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The Elecsys T3 CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys T3 quantitative assay reagent on the indicated Elecsys and cobas e immunoassay analyzers, for in vitro diagnostic use only.

The Elecsys T3 CalCheck 5 is a lyophilized product consisting of T3 in human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.

The provided text describes the Elecsys T3 CalCheck 5, an assayed control for use in calibration verification and assay range verification on Elecsys and cobas e immunoassay analyzers. However, the document provided is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance data in the format requested.

Therefore, much of the requested information, such as detailed acceptance criteria with reported device performance values, sample sizes for test and training sets, expert qualifications, and specific study designs (MRMC, standalone), is not explicitly available in this summary.

Here's a breakdown of what can be extracted and what is missing:

1. Table of acceptance criteria and the reported device performance

   The document does not explicitly state acceptance criteria in the format of a typical performance study. Instead, it compares the characteristics of the candidate device (Elecsys T3 CalCheck 5) with a predicate device (Elecsys T3 CalCheck, K963167) to demonstrate substantial equivalence.

   The "Performance Characteristics" section only states: "The Elecsys T3 CalCheck 5 was evaluated for value assignment and stability." It does not provide the results of these evaluations or specific acceptance criteria for them.

   Characteristic	Elecsys T3 CalCheck 5 (Candidate Device)	Elecsys T3 CalCheck (K963167)	Acceptance Criteria (not explicitly stated in document)	Reported Device Performance (not explicitly stated in document)
   Intended Use	Assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys T3 quantitative assay reagent on the indicated Elecsys and cobas e immunoassay analyzers.	For use in the verification of the calibration established by the Elecsys T3 regent on indicated Elecsys and cobas e immunoassay analyzers.	Equivalent to predicate	Equivalent
   Analyte	T3	T3	Identical to predicate	Identical
   Levels	Five	Three	Acceptable difference	Five levels
   Assay Measuring Range	0.300 - 10.0 nmol/L	0.300 - 10.0 nmol/L	Identical to predicate	Identical
   Check Target Values	Check 1: ≤ 0.2 nmol/L

Check 2: 2.0 nmol/L
Check 3: 5 nmol/L
Check 4: 8 nmol/L
Check 5: 10 nmol/L | Check 1: 0 ng/ml
Check 2: 1.6 ng/ml
Check 3: 5.8 ng/ml | Within expected range | Specified values |
| Format | Lyophilized | Lyophilized | Identical to predicate | Identical |
| Handling | Reconstitute with 1.0 mL distilled or deionized water, stand 15 minutes, mix gently. | Reconstitute with 1.0 mL distilled or deionized water, stand 15 minutes, mix gently. | Equivalent to predicate | Equivalent |
| Stability (Unopened) | Store at 2-8°C until expiration date | Store at 2-8°C until expiration date | Identical to predicate | Identical |
| Stability (Reconstituted) | 20-25°C: 4 hours | 15-25°C: 4 hours | Within acceptable range | 20-25°C: 4 hours |
| Matrix | Human serum matrix | Human serum matrix | Identical to predicate | Identical |

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 510(k) summary. The document mentions "value assignment and stability" evaluations but does not detail the methodology, sample sizes, 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 is not applicable as the device is a quality control material for an immunoassay, not an AI/imaging device requiring expert interpretation for ground truth.

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

   Not applicable for this type of device and study description.

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 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

   Not applicable. This device is a quality control material, not an algorithm. The "performance" here refers to the chemical and physical characteristics of the control material (value assignment, stability) rather than diagnostic accuracy.

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

   For a quality control material, the "ground truth" for value assignment would typically be established through reference methods or highly calibrated and validated primary assays on the manufacturing end. The document does not specify the exact methods for value assignment, only that it was "evaluated for value assignment."

8. The sample size for the training set

   Not applicable. This device is a quality control material, not an AI model that requires a training set.

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

   Not applicable.

In summary, the provided 510(k) document is for a medical device (a quality control material) that does not involve AI or human interpretation in the way that would necessitate the study details requested in questions 2-9. Its clearance is based on substantial equivalence to a predicate device, focusing on similar intended use, analyte, matrix, and performance characteristics (which are not fully detailed in this summary). The "studies" mentioned refer to evaluations of the product's physicochemical properties (value assignment and stability) rather than clinical performance or diagnostic accuracy.

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