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The DSL IGF-I IRMA assay is intended for the quantitative determination of IGF-I in human serum or EDTA plasma. The measurement of serum/plasma IGF-I is used as a diagnostic aid in the evaluation of growth status disorders.

The DSL Active IGF-I IRMA kit was developed for the quantitative measurement of Insulin-like Growth Factor-I in human serum and plasma. This IRMA format is a capture assay. Mouse monoclonal antibody to IGF-I is immobilized to the inner surface of the coated test tubes. IGF-I in the standards or samples is "sandwiched" between this monoclonal and the goat-anti-IGF-I polyclonal antibody labelled with lodine-125.

The provided document describes a medical device, the "DSL 2800 IGF-I IRMA Kit," for the quantitative measurement of Insulin-like Growth Factor-I (IGF-I). It details the device's intended use and compares it to a substantially equivalent device, the "DSL 5600 IGF-I IRMA."

However, the provided text does not contain information related to acceptance criteria, detailed study designs, expert involvement, or any aspects of AI/algorithm performance. The document is a summary of safety and effectiveness, focusing on demonstrating substantial equivalence between two kits by comparing their measurement results on patient samples.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer most of the requested questions because the necessary information is not present in the input text.

Here's what I can extract and what is missing based on the provided text:

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

• Acceptance Criteria: Not explicitly stated in the document.
• Reported Device Performance:
  • Comparison with DSL 5600 IGF-I IRMA: Y = 1.19(X) - 22.07 (Linear regression equation)
  • Correlation Coefficient (r): 0.98

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 for Test Set: 146 patient samples.
• Data Provenance:
  • Country of Origin: Not specified.
  • Retrospective or Prospective: Not specified, but samples were "collected and assayed simultaneously by both methods," suggesting a prospective collection or at least simultaneous testing of existing samples. The selection based on "expected IGF-I levels" implies a targeted, rather than purely random, selection.

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. This is a measurement assay comparison, not an expert-driven diagnostic interpretation. "Ground truth" in this context is established by the reference assay (DSL 5600 IGF-I IRMA) on the same samples.

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

• Not applicable. There's no adjudication process described as it's a quantitative measurement comparison, not an interpretation task.

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 MRMC study was done. This document describes a comparison between two lab assay kits, not an AI system or human reader performance.

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

• Not applicable. This device is a diagnostic assay kit, not an algorithm or AI system. Its performance is inherent to the kit's chemical and immunological reactions.

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

• For the purpose of demonstrating substantial equivalence, the "ground truth" was defined by the results obtained from the DSL 5600 IGF-I IRMA kit on the same patient samples. This kit is presented as the substantially equivalent device to which the new device (DSL 2800 IGF-I IRMA Kit) is being compared.

8. The sample size for the training set:

• Not applicable. This is not a machine learning or AI device that requires a training set. The assay's performance is based on its chemical and immunological design.

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

• Not applicable. No training set for an AI model is described.

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