(45 days)
The MAGO is intended to be used as a general purpose automated EIA processor. The MAGO is indicated for use in moderate complexity laboratories for performing automated EIA procedures.
The Diamedix MAGO is indicated for use as a general purpose automated EIA processor for use in clinical laboratories.
The MAGO and its predicates all share the same principle of operation. Each device provides a pipetting station which is capable of performing normal pipetting functions such as, accurately aspirating and dispensing fluids into microplates and a wash station capable of simulating a microplate washing device. The device allows user programming which controls the sequence of activity to allow sample dilution and addition, incubation, and reagent dispensing which mimics and duplicates manual assay procedures.
The provided text describes the Diamedix MAGO™ Automated EIA Processor, a device intended for general-purpose automated EIA processing in moderate complexity laboratories. The submission focuses on establishing substantial equivalence to existing manual methods and predicate devices rather than complex clinical performance studies with detailed acceptance criteria as might be expected for an AI/ML powered diagnostic device.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in the format typically seen for a new diagnostic assay. Instead, the performance objective was "no substantial difference" between the MAGO and manual methods.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functioned as intended | MAGO functioned as intended |
| No substantial difference between automated and manual methods | Demonstrated no substantial difference between performing the test manually and performing the assay on the MAGO |
2. Sample Size Used for the Test Set and Data Provenance
The text states: "The MAGO was compared to the standard manual procedures in six separate EIA systems."
- Sample Size for Test Set: This phrasing suggests that six separate EIA systems were used for comparison, but it does not specify the number of individual tests, assays, or patient samples run within each of those systems. It implies that the comparison was across different types of EIA systems (e.g., different assays), rather than a specific number of samples within one system.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided. The comparison was against "standard manual procedures," implying existing validated manual methods served as the reference, but no information on expert review or ground truth establishment is given.
4. Adjudication Method for the Test Set
No adjudication method is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was conducted or mentioned. The device is an automated processor, not a diagnostic aid requiring human interpretation of output. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this type of device.
6. Standalone Performance Study
Yes, a standalone study was done in the sense that the MAGO's performance was directly compared to manual methods. The purpose was to show that the automated system could replicate the results of the manual methods without human intervention beyond setting up the machine.
7. Type of Ground Truth Used
The "ground truth" was established by standard manual procedures for Enzyme Immunoassay (EIA) systems. This means the results obtained from manually performed EIA tests were considered the reference truth against which the automated MAGO's results were compared.
8. Sample Size for the Training Set
Not applicable. This device is an automated processor, not an AI/ML algorithm that requires a "training set" in the context of machine learning. Its operation is based on programmed protocols simulating manual pipetting, washing, and incubation steps.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the machine learning sense for this device.
§ 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.