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510(k) Data Aggregation
(60 days)
This section contains a brief statement of intended use for the method as a in vitro diagnostic procedure for quantitating analytes in human serum.
The Technicon Immuno 100 system is an automated clinical immunoassav analyzer. All tests can be run in random access, batch, and STAT modes at a throughput rate of up to 120 tests per hour. Up to twenty-two (22) methods can be loaded on the system at one time. The system performs latex agglutination and magneticseparation enzyme immunoassays on serum. Magneticseparation enzyme immunoassays are divided into two (2) groups: sandwich assays and competitive assays.
The provided text describes the operational aspects, calibration, and quality control of the Technicon Immuno 1 system, an automated clinical immunoassay analyzer. It focuses on the general procedures for handling reagents, calibrators, controls, and includes details about how performance characteristics like imprecision, correlation, and sensitivity are determined. However, the document does not contain a study or specific data proving that the device (the Technicon Immuno 1 system itself) meets an overall acceptance criterion.
Instead, the document details how individual assays/methods performed on the system have their performance characteristics established, and how laboratories should verify ongoing performance through quality control and calibration. The acceptance criteria mentioned are primarily for quality control and calibration, not for the overall device performance in a single study.
Therefore, many of the requested items cannot be directly extracted from this document, as it is a general manual for the system, not a specific performance validation study.
Here's an breakdown of what can be inferred or directly stated from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes how performance characteristics are defined and measured for individual assays, rather than providing an acceptance criterion for the overarching "device" or its overall performance in a single study. The key performance criteria for individual assays are:
| Acceptance Criterion Type (for individual assays) | Reported Device Performance (General description of how it's measured/evaluated) |
|---|---|
| Imprecision | |
| (Within-run, Total) | Evaluated using human serum pools/control materials according to NCCLS EP5-T2, using two systems, 20 days, 1-2 runs/day, 2+ samples/run. Users should obtain data passing Chi Square test at 95% confidence. Values are "point estimates of average imprecision." |
| Correlation | Determined using human serum samples from external evaluation sites, comparing Technicon Immuno 1 with reference/comparative systems. Regression statistics computed per NCCLS EP9-T. |
| Sensitivity (Minimum Detectable Concentration) | Smallest concentration detected within a run, equivalent to two within-run standard deviations of the Level 1 (0.0) calibrator. Measured by running 0.0 calibrator 20 times on three systems. |
| Specificity | Lists highest concentration of common interfering substances evaluated and found not to have a significant effect. Also lists % observed cross-reactivity. |
| Analytical Range | Describes the concentration range for acceptable results. |
| Quality Control (QC) Acceptance | Control results must meet the laboratory's established criteria for acceptability. If not, patient test results from that run must be evaluated, and corrective actions (e.g., recalibration) taken. Controls should be within ±2 total standard deviations. |
| Calibration Stability | Minimum duration of calibration stability is established. Users may extend if QC indicates acceptable performance (control recovery within ±2 total standard deviations). |
| Reagent Stability (On-System) | Minimum stable period stated in method sheet. Established by monitoring control recovery means within ±2 total standard deviations after activation. |
2. Sample size used for the test set and the data provenance
For Imprecision:
- Sample Size: For each method, imprecision was evaluated using "two (2) systems per method, twenty (20) days per system, one to two (1 - 2) runs per day, and two (2) or more samples per run." The samples are "human serum pools and control materials."
- Data Provenance: Not explicitly stated (e.g., country of origin). The study design appears to be prospective in nature, following a protocol similar to NCCLS document EP5-T2.
For Correlation:
- Sample Size: "human serum samples." The number is not specified.
- Data Provenance: "from external evaluation sites." Not explicitly stated (e.g., country of origin, retrospective or prospective). Similar to NCCLS document EP9-T.
For Sensitivity:
- Sample Size: The "0.0 calibrator is run twenty (20) times on three (3) systems." This refers to runs, not unique patient samples.
- Data Provenance: Not explicitly stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention the use of experts to establish ground truth for a test set in the context of device performance validation. The performance characteristics are determined using reference methods, calibrators, and control materials, according to established NCCLS guidelines.
For "Expected Values," asymptomatic donors' sera (approx. 100) were used, and the central 95% range was calculated. This is a statistical determination, not an expert panel establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
No adjudication method is mentioned. The performance studies rely on quantitative measurements against reference methods or defined calibrator values.
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 MRMC study was mentioned. The device is an automated immunoassay analyzer, not an AI-assisted diagnostic imaging tool with human interpretation. Therefore, this question is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The Technicon Immuno 1 system is an automated analyzer, meaning it operates in a standalone manner for performing immunoassays. Its performance characteristics (imprecision, correlation, sensitivity) described are standalone performance metrics of the instrument. Human intervention is primarily for sample loading, maintenance, calibration, quality control, and interpretation of results by laboratory personnel.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance characteristic studies appears to be based on:
- Reference methods: For correlation studies, the Technicon Immuno 1 system is compared against "a reference method or a comparative system."
- Defined calibrator values: For sensitivity, the "Level 1 (0.0) calibrator" is used. For imprecision and stability, control materials and human serum pools with known or expected values underpin the evaluation.
- Statistical methods: For "Expected Values," statistical calculation (nonparametric or parametric) from asymptomatic donors' sera is used.
8. The sample size for the training set
The document refers to performance validation studies, not "training sets" in the context of machine learning. The system's operation is based on established biochemical principles and calibration, not machine learning models that require a distinct training set. Therefore, this question is not applicable in the typical sense.
9. How the ground truth for the training set was established
Not applicable, as no machine learning training set is described. The analytical methods are based on chemical reactions and optical density measurements, which are calibrated and controlled using established laboratory standards.
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