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1 & 2. The VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2 and the VITROS Immunodiagnostic Products Vitamin B12/ Folate Reagent Pack 3 quantitatively measures vitamin B12 concentration in human serum and plasma (EDTA or heparin), to aid in the diagnosis of anemia using the VITROS ECi Immunodiagnostic System with Intellicheck.

3. The VITROS Immunodiagnostic Products Vitamin B12 Calibrators- for use in the calibration of the Vitros Immunodiagnostic System for the quantitative measurement of vitamin B12 in human serum and plasma (EDTA or heparin).

The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum and plasma. Coated microwells are used as the solid phase separation system.
The system is comprised of three main elements:

1. The VITROS Immunodiagnostic Products range of immunoassay products (in this case VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/ 2, VITROS Immunodiagnostic Products Vitamin B12/ Folate Reagent Pack 3, Vitros Immunodiagnostic Products Vitamin B12 Calibrators, which are combined by the VITROS Immunodiagnostic System to perform the VITROS Vitamin B12 assay.
2. The VITROS Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) premarket notification (K962919).
3. Common reagents used by the VITROS System in each assay. The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 Reagent Pack and VITROS Immunodiagnostic Products Total T3 Calibrators 510(k) premarket notification (K964310).
   The VITROS System and common reagents are dedicated specifically for use only with the VITROS Immunodiagnostic Products range of immunoassay products.

I am sorry, but based on the provided text, I cannot extract the specific acceptance criteria and the detailed study results that prove the device meets these criteria in the format you requested.

The document is a 510(k) summary for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed breakdown of acceptance criteria and a standalone study report against those criteria.

Here's what I can tell you based on the document and why I cannot fulfill your request completely:

• No explicit acceptance criteria table: The document does not provide a table of pre-defined acceptance criteria (e.g., specific thresholds for precision, sensitivity, etc.) that the device needed to meet.
• Study is for substantial equivalence, not standalone performance against acceptance criteria: The primary study described is a comparison study to a predicate device (BECKMAN Access Vitamin B12 assay) to establish substantial equivalence. It's not a study designed to prove the device meets pre-defined acceptance criteria for its performance characteristics in isolation.
• Limited detail on individual study results: While it mentions "studies were performed to determine the precision, analytical sensitivity, specificity and expected values," it specifically states to "refer to the VITROS Vitamin B12 Assay Test Methodology Sheet for summaries of the results of these studies." This detailed information is not included in the provided text.

Here's a breakdown of what is available in the document regarding the device and its evaluation:

1. A table of acceptance criteria and the reported device performance:
* Acceptance Criteria: Not explicitly stated as a separate table with specific targets.
* Reported Device Performance (from comparison study):
* Relationship to Predicate Device: VITROS Vitamin B12 assay = 1.028 x X - 9.34 (pg/mL), where X is BECKMAN Access Vitamin B12 Assay.
* Correlation Coefficient: 0.943

2. Sample size used for the test set and the data provenance:
* Test Set Sample Size: Not explicitly stated. The document mentions "a panel of patient samples from a variety of clinical categories."
* Data Provenance: "patient samples from a variety of clinical categories." No specific country of origin is given. The study appears retrospective as it's comparing the new device against a legally marketed predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* This information is not provided in the document. For diagnostic assays like this, "ground truth" would typically come from a reference method or clinical diagnosis, not necessarily "experts" in the way you might define them for image interpretation.

4. Adjudication method for the test set:
* Not applicable as the ground truth establishment method (if any beyond the predicate device's measurement) is not detailed. The comparison is between the new device's measurements and the predicate device's measurements.

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 an in-vitro diagnostic (IVD) assay for vitamin B12. MRMC studies are typically for image interpretation tasks where human readers are involved. This device automates the measurement.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
* Yes, the device itself is a standalone automated assay. The studies conducted (precision, analytical sensitivity, specificity, expected values) would inherently be evaluating its standalone performance. However, the results of these standalone studies are not provided in detail within the summary, only referenced as existing in a separate "Test Methodology Sheet."

7. The type of ground truth used:
* For the comparison study: The predicate device's measurements (BECKMAN Access Vitamin B12 Assay) served as the comparative reference.
* For other studies (precision, sensitivity, specificity): The implicit ground truth would be against known concentrations of vitamin B12 in spiked samples or against a more definitive reference method, though this is not explicitly detailed.

8. The sample size for the training set:
* This is not a machine learning device in the contemporary sense that would have a "training set" for an algorithm. It's an immunoassay. The development and calibration of such assays involve various samples, but they aren't typically referred to as a "training set" in this context.

9. How the ground truth for the training set was established:
* Not applicable for a chemical immunoassay in the context of a "training set."

In summary, the provided 510(k) document is a high-level summary focused on demonstrating substantial equivalence. It refers to detailed performance studies but does not provide the granular data you are requesting for acceptance criteria and specific study results.

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