(227 days)
CueSee® Hypoxic is a pre-tonometered bovine hemoglobin (Hb) quality control material for professional use for monitoring blood gas analyzers' performance of Oxygen partial pressure (pO2).
CueSee® Hypoxic is prepared from a stroma-free bovine hemoglobin solution and provides the oxygen buffering characteristics of fresh whole blood. The concentrations of total hemoglobin and acid-base levels are within the normal physiological range. Tonometry with a predetermined level of oxygen balanced with nitrogen provides a distinct assay value for partial pressure of oxygen measurements. CueSee® Hypoxic contains no preservatives, viscosity adjusters or other additives that might adversely effect electrode measurements.
CueSee® Hypoxic provides one level in the critical low pO2 value range, each ampule holding 2.5 mL of solution.
CueSee® Hypoxic is packed in a carton box containing 5 ampules.
The provided text describes the 510(k) submission for the CueSee® Hypoxic device, a quality control material for blood gas analyzers. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria for a diagnostic (e.g., accuracy, sensitivity, specificity for a medical condition).
Therefore, the document does not contain the information required to populate a table of acceptance criteria and device performance or describe a study for a diagnostic device in the sense of accuracy, sensitivity, or specificity. The "study" described is primarily about establishing stability and value assignment for a quality control material.
However, I can extract the relevant information regarding the product's characteristics and the tests performed to support its claims as a quality control material.
Here's what can be extracted and how it relates to the given prompt, with explanations for what is not present:
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide a typical "acceptance criteria" table for diagnostic performance (e.g., sensitivity, specificity, accuracy against a disease state). Instead, it discusses stability and value assignment as key performance aspects for a quality control material.
| Characteristic | Acceptance Criteria (Implicit for QC Material) | Reported Device Performance (as a QC material) |
|---|---|---|
| Stability (Sealed Ampule) | Must maintain integrity and assigned values over time. | 31 days at 2-8°C |
| Stability (Open Vial) | Must maintain integrity and assigned values for a short period after opening. | 10 minutes |
| Value Assignment (pO2) | Values must be assignable and reproducible for monitoring blood gas analyzers. | Lot specific values determined by the mean of multiple determinations on randomly selected samples; Ranges assigned using pre-determined intervals. |
| Traceability | Values should be traceable to a recognized standard. | Traceable to NIST SRM: 2658a (for pO2) |
Notes:
- For a quality control material, the "performance" isn't about diagnosing a condition, but rather accurately reflecting a known concentration or value to allow verification of a diagnostic instrument.
- The document implies that the device "meets" its purpose by demonstrating these characteristics, which are standard for quality control materials.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for specific tests (e.g., stability or value assignment). For value assignment, it mentions "multiple replicates of test samples" and "mean of multiple determinations performed on randomly selected samples from each lot," but no specific number.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). It's implied to be internal testing by the manufacturer (Eurotrol B.V., Netherlands).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this document. For a quality control material, the "ground truth" (or assigned value) is established through rigorous internal testing against reference materials using validated methods, not typically by expert consensus in clinical interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as the "ground truth" for a QC material's value assignment is based on metrology and analytical chemistry, not clinical adjudication.
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 a quality control material, not an AI-based diagnostic tool requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical quality control material, not an algorithm. Its "standalone performance" refers to its ability to yield consistent and accurate pO2 values when measured correctly. The document describes protocols for how these values are determined (section "12. Value Assignment").
7. The type of ground truth used:
- For Value Assignment (pO2): Traceability to NIST SRM: 2658a (National Institute of Standards and Technology Standard Reference Material). This is a metrological ground truth derived from international standards, not expert consensus, pathology, or outcomes data.
8. The sample size for the training set:
- Not applicable. This is a quality control material, not an AI model or a device that requires "training."
9. How the ground truth for the training set was established:
- Not applicable. As above, there's no "training set." The values of the QC material are established by direct measurement on a calibrated blood gas analyzer and traceable to a NIST Standard Reference Material.
Summary of Device and Study Focus:
The device, CueSee® Hypoxic, is a quality control material (Class I, reserved), not a diagnostic device that directly interprets patient data. Its primary purpose is to monitor the performance of blood gas analyzers for Oxygen partial pressure (pO2).
The "study" or evidence provided in the 510(k) summary focuses on demonstrating:
- Its intended use as a quality control material for pO2.
- Its composition and physical characteristics (e.g., bovine hemoglobin solution, 2.5 mL volume, liquid form).
- Its stability (31 days un-opened, 10 minutes opened).
- Its value assignment method (multiple replicates, mean determination, lot-specific values).
- Its traceability to a recognized standard (NIST SRM 2658a for pO2).
- Its substantial equivalence to a predicate device (RNA Medical® Brand QC 823 Range Blood Gas Electrolyte Metabolite Control) in terms of fundamental scientific technology, features, and characteristics, despite some differences (e.g., number of levels, analytes covered).
The provided text details the regulatory clearance for a quality control material, not an AI/diagnostic device that processes patient data and requires typical clinical performance metrics like sensitivity, specificity, or reader studies.
§ 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.