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510(k) Data Aggregation
(13 days)
Elecsys CalCheck FT 3 is intended for use in the quantitative verification of the calibration curve established by the Elecsys FT 3 reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers.
The Elecsys CalCheck FT 3 is a three level single analyte set of lyophilized, human based materials. After reconstitution they are assayed in triplicate and the results are compared to the target values.
The provided text describes a 510(k) summary for a medical device called "Elecsys® CalCheck™ FT 3". This device is a calibration verification material, not a diagnostic AI device. As such, the typical acceptance criteria and study design elements requested in the prompt (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this type of product.
Calibration verification materials are used to ensure the accuracy of an analytical instrument's calibration curve. Their performance is typically established by comparing their values to known target values and demonstrating consistency and stability, rather than by evaluating their ability to diagnose a condition or improve human reader performance.
Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance from the provided text in the way you've outlined, as the information is not relevant to this type of device.
However, I can extract the relevant information about the intended use and comparison to a predicate device, which is the primary "acceptance criteria" for a 510(k) submission for a calibration verification material.
Based on the provided text, here's what can be extracted, acknowledging that most of the requested fields are not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied for 510(k) of a Calibration Verification Material) | Reported Device Performance (from text) |
|---|---|
| Intended Use: Verification of calibration curve for Elecsys FT 3 reagents and calibrators on Elecsys 1010/2010 immunoassay analyzers. | Intended Use: Elecsys CalCheck FT 3 is intended for use in the quantitative verification of the calibration curve established by the Elecsys FT 3 reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers. |
| Substantial Equivalence to Predicate Device: Tosoh Medic AIA-Pack HCG Calibration Verification Test Set (K924862) for similar intended use. | Substantial Equivalence Claimed: "The Boehringer Mannheim Elecsys CalCheck FT 3 is substantially equivalent to the currently marketed Tosoh Medics AIA-Pack HCG Calibration Verification Test Set, K924862. The intended use of both the Elecsys CalCheck FT 3 and the predicate device are the same in that they are intended to be used for the calibration verification for their labeled analytes on automated immunoassay analyzers." |
| Material Description: Three-level, lyophilized, human-based materials. Assayed in triplicate post-reconstitution and compared to target values. | Description: The Elecsys CalCheck FT 3 is a three level single analyte set of lyophilized, human based materials. After reconstitution they are assayed in triplicate and the results are compared to the target values. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This device is a calibration material, not a diagnostic test evaluated on patient samples. Its performance would be evaluated through internal QC processes, stability studies, and verification against known concentrations, not a "test set" of patient data.
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)
- Not Applicable. Ground truth for calibration materials is established based on highly accurate reference methods or certified reference materials, not expert consensus on patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable.
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
- Not Applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm or diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Implied: For calibration verification materials, the "ground truth" would be certified reference values or values established through highly accurate and traceable analytical methods. The text mentions "target values," which implies these scientifically established reference points.
8. The sample size for the training set
- Not Applicable. This device does not use machine learning or AI that requires a "training set."
9. How the ground truth for the training set was established
- Not Applicable.
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(10 days)
Elecsys CalCheck TSH is intended for use in the quantitative verification of the calibration curve established by the Elecsys TSH reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers.
The Elecsys CalCheck TSH is a three level single analyte set of lyophilized, human based materials. After reconstitution they are assayed in triplicate and the results are compared to the target values.
The provided text does not contain information about acceptance criteria or a study proving that the device meets them. The document is a 510(k) summary for a calibration verification material (Elecsys CalCheck TSH), focusing on its intended use and establishing substantial equivalence to a predicate device.
Therefore, I cannot populate the requested tables and answer the questions based on the given input.
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