(217 days)
The Avoceter-Home is intended for quantitative prothrombin time testing of fresh, capillary whole blood for monitoring of oral anticoagulation therapy by trained patients or their caregivers, on the prescription or other order of a treating physician.
The AvocetpT-Home is a membrane-based, dry-reagent system for use with fresh capillary whole blood. The system uses a 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 AvocetpT-Home is the same device as the Avocetpт, except that it has the citrated whole blood and plasma sample modes deactivated in the meter software, a test strip CAL code is only given for capillary whole blood and the labeling has been modified for readability by the lay user.
Here's an analysis of the provided text to extract the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text focuses on regulatory approval and equivalence, not specific quantitative acceptance criteria with numerical targets. Instead, it states the device was found to perform "equivalently" to a reference method and between different user groups. Therefore, the table will reflect this qualitative equivalence.
| Criterion Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Equivalence to Predicate Device | The AvocetpT-Home must be substantially equivalent in materials, design, and intended use to the AvocetpT predicate device. | The AvocetpT-Home is stated to be "identical in materials, design and function to the AvocetpT," with only labeling changes for home use. |
| Performance by Different User Groups | Performance when used by trained lay users should be equivalent to performance by healthcare professionals. | The AvocetpT-Home System "was found to perform equivalently when used by trained lay users and healthcare professionals." |
| Equivalence to Reference Method | Results generated by both user populations (lay and healthcare professionals) should be equivalent to an established reference method. | "Furthermore, both user populations generated results found to be equivalent to an established reference method." |
2. Sample Sized Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size used for the performance study. It mentions the study involved "trained lay users" and "healthcare professionals." The provenance of the data (country of origin, retrospective/prospective) is also not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document refers to an "established reference method" for ground truth but does not mention the involvement of experts in establishing this ground truth, nor their number or qualifications. This suggests the reference method itself is the standard against which the device is compared, rather than a panel of human experts.
4. Adjudication Method for the Test Set
No adjudication method is described. The comparison is made against an "established reference method."
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
An MRMC study was not conducted. This device is a standalone in vitro diagnostic system for Prothrombin Time/INR measurement, not an AI-assisted diagnostic tool for human readers. Therefore, there's no mention of human reader improvement with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance assessment was effectively done. The device, AvocetpT-Home, generates a quantitative result (INR) directly. The study evaluated its performance (accuracy and equivalence) when used by different types of users and compared to a reference method, which is characteristic of a standalone diagnostic device. The "algorithm" here is the device's internal process for measuring PT and calculating INR.
7. The Type of Ground Truth Used
The ground truth used was an "established reference method" for Prothrombin Time/INR testing. This implies a gold standard laboratory method or a highly accurate and validated prothrombin time testing system.
8. The Sample Size for the Training Set
The document does not mention a "training set" or "training data" in the context of machine learning, as this is a medical device, not an AI algorithm in the traditional sense. The device's internal algorithms would have been developed and validated during its design and engineering phases, but no specific training set size is provided for that process.
9. How the Ground Truth for the Training Set Was Established
As this is not an AI algorithm with a distinct "training set" in the machine learning sense, the concept of establishing ground truth for a training set does not directly apply. The device's underlying principles are based on established biochemical reactions (thrombin generation, fluorescence kinetics) for PT/INR measurement. The "ground truth" for its development would be derived from fundamental principles of coagulation testing and validation against known standards.
§ 864.7750 Prothrombin time test.
(a)
Identification. A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).(b)
Classification. Class II (performance standards).