(48 days)
The Enzyme II Calibrator is an in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALTI) on the Dimension® clinical chemistry system.
ENZ II CAL is a liquid, multi-analyte, bovine serum albumin based product containing alanine aminotransferase from porcine heart.
The provided text describes a 510(k) summary for a medical device called "Dimension® ENZ II CAL," an in vitro diagnostic product for the calibration of the alanine aminotransferase (ALT I) method on the Dimension® clinical chemistry system.
However, the document does not contain the following information that you requested:
- A table of acceptance criteria and the reported device performance. The document focuses on comparing the new device to a predicate device based on features and intended use, rather than presenting specific performance data against predefined acceptance criteria.
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size. This type of study is not relevant for a calibrator device.
- If a standalone performance study was done. This study type is not explicitly mentioned with performance metrics.
- The type of ground truth used. For a calibrator, "ground truth" would likely refer to the assigned values based on a primary reference method, which is mentioned, but not in the context of a "test set" for performance evaluation in the way it would be for a diagnostic algorithm.
- The sample size for the training set. Calibrators are not typically "trained" in the sense that an AI algorithm is.
- How the ground truth for the training set was established. Again, not applicable to a calibrator in the context of machine learning.
What is available in the document regarding "acceptance criteria" and "study":
The document establishes substantial equivalence to a predicate device (Dimension Vista® ENZ 2 CAL) as its primary method of demonstrating safety and effectiveness. This means the "acceptance criteria" are implicitly met by demonstrating that the new device is as safe and effective as a legally marketed device.
The "study" that proves the device meets (implicitly) the acceptance criteria is a comparative analysis of features and intended use between the new device and the predicate device, along with verification that the new device's calibration is traceable to an established standard.
Here's a breakdown of what can be extracted from the provided text, addressing your points where possible:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with reported device performance in the traditional sense for a diagnostic algorithm. Instead, it relies on demonstrating substantial equivalence to a legally marketed predicate device. The "performance" is implied by its intended use as a calibrator and its traceability to a reference method.
The key "performance" aspect mentioned is:
- Traceability: ENZ II CAL's ALT I is traceable to the IFCC ALT @ 37°C primary reference method. This ensures its accuracy as a calibrator.
2. Sample sized used for the test set and the data provenance
Not applicable/Not provided. The document outlines a comparison of features for substantial equivalence, not a performance study on a "test set" of patient data for diagnostic accuracy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not provided.
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 for a clinical chemistry system, not an AI-powered diagnostic tool for human readers.
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 product. The calibrator itself performs no "algorithm" to generate a diagnostic result. Its "performance" is in its ability to accurately set the measurement scale for an analyzer. The document implies that the device's ability to calibrate is verified by its traceability.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the calibrator, the "ground truth" for the assigned values is established through traceability to a primary reference method: "ALT I traceable to the IFCC ALT @ 37°C primary reference method."
8. The sample size for the training set
Not applicable. This device is a calibrator, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
Summary for the Calibrator Device:
- Acceptance Criteria & Performance: The primary "acceptance criterion" is establishing substantial equivalence to a predicate device (Dimension Vista® ENZ 2 Calibrator) regarding intended use, form, packaging, stability, and storage. Differences pertain to specific constituents and traceability methods.
- New Device Performance Claim: ALT I traceable to the IFCC ALT @ 37°C primary reference method.
- Study Proving Compliance: The "study" is a comparative analysis documented in the 510(k) submission, highlighting similarities and differences between the new Dimension® ENZ II Calibrator and the predicate Dimension Vista® ENZ 2 Calibrator. The traceability claim is fundamental to its "performance."
- Ground Truth: For the calibrator's assigned values, the ground truth is established by its traceability to the IFCC ALT @ 37°C primary reference method.
- Other details (sample sizes, experts, adjudication, MRMC, standalone performance, training sets): These concepts are not applicable or not provided in the context of this calibrator device's submission. The 510(k) focuses on equivalence to a predicate based on manufacturing, content, and intended use, rather than a clinical performance study with patient data for diagnostic accuracy.
§ 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.