(29 days)
The Ischemia ACB® Assay Verification Set is intended for use in verifying accuracy of the ACB Test on the Roche Integra 700/800. It is recommended as a part of assay installation. For In Vitro Diagnostic Use.
The Assay Verification Set consists of twenty (20) single vial 0.5 mL aliquots of frozen serum based samples with assigned IMA values over the physiological range.
This looks like a submission for a "Quality Control Material" device, not an AI or imaging device. The provided text describes a verification set for an assay, which is a laboratory test. Therefore, many of the requested fields are not applicable to this type of device.
However, I can extract the relevant information where possible:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state formal "acceptance criteria" with numerical targets for the Assay Verification Set itself. Instead, it describes its intended use for verifying the accuracy of another device (the ACB Test) and its characteristics.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use | The Ischemia ACB® Assay Verification Set is intended for use in verifying accuracy of the ACB Test on the Roche Integra 700/800. It is recommended as a part of assay installation. For In Vitro Diagnostic Use. |
| Technological Characteristics | The Assay Verification Set consists of twenty (20) single vial 0.5 mL aliquots of frozen serum based samples with assigned IMA values over the physiological range. |
| Evaluation Purpose | The Assay Verification Set was evaluated for expiry date and for range setting values. |
| Evaluation Location | Internally and at multiple clinical sites. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: The device itself is the "test set" and consists of "twenty (20) single vial 0.5 mL aliquots of frozen serum based samples."
- Data provenance: Not specified, but the evaluation was done "internally and at multiple clinical sites."
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. This device is a quality control material with "assigned IMA values." These values are likely laboratory-derived and not based on expert consensus in the way a diagnostic imaging device would be.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. "Adjudication" typically refers to the process of resolving disagreements among experts when establishing ground truth, which is not relevant for a quality control material with assigned values.
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 or imaging device 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 device is a quality control material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for this device is described as "assigned IMA values over the physiological range." This implies laboratory-determined values for the components of the serum samples.
8. The sample size for the training set
Not applicable. This device is a quality control material, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this device does not have a training set in the context of machine learning.
§ 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.