(54 days)
Mission Complete™ Linearity Controls are intended to be used for confirming the calibration and linearity of instruments measuring pH, pCO2, pO2, Na *, K *, Cr *, CI , Glucose, and Lactate. For In Vitro Diagnostic Use
This control material is provided in five (5) distinct levels of pH, pCO2, pO2, Na *, K , Cl., Ca *, Glucose & Lactate covering the significant range of the instrument performance. It is packaged in sealed glass ampules, each containing 1.8 ml of solution. Ampules are packaged in kits containing four (4) ampules of each level.
This document describes the Mission Complete™ Linearity Controls, a quality control material for blood gas, electrolyte, and metabolite analyzers.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state quantitative "acceptance criteria" for the performance of the Mission Complete™ device in terms of numerical thresholds for accuracy, precision, or other performance metrics. Instead, the "acceptance" for this device appears to be based on demonstrating substantial equivalence to a predicate device (RNA Medical CVC 123) in terms of its technological characteristics, formulation, and intended use.
The "reported device performance" is primarily qualitative, focusing on similarity to the predicate.
| Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance (Mission Complete™) |
|---|---|---|
| Intended Use | For confirming calibration and linearity of blood gas, electrolyte, and metabolite instruments for listed analytes. | Confirms calibration and linearity of blood gas, electrolyte, and metabolite instruments for pH, pCO2, pO2, Na+, K+, Cl-, Ca+, Glucose, and Lactate. |
| Material Composition | Aqueous solution of buffers, electrolytes, glucose, lactate, equilibrated with CO2, O2, N2. No human or animal materials. | Aqueous solution of buffers, electrolytes, glucose, lactate, equilibrated with CO2, O2, N2. Contains no human or animal materials. |
| Levels | 5 distinct levels covering instrument performance range. | 5 distinct levels covering significant range of instrument performance. |
| Container | Glass ampule | Sealed glass ampule |
| Package Size | Similar to predicate (20 x 2.5ml for predicate) | 20 x 1.8 ml (Slight difference from predicate, but within acceptable range for a control material) |
| Color | Clear | Clear |
| Storage | 2° - 8°C | 2° - 8°C |
| Expiration/Shelf Life | 3 years | 3 years |
| Substantial Equivalence | Equivalent to RNA Medical CVC 123 in function, safety, and efficacy. | Claimed to be equivalent (and affirmed by FDA clearance). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" in the context of clinical trials on patients. For this type of device (quality control material), the "testing" involves non-clinical studies to demonstrate its characteristics and performance.
- Sample Size for Non-clinical Tests: Not explicitly stated as a number of "samples" in the traditional sense. The studies involved general "stability for shelf life claim" and "performance & correlation to equivalent device." These would involve multiple ampules and measurements, but a distinct sample size number is not provided.
- Data Provenance: Not explicitly stated. Given this is a 510(k) submission from a US company (Diamond Diagnostics, Holliston MA), the studies were likely conducted in the US. The studies are non-clinical (bench testing, stability studies, etc.) rather than involving human subjects, so concepts like "retrospective or prospective" don't directly apply in the same way as clinical trials.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable and not provided in the document. For a quality control material, "ground truth" is typically established by certified reference materials, analytical standards, or highly precise and accurate reference methods, not by expert human interpretation like radiologists. The purpose of the control material is to verify the performance of an instrument against known values.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation (e.g., image reading) where there might be disagreement among experts. Since this device is a quality control material and its "ground truth" is analytical, such methods are not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation and aims to assess how a device (e.g., an AI algorithm) impacts human reader performance. The Mission Complete™ Linearity Controls is a quality control material, not a diagnostic device for human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a "standalone" performance study in the context of an algorithm or AI is not applicable here. This device is a physical control material, not an algorithm. Its performance is evaluated through its chemical stability, consistency, and ability to produce expected results when analyzed by an instrument, not as an algorithm operating independently.
7. The Type of Ground Truth Used
The "ground truth" for a quality control material like this would be established through:
- Certified Reference Materials/Standards: Precisely known concentrations of analytes (pH, pCO2, pO2, Na+, K+, Cl-, Ca+, Glucose, Lactate) used to develop and characterize the control material.
- Reference Methods: Highly accurate and precise analytical methods used to determine the exact values of the analytes within the control material batches.
- Assayed Values: The Expected Values Chart provided with the control material lists the "assay values" for each analyte and level, which are determined by the manufacturer using reference methods and calibrated instruments.
Therefore, the ground truth is analytical and based on reference methods and certified standards, not expert consensus, pathology, or outcomes data in the usual sense.
8. The Sample Size for the Training Set
This information is not applicable and not provided. This device is a physical quality control material and does not involve AI/machine learning algorithms that require a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided, as there is no "training set" for this type of device.
§ 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.