Search Results

The STA® Liatest® Control [N]+[P] kit is intended for use as control plasmas (Normal and Abnormal levels) for von Willebrand Factor (vWF) and D-dimer antigen assays by the immuno-turbidimetric method performed on STA® analyzers (Diagnostica Stago, France: STA® full-size model, K942117; STA® Compact model, K961579).

The STA®-Liatest® Control [N]+[P] kit provides two citrated human plasmas intended for use as normal and abnormal controls for von Willebrand Factor (vWF) and D-dimer antigen assays by the immino-turbidimetric method performed on STA® analyzers (Diagnostic Stago, France: STA® full-size model and STA® Compact model).

Each STA®-Liatest® Control [N]+[P] kit provides 12 x 1-ml vials of freeze-dried human plasma containing vWF and D-dimer at normal levels (STA®-Liatest® Control [N]) and 12 x 1-ml vials of freeze-dried human plasma containing vWF and D-dimer at abnormal levels (STA®-Liatest® Control [P]).

Both the normal and abnormal plasmas in the freeze-dried state are stable for 24 months after the date of manufacture, when stored at 2°-8°C; after reconstitution with water, both plasmas are stable for 8 hours on board STA® analyzers.

The provided text does not contain typical acceptance criteria and study results in the format expected for medical device performance evaluation. This document is a 510(k) Premarket Notification for a control kit (STA®-Liatest® Control [N]+[P] Kit), which is used to ensure the proper functioning of other assays, specifically for von Willebrand Factor (vWF) and D-dimer antigen.

For a control kit, "acceptance criteria" usually relate to the stability and consistency of the control material itself, rather than performance metrics like sensitivity, specificity, or AI accuracy that would be expected for a diagnostic device. The provided text describes the product, its intended use, and its stability.

Here's the breakdown of what can be extracted or inferred, and what is missing based on your requested format:

What can be inferred from the provided text:

• Device: STA®-Liatest® Control [N]+[P] Kit
• Intended Use: Normal and abnormal controls for vWF and D-dimer antigen assays by the immuno-turbidimetric method performed on STA® analyzers.
• Purpose of the "Study" mentioned (implicitly): To demonstrate the stability of the control plasmas.

What is present regarding "Acceptance Criteria" (interpreted for a control kit):

Missing Information (as per your request, because this is for a control kit, not a diagnostic device with AI):

The following points are not applicable or not provided in the context of this 510(k) submission for a control kit:

1. Sample size for the test set and data provenance: Not explicitly stated for performance validation. The "study" here is likely internal manufacturing/stability testing, not a clinical trial with a "test set" of patients.
2. Number of experts used to establish the ground truth for the test set and qualifications: Not applicable for a control kit. Ground truth for a control kit refers to the known concentrations of its analytes, established during manufacturing.
3. Adjudication method for the test set: Not applicable.
4. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This kit controls human readers of an assay, it is not an AI algorithm assisting human readers.
5. Standalone (algorithm-only) performance: Not applicable, as this is a physical control substance, not an algorithm.
6. Type of ground truth used: For a control, the "ground truth" would be the assayed values of vWF and D-dimer established during manufacturing, possibly against a reference standard. The text doesn't specify how these were established.
7. Sample size for the training set: Not applicable. Control kits don't have "training sets."
8. How the ground truth for the training set was established: Not applicable.

In summary: The provided document is a regulatory approval for a control kit, not a performance study of a diagnostic device with AI. Therefore, most of your requested detailed study information is not available and not relevant to this specific type of device. The document primarily focuses on the product description and its stability claims.

Ask a specific question about this device

The STA®-Liatest® D-Di test kit is intended for use with STA® analyzers (Diagnostica Stago, France: STA® full-size model, K942117; STA® Compact model, K961579) to perform quantitative determinations of D-dimer antigen levels in citrated plasma by the immuno-turbidimetric method based on the measurement of light absorbance produced by a suspension of microlatex particles coated with mouse anti-human D-dimer monoclonal antibodies.

The STA®-Liatest® D-Di test kit is intended for use with STA® analyzers to perform quantitative assays of D-dimer antigen in citrated plasma by the immuno-turbidimetric method based on the measurement of light absorbance produced by a suspension of microlatex particles coated with specific mouse anti-human D-dimer monoclonal antibodies.

Each STA®-Liatest® D-Di test kit provides: 6 x 5-ml vials of ready-for-use Tris buffer and 6 x 6-ml vials of a suspension of microlatex particles coated with mouse anti-human D-dimer monoclonal antibodies.

Reagents in intact vials remain stable for 18 months after the date of manufacture, when stored at 2°-8°C. After opening of the vials, kit reagents (with STA®-Reducers and perforated caps installed on the vials) are stable for 15 days on board STA® analyzers.

The provided text does not contain detailed acceptance criteria or a study proving the device meets specific performance metrics. Instead, it describes a 510(k) premarket notification for a medical device, the STA®-Liatest® D-Di Test Kit, which indicates it has been found "substantially equivalent" to a predicate device. This substantial equivalence determination generally means that the new device is as safe and effective as a legally marketed device that is not subject to premarket approval.

Here's a breakdown of the requested information based on the provided text, and where the information is not available:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size: Not specified.
• Data provenance: Not specified.

3. 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)

• Not applicable/Not specified. The substantial equivalence claim is made against a predicate device, not by establishing ground truth based on expert consensus for the new device's performance.

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

• Not applicable/Not specified. The document does not describe a test set or an adjudication process for such a set.

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

• No. This device is an in-vitro diagnostic test kit (an immuno-turbidimetric method), not an AI-powered diagnostic tool requiring human reader interpretation in the context of an MRMC study.

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

• Not applicable. This is an automated laboratory test kit; its performance is inherently "standalone" in the sense that the analyzer performs the measurement. However, it's not an "algorithm only" in the context of AI.

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

• The ground truth for chemical assays like D-dimer is typically established through reference methods or validated standards. The document states the new device is "substantially equivalent" to the ASSERACHROM® D-Di kit, which is a "microtiter ELISA-based procedure." This implies the predicate device's established performance serves as the benchmark. The inherent ground truth for D-dimer measurements relates to the actual concentration of D-dimer antigen in the plasma, which would be determined by a highly accurate and precise analytical method. The document does not specify details on how the accuracy of either device was independently validated against a gold standard.

8. The sample size for the training set

• Not applicable/Not specified. This device is a reagent kit and analyzer system, not a machine learning algorithm that requires a "training set" in the conventional sense of AI development.

9. How the ground truth for the training set was established

• Not applicable/Not specified. As mentioned above, there is no "training set" in the context of an AI algorithm for this device.

Ask a specific question about this device

The STA® D-Di Calibrator kit is intended for use as a calibration plasma for D-dimer antigen assays by the immuno-turbidimetric method performed on STA® analyzers (Diagnostica Stago, France: STA® full-size model, K942117; STA® Compact model, K961579).

The STA® D-Di Calibrator is a citrated human plasma containing D-dimer at a known level, intended for use as a calibration plasma for the assay of D-dimer antigen by the immuno-turbidimetric method performed on STA® analyzers (Diagnostica Stago, France: STA® full-size model and STA® Compact model). Each STA® D-Di Calibrator kit provides 6 x 1-ml vials of citrated human plasma in lyophilized form. The D-dimer value of each lot is indicated in the Assay Value insert supplied with each kit. The freeze-dried reagent in intact vials is stable for 24 months after the date of manufacture, when stored at 2°-8°C; the reconstituted plasma remains stable for 4 hours on board STA® analyzers.

The provided text primarily focuses on the regulatory approval of the STA® D-Di Calibrator Kit and its intended use as a calibration plasma. It does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of device performance metrics such as sensitivity, specificity, or accuracy.

The document is a 510(k) clearance letter from the FDA, indicating that the device has been found substantially equivalent to a predicate device. This type of submission generally relies on demonstrating equivalence rather than providing detailed performance studies against specific acceptance criteria for a new device's efficacy or diagnostic accuracy.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance results.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The provided text only offers the following relevant details:

• Device Name: STA® D-Di Calibrator Kit
• Intended Use: To be used as a calibration plasma for the assay of D-dimer antigen by the immuno-turbidimetric method performed on STA® analyzers (STA® full-size model and STA® Compact model).
• Regulatory Status: 510(k) cleared (K964718), found substantially equivalent to predicate devices.
• Product Description: Citrated human plasma containing D-dimer at a known level, supplied in 6 x 1-ml vials in lyophilized form.
• Stability: Freeze-dried reagent is stable for 24 months at 2°-8°C. Reconstituted plasma is stable for 4 hours on board STA® analyzers.

To obtain the information requested, a detailed performance study report or design validation document would be necessary, which is not present in the provided text.

Ask a specific question about this device

The STA®-VWF Calibrator is a citrated human plasma containing von Willebrand Factor (vWF) at the normal level, intended for use as a calibration plasma for the assay of vWF antigen by the immuno-turbidimetric method performed on the STA® analyzer (Diagnostica Stago, France; K942117).

The STA®-VWF Calibrator is a citrated human plasma containing von Willebrand Factor (vWF) at the normal level. Each manufactured lot of STA®-vWF Calibrator is assigned a vWF value which is determined with an internal VWF reference that has been assayed against the third International Standard 91/666 for Factor VIII and von Willebrand Factor established in 1992. Each STA®-vWF Calibrator kit provides 6 x 1-ml vials of citrated human plasma in freeze-dried form. The vWF value of each lot is provided in the Assay Value insert supplied with each kit. The freeze-dried reagent in intact vials is stable for 24 months after the date of manufacture, when stored at 2°-8°C; the reconstituted plasma remains stable for 4 hours on board the STA® analyzer.

This document does not contain the information requested for acceptance criteria and study details.

The provided text is a summary for a 510(k) premarket notification for a medical device (STA®-vWF Calibrator Kit). It describes:

• The device's intended use: A calibrator for von Willebrand Factor (vWF) antigen assays.
• How the vWF value is assigned: Against an internal reference calibrated to an international standard.
• Kit contents and stability: 6 x 1-ml vials, freeze-dried, 24 months stability at 2°-8°C, 4 hours on board the analyzer after reconstitution.

It does not include any performance data, acceptance criteria, study methodologies, or details about ground truth establishment, sample sizes, or expert involvement. These types of details are typically found in a clinical study report or a more extensive section on performance characteristics, neither of which is present here.

Ask a specific question about this device

The STA® vWF Control [N]+[P] kit provides two citrated human plasmas intended for use as a normal and an abnormal controls for von Willebrand Factor (vWF) antigen assays by the immuno-turbidimetric method performed on the STA® analyzer (Diagnostica Stago, France; K942117).

Each STA®-VWF Control [N]+[P] kit provides 12 x 1-ml vials of freeze-dried human plasma containing vWF at the normal level (STA®-vWF Control [N]) and 12 x 1-ml vials of freeze-dried human plasma containing vWF at the abnormal level (STA vWF Control [P]). Both the normal and abnormal plasmas in the freeze-dried state are stable for 24 months after the date of manufacture, when stored at 2°-8°C; after reconstitution with water, both plasmas are stable for 8 hours on board the STA® analyzer.

This document, K962674, is a 510(k) Premarket Notification for a control kit used in conjunction with a diagnostic device, specifically the STA®-vWF Control [N]+[P] kit. It is not describing a diagnostic device that produces a "result" in the traditional sense that would require performance metrics like sensitivity, specificity, or and AUC, or involve human readers or AI.

Therefore, many of the requested categories (like sample size for test set, number of experts, adjudication, MRMC, standalone performance, training set details) are not applicable to this type of submission.

Here's an attempt to answer the relevant aspects based on the provided text, while clearly indicating where information is not available or not applicable:

Acceptance Criteria and Device Performance for STA®-vWF Control [N]+[P] Kit

This submission describes a control kit, not a diagnostic device with performance metrics related to diagnostic accuracy. The "acceptance criteria" and "device performance" in this context refer to the product's ability to serve its intended function as a quality control.

Study Details:

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

   • Test Set Sample Size: Not applicable. This is not a study evaluating a diagnostic device's performance on patient samples. Instead, it's about the quality and consistency of a control product.
   • Data Provenance: Not applicable in the context of a diagnostic performance study. The "data" pertains to the characterization and stability of the control plasma itself.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. Ground truth in this context relates to the assigned vWF values and stability characteristics, which are determined through laboratory testing and referencing, not expert consensus on patient interpretations.

3. Adjudication method for the test set:

   • Not applicable. There is no "adjudication" of patient results or interpretations involved.

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:

   • Not applicable. This is not a diagnostic device, and therefore no human-in-the-loop AI studies would be relevant.

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

   • Not applicable. This is not an algorithmic device.

6. The type of ground truth used:

   • For the vWF value assignment, the "ground truth" is established by referencing against the third International Standard 91/666 for Factor VIII and von Willebrand Factor (1992).
   • For stability, the ground truth is established through laboratory testing to determine the duration the product maintains its specified characteristics under defined storage conditions.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or algorithmic device that requires a training set.

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

   • Not applicable for the same reason as above.

Ask a specific question about this device