(78 days)
The ENZ 6 CAL is an in vitro diagnostic product for the calibration of the Creatine Kinase (CKI) and Creatine Kinase MB (MBI) methods on the Dimension Mista® System.
The Dimension Vista® System Enzyme 6 Calibrator (Enz 6 CAL) is a liquid, multianalyte, human serum albumin based product containing creatine kinase MM (human source) and creatine kinase MB (porcine source). The kit consists of three vials of Calibrator A, 2.0 ml per vial. Level 1 calibrator for Enz 6 CAL is not included. Purified Water Diluent or reagent grade water is required for use as Calibrator Level 1. Description of the manufacturing, value assignment and stability testing process are provided in this submission report.
The provided document is a 510(k) Summary for a medical device calibrator, the "Dimension Vista® System Enzyme 6 Calibrator (KC360)". It does not contain detailed information about specific acceptance criteria, a comprehensive study design with sample sizes for test and training sets, expert involvement, or adjudication methods in the format requested. The document primarily focuses on establishing substantial equivalence to a predicate device.
However, I can extract and infer some information based on the typical content of a 510(k) submission for a calibrator.
Here's an attempt to answer your questions based on the available text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria for performance metrics (like accuracy, precision, stability, etc.) in a table format. It states: "Comparative testing described in the protocol included in this submission demonstrates substantial equivalent performance." This implies that the device's performance met criteria that demonstrated equivalence to the predicate device. Without the actual protocol, the specific acceptance criteria and performance data are not available in this summary.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for the test set. It mentions "comparative testing" but does not detail the number of samples or runs. There is no information about the data provenance (country of origin, retrospective/prospective).
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 applicable or not provided. For a calibrator, "ground truth" typically refers to the assigned target values for the analytes, which are established through a robust value assignment process (often involving reference methods or extensive inter-laboratory studies) rather than expert consensus on individual "cases." The document states, "Description of the manufacturing, value assignment and stability testing process are provided in this submission report," but details are not included in the summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable to a calibrator's performance study as described here. Adjudication methods are typically used in clinical studies where expert interpretation of results is involved (e.g., imaging studies).
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
No. This type of study (MRMC for human readers with/without AI assistance) is not relevant to a calibrator device. Calibrators are reagents used in automated laboratory systems and do not directly involve human "readers" interpreting results in the same way an imaging AI might.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable to a calibrator. A calibrator's performance is assessed by how well it enables the analytical system to accurately measure analytes. The "algorithm" here would be the instrument's measurement algorithm, and its performance is evaluated in conjunction with the calibrator. The document implies a standalone evaluation of the calibrator's properties (like value assignment and stability) and then its performance when used with the Dimension Vista® System.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a calibrator, the "ground truth" for the assigned values would be established through a value assignment process, likely involving:
- Reference methods: Highly accurate and precise analytical methods.
- Traceability to international reference materials: Ensuring that the values are consistent with established standards.
- Extensive internal studies: Multiple measurements by qualified personnel using validated methods.
The document states, "Description of the manufacturing, value assignment and stability testing process are provided in this submission report," indicating that a robust process for establishing these values exists.
8. The sample size for the training set
The document does not mention a training set. Calibrators are not typically "trained" in the machine learning sense. Their properties (value, stability) are determined through analytical testing.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of this calibrator's development.
§ 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.