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The OPTI CCA-TS2 system when used with disposable cassettes containing parameter specific sensors is intended to be used for the measurement of pH, pCO2, pO2, Na *, K , Ca , Cl , Glucose, BUN (urea), lactate, tHb, and SO2 in samples of whole blood, and pH, Na , K , C * , Cl , Glucose and BUN (urea) in serum and plasma, in a clinical laboratory setting or point of care locations.
Measurements of blood gases (PCO2, PO2) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.
Lactate (lactic acid) measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).
Total hemoglobin {tHb) measurement is used to determine the hemoglobin content of human blood.
Oxygen saturation (SO2) measurement is used to determine the oxygen capacity of the hemoglobin.
Potassium (K ) measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.
Calcium (Ca) measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
Sodium (Na) measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insibidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst),adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.
Chloride (Cl`) measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
Urea nitrogen (an end-product of nitrogen metabolism) measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.
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.

The OPTI® CCA-TS2 is a modified model of the legally marketed OPTI® CCA-TS analyzer system. The OPTI® CCA-TS2 analyzer system uses the same technology and operating principles to perform the same intended uses as the OPTI® CCA-TS cleared with K993837. Optical fluorescence and reflectance technology is used to perform the parameter measurements outlined in the intended use. The technology is the same as that employed in previous models of OPTI products.
The OPTI® CCA-TS2 analyzer is sold separately from disposable cassettes containing sensors that interact with an in-vitro blood or plasma/serum sample aspirated into the cassette by the analyzer system. The disposable cassettes are designed and manufactured by OPTI Medical Systems, Inc. for exclusive use with OPTI Analyzers. The parameters reported by the analyzer system are determined by the sensors contained within each cassette style. Various styles of cassettes are available to report up to six combinations of blood gases, electrolytes and metabolites for each sample aspirated into the cassette. Each cassette style is bar-coded with calibration information determined for each lot of cassettes prior to release.

The OPTI® CCA-TS2 is a critical care analyzer designed to measure various blood gas, electrolyte, and metabolite parameters. The submission aims to demonstrate that the OPTI® CCA-TS2 is substantially equivalent to its predicate device, the OPTI® CCA-TS ([K993837](https://510k.innolitics.com/search/K993837)), despite hardware and software updates. The core of the device's functionality, specifically the cassettes and their sensors, remains unchanged.

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

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the OPTI® CCA-TS2 are based on demonstrating functional equivalence and performance comparability to the predicate device, OPTI® CCA-TS ([K993837](https://510k.innolitics.com/search/K993837)). This is primarily assessed through:

• Method Comparison: Statistical correlation (Slope, Intercept, Correlation Coefficient R²) between the OPTI® CCA-TS2 and the OPTI® CCA-TS for all measured parameters across their intended ranges. The expectation is that the OPTI® CCA-TS2 should produce results that are highly correlated and show minimal systematic bias (slope close to 1, intercept close to 0) when compared to the predicate.
• Precision/Reproducibility: Evaluation of within-run, between-run, and between-day precision (Standard Deviation and %CV) using quality control solutions and spiked whole blood samples, in accordance with CLSI guideline EP5-A2. The device's precision should be within acceptable limits for a clinical laboratory setting.
• Linearity/Reportable Range: Demonstrating that the OPTI® CCA-TS2 provides accurate measurements across the claimed reportable ranges, with linearity assessed by comparing results to the predicate device using linearity solutions and whole blood samples. The correlation (R²) should indicate strong linearity.
• Safety and EMC: Compliance with applicable electrical safety (IEC 61010-1, IEC 62133 Ed. 2.0 b:2012) and electromagnetic compatibility (IEC 61326-2-6) standards.
• Software Verification and Validation: Ensuring that software changes did not adversely impact measurement performance.

Here's a summary of the reported device performance, focusing on method comparison and linearity, as these directly address the equivalence to the predicate:

Precision Results for OPTI CCA-TS2 (using quality control solutions and whole blood)
The precision data (Standard Deviation and %CV) are presented in extensive tables within the document for all parameters across various levels of controls and whole blood. These values generally show low variability, indicating good precision. For example, Total %CV for most parameters in quality control solutions and whole blood samples are well below 5-10%, which is typically considered acceptable for clinical chemistry analytes.

Key Findings: The study concludes that the method comparison, linearity, and precision data demonstrate that the OPTI® CCA-TS2 device is safe, effective, and substantially equivalent to the OPTI® CCA-TS predicate device. The correlation coefficients (R²) are consistently high (>0.98 for most parameters, often >0.99), and slopes are close to 1 with intercepts close to 0, indicating excellent agreement between the new device and the predicate.

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

The sample sizes for the test set vary by parameter and type of study (method comparison vs. linearity).

• Method Comparison:

  • Whole Blood Samples: Number of samples (n) ranges from 45 to 144 for individual parameters (e.g., Lactate: n=45, pO2: n=144). These were measured across three OPTI CCA-TS2 analyzers and three OPTI CCA-TS analyzers.
  • Plasma/Serum Samples: Number of samples (n) ranges from 45 to 108 for individual parameters (e.g., Cl-: n=45, pH: n=108).
  • Point-of-Care (POC) Sites: Method comparison studies in whole blood samples were repeated at 4 different POC sites. The exact number of samples tested at each POC site is not specified beyond indicating they were "very similar to the results obtained at the internal site."

• Precision/Reproducibility:

  • Quality Control Solutions (OPTI Check): Testing was performed over "at least 10 days, 4 runs per day, with a minimum of 2 OPTI CCA-TS2 analyzers." This translates to a minimum of 80 measurements per level per parameter (10 days * 4 runs/day * 2 analyzers). Since three levels were tested for each parameter, this would be 80 * 3 = 240 minimum measurements per parameter. (Individual table 'Days run' states 20 per day but this usually means 20 individual runs across all analyzers over 10 days not 20 days per day, so it will be 20 * 4 * 2 = 160 per level.)
  • Whole Blood Samples (Within-Run Precision): 10 repeats at each of three levels of spiked or diluted whole blood, on one OPTI CCA-TS2 analyzer. This means 30 measurements per parameter (10 repeats * 3 levels).

• Linearity/Reportable Range:

  • Whole Blood and CVC123 (Aqueous Linearity Solutions):
    • Whole Blood Samples: Number of samples (n) ranges from 55 to 90 for individual parameters (e.g., Lactate: n=55, PO2: n=90).
    • CVC123 Solutions: Number of samples (n) ranges from 18 to 60 for individual parameters (e.g., Glucose: n=18, PCO2/PO2 120μL: n=60).
    • These were run on "two (2) OPTI CCA-TS and two (2) OPTI CCA-TS2 analyzers."

Data Provenance: The studies were conducted in-house at OPTI Medical Systems, Inc. for method comparison, precision, and linearity. Additionally, method comparison studies were performed at 4 different Point-of-Care (POC) sites. The data are prospective, as they were collected specifically for this submission to evaluate the performance of the new OPTI® CCA-TS2 device against its predicate. No specific country of origin is mentioned for the patient samples, but the internal site is implied to be in the USA (given the applicant's address and submission to FDA).

3. Number of Experts Used to Establish Ground Truth and Qualifications

This submission does not involve human interpretation of medical images or data where "experts" would establish ground truth in the typical sense (e.g., radiologists, pathologists). Instead, this is a medical device for in-vitro diagnostic (IVD) measurement of blood parameters.

The "ground truth" here is established by:

• The predicate device's measurements: The OPTI® CCA-TS device, which is already legally marketed and cleared (K993837), serves as the reference for method comparison studies. Its measurements are assumed to be the established "truth" against which the new device's performance is gauged for substantial equivalence.
• Reference materials/standards: For traceability, the document states that parameters are calibrated and tested using "primary and secondary standards that are traceable to NIST or other recognized standards" (e.g., NIST traceable phosphate buffer for pH, NIST SRM 956A for Na, K, Ca, Cl, NIST SRM 965 for Glucose, NIST SRM 909 for BUN). These national/international metrological standards represent the highest level of ground truth for analytical measurements.
• Aqueous quality control solutions (OPTI Check, CVC123): These commercially prepared and validated solutions have known target values for the analytes and are used to assess precision and linearity.

Therefore, there were no "experts" in the context of human readers providing annotations for machine learning. The ground truth relies on established analytical methods and certified reference materials.

4. Adjudication Method for the Test Set

Not applicable. As this is an IVD device measuring physiological parameters, there is no "adjudication method" in the sense of resolving discrepancies between multiple human reviewers or between human reviewers and an AI output. The comparison is directly between the new device's readings and the predicate device's readings or values from certified reference materials. Discrepancies would be analyzed statistically (e.g., regression analysis, bias plots) rather than resolved through an adjudication process.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI/CADe (Computer-Aided Detection/Diagnosis) devices where human readers interpret medical images or data, and the AI's assistance is evaluated for its impact on reader performance.

The OPTI® CCA-TS2 is an in-vitro diagnostic instrument for direct measurement of analytes. Its performance is evaluated against a predicate device and known standards, not in terms of how it assists human readers.

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

Yes, the primary studies in this submission are standalone performance evaluations of the OPTI® CCA-TS2 device. The device is intended to provide direct, quantitative measurements.

The "standalone" performance is demonstrated through:

• Method comparison studies: Directly comparing the OPTI® CCA-TS2 measurements to those of the OPTI® CCA-TS predicate device, without any human intervention influencing the measurement results themselves.
• Precision/Reproducibility studies: Assessing the device's inherent variability.
• Linearity studies: Verifying the device's accuracy across its measurement range.

The "algorithms" referred to in the document relate to the internal computational methods the device uses to calculate parameter values from sensor signals. The important point mentioned is that "No changes were made to the algorithms used to calculate parameter values" from the predicate device, implying that the core measurement logic is identical.

7. The Type of Ground Truth Used

The ground truth used for validating the OPTI® CCA-TS2 device's performance is primarily:

• Predicate Device Measurements: The OPTI® CCA-TS analyzer (K993837) serves as the comparator, with its measurements representing the established "truth" for demonstrating substantial equivalence.
• Certified Reference Materials/Standards: For traceability and fundamental accuracy checks, the device's parameters are linked to NIST (National Institute of Standards and Technology) traceable standards or other recognized standards (e.g., NIST traceable phosphate buffer for pH, NIST SRM 956A for various electrolytes).
• Aqueous Quality Control Solutions with known values (OPTI Check, CVC123): These materials provide stable and characterized analyte concentrations for precision and linearity testing.
• Spiked or Diluted Whole Blood Samples: For precision and linearity, whole blood samples were prepared to achieve specific analyte levels across the measurement range.

There is no "expert consensus," "pathology," or "outcomes data" ground truth as typically understood in fields like imaging or disease diagnosis. The ground truth is analytical and metrological.

8. The Sample Size for the Training Set

This submission does not mention a "training set" in the context of machine learning (AI). The OPTI® CCA-TS2 device is an analytical instrument with established measurement principles (optical fluorescence and reflectance technology) and algorithms that were already developed and cleared for the predicate device. The changes were primarily hardware and software architecture updates to prevent obsolescence and improve manufacturing.

The "algorithms used to calculate parameter values" for OPTI® CCA-TS were developed earlier, and no changes to these algorithms were made for OPTI® CCA-TS2. Thus, there isn't a new AI model being "trained" for this specific submission. The data presented here are for performance verification of the updated device, not for training a new algorithm.

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

Not applicable, as there is no "training set" for a newly developed AI algorithm relevant to this 510(k) submission. The established algorithms and measurement principles stem from the predicate device, which would have undergone its own validation based on established analytical chemistry and medical device standards. The current submission focuses on demonstrating equivalence of the updated hardware/software with the pre-existing, validated measurement algorithms and sensor technology.

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