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The Methadone or Propoxyphene Urine Drugs of Abuse Calibrators are intended for in vitro diagnostic use for the calibration of their respective enzyme immunoassays to detect methadone or propoxyphene in human urine.

The Methadone or Propoxyphene Urine Drugs of Abuse Controls are intended for in vitro diagnostic use for the validation of their respective enzyme immunoassays to detect methadone or propoxyphene in human urine.

All of the Single Analyte Urine DAU Calibrators and Controls are human urine-based liquid, and ready to use. These Calibrators and Controls do not have any especially unique technical characteristics. Each contains a known concentration of a specific drug analyte.

The Negative DAU calibrator is a processed, drug-free human urine matrix. The Low, Cutoff, Intermediate, and High Calibrators, as well as the 2 levels of Controls are prepared by spiking known concentrations of drug analyte into the Negative DAU Calibrator matrix.

The provided document describes the acceptance criteria and study for Lin-Zhi International, Inc.'s Single Analyte (Methadone or Propoxyphene) Urine Drugs of Abuse Calibrators and Controls. These are not AI/ML devices, but rather laboratory calibrators and controls used for drug testing. Therefore, many of the typical AI/ML study components (like human reader studies, ground truth establishment by experts, training set details, etc.) are not applicable here.

Nevertheless, I can extract the relevant information regarding their performance characteristics and the supporting studies.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for precision or accuracy in a numerical format that would typically be found in an AI/ML context (e.g., minimum sensitivity, specificity). Instead, it presents the results of performance studies (reproducibility and accuracy) and implicitly suggests that these results demonstrate acceptable performance for the intended use and for substantial equivalence to a predicate device.

The "reported device performance" are the results from the reproducibility and accuracy studies.

Reproducibility (Precision) - Based on %Coefficient of Variation (%CV)

Accuracy - Comparison of Expected vs. GC/MS Measured Concentrations (ng/mL)

Stability: The study indicated no significant difference between Calibrators and Controls stored at room temperature for 6 months compared to those stored at 2°C to 8°C. Real-time stability studies were ongoing with an anticipated shelf life of at least 12 months at 2°C to 8°C. Previous evaluations of artificial matrix controls showed >24 months real-time stability.

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

• Reproducibility Test Set: 12 vials each of Calibrators and Controls for both Methadone and Propoxyphene.
• Accuracy Test Set: The number of samples for GC/MS confirmation is not explicitly stated as a separate "test set" size. The table lists one GC/MS value per calibrator/control level.
• Data Provenance: Not specified, but implied to be from internal lab studies conducted by Lin-Zhi International, Inc. The products contain "human urine-based" matrix, but no geographic origin for the human urine is provided. The study is retrospective in the sense that the data presented is the result of completed tests.

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

Not applicable. This device is a chemical calibrator/control, not an imaging or diagnostic AI/ML device that requires human expert interpretation for ground truth. The "ground truth" for calibrator concentrations is established by analytical methods (GC/MS).

4. Adjudication method for the test set

Not applicable. Not an AI/ML device requiring human adjudication.

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. Not an AI/ML device.

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

Not applicable. This is not an algorithm. The device itself is the calibrator/control material. The performance characteristics described are how well the calibrators/controls perform in their intended use setting (i.e., in enzyme immunoassays).

7. The type of ground truth used

The "ground truth" for the concentration of the analytes (methadone and propoxyphene) in the calibrators and controls was established using Gas Chromatography/Mass Spectroscopy (GC/MS) technique. This is a highly accurate and widely accepted analytical method for confirming drug concentrations. The reference materials used for spiking were traceable to NIST standards (Methadone) or USP reference standards (Propoxyphene).

8. The sample size for the training set

Not applicable. This is not an AI/ML device that uses training sets. The calibrators and controls are manufactured to specific concentrations.

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

Not applicable. As above, no training set is used. The ground truth for the product's declared concentrations is established through manufacturing processes and confirmed using GC/MS (as described in section 7). The calibrators are prepared by spiking known concentrations of drug analyte into a processed, drug-free human urine matrix.

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The Single Analyte Urine Drugs of Abuse (DAU) Calibrators are intended for in vitro diagnostic use for the calibration of their respective DAU enzyme immunoassays to detect phencyclidine, opiates, cocaine metabolite, or amphetamines in human urine.

The Single Analyte Urine Drugs of Abuse (DAU) Controls are intended for in vitro diagnostic use for the validation of their respective DAU enzyme immunoassays to detect phencyclidine, opiates, cocaine metabolite, or amphetamines in human urine.

All of the Single Analyte Urine DAU Calibrators and Controls are human urine-based liquid, and ready to use. These Calibrators and Controls do not have any especially unique technical characteristics. When applicable, they contain known concentration of a specific drug analyte.

The Negative DAU Calibrator is a processed, drug-free human urine matrix. The Low, Cutoff, Intermediate, and High Calibrators, as well as the 2 levels of Controls are prepared by spiking known concentrations of drug analyte into the Negative DAU Calibrator matrix. The various concentrations of each drug analyte in their corresponding calibrators and controls are summarized as follows:

The nominal concentrations of the analyte in the calibrators and controls are determined and confirmed by GC/MS.

The provided document describes a 510(k) premarket notification for "Single Analyte Urine Drugs of Abuse Calibrators and Controls". This device is a set of calibrators and controls used for in vitro diagnostic tests, rather than an AI-powered diagnostic device. As such, many of the requested categories in the prompt (e.g., AI performance, expert adjudication, MRMC studies, training set details) are not applicable.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" for the LZI device. Instead, it demonstrates substantial equivalence to a predicate device (DRI's Drugs of Abuse Urine Calibrators and Controls) by highlighting similarities in intended use, matrix, and performance characteristics. The performance characteristics mentioned as similar are precision, accuracy, and stability. However, specific numerical targets or benchmarks for these characteristics for the LZI device are not provided in this summary.

The table below summarizes the device's characteristics and how they compare to the predicate, which implicitly defines the performance expectations for equivalence.

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

The document does not provide details on sample size or data provenance for any "test set" in the context of device performance testing. The evaluation focused on demonstrating substantial equivalence to a predicate device based on characteristics and general performance attributes, rather than presenting a detailed clinical study with a test set. The nominal concentrations of analytes in the calibrators and controls are "determined and confirmed by GC/MS," which implies internal analytical testing, but specifics are not given.

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

Not applicable. This device is a set of calibrators and controls for laboratory assays, not an AI or diagnostic device that requires expert ground truthing of clinical data for performance evaluation. The "ground truth" for the calibrators and controls is the precisely known concentration of drug analytes, which is confirmed by analytical methods like GC/MS.

4. Adjudication Method:

Not applicable for the reasons stated above.

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 is not an AI-powered device.

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

Not applicable. This is not an AI-powered device with an algorithm for standalone performance. The device itself (calibrators and controls) is a component used in an assay.

7. The Type of Ground Truth Used:

The ground truth for the device's characteristics is the precisely known (nominal) concentrations of drug analytes spiked into the urine matrix, which are confirmed by Gas Chromatography/Mass Spectrometry (GC/MS).

8. The Sample Size for the Training Set:

Not applicable. This is not an AI-powered device that requires a "training set." The development of calibrators and controls relies on precise chemical formulations and analytical validation.

9. How the Ground Truth for the Training Set was Established:

Not applicable. As there is no training set for this type of device, this question is not relevant. The "ground truth" for the product itself (known analyte concentrations) is established through analytical chemistry methods like GC/MS.

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