(86 days)
The AutoCheck6+ is a liquid four ampoule quality control system for checking the precision and accuracy of Radiometer Medical ApS analyzers for pH/Blood Gases, Co-oximetry, Electrolytes, Bilirubin, Glucose, Lactate, and Creatinine.
AutoCheck6+ is a four level quality control system consisting of part numbers S7835, S7845, S7855, and S7865. Each level consists of 30 ampoules per box.
The provided text is a 510(k) summary for the AutoCheck6+ device, a quality control system for medical analyzers. Due to the nature of this submission, it focuses on demonstrating substantial equivalence to predicate devices and detailing the device's technical specifications and intended use, rather than presenting a performance study with detailed acceptance criteria and results in the format requested.
Therefore, much of the specific information requested in the prompt (e.g., sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance studies, and detailed ground truth establishment) is not present in the provided document. The document describes the device but not a clinical performance study in the traditional sense for diagnostic accuracy.
However, I can extract and infer some information based on the context of a 510(k) submission for a quality control material:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" and "reported device performance" in terms of diagnostic metrics. For quality control materials, "performance" relates to their stability, homogeneity, and their ability to produce expected values on analyzers, thereby verifying the analyzer's precision and accuracy.
The 510(k) focuses on the technical similarity and substantial equivalence to predicate devices. The "performance" described is the device's composition and its intended function in ensuring the precision and accuracy of Radiometer analyzers.
| Acceptance Criteria Category (Inferred for a QC Device) | Reported Device Performance (Inferred/Stated) |
|---|---|
| Composition/Formulation | Aqueous solutions with components similar to predicate devices (QUALICHECK5+ and AutoCheck5+). Additional specific amounts of creatine and creatinine, and the enzyme creatininase, were added for AutoCheck6+. |
| Stability | Not explicitly stated, but implied as a necessary characteristic for a QC material. The addition of creatininase is mentioned for "stabilizes the equilibrium between creatine and creatinine." |
| Homogeneity | Not explicitly stated, but implied as a necessary characteristic for a QC material. |
| Functionality with Analyzers | Intended for checking precision and accuracy of Radiometer analyzers for pH/Blood Gases, Co-oximetry, Electrolytes, Bilirubin, Glucose, Lactate, and Creatinine. Performance is "equivalent to the measuring of the QUALICHECK5+ and AutoCheck5+," according to the technology section. |
| Intended Use Equivalence | "Substantially equivalent in features and characteristics to the predicate devices... The major difference is the addition of the creatinine (cCrea) analyte." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in the document.
- Data Provenance: Not specified, but given it's a Danish company, internal testing or data from the manufacturer (Radiometer Medical ApS) in Denmark would be the most likely source for any supporting data, though no specific study is detailed. It's likely a retrospective analysis of formulation and manufacturing data rather than a prospective clinical study involving patient samples.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Number of Experts: Not applicable. For a quality control material, "ground truth" isn't established by expert consensus on diagnostic images or clinical cases. Instead, the "truth" is the known (manufactured) concentration of analytes within the QC material, verified through analytical testing.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set:
- Not applicable as no expert adjudication of "truth" for a test set is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC study was not done. This type of study is relevant for diagnostic imaging or clinical decision-support devices where human readers or clinicians apply an algorithm. AutoCheck6+ is a quality control material, not a diagnostic device that humans interpret.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Given that AutoCheck6+ is a quality control solution rather than an algorithm (AI), the concept of "standalone performance" for an algorithm doesn't directly apply here. Its performance is inherent in its chemical composition and stability which allows it to serve its intended function.
7. The Type of Ground Truth Used:
- For a quality control material, the "ground truth" would be the assigned target values or certified values for each analyte concentration within the four levels of the AutoCheck6+ solution. These values are determined through rigorous analytical methods during the manufacturing and characterization process, typically traceable to international reference standards. The document doesn't detail the methodology for establishing these specific target values, but it's an industry standard for QC materials.
8. The Sample Size for the Training Set:
- Not applicable. There is no mention of a "training set" as this is not an AI/ML device requiring a training phase for an algorithm.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as no training set or algorithm is described.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.