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510(k) Data Aggregation
(71 days)
AVOCET MEDICAL, INC.
The AcuSure System for Patient Self-Testing is intended for the quantitative prothombin time testing of fresh, capillary whole blood by selected and suitably trained patients or their caregivers on the prescription of the treating physician. The AcuSure System for Patient Self-Testing is for the monitoring of patients on oral anticoagulant therapy and not intended to be used for screening purposes.
The AcuSure Pro System for Professional Use is intended for the quantitative prothrombin time testing of fresh, capillary whole blood by healthcare professionals. The AcuSure Pro System is for the monitoring of patients on oral anticoagulant therapy and not intended to be used for screening purposes.
The AcuSure and AcuSure Pro test strips and meter measure capillary blood PT levels. When the sample is applied to the target area on the test strip, the meter detects the electrical drop between two electrodes on the test strip and begins the test. Inside the membrane of the test strip the red blood cells are separated from the plasma. The membrane also contains the reagents necessary to cause the coagulation reaction (clot formation) to occur. The thrombin, formed as part of the coagulation reaction, reacts with a reagent, which causes a fluorescent molecule to be released The time from the initial resistance drop to the onset of fluorescence is proportional to the prothrombin time of the sample.
The provided text is a 510(k) summary for the Avocet AcuSure System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain specific details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any AI-related information.
Therefore, I cannot fulfill your request for the detailed table and study information as the input text does not include that data. The document focuses on regulatory approval and substantial equivalence rather than detailed performance metrics.
To answer your request, I would need a document that describes the clinical studies, their methodology, and results, including acceptance criteria and performance data.
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(217 days)
AVOCET MEDICAL, INC.
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.
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(210 days)
AVOCET MEDICAL, INC.
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.
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(30 days)
AVOCET MEDICAL, INC.
This product (The AvocetpT System Liquid Controls, Level 1 and Level 2) is used with the Avocetor in vitro diagnostic system to validate system performance. It is intended for use by health care professionals in assessing the functionality of the Avocetor System when monitoring patients who are on warfarin-type (coumarin) anticoagulation therapy.
AvocetpT System Liquid Controls, Level 1 and Level 2
The provided document is a 510(k) clearance letter from the FDA for the Avocet System Liquid Controls, Level 1 and 2. It indicates that the device has been found substantially equivalent to predicate devices. However, this document does not contain any information regarding acceptance criteria, study details, performance metrics, sample sizes, or ground truth establishment relevant to the device's efficacy or accuracy.
The letter primarily focuses on:
- The regulatory classification of the device.
- Indications for Use (which states it's for validating system performance of the Avocet System when monitoring patients on warfarin).
- Compliance with general controls and regulations.
- Contact information for further regulatory guidance.
Therefore, I cannot provide the requested information based solely on this document. There is no study data, acceptance criteria table, or performance metrics within these pages.
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