(31 days)
Boehringer Mannheim Precinorm ® Protein Precipath ® Protein Controls are intended for use as a control in the immunoturbidimetric assay of serum proteins. It is well suited for automated analytical procedures. The assigned values for each constituent are obtained on Boehringer Mannheim/Hitachi systems.
Boehringer Mannheim Precinorm ® Protein Precipath ® Protein Controls are a two-level liquid preparation of pooled human sera with constituents in the normal (Precinorm ® Protein) and pathological (Precipath ® Protein) ranges.
The provided document is a 510(k) summary for the Boehringer Mannheim Precinorm® Protein Precipath® Protein Controls. This type of regulatory submission primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies against specific acceptance criteria.
Therefore, many of the requested details such as acceptance criteria, specific study design, sample sizes for test and training sets, number and qualifications of experts, the type of ground truth, and effects of AI assistance are not available in this document. The device is a quality control material intended to ensure the accuracy of immunoturbidimetric assays for serum proteins, not a diagnostic algorithm that would typically have these types of performance metrics.
Here's what can be extracted from the document:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the 510(k) summary. The summary focuses on comparing the new device to predicate devices rather than defining specific performance acceptance criteria and then showing data that meets them. The device's performance is implicitly evaluated by its suitability for "use as a control in the immunoturbidimetric assay of serum proteins" and its "assigned values for each constituent are obtained on Boehringer Mannheim/Hitachi systems."
2. Sample size 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. The document does not describe a performance study with a test set in the typical sense for a diagnostic device.
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 provided. As this is a control material, "ground truth" would likely refer to the target values of the constituents, which are established during the manufacturing process and assigned using specific analytical systems. Experts in clinical interpretation for ground truth are not relevant for this type of device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided. Adjudication methods are not applicable to the evaluation of a quality control material.
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 is not applicable to this device. This device is a 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 is not applicable to this device. This device is a control material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The concept of "ground truth" as it applies to an imaging or diagnostic algorithm is not relevant here. For a quality control material, the "ground truth" would be the assigned values (target concentrations) for each protein constituent within the control. These values are established through rigorous analytical testing during the manufacturing process, typically using reference methods or the specified analytical system (Boehringer Mannheim/Hitachi systems as mentioned in the "Indications for Use").
8. The sample size for the training set:
This information is not provided. The document doesn't describe a "training set" in the context of machine learning or algorithm development.
9. How the ground truth for the training set was established:
This information is not provided. As above, the concept of a "training set" and associated ground truth establishment is not relevant for this type of device.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.