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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:

• Capillary mode: Total %CV from 1.4% to 3.8%
• Syringe mode: Total %CV from 1.3% to 4.6%
  Spiked Adult Whole Blood (1-day pooled):
• Capillary mode: Total %CV from 1.6% to 14.0%
• Syringe mode: Total %CV from 1.0% to 8.7%
  Spiked Adult Whole Blood & Cord Blood (1-day lab):
• Capillary mode: Total %CV from 1.1% to 7.7% for adult, 0.9% to 7.4% for cord. |
  | Method Comparison (vs. Predicate ABL800 FLEX) | Good correlation with the predicate device and very good agreement between the two modes. | Syringe mode (pooled): Slope = 0.9903 (95% CI: 0.975-1.005), Intercept = 0.6574, R² = 0.9878
  Capillary mode (pooled): Slope = 0.9760 (95% CI: 0.961-0.991), Intercept = 0.7741, R² = 0.9861 |
  | Linearity | Linear over the entire measuring range and fulfills requirements for allowable error due to non-linearity. | Linear (first order) over the entire measuring range. R² = 0.9996 for Bilirubin: ABL90 vs. Sample Conc. |
  | Interference (Non-Significant) |

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