Search Results

Beckman Coulter's Access Ostase QC is intended for use in monitoring the reliability and overall performance of the Access Ostase Immunoassay system in the clinical laboratory. The use of control materials allow the laboratorian to monitor linearity along with analytical error and imprecision.

The Access Ostase QC are bi-level ready-to-use defined protein-based liquid controls manufactured by Beckman Coulter, Inc. Each kit contains 1 X 4 mL bottles for each level of control.

The provided text does not contain detailed information about the acceptance criteria and the study that proves the device meets those acceptance criteria. It primarily focuses on the submission details, regulatory classification, and intended use of the Access Ostase QC device.

However, based on the general understanding of Quality Control Materials for in vitro diagnostics, I can infer the likely nature of such a study and the potential acceptance criteria, though the specific values are not present in the document.

Here's a breakdown of what can be extracted and what needs to be inferred for a Quality Control Material like "Access Ostase QC":

Inferred Acceptance Criteria and Reported Device Performance (as typically expected for QC materials):

Since the provided document is a 510(k) summary for a Class I device (Quality Control Material), it typically focuses on substantial equivalence rather than presenting a full performance study with detailed acceptance criteria and results. The key information for a Class I device like this is that it performs its intended function (monitoring reliability and performance of an immunoassay system) similarly to an already legally marketed equivalent device (the predicate device).

Regarding the specific questions:

1. A table of acceptance criteria and the reported device performance: As shown above, this information is not present in the provided text. The document states "Beckman Coulter's Access Ostase QC is intended for use in monitoring the reliability and overall performance of the Access Ostase Immunoassay system... The use of control materials allow the laboratorian to monitor linearity along with analytical error and imprecision." This describes the purpose relevant to performance, but not the quantitative criteria or results.

2. Sample size used for the test set and the data provenance: This information is not provided in the text. For a QC material, a "test set" would typically refer to a series of runs or measurements performed to establish its performance characteristics (accuracy, precision, stability). No details on the number of samples, runs, or laboratories are given. The provenance (e.g., country of origin, retrospective/prospective) is also not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable in the traditional sense for a Quality Control Material. For a QC material, the "ground truth" or "assigned values" are typically established through extensive testing by the manufacturer, possibly in comparison to reference methods or through value assignment protocols using multiple instruments/laboratories, not directly by "experts" reviewing individual cases.

4. Adjudication method for the test set: This is not applicable for a Quality Control Material. Adjudication methods (like 2+1, 3+1) are used in diagnostic studies where multiple human readers assess cases, and their opinions need to be reconciled to establish a consensus ground truth. For QC materials, performance is assessed through quantitative measurements against established statistical criteria.

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: This is not applicable to this device. An MRMC study is relevant for diagnostic devices (often imaging AI) where human performance is compared with and without AI assistance on a set of clinical cases. The Access Ostase QC is a quality control material, not a diagnostic device that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: This is not applicable to this device. "Standalone performance" refers to the performance of an algorithm or diagnostic device without human intervention. The Access Ostase QC is a physical reference material used by a laboratorian with an immunoassay system, not an algorithm.

7. The type of ground truth used: For a Quality Control Material, the "ground truth" refers to its assigned value(s). These values are typically established through:

   • Value Assignment Studies: Extensive testing by the manufacturer using calibrated reference methods or multiple qualified instruments/laboratories to determine target values and acceptable ranges for the control material.
   • Traceability: Often, the assigned values are made traceable to reference materials or a higher-order measurement procedure.
     The document itself does not specify the method for establishing "ground truth" for the assigned values of the Access Ostase QC.

8. The sample size for the training set: This is not applicable as the Access Ostase QC is not an AI/ML algorithm that requires a "training set." It is a physical quality control material.

9. How the ground truth for the training set was established: This is not applicable as there is no "training set" for this device.

Ask a specific question about this device