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The Dimension ® clinical chemistry system is an in vitro diagnostic device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids.

The Dimension system chemical and immunochemical applications utilize photometric, turbidimetric, and integrated ion selective multisensor technology for clinical use.

Sodium measurements are used for monitoring electrolyte imbalances.

Potassium measurements are used for diagnosis in diseases with high and low Potassium levels.

Chloride measurements are primarily use to detect and treatment of metabolic disorders.

Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Thyroid stimulating hormone measurements are used in diagnosis of thyroid or pituitary disorders.

Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.

The Siemens Healthcare Diagnostics Dimension® clinical chemistry analyzers are floor model, fully automated, microprocessor-controlled, integrated instrument systems that use prepackaged Flex® reagent test cartridges to measure a variety of analytes in human body fluids. The systems can process samples in random access, batch and stat modes. The systems are multi-functional analytical tools that process chemical and immunochenical methodologies, utilizing photometric, and integrated ion selective multisensor detection technologies for clinical use. The Dimension systems include the ability to communicate and connect with laboratory information system (LIS) networks.

With revision 10.0 software, the Operating System of the Dimension clinical chemistry analyzers, RxL/ RxLMax (K963498), Xpand Plus (K010061), will change from QNX to Linux.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

Device: Dimension® RxL/RxL Max clinical chemistry analyzer (with Linux Operating System)

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantified, pass/fail manner. Instead, the acceptance criteria for this 510(k) submission are implicitly tied to demonstrating substantial equivalence to the predicate device. The key performance metrics evaluated were Method Comparison and Precision (within run, within lab) for specific representative assays. The performance is reported as meeting this equivalency.

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

• Sample Size: The document states that "representative methods were tested" and compares "the same samples and methods" on predicate and test instruments. However, the specific number of samples (sample size) used for the test set for Method Comparison and Precision studies is not provided.
• Data Provenance: Not explicitly stated (e.g., country of origin). The study appears to be prospective in the sense that samples were deliberately run on both the predicate and test devices for comparison purposes.

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

Not applicable. This device is an in vitro diagnostic chemistry analyzer, and its performance is evaluated against itself (predicate device performance) using quantitative measurements, not against expert human interpretations or diagnoses. The ground truth would be the actual concentration of analytes in the samples.

4. Adjudication Method for the Test Set:

Not applicable. As noted above, this is a quantitative analytical device comparison, not a diagnostic interpretation where adjudication of expert opinions would be necessary.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This type of study (MRMC) is typically performed for diagnostic imaging or similar devices where multiple human readers interpret cases. This submission is for a clinical chemistry analyzer, which does not involve human interpretation of outputs in the same way. The evaluation is purely based on instrument performance.

6. Standalone (Algorithm Only) Performance:

Yes, an equivalent of a "standalone" performance was done. The study directly compared the analytical results obtained from the Dimension® clinical chemistry system with the Linux operating system (test device) against the analytical results obtained from the Dimension® clinical chemistry system with the QNX operating system (predicate device). The evaluation focuses solely on the output of the instrument itself, without human intervention in the result generation.

7. Type of Ground Truth Used:

The ground truth implicitly used for the performance comparison is the analytical result produced by the predicate device. The goal was to show that the new device (with Linux OS) produces equivalent results to the established predicate device (with QNX OS) when processing the same samples. The underlying ground truth for the analytes themselves would be the true concentration in the human body fluids, likely measured by a highly accurate validated method, but the comparison here is between two versions of the same product.

8. Sample Size for the Training Set:

Not applicable. This device is a measurement instrument, not an AI or machine learning model that requires a training set in the conventional sense. The "training" of such a system would involve instrument calibration and quality control procedures, but not a data-driven training set like an AI algorithm.

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

Not applicable, for the same reasons as point 8.

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MPO Flex® reagent cartridge: The MPO method is an in vitro diagnostic test for the quantitative measurement of myeloperoxidase (MPO) in human plasma on the Dimension® clinical chemistry system with the heterogeneous immunoassay module. Myeloperoxidase measurements may be used in conjunction with clinical history, ECG, and cardiac biomarkers to evaluate patients presenting with chest pain that are at risk for major adverse cardiac events, including myocardial infarction, need for revascularization, or death.

MPO Calibrator: The MPO Calibrator is an in vitro diagnostic product intended to be used to calibrate the Myeloperoxidase (MPO) method on the Dimension® clinical chemistry system with the heterogeneous immunoassay module.

MPO Control: The myeloperoxidase control is an in vitro diagnostic product intended for use as an assayed quality control product to monitor the performance of the Myeloperoxidase (MPO) method on the Dimension® clinical chemistry system with the heterogeneous immunoassay module.

The MPO method is a one-step enzyme immunoassay based on the "sandwich" principle. The sample is incubated with chromium dioxide particles coated with monoclonal antibodies specific for MPO, and conjugate reagent (13-galactosidase labeled monoclonal antibodies specific for MPO). A particle/MPO/conjugate sandwich forms during the incubation period. Unbound conjugate is removed by magnetic separation and washing. The sandwich bound fl-galactosidase is combined with the chromogenic substrate chlorophenol red-ß-D-galactopyranoside (CPRG). Hydrolysis of CPRG releases a chromophore (CPR). The concentration of MPO present in the patient sample is directly proportional to the rate of color change due to formation of CPR measured at 577 nm.

The provided text describes the Siemens Healthcare Diagnostics Dimension MPO Flex® reagent cartridge and its associated calibrator and control. The information focuses on demonstrating substantial equivalence to a predicate device, the PrognostiX CardioMPO™ Enzyme Immunoassay. The study does not involve an AI device, therefore, some of the requested information such as MRMC study, and number of experts to establish ground truth is not applicable.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria (from predicate device) and Reported Device Performance:

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The ENZ I CAL is an in vitro diagnostic product for the calibration of the LDI method on the Dimension® clinical chemistry system.

ENZ I CAL is a liquid, bovine serum albumin based product containing lactate dehydrogenase (chicken heart). The calibrator packaging contains 4 vials, 2 vials of Level 2 and two vials of Level 3, with 1.5 mL per vial. Level 1 calibrator for LDI is not included in the ENZ I CAL carton. Purified Water Diluent (Cat. No. 710615901) or reagent grade water is required for use as Calibrator Level 1 for the LDI method.

This document is a 510(k) summary for a Calibrator Material (specifically, a lactate dehydrogenase calibrator) used in a clinical chemistry system. The information provided in the input is about a calibration device, not a diagnostic AI device that would have acceptance criteria and performance metrics for patient diagnosis.

Therefore, many of the requested categories are not applicable to the provided document. I will address the applicable points and note where information is not present or relevant for a calibrator.

Here's a breakdown based on the provided text:

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

The provided 510(k) summary for the "Dimension® clinical chemistry system Enzyme I Calibrator" does not include a table of acceptance criteria and reported device performance in the manner typically expected for a diagnostic device that classifies or predicts. This document focuses on demonstrating substantial equivalence to a predicate device, which is a different regulatory pathway.

The key performance criterion for a calibrator is its traceability and ability to correctly calibrate the assay, which is indirectly addressed by the stated traceability to the IFCC LD method.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is a calibrator, not a diagnostic device that uses a test set of patient data. The submission focuses on comparing the new calibrator's characteristics to a predicate calibrator.

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 calibrator. The "ground truth" for a calibrator is its accurately assigned value, which is established through traceability to a reference method (in this case, IFCC LD at 37°C primary reference method). This doesn't involve expert readers for a test set in the same way a diagnostic image analysis algorithm would.

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

Not applicable. There is no test set or human adjudication process for a calibrator's performance.

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 a calibrator, not an AI diagnostic device.

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

Not applicable. This is a calibrator, not an algorithm.

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

For the calibrator itself, the "ground truth" (or basis for its assigned values) is its traceability to the IFCC LD at 37°C primary reference method. This is a recognized international standard for lactate dehydrogenase measurements.

8. The sample size for the training set

Not applicable. This is a calibrator, not an AI device trained on a dataset.

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

Not applicable. This is a calibrator, not an AI device.

Summary Table for Applicable Information:

• Analyte: Lactate dehydrogenase
• Use: Calibration of LDI method
• Matrix: Liquid bovine serum albumin base
• Form: Liquid
• Traceability: IFCC LD at 37°C primary reference method. |
  | Reported Device Performance | No specific performance metrics (e.g., sensitivity, specificity, accuracy) are reported for the calibrator itself, as its performance is tied to its ability to accurately calibrate the assay. The report states it is "substantially equivalent" to the predicate. |
  | Sample Size (Test Set) | Not applicable (no diagnostic test set). |
  | Data Provenance (Test Set) | Not applicable. |
  | Number of Experts (Ground Truth) | Not applicable for establishing "ground truth" in the context of diagnostic interpretation. The calibrator's value traceability is established by laboratory practices and international standards. |
  | Qualifications of Experts | Not applicable. |
  | Adjudication Method | Not applicable. |
  | MRMC Comparative Effectiveness Study | Not applicable. |
  | Standalone Performance Study (Algorithm Only) | Not applicable. |
  | Type of Ground Truth Used | Traceability to IFCC LD at 37°C primary reference method for the calibrator's assigned values. |
  | Sample Size (Training Set) | Not applicable (no training set). |
  | Ground Truth Establishment (Training Set) | Not applicable. |

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The LIPL Calibrator is an in vitro diagnostic product to be used to calibrate the Lipase (LIPL) method for the Dimension® clinical chemistry systems.

The LIPL calibrator is a liquid bovine serum albumin-based product. The level 1 calibrator contains no detectable lipase. Levels 2 and 3 contain porcine pancreas lipase. The kit consists of six vials, two vials of Calibrator Level 1, two vials of Calibrator Level 2, and two vials of Calibrator Level 3 which are ready for use (no preparation is required). The volume per vial is 1.0 mL.

The provided text describes a 510(k) premarket notification for a medical device, specifically the Dimension® Clinical Chemistry System Lipase Calibrator (LIPL CAL - DC56). This device is a calibrator material used to calibrate the Lipase (LIPL) method for Dimension® clinical chemistry systems.

It is important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than comprehensive performance studies with acceptance criteria in the same way one might assess the accuracy of a diagnostic test. For a calibrator, the primary performance characteristic is its traceability to reference materials and the consistency of its assigned values.

Here's an analysis of the provided information concerning acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

For calibrators, explicit "acceptance criteria" in terms of clinical sensitivity/specificity or other diagnostic performance metrics are not typically provided. Instead, the focus is on traceability and value assignment consistency.

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

The document does not explicitly define a "test set" in the traditional sense for evaluating diagnostic performance. The evaluation described relates to the traceability and value assignment process of the calibrator.

• Sample Size: The master pool levels 2 and 3 are assigned on "multiple instruments." The number of instruments is not specified. Calibrator concentrations are verified against Master Pool values, which implies testing a certain number of calibrator vials, but the exact number isn't given.
• Data Provenance: The data comes from internal testing and validation by Siemens Healthcare Diagnostics Inc. No country of origin for patients or samples is relevant as this is a calibrator, not a patient-facing diagnostic. The studies are by nature prospective in the sense of manufacturing and validating new lots of calibrator.

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

• Number of Experts: Not applicable in the context of this calibrator validation. The "ground truth" for calibrators is established through a hierarchical traceability chain to reference materials and methods, not expert consensus on patient data.
• Qualifications of Experts: Not applicable. The process relies on laboratory procedures, validated analytical methods, and qualified personnel following good manufacturing and laboratory practices, rather than expert interpretation of a test set.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" of patient samples requiring expert adjudication. The process involves analytical measurements and comparison to established reference values and internal controls.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is a calibrator, not a diagnostic device that requires human interpretation. Therefore, MRMC studies are not relevant.

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

Yes, in a sense. The performance described is inherent to the calibrator material and its assigned values, which are determined through analytical procedures, not human-in-the-loop interpretation. The "algorithm" here is the analytical method used to assign the calibrator values and the instrument's subsequent calibration function.

7. The Type of Ground Truth Used

The "ground truth" for the calibrator is established through:

• Reference Materials/Methods: The LIPL Anchor Pool values are assigned using an external reference system (PBS/Precical®).
• Gravimetric Preparation: Calibrators are prepared gravimetrically from porcine lipase, providing a known starting concentration.
• Hierarchical Traceability: The process involves tracing values from a Master Pool, which is itself traceable to an Anchor Pool, and ultimately to an external reference system.

8. The Sample Size for the Training Set

Not applicable. As a calibrator, this device does not involve machine learning or AI that would require a "training set." Its values are determined through analytical and manufacturing processes.

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

Not applicable, as no training set is involved.

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