(50 days)
The Stratus® CS Acute Care™ Troponin I method is an in vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma. Cardiac troponin I measurements can be used as an aid in the diagnosis of myocardial infarction. Cardiac troponin I can also be used as an aid in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.
The Stratus® CS Acute Care™ Troponin I TestPak is an in vitro immunoassay.
Here's an analysis of the provided text regarding the Stratus® CS Acute Care™ Troponin I TestPak, focusing on acceptance criteria and supporting studies, while noting the limitations of the provided document in answering all your specific questions:
The document (K033487) describes a 510(k) premarket notification for a revised labeling of an existing device, the Stratus® CS cTnI TestPak, which is now branded as Stratus® CS Acute Care™ Troponin I TestPak. The key assertion is that the device itself is identical to the predicate, with only the insert sheet (labeling) being updated. Therefore, the "acceptance criteria" and "studies" are primarily related to the validity of the labeling changes rather than a new device proving its performance from scratch.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a labeling change for an identical device, specific "acceptance criteria" in the traditional sense (e.g., sensitivity, specificity thresholds for a novel device) are not explicitly stated for this submission. Instead, the changes in the insert sheet reflect updates based on current clinical understanding and internal/external studies. The performance of the device is implicit in its substantial equivalence to the predicate.
Here's a table summarizing the changes introduced in the revised insert sheet and the source data that supports those changes, which can be interpreted as the basis for accepting the new labeling:
| Acceptance Criteria (Related to Labeling Change) | Reported Device Performance/Supporting Data |
|---|---|
| Method Name Update: Reflect the new "Acute Care" designation. | N/A: A branding/naming change. |
| Test Steps Clarification: Simplified presentation by implying automated steps. | N/A: A reformatting of instructions. |
| Interpretation of Results - Added Clinical Guidance: | 1. National Academy of Clinical Biochemistry statement: Incorporated into the insert. |
| 2. Medical history consideration: Added as a general principle of interpretation. | |
| 3. Statements moved from Diagnosis of AMI: Reorganization for clarity. | |
| 4. Institutional reference intervals & myocardial injury causes: Added for comprehensive guidance. | |
| Reference Interval - Updated Percentiles: Use 97.5th and 99th percentiles. | Internal and external reference interval studies: These studies provided the data to support the change from 95th to 97.5th and 99th percentiles. (No specific values provided in this document). |
| Risk Stratification - Added ACC/AHA Definition: Incorporate current clinical guidelines. | 1. Lower risk stratification concentration (0.1 ng/mL) based on recommendations from: American College of Cardiology (ACC), American Heart Association, and multiple hospital clinical studies. |
| Diagnosis of AMI - Added Specific Information: | 1. Sensitivity/specificity graph: Added to the insert. |
| 2. EU Society of Cardiology/ACC statement on MI definition: Incorporated into the insert. | |
| 3. Functional sensitivity information at 99th percentile: Added to the insert. | |
| 4. Low-end, functional sensitivity precision studies: Indicated a high sensitivity method (underlying data for functional sensitivity). | |
| Performance Characteristics - Added Plasma Pool Reproducibility Data: | Plasma pool reproducibility data: Added to the insert (no specific data shown in this document). |
| Correlation Data - Added Comparison to Predicate: Dade Behring Dimension®. | Performance comparison versus Dade Behring Dimension® clinical chemistry system: Added to the insert (no specific data shown in this document). |
| Recovery - Clarified Titles: Better presentation of recovery data. | N/A: A formatting change. |
| Bibliography - Added References: Update with current literature. | N/A: Update of references section. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" sample size in the context of a new device validation. The studies mentioned are:
- "Internal and external reference interval studies"
- "Low-end, functional sensitivity precision studies"
- "Multiple hospital clinical studies" (related to risk stratification concentration)
The data provenance is generally described as internal and external studies, but specific countries of origin or whether they were retrospective or prospective are not detailed within this summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The studies referenced are laboratory performance or clinical guideline-driven, not expert adjudication of a test set in the way a diagnostic imaging AI might be evaluated.
4. Adjudication Method for the Test Set
This information is not provided, as the nature of the studies supporting the labeling changes does not involve expert adjudication of a test set in the context of diagnostic accuracy.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study is not mentioned or suggested by the document. This type of study is typical for diagnostic imaging AI, where human readers interact with the device. This submission is for an in-vitro diagnostic (IVD) assay with labeling changes, not an AI with human-in-the-loop performance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device is an IVD assay, which by its nature operates "standalone" in generating a numerical result. The interpretation of that result is then done by a clinician. The focus of this submission is on the labeling of this standalone result, ensuring it aligns with current clinical guidelines and reflects validated performance characteristics (like precision and reference intervals). Therefore, in a sense, the data does represent "standalone" performance, but not in the context of an "algorithm" as might be understood for AI.
7. The Type of Ground Truth Used
The "ground truth" for the information added to the labeling seems to be:
- Clinical guidelines and consensus statements: From organizations like the National Academy of Clinical Biochemistry, American College of Cardiology (ACC), American Heart Association, and EU Society of Cardiology.
- Internal and external study data: For reference intervals, functional sensitivity, and reproducibility. The ultimate outcome this device aids in diagnosing (Myocardial Infarction) would be confirmed by a combination of clinical presentation, ECG, and serial biomarker measurements, often with pathology (e.g., autopsy) or long-term outcomes for definitive cases, but this document focuses on the assay's performance and appropriate use.
8. The Sample Size for the Training Set
This information is not provided. The studies mentioned (e.g., "internal and external reference interval studies", "low-end, functional sensitivity precision studies") would have involved sample sizes, but they are not detailed in this summary.
9. How the Ground Truth for the Training Set Was Established
This information is not provided. For reference interval studies, "ground truth" would typically mean carefully selected healthy populations and/or patient cohorts. For functional sensitivity, it involves spiking known concentrations and evaluating analytical performance. The document points to these types of studies but does not detail their methodology or how their "ground truth" (i.e., the true state or value) was established.
§ 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.