(25 days)
The LOCI NTP CAL is an in vitro diagnostic product for the calibration of the Nterminal pro-brain natriuretic peptide (NTP Cat. No. RF623) method on the Dimension® EXL™ integrated chemistry system with LOCI® Module.
The LOCI NTP CAL is a frozen liquid product containing synthetic human N-terminal pro-brain natriuretic peptide in bovine albumin matrix with stabilizers and preservative. The kit consists of ten vials, two vials per level (A, B, C, D, and E), 1.0 mL per vial.
The provided document is a 510(k) summary for a calibrator device, not a diagnostic device that performs a clinical assessment. Therefore, the typical acceptance criteria and study designs described for diagnostic or AI-powered devices (such as sensitivity, specificity, MRMC studies, or multi-reader studies) are not applicable here.
The document primarily focuses on demonstrating substantial equivalence to an existing predicate device by comparing the product's features and intended use. The "performance" in this context refers to the calibrator's ability to provide accurate values for the calibration of a specific N-terminal pro-brain natriuretic peptide (NTP) method.
Here's an analysis based on the information provided, tailored to a calibrator device:
1. Table of Acceptance Criteria and the Reported Device Performance:
The document does not explicitly state quantitative "acceptance criteria" in terms of performance metrics like accuracy, precision, or detection limits for the calibrator itself, as one might for a diagnostic assay. Instead, the primary "acceptance criterion" for this 510(k) submission is substantial equivalence to the predicate device.
| Feature/Criterion | Predicate Device (Dimension Vista® PBNP Flex® Calibrator (KC676A)) | Reported Performance (LOCI NTP CAL - RC623) | Notes/Comparison |
|---|---|---|---|
| Intended Use | Calibration of PBNP method on Dimension Vista® System. | Calibration of NTP method on Dimension® EXL™ integrated chemistry system with LOCI® Module. | Although the specific systems differ, the core intended use (calibration of similar analytes) is deemed substantially equivalent. |
| Analyte | Synthetic PBNP | Synthetic PBNP | Identical. |
| Matrix | Bovine Albumin | Bovine Albumin | Identical. |
| Form | Liquid, frozen | Liquid, frozen | Identical. |
| Volume | Ten vials, two vials per level (A, B, C, D, and E), 1.0 mL per vial. | Ten vials, two vials per level (A, B, C, D, and E), 1.0 mL per vial. | Identical. |
| Levels | Five Levels (0, 250, 1500, 12,000, 36,750 pg/mL) | Five Levels (0, 250, 1500, 12,000, 36,750 pg/mL) | Identical. |
| Overall Performance | Cleared under K080578, implying its performance met regulatory standards for a calibrator. | "Comparative testing described in the protocol included in this submission demonstrates substantial equivalent performance." | The submission asserts that the new device performs equivalently to the predicate based on unspecified "comparative testing." Details of this testing are not provided in the summary. |
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not provide details on the sample size used for any "test set" in the traditional sense of evaluating a diagnostic algorithm. For a calibrator, "testing" would involve evaluating its stability, accuracy of assigned values, and its ability to properly calibrate the associated assay. The summary mentions "Comparative testing described in the protocol included in this submission," but no specific sample sizes or data provenance (e.g., country of origin, retrospective/prospective) are given for this testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This is not applicable for a calibrator device. Ground truth, in the context of clinical diagnostics, refers to definitive patient diagnoses or outcomes. For a calibrator, the "truth" is its assigned value, which is determined through a manufacturing and value assignment process, not by expert consensus on clinical cases.
4. Adjudication Method for the Test Set:
This is not applicable for a calibrator device. Adjudication methods like 2+1 or 3+1 are used to resolve discrepancies among expert readers in diagnostic studies.
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 as the device is a calibrator, not a diagnostic or AI-powered system that human readers would use or interact with.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable as the device is a calibrator, and there is no "algorithm" in the sense of a standalone diagnostic or interpretative system. Its performance is tied directly to its chemical and physical properties and its ability to correctly standardize an assay.
7. The Type of Ground Truth Used:
For a calibrator, the "ground truth" is its assigned value (e.g., specific concentrations of NTP). This is established through rigorous analytical methods (e.g., gravimetric preparation, reference methods, or comparison to established reference materials) during the manufacturing and value assignment process, not through expert consensus, pathology, or outcomes data in the clinical sense. The document states "Description of the manufacturing, value assignment and stability testing process are provided in this submission report," indicating that these processes define the "truth" of the calibrator.
8. The Sample Size for the Training Set:
This is not applicable. Calibrators are not "trained" like machine learning algorithms. Their properties are determined during manufacturing and quality control.
9. How the Ground Truth for the Training Set Was Established:
This is not applicable. There is no "training set" for a calibrator. The "truth" of its assigned values is established through the analytical and quality control processes mentioned above (manufacturing, value assignment, stability testing).
§ 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.