Calibrators) | Difference/Improvement (New vs. Predicate) |
|---|---|---|---|
| Analyte | Cardiac Troponin I | Cardiac Troponin I | Same |
| Sample Type (Main) | Serum and heparinized plasma (also EDTA plasma claim) | Serum and plasma (No EDTA plasma claim) | New device does not support EDTA plasma. |
| Assay Principle | Chemiluminescent sandwich immunoassay | Chemiluminescent sandwich immunoassay | Same |
| Test System | Automated immunoassay instrument | Automated immunoassay instrument (Access 2 Immunoassay System) | Same type of system. |
| Analytical Measuring Range | 0.008 ng/mL to 50 ng/mL | 0.02 ng/mL to 100 ng/mL | Wider upper detection limit (up to 100 ng/mL vs. 50 ng/mL). |
| AMI Cutoff (WHO-defined) | 0.9 ng/mL | 0.03 ng/mL | Significantly lower cutoff, suggesting higher sensitivity for AMI diagnosis. |
| Expected Results (99th %tile URL) | 0.04 ng/mL; range of 0.02-0.06 ng/mL | 0.02 ng/mL with a 95% Confidence Interval (CI) of 0.01-0.05 ng/mL | Lower 99th percentile URL, indicating better differentiation of healthy vs. MI. |
| Precision | Total CV of 10% at 0.042 ng/mL | Total CV of ≤8% at concentrations >0.075 ng/mL. SD ≤0.006 at concentrations ≤0.075 ng/mL | Improved precision (lower CV) at higher concentrations and lower SD at lower concentrations. |
| Sample Volume | 100μL | 55μL | Smaller sample volume required. |
Access 2 Immunoassay System (New vs. Predicate)
| Characteristic | Predicate Device (Access 2 System K922823/A007) | New Device (Access 2 Immunoassay System) | Difference/Improvement (New vs. Predicate) |
|---|---|---|---|
| Thermal algorithm capability | Not present | Present | New feature: enhanced thermal algorithm. |
| Software | Version 2.4-3.2 | Version 3.3: added capability to implement thermal algorithm and "U" Command; added result suppression when instrument internal case temperature is outside 18° to 36°C | Improved software with new functionalities and safety features. |
| Operating Temperature | 18°C to 32°C ambient | 18°C to 28°C ambient (18°C to 36°C internal) | Narrower ambient operating temperature range, but wider internal temperature monitoring. |
The study demonstrates that the new device meets or exceeds the critical performance characteristics of the predicate device for clinical utility (e.g., sensitivity, measuring range, precision) and introduces enhanced features in the accompanying instrument system.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document explicitly states:
- AMI Cutoff: "0.03ng/mL based on clinical trial outcome"
- Expected Results (99th percentile URL): "99th percentile of 0.02 with a 95% Confidence Interval (CI) of 0.01-0.05 ng/mL"
However, the specific sample size for this clinical trial, the data provenance (e.g., country), or whether it was retrospective or prospective are not detailed in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
The document states that the AMI cutoff is "based on clinical trial outcome" and the 99th percentile URL is derived from a reference population. However, it does not specify the number or qualifications of experts used to establish the ground truth or interpret the clinical trial outcomes. The diagnosis of myocardial infarction typically involves clinical judgment by cardiologists, but the role of experts in establishing the ground truth for the test set (e.g., for sample classification) is not described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
The document does not provide any information on the adjudication method used for the test set.
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
This device is an immunoassay system for measuring a biomarker (Troponin I), not an imaging diagnostic device typically evaluated with MRMC studies or human-in-the-loop AI assistance. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this type of device and was not mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the performance characteristics (Analytical Measuring Range, AMI Cutoff, Expected Results, Precision) presented in the table are standalone performance metrics of the Access AccuTnI+3 Reagent and Access 2 Immunoassay System. This device is an automated in vitro diagnostic test, meaning its output (cTnI concentration) is generated by the algorithm/system without direct human-in-the-loop interpretation changing the result itself. Human clinicians then use this quantitative result to aid in diagnosis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for the AMI cutoff and expected results seems to be based on:
- "Clinical trial outcome" for the AMI cutoff (implying patient diagnosis and potentially follow-up outcomes).
- "99th percentile" for the upper reference limit, which is typically established by testing a large cohort of apparently healthy individuals.
The document does not explicitly state "expert consensus," "pathology," or "outcomes data" as the ground truth, but "clinical trial outcome" suggests reliance on established clinical diagnostic criteria for myocardial infarction for the first, and a healthy reference population for the second.
8. The sample size for the training set
The document does not specify a training set sample size. For an immunoassay, the "training set" would typically refer to the data used during assay development and optimization (e.g., reagent formulation, calibration curve development), rather than a machine learning context. The document focuses on the performance verification of the final device.
9. How the ground truth for the training set was established
As there is no explicit mention of a "training set" in the context of machine learning, the question of how its ground truth was established is not directly addressed. For the development of the assay, the ground truth would inherently come from known concentrations of cTnI in spiked samples, reference materials, and characterized clinical samples used during method development and validation.
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