(11 days)
- Recording of up to nine-channel surface ECG (Electrocardiogram) data from ambulatory patients during a 96-hour maximum period.
- High-resolution recording of surface ECG data.
- Note: Analysis of recorded Holter ECG data requires separately-supplied ELA Synetec, Syneview, or Synescope Holter analysis software.
The SpiderView ™ Holter recorder is designed to acquire and store, in a digital format, multiple channels of surface ECG data (from 2 to 9 Leads) for a period up to 96 hours. The device stores the acquired ECG data on a removable flash memory card. ECG signals are converted at a rate of 200 to 1000 samples per second, which allows accurate reproduction of the ECG signal to perform signal averaging ECG analysis. The Holter scanner software (sold separately) reads these data and prints them out in tabular or graphical form. This recorder does not perform any analysis on the ECG data. SpiderView™ is supplied in a case containing a 16, 32, or 64 MB flash-memory card, one 1.5 V AA battery, a carrying case, a strap, five patient cables, a set of ECG electrodes, and a user's manual.
The manufacturer, ELA Medical, Inc., submitted a 510(k) premarket notification for the SpiderView Holter ECG recorder. This device is intended to acquire and store multi-channel surface ECG data for up to 96 hours. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document primarily focuses on demonstrating substantial equivalence by comparing the SpiderView Holter ECG recorder's technological characteristics to those of predicate devices. Formal acceptance criteria with specific performance thresholds (e.g., accuracy percentages) are not explicitly stated in the provided text. Instead, the "performance" is implicitly demonstrated through the functional capabilities and specifications that are comparable to or exceed those of the predicate devices.
| Feature | Acceptance Criteria (Inferred from Predicate Equivalence) | Reported SpiderView Performance |
|---|---|---|
| Device Type | Digital Holter recorder | Digital |
| Analysis | Retrospective (on the analyzer) | Retrospective (on the analyzer) - Note: Device does not perform analysis itself. |
| Record Duration | At least 24 hours (predicates range from 24H to 120H) | 24H to 96H |
| Recording Medium | Removable memory card (e.g., PCMCIA, CompactFlash, MMC, SD) | MMC or SD Flash card (16, 32, 64 MB) |
| Data Transfer | Via Removable memory card or USB port | Via Removable memory card |
| Signal Compression | Acceptable if no notable loss OR no compression (predicates vary) | Yes (delta + variable length bit coding = no notable loss) |
| Channels | 2 or 3 channels (predicates offer 2, 3, 5, 7, 9, 12) | 2, 3, 5, or 9 (5-channel recording authorizes true 9-lead ECG by calculation) |
| Sampling Rate | Comparable to predicate devices (e.g., 175sps to 1024sps) | 200sps (standard) / 1000sps (High Resolution mode) |
| Frequency Response | Comparable to predicate devices (e.g., 0.05Hz to 25Hz, up to 150Hz) | 0.05Hz to 25Hz (standard) / 0.05Hz to 100Hz (no compression mode) |
| Dynamic Range | Comparable to predicate devices (e.g., +/-6mV to +/-10mV, 10-12 bit) | +/-16 mV (15 bit) |
| Amplitude Resolution | Comparable to predicate devices (e.g., 1.465μV to 10μV) | 10μV (standard) / 2.5μV (High Resolution mode) |
| High Resolution Mode | Available on some predicates | Yes (with 1000sps sampling rate and software utility for ISHNE format transfer) |
| Setup | Graphic display + keyboard | With the graphic display + keyboard |
| ECG Channel Preview | Yes | Yes |
| CABLE | 3, 5, 7, or 10 wires (predicates vary) | 3, 5 or 7 wires |
| Test Cable | Yes on some predicates | Yes |
| Impedance measurement | Yes | Yes |
| Power | AA 1.5V batteries (rechargeable options acceptable) | 1 AA 1.5V battery or 1 AA 1.2V NiMH rechargeable battery |
| Pacemaker Detection | Yes | Yes |
| Display | Graphic LCD or LCD | GRAPHIC LCD |
| Time Displayed | Yes (at least during hookup) | Yes (only during hookup) |
| Patient event marker | Yes | Yes |
| On-board ECG analysis | No (for most predicates for comparable function) | No |
| Safety Testing | Compliance with standards IEC 60601-2-47, IEC 60601-1-2, ANSI/AAMI EC38-1998 | Environmental and safety tests, including EMC tests, according to the specified standards. |
| Software Validation | Module and functional testing for software applications | Module and functional testing for SpiderView™ software applications |
2. Sample Size and Data Provenance for Test Set
The provided summary does not detail a "test set" in the context of clinical performance data. The studies mentioned are:
- In-vitro functional testing: This refers to the testing performed in a controlled laboratory environment, not on human subjects.
- Safety testing: This includes environmental, safety, and EMC tests according to specified standards.
- Software validation and verification testing: Module and functional testing for software applications.
Therefore, there is no sample size or data provenance for a clinical test set involving patient data mentioned for the SpiderView Holter ECG recorder. The device is a data acquisition device, and its safety and performance are primarily assessed through engineering and functional testing against standards, and comparison of its technical specifications to those of legally marketed predicate devices.
3. Number of Experts and Qualifications for Ground Truth of Test Set
As there is no clinical "test set" or human-in-the-loop performance evaluation described, there are no experts mentioned as establishing ground truth for such a set. The "ground truth" for the functional and safety testing would be adherence to engineering specifications and regulatory standards.
4. Adjudication method for the Test Set
Given the nature of the studies described (in-vitro functional, safety, and software validation), an adjudication method (like 2+1, 3+1) is not applicable or mentioned. Adjudication typically applies to evaluating interpretations of clinical data by multiple human readers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. This type of study would typically assess how human readers perform with and without an AI-assisted device in interpreting clinical cases. Since the SpiderView device is solely a data recorder and does not perform any analysis or interpretation, an MRMC study is not relevant or described in the submission.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
No standalone performance study is explicitly described as the device itself does not contain an "algorithm" for analysis or interpretation of ECG data. Its function is to record high-fidelity ECG signals. The statement "This recorder does not perform any analysis on the ECG data" directly indicates that it is not an AI-enabled interpretative device. The software validation mentioned is for the device's operational software, not an analytical algorithm.
7. Type of Ground Truth Used
For the in-vitro functional, safety, and software validation testing, the ground truth would be based on:
- Engineering specifications: The device is expected to perform according to its design specifications.
- Regulatory standards: The safety and EMC testing confirms compliance with harmonized standards (IEC 60601-2-47, IEC 60601-1-2, ANSI/AAMI EC38-1998).
- Predicate device characteristics: Substantial equivalence is argued based on the SpiderView's technical characteristics being comparable to, or improved upon, the predicate devices.
There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this device's premarket notification.
8. Sample Size for the Training Set
Since the SpiderView is a data recording device and not an analytical or AI-driven system that would require a "training set" for an algorithm, there is no training set sample size mentioned.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an analytical algorithm, the concept of establishing ground truth for a training set is not applicable to this submission.
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).