(239 days)
Diamond Calibrators for Medica ISE Modules are intended for in-vitro diagnostics use to provide calibration points for the Na *, K , and Ci electrodes on the Poly-Chem and Randox Daytona instruments having the Medica ISE Module.
Diamond Calibrant A matrix consists of a buffered solution of electrolytes and preservative. It contains no human or biological materials. It is packaged in a foil bag with a draw tube and covered in a corrugated box. Each foil bag contains 500 ml of solution.
Diamond Calibrant B matrix consists of a buffered solution of electrolytes and preservative. It contains no human or biological materials. It is packaged in a plastic bottle with a cap. Each plastic bottle contains 125 ml of solution.
Here's a breakdown of the acceptance criteria and the study information for the Diamond Calibrators for Medica ISE Module, based on the provided text:
Acceptance Criteria and Reported Device Performance
The core acceptance criteria for these calibrators revolve around their ability to provide accurate calibration points for Na+, K+, and Cl- electrodes, effectively performing equivalently to the predicate device. The values for Calibrant A and B are explicitly stated:
| PN | ISE Module Calibrator | Na+ (mmol/L) | K+ (mmol/L) | Cl- (mmol/L) |
|---|---|---|---|---|
| ME-6370D | A | $140 \pm 2.0$ | $4.00 \pm 0.05$ | $125 \pm 2$ |
| ME-5410D | B | $70 \pm 1.5$ | $8.0 \pm 0.08$ | $41 \pm 1.5$ |
Reported Device Performance:
The summary states: "Results show equivalent performance for Na+, K+, and Cl calibration and precision. The devices show good correlation." This indicates that the Diamond Calibrators met the objective of providing calibration points within acceptable limits and demonstrating similar precision to the predicate device. While specific measured values are not provided in this summary, the declaration of "equivalent performance" and "good correlation" implies that the new device's output falls within the expected ranges and performs comparably to the predicate.
Study Details:
Based on the provided text, the study conducted is focused on demonstrating substantial equivalence to an existing predicate device rather than an independent standalone performance study or a comparative effectiveness study with human readers.
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The text mentions "Calibrators for Medica ISE Module were tested side by side with the predicate device on the Poly-Chem Dallrona Galleralyzer and Randox Daytona instruments." This implies multiple test runs or samples, but the exact number is not quantified.
- Data Provenance: Not explicitly stated. However, given it's a 510(k) submission from a US company (Holliston, MA), it's highly likely the testing was conducted in the US. The time frame (October 2009 submission) suggests prospective testing for this specific submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable and not provided as this is a chemical calibrator, not an imaging or diagnostic device requiring expert interpretation of results to establish ground truth. The "ground truth" for calibrators is their known chemical composition and the accuracy of the measurements they enable on an instrument.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable and not provided. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, which is not the case for a chemical calibrator. The performance here is objectively measured by the instrument.
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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:
- No, an MRMC comparative effectiveness study was not done. This type of study is completely irrelevant for a chemical calibrator. The device described is not an AI-assisted diagnostic tool that aids human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone (algorithm-only) performance study was not done in the context of AI. However, the study essentially functions as an instrument-based standalone performance study for the calibrators. The "algorithm" here is the chemical process and the instrument's measurement system. The calibrators themselves were tested "side by side with the predicate device on the Poly-Chem Dallrona Galleralyzer and Randox Daytona instruments." This represents the performance of the calibrators as measured by the instrument, without human intervention in the measurement process itself, beyond operating the analyzer.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the calibrators is their certified chemical concentrations (e.g., $140 \pm 2.0$ mmol/L for Na+ in Calibrant A). These are established through precise manufacturing and analytical chemistry methods. The "ground truth" during the comparison study would be the expected values on the instruments when calibrated correctly, as confirmed by the predicate device's performance.
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The sample size for the training set:
- This is not applicable and not provided. This device is a chemical calibrator, not a machine learning algorithm that requires a "training set."
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How the ground truth for the training set was established:
- This is not applicable as there is no "training set" for this type of device. The ground truth for the calibrators themselves is established through their precise formulation and analytical verification during manufacturing.
§ 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.