(20 days)
The MYO CalPak is an in vitro diagnostic product used to calibrate the myoglobin method on the Stratus® CS STAT fluorometric analyzer. This calibrator is a device intended to establish a point of reference that is used in the determination of myoglobin values.
The Stratus® CS MYO CalPak is an in vitro diagnostic product used to calibrate the myoglobin method on the Stratus® CS STAT fluorometric analyzer. The MYO CalPak is a liquid, buffered bovine protein matrix product with myoglobin at an approximate concentration of 850 ng/mL. The CalPak is a plastic cartridge which contains the calibrator material in reagent wells. It is a single-use product.
The provided text describes a calibrator (Stratus® CS MYO CalPak) for an in vitro diagnostic device, not an AI/ML-driven medical device that analyzes data or images. As such, most of the questions regarding acceptance criteria, study design, expert involvement, and ground truth are not applicable to this type of product.
The submission is for a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a predicate device. The basis for acceptance is typically analytical performance, consistency, and stability of the calibrator itself, and its ability to properly calibrate the associated assay.
Here's an attempt to address the relevant points based on the provided text, and noting the inapplicable nature of others:
Device Name: Stratus® CS MYO CalPak
Device Type: In vitro diagnostic product (Calibrator for myoglobin method on Stratus® CS STAT fluorometric analyzer)
1. A table of acceptance criteria and the reported device performance
The provided text only states that the Stratus® CS MYO CalPak is "substantially equivalent to the Stratus® myoglobin calibrator as they are both intended to be used as calibrators for similar myoglobin methods." It does not provide specific acceptance criteria or performance data (e.g., precision, accuracy, linearity, stability) for the calibrator itself or the myoglobin assay when using this calibrator, which would typically be part of a full 510(k) submission.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the provided text. | Substantially equivalent to the Stratus® myoglobin calibrator. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This is a calibrator, not a diagnostic test for patient samples. Testing would involve analytical studies of the calibrator's properties and its effect on the assay, rather than evaluation with a "test set" of patient samples in the traditional sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. Ground truth for patient data is not established for a calibrator. The "ground truth" for a calibrator would relate to its manufacturing specifications and the known concentration of its analyte(s).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are used for interpreting clinical data, which is not the focus of this calibrator submission.
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 device is a calibrator, not an AI/ML diagnostic aid for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a calibrator; it does not have an algorithm or standalone performance in the context of AI/ML.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For a calibrator, the "ground truth" typically refers to the certified or assigned value of the analyte (myoglobin in this case) within the calibrator material, established through precise analytical methods and often traceable to higher-order reference materials. The text states the CalPak has myoglobin at an approximate concentration of 850 ng/mL, implying this is its intended "ground truth" value for calibration.
8. The sample size for the training set
- Not Applicable. This is a calibrator, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. As above, no training set for an AI/ML model.
§ 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.