(25 days)
The DOCUMENT® Salicylate CAL•VER® solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification, verification of Analytical Measurement Range (AMR) and verification of the reportable range on immunochemistry and clinical chemistry systems for salicylate. Multiple levels are provided to establish the linear relationship between theorctical operation and actual performance. There exists a linear relationship among each of the solutions.
The DOCUMENT® Salicylate CAL•VER® set consists of 5 levels of solutions containing salicylate - Levels 1 through 5 - with concentrations ranging between 0 to approximately 100 mg salicylate/dL. The base matrix for these solutions is human serum with preservatives added for stability.
The provided text describes a 510(k) summary for the DOCUMENT® Salicylate CAL•VER® kit, which is a quality control material. This type of device does not typically involve the kinds of studies (e.g., clinical trials, AI performance studies, human reader studies) that would have acceptance criteria and performance metrics in the way a diagnostic imaging device or an AI algorithm would.
The submission focuses on demonstrating substantial equivalence to a predicate device (DOCUMENT® Thyroid CAL•VER® kit, K992034) based on intended use and physical properties. There are no performance characteristics for the device itself that would require a study as described in the prompt's requirements (e.g., accuracy, sensitivity, specificity of an algorithm). The device is a calibration verification material, not a diagnostic tool that produces clinical results.
Therefore, many of the requested items are not applicable to this specific device submission. I will address the relevant points based on the provided text, and explicitly state where information is not available or not applicable.
1. Table of acceptance criteria and the reported device performance
For this type of device (calibration verification material), the "performance" is implicitly its ability to fulfill its intended use (linearity, calibration verification) and its physical characteristics matching the predicate. The "acceptance criteria" for regulatory clearance are based on demonstrating substantial equivalence.
| Acceptance Criteria Category | Specific Criteria (Implicit for Substantial Equivalence) | Reported Device Performance / Characteristics (from comparison table) |
|---|---|---|
| Intended Use | Intended use aligns with predicate device type (in vitro diagnostic for quantitative determination of linearity, calibration verification, etc.). | Subject Device: In vitro diagnostic use in the quantitative determination of linearity, calibration verification, verification of Analytical Measurement Range (AMR), and verification of the reportable range on immunochemistry and clinical chemistry systems for salicylate. Multiple levels provided to establish linear relationship. |
| Predicate Device (K992034): Assayed solutions for in vitro diagnostic use in quantitative determination of linearity, calibration verification, and verification of reportable range on immunochemistry and clinical chemistry systems for specific analytes (T4, T3, TSH). | ||
| Analytes | Analytes are specified and appropriate for the intended purpose. | Subject Device: Salicylate |
| Predicate Device: Thyroxine (T4), Triiodothyronine (T3), Thyroid Stimulating Hormone (TSH) | ||
| Matrix | Matrix is appropriate and similar to predicate. | Subject Device: Human Serum |
| Predicate Device: Human Serum | ||
| Control Form | Physical form is appropriate and similar to predicate. | Subject Device: Liquid |
| Predicate Device: Liquid | ||
| Control Levels | Number and range of levels are suitable for linearity and calibration verification. | Subject Device: Five target levels ranging from 0 to approximately 100 mg/dL. |
| Predicate Device: Eight levels across the reportable range. | ||
| Storage & Stability | Storage conditions and stability are appropriate for the shelf-life claimed. | Subject Device: 2°C to 8°C until expiration date, noted on vial label. |
| Predicate Device: 2°C to 8°C until expiration date, noted on vial label. | ||
| Safety and Effectiveness | The device is safe and effective for its stated intended use, equivalent to a legally marketed predicate. (This is the overarching regulatory acceptance criterion). | "The information supplied in this pre-market notification provides reasonable assurance that DOCUMENT® Salicylate CAL • VER® kit is safe and effective for its stated intended use." (from Section II, Summary) |
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 applicable as there is no "test set" in the context of clinical studies or AI algorithm validation described for this type of device. The submission focuses on demonstrating substantial equivalence through comparison of characteristics to a predicate 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 applicable. The device is a quality control material; its intended use does not involve a diagnostic 'test set' that requires expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. See point 3.
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 information is not applicable. The device is a quality control solution, not an AI-based diagnostic tool, and therefore no MRMC studies or human reader performance analyses were conducted or are relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is not an algorithm or an AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable. As a calibration verification material, the "ground truth" relates to the assigned values of the salicylate concentrations within the control solutions, which would typically be established through highly accurate reference methods, not expert consensus on pathology, outcomes, etc. The document does not detail how these salicylate concentrations were assigned or verified, beyond stating they "consist of 5 levels of solutions containing salicylate" and "There exists a linear relationship among each of the solutions."
8. The sample size for the training set
This information is not applicable. The device is not learning-based and does not have a "training set."
9. How the ground truth for the training set was established
This information is not applicable. As there is no training set, there is no ground truth establishment for one.
§ 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.