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The LD-1 assay is used for the quantitation of LD-1 (one of a group of enzymes with similar biological activity) in serum. Measurement of LD-1 is used in the diagnosis and treatment of cardiac diseases, such as myocardial infarction.

LD-1 is an in vitro diagnostic assay for the quantitative determination of LD-1 in serum. The LD-1 assay is a clinical chemistry assay and employs sodium perchlorate, a chaotropic agent to selectively denature the LDH isoenzyme teteramers with one or more "M" subunits, removing their enzymatic activity. LD-1 is resistant to this denaturation and is assayed simultaneously. The method for measurement of the LDH activity employs the conversion of lactate to pyruvate by LD-1 with a concomitant reduction of NAD to NADH. The rate of NADH formation, as measured by the rate of absorbance increase at 340 nm, is directly proportional to LD-1 activity in the sample.

The provided document describes the LD-1 assay, an in vitro diagnostic assay for the quantitative determination of LD-1 in serum. The study aims to demonstrate substantial equivalence to a predicate device, not necessarily to establish de novo performance against a defined acceptance criterion for a novel device.

Here's an analysis of the provided information, framed within your requested structure:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The LD-1 assay's acceptance criteria and proven performance are established through a substantial equivalence comparison to a predicate device, the Roche® Cobas Mira® Plus Automated Chemistry System LD-1 assay (K894081). The study demonstrates that the LD-1 assay yields similar performance characteristics to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are implied by the declaration of substantial equivalence to the Roche Cobas Mira Plus LD-1 assay. Specific numerical thresholds for "acceptance" beyond the reported values themselves are not explicitly detailed in the summary. The core "acceptance" is the FDA's agreement that the performance characteristics are sufficiently similar to the legally marketed predicate.

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size: The document does not specify the exact sample size for the comparative performance studies (method comparison and precision studies). It only states that "Comparative performance studies were conducted."
• Data Provenance: The data provenance (country of origin, retrospective/prospective) is not explicitly stated. However, given it is a 510(k) submission in the US, it is generally assumed that the studies were conducted by or for Abbott Laboratories, a US-based company, and the data would likely be prospective clinical samples or laboratory-generated samples for method performance evaluation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This section is not applicable as the device is a quantitative in vitro diagnostic assay for measuring LD-1 levels. The "ground truth" for such assays is typically established by comparing the device's results to a legally marketed predicate device (as done here) or a reference method/material, rather than expert consensus on individual cases. No experts were involved in establishing "ground truth" for the test set in the traditional sense of medical image interpretation or clinical diagnosis.

4. Adjudication Method for the Test Set

This section is not applicable for a quantitative in vitro diagnostic assay. Adjudication methods (like 2+1, 3+1) are typically used in studies where human readers interpret data (e.g., medical images) and their interpretations need to be reconciled to establish a consensus ground truth. For this type of device, the "ground truth" is the result from the predicate device or a reference method.

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 section is not applicable. The device is an in vitro diagnostic assay, not an AI-powered diagnostic tool requiring human interpretation or assistance. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study evaluating human reader performance with or without AI assistance was not conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The study described is inherently a standalone performance evaluation of the LD-1 assay. As an automated clinical chemistry assay, its performance is assessed directly (correlation, precision, linearity, sensitivity) without human intervention in the result generation or interpretation process of the assay itself. The comparison is algorithm (LD-1 assay) to algorithm (Roche Cobas Mira Plus LD-1 assay).

7. The Type of Ground Truth Used

The "ground truth" used for evaluating the LD-1 assay's performance was the results obtained from the legally marketed predicate device, the Roche Cobas Mira Plus Automated Chemistry System LD-1 assay (K894081). For precision studies, specific control materials with known or expected ranges were used.

8. The Sample Size for the Training Set

This information is not provided and is generally not applicable in the same way it would be for machine learning algorithms. The LD-1 assay is a chemical reaction-based clinical chemistry method. There isn't a "training set" in the sense of data used to train a model. The assay's parameters (reagent concentrations, incubation times, etc.) would be optimized during its development, but this process doesn't typically involve a "training set" with ground truth in the context of a 510(k) submission summary.

9. How the Ground Truth for the Training Set Was Established

This section is not applicable for the reasons stated above (see point 8). The assay is based on established chemical principles, not a machine learning model requiring a trained ground truth dataset.

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