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The Thermo Electron Enzymatic Creatinine reagent is intended for the in vitro quantitative determination of Creatinine in human serum, plasma or urine. Creatinine determinations are used in the diagnosis and treatment of renal impairment, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

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This looks like a 510(k) clearance letter for an in vitro diagnostic device, specifically a creatinine reagent. These types of documents typically do not contain detailed information about the acceptance criteria and study results in the way that would be provided for an AI/ML-based diagnostic device. The letter confirms substantial equivalence to a predicate device, which is a different regulatory pathway than proving de novo effectiveness with detailed performance metrics.

Therefore, many of the requested items (e.g., sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance) are not applicable or extractable from this document.

However, I can provide what can be inferred from the document regarding the device's purpose and general regulatory standing.

Analysis based on the provided document:

Based on the provided FDA 510(k) clearance letter for the "Thermo Electron Enzymatic Creatinine Reagent," the document itself does not contain the detailed acceptance criteria and study results as would be found in a submission for an AI/ML-based diagnostic. This is a clearance for an in vitro diagnostic (IVD) reagent, and its substantial equivalence is typically demonstrated through performance characteristics like accuracy, precision, linearity, and interference studies compared against a predicate device, rather than detailed clinical effectiveness studies with ground truth established by experts.

Therefore, many of the requested fields cannot be directly answered from this document.

Here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated in this clearance letter. For IVD reagents, acceptance criteria are typically related to the analytical performance (e.g., accuracy, precision, linearity, limits of detection/quantitation, interference) compared to a predicate device or established clinical standards.
• Reported Device Performance: Not explicitly stated in this clearance letter. The letter confirms that the FDA reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This indicates that the performance data submitted by Thermo Electron Corporation met the FDA's criteria for substantial equivalence relative to the predicate.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified in this document.
• Data Provenance: Not specified in this document.

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 / Not specified. For IVD reagents, "ground truth" is typically established through reference methods or established laboratory standards for analyte concentration, not expert consensus in the same way as an imaging or clinical diagnostic algorithm.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable / Not specified.

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. This is an IVD reagent, not an AI/ML-based diagnostic that would involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is an IVD reagent device; it does not involve algorithms or human-in-the-loop performance in the context of AI. It's a laboratory test.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Inferred: For creatinine reagents, the "ground truth" for analytical performance would typically be established by highly accurate reference methods (e.g., isotope dilution mass spectrometry (IDMS)) or by comparison to results from other validated and legally marketed creatinine assays (the predicate device). It's based on objective chemical measurement, not expert consensus, pathology, or outcomes data in the usual sense.

8. The sample size for the training set

• Not applicable / Not specified. This type of device does not typically involve "training sets" in the context of AI/ML.

9. How the ground truth for the training set was established

• Not applicable / Not specified.

Summary based on the document:

The device, "Thermo Electron Enzymatic Creatinine Reagent," is an in vitro diagnostic intended for quantitative determination of Creatinine in human serum, plasma, or urine, used in the diagnosis/treatment of renal impairment and monitoring renal dialysis. The FDA determined it to be substantially equivalent to legally marketed predicate devices, meaning its performance characteristics were demonstrated to be comparable and safe/effective for its intended use. The detailed analytical performance studies and their acceptance criteria would have been part of the 510(k) submission, but are not present in this clearance letter.

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