(138 days)
The ABL700 Series Analyzer with the AutoCheck module is a stand-alone blood gas analyzer that measures pH, pCO2, pO2, cNa+, cK+, cCa2+, cCL-, Glucose, Lactate, and Co-oximetry parameters on human arterial/venous and capillary whole blood. The AutoCheck Module is an added functionality to perform automated analysis of quality control fluids.
The ABL700 Series Analyzer with the AutoCheck module is an ABL700 Analyzer with the added capability of performing automated analysis of quality control fluids. The AutoCheck module is designed to work with a quality control fluid system named AutoCheck 5+. The AutoCheck 5+ is an ampouled four level quality control fluid system. The composition of the various levels of Quality control fluids in AutoCheck 5+ correspond to the composition of the corresponding levels of Qualicheck 5+ system (K980135).
The AutoCheck 5+ ampoules comprise a cap on the top of the ampoules designed to break the top of an ampoule when it is to be used. Furthermore, each ampoule has a bar code containing information on the specific level and lot of the quality control fluid.
Installing an AutoCheck module into an existing ABL700 Series Analyzer includes physically installing the module and loading upgraded software which controls the function of the AutoCheck module. The AutoCheck module comprises an ampoule carrousel carrying 20 ampoules of quality control fluid and further comprises a bar code reader for reading the bar code located on each ampoule. When installed into the ABL700 Series Analyzer, the AutoCheck module automatically performs the quality control of the analyzer. Thus, when a quality control is due, the analyzer warns the user and if the user accepts, the quality control is performed. The software selects the appropriate ampoule, the AutoCheck module opens the ampoule by pressing the cap through the top of the ampoule, the quality control fluid is automatically introduced into the analyzer inlet and the measurements are performed. The upgraded software controls all steps. If required, a manual quality control may be performed as well.
The provided text describes a medical device, the ABL700 with AutoCheck Module, and its 510(k) submission for market clearance. However, it does not contain information about specific acceptance criteria, a detailed study proving performance against those criteria, or the statistical metrics (e.g., sensitivity, specificity, accuracy) that would typically be found in such a study report.
The document focuses on:
- Product Description: How the AutoCheck module adds automated quality control functionality to the ABL700 analyzer.
- Intended Use: The parameters measured (pH, pCO2, pO2, etc.) and the types of samples (human arterial/venous and capillary whole blood).
- Technological Characteristics vs. Predicate Device: Stating it's "Similar to the ABL700 Series."
- Substantial Equivalence: Claiming it's substantially equivalent to the existing ABL700 Series (K980130).
The mention of "automated analysis of quality control fluids" is the closest it comes to a performance claim, but no specific performance targets or results are presented.
Therefore, many of the requested sections cannot be filled from the provided text.
Here's an attempt to answer based on the available information, noting where data is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | The device performs automated analysis of quality control fluids. |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified. The document refers to "automated analysis of quality control fluids" but does not detail a specific test study with a defined sample size of these fluids.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable/Not specified. Ground truth for automated quality control measurements on a device would typically be established by comparing against known reference values of the quality control fluids, not expert consensus.
- Qualifications of Experts: Not applicable/Not specified.
4. Adjudication method for the test set
- Adjudication Method: 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
- MRMC Study: No, this is not an MRMC study. The device is an automated blood gas analyzer with an automated quality control module. It does not involve human readers interpreting medical images or data that would be assisted by AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes, implicitly this device operates in a standalone manner for its quality control function. The AutoCheck module "automatically performs the quality control of the analyzer." However, specific performance metrics for this standalone function are not provided.
7. The type of ground truth used
- Type of Ground Truth: For quality control fluids, the ground truth would typically be the known, certified values of the analytes (pH, pCO2, pO2, etc.) within the quality control solutions themselves. The document mentions "AutoCheck 5+ is an ampouled four level quality control fluid system. The composition of the various levels of Quality control fluids...correspond to the composition of the corresponding levels of Qualicheck 5+ system (K980135)," indicating the use of commercial quality control materials with established values.
8. The sample size for the training set
- Sample Size (Training Set): Not specified. The device is an analyzer for blood gases and electrolytes, not an AI/ML algorithm that would typically have a "training set" in the conventional sense of machine learning. The "upgraded software" mentioned controls the automated quality control process, but the document does not describe its development in terms of a training set.
9. How the ground truth for the training set was established
- Ground Truth Establishment (Training Set): Not applicable/Not specified, as this is not a traditional AI/ML training context for which a ground truth for a training set would be established. The "ground truth" for the device's functionality would be the accuracy and precision of its measurements against known standards, including those provided by the quality control fluids.
§ 862.1120 Blood gases (P
CO2 , PO2 ) and blood pH test system.(a)
Identification. A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.(b)
Classification. Class II.