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The ABL80 FLEX CO-OX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL80 FLEX CO-OX system 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:

pH, pO2, and pCO2 : pH, pCO2 and pO2 measurements are used in the diagnosis and treatment of life-threatening acid-base disturbances.

Potassium (cK'): potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.

Sodium (cNa"): sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic secretion, or other diseases involving electrolyte imbalance.

Calcium (cCa2+): calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.

Chloride (cCI): chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such a cystic fibrosis and diabetic acidosis.

Glucose (cGlu): 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 following six parameters will be introduced with the ABL80 FLEX CO-OX:

Total Hemoglobin (ctHb): total hemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia.

sOx oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus reduced hemoglobin.

FO₂Hb: oxyhemoglobin as a fraction of total hemoglobin.

FCOHb: carboxyhemoglobin measurements are used to determine the carboxyhemoglobin content of human blood as an aid in the diagnosis of carbon monoxide poisoning.

FMetHb: methemoglobin as a fraction of total hemoglobin.

FHHb: reduced hemoglobin as a fraction of total hemoglobin.

The ABL80 FLEX CO-OX syste:n consists òf a modular analy.cer incorporating a user interface module with a large color touch screen interfacing to analyzer electronic and fluidis modules. The user interface module contains the analyzer CP1J and all of the required electronic interfaces for external communication and data stor:ge.

Sensors that measure pH, pCO2, pO2, cCa2', cCI, cK* cNa* and cGlu are contained in a cassette that also contains the sample inlet. This cassette attaches to the front of the analyzer.

The oximetry module measures ctHb, sO2, FO2Hb, F MetHb and FHHb. This module consists of a spectrometer, an ultrasonic hemolyzer and thermostatic components integrated into the analyzer.

The system also includes a reagent cartridge for the calibration and automatic quality control of the sensor and oximetry system. The calibration and quality control reagents are packaged in sealed foil pouches.

The analyzer and consumables incorporate "smart chip" technology for unique identification and lot specific calibration and quality control data.

The provided document describes the ABL80 FLEX CO-OX system, an automated analyzer for measuring various blood parameters. While it lists "Performance Data" categories, the document does not explicitly state acceptance criteria or present the results of a study demonstrating the device meets specific acceptance criteria.

Instead, the document primarily focuses on:

• Device Description: How the ABL80 FLEX CO-OX system works, including its components and measurement principles.
• Intended Use / Indications for Use: What the device measures and for what clinical purposes, and who should use it.
• Substantial Equivalence: Comparing the ABL80 FLEX CO-OX to predicate devices (ABL80 FLEX and ABL700) and highlighting similarities in operational principles.
• FDA 510(k) Clearance: The formal notification from the FDA approving the device for marketing.

The "PERFORMANCE DATA" section merely lists the types of studies that were performed (Method Comparison, Precision, Linearity, Calibration/Quality Control, Analytical Specificity, User Testing) and states that the ABL700 (a predicate device) was used for some of this data. It does not provide the results of these studies nor does it define what would be considered "acceptable" performance for each category.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria and study results based solely on the provided text. The document acts as an overview and regulatory clearance, not a detailed performance study report.

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The ABL 80 FLEX is a portable, automated system that measures pH, blood gases, electrolytes, glucose, and hematocrit in whole blood. The ABL80 FLEX system 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 physicians order:

pH: pH is the indispensable measure of acidemia or alkalemia and is therefore an essential part of the pH/Blood gas measurement.

pO2: The arterial oxygen tension is an indicator of the oxygen uptake in the lungs.

pCO2: pCO2is a direct reflection of the adequacy of alveclar ventilation in relation to the metabolic rate.

Potassium (cK*): The potassium level is the predominant intracellular cation. It is fundamental for correct neuromuscular activity

Sodium (cNa"): The sodium ion is the most abundant cation in plasma. It is the foremost agent involved in maintenance of osmolality and body fluid volumes.

Calcium (cCa2): The calcium ion is the most abundant mineral element in the human body and is involved in numerous enzymatic processes, blood coagulation, cell growth, and membrane transport mechanisms as well as plays an important role in nervous impulse conduction, neuromuscular transmission, and muscular contraction and relaxation.

Chloride (cCl): The chloride ion is the main extracellular anion and plays an important role in maintaining electrical neutrality.

Hematocrit (Hct): The hematocrit measurement is the ratio of the volume of red blood cells in whole blood in comparison to the total volume.

Glucose (cGlu): The glucose measurements are used to screen for, diagnose and monitor glycemic levels in potential pre-diabetic, diabetic, hypoglycemic patients.

The ABL80 FLEX System consists of a modular analyzer incorporating a user interface module with a large color touch screen interfacing to analyzer electronic and fluidic modules. The user interface module contains the analyzer CPU and all of the required electronic interfaces for external communication and data storage. The system also includes a reagent cartridge for the calibration and automatic quality control of the analyzer and sensor system. The calibration and quality control reagents are packaged in sealed foil pouches, similar to the existing ABL 77 cal pack. The analyzer and consumables incorporate "smart chip" technology for unique identification and lot specific calibration data.

The ABL80 FLEX System is a portable, automated system that measures pH, blood gases, electrolytes, glucose, and hematocrit in whole blood.

The following information describes the acceptance criteria and the study that proves the device meets the acceptance criteria:

1. Table of acceptance criteria and reported device performance:

2. Sample size used for the test set and data provenance:
   The document does not specify the exact sample size for the test set. The provenance of the data (e.g., country of origin, retrospective/prospective) is also not specified.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
   This information is not provided in the document. The ground truth was established by comparison to other analytical methods/devices rather than expert consensus.

4. Adjudication method for the test set:
   Not applicable, as the performance testing involved method comparisons against established standards or predicate devices, rather than expert adjudication of results.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
   No, an MRMC comparative effectiveness study was not done. The device is an automated system for measuring analytes, not an imaging or diagnostic AI system requiring human reader performance studies.

6. If a standalone study (algorithm only without human-in-the-loop performance) was done:
   Yes, the performance data described is a standalone evaluation of the ABL80 FLEX System's analytical performance (algorithm only) compared to reference methods and predicate devices. There is no mention of human-in-the-loop performance in the context of this device's validation.

7. The type of ground truth used:
   The ground truth used was based on established analytical methods and reference devices:

   • For pH, sodium, potassium, calcium, and chloride: The measurement standard was the ABL™700, and method comparison was conducted against 2 ABL725 analyzers.
   • For blood gases (pCO2 and pO2): Target tonometry levels, with values calculated from certified tonometry gas mixtures traceable to NIST.
   • For glucose: Serum standard per NCCLS Publication RS1-A.
   • For hematocrit: Micro-hematocrit method using centrifugation per CLSI standard H7-A3.

8. The sample size for the training set:
   This information is not specified in the document. The ABL80 FLEX System is a medical device for analyte measurement, and the concept of a "training set" in the context of machine learning is not directly applicable to its analytical validation as described. The system's design and performance are based on established electrochemical and spectrophotometric principles, likely calibrated during manufacturing.

9. How the ground truth for the training set was established:
   Not applicable, as the document does not describe a training set in the context of machine learning. The ground truth for the performance evaluation was established through comparison with established analytical methods and reference devices, as detailed in point 7.

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The ABL 77 pH, Blood Gas and Electrolyte Analysis System is intended to measure blood oxygen, carbon dioxide, pH, sodium, potassium, chloride, ionized calcium and hematocrit in whole blood. The ABL 77 pH, Blood Gas and Electrolyte Analysis System can be used in the laboratory, near patient, or point-of-care settings. It is intended for the measurement of blood gases, electrolytes and hematocrit in arterial and venous whole blood samples.

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I am sorry, but the provided text does not contain the detailed information necessary to answer your request about the acceptance criteria and the study that proves the device meets the acceptance criteria.

The document is a 510(k) clearance letter from the FDA for the "ABL 77 pH, Blood Gas and Electrolyte Analysis System." While it establishes that the device is substantially equivalent to a legally marketed predicate device, it does not include:

• A table of acceptance criteria and reported device performance.
• Details on sample sizes, data provenance, or ground truth establishment.
• Information about expert involvement, adjudication methods, or MRMC studies.
• Any mention of standalone algorithm performance or training set details.

This document indicates the device has received FDA clearance for marketing, but the specifics of its performance testing and acceptance criteria are not included in this particular letter.

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The SenDx 100™ pH, Blood Gas and Electrolyte Analysis System (SenDx 100™) is intended to measure blood oxygen, carbon dioxide, pH, sodium, potassium, chloride, ionized calcium and hematocrit in whole blood.

The SenDx 100™ system can be used in the laboratory, near patient, or in point-of-care settings. It is intended for the measurement of blood gases, electrolytes and hematocrit in arterial or venous whole blood samples.

The SenDx 100™ system consists of the analyzer, a multi-use, disposable sensor cassette and a calibration solution pack. A bar code label containing lot and sensor-specific identifying parameters accompanies each new sensor cassette and calibration solution pack.

The SenDx 100™ line is available in two versions:
Model SD 100 B with modem
Model SD 100 IB without modem for international use

The SD100B is sold in the United States and is UL certified. The unit is battery powered and requires an external battery charger that is provided by SenDx Medical, Inc. Use only Jerome Industries power supply model WSZ118M which requires 100 to 250 VAC, 50 to 60 Hertz with these units. It also has a modem.

The SD1001B is sold internationally and is certified by TUV Rheinland. This unit is also battery powered and requires an external battery charger that is provided by SenDx Medical, Inc. Use only Advance Power Solutions power supply model AD-740U-1180 which requires 100 to 240 VAC, 50 to 60 Hertz with these units. This model is not equipped with a modem.

The SenDx 100™ analyzer utilizes microprocessor controlled electronics. The microprocessor controls the touch screen display, the analog electronics for processing sensor output, and the integral thermal printer. The printer provides a hard copy of the measured and calculated values. Samples are introduced into the analyzer via an aspiration stylus.

The SenDx 100™ sensor incorporates microelectrode technology for the measurement of blood oxygen (pO2), carbon dioxide (pCO2), pHx, sodium (Na+), potassium (K+), chloride (Cl-), ionized calcium (iCa++), and hematocrit (Hct) in a multi-use, disposable cassette assembly.

The sensors are analogous to traditional electrode methodologies for the measurement of blood gases and electrolytes. A Clark cell for pO2 measurement and potentiometric ion-selective electrodes for the measurement of pH, pCO2, Na+, K+, Cl- and iCa++ have been miniaturized for placement on a 1-3/8" x 3/8" sensing "chip". Hematocrit is measured by using conductivity.

The sensors are contained in a low volume flow-through cell. The sensor cassette contains reference electrodes for the potentiometric sensors and an integral temperature sensor and heating element for precise temperature control. Calibration and analysis are carried out at 37.0°C. The SenDx 100™ analyzer allows for patient temperature correction over the range of 12-45°C.

All SenDx 100™ sensor cassettes are 100% tested at the factory with multiple precision reference solutions.

Calibration of the system is accomplished using a calibration solution pack which contains two levels of precision tonometered electrolyte solutions packaged in gas tight disposable cartridges. Precise pH, blood gas, and electrolyte calibration values for each pack are provided on an attached calibration bar code label.

The SenDx 100TM performs two point calibrations at automatic intervals. Throughout the calibration and sample analysis phases, sensor signals are continuously monitored. If any abnormal conditions are detected, an error message is generated.

Blood analysis and the subsequent system calibration and flush take approximately 50-75 seconds. After analysis, pH, pCO2, pO2, Na+, K+, Cl-, iCa++, and Hct measurement results are displayed on the analyzer touch screen. The measured values and derived values (HCO3-, BEb, BEecf, TCO3, SBC, Hb, and %O2 Sat) are automatically printed.

The SenDx 100™ system can be interfaced via the RS232 serial data port with PC based or LIS/HIS data management systems.

Here's a breakdown of the acceptance criteria and the study information regarding the SenDx 100 Blood Gas and Electrolyte Analysis System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a numerical or categorical format with pass/fail thresholds. Instead, it demonstrates the device's performance through correlation and precision studies against predicate devices and known control values. The implicit acceptance criterion is that the device demonstrates performance substantially equivalent to these predicate devices or acceptable precision for clinical use.

Here's a summary of the reported performance, categorized by study type:

A. Linearity of Recovery (Internal Study)
(Comparison against Corning 850 for pH, pCO2, pO2, Na+, K+, Cl-, iCa++; spun hematocrit for Hct)

B. Correlations (Internal Study)
(Comparison against Corning 850 and spun hematocrit using tonometered and spiked whole blood)

C. Precision (Internal Study) - Using RNA Medical Qualidata and Hct Levels
(Summary of Mean, S.D., %CV)

D. Clinical Study - Hospital Stat Lab (Representative Site)
(Comparison against Corning 865, Nova Stat Profile 5, Corning Co-oximeter, and spun hematocrit)

E. Clinical Study - Hospital Operating Room Point-Of-Care (Representative Site)
(Comparison against Mallinckrodt Hem-Premier)

F. Clinical Precision Study (Site to Site)
(Summarized data from four clinical sites for pH, blood gases, electrolytes and hematocrit)

• pH: Site to Site* Mean ranges from 7.192 to 7.602, S.D. 0.006-0.008, %CV 0.075-0.102.
• pCO2: Site to Site* Mean ranges from 23.3 to 66.4, S.D. 0.385-1.883, %CV 1.653-2.835.
• pO2: Site to Site* Mean ranges from 68.2 to 143.1, S.D. 1.328-2.546, %CV 1.236-3.667.
• Na+: Site to Site* Mean ranges from 107.4 to 156.2, S.D. 1.176-2.133, %CV 0.753-1.987.
• K+: Site to Site* Mean ranges from 1.81 to 6.43, S.D. 0.019-0.047, %CV 0.728-1.055.
• iCa++: Site to Site* Mean ranges from 0.49 to 1.52, S.D. 0.008-0.045, %CV 1.681-2.959.
• Hct: Site to Site* Mean ranges from 34.2 to 57.3, S.D. 0.546-0.797, %CV 1.391-1.594.

The conclusion states that the performance is "substantially equivalent" to predicate devices, implying these reported values meet the unstated acceptance criteria for equivalency.

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

• Non-Clinical Testing (Linearity and Correlations):

  • Sample Sizes: For linearity, individual analyte 'n' values range from 321 (pO2) to 747 (Hct). For correlations, 'n' values range from 413 (pCO2) to 1677 (pO2). These represent the number of samples tested for each analyte.
  • Data Provenance: The data was generated on-site at SenDx Medical, Inc. The samples used were "pooled whole blood" for linearity of pH, K+, Na+, Cl-, iCa++, and "tonometered and spiked whole blood" for correlations. This indicates the data is retrospective in nature, likely laboratory-controlled samples, not from real patients.

• Clinical Testing:

  • Sample Sizes: Over 400 split-samples were evaluated across four clinical sites. Individual analyte 'n' values for representative sites range from 97 (iCa++ in OR POC) to 120 (pH, Na+, K+ in Stat Lab). This indicates the number of patient samples.
  • Data Provenance: Conducted at four different geographical sites (hospitals: Stat Lab and Operating Room Point-Of-Care). These were prospective clinical studies using patient samples ("split-samples"). The country of origin is not explicitly stated but implied to be the US given the submission to the FDA.

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

The document does not mention the use of "experts" to establish ground truth in the typical sense of human readers for images or diagnoses. Instead, the ground truth was established by measurements from established, legally marketed predicate devices (e.g., Corning 850, Corning 865, Nova Stat Profile 5, Mallinckrodt Gem-Premier, and spun hematocrit).

The qualifications of operators for these predicate devices or for collecting calibration data are not specified, but it's implied they are trained laboratory personnel ("trained technologists, nurses, physicians, and therapists" as per the SenDx 100's intended use).

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by instrumental measurements from predicate devices, not by human interpretation requiring adjudication.

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

No. This type of study is designed to assess the impact of an AI algorithm on human reader performance, typically for diagnostic imaging interpretation. This device is a blood gas and electrolyte analyzer, and its output is a direct quantitative measurement, not an interpretation by a human reader.

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

Yes, this entire submission is essentially a standalone performance study. The SenDx 100 system itself is the "algorithm" (or rather, the automated analytical device) that measures the parameters. Its performance is compared directly against established laboratory reference methods and other commercially available automated analyzers without human intervention in the measurement process itself, beyond sample introduction and standard operating procedures. The data presented are the results from the SenDx 100 as an automated system.

7. Type of Ground Truth Used

The ground truth for both non-clinical and clinical testing was established by:

• Measurements from Predicate Devices: For all analytes, readouts from the Corning 850, Corning 865, Nova Stat Profile 5, and Mallinckrodt Gem-Premier served as the comparison for blood gases and electrolytes.
• Spun Hematocrit (Micro-centrifuge): For hematocrit measurements.
• Reference Materials: RNA Medical Qualidata levels 1, 2, 3 for blood gases and electrolytes, and RNA Medical hematocrit levels low and high were used in precision studies.
• Tonometered and Spiked Whole Blood: Used in non-clinical studies to create known concentrations for linearity and correlation.

This is best described as comparison against established reference methods and certified reference materials.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of an AI/machine learning algorithm. The SenDx 100 is an electrochemical and optical measurement device, not an AI algorithm that learns from data in that sense.

However, the "training" analogous to an AI algorithm would be the internal development and calibration processes. The document states:

• "All SenDx 100™ sensor cassettes are 100% tested at the factory with multiple precision reference solutions."
• The system performs "two point calibrations at automatic intervals" using "calibration solution pack which contains two levels of precision tonometered electrolyte solutions."

The specific sample size (number of runs, types of solutions) for these internal factory tests and ongoing calibrations is not provided, only that they are performed extensively ("100% tested," "multiple precision reference solutions").

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

As explained above, there isn't a "training set" in the common AI sense. For the internal development and calibration of the instrument, the ground truth was established by:

• Known concentrations of precision reference solutions: Used for factory testing and calibration.
• Precision tonometered electrolyte solutions: Used in calibration packs for ongoing automatic calibrations.

These solutions would have their analyte values determined by highly accurate, often gravimetric or spectroscopically verified, methods.

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