Search Results

For in-vitro diagnostic use for measuring platelet aggregation and ATP secretion in whole blood or platelet rich plasma.

The Chrono-log Model 700 Aggregometer measures platelet function on patient samples using electrical impedance in whole blood or optical density in plasma. The Model 700 Aggregometer has the capability to simultaneously measure ATP release with either method using luminescence. The Model 700 Aggregometer is also used to run the Ristocetin Cofactor Assay which is used to diagnose patients with von Willebrands disease. The instrument comes with a starter kit consisting of the following Chrono-log reagents and supplies: ADP, Arachondic Acid, Collagen, Epinephrine, Ristocetin, Thrombin, a CHRONO-LUME® Kit, a Ristocetin Cofactor Kit, cuvettes, stir bars and pipettes. The output of the Model 700 can be connected to either a strip chart recorder or to a Computer. Software is provided the computer interface option. The computer interface option is used to collect data only. The computer is not used for diagnosis or treatment and does not have any control over or input into the Model 700 Aggregometer.

Here's an analysis of the provided text, focusing on the acceptance criteria and study details for the Chrono-log Model 700 Whole Blood Lumi-Aggregometer:

Acceptance Criteria and Device Performance

The provided document describes a 510(k) submission, which aims to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than establishing explicit acceptance criteria with pre-defined thresholds for performance. The "acceptance criteria" here are implicitly linked to achieving a high correlation with the predicate devices, indicating comparable performance.

Here's a table summarizing the reported device performance, with the understanding that the "acceptance criteria" were met by demonstrating strong correlation:

Study Details

Here's the breakdown of the study information based on your requested categories:

1. Sample size used for the test set and the data provenance:

   • Optical Aggregation in PRP: 149 comparison tests
   • ATP Release by Luminescence in PRP: 167 luminescence tests
   • Impedance Aggregation in Whole Blood: 267 comparison tests
   • ATP Release by Luminescence in Whole Blood: 300 luminescence tests
   • Disposable Electrode Comparison: The table lists individual reagent tests (e.g., ADP 5, Collagen 2), but a total sample size for this specific comparison isn't explicitly stated beyond the reagent-specific values.
   • Data Provenance: "Whole blood and Platelet Rich Plasma samples from normal, healthy, drug free subjects" were used. The country of origin is not specified, but given the submission is to the FDA, it is likely the US. The study appears to be prospective as comparison studies were "run" to compare the new device to existing ones.

2. 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 does not mention the use of experts to establish ground truth in the context of these comparison studies. The ground truth in this type of submission is typically derived from the performance of the legally marketed predicate device itself.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • "None" explicitly stated. The comparison is directly between the new device and the predicate device's measurements. There is no mention of independent adjudication of results.

4. 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:

   • No, a multi-reader, multi-case comparative effectiveness study was not performed. This device is a quantitative laboratory instrument, not an AI-assisted diagnostic imaging tool that would involve human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Yes, this study represents a standalone performance evaluation of the Model 700 device itself, comparing its measurements to those of the predicate devices. There is no human-in-the-loop component in the measurement process. The device's output can be connected to a computer for data collection, but the computer is explicitly stated as "not used for diagnosis or treatment and does not have any control over or input into the Model 700 Aggregometer."

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The ground truth is established by the measurements obtained from the legally marketed predicate devices (Chrono-log Model 560 and Model 591A/592A). The concept of "ground truth" here is the established, accepted performance of the existing, equivalent devices. For the disposable electrodes, the ground truth is that the results should be "within the normal range as shown in the model 591A/592A Instruction Manual."

7. The sample size for the training set:

   • The document does not specify a training set. This is a comparison study for a new iteration of an existing mechanical/electronic instrument, not a machine learning or AI algorithm that typically requires a separate training set.

8. How the ground truth for the training set was established:

   • Not applicable, as no training set is mentioned or implied for this type of device comparison study.

Ask a specific question about this device