(31 days)
The products encompassed by this request are intended for in-vitro diagnostics use and are intended for use in calibrating the electrodes and flushing the sample flow path of the equivalent OEM Analyzers.
The Calibrators for the OEM Instruments are aqueous reagents with salts added to obtain desired analyte levels to provide calibration of the electrodes and rinse the sample path. Mission uses a similar composition, description and packaging as that used by the OEM in its products.
This document pertains to the 510(k) submission for Mission Diagnostic Reagents. It's important to note that this submission is for calibrating reagents used with pH/Blood Gas and Electrolyte Analyzers, not for a medical device that diagnoses or treats patients. Therefore, the typical acceptance criteria and study designs for diagnostic AI/ML models (e.g., sensitivity, specificity, reader studies, ground truth involving expert consensus or pathology) are not directly applicable here.
Instead, the "acceptance criteria" for these calibrating reagents largely revolve around demonstrating substantial equivalence to existing predicate devices (the OEM calibrators) in terms of composition and performance when used with the specified instruments. The "study" mentioned is a performance study to show this equivalence.
Here's an attempt to answer the questions based on the provided text, adapting for the nature of the device:
Acceptance Criteria and Device Performance Study for Mission Diagnostic Calibrating Reagents
The "acceptance criteria" for these calibrating reagents are implicitly tied to demonstrating substantial equivalence to the predicate OEM calibrators, specifically in terms of their ability to correctly calibrate the target instruments. The primary performance characteristic assessed is correlation and precision compared to the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a table format. However, it indicates that the device performance is evaluated through "Precision and correlation data collected per SOP23-01-02 Performance Study Protocol for 510(k) Submission 0". The reported performance is implicitly that the Mission Diagnostics reagents are substantially equivalent to the OEM equivalents, indicating that the precision and correlation achieved are acceptable for their intended use as direct replacements.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|---|
| Precision | Demonstrated precision comparable to OEM predicate calibrators. | Data collected per SOP23-01-02 and recorded on SOP23-03F. |
| Correlation | Demonstrated correlation comparable to OEM predicate calibrators. | Data collected per SOP23-01-02 and recorded on SOP23-03F. |
| Functional Equivalence | Able to calibrate electrodes and flush sample path on OEM instruments as intended by the OEM predicate. | The FDA’s substantial equivalence determination confirms this. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical sample size for the test set. It states that "Data for each instrument and each run are recorded on SOP23-03F Performance Study O Record Sheet." This suggests that multiple runs were performed on each instrument with the Mission Diagnostic calibrators.
- Data Provenance: The data appears to be prospective as it was collected specifically for this 510(k) submission as part of a "Performance Study Protocol." The country of origin of the data is not explicitly stated, but given the submitter's address is in Holliston, MA, USA, and the FDA is the reviewing body, it is highly probable the testing was conducted in the USA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This section does not apply in the traditional sense of diagnostic AI/ML devices. For calibrating reagents, the "ground truth" is typically established by the known stable values of the calibrators themselves, which are manufactured to highly precise specifications. The accuracy would be assessed against these known values and the performance of the predicate calibrators. There are no "experts" establishing a ground truth in the context of clinical interpretation, but rather skilled laboratory personnel following a quality-controlled protocol.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human interpretation or subjective assessments that would require adjudication. The performance is objectively measured by the instruments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is not a diagnostic device that involves human readers or interpretation of clinical cases. Therefore, an MRMC study and measures like "human readers improve with AI vs without AI assistance" are not relevant here.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
While the device itself (calibrating reagent) is "standalone" in that it performs its function without human interpretation, the concept of "standalone performance" in the context of AI/ML algorithms is not applicable here. The calibrator's performance is intrinsically linked to its interaction with the analyzer instrument. The performance study measures the calibrator's output on the instrument.
7. The Type of Ground Truth Used
The ground truth for calibrating reagents is the known, manufactured analyte concentrations/pH values of the calibrating solutions themselves. These values are established through rigorous manufacturing processes and quality control, traceable to reference standards. The performance study evaluates if the instrument, when calibrated with the Mission Diagnostics reagents, accurately measures these known values and performs comparably to when calibrated with the OEM predicate.
8. The Sample Size for the Training Set
Not applicable. These are chemical reagents, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable as there is no training set.
§ 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.