(39 days)
The three products encompassed by this request are intended for in-vitro diagnostics use. Mission Electrolyte Reference Reagent provides reference points for Na, K, CI, Ca (on Delta's only) and TCO2. When used in conjunction with CO2 Acid Reagent, CO2 Alkaline Buffer and Electrolyte Buffer, the ISE Electrolyte Reference is used for the calibration of the ISE electrodes; sodium, potassium chloride and calcium (on Delta's only) and CO2. The CO2 Acid reagent is used to release CO2 from samples. The CO2 Alkaline in used to provide a constant CO2 concentration as reference for the CO2 electrode. Mission reagents are intended to serve as direct replacements to the predicate devices manufactured by the OEM. The products encompassed are to be handled using normal laboratory precautions.
The Calibrators for the OEM Instruments are aqueous reagents with salts added to obtain desired analyte levels to provide calibration of the electrodes. The reagents are intended for use on equivalent OEM Instruments. Mission uses a similar composition, description and packaging as that used by the OEM in its products.
The provided document describes the 510(k) submission for Mission ISE Reference & CO2 Reagents. The study aimed to demonstrate substantial equivalence to predicate devices (OEM materials) by comparing performance on an equivalent OEM analyzer.
Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria in a dedicated table format with pass/fail thresholds. Instead, it states: "All analytes tested passed criteria per SOP23-01-02 Performance Study Protocol for 510(k) Submission and performed equally to the OEM." The performance is then presented through precision and correlation data.
Assuming "performed equally to the OEM" implies that the precision and correlation values of the Mission reagents should be comparable to or within acceptable variations of the OEM reagents, the presented data serves as the performance demonstration against this implicit criterion.
| Analyte (Matrix) | Performance Metric | Mission Reagent Performance (Range/Value) | Implied Acceptance Criteria (relative to OEM) | Does it meet criteria? |
|---|---|---|---|---|
| Precision of Serum Controls (CX® Delta) | %CV | Na: 4.4 - 4.5% | Comparable to OEM reagents | Yes (Implied) |
| K: 4.59 - 5.10% | Comparable to OEM reagents | Yes (Implied) | ||
| Cl: 4% | Comparable to OEM reagents | Yes (Implied) | ||
| Ca: 3.06 - 5.23% | Comparable to OEM reagents | Yes (Implied) | ||
| CO2: 4.2 - 4.4% | Comparable to OEM reagents | Yes (Implied) | ||
| Precision of CSF Controls (CX® Delta) | %CV | Na: 3.8 - 4.9% | Comparable to OEM reagents | Yes (Implied) |
| Cl: 3 - 4% | Comparable to OEM reagents | Yes (Implied) | ||
| Precision of Urine Controls (CX® Delta) | %CV | Na: 3.8 - 7.5% | Comparable to OEM reagents | Yes (Implied) |
| K: 5.6 - 6.4% | Comparable to OEM reagents | Yes (Implied) | ||
| Cl: 4 - 6% | Comparable to OEM reagents | Yes (Implied) | ||
| Ca: 3.99 - 8.97% | Comparable to OEM reagents | Yes (Implied) | ||
| Precision of Serum Samples (CX® Delta) | %CV | Ca: 2.5 - 3.6% | Comparable to OEM reagents | Yes (Implied) |
| Precision of Serum Controls (CX®) | %CV | Na: 0.6 - 0.7% | Comparable to OEM reagents | Yes (Implied) |
| K: 0.29 - 0.42% | Comparable to OEM reagents | Yes (Implied) | ||
| Cl: 0.5 - 0.7% | Comparable to OEM reagents | Yes (Implied) | ||
| CO2: 1.3 - 1.4% | Comparable to OEM reagents | Yes (Implied) | ||
| Correlation – Serum Values (CX®) | R² | Na: >0.99 | High correlation (close to 1) with OEM results | Yes |
| K: >0.99 | High correlation (close to 1) with OEM results | Yes | ||
| Cl: >0.99 | High correlation (close to 1) with OEM results | Yes | ||
| CO2: >0.99 | High correlation (close to 1) with OEM results | Yes |
2. Sample Sizes Used for the Test Set and Data Provenance:
The sample sizes for the test sets (controls and serum samples) are provided in the tables:
- Precision Studies (CX® Delta):
- Serum Controls: N ranges from 27 to 43 per analyte and control level.
- CSF Controls: N ranges from 12 to 13 per analyte and control level.
- Urine Controls: N ranges from 29 to 48 per analyte and control level.
- Serum Samples (Ca): N = 18 per control level.
- Precision Studies (CX®):
- Serum Controls: N ranges from 12 to 18 per analyte and control level.
- Correlation Studies (CX®):
- Na: N = 62
- K: N = 91
- Cl: N = 76
- CO2: N = 76
Data Provenance:
The document does not explicitly state the country of origin of the data. It refers to testing performed on "CX® Delta and CX® depending on availability," indicating the tests were conducted using Beckman Synchron Delta and CX® systems. The submission is made by "Mission Diagnostics, Holliston MA 01746," suggesting potential US origin for the testing or data collection, but this is not explicitly confirmed. The studies appear to be prospective as they were conducted to generate data for the 510(k) submission, following a defined protocol (SOP23-01-02).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This is a device for in-vitro diagnostics (reagents), specifically calibrators. Ground truth for such devices is typically established through a reference method or comparison to an established, validated predicate device (the OEM reagents in this case), not through expert consensus on interpretation. Therefore, the concept of "experts" in the context of radiologists or similar interpretive fields is not applicable here. The "ground truth" is the established performance of the predicate OEM reagents and the analytical accuracy of the instrument.
4. Adjudication Method for the Test Set:
Not applicable. As this is a quantitative analytical device (reagents for calibrating an instrument), there are no human interpretations or classifications that would require adjudication. The performance is assessed through statistical measures like precision and correlation against the predicate.
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 not an AI/medical imaging device requiring human reader studies. It is a set of chemical reagents for in-vitro diagnostic use.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not a software algorithm device. It is a set of chemical reagents.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for demonstrating substantial equivalence for these diagnostic reagents is the analytical performance of the legally marketed predicate devices (OEM reagents) and the analytical accuracy of the Beckman Synchron Delta & CX® Systems. The studies compare the performance of the Mission reagents calibrated system to the OEM reagents calibrated system via method comparison, precision, and correlation. The implicit "ground truth" is that the OEM reagents and the instrument provide accurate measurements.
8. The Sample Size for the Training Set:
The document does not mention a "training set" in the context of device development or validation. This is a chemical reagent product, not a machine learning model, so the concept of a training set is not applicable. The provided data relates to the performance testing (validation) of the new Mission reagents.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set in this context.
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.