(72 days)
The products encompassed by this request are intended for in-vitro diagnostics use and are intended for use in calibrating the electrodes. Mission reagents are intended to serve as direct replacements to like named products manufactured by the OEM. The products encompassed are to be handled using normal laboratory precautions.
The Mission Fluid Packs (PN = ME-XXXXD or IL-XXXXD or MN-XXXXD) are equivalent to the Medica EasyLyte Solutions Packs or IL Test™ Solutions Packs or Menarinin Spotlyte™ Packs. They are a self-contained closed reagent package containing all the calibrating and wash reagents. The Solutions Packs slide into the front of the instrument for operation. The Calibrators for the OEM Instruments are aqueous reagents with salts (chemical constituents) added to obtain desired analyte levels to provide the desired calibration.
Here's an analysis of the provided text, outlining the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Mission Diagnostic Fluid Packs are implicitly established by demonstrating "substantial equivalence" to the predicate devices (Medica Fluid Packs). This is shown through precision and correlation studies. While explicit numerical acceptance criteria for precision (e.g., maximum allowable %CV difference) or correlation (e.g., minimum R-squared, acceptable slope/intercept range) are not directly stated in the summaries, the data presented aims to show that the Mission reagents perform similarly to the predicate.
| Performance Metric | Acceptance Criteria (Implicit from "Substantial Equivalence") | Reported Device Performance (Mission Reagents) |
|---|---|---|
| Precision with Mission Reagents (Analyte %CV) | %CV for Mission reagents should be comparable to or better than predicate reagents. | Na: Level 1: 2.6%, Level 2: 0.9%, Level 3: 1.8% |
| K: Level 1: 3.5%, Level 2: 0.5%, Level 3: 0.8% | ||
| Cl: Level 1: 3.6%, Level 2: 3.6%, Level 3: 4.3% | ||
| Li: (No %CV provided for Li in Mission table) | ||
| Precision with Predicate Reagents (Analyte %CV - for comparison) | Na: Level 1: 4.6%, Level 2: 2.5%, Level 3: 1.8% | |
| K: Level 1: 2.9%, Level 2: 0.5%, Level 3: 1.1% | ||
| Cl: Level 1: 7.3%, Level 2: 6.5%, Level 3: 5.7% | ||
| Li: (No %CV provided for Li in predicate table) | ||
| Correlation (Slope) | Slope should be approximately 1.0 (indicating proportional agreement). | Na: 1.0 |
| K: 1.0 | ||
| Cl: 1.0 | ||
| Li: 0.9 | ||
| Correlation (Intercept) | Intercept should be approximately 0 (indicating no systematic bias). | Na: 5.2 |
| K: 0.03 | ||
| Cl: 4.6 | ||
| Li: 0.09 | ||
| Correlation (R-squared) | R-squared should be close to 1.00 (indicating strong linear relationship). | Na: 0.99 |
| K: 1.00 | ||
| Cl: 1.00 | ||
| Li: 1.00 |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Description:
- Precision Data: Three levels of control materials were analyzed. Each level was tested a minimum of two runs per day, with each run being part of a dataset of N=12 measurements for each analyte at each level, for both Mission and Medica reagents. The provenance of the control materials is not specified (e.g., commercial control, in-house), nor is the country of origin of this data. It appears to be prospective testing conducted for the 510(k) submission.
- Correlation Data: Samples consisted of human serum samples for Na, K, Cl, Ca, and Li. These were "spiked to yield varying concentrations" of each analyte.
- N = 55 for Na, K, Cl.
- N = 15 for Li.
- The country of origin for these human serum samples is not specified. The study appears to be prospective, designed specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of device (reagents for an electrolyte analyzer) does not typically involve human expert interpretation for establishing ground truth in the same way an imaging AI would. The "ground truth" for the test set is derived from the measurements obtained by the predicate device (Medica Fluid Packs) itself. The predicate device's measurements are considered the reference against which the Mission Fluid Packs' measurements are compared. Therefore, no human experts as clinicians/radiologists were used to establish ground truth.
4. Adjudication Method for the Test Set
Not applicable. As described above, this is a comparison study against a predicate device's measurements, not an expert-adjudicated clinical study involving interpretation of results.
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 a human-in-the-loop AI device; it is a laboratory reagent. No MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a way. The performance studies for the Mission Diagnostic Fluid Packs (precision and correlation) represent the standalone performance of the reagents on the Medica analyzers. The "algorithm" here would be the chemical reactions and physical detection performed by the analyzer when using these reagents. The studies compare this standalone performance against the standalone performance when using the predicate reagents.
7. The Type of Ground Truth Used
The ground truth for the correlation study was the measurements obtained from the predicate device (Medica Fluid Packs) when running the same human serum samples. For the precision study, there isn't a direct "ground truth" in the same sense; rather, the "truth" is the internal consistency and reproducibility of the measurements, which are then compared between the new and predicate reagents.
8. The Sample Size for the Training Set
Not applicable. These are diagnostic reagents, not a machine learning model that requires a training set. The "development" process for these reagents would involve chemical formulation and quality control, not data training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 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.