(26 days)
ABL700 Series is a stand-alone blood gas analyzer that measures pH, pCO2, pO2 cNat, cK+, cCa+, cCL;, Glucose, Lactate, and Co-oximetry parameters on human arterial/venous and capillary whole blood, and pO2 and pCO2 on expired air.
ABL700 Series, is an automated blood gas, co-oximetry electrolyte and metabolite analyzer that is 44 cm x 70 cm x 50 cm (HWD) and weighs 30 kg. It measures on whole blood in approximately 60 seconds.
This is an in vitro diagnostic device, not one for which the requested information (like expert readers, adjudication methods, multi-reader multi-case studies, or ground truth types like pathology/outcomes data) is typically relevant or provided in a 510(k) summary. The document describes a blood gas analyzer, and its performance is typically evaluated against reference methods or established predicate devices, not through human interpretation of images or signals.
Therefore, much of the requested information cannot be extracted from the provided text because it doesn't pertain to this type of medical device submission.
However, I can provide what is relevant and available:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document (HSC130) is a 510(k) summary for the Radiometer America Inc. ABL700 Series. It states that the device is "substantially equivalent" to predicate devices, namely the ABL625 (K962334) and ABL555 (K973367). In 510(k) submissions for in vitro diagnostic (IVD) devices like blood gas analyzers, "acceptance criteria" and "reported device performance" are typically demonstrated through comparisons to these predicate devices or established reference methods. However, the specific numerical performance data or acceptance criteria are not detailed in this summary. The summary focuses on technological characteristics and intended use.
Therefore, an explicit table of acceptance criteria and reported device performance from the provided document cannot be constructed. The statement of substantial equivalence implies that the device performs comparably to the predicate devices and meets a level of performance acceptable for its intended use, but the detailed metrics are not included in this summary.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided summary.
- Data Provenance: Not specified in the provided summary. Performance studies for IVD devices typically involve testing patient samples, but details on the source (e.g., country of origin) or whether it was retrospective/prospective are not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not relevant for this type of in vitro diagnostic device. The "ground truth" for a blood gas analyzer's measurements would typically be established by comparing its results to a well-calibrated reference method or accepted laboratory standard, not through expert consensus on images or interpretations.
4. Adjudication method for the test set:
Not relevant for this type of in vitro diagnostic device. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human readers or interpreters, which is not applicable here.
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 is an automated blood gas analyzer, not an AI-assisted diagnostic tool that aids human readers in interpreting images or data.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Yes, the ABL700 Series is described as a "stand-alone blood gas analyzer." Its performance evaluation would inherently be "standalone" in this context, meaning the device itself produces the measurement results without human interpretation being part of the primary diagnostic output being evaluated.
7. The type of ground truth used:
The type of "ground truth" for a blood gas analyzer would be established by:
- Reference methods: Comparison of the ABL700's measurements (pH, pCO2, pO2, etc.) against established, highly accurate reference laboratory methods.
- Predicate device comparison: Performance comparison against the ABL625 and ABL555 predicate devices, implying that the predicate devices' established performance serves as a benchmark for "truth."
This exact detail is not explicitly stated as "ground truth" in the summary but is implied by the nature of device testing.
8. The sample size for the training set:
Not applicable or specified. Blood gas analyzers are typically calibrated using known standards and reagents, not "trained" on a data set in the same way machine learning algorithms are.
9. How the ground truth for the training set was established:
Not applicable for this type of device. Calibration of the device is typically done using standardized calibrants with known values, not through establishing "ground truth" for a training set in the context of machine learning.
§ 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.