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510(k) Data Aggregation
(123 days)
myPatch®s is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizht headedness, pre-syncope, fatigue, chest pain and/or anxiety. The myPatch®s is intended for use by Adults and all Pediatric subgroups.
The myPatch®s ambulatory electrocardiograph (ECG) recorder is a small, lightweight monitor that records EG continuously. The unit records 1, 2 or 3 channels of ECG up to 7 days. The device is composed of a large EGG electrode and an ECG recorder. The ECG recorder snaps onto the electrode and records until the recorder is removed from the electrode. At the end of the recorder can be plugged into a PC via a USB cable. The ECG recording can be transferred in an available file format that can be processed through recording processing software provided by recording processing software manufacturers and analyzed by qualified healthcare providers.
The provided document is a 510(k) Summary for the myPatch®s device, which is an ambulatory ECG recorder. It seeks substantial equivalence to the legally marketed myPatch® Ambulatory ECG Recorder (K131190). The document focuses on demonstrating that the modified device (myPatch®s) does not raise any new safety or effectiveness issues despite certain changes.
Based on the information provided, here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
The document doesn't present a single, explicit table of "acceptance criteria" with a corresponding "reported device performance" against those criteria in a pass/fail format for a clinical study. Instead, it details various bench tests and their outcomes, comparing the myPatch®s to its predicate device, myPatch®. The acceptance is implied by the "Substantially Equivalent" conclusion for each test.
Here's an attempt to synthesize the electrical performance aspects into such a table, based on the "Bench Testing" section:
| Acceptance Criteria (Implied from Predicate Performance or Standards) | myPatch®s Reported Performance | Conclusion (vs. Predicate) |
|---|---|---|
| Linearity and Dynamic Range: Min. amplitude p-v difference to input signal < 10% or 50 µV (smallest value) for 4Hz sine wave at 0.5mV, 1mV, 10mV p-v with ±300 offset. | Passed | Substantially Equivalent |
| Common Mode Rejection: ≥ 60dB for sinusoidal signal at supply mains frequency; ≥ 45dB at twice supply mains frequency. Measured output during test period ≤ 4mV p-v. | Max CMMR 56/60Hz: 79dB (tested at 1024Hz sample speed) | Substantially Equivalent (Passed within similar range) |
| Input Impedance: Performance comparable to predicate device. | Passed (at 1024HZ sample rate, highest frequency sample speed) | Substantially Equivalent (Passed within similar range) |
| Gain Accuracy: Performance comparable to predicate device. | Passed | Substantially Equivalent (Passed within similar range) |
| Gain Stability: Performance comparable to predicate device. | Passed (measured at different sampling rates up to 10 days) | Substantially Equivalent (Passed within similar range) |
| System Noise: Performance comparable to predicate device (predicate tested at 21 µV). | 16 µV – 30 µV on all 3 channels in all sample rates (128, 246, 512 and 1024) | Substantially Equivalent (Passed within similar range) |
| Baseline Drift: Performance comparable to predicate device (predicate tested at 20 µV on all channels for 3 days). | 20 µV on all channels (tested over 10 days at 128 sample rate, 4.7 days at 256, 3 days at 512) | Substantially Equivalent (Same) |
| Multi-channel Crosstalk: Flat line on remaining channels during 10Hz sine wave, 4mV p-v input to one channel. | Flat line on remaining 2 channels (myPatch®s) and 1 channel (myPatch®) at 25 µV | Substantially Equivalent (Same) |
| Frequency Response (Rectangular Pulse): Baseline amplitude displacement < 0.1 mV; slope < 0.3 mV/s; leading edge overshoot < 10%. | Passed | Substantially Equivalent (Same) |
| Frequency Response (Sinusoidal Signal): Amplitude response between 140% and 70% (+3dB to -3dB) of response at 5Hz (within 0.50Hz to 110Hz range). | Passed | Substantially Equivalent (Passed in appropriate ranges) |
| Frequency Response (Triangular Pulse): Responses to 1.5mV, 40ms triangular pulse train within 70%-110% of max amplitude of 1.5mV, 200ms pulses. Lowest peak-to-base amplitude of 40ms pulse train not < 60% of highest peak-to-base amplitude for 200ms. | All results from both units within 70% - 100% (myPatch®s tested at 128, 256, 512, 1024 sample rates). | Substantially Equivalent |
| Timing Accuracy > 24 hours: Error < 0.0057% (predicate tested at 0.0057% error). | < 0.005% error | Substantially Equivalent (Nearly identical) |
| Temporal Alignment: No skew of rising/falling edges between channels > 20ms. | Passed (myPatch®s tested at all sample rates) | Substantially Equivalent (Identical) |
| Monitoring Time: Recording duration confirmed (predicate 72 hours). | 257 hours (128 sample rate), 114 hours (256 sample rate), 98 hours (512 sample rate), 92 hours (1024 sample rate) | Substantially Equivalent (As expected, designed for different times) |
| Data Retention: Data retained for minimum 72 hours after removal from electrode. | Passed | Substantially Equivalent |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes bench testing, comparing the myPatch®s device directly against its predicate, myPatch®, and against established electrical standards. This is not a clinical study with human subjects that would typically involve a "test set" sample size in the usual sense for evaluating performance on patient data.
- Test Set Sample Size: Not applicable in the context of a clinical test set. The tests involve the physical devices (myPatch® and myPatch®s) and signal generators.
- Data Provenance: Not applicable as it's bench testing, not human data. The tests confirm the device's adherence to technical specifications.
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. Ground truth for bench testing is established by engineering specifications and standard requirements (e.g., IEC 60601-2-47, ANSI/AAMI EC12). The "ground truth" is the expected electrical output or performance according to these standards, not expert medical opinion on a diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically for resolving discrepancies in expert interpretations of clinical data, which is not what these bench tests entail.
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
No. This document does not mention any MRMC study. The device is a data acquisition device (ECG recorder), not an AI-powered diagnostic tool. The performance data focuses on its recording capabilities and electrical characteristics.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, this is not an algorithm-only device. It's a medical device that records ECG data. The "software" mentioned refers to embedded firmware for data collection and processing, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth used for these performance tests is based on engineering specifications and recognized international standards for medical electrical equipment (e.g., IEC 60601-2-47 for ambulatory ECG systems, IEC 60601-1-2 for EMC, ANSI/AAMI EC12 for electrodes). For biocompatibility, it refers to ISO 10993. The "ground truth" is the specified electrical performance, safety, and compatibility requirements.
8. The sample size for the training set
Not applicable. This device does not use machine learning in a way that would require a "training set" of data for an algorithm. The software is for device control and data storage, not for learning or diagnostic predictions.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a machine learning algorithm.
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