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510(k) Data Aggregation
(69 days)
PreciControl Tumor Marker is used for quality control of Elecsys immunoassays on Elecsys immunoassay systems. The controls are used for monitoring the accuracy and precision of Elecsys immunoassays.
PreciControl Tumor Marker contains lyophilized control serum based on human serum. The concentrations are in two clinically relevant ranges. The controls are used for monitoring the accuracy and precision of Elecsys immunoassays.
The provided text does not contain detailed information about acceptance criteria or a specific study proving the device meets those criteria. It is a 510(k) summary for a quality control material (Elecsys® PreciControl Tumor Marker), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting analytical accuracy or clinical performance studies of the device being controlled.
Therefore, many of the requested sections regarding study design, sample sizes, ground truth establishment, and MRMC studies cannot be answered from the provided text.
Here's the information that can be extracted or deduced from the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a performance study for a diagnostic device. Instead, it describes characteristics of the control material and compares them to a predicate device to establish substantial equivalence.
| Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance |
|---|---|---|
| Intended Use | Quality control for Elecsys immunoassays using Elecsys immunoassay systems (Elecsys 2010, 1010, and other Elecsys family instruments). | Quality control for Elecsys immunoassays on Elecsys immunoassay systems. (Stated as similar to predicate). |
| Analyzer System | Elecsys® immunoassay analyzers | Same |
| Reagent Format | Lyophilized, based on human serum | Same |
| Analyte Concentration (PC TM1 / PC TM2) | AFP: approx. 8 & 100 IU/ml | |
| CEA: approx. 5 & 50 ng/ml | ||
| CA 15-3 II: approx. 20 & 100 U/mL | ||
| CA 125 II: approx. 35 & 100 U/mL | ||
| Ferritin: approx. 25 & 200 ng/mL | ||
| fPSA: approx. 1 & 10 ng/mL | ||
| tPSA: approx. 4 & 40 ng/mL | AFP: approx. 8 & 100 IU/ml | |
| CEA: approx. 5 & 50 ng/ml | ||
| CA 15-3 II: approx. 20 & 100 U/mL | ||
| CA 125 II: approx. 35 & 100 U/mL | ||
| Ferritin: approx. 25 & 200 ng/mL | ||
| fPSA: approx. 1 & 10 ng/mL | ||
| tPSA: approx. 4 & 40 ng/mL | ||
| CA 19-9: approx. 20 & 100 U/mL (Added to modified device) | ||
| Stability | @ 2-8° C: unopened until expiration date, opened for 2 weeks. | |
| @ 20-25° C: on analyzers up to 5 hours, 24 hours. | ||
| @ -20° C: 1 month (freeze only once). | Same (with slight rephrasing: "1 month (freeze only once) months at -20° C (only freeze once)" which appears to be a typo/redundancy in the original text, but implies the same stability). |
The key difference highlighted is the addition of CA 19-9 to the analyte concentration list for the modified device. For the other parameters, the device performance is reported as "Same" or very similar to the predicate, indicating it meets the implied "acceptance criteria" of being substantially equivalent to the previously cleared device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The 510(k) pertains to a quality control material and focuses on demonstrating substantial equivalence, not on a performance study of the control material's ability to diagnose or monitor a condition. Therefore, there's no mention of a "test set" in the context of patient samples or data provenance.
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 information is not applicable and not provided. The device is a quality control material. Ground truth in the context of diagnostic accuracy for patient samples is not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided.
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
This information is not applicable and not provided. The device is a quality control material, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. The device is a quality control material, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable and not provided. As a quality control material, the "ground truth" would refer to the assigned target values for the analytes within the control. The method for establishing these target values is not detailed, but typically involves a reference method or consensus of methods for the specific analytes.
8. The sample size for the training set
This information is not applicable and not provided. The concept of a "training set" is not relevant for a quality control material whose substantial equivalence is being demonstrated.
9. How the ground truth for the training set was established
This information is not applicable and not provided.
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