(58 days)
A calcium test system is a device intended to measure the total calcium level in serum, plasma, and urine. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
Calcium is an in vitro diagnostic assay for the quantitation of Calcium in human scrum, plasma, or urine. Arscnazo-III dye reacts with calcium in an acid solution to form a blue-purple complex. The color developed is measured at 660 nm and is proportional to the calcium concentration in the sample.
The provided text describes the performance characteristics of the Abbott Laboratories Calcium assay (K062855) and its equivalence to a predicate device (Abbott Calcium assay, LN 7D61, K981578). This is an in vitro diagnostic assay, so the acceptance criteria and study data relate to analytical performance, not human-AI collaboration for image analysis.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" as a separate, pre-defined set of thresholds. Instead, it demonstrates performance by comparing it to a predicate device and showing acceptable correlation and precision. The "acceptance" is implicitly defined by the substantial equivalence to the predicate.
| Performance Metric | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (K062855) |
|---|---|---|
| Correlation Coefficient (AEROSET vs. Predicate) | High correlation (e.g., typically >0.97 for method comparison for clinical assays) | Serum: 0.9993 |
| Urine: 0.9994 | ||
| Slope (AEROSET vs. Predicate) | Close to 1.0 | Serum: 0.96 |
| Urine: 0.95 | ||
| Y-intercept (AEROSET vs. Predicate) | Close to 0 | Serum: 0.31 mg/dL |
| Urine: 0.17 mg/dL | ||
| Correlation Coefficient (ARCHITECT c8000 vs. Predicate) | High correlation | Serum: 0.9989 |
| Urine: 0.9986 | ||
| Slope (ARCHITECT c8000 vs. Predicate) | Close to 1.0 | Serum: 0.96 |
| Urine: 0.94 | ||
| Y-intercept (ARCHITECT c8000 vs. Predicate) | Close to 0 | Serum: 0.31 mg/dL |
| Urine: 0.17 mg/dL | ||
| Overall Precision (AEROSET, Serum) | (Not explicitly stated, but typically low CV) | Level 1: 1.01% CV |
| Level 2: 0.82% CV | ||
| Overall Precision (AEROSET, Urine) | (Not explicitly stated, but typically low CV) | Level 1: 0.74% CV |
| Level 2: 0.65% CV | ||
| Overall Precision (ARCHITECT c8000, Serum) | (Not explicitly stated, but typically low CV) | Level 1: 1.23% CV |
| Level 2: 0.95% CV | ||
| Overall Precision (ARCHITECT c8000, Urine) | (Not explicitly stated, but typically low CV) | Level 1: 0.72% CV |
| Level 2: 0.66% CV | ||
| Linearity (Serum) | Within 2 to 24 mg/dL | 2 to 24 mg/dL |
| Linearity (Urine) | Within 2 to 24 mg/dL | 2 to 24 mg/dL |
| Limit of Quantitation (Sensitivity, Serum) | (Not explicitly stated, but typically low) | 1.0 mg/dL |
| Limit of Quantitation (Sensitivity, Urine) | (Not explicitly stated, but typically low) | 1.0 mg/dL |
2. Sample size used for the test set and the data provenance
The document indicates "comparative performance studies were conducted" and "precision studies were conducted," but does not specify the sample sizes used for these studies. The data provenance (country of origin, retrospective/prospective) is also not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is an in vitro diagnostic assay that measures a chemical concentration. Therefore, the concept of "experts" and "ground truth" in the context of image analysis or diagnostic interpretation by human readers does not apply. The ground truth for such devices is typically established through reference methods or by comparison to legally marketed predicate devices, which is the case here.
4. Adjudication method for the test set
Not applicable, as this is an in vitro diagnostic device measuring a chemical concentration, not a subjective interpretation requiring adjudication of expert opinions.
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 is an in vitro diagnostic device, not an AI-assisted diagnostic tool for human readers interpreting images or other data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance evaluation was done for the device (K062855) by comparing its results directly against the predicate device (K981578) and also between the two systems (AEROSET and ARCHITECT c8000). The reported performance characteristics (correlation, slope, Y-intercept, precision, linearity, sensitivity) reflect the algorithm's performance in quantitating Calcium. There is no human-in-the-loop component for this type of device.
7. The type of ground truth used
The ground truth was established by:
- Comparison to a Legally Marketed Predicate Device: The performance of the new Calcium assay (K062855) was compared directly to "the Abbott Calcium assay, LN 7D61, (K981578) on the AEROSET and ARCHITECT c8000 Systems (Predicate Device)." This means the established performance of the predicate served as the reference for determining substantial equivalence.
8. The sample size for the training set
The document does not mention a training set or any machine learning/AI components. For a traditional in vitro diagnostic assay, there isn't a "training set" in the sense of AI model development. The assay's parameters would have been optimized during its development, but this process is not detailed here.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set for an AI model. For the development of the assay itself, the ground truth would typically be established through rigorous analytical chemistry principles and potentially reference methods, but this information is not provided in the summary.
§ 862.1145 Calcium test system.
(a)
Identification. A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).(b)
Classification. Class II.