(420 days)
For use only by a digital device to measure ST-segment shifts. Assessment of real time ST segment analysis in adult patients. The MIDA™ Algorithm Rev. B is intended for use in the hospital environment for the following patient population: Ages: 33-82 years Heights: 147 to 185cm (58 to 73 in.) Weights: 53 to 118kg (117 to 261 lbs.) Height to weight ratios: 1.41 to 2.99 cm/kg (0.25 to 0.54 in/lb) The use of EASI leads implies that the results may not be of diagnostic quality.
The new device is a modification that allows the MIDA™ algorithm to use vectorcardiogram from the five leads system EASI.
Acceptance Criteria and Device Performance Study for MIDA™ Algorithm Rev. B.
The Acceptance Criteria and the study proving the device meets these criteria for the MIDA™ Algorithm Rev. B are detailed below, based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state quantitative acceptance criteria in terms of metrics like sensitivity, specificity, or accuracy. Instead, the "acceptance criteria" appear to be met through a demonstration of "substantial equivalence" to a predicate device, specifically regarding the ability to measure ST-segment shifts using a 5-lead EASI system compared to a system using Frank electrode placement.
The "reported device performance" is framed as the ability of the MIDA™ Algorithm Rev. B to calculate ST-segment shifts when using the EASI lead system, and its comparability to the results obtained from Frank electrode placement.
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Substantial equivalence in | MIDA™ Algorithm Rev. B calculates ST-segment shifts using |
| ST-segment shift measurement | EASI electrode placement. |
| capability when using EASI | The calculated ST-segment shifts for both Frank and EASI |
| leads compared to Frank | electrode placements were compared, demonstrating sufficient |
| electrode placement. | similarity to establish substantial equivalence. |
| Functionality in a hospital | Intended for use in the hospital environment for adult patients |
| environment for specified | within specified age, height, and weight ranges. |
| adult patient population. | |
| Ability to measure ST-segment | The device is described as allowing the MIDA™ algorithm to |
| shifts. | use vectorcardiogram from the five leads system EASI to |
| measure ST-segment shifts. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The text states, "Testing involved acquirement of data for patients that was undergoing PTCA." It does not specify the exact number of patients or the size of the test set.
- Data Provenance: The patients were "undergoing PTCA" (Percutaneous Transluminal Coronary Angioplasty), indicating a medical procedure associated with cardiac conditions. The country of origin is not explicitly stated. The study appears to be prospective as it involved "acquirement of data for patients" during a procedure, suggesting real-time data collection or at least data collected specifically for this testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts used to establish ground truth or their qualifications. The comparison was made between ST-segment shifts calculated by the MIDA algorithm using different lead placements, not against an expert-adjudicated ground truth for the presence of ischemia or ST-elevation.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method involving experts for establishing ground truth. The comparison was directly between the calculated ST-segment shifts from two different electrode placements (Frank vs. EASI) within the MIDA™ Algorithm, not against an external "ground truth" adjudicated by multiple experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported. The study focused on the algorithm's performance in calculating ST-segment shifts with different lead systems, not on its impact on human reader performance or diagnostic accuracy.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone performance study was done. The study involved comparing the ST-segment shifts calculated by the MIDA™ Algorithm Rev. B using EASI lead placement against the ST-segment shifts calculated by the same algorithm using Frank electrode placement. The conclusion is based on a "Software Test Report MIDA Algorithm Rev B. ID: P-593-062." This clearly indicates an assessment of the algorithm's output without direct human intervention in the interpretation or diagnostic process for the comparison.
7. Type of Ground Truth Used
The "ground truth" in this context was the ST-segment shifts calculated by the MIDA™ Algorithm using Frank electrode placement. The study aimed to demonstrate that using EASI leads with the MIDA™ Algorithm produced comparable results to the established Frank lead system within the same algorithm. It was not based on pathology, clinical outcomes, or expert consensus regarding the presence of a condition, but rather on the consistency of a measurement between two different input methods for the same algorithm.
8. Sample Size for the Training Set
The document does not provide information regarding a specific training set size. The description focuses on the verification and validation of the device, which typically involves a test set. It is possible that the MIDA™ Algorithm itself was developed using a separate dataset, but details are not provided in this 510(k) summary.
9. How Ground Truth for the Training Set Was Established
Since information on a training set is not provided, the method for establishing its ground truth is also not mentioned.
§ 870.2400 Vectorcardiograph.
(a)
Identification. A vectorcardiograph is a device used to process the electrical signal transmitted through electrocardiograph electrodes and to produce a visual display of the magnitude and direction of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).