(28 days)
ABL555 is a stand alone, blood gas, electrolyte and metabolite analyzer that measures pH, pCO2, pO2 Na+, K+, and glucose on whole blood.
ABL555 is an automated blood gas, electrolyte and metabolite analyzer that is 40 cm x 55 cm x 40 cm (WHD) and weighs 37.5 kg. It measures on whole blood in approximately 54 seconds.
The provided text describes the Radiometer America Inc. ABL555, an automated blood gas, electrolyte, and metabolite analyzer. However, it does not contain specific acceptance criteria, study data, or details about the methodology used to prove the device meets any such criteria. The document is a 510(k) summary for premarket notification, primarily focused on establishing substantial equivalence to a predicate device.
Therefore, many of the requested details cannot be extracted from this specific document.
Here's what can be inferred or stated based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not specify any acceptance criteria (e.g., accuracy, precision targets) nor does it report specific device performance metrics against such criteria. It states that the ABL555 is "substantially equivalent in features and characteristics to the current ABL505."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document does not mention any specific test set, its sample size, or the provenance of any data used for testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Cannot be provided. There is no mention of a test set, ground truth establishment, or experts involved in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. No information on a test set or adjudication methods is present.
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 an automated analyzer, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study related to human reader improvement with AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Implied, but details are absent. The ABL555 is described as an "automated blood gas, electrolyte and metabolite analyzer" and a "stand-alone" device. This implies its performance is assessed independently, without human-in-the-loop performance as a primary measure. However, no specific "standalone" study details, methodology, or results are provided in this document.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. The document does not describe how any ground truth was established for performance evaluation. For a blood gas analyzer, ground truth would typically come from reference methods or established calibration standards, but this is not detailed here.
8. The sample size for the training set
- Not applicable / Cannot be provided. This device, as described, is a physical instrument for measuring analytes, not a machine learning algorithm that requires a "training set" in the conventional AI sense. If it contains internal algorithms for calibration or data processing, the details of those are not provided, nor is the concept of a "training set" used.
9. How the ground truth for the training set was established
- Not applicable / Cannot be provided. As above, the concept of a "training set" for an AI model is not mentioned or relevant to the description of this device in the document.
§ 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.