(45 days)
The IBCT Calibrator for the Dimension® Clinical Chemistry System is a device intended to calibrate the Dimension® clinical chemistry system for total iron binding capacity (IBCT) method.
The Dimension® IBCT Calibrator is a liquid protein based product. The kit consists of six vials; two at each of three levels.
This document is a 510(k) summary for the Dimension® IBCT Calibrator, a device used to calibrate total iron binding capacity (IBCT) methods on the Dimension® clinical chemistry system. It is a regulatory submission, not a study report detailing specific performance metrics or clinical efficacy. Therefore, much of the requested information regarding acceptance criteria, study design, and performance statistics is not present in the provided text.
Based on the provided information, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The document is a 510(k) submission asserting substantial equivalence to a predicate device, not a performance study report with specific acceptance criteria and detailed device performance data.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to the device as a "liquid protein based product" for calibration, implying its performance would be assessed in a laboratory setting for accuracy, precision, etc., but the details of such assessments are absent.
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)
This information is not provided in the document. The concept of "ground truth" as typically applied in AI/medical imaging studies (e.g., expert consensus on image interpretation) is not relevant to a calibrator device for clinical chemistry. The ground truth for a calibrator would be its accurate concentration and stability, which are established through analytical methods, not typically by expert interpretation in the way "ground truth" is used in the prompt. The primary standard for the calibrator is mentioned as "NIST Iron Standard SRM 937".
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. Adjudication methods are typically used in studies involving human interpretation (e.g., radiologists reading images) to resolve discrepancies, which is not applicable to a calibrator device.
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
This information is not provided in the document. An MRMC study is relevant to imaging diagnostics or AI-assisted interpretation, where human readers are involved. This document describes a calibrator for a clinical chemistry system, which does not involve human readers interpreting "cases" in the same way.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided in the document. The device is a calibrator, not an algorithm. Its performance is inherent to its chemical composition and stability, and its effect on instrument accuracy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the calibrator itself is established by its manufacturing process and verified against a primary standard. The document states:
- Primary standard: NIST Iron Standard SRM 937
This refers to a certified reference material used to ensure the accuracy of the calibrator's stated values. This is an analytical standard, not an "expert consensus" or "pathology" in the typical sense.
8. The sample size for the training set
This information is not provided in the document. The concept of a "training set" is not applicable to a calibrator device. Calibrators are manufactured products, not AI algorithms that require training data.
9. How the ground truth for the training set was established
This information is not provided and is not applicable, as there is no "training set" for a calibrator device.
Summary regarding the provided document:
The provided document is a 510(k) premarket notification for a medical device (a calibrator). Its primary purpose is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than to present detailed performance data against specific acceptance criteria. Therefore, most of the questions, which are geared towards performance studies for diagnostic algorithms or imaging devices, are not addressed within this type of regulatory submission. The "study" referenced in the prompt's context is effectively the substantial equivalence comparison documented by the submitter, which focuses on device characteristics and intended use rather than specific clinical performance metrics.
§ 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.