Search Results

The Access Ostase assay is a paramagnetic particle, chemiluminescent immunoassay for use with the Access Immunoassay Systems for the quantitative measurement of bone alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum and plasma. This device is intended to be used as an aid in the management of postmenopausal osteoporosis and Paget's disease.

The Access Ostase assay is a one-step sandwich immunoenzymatic assay. The Access Ostase assay consists of the reagent pack, calibrators and QCs. Other items needed to run the assay include substrate and wash buffer. The Access Ostase assay reagent pack, Access Ostase assay calibrators, Access Ostase QCs, along with the UniCel Dxl Wash Buffer II are designed for use with the Dxl 9000 Access Immunoassay Analyzer in a clinical laboratory setting.

The provided text describes the performance of the Beckman Coulter Access Ostase assay on the Dxl 9000 Access Immunoassay Analyzer, comparing it to the predicate device (Access Ostase on Access 2 Immunoassay System).

Here's an analysis of the acceptance criteria and the studies performed, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" for each performance characteristic in a separate, clear table format. However, it does outline the assay's design goals for imprecision and then presents the results. For other parameters like linearity and detection limits, it states the claimed values or that linearity was demonstrated. I will infer the acceptance criteria for imprecision from the "designed to have" statement and present the reported performance.

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

• Method Comparison Test Set:

  • Sample Size: 163
  • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the study involved comparing results from two different immunoassay systems (Access 2 and Dxl 9000) using patient samples, implying real-world or simulated clinical samples.

• Imprecision Test Set:

  • Sample Size: 80 for each of the 5 samples tested (total of 400 individual measurements of samples).
  • Data Provenance: Not explicitly stated. The study involved testing "multiple samples in duplicate in 2 runs per day for a minimum of 20 days," which suggests a controlled laboratory setting.

• Linearity, LoB, LoD, LoQ: The sample sizes for these studies are not explicitly mentioned, nor is their specific provenance beyond being performed "on the Dxl 9000 Access Immunoassay Analyzer."

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

This information is not applicable to an in vitro diagnostic (IVD) assay that measures quantitative analytes like bone alkaline phosphatase. The "ground truth" for such devices is typically established through reference methods, certified reference materials, or statistical comparison to a legally marketed predicate device (as done here). There are no "experts" in the human perception or diagnostic interpretation sense used to establish ground truth for this type of test.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiology reads) where discrepancies between experts need to be resolved to establish ground truth. This is a quantitative immunoassay.

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:

Not applicable. This device is an in vitro diagnostic immunoassay, not an AI-assisted diagnostic tool for human readers. No MRMC study was performed.

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

This device is an automated immunoassay system that provides quantitative results. The performance studies described (Method Comparison, Imprecision, Linearity, LoB/LoD/LoQ) inherently represent the standalone performance of the device (including its reagents and analyzer software) in generating these quantitative results. It operates without direct human-in-the-loop interpretation of the primary measurement signal for the reported value. A human reviews the final numerical result, but the device itself generates that result primarily through an automated process.

7. The type of ground truth used:

• Method Comparison: The ground truth was established by comparison to the predicate device (Access Ostase on Access 2 Immunoassay System). This assumes the predicate device's measurements represent a valid "truth" for substantial equivalence purposes. Patient samples were used, and their values from one system were compared to the other.
• Imprecision: The ground truth for evaluating imprecision is the inherent variability of the measurement process itself, determined by repeated measurements of samples with known (or established) concentrations.
• Linearity, LoB, LoD, LoQ: These are determined using samples of known concentrations (dilutions, blank samples, low-concentration samples) and statistical methods based on CLSI guidelines.

8. The sample size for the training set:

Not applicable. This device is a quantitative immunoassay system, not a machine learning or AI model that requires a "training set" in the conventional sense. The development of such assays involves extensive research, development, and optimization of reagents and protocols, but this is distinct from "training data" for an algorithm.

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

Not applicable, as there is no "training set" in the context of an AI/ML algorithm.

Ask a specific question about this device

Beckman Coulter, Inc's Access Ostase Assay is a paramagnetic particle, chemiluminescent immunoassay for use with the Access Immunoassay System for the quantitative measurement of bone alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum and plasma. This device is intended to be used as an aid in the management of postmenopausal osteoporosis and Paget's disease.

The Access Ostase Assay is a paramagnetic particle, chemiluminescent immunoassay for use with the Access Immunoassay System for the quantitative measurement of bone alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum and plasma.

{
  "acceptance_criteria_and_device_performance": {
    "title": "Acceptance Criteria and Reported Device Performance for Access® Ostase® Assay",
    "table": {
      "headers": ["Performance Characteristic", "Acceptance Criteria (Implicit via predicate comparison)", "Reported Device Performance"],
      "rows": [
        ["Method Comparison (Slope vs. Predicate)", "Close to 1", "0.9756"],
        ["Method Comparison (Intercept vs. Predicate)", "Close to 0", "-0.5987"],
        ["Method Comparison (Correlation r vs. Predicate)", "Close to 1", "0.9895"],
        ["Mean % Difference (Osteoporosis vs. Predicate)", "Low Percentage Difference", "-5.96%"],
        ["Mean % Difference (Paget's vs. Predicate)", "Low Percentage Difference", "-7.01%"],
        ["Between-Run %CV (Imprecision)", "Low Percentage (e.g., <10%)", "3.3% to 5.9%"],
        ["Within-Run %CV (Imprecision)", "Low Percentage (e.g., <10%)", "1.5% to 2.6%"],
        ["Total %CV (Imprecision)", "Low Percentage (e.g., <10%)", "3.6% to 6.4%"],
        ["Recovery (Spike and Recovery)", "Close to 100%", "Average 92.4% (range 89.9% to 95.3%)"],
        ["Recovery (Specimen Dilution Average)", "Close to 100%", "Average 92.2% (range 78.1% to 106.1%)"],
        ["Interference (Absence of significant interference)", "No significant interference", "No significant interference from tested substances"]
      ]
    },
    "notes": "The acceptance criteria for the Access® Ostase® Assay are implicitly defined by its substantial equivalence claim to the Tandem®-R Ostase® Assay predicate device. The reported performance data demonstrate close agreement, high correlation, and low variability, indicating that the device performs comparably to the predicate and meets general expectations for diagnostic assays."
  },
  "study_details": {
    "sample_size_test_set": {
      "method_comparison": "172 samples (88 osteoporosis, 84 Paget's)",
      "imprecision": "Across various concentrations (exact number of individual samples not specified, but multiple runs and concentrations were evaluated).",
      "recovery_spike": "15 samples",
      "recovery_dilution": "10 samples",
      "interfering_substances": "Not explicitly stated for the test set, but substances were tested at specified concentrations.",
      "data_provenance": "Not explicitly stated for the test set. However, a crucial statement indicates that all clinical studies were generated using the Tandem-R Ostase Assay (the predicate device), implying that the clinical utility data, rather than the analytical performance data, came from studies on the predicate."
    },
    "number_of_experts_ground_truth_test_set": "Not applicable; this is a quantitative immunoassay comparing a new device to a predicate device, not a qualitative diagnostic interpretation requiring expert consensus on images or similar data.",
    "qualifications_of_experts": "Not applicable.",
    "adjudication_method": "Not applicable.",
    "multi_reader_multi_case_comparative_effectiveness_study": "No, this is an in vitro diagnostic (IVD) device for quantitative measurement of a biomarker, not an imaging or interpretive device requiring human-in-the-loop assessment.",
    "standalone_performance": "Yes, the study presents the standalone performance of the Access® Ostase® Assay by comparing its measurements directly to those of the predicate device (Tandem®-R Ostase® Assay) and evaluating its analytical characteristics (imprecision, recovery, interference).",
    "type_of_ground_truth_test_set": "The 'ground truth' for the analytical performance studies (method comparison, imprecision, etc.) is the quantitative measurement provided by the established predicate device (Tandem®-R Ostase® Assay) and established analytical methodologies. For clinical utility, the 'ground truth' for indications (managing osteoporosis and Paget's disease) was established by studies performed using the predicate device, which were then referenced for the new device through the substantial equivalence pathway.",
    "sample_size_training_set": "Not applicable for this type of IVD device. The device is not based on a machine learning algorithm that requires a dedicated training set in the typical sense. Performance is established through analytical validation against a predicate.",
    "ground_truth_for_training_set_established": "Not applicable."
  }
}

Ask a specific question about this device

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