(7 days)
The Access Free T3 Calibrator set is a device intended for medical purposes for use in the Access Immunoassay Systems to establish points of reference that are used in the determination of values in the measurement of free T3 levels in human serum and plasma.
The Access Free T3 Calibrators are designed for use with the Access Free T3 Reagent for generation of the Free T3 assay calibration curve on Beckman Coulter's Access Immunoassay Systems. The Access Free T3 Calibrator kit contains 6 X 2.5 mL bottles, one for each of six calibrator levels. The Access Immunoassay Systems utilize a competitive binding immunoenzymatic method for quantitative analyte measurement.
The provided text describes a 510(k) premarket notification for the "Access Free T3 Calibrators" and discusses its substantial equivalence to a predicate device. However, the document does not contain explicit acceptance criteria or detailed study results that prove the device meets specific performance thresholds.
It states that "Performance data from validation testing supports a finding of substantial equivalence to the Beckman Coulter Access Ultrasensitive hGH Calibrators already in commercial distribution," and mentions "Product claims and specifications." However, these claims and specifications, along with the actual performance data, are not provided in the submitted text.
Therefore, I cannot populate most of the requested fields as the information is not present in the provided document.
Here's an assessment based on the available information:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | Not specified in the document (Simply states "demonstrated to be equivalent to the predicate product" and "supports a finding of substantial equivalence" based on unspecified "product claims and specifications.") |
Study Details
- Sample size used for the test set and the data provenance: Not specified in the document.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in the document.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not specified in the document.
- 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 calibrator for an immunoassay system, not an AI-assisted diagnostic tool for human readers.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable in the context of an "algorithm only" as a calibrator is a physical product used in conjunction with an immunoassay system. The performance of the calibrators themselves would be evaluated, likely for stability, accuracy in generating a calibration curve, and equivalence to the predicate.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not specified in the document.
- The sample size for the training set: Not applicable and not specified. The device is a calibrator, not a machine learning algorithm that requires a "training set" in the conventional sense. Testing would involve validation of its manufacturing and functional performance.
- How the ground truth for the training set was established: Not applicable and not specified.
Conclusion: The provided document is a 510(k) summary focused on demonstrating substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria and results. The "Summary of Performance Data" section is very high-level and refers to unspecified "product claims and specifications" and "validation testing." To answer the questions thoroughly, the actual validation reports and performance data submitted to the FDA would be required.
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.