(120 days)
Substantial equivalence has been demonstrated between the INNOFLUOR™ Quinidine Assay System (Modified) the INNOFLUOR™ Quinidine Reagent Set (Existing) and the Abbott Quinidine Assay.
The technological characteristics, performance and intended use of the INNOFLUOR™ Quinidine Assay System (Modified) are substantially equivalent to the INNOFLUOR™ Quinidine Reagent Set (Existing) and the Abbott Quinidine Assay.
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Here's a breakdown of the provided information concerning the INNOFLUOR™ Quinidine Assay System (Modified), structured according to your request.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Existing Devices: | Demonstrated: The INNOFLUOR™ Quinidine Assay System (Modified) is deemed substantially equivalent to the INNOFLUOR™ Quinidine Reagent Set (Existing) and the Abbott Quinidine Assay in terms of technological characteristics, performance, and intended use. |
| Linear Regression - Slope: | 0.958 |
| Linear Regression - Intercept: | -0.077 |
| Correlation Coefficient (r): | 0.986 |
| Assumed Implied Acceptance Range for Slope: (Not explicitly stated, but typically close to 1) | 0.958 (within an acceptable range around 1, though not specified here) |
| Assumed Implied Acceptance Range for Intercept: (Not explicitly stated, but typically close to 0) | -0.077 (within an acceptable range around 0, though not specified here) |
| Assumed Implied Acceptance Range for Correlation Coefficient (r): (Not explicitly stated, but typically high, close to 1) | 0.986 (demonstrates strong correlation) |
Note: The document explicitly states "Substantial equivalence has been demonstrated." While specific numerical acceptance thresholds for slope, intercept, and correlation coefficient are not explicitly provided in the input, the reported values are presented as evidence supporting this claim of substantial equivalence. For a medical device, these metrics being close to 1 (for slope and correlation) and 0 (for intercept) are generally considered indicative of good agreement between methods.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 49 serum patient samples.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It only mentions "patient samples."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable to this type of device and study. The "ground truth" for this performance study is established by a reference assay (the Abbott Quinidine Assay), not by human expert interpretation of images or clinical findings.
4. Adjudication Method for the Test Set
This section is not applicable. Adjudication methods (like 2+1, 3+1) are typically used when human interpretation is involved in establishing a ground truth or resolving discrepancies between reviewers. In this case, the comparison is between two analytical assays.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study involves multiple human readers interpreting cases, often with and without AI assistance, to assess the impact of AI on reader performance. The provided study focuses on comparing the output of an automated assay system directly against a reference assay.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance study was done. The INNOFLUOR™ Quinidine Assay System (Modified) is an automated assay system. Its performance was evaluated directly against a reference assay (Abbott Quinidine Assay) without human intervention in the analysis process beyond initiating the test and reading the results.
7. The Type of Ground Truth Used
The "ground truth" in this study is established by the Abbott Quinidine Assay. This is a reference standard or comparator method rather than one of the typical ground truth categories like "expert consensus" or "pathology" for diagnostic imaging. The performance of the modified INNOFLUOR™ system is being evaluated relative to this established, existing assay.
8. The Sample Size for the Training Set
The document does not provide any information about a training set size. This suggests that the INNOFLUOR™ Quinidine Assay System (Modified) is likely a re-formulation or modification of an existing assay, and its performance is being compared to established methods rather than being an AI algorithm that requires a distinct training phase in the typical sense. If there was any "training" involved, it would be in the initial development and calibration of the assay, but the document does not detail this.
9. How the Ground Truth for the Training Set Was Established
Since no training set information is provided, how its "ground truth" was established is also not applicable/not documented in the provided summary.
§ 862.3320 Digoxin test system.
(a)
Identification. A digoxin test system is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.(b)
Classification. Class II.