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510(k) Data Aggregation
(24 days)
The CEDIA Digoxin Calibrators are used to calibrate the CEDIA Digoxin II assay on the Synchron. The CEDIA Digoxin Calibrators are used to determine drug concentrations.
The CEDIA Digoxin Calibrators are manufactured using bovine serum albumin, digoxin, stabilizers, and preservatives. The drug is 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 regulatory document describes the Boehringer Mannheim Corporation's CEDIA Digoxin Calibrators and their substantial equivalence to a predicate device. It does not contain information related to acceptance criteria, specific device performance statistics, or details of a study meeting such criteria with the level of detail requested in the prompt. The document is primarily a 510(k) summary for a diagnostic device, focusing on its intended use, comparison to a predicate, and performance characteristics in terms of method correlation and stability relative to the predicate.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from the provided text.
However, I can extract the information that is present:
No specific acceptance criteria or detailed device performance statistics are provided in the document beyond a qualitative statement of equivalence to a predicate device.
1. A table of acceptance criteria and the reported device performance
Not available in the provided text. The document only states:
- "Method Comparison: equivalent correlation between predicate device Multi-Calibrators and the CEDIA Digoxin Calibrators."
- "Stability: equivalent open vial and shelf-life stability performance to the predicate device."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not available in the provided text.
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)
Not applicable. This is a calibrator for an in vitro diagnostic device, not an imaging or diagnostic AI device that would typically involve expert ground truth for interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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
Not applicable. This is a calibrator for an in vitro diagnostic device, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a calibrator for an in vitro diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not explicitly stated for the "equivalent correlation" or "equivalent stability" studies, but for calibrators, the "ground truth" would typically involve established reference methods or traceable standards for digoxin concentration. The document mentions "in-house reference calibrators (prepared using a similar procedure) which have been value assigned by comparison to the predicate device."
8. The sample size for the training set
Not applicable. This is not an AI/ML device that uses a training set.
9. How the ground truth for the training set was established
Not applicable.
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(72 days)
The CEDIA Digoxin II homogeneous enzyme immunoassay is for the quantitation of digoxin in human serum or plasma using automated clinical chemistry analyzers. Measurements are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure proper therapy.
The CEDIA® Digoxin II Assay is based on the bacterial enzyme ßgalactosidase, which has been genetically engineered into two inactive fragments. These fragments spontaneously reassociate to form fully active enzyme that, in the assay format, cleaves a substrate, generating a color change that can be measured spectrophotometrically. In the assay, digoxin in the sample competes with analyte conjugated to one inactive fragment of B-galactosidase for antibody binding site. If analyte is present in the sample, it binds to antibody, leaving the inactive enzyme fragments free to form active enzyme. If analyte is not present in the sample, antibody binds to analyte conjugated on the inactive fragment, inhibiting the reassociation of inactive ß-galactosidase fragments, and no active enzyme is formed.
The presented document is a 510(k) Summary for the CEDIA® Digoxin II Assay. It describes the device, its intended use, and compares its performance characteristics to a predicate device, the Abbott TDx® Digoxin II Assay.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as distinct acceptance thresholds (i.e., "the device must achieve X performance"). Instead, the performance of the CEDIA® Digoxin II Assay is compared directly to the predicate device, the Abbott TDx® Digoxin II Assay, implying that substantial equivalence to the predicate's performance is the overarching acceptance criterion.
| Feature | Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (CEDIA® Digoxin II) |
|---|---|---|
| Precision | Modified NCCLS (ng/mL): | |
| Level 1 | Within run %CV: 5.75, Total %CV: 7.67 | Within run %CV: 4.25, Total %CV: 5.44 |
| Level 2 | Within run %CV: 3.15, Total %CV: 3.98 | Within run %CV: 2.22, Total %CV: 3.58 |
| Level 3 | Within run %CV: 1.87, Total %CV: 1.91 | Within run %CV: 1.56, Total %CV: 2.34 |
| Lower Detection Limit | 0.2 ng/mL | 0.15 ng/mL |
| Linearity Range | 0.0 - 4.0 ng/mL | 0.15 - 4 ng/mL |
| Method Comparison | ||
| vs Abbott TDx Digoxin | (Implied high correlation) | y = 0.94x + 0.08, r = 0.962 (N=200) |
| vs Baxter Dade Stratus | (Implied high correlation) | y = 0.98x - 0.12, r = 0.955 (N=99) |
| Deming's: y = 1.02x - 0.17, r = 0.955 (N=99) | ||
| Interfering Substances | No interference at (within ±10% of baseline): | |
| Bilirubin | 20 mg/dL | 66 mg/dL |
| Hemoglobin | 1000 mg/dL | 1000 mg/dL |
| Triglyceride Lipemia | 2500 mg/dL | 100 mg/dL |
| Total Protein | N/A (not provided for predicate) | 10 g/dL |
| Rheumatoid Factor | N/A (not provided for predicate) | 100 IU/mL |
| Specificity (% Cross-reactivity) | ||
| Digoxigenin | up to 200 | 60.5 |
| β-Acetyldigoxin | not tested | 77.0 |
| α-Acetyldigoxin | not tested | 75.3 |
| Gitalin | not tested | 2.1 |
| Digoxingenin-Mono-Digitoxiside | up to 200 | 102.5 |
| Digitoxin-Bis-Digitoxiside | up to 200 | 86.3 |
| Digitoxin | up to 200 | 1.5 |
| β-Methyldigoxin | 4.8 | 76.3 |
| 3-Epe-Digoxigenin | not tested | 37.6 |
| 3-Dehydrodigoxigenin | not tested | 82.6 |
| Epi-Digoxigenin-Glucuronide | not tested | 42.9 |
2. Sample Sizes Used for the Test Set and Data Provenance
- Precision Test Set N: 120 for each of 3 levels (Level 1, Level 2, Level 3). (Total 360 individual measurements for precision, but N refers to the number of individual tests run for each level.)
- Method Comparison Test Set N:
- Vs Abbott TDx Digoxin: N=200
- Vs Baxter Dade Stratus: N=99
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). The samples are referred to as "human serum and plasma."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of experts being used to establish ground truth for this diagnostic assay. The "ground truth" for quantitative assays like this is typically established by comparative analysis against established, often reference, methods or instruments.
4. Adjudication Method for the Test Set
Not applicable. As this is an in vitro diagnostic (IVD) assay for quantitative determination, there is no mention of adjudication by human readers/experts for the test results. The device's output is a quantitative value, not subject to interpretation needing adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document describes an in vitro diagnostic (IVD) assay, not an imaging device or AI algorithm intended for human-in-the-loop interpretation that would typically involve an MRMC study.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)
Yes, the performance characteristics presented (precision, linearity, detection limit, method comparison, interfering substances, specificity) represent the standalone performance of the CEDIA® Digoxin II Assay. There is no human-in-the-loop component mentioned in its operation for these performance metrics.
7. Type of Ground Truth Used
The "ground truth" for the performance studies appears to be based on:
- Reference Methods/Predicate Devices: For method comparison, the results of the CEDIA® assay were compared against the Abbott TDx® Digoxin II Assay and the Baxter Dade Stratus, which serve as reference or predicate methods.
- Standard Spiked Samples: For parameters like precision, linearity, and detection limit, it is implied that samples with known concentrations of digoxin were used, or that the "levels" described were standardized reference materials.
- Known Concentrations of Interfering Substances: For interference and specificity studies, substances were tested at known concentrations.
8. Sample Size for the Training Set
The document does not specify a separate "training set" or its size. This is common for traditional in vitro diagnostic assays that are developed using biochemical principles rather than machine learning algorithms requiring explicit training data. The development and optimization process itself serves a similar function to "training," but it doesn't involve a distinct, quantifiable training set in the machine learning sense.
9. How the Ground Truth for the Training Set Was Established
As there is no explicit "training set" mentioned in the context of machine learning, this question is not directly applicable. The device's underlying principles are based on enzyme immunoassay chemistry, where performance is optimized through reagent formulation and assay design, not by training on a labeled dataset.
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(65 days)
Immunoassay for the in vitro quantitative determination of Digoman serum and plasma.
Homogeneous enzyme immunoassay for the determination of Digoxin.
The acceptance criteria and study proving the device meets them are described below for the CEDIA Digoxin Assay.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" but rather a "Comparison to predicate device" which contains performance characteristics of the CEDIA Digoxin Assay and the predicate device (Abbott TDx® Digoxin II Assay). The acceptance criteria for substantial equivalence are implicitly linked to demonstrating comparable performance to the predicate device.
| Feature | Acceptance Criteria (Implicit - based on Predicate Device) | Reported Device Performance (CEDIA® Digoxin) |
|---|---|---|
| Precision (Within run) | Comparable to TDx Digoxin II (e.g., %CV ~0.96) | Least Squares: y = 0.97x - 0.17, r = 0.9667 (N=99) |
| Deming's: y = 1.00x - 0.22, r = 0.9667 (N=99) | ||
| Interfering Substances | No significant interference at specified levels | Bilirubin (66 mg/dL): No interference |
| Hemoglobin (1000 mg/dL): No interference | ||
| Triglyceride Lipemia (100 mg/dL): No interference | ||
| Total Protein (10 g/dL): No interference | ||
| Rheumatoid Factor (100 IU/mL): No interference | ||
| Specificity (% Cross-reactivity) | Acceptable cross-reactivity profile | Digoxigenin: 59.3%, B-Acetyldigoxin: 71.3%, etc. (detailed in image) |
2. Sample Sizes Used for the Test Set and Data Provenance
- Precision: For "Within run" and "Total" precision, N=120 samples were used for each of three levels (Level 1, Level 2, Level 3) for the CEDIA Digoxin assay. The document does not specify the provenance (e.g., country of origin) or whether the data was retrospective or prospective.
- Method Comparison: N=99 samples were used for the method comparison study against the Abbott TDx Digoxin. The document does not specify the provenance or whether the data was retrospective or prospective.
- Interfering Substances & Specificity: The document does not explicitly state the sample sizes for these tests, implying they were conducted with an appropriate number of samples to demonstrate the stated performance. The provenance and data type are not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable to an in vitro diagnostic (IVD) assay like the CEDIA Digoxin Assay. Ground truth for such devices is established through laboratory analyses and reference methodologies, not expert consensus in the way clinical image interpretation studies might use radiologists.
4. Adjudication Method for the Test Set
This is not applicable to an IVD assay. Performance is determined by direct comparison to reference methods or to the predicate device's measured performance characteristics.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
This is not applicable as the device is an in vitro diagnostic assay, not an imaging device requiring human reader interpretation. No MRMC study was conducted.
6. If a Standalone (Algorithm Only) Performance Study Was Done
The performance characteristics presented (Precision, Lower Detection Limit, Linearity, Method Comparison, Interfering Substances, Specificity) represent the standalone performance of the CEDIA Digoxin Assay as a laboratory instrument and reagent system. This is the equivalent of a "standalone" performance study for an IVD.
7. The Type of Ground Truth Used
The ground truth for the CEDIA Digoxin Assay performance studies is derived from:
- Reference materials/known concentrations: For precision, linearity, and lower detection limit, control samples or samples with known, verified concentrations of Digoxin would be used.
- Predicate device comparison: For method comparison, the Abbott TDx® Digoxin II Assay serves as the comparator or "reference" for evaluating agreement.
- Spiking studies/known interfering substances: For interfering substances and specificity, samples spiked with known concentrations of potential interferents or cross-reactants are used.
8. The Sample Size for the Training Set
The document does not provide information about a "training set" as this is not typically applicable in the same way to IVD assays. The development and optimization of the assay would involve internal development studies and validation, but these are not usually categorized as distinct "training" datasets in the context of device submission. The presented data represents validation/performance testing data.
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, the concept of a training set with established ground truth as in AI/machine learning is not directly relevant here. The development of the assay would have involved rigorous chemical and biological characterization, using known concentrations and reference methods to achieve the desired performance characteristics.
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