(138 days)
The CEDIA Cardiac TDM Multi-Cals are used to calibrate the CEDIA assays for digoxin, N-acetylprocainamide, and procainamide, in human serum and plasma.
The CEDIA Cardiac TDM Calibrators are manufactured using bovine serum albumin, digoxin, N-acetylprocainamide, procainamide, stabilizers, and preservatives. The drugs are appropriately spiked into the calibrator matrix to the correct calibrator concentration levels. The calibrators are in process checked and quality controlled against in-house reference calibrators (prepared using a similar procedure) which have been value assigned by comparison to the predicate device to ensure correct assay calibration.
The provided text is a 510(k) Summary for the CEDIA Cardiac TDM Multi-Cals, which are calibrators for therapeutic drug monitoring assays. This document focuses on demonstrating substantial equivalence to predicate devices, not on the performance of a diagnostic device that detects or measures a condition. Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance (like sensitivity, specificity, or human reader improvement with AI) are not applicable to this type of submission.
However, I can extract the relevant information regarding the "performance characteristics" and the comparison to predicate devices, which serve as the "acceptance criteria" for a calibrator.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
For calibrators, performance is primarily assessed by their ability to provide equivalent calibration to existing, approved calibrators. The key acceptance criterion is "equivalent correlation" between the new calibrators and the predicate device's calibrators.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Equivalent correlation between: | Achieved: "equivalent correlation between predicate device kit calibrators and CEDIA Cardiac TDM Multi-Cals." |
| - CEDIA Cardiac TDM Multi-Cals | |
| - Predicate device kit calibrators for: | |
| - Digoxin (K910642) | |
| - Procainamide (K834464) | |
| - N-acetylprocainamide (K830206) |
2. Sample size used for the test set and the data provenance
The document states, "Specific data on the performance of the test have been incorporated into the draft labeling in attachment 5." However, the actual sample size, details on the test set, and data provenance (e.g., country of origin, retrospective/prospective) are not provided in the excerpt.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. For calibrators, "ground truth" is typically defined by reference methods or established values, not expert consensus in the same way it would be for a diagnostic image or clinical finding. The calibrators are "value assigned by comparison to the predicate device."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not provided. This concept is generally used in studies involving human interpretation or subjective assessments, which is not the primary focus of calibrator validation.
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
No. This is not an AI device, nor is it a diagnostic device that humans interpret. Therefore, an MRMC study and AI assistance effect size are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in essence. The testing of the calibrators themselves against predicate calibrators constitutes a "standalone" evaluation of their performance in achieving equivalent calibration. There is no "human-in-the-loop" component in the calibrator's function itself. The calibrator's performance is objective against an established reference.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the CEDIA Cardiac TDM Multi-Cals is established by comparison to the predicate device's kit calibrators. The predicate calibrators themselves would have had their values established through validated analytical methods and reference standards. The document states the new calibrators "have been value assigned by comparison to the predicate device to ensure correct assay calibration."
8. The sample size for the training set
Not applicable/Not provided. This is not a machine learning or AI device that requires a training set. The calibrators are manufactured reagents.
9. How the ground truth for the training set was established
Not applicable/Not provided. As stated above, there is no training set for this type of device.
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| K962269 | OCT 29 1996 | ||
|---|---|---|---|
| 510(k) Summary | |||
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence. | ||
| 1.Submittername,address,contact | Boehringer Mannheim Corporation2400 Bisso LaneConcord, CA 94524-4117(510) 674-0690 extension 8415 | ||
| Contact Person: Mary KoningDate Prepared: October 25, 1996 | |||
| 2.Device name | Proprietary name: CEDIA Cardiac TDM Multi-CalsCommon name: Therapeutic drug monitoring calibrators for use in thecalibration of the CEDIA assays for digoxin, N-acetylprocainamide, andprocainamide. | ||
| Classification name: Calibrators, drug mixture | |||
| 3.Predicatedevice | The Boehringer Mannheim CEDIA Cardiac TDM Multi-Cals aresubstantially equivalent to the kit calibrators included in CEDIA Digoxin(K910642), TDx Procainamide (K834464), and TDx N-acetylprocainamide(K830206) Assays. | ||
| 4.DeviceDescription | The CEDIA Cardiac TDM Calibrators are manufactured using bovine serumalbumin, digoxin, N-acetylprocainamide, procainamide, stabilizers, andpreservatives. The drugs are appropriately spiked into the calibrator matrixto the correct calibrator concentration levels. The calibrators are in processchecked and quality controlled against in-house reference calibrators (preparedusing a similar procedure) which have been value assigned by comparison tothe predicate device to ensure correct assay calibration. | ||
| 5.Intended use | The CEDIA Cardiac TDM Multi-Cals are used to calibrate the CEDIAassays for digoxin, N-acetylprocainamide, and procainamide, in human serumand plasma. | ||
| 6.Comparisonto predicatedevice | The Boehringer Mannheim CEDIA Cardiac TDM Multi-Cals aresubstantially equivalent to the kit calibrators included in CEDIA Digoxin(K910642), TDx Procainamide (K834464), and TDx N-acetylprocainamide(K830206) Assays. | ||
| The following table compares the CEDIA Cardiac TDM Multi-Cals with thepredicate devices, CEDIA Digoxin, TDx Procainamide, and TDx N-acetylprocainamide assay's kit calibrators. Specific data on the performanceof the test have been incorporated into the draft labeling in attachment 5.Labeling for the predicate device in provided in attachment 6. | |||
| Similarities: |
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510(k) Summary, Continued
· Similar concentrations of digoxin, N-acetylprocainamide, and procainamide.
Differences:
| Feature | Cardiac TDM Multi-Cals | Kit Calibrators |
|---|---|---|
| Configuration | sold separately from reagents | sold with reagents in kit |
| Number of calibrators inset (N-acetylprocainamide,Procainamide) | 2 | 6 |
| Matrix | Bovine Serum Albumin | Human Serum |
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510(k) Summary, Continued
Performance Characteristics: 6. Comparison to predicate device, (cont.)
· Method Comparison: equivalent correlation between predicate device kit calibrators and CEDIA Cardiac TDM Multi-Cals.
§ 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.