(260 days)
Diamond Diagnostics ATAC 8000/Envoy 500 ISE calibrators are intended to provide calibration points for the Na+, K+, Cl-, and CO2 electrodes on the ATAC 8000 and Envoy 500 instruments.
Diamond Diagnostics ATAC 8000/Envoy 500 ISE Calibrators are intended to serve as a direct replacement to ATAC 8000/Envoy 500 ISE Calibrators. Diamond Calibrator Low consists of an aqueous buffered solution of electrolytes and preservative in De-ionized water. It contains NO human or animal products. It is a liquid packaged in a 22ml screw top amber vial. Each vial contains 20 ml of solution. Diamond Calibrator High consists of an aqueous buffered solution of electrolytes and preservative in De-ionized water. It contains NO human or animal products. It is a liquid packaged in a 22ml screw top amber vial. Each vial contains 20 ml of solution.
The provided text describes a 510(k) summary for a medical device (calibrators) and does not contain information about studies proving the device meets acceptance criteria in the manner expected for diagnostic algorithms or imaging devices. The acceptance criteria and "device performance" in this context refer to the established concentration ranges for the analytes within the calibrator solutions. The "study" here is a stability test and analytical testing to verify the stated concentrations and demonstrate substantial equivalence, rather than a clinical performance study with patient data.
Here's the information extracted and formatted, with explanations for where certain requested details are not applicable to this type of device submission:
Acceptance Criteria and Reported Device Performance
| Analyte | Acceptance Criteria (Target Value ± Standard Deviation) | Reported Device Performance (as stated in the 510(k) summary) |
|---|---|---|
| Low Calibrator | ||
| Na+ (mmol/L) | 3.05 ± 0.05 | Not explicitly stated as "reported performance" but this is the target/specification for the product. |
| K+ (mmol/L) | 10.2 ± 0.1 | Not explicitly stated as "reported performance" but this is the target/specification for the product. |
| Cl- (mmol/L) | 78 ± 2 | Not explicitly stated as "reported performance" but this is the target/specification for the product. |
| CO2 (mmol/L) | 11 ± 1 | Not explicitly stated as "reported performance" but this is the target/specification for the product. |
| High Calibrator | ||
| Na+ (mmol/L) | 126 ± 1 | Not explicitly stated as "reported performance" but this is the target/specification for the product. |
| K+ (mmol/L) | 92 ± 2.0 | Not explicitly stated as "reported performance" but this is the target/specification for the product. |
| Cl- (mmol/L) | 162 ± 1.0 | Not explicitly stated as "reported performance" but this is the target/specification for the product. |
| CO2 (mmol/L) | 34.5 ± 1 | Not explicitly stated as "reported performance" but this is the target/specification for the product. |
Note on "Reported Device Performance": For calibrators, "performance" is typically defined by the accuracy and stability of the analyte concentrations within the specified ranges. The 510(k) summary states that "Target values, (or specifications) were obtained by testing reagents analytically prior to bottling, adjusting if necessary to meet specifications, testing analytically during the bottling process and prior to release to stock for distribution." This implies that the device meets these target values as part of its manufacturing and quality control process. The stability study further supports that these values are maintained over time.
Study Details
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document does not explicitly state a "test set" sample size in terms of clinical subjects or a specific number of calibrator units tested.
- The "test" here involves analytical testing of the calibrator solutions themselves.
- Data provenance: Not specified in terms of country, but it's an in-vitro diagnostic device manufactured by Diamond Diagnostics Inc. in Holliston, MA. The testing is analytical, not clinical, so retrospective/prospective does not apply in the typical sense.
-
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. For a calibrator device, the "ground truth" for the analyte concentrations is established through analytical methods using NIST standards, not through expert human interpretation.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. "Adjudication" typically refers to resolving disagreements among human readers in a clinical study. Here, the "truth" is determined by reference analytical methods.
-
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 calibrator, not an AI-powered diagnostic algorithm. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The device itself is a standalone calibrator solution. Its "performance" is its ability to accurately provide known concentrations for instrument calibration.
- The "study" supporting this involved:
- Stability testing: "Accelerated (high temperature) stress test was conducted to support stability claim. Heat stressed reagents showed that calibrator parameters remained within specification thereby demonstrating stability equivalent to ATAC 8000 calibrators." This is a standalone performance test of the calibrator's chemical integrity over time.
- Traceability and Analytical Testing: Analytes were determined using NIST standards (NIST 919a, 918a, 351). Instruments used for verification included IL 943 (Flame Photometry for Na, K), Corning 925, SAT-500 Salt Analyzer (Titrimetric for Cl), and Hitachi 912, Olympus-Beckman CX-7 (for CO2). This constitutes the direct analytical performance demonstration.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Reference Standards / Analytical Methods: The ground truth for the analyte concentrations (Na+, K+, Cl-, CO2) was established using certified National Institute of Standards and Technology (NIST) reference materials and validated reference analytical methods (Flame Photometry, Titrimetry).
-
The sample size for the training set:
- Not applicable. This device is not an AI algorithm that requires a "training set."
-
How the ground truth for the training set was established:
- Not applicable. This device is not an AI algorithm. The ground truth for the calibrator's analyte concentrations is established during its manufacturing and quality control process using NIST-traceable standards and analytical methods, as described in point 6.
§ 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.