(20 days)
The Dimension ®Drug Calibrator II is an in vitro diagnostic product intended for the calibration of the following methods packages in Flex™ reagent cartridges:
Acetominophen (ACTM) Carbamazepine (CRBM) Digitoxin (DGTX) Gentamicin (GENT) Tobramycin (TOBR) Valproic Acid (VALP) Vancomycin (VANC)
The Dimension® Drug Calibrator II is a liquid bovine serum-based product. The kit consists of ten vials; two at each of five levels.
The provided document is a 510(k) premarket notification for a medical device called "Dimension® Drug Calibrator II". It describes the device's intended use and compares it to a predicate device ("aca® Digitoxin Calibrator") to establish substantial equivalence.
However, the document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way typically found for AI/ML-based medical devices or diagnostic tests that have quantitative performance metrics (e.g., sensitivity, specificity, accuracy, precision, etc.).
Instead, this submission is for a calibrator, which is a reference material used to set instruments so that they can accurately measure analytes. The primary demonstration for this type of device in a 510(k) submission is typically showing substantial equivalence to an existing, legally marketed predicate device, rather than a clinical performance study with statistical metrics against a ground truth.
The "Comparison to Predicate Device" table (page 1) effectively serves as the "acceptance criteria" and "reported device performance" in the context of a substantial equivalence claim for a calibrator. The acceptance criterion is that the new device is sufficiently similar to the predicate device in key aspects such as intended use, analytes, matrix, form, volume, levels, and reference standards. The "reported device performance" is simply a description of these attributes for the new device and the predicate.
Here's an attempt to answer your questions based on the available information, noting that many items will be "Not Applicable" or "Not Provided" given the nature of a calibrator 510(k) submission:
- A table of acceptance criteria and the reported device performance
| Item | Acceptance Criteria (based on predicate) | Reported Device Performance (Dimension® Drug Calibrator II) |
|---|---|---|
| Intended Use | Calibrator | Calibrator |
| Analytes | Includes digitoxin | digitoxin, acetaminophen, carbamazepine, gentamicin, tobramycin, vancomycin |
| Matrix | Human serum base (for aca predicate) | Bovine serum base |
| Form | Lyophilized (for aca predicate | Liquid |
| Volume | 3.0 mL per vial, reconstituted | 5.0 mL per vial |
| Levels | 3 levels | 5 levels |
| Digitoxin Reference | Primary standard -- USP Digitoxin | Primary standard - USP Digitoxin |
| Overall Equivalence | Substantially equivalent to predicate | Deemed substantially equivalent to aca® Digitoxin Calibrator by FDA |
*Note: For a calibrator, the "acceptance criteria" are generally aligned with demonstrating that the new device performs its function as a calibrator effectively and safely, and often, without being significantly different to a predicate device regarding fundamental characteristics. The performance is assessed by comparison, not a clinical accuracy study.*
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 / Not Provided. This document does not describe a clinical test set or data provenance in the context of device performance metrics like sensitivity or specificity. The evaluation for this calibrator is based on its physical and chemical characteristics in comparison to a predicate device.
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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. Establishing ground truth by experts is not relevant for this type of calibrator submission. The "ground truth" for a calibrator relates to its assigned values and stability, which are typically determined through laboratory validation methods, not expert consensus on clinical cases.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or adjudication method is described.
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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-based diagnostic system for human readers.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This device is a calibrator, not an algorithm or AI system.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable / Inferred. For a calibrator, the "ground truth" would be the assigned target values for the analytes at each level, established through highly accurate analytical methods traceable to primary reference materials (e.g., USP Digitoxin primary standard as mentioned). This is a metrological and analytical ground truth, not a clinical ground truth.
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The sample size for the training set
- Not Applicable. This device is a calibrator, not an AI/ML system that requires a training set.
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How the ground truth for the training set was established
- Not Applicable. No training set is involved.
§ 862.3200 Clinical toxicology calibrator.
(a)
Identification. A clinical toxicology 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. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (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.