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The COBAS INTEGRA ISE module applications are intended for use for the quantitative determination of sodium, potassium, chloride, and lithium concentrations using ionselective electrodes:

• . the direct application is intended for undiluted serum and plasma
• the indirect application is intended for diluted serum and plasma (does not include . lithium)
• the urine application is intended for diluted urine (does not include lithium) ●

The COBAS INTEGRA Analyzer and COBAS INTEGRA Reagent cassettes together provide an integrated system for in vitro diagnostic testing. The COBAS INTEGRA Analyzer utilizes three measuring principles, i.e., absorbance, fluorescence polarization and ion-selective electrodes. The analyzer has a throughput of up to 600 tests per hour with STAT samples prioritized and tested immediately. Random sample access, robotics and a user interface optimize time management and streamline workflow. The COBAS INTEGRA can store up to 68 COBAS INTEGRA Reagent Cassettes on board, 24 hours a day at 2-8°C. The COBAS INTEGRA Reagent Cassettes are compact and preparation-free with the added convenience of long term on-board stability. Barcode readers are used to identify newly loaded reagent cassettes, samples for patient identification, and rack inserts and to read calibration and control data from the cassette label. COBAS INTEGRA tests include chemistry, drugs of abuse, immunology, ion selective electrodes, therapeutic drug monitoring, and hematology reagents.

Through this submission, it is the intention of Roche Diagnostic Systems to gain clearance of a modified ISE Module which includes modified versions of the Direct Sodium, Direct Potassium, and Direct Chloride applications. These applications were previously cleared on September 8, 1995 (K951595). This premarket notification also includes new ISE applications for Direct Lithium, Indirect Sodium, Indirect Potassium, Indirect Chloride, Urine Sodium, Urine Potassium, and Urine Chloride.

The provided text describes modifications to the Roche COBAS INTEGRA ISE Module and new ISE applications, along with performance characteristics compared to predicate devices. It focuses on analytical performance rather than clinical studies with human readers or diagnostic accuracy in a clinical setting. Therefore, many of the requested categories are not applicable to this type of device and study.

Here's an analysis of the available information:

Acceptance Criteria and Device Performance for Roche COBAS INTEGRA ISE Module Modifications

The acceptance criteria for each analyte are implied by the "Performance Characteristics" section of each comparison table. The device performance (Modified COBAS INTEGRA ISE Application) is shown alongside these implied criteria and compared to predicate devices. The primary metrics are Test Range, Precision (Mean, %CV within run, %CV total), and Accuracy (linear regression relative to a predicate device or reference method).

Note: For this device, "acceptance criteria" are not explicitly stated as distinct numerical targets but are demonstrated by showing performance that is comparable to or better than established predicate devices. The "reported device performance" is the direct result reported in the tables for the COBAS INTEGRA Modified ISE Applications.

Table of Acceptance Criteria and Reported Device Performance

Due to the volume and nature of the data (comparing against multiple predicate devices and different measurement types), a single comprehensive table would be extremely large. Instead, I will present a summary for one example (Direct Sodium) and describe how to infer the information for others.

Example: Direct Sodium

To infer for other applications:

• Acceptance Criteria: Look at the "Predicate Device" columns for the respective analytes (BM/Hitachi 911 or Kodak Ectachem 250) under "Performance Characteristics." These values represent the established performance of legally marketed devices to which equivalence is claimed.
• Reported Device Performance: Look at the "COBAS INTEGRA Modified ISE ... Application" columns under "Performance Characteristics" for the respective analytes.

Study Details

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: "Greater than 200 specimens were tested on both systems for each application" in the correlation studies (Sodium, Potassium, Chloride, Lithium). Specific numbers are provided in the accuracy (correlation) sections: n=208 for most modified COBAS INTEGRA ISE applications (Sodium, Potassium, Chloride, Indirect/Urine applications), n=244 for Direct Lithium, n=174 for Urine Sodium, n=162 for Urine Potassium, and n=164 for Urine Chloride.
   • Data Provenance: Not explicitly stated. The studies were likely conducted internally by the manufacturer (Roche Diagnostic Systems, Inc.) or a contracted lab. It's not specified if the data is retrospective or prospective, but given they are performance studies for a device, they would typically be prospective for the purpose of generating new performance data. There is no mention of country of origin for the data.

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

   • Not Applicable. This is an in vitro diagnostic device for quantitative determination of analytes. The "ground truth" is established by a reference method or a predicate device, not by expert human interpretation (like in imaging diagnostics).

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

   • Not Applicable. As mentioned above, this is an analytical performance study for an IVD, not a diagnostic study requiring human expert adjudication.

4. 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. This is not an MRMC study. It is a comparison of analytical performance between a new device and predicate devices/reference methods. This type of study is not applicable to a laboratory analyzer.

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

   • Yes. The performance studies presented are for the device (COBAS INTEGRA ISE Module) operating in a standalone manner. There is no human-in-the-loop component for the analytical measurement reported. The results are generated directly by the automated analyzer.

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

   • The "ground truth" (reference method) used for accuracy (correlation) studies included:
     • Boehringer Mannheim / Hitachi 911 analyzer (for Sodium, Potassium, Chloride – direct, indirect, urine applications)
     • Kodak Ectachem 250 analyzer (for Lithium)
     • Flame photometry (for Sodium, Potassium, Chloride (predicate device reference))
     • Chloridometer (for Chloride (predicate device reference))

7. The sample size for the training set:

   • Not explicitly stated/Likely not applicable in the traditional sense. For an IVD like this, a "training set" doesn't typically exist in the same way as for machine learning algorithms. The device calibration and algorithm parameters are established during product development and manufacturing based on internal experimentation and characterization, not typically based on a "training set" of patient data that is then separated from a "test set" for regulatory submission. The provided correlation studies are focused on verification of the final product's performance against established methods.

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

   • Not Applicable. See point 8 above. The establishment of internal "ground truth" for the device's development and calibration would typically involve highly characterized reference materials and methods, but this is part of the engineering and development process, not usually reported as a "training set ground truth" in a 510(k) summary focused on performance data.

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