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510(k) Data Aggregation
(213 days)
The ESA615 Electrical Safety Analyzer is an electronic signal source and measurement device for verifying the electrical safety of medical devices. The ESA615 also provides ECG simulation and performance waveforms to verify patient monitors are performing within their operating specifications. The ESA615 provides following function categories: ECG Functions, ECG-Performance Testing.
Fluke Biomedical's ESA615 Electrical Safety Analyzer (hereafter referred to as the ESA615) provides a basis for verifying the electrical safety of medical devices. The Product also provides ECG simulation and performance waveforms to verify patient monitors are performing within their operating specifications. The ESA615 can be controlled by a suitably equipped computer to carry out tests, via either a cable or wirelessly. The ESA615 consists of the following components: 1) Printed Circuit Board Assemblies using surface mount components and firmware loaded in embedded processors. 2) Plastic injection molded case parts. 3) Liquid Crystal Display for user interface. 4) Power cord for powering the unit at 120V and 60Hz.
Here's a summary of the acceptance criteria and study information for the ESA615 Electrical Safety Analyzer, based on the provided text:
Device: ESA615 Electrical Safety Analyzer
1. Table of Acceptance Criteria and Reported Device Performance
The submission claims substantial equivalence to the predicate device (MPS450) based on similar technological characteristics and performance, not against specific, quantifiable acceptance criteria. The "differences" column below highlights how ESA615 performance differs from the predicate.
| Feature | Acceptance Criteria (Predicate: MPS450) | Reported Device Performance (ESA615) | Met Criteria? (Comparison to Predicate) |
|---|---|---|---|
| Intended Use | Test and verify basic operation of patient monitoring devices for ECG, Respiration, Invasive Blood Pressure, and Cardiac Output. | Verify electrical safety of medical devices; provide ECG simulation and performance waveforms. | Differs: Fewer functions (no Respiration, Invasive Blood Pressure, Cardiac Output), but adds Electrical Safety Analysis. |
| Construction | Plastic Case | Plastic Case | Yes |
| Size | 5.5" wide x 7.5" deep x 1.8" high | 6.94" wide x 3.3" deep x 11.2" high | Bigger |
| Weight | 2 lbs | 3.5 lbs | Heavier |
| Display | 4 line x 20-character super twist LCD display | 3" diagonal screen Monochrome STN transflective | Larger screen |
| Function Key | Soft | Soft | Yes |
| ECG Leads | 10 binding posts | 5 applied parts jacks (with optional expander box) | Fewer applied parts |
| Communications Port | RS232 | USB | Change from RS232 to USB |
| Power | 9V alkaline battery & battery eliminator | No Battery - AC line powered only | No battery due to higher power demands |
| Lead Configuration | 12 leads | 5 leads | Fewer leads |
| Amplitude Accuracy | ±2% of setting | ± 5% of 1mV setting | Less accurate |
| Rate Accuracy | ±1% setting | ± 2% of setting | Less accurate |
| Normal Sinus Rhythm | 30, 40, 45, 60, 80, 90, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300 bpm | 30, 60, 120, 180, 240 bpm | Fewer NSR waves |
| Sine wave | 0.5, 5, 10, 40, 50, 60, 100 Hz | 10, 40, 50, 60, 100 Hz | Fewer frequencies |
| Square wave | 0.125, 2.0 Hz | 0.125, 2.0 Hz | Yes |
| Triangle wave | 2.0, 2.5 Hz | 2.0 Hz | Fewer frequencies |
| Pulse wave | 30, 60 bpm, 60 ms pulse width | 30, 60 bpm, 63 ms pulse width | Wider pulse width |
| Cable Connector | ECG leads, 10 binding postings | ECG leads, 5 binding postings | Fewer binding postings |
2. Sample size used for the test set and the data provenance
The document mentions "Laboratory studies have been conducted with a representative patient monitor..." but does not specify the sample size (number of "representative patient monitors" or tests performed) or the data provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The device is an analyzer, not a diagnostic tool requiring expert interpretation. The "ground truth" for its performance is its physical and electronic output measurements compared against its published specifications.
4. Adjudication method for the test set
Not applicable, as this is a device performance verification, not a clinical study requiring human interpretation and multi-expert adjudication.
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 device is an electrical safety analyzer and ECG simulator, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the testing described appears to be standalone performance verification of the ESA615 itself, against its published specifications. The description "Laboratory studies have been conducted with a representative patient monitor to verify and validate the ESA615 will perform within its' published specifications" indicates this.
7. The type of ground truth used
The ground truth for the test set appears to be its own published specifications, as verified by "Laboratory studies... to verify and validate the ESA615 will perform within its' published specifications."
8. The sample size for the training set
Not applicable. This is a hardware device with firmware, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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