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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 ABL90 FLEX analyzer is an in vitro diagnostic, portable, automated analyzer that quantitatively measures neonatal bilirubin in heparinised capillary whole blood. The ABL90 FLEX analyzer is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting. These tests are only performed under a physician's order. Bilirubin measurements on the ABL90 FLEX analyzer are intended to aid in assessing the risk of kernicterus in neonates.

The ABL90 FLEX is a portable, automated system intended for in vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, potassium, sodium, chloride, glucose, lactate, neonatal bilirubin and co-oximetry parameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF). The ABL90 FLEX consists of an instrument with a sensor cassette and a solution pack as the main accessories. Multiple models of sensor cassettes are available. The various sensor cassette models for different parameter combinations. For each parameter combination, models allowing for different test load are available. The solution pack is available in one model. The ABL 90 FLEX electrochemical sensors are miniaturized, manufactured by film technology and integrated in a common sensor cassette. Likewise, the ABL90 FLEX optical oxygen sensor is integrated in the sensor cassette. A 256-pixel array spectrophotometer is used for the co-oximetry parameters and bilirubin.

Here's a breakdown of the acceptance criteria and study information for the ABL90 FLEX device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Precision Studies:
  • Aqueous Solutions (20-day): 240 samples (pooled data for capillary and syringe modes) across three point-of-care (POC) sites.
  • Spiked Adult Whole Blood (1-day): 75 samples (pooled data for capillary and syringe modes) across three POC sites.
  • Spiked Adult Whole Blood and Cord Blood (1-day laboratory): 25 samples per category (Adult Blood Samples 1, 2, 3 and Cord Blood Samples 1, 2, 3) for both capillary and syringe modes an additional sample for adult blood for syringe and capillary, making it 150 samples just for adult blood samples and 150 for cord blood samples.
• Method Comparison:
  • Syringe Mode: 210 samples (pooled from 74, 51, and 85 samples from three sites).
  • Capillary Mode: 224 samples (pooled from 77, 56, and 91 samples from three sites).
• Linearity: The specific number of samples is not explicitly stated, but data points appear to cover a range shown in the figure.
• Interference: The specific number of samples per interferent tested is not explicitly stated.
• LoB, LoD, LoQ: The specific number of samples used for these determinations is not explicitly stated.
• Data Provenance: Studies were conducted at three point-of-care (POC) sites and Radiometer's laboratory facility. The country of origin for the data is not specifically mentioned, but the manufacturer is based in Denmark. The studies appear to be prospective as they were specifically conducted to evaluate the device's performance.

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

• The ground truth for this device (Bilirubin measurement) is established by quantitative measurement against a reference method (the predicate device) or known concentrations (aqueous solutions, spiked blood).
• Therefore, the concept of "experts" to establish a ground truth for a diagnostic measurement device like this (unlike image-based diagnostic AI) is not directly applicable in the same way. The accuracy is determined by comparing its measurements to established, validated methods or known standards.

4. Adjudication Method for the Test Set:

• Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where subjective interpretation by multiple readers is involved (e.g., radiologists reviewing images).
• For a quantitative in vitro diagnostic device measuring a biomarker, the "adjudication" is inherent in the reference method used for comparison (e.g., the ABL800 FLEX predicate device in the method comparison study, or the gravimetric methods for preparing known concentrations in precision and linearity studies). There is no explicit expert adjudication process described for the quantitative measurements themselves.

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:

• No, an MRMC comparative effectiveness study was not done.
• This device is an in vitro diagnostic analyzer that quantitatively measures neonatal bilirubin, not an AI-assisted diagnostic tool that aids human readers in interpreting clinical data or images. Therefore, the concept of "human readers improve with AI vs. without AI assistance" does not apply to this device.

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

• Yes, this entire study is a standalone performance evaluation.
• The ABL90 FLEX analyzer is an automated device designed to provide a direct readout of neonatal bilirubin. The performance data presented (precision, method comparison, linearity, interference, LoB/LoD/LoQ) all represent the performance of the device itself, without human intervention in the measurement process after the sample is introduced. Human users are involved in operating the device and interpreting its results within a clinical context, but the measurements themselves are fully automated.

7. The Type of Ground Truth Used:

• Reference Method / Known Concentrations:
  • For Precision, the ground truth was established by aqueous samples and spiked adult whole blood samples with known concentrations of bilirubin.
  • For Method Comparison, the ground truth was the measurements obtained from the predicate device (ABL800 FLEX analyzer).
  • For Linearity, the ground truth was samples with known target values of bilirubin concentration.
  • For Interference, the ground truth was the expected bilirubin value in the presence of varying concentrations of potential interferents.
  • For LoB, LoD, LoQ, the ground truth would be based on statistical analysis of samples with very low or no analyte present, often using a highly sensitive reference method to confirm absence or very low levels.

8. The Sample Size for the Training Set:

• This is a traditional in-vitro diagnostic device, not an AI/Machine Learning algorithm that requires a "training set" in the conventional sense. The device's spectrophotometric multi-component analysis method is based on established scientific principles and calibrated using known standards. Therefore, the concept of a "training set" as it applies to AI models is not relevant here. The device is developed and validated, not "trained."

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

• As mentioned above, there is no "training set" for this type of device in the AI sense. The principle behind the device's measurement (spectrophotometric multi-component analysis) relies on fundamental physics and chemistry, with calibration done using solutions of known concentrations. This calibration process ensures accuracy, but it's not "training" an algorithm to learn from data.

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