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510(k) Data Aggregation
(51 days)
The SYNCHRON® Systems Ammonia (AMM) Reagent, in conjunction with SYNCHRON® Systems Ammonia Calibrators, is intended for the quantitative determination of ammonia concentration in plasma on SYNCHRON® Systems.
The SYNCHRON System Ammonia Reagent is designed for optimal performance on the SYNCHRON CX and LX Systems. It is intended for use in the quantitative determination of ammonia in plasma.
The provided text describes a 510(k) premarket notification for the SYNCHRON® Systems Ammonia (AMM) Reagent, intending to demonstrate substantial equivalence to a predicate device. The information focuses on method comparison and imprecision studies for this in vitro diagnostic device.
Here's an analysis of the provided text in relation to your questions:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for precision or method comparison in the format of pass/fail thresholds. Instead, it presents observed performance data and implicitly assumes these results demonstrate substantial equivalence.
Based on the "Summary of Performance Data" section, we can infer the performance metrics reported:
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance (SYNCHRON® CX System) | Reported Device Performance (SYNCHRON® LX System) |
|---|---|---|---|
| Method Comparison (vs. Predicate: Dade aca®) | No explicit criteria stated, but values close to 1.0 for slope and close to 0 for intercept, with high 'r' value, are indicative of good agreement. | Slope: 1.018 | |
| Intercept: -5.3 µmol/L | |||
| r: 0.9991 | Slope: 1.003 | ||
| Intercept: -2.2 µmol/L | |||
| r: 0.9986 | |||
| Within-Run Imprecision (C.V.%) | No explicit criteria stated, but low C.V.% values indicate good precision. Industry standards typically expect low single-digit C.V.% for chemistry assays. | Level 1: 4.2% | |
| Level 2: 2.3% | |||
| Level 3: 0.8% | Level 1: 4.9% | ||
| Level 2: 2.2% | |||
| Level 3: 0.8% |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Method Comparison Test Set Sample Size: 82 plasma samples ("n = 82").
- Imprecision Test Set Sample Size: For each of the three levels tested on both CX and LX systems, there were 15 replicates ("N = 15"). So, 3 levels * 15 replicates * 2 systems = 90 total imprecision measurements.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or 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 is an in vitro diagnostic device (reagent for chemical analysis). The "ground truth" for method comparison is established by the predicate device's measurement, not by human expert opinion or interpretation in the way it would be for an imaging AI device. Therefore, this question is not directly applicable to this type of device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods like 2+1 or 3+1 refer to consensus processes among human experts, typically used in imaging or clinical evaluation studies to establish ground truth. Since this is an in vitro diagnostic device where the reference standard is another device (the predicate) and standard laboratory methods, there is no human adjudication process involved.
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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic aids that assist human readers (e.g., radiologists interpreting images). The SYNCHRON® Systems Ammonia (AMM) Reagent is a laboratory reagent for quantitative chemical analysis, not an AI-assisted diagnostic tool that involves human "readers."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the performance data presented (method comparison and imprecision) represents the standalone performance of the SYNCHRON® Systems Ammonia (AMM) Reagent when used on the specified SYNCHRON® CX and LX Systems. There is no "human-in-the-loop" aspect to the fundamental measurement process of this chemical reagent. The device itself performs the measurement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" or reference standard for the method comparison study was the measurement result from the predicate device, the Dade aca®* clinical analyzer, using its ammonia reagent.
8. The sample size for the training set
The document does not describe a "training set" in the context of machine learning. This device is a chemical reagent and an associated analytical system, not an AI algorithm that requires training data in the typical sense. The development of such a system involves chemical formulation and analytical optimization, not an AI model training process.
9. How the ground truth for the training set was established
As there is no "training set" for an AI algorithm in this context, this question is not applicable.
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