(170 days)
This notification is for an in vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.
A random access, automated Clinical Micro-Chemistry Analyzer with a throughput of up to 180 test per hour which is intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry. monitoring drugs of abuse and in therapeutic drug monitoring.
The provided text describes a 510(k) premarket notification for the Vitalab Flexor Clinical Laboratory Analysis and Reagent System, asserting its substantial equivalence to the Roche Cobas Mira. The document focuses on demonstrating comparable performance through various analytical modes for a range of analytes.
Here's an analysis of the acceptance criteria and the study as per your request:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly define quantitative "acceptance criteria" in the format of specific thresholds (e.g., "accuracy > 95%"). Instead, it states that the device's performance "demonstrates general agreement with levels that are comparable to other systems presently being marketed commercially in the United States" and shows "positive correlation and substantial equivalence" to the predicate device.
The reported device performance is qualitative in nature, emphasizing comparability rather than meeting pre-defined numerical targets.
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Precision | Comparable to commercially marketed systems | Demonstrates general agreement with comparable levels |
| Accuracy | Comparable to commercially marketed systems | Demonstrates general agreement with comparable levels |
| Linearity | Comparable to commercially marketed systems | Demonstrates general agreement with comparable levels |
| Drift | Comparable to commercially marketed systems | Demonstrates general agreement with comparable levels |
| Correlation | Positive correlation with predicate device | Data demonstrates positive correlation and substantial equivalence |
| Analytical Modes | Accommodate various analytical modes (endpoint, kinetic, bichromatic, two-point kinetic, non-linear calibration) | Evaluated methods include these modes. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document mentions "data on twenty-nine (29) representative Clinical Chemistry analytes," "seven (7) representative analytes for Drugs of Abuse," and "two (2) representative analytes for therapeutic drug monitoring." Additionally, it states "Thirty-eight (38) representative methods were selected for evaluation." The exact number of individual samples (patients or controls) analyzed for each analyte or method is not specified. It refers to analytes/methods as the units of evaluation, not individual patient samples.
- Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given that the manufacturer is based in the Netherlands and has a USA branch, the studies could have been conducted in either location or a combination. The submission is for marketing in the United States.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided in the document. The study appears to be a technical validation of an in-vitro diagnostic device assessing its analytical performance against a predicate device, rather than a clinical study requiring expert interpretation of diagnostic outcomes. Ground truth for chemical analytes would typically be established by established reference methods, not expert consensus in the diagnostic sense.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. As noted above, the evaluation is a technical comparison of an in-vitro diagnostic device's analytical performance against a predicate, not a clinical study involving human interpretation that would require adjudication.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This device is an automated in-vitro diagnostic chemistry analyzer, meaning it performs chemical analysis of biological samples without direct human-in-the-loop interpretation of visual or complex data that would involve "readers" in the context of an MRMC study. The concept of "human readers improve with AI" is not relevant to this type of device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
The device itself is an automated system (algorithm only). The performance data presented (precision, accuracy, linearity, drift) specifically represents the standalone performance of the Vitalab Flexor system in processing samples and measuring analytes. Without a human in the loop, this is a standalone performance evaluation.
7. The Type of Ground Truth Used
The ground truth used for this type of device is implicitly based on:
- Reference Methods/Predicate Device: The performance is compared to "levels that are comparable to other systems presently being marketed commercially in the United States," specifically stating that the Vitalab Flexor is "substantially equivalent to the Roche Cobas Mira." Therefore, the predicate device (Roche Cobas Mira) itself, validated through its own established analytical performance, serves as a de facto "ground truth" or standard for comparison.
- Established Analytical Principles: The evaluation of precision, accuracy, linearity, and drift relies on established analytical principles and statistical methods commonly applied in clinical chemistry. These are fundamental measures of analytical performance, where "ground truth" would be the true value of an analyte as determined by highly accurate reference methods, or the expected range given a control material.
8. The Sample Size for the Training Set
This information is not provided and is not applicable in the context of this device. The Vitalab Flexor is a traditional clinical chemistry analyzer, not a machine learning or AI-driven system that requires a "training set" in the conventional sense of supervised learning. Its operational parameters and calibration are established through manufacturers' protocols and reference materials, not through a large dataset of labeled training examples.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
§ 862.2170 Micro chemistry analyzer for clinical use.
(a)
Identification. A micro chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. The distinguishing characteristic of the device is that it requires only micro volume samples obtainable from pediatric patients. This device is intended for use in conjunction with certain materials to measure a variety of analytes.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.