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Intended Use:

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

Indications for use:

These tests are only performed under a physicians order:

pH, pO2.and pCO2 . pH, pCO2 and pO2 measurements are used in the diagnosis and treatment of life-threatening acidbase 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 (cCl-): 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. Total Hemoglobin (ctHb): total hemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia.

sO2: oxygen saturation, more specifically the ratio between the concentration of 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 with AQURE connectivity is a portable, automated system intended for in vitro testing of samples of whole blood. The device is manufactured by SenDx Medical Inc, Carlsbad, CA, USA.

ABL80 FLEX CO-OX consists of an instrument with a sensor cassette and a solution pack as the main accessories. Multiple models of sensor cassettes and solution packs are available. The various sensor cassette models include models for the different parameter configurations.

Four measuring principles are employed in ABL80 FLEX analyzers.

• Potentiometry: The potential of a sensor chain is recorded using a voltmeter, and related ● to the concentration of the sample (the Nernst equation).
• . Amperometry: The magnitude of an electrical current flowing through a sensor chain is proportional to the concentration of the substance being oxidized or reduced at an electrode in the chain.
• . Conductometry: Specific impedance of a sample as measured by two conducting electrodes held at a constant voltage is directly proportional to the conductive properties of that sample.
• . Spectrophotometry: Light passes through a cuvette containing a hemolyzed blood sample. The specific wavelengths absorbed and their intensity generates an absorption spectrum used to calculate oximetry parameters. This measuring principle is used in the ABL80 FLEX CO-OX analyzer only.

The modification consists of integration with the Data Management software called AQURE system. The software enables the initiation of device actions on connected ABL80 FLEX analyzers.

The provided text describes the 510(k) premarket notification for the ABL80 FLEX CO-OX with AQURE connectivity, primarily focusing on the integration of data management software. It states that the performance characteristics of the device were not affected by this change. Therefore, the document does not contain specific acceptance criteria for the diagnostic performance of the measured parameters (pH, blood gases, electrolytes, glucose, oximetry) nor does it detail a study proving the device meets such criteria.

Instead, the document highlights the validation of the remote functionality introduced by the AQURE connectivity, stating that "Remote functionality was verified and validated on both ABL80 FLEX and ABL80 FLEX CO-OX analyzers, and the acceptance criteria was met." However, it does not elaborate on what those specific acceptance criteria for remote functionality were, nor does it provide details of the verification and validation study.

The document explicitly states: "No performance characteristics are affected by the change. The performance data submitted in the original submission (K051804 as modified by K080370) still apply." This indicates that the diagnostic performance data for the measurement of pH, blood gases, electrolytes, glucose, and oximetry parameters would be found in the referenced predicate device submissions (K051804 and K080370), not in this particular 510(k) filing.

Given this, I can only address aspects described in the provided document regarding the AQURE connectivity:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the study that proves the device meets acceptance criteria:

The document states that "Remote functionality was verified and validated on both ABL80 FLEX and ABL80 FLEX CO-OX analyzers." This indicates a verification and validation study was conducted for the new AQURE connectivity features. However, the details of this study are not provided in the text.

2. Sample size used for the test set and the data provenance: Not specified in the provided text for the remote functionality study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not specified, as the study focused on technical software functionality rather than clinical diagnostic performance necessitating expert ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/not specified.

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: Not applicable. This device is a blood gas analyzer with data management connectivity, not an AI-assisted diagnostic imaging device requiring human reader studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable in the context of an "algorithm only" device as described for AI. The device itself is an automated analyzer, and the study focused on the proper functioning of its remote connectivity.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the remote functionality, the "ground truth" would likely be defined by system specifications and expected behavior, verified through testing.

8. The sample size for the training set: Not applicable for this type of device and study.

9. How the ground truth for the training set was established: Not applicable.

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