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The OPTI® B-Lac cassette is intended to be used for the in vitro measurement of pH, PO2, total hemoglobin (tHb), and % Saturated O2 in sodium heparinized venous blood samples on the OPTI CCA-TS and OPTI CCA-TS2 platform in a clinical laboratory location.
· Measurements of blood gases (pCO2, pO2) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.

• · 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.

The OPTI CCA-TS/TS2 are portable devices, microprocessor-based instrument using optical fluorescence for the measurement blood gases, electrolytes and enzymes. The OPTI CCA-TS/TS2 utilize a color, graphical touch screen user interface. A disposable, single-use cassette contains all of the elements needed for calibration, sample measurement, and waste containment. Specific calibration from the cassette is scanned into the analyzer by holding the cassette package in front of the bar code scanner. The cassette is then placed into the measurement chamber. The analyzer warms the cassette to 37.0±0.1°C and performs a calibration verification. When calibration is verified, the analyzer aspirates the blood sample into the cassette and across the optode sensors. Fluorescence emission is then measured after equilibrating with the blood sample. After a single measurement, the cassette containing the blood sample is removed from the analyzer and discarded. The analyzer contains no reagents, blood, or waste. The B-Lac cassette is a disposable, single use cassette that contains four (4) sensors for in vitro quantitative measurements of PO2, PCO2, pH. There is an additional laser based measurement of total hemoglobin (tHb) and SO2. The B-Lac cassette is sealed in a foil pouch along with a desiccant and is marked with a barcode label that includes a lot identification number, calibration information, and expiration date.

The provided document describes the OPTI® B-Lac Cassette for in vitro measurement of blood gases and related parameters. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the performance of the redesigned B-Lac cassette was determined to meet the performance claims made in the original B-Lac cassette submission (K093280) for all analytes. However, the specific quantitative acceptance criteria from K093280 are not detailed in this document. The reported device performance is indicated by the statement that the device "meets the performance claims" or "was demonstrated to meet the performance claims."

Here's a table based on the information provided, noting where specific numerical criteria are not available in this document:

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

• 20-Day Precision:

  • Sample Size: Paired samples run twice daily over 20 days. Three lots of B-Lac cassettes were used, and three levels of aqueous quality control solution.
  • Data Provenance: In-house (presumably US-based, as the company is in Georgia, USA). Retrospective data analysis of prospective testing.

• Within-Run Precision:

  • Sample Size: Multiple repeats using three lots of B-Lac cassettes, three levels of aqueous quality controls, and whole blood manipulated to 3 different levels.
  • Data Provenance: In-house. Retrospective data analysis of prospective testing.

• Method Comparison (in-house):

  • Sample Size: Whole blood samples tonometered to different levels using different O2/CO2 gas mixtures to generate test levels for pH, PCO2, PO2, and SO2. Samples manipulated for tHb. The exact numerical count of samples or measurements is not specified.
  • Data Provenance: In-house. Retrospective data analysis of prospective testing.

• Method Comparison (Altitude):

  • Sample Size: Whole blood samples were tonometered to obtain samples that span the range for PCO2, PO2, and pH, and spiked or diluted for tHb. Aqueous solutions were measured. Number of samples/measurements not specified, but done at 4 distinct altitude sites (75 ft, 1080 ft, 5560 ft, 10151 ft).
  • Data Provenance: Conducted in the USA (Maine, Georgia, North Carolina, Colorado). Retrospective data analysis of prospective testing.

• Interference Testing:

  • Sample Size: 16 interferents tested for each analyte (PCO2, PO2, pH, tHb, SO2). The number of samples per interferent is not specified.
  • Data Provenance: In-house. Retrospective data analysis of prospective testing.

• Stability Testing:

  • Sample Size: Three lots of B-Lac cassettes were tested. One lot was subjected to two cycles of elevated and frozen temperatures.
  • Data Provenance: In-house. Retrospective data analysis of prospective testing for the initial 6 months, with real-time testing ongoing.

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

This document describes a medical device for in vitro diagnostic measurements. The "ground truth" for the test set is established by:

• Reference Methods/Predicate Devices:

  • Gravimetric target for PCO2 and PO2 (based on gas concentration).
  • Predicate device ABL90 Flex for pH, PCO2, PO2, and tHb.
  • E series cassettes on the OPTI CCA-TS/TS2 for SO2.

• No human "experts" (e.g., radiologists) were involved in establishing the ground truth in the way
  this question implies for imaging or subjective interpretation devices. The ground truth is
  based on established analytical methods and reference instruments.

4. Adjudication Method for the Test Set

Not applicable. This device provides quantitative measurements, and ground truth is established by reference methods/instruments, not through expert consensus requiring adjudication.

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

No. This document does not mention any MRMC comparative effectiveness study where human readers improve with or without AI assistance. This device is an in vitro diagnostic instrument, not an AI-assisted diagnostic tool for human interpretation.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

Yes, the studies described are of standalone performance of the device (OPTI® B-Lac Cassette on OPTI CCA-TS/TS2 platforms). The measurements are performed automatically by the instrument and its embedded algorithms. There is no human-in-the-loop performance described or implied for the measurement process itself, although clinical interpretation of the results by healthcare professionals would follow.

7. Type of Ground Truth Used

The ground truth used for performance evaluation includes:

• Gravimetric targets: For PCO2 and PO2 (based on gas concentration for tonometered samples).
• Predicate device measurements: Measurements from the Radiometer ABL90 Flex for pH, PCO2, PO2, tHb, and from the OPTI CCA TS2 E-Series Cassettes for SO2.
• Aqueous quality control solutions and manipulated whole blood samples: Used for precision and linearity studies, where the expected values are known or derived from previous characterization.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning. The device utilizes "new algorithms utilized to calculate concentrations for these sensors" (specifically for PCO2) and has updated software. However, the data sets described are for performance verification and validation, not for training a new algorithm from scratch in the classical AI sense. If there was an internal dataset used for algorithm development or "training" (e.g., to derive calibration curves or correction factors), that information is not provided. The described studies are primarily for demonstrating post-development performance.

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

As no specific "training set" is described for algorithm development, the method of establishing ground truth for such a set is not provided. The document focuses on the verification and validation of the device's performance against established clinical and analytical standards.

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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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The OPTI CCA-TS B-Lac cassette is intended to be used for in vitro measurements of pH, PCO2, PO2, lactate (lactic acid), total hemoglobin (tHb), and oxygen saturation (SO2), in heparinized whole blood samples (either arterial or venous) on the OPTI CCA-TS system, in either a clinical 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 measurement is used to determine the hemoglobin content of human blood. Oxygen saturation measurement is used to determine the oxygen capacity of the hemoglobin.

The OPTI CCA-TS B-Lac cassette is for prescription use only.

The OPTI CCA-TS system is a portable [4.7 x 14.2 x 9.1 inches, 12 pounds], microprocessor-based instrument using optical fluorescence for the measurement blood gases, electrolytes and enzymes and utilizes a graphical touch screen interface. There is an additional laser based measurement of total hemoglobin (tHb) and SO2 capability available with any cassette that contains a pO₂ sensor.

The OPTI CCA-TS system is currently cleared [K993837, K984299, and K974784] for the measurement of pH, PO2, PCO2, Na, K, Ca, Cl, Glucose, BUN (Urea), tHb and SO2, Measurements made on the OPTI CCA-TS system require the use of the OPTI CCA-TS analyzer, a disposable cassette containing fluorescent sensors for the measurement of the analytes (except tHb and SO2) and presentation of the blood sample for measurement of tHb and SO2 by lasers on board the CCA-TS analyzer, and software to calculate measurements from the optical data provided by the analyzer for a blood sample and perform on-board QC tests to safeguard results using known standards.

OPTI Medical has designed a lactic acid (lactate) sensor to provide lactate results when a cassette containing the lactate sensor is used with the OPTI CCA-TS analyzer. The B-Lac cassette is a disposable, single use cassette that contains four (4) sensors for in vitro measurements of pH, PCO2, PO2, and Lactate. The B-Lac cassette is sealed in a foil pouch along with a desiccant and is marked with a barcode label that includes a lot identification number, calibration information, and expiration date.

The OPTI Critical Care Analyzer (CCA-TS model) hardware is unchanged from the design described in the most recent clearance [K993837] of the device. The capacity to add analytes was part of the design since product inception and electromagnetic compatibility is unaffected. Software changes were made to add the lactate measurement algorithms and operational features for the B-Lac cassette addition.

Here's a breakdown of the acceptance criteria and study information for the OPTI CCA-TS B-Lac cassette, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The document doesn't explicitly state "acceptance criteria" for each parameter in a quantifiable manner (e.g., "accuracy must be within X%"). Instead, it states that the device's performance was equivalent to marketed devices. The "Reportable ranges" for each analyte serve as a de facto target range for accuracy and linearity.

Study Details

The provided document describes both non-clinical (in-house) and clinical site testing to demonstrate the device's performance.

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

• Test Set (Clinical Site Studies): The document states "Specimens analyzed were remnant from patient samples of whole blood collected from routine analysis on existing instrumentation." It also mentions "whole blood sample discards were used by multiple clinicians". The exact number of samples is not specified in the provided text.
• Data Provenance (Clinical Site Studies): The studies were conducted at "multiple user sites" in a "clinical setting or point-of-care locations." The country of origin is not explicitly stated, but the FDA 510(k) submission is for the USA, implying studies likely took place within the US or under US regulatory standards. The data is retrospective as it utilized "remnant from patient samples" and "whole blood sample discards."
• Test Set (Non-Clinical/In-house Studies): "In-house studies were conducted using CLSI guidelines on both aqueous controls and whole blood samples." The sample size for these studies is not specified.
• Data Provenance (Non-Clinical/In-house Studies): Likely performed at the manufacturer's facility.

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

• The document mentions that clinical site studies were performed "by several personnel trained to perform and report these analyses." It also states "multiple clinicians" introduced samples.
• The ground truth for comparison was established by "legally marketed devices in a clinical setting," specifically the Instrument Laboratory Co. GEM Premier 4000 (K061974).
• The "experts" establishing the ground truth were the legally marketed predicate device itself, and the "several personnel trained to perform and report these analyses" would be the clinical laboratory professionals operating both the test device and the predicate device for comparison. Specific qualifications (e.g., "radiologist with 10 years of experience") are not provided.

4. Adjudication Method for the Test Set:

• The document describes a method comparison study where the OPTI CCA-TS B-Lac cassette's results were compared against the predicate device (GEM Premier 4000). There is no mention of an adjudication method in the context of expert consensus for resolving discrepancies. The comparison relies on the results generated by the predicate device as the reference.

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

• No, an MRMC comparative effectiveness study as typically understood in diagnostic imaging (human readers with/without AI assistance) was not done. This device is a diagnostic instrument, not an AI-assisted diagnostic imaging system. The comparison involved the device reading samples and comparing those results to a predicate device.

6. If a Standalone (Algorithm Only) Performance Study was Done:

• Yes, the performance studies described (both non-clinical and clinical site studies) assess the standalone performance of the OPTI CCA-TS system with the B-Lac cassette. The algorithm (software) for calculating measurements is integrated into the device, and its output is directly compared to a reference standard (gravimetric tonometry for blood gases) or a predicate device. The performance data presented in the 510(k) is intrinsic to the device operating independently.

7. The Type of Ground Truth Used:

• For Blood Gases (PO2, PCO2): Gravimetric tonometry standards were used in non-clinical studies.
• For all analytes (Lactate, pH, PCO2, PO2, tHb, SO2): The legally marketed predicate device (Instrument Laboratory Co. GEM Premier 4000) served as the primary ground truth/reference method in the clinical site studies for method comparison. It also likely served as the ground truth for some in-house studies.

8. The Sample Size for the Training Set:

• The document does not specify a training set sample size. This device is an analyzer that uses optical fluorescence and enzymatic oxidation principles, not a machine learning model that requires explicit "training data" in the conventional sense. While the software algorithms for calculation were developed and "modified," this is more akin to traditional software engineering verification and validation, rather than a deep learning model's training phase with labeled data.

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

• As noted above, a distinct "training set" in the context of machine learning is not described. The device's operational parameters and algorithms (lactate sensor calculations and calculation parameters for dry storage pH, PCO2, and PO2 sensors) would have been developed and validated against known laboratory standards, reference methods (like gravimetric tonometry), and possibly internal reference samples. The principles of measurement are based on established chemical and physical reactions/optics, not on learning from a large, labeled dataset in a way that necessitates a "ground truth for a training set" in the AI/ML sense.

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