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The Vital Scientific PT with Calcium is an in vitro diagnostic test intended for use for the performance of Prothrombin Time (PT) testing and quantitative PT-based factor assays (for Factors II, V, VII and X). The test is used for the quantitative determination of blood clotting factors in the extrinsic pathway, (VII), and common pathway (II, V and X) of coagulation. The capacity of blood to form a fibrin clot by way of the extrinsic haemostatic pathway requires thromboplastin, calcium, factors VII, V, X, II and I. The Vital Scientific PT with Calcium consists of a lyophilized extract of rabbit brain thromboplastin calcium salt, buffers and stabilizers.

The Vital Scientific PT with Calcium is an in-vitro diagnostic reagent intended for use for the performance of one-stage Prothrombin Time (PT) Testing and assays which are based on a modified prothrombin time.

The Vital Scientific PT with Calcium is an in vitro diagnostic test intended for use for the performance of Prothrombin Time (PT) testing and quantitative PT-based factor assays (for Factors II, V, VII and X). The test is used for the quantitative determination of blood clotting factors in the extrinsic pathway, (VII), and common pathway (II, V and X) of coagulation. The capacity of blood to form a fibrin clot by way of the extrinsic haemostatic pathway requires thromboplastin, calcium, factors VII, V, X, II and I. The Vital Scientific PT with Calcium consists of a lyophilized extract of rabbit brain thromboplastin calcium salt, buffers and stabilizers.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

Device: Vital Scientific PT with Calcium (Prothrombin Time Test)
Predicate Device: Instrumentation Laboratory Inc. IL Test PT-Fibrinogen HS (K981479)

The provided text describes a substantial equivalence comparison study, not a study specifically designed to meet pre-defined acceptance criteria with absolute thresholds for performance metrics. Instead, the "acceptance criteria" are implicitly defined by the need to demonstrate performance comparable to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not explicitly stated as a single number. The text mentions "PT testing of specimens from normal and abnormal patients, as well as samples from patients receiving anti-coagulant therapy." The specific number of patients or samples within each category is not provided.
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the study was conducted "at a community hospital," implying a clinical setting within the country where the submission was made (presumably the USA, given the FDA context).
  • Retrospective or Prospective: Not explicitly stated. The phrasing "were tested using both reagent devices" could imply either. However, in substantial equivalence studies, retrospective analysis of banked samples or a prospective collection for comparison is common. It's more likely a prospective collection for the study or a retrospective analysis of samples that fit the criteria.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: Not applicable. This study does not involve expert interpretation or ground truth establishment in the way a diagnostic imaging study might. The "ground truth" or reference values are derived from the predicate device's performance on the same patient samples.
• Qualifications of Experts: Not applicable. The comparison is against an established, legally marketed diagnostic device.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No expert adjudication process is described for this type of in-vitro diagnostic device comparison study. The comparison is quantitative based on assay results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• MRMC Study Done: No. This is not an AI/imaging device. It's an in-vitro diagnostic reagent.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance: Yes, in a sense. The device itself (the reagent system) is a standalone diagnostic tool. Its performance is measured directly by comparing its output (PT results, INR) to the predicate device's output on the same samples. There isn't a human-in-the-loop for interpreting the core result of the PT test itself; it's a quantitative measurement.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this study is the results obtained from the legally marketed predicate device (IL Test PT-Fibrinogen HS (K981479)) when run on the same patient samples. This is a common approach for demonstrating substantial equivalence for in-vitro diagnostics. In essence, the predicate device serves as the reference standard.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is not a machine learning/AI device, so there is no "training set." The device is a chemical reagent.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

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