(75 days)
The Bayer Immuno 1™ System has been upgraded for Laboratory Automation capability. Software and Hardware will facilitate communication and robotic transfer of samples to and from a Laboratory Automation system. The Laboratory Automation System (LAS) will coordinate the scheduling, sample identification, and physical transfer of samples, as demonstrated for the following representative methods: CEA, FSH, Free T4, PSA, T3, T4, TSH, and T-Uptake.
Bayer Immuno 1" System Upgraded for Laboratory Automation Capability
Here's an analysis of the provided text, focusing on acceptance criteria and the study performed:
1. Table of Acceptance Criteria and Reported Device Performance
The document is a 510(k) summary for an upgrade to the Bayer Immuno 1™ System. The primary goal of the submission is to demonstrate substantial equivalence to the predicate device (the original Bayer Immuno 1™ System). Therefore, the "acceptance criteria" are implicitly defined by the performance of the predicate device. The study aims to show that the "Bayer Immuno 1™ System Upgraded for Laboratory Automation Capability" (the upgraded device) performs comparably to the "Bayer Immuno 1™ System" (the predicate device).
The document presents two key performance metrics for eight representative assays: Precision (Total CV %) and Correlation (Correlation Coefficient 'r' and Standard Error 'Sy.x') between the upgraded and predicate systems.
| Method | Performance Metric | Acceptance Criteria (Predicate Device) | Reported Device Performance (Upgraded System) | Comparison / Implied Acceptance |
|---|---|---|---|---|
| Precision (Total CV %) | ||||
| CEA | Total CV | 2.3% - 1.8% | 3.3% - 1.2% | The CVs for the upgraded system are largely comparable to, and in some cases better (e.g., 1.2% vs 2.2% at 13.29 ng/mL), or slightly higher (3.3% vs 2.3% at 1.54 ng/mL) than the predicate. The exact acceptance threshold for differences in CV isn't explicitly stated, but the values suggest a similar level of precision. |
| FSH | Total CV | 3.2% - 2.8% | 1.6% - 0.7% | Upgraded system shows consistently lower (better) CVs than the predicate device. |
| Free T4 | Total CV | 15.4% - 3.1% | 4.1% - 4.7% | Upgraded system shows significantly better CVs at lower concentrations (4.1% vs 15.4%) and comparable or slightly higher at higher concentrations. |
| PSA | Total CV | 0.007% - 3.4% | 3.1% - 2.4% | The range of concentrations and corresponding CVs don't perfectly align, but the upgraded system's CVs generally fall within a similar low percentage range, indicating comparable precision. |
| T3 | Total CV | 13.3% - 3.9% | 5.1% - 2.0% | Upgraded system shows consistently lower (better) CVs, especially at lower concentrations (5.1% vs 13.3%). |
| T4 | Total CV | 3.6% - 2.5% | 1.6% - 1.2% | Upgraded system shows consistently lower (better) CVs. |
| TSH | Total CV | 13.0% - 1.8% | 6.4% - 1.2% | Upgraded system shows lower (better) CVs, particularly at lower concentrations (6.4% vs 13.0%). |
| T-Uptake | Total CV | 2.8% - 2.4% | 3.3% - 2.2% | Generally comparable, with some values slightly higher or lower than the predicate. |
| Correlation | ||||
| CEA | Correlation Coeff 'r' | N/A (implicit target >0.98) | 0.998 | Excellent correlation, indicating substantial equivalence. |
| Standard Error 'Sy.x' | N/A | 0.116 | Low standard error, indicating good agreement. | |
| FSH | Correlation Coeff 'r' | N/A | 0.999 | Excellent correlation. |
| Standard Error 'Sy.x' | N/A | 0.841 | Low standard error. | |
| Free T4 | Correlation Coeff 'r' | N/A | 0.988 | Good correlation. |
| Standard Error 'Sy.x' | N/A | 0.042 | Low standard error. | |
| PSA | Correlation Coeff 'r' | N/A | 1.000 | Excellent correlation. |
| Standard Error 'Sy.x' | N/A | 0.066 | Low standard error. | |
| T3 | Correlation Coeff 'r' | N/A | 0.987 | Good correlation. |
| Standard Error 'Sy.x' | N/A | 0.046 | Low standard error. | |
| T4 | Correlation Coeff 'r' | N/A | 0.997 | Excellent correlation. |
| Standard Error 'Sy.x' | N/A | 0.141 | Low standard error. | |
| TSH | Correlation Coeff 'r' | N/A | 1.000 | Excellent correlation. |
| Standard Error 'Sy.x' | N/A | 0.108 | Low standard error. | |
| T-Uptake | Correlation Coeff 'r' | N/A | 0.991 | Excellent correlation. |
| Standard Error 'Sy.x' | N/A | 0.019 | Low standard error. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- CEA, FSH, T3, TSH: 360 samples each
- Free T4: 355 samples
- PSA: 200 samples
- T4: 356 samples
- T-Uptake: 358 samples
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given it's a 510(k) submission to the FDA (USA), it's highly probable the testing was conducted in the US, but this is not confirmed. The nature of precision and correlation studies for in vitro diagnostics usually involves prospective testing of prepared samples and patient samples.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
This type of study does not involve "experts" in the sense of clinical reviewers establishing a diagnostic "ground truth." Instead, the "ground truth" for the test set is established by the measurements from the predicate device itself. The comparison is between the assay results from the upgraded device and the predicate device. Therefore, this question is not directly applicable to this type of performance study.
4. Adjudication Method for the Test Set
Not applicable. There is no adjudication method used as the study compares the quantitative output of one instrument against another, not diagnostic interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance.
Not applicable. This is not an AI-assisted diagnostic device, nor does it involve human readers interpreting cases. It's an in vitro diagnostic device for automated laboratory testing.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done.
Yes, the performance data presented is for the device's standalone performance. The "upgraded system" operates automatically within the laboratory automation context. The data in Attachment 3 shows the precision and correlation of the upgraded automated system compared to the predicate automated system.
7. The Type of Ground Truth Used
The "ground truth" (or reference standard) is the measurements obtained from the Bayer Immuno 1™ System (the predicate device). The study's purpose is to demonstrate that the upgraded system provides results that are substantially equivalent to those produced by the predicate device.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a distinct "training set" in the conventional sense. The device's operation is based on established immuno-assay principles and factory calibration, not on learning from a large dataset. The data presented demonstrates the analytical performance of the system.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" in the context of this device's technology. The calibration and control procedures for such a device would typically follow standard laboratory quality control protocols using certified reference materials or established control samples.
§ 862.2160 Discrete photometric chemistry analyzer for clinical use.
(a)
Identification. A discrete photometric 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. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.(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.