(210 days)
The AvocetpT is an in vitro diagnostic system that provides a quantitative prothrombin time result, expressed as an International Normalized Ratio (INR). It is intended for use by health care professionals in monitoring patients who are on warfarin-type (coumarin) anticoagulation therapy.
The Avocetpr is a membrane-based, dry-reagent system for use with fresh capillary or venous whole blood, and citrated venous whole blood or citrated plasma. The system uses an membrane to separate plasma from red cells. The membrane contains calcium and thromboplastin, and permits the reactions of the complete extrinsic pathway to occur with minimal distortion from membrane surface interactions. Thrombin generation is monitored optically using a rhodamine-110-based fluorescent thrombin substrate. Fluorescence kinetics are analyzed to produce a prothrombin-time-equivalent parameter that is converted to an international normalized ratio (INR) value.
The provided text describes the AvocetpT System, a device for measuring Prothrombin Time (INR). However, it does not contain explicit acceptance criteria in the format of a table with specific thresholds or targets (e.g., sensitivity > X%, specificity > Y%).
Instead, the acceptance criteria are implicitly stated through the claim of "substantial equivalence" to a predicate device and the outcomes of a performance study.
Here's an attempt to extract and infer the requested information based on the provided text:
AvocetpT System Acceptance Criteria and Study Details
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (as stated in document) |
|---|---|
| Accuracy | Equivalent to CoaguChek™ and a reference method (r > 0.95) |
| Precision | Acceptable |
| Linearity | Acceptable |
| Interfering Substances | Results are reflected in the product labeling |
| Hematocrit | Results are reflected in the product labeling |
| RBC Abnormalities | Results are reflected in the product labeling |
| Factor Deficiencies | Results are reflected in the product labeling |
Note: The document does not provide specific numerical thresholds for "acceptable" beyond the r > 0.95 for accuracy.
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "field studies" for accuracy comparison.
- Sample Size: Not explicitly stated.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, "field studies" generally imply prospective data collection in a clinical setting.
3. Number of Experts and Qualifications for Ground Truth Establishment
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: Not explicitly stated. The comparison is made against a "reference method" and the predicate device (CoaguChek™), implying that the ground truth is established by these existing, presumably validated, methodologies, not necessarily by human expert interpretation of device raw output.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable or not explicitly stated. The study focuses on comparing the AvocetpT System's measurements against a reference method and a predicate device. There is no indication of human interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. This device is an in vitro diagnostic system that provides quantitative numerical results (INR). It does not involve human readers interpreting images or other data that would necessitate an MRMC study or AI-assistance in interpretation.
6. Standalone Performance Study
- Standalone Performance: Yes, implicitly. The "accuracy of the AvocetpT was compared to the CoaguChek and a reference method in field studies." This indicates that the AvocetpT System's performance was evaluated as a standalone device without human-in-the-loop assistance in obtaining the INR output itself.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the performance evaluation appears to be established by:
- Measurements from a "reference method": This typically implies a well-established, highly accurate laboratory method for prothrombin time/INR.
- Measurements from the predicate device (CoaguChek™): Used for concordance and equivalence comparison.
8. Sample Size for the Training Set
- Sample Size: Not applicable / Not stated. As an IVD device producing a direct quantitative measurement, it's unlikely to have a "training set" in the machine learning sense for its primary function. If there were internal calibration or algorithm development, details are not provided.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable / Not stated for a "training set." The device itself provides a direct measurement based on a biochemical reaction and optical detection, rather than a learned prediction from a dataset.
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.