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510(k) Data Aggregation
(68 days)
myPatch®sl is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light headedness, pre-syncope, syncope, fatigue, chest pain and/or anxiety.
The myPatch®sl is intended for use by Adults and all Pediatric subgroups
The myPatch®sl (model # 3000sl) ambulatory electrocardiograph (ECG) recorder is a small, lightweight ambulatory ECG recorder that records ECG continuously. The unit records 1 or 2 channels of ECG up to 14 days and 3 channels up to 9 days. The device is composed of a large ECG electrode and an ECG recorder. The ECG recorder snaps onto the electrode and records until the recorder is turned off or the battery is drained. At the end of the recording, the recorder can be plugged into a PC via a USB cable. The ECG recording can be transferred to a pc where processing software can transfer the data to a format that can be processed through recording processing software provided by recording processing software manufacturers and analyzed by qualified healthcare providers. Only the recorder is part of this 510(k) application.
The myPatch®sI recorder also incorporates an Event feature where the patient double taps on the recorder when they feel a symptom.
The myPatch®sI recorder has a power button on the recorder. Once depressed for 1 second, the green LED flashes. The LED will flash for 30 seconds as a "start-up" period. This gives the user time to apply the electrode to the patient's sternum without recording artifact during the hookup period. To power off the recorder, the button is held down 2 seconds. A red light will flash and the recording period ends.
As the mvPatch®sl is worn continuously up to 14 davs it will be worn (used) in homes. healthcare facilities, hospitals, and where ever the patient may go.
The associated accessories that are part of the myPatch®-sl recorder are a lead wire, USB cable and the mvPatch®-sI electrode.
Per the Class II Special Controls Guidance Document: Electrocardiograph Electrodes, issued on July 21, 2011 "the FDA has determined that a 510(k) is not necessary to provide reasonable assurance of the safety and effectiveness of this generic type of device if the manufacturer follows the recommendations in this special controls guidance to address the issues identified in this guidance." The scope of the guidance includes "bare ECG electrodes or ECG electrodes that incorporate as part of their design, a conductive gel, an adhesive system or a lead wire". Per this guidance, we have the device specifications, composition, formulation, component specifications, engineering drawings with dimensions & composition, written description of how the electrode connects to the myPatch®sI and a list of features and specifications in tabular format.
The lead wire has been tested by the manufacturer to EN 55024:1998 +A1:2001 +A2:2003 and EN 55022:1998+A1:2000+A2:2003 standards. The copy of the Certificate of Conformity is in our files.
The myPatch®sI records ECG in accordance to the standard IEC 60601-2-47:2012 for ambulatory ECG Recorders.
During the recording the patient wears the myPatch®sI connected to an electrode on the upper sternum. The myPatch®sI consists of a microprocessor, recording circuit, memory, data storage, light-emitting diode (trans-illuminates the power button), and snap contacts to the electrode. In addition to that, myPatch®sI contains firmware to control the recording of the ECG data and software to transfer the recorded ECG file to the pc.
The battery is a rechargeable lithium polymer battery with a built-in protection circuit. The charge of the myPatch®sI is by use of a USB cable with a proprietary connector which can only be connected to myPatch®sl when it is not connected to the electrode.
The myPatch®sI has a serial number and product number in a bar code format and numbers to secure the traceability of the equipment and the data during and after the studies.
mvPatch®sI is reusable.
The electrode (accessory to myPatch®sl) is the passive part. The electrode consists of one laver of one-sided adhesive tape that runs the full length of the electrode. This adhesive tape allows the electrode to be placed on the upper sternum. The electrode gel is placed on the underneath side of the adhesive tape. Through this electrode qel the ECG of the patient is recorded. The top side of the electrode has 4 snaps that will connect in only one way to the myPatch®sl and one snap for an optional lead wire. The conductor paths are flex strips that run between the connector and the electrode gel. A release liner is placed on the underside of the electrode. The release liner covers the adhesive tape and the electrode gel. This liner is torn off when placing the myPatch®sl on the upper sternum. The electrode must be connected to the myPatch®sI to have any practical use. The electrode is a single use device and is disposed of after the one single use.
When recording a 3 channel ECG, a standard lead wire is attached to the snap on the front, bottom of the electrode. This lead wire attaches to any standard ECG electrode. The normal placement of this electrode is the V5 position.
The case of the myPatch®sI recorder is a Sabic/Lexan HP1 high flow polycarbonate for medical device applications and has the following certifications: ISO10993 or USP Class VI.
The provided document contains information about the myPatch®sl ambulatory ECG recorder. It describes the device's characteristics, comparison to a predicate device, and various non-clinical performance data. However, it explicitly states that clinical studies were not required to support substantial equivalence. Therefore, the document does not contain acceptance criteria and a study proving the device meets those criteria in a clinical context involving human outcomes or expert assessment of diagnostic accuracy.
Here's an analysis of the information that is available, and what is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
Since no clinical study with predefined acceptance criteria for diagnostic performance is reported, this table cannot be fully populated as requested. The document focuses on performance relative to engineering and safety standards.
| Acceptance Criteria (Not explicitly stated for diagnostic performance) | Reported Device Performance |
|---|---|
| Device Characteristics (Comparison to Predicate) | |
| Type of ECG Recorder | Patch (Same as predicate) |
| Number of ECG Channels | 1, 2 or 3 (Predicate: 1 or 2) - Similar |
| Wear Time | Up to 14 days (Predicate: Up to 7 days) - Different (Improved) |
| Recording Format | Continuous (Same as predicate) |
| Power Requirement | Lithium Polymer 3.7v 600 mAh (Predicate: 3.7v 350 mAh) - Similar |
| Dimensions | 1.75"x 2" x .5" (Slightly larger than predicate) - Similar |
| Weight | 25 grams (Slightly heavier than predicate) - Similar |
| Frequency Response | 0.05Hz – 175Hz (Predicate: 0.05Hz – 110 Hz) - Similar |
| Input Impedance | >10MOhms (Same as predicate) |
| Resolution | 12 bits (Same as predicate) |
| Performance Standard | Design Verification IEC 60601-2-47 (Same as predicate) |
| Safety | IEC 60601-1 Basic Safety & Essential Performance IEC 60601-2-47 (Same) |
| Duration of Skin Contact | Up to 14 days (Predicate: Up to 7 days) - Different (Improved) |
| Recording Period | Up to 14 Days (Predicate: Up to 7 Days) - Different (Improved) |
| Compliance with Standards (Non-clinical) | |
| IEC 60601-1:2005 (Basic Safety) | Designed and tested for compliance |
| IEC 60601-1-6:2010 (Usability) | Designed and tested for compliance |
| IEC 60601-1-11:2015 (Basic Safety) | Designed and tested for compliance |
| IEC 60601-2-47:2012 (Ambulatory ECG Systems) | Designed and tested for compliance, records ECG in accordance with standard |
| IEC 62366:2007 (Usability Engineering) | Followed guidance |
| IEC 62304:2006 (Software Life Cycle) | Designed and manufactured according to standard |
| IEC 62133:2012 (Battery Safety) | Compliant / Certified, larger battery is certified |
| IEC/EN 60601-1-2 (2015) (EMC) | Designed and tested for compliance |
| ISO 15223-1:2012 (Symbols for Medical Devices) | Designed and tested for compliance |
| ANSI/AAMI EC12 (Disposable ECG Electrodes) | Designed and tested for compliance |
| 21 CFR Part 820 (Quality Systems) | Designed and manufactured according to regulation |
| ISO 10993 (Biocompatibility) | Evaluation conducted in compliance (Parts 5 & 12) |
| FDA Guidance for Premarket Submissions for Software | Software verification and validation testing conducted following guidance |
| ISO 14971 (Risk Management) | Risk Management process performed according to standard |
| IP Rating | IP 68 for submersion up to 2 meters for 1 hour |
| Recording data storage | Able to store data for 14 days (at 128 sample rate) |
2. Sample Size Used for the Test Set and Data Provenance
As no clinical study with a "test set" for diagnostic performance was conducted or reported for this submission:
- Sample Size for Test Set: Not applicable / Not reported for diagnostic performance.
- Data Provenance: Not applicable for diagnostic performance.
However, the document mentions "Usability Testing" with human subjects:
- Usability Testing Sample Sizes:
- Ocean swimming activities: 45 subjects (20 aged 11-20 years, 25 aged 21-59 years).
- Daily activities with showers: 65 subjects (25 aged 5-20 years, 40 aged 20-75 years).
- Gym workouts, showers, daily activities: 25 subjects (aged 19-59 years).
- Daily environment with baths: 15 tests on age group 2 months to 1 year.
- Two-week validation studies: 40 studies (20 in 6-19 years, 20 in 21-78 years) + 15 studies (ages 2 months to 1 year).
- Provenance of Usability Data: The context suggests these were prospective, in-house tests, likely conducted in the US (given the FDA submission, though not explicitly stated for individual subjects).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable, as no clinical study with a diagnostic "ground truth" was reported.
4. Adjudication Method for the Test Set
Not applicable, as no clinical study with adjudication of a test set for diagnostic performance was reported.
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. The device is an ECG recorder, not an AI-assisted diagnostic tool for human readers. No MRMC study was mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable for diagnostic algorithm performance. The device records ECG data, which is then transferred to a Holter analysis system (provided by other manufacturers) and analyzed by qualified healthcare providers. The submission focuses on the recorder's ability to accurately capture and store ECG signals per standards, not on automated diagnostic interpretation.
7. The Type of Ground Truth Used
- For the non-clinical performance data (e.g., electrical safety, EMC, battery safety, biocompatibility, software validation, mechanical testing), the "ground truth" is defined by compliance with established international and FDA-recognized standards (e.g., IEC 60601 series, ISO 10993, 21 CFR Part 820). The device demonstrates its performance against these engineering and safety benchmarks.
- For Usability Testing, the "ground truth" is subjective user feedback and observation of device function during use, demonstrating its practical application and adherence.
8. The Sample Size for the Training Set
Not applicable, as this device submission does not describe an AI/machine learning algorithm that requires a training set for diagnostic classification. The device itself is a data acquisition tool.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set for an AI/machine learning algorithm is described.
Summary of Device Rationale for Substantial Equivalence:
The myPatch®sl demonstrates substantial equivalence to its predicate device (myPatch®s) primarily through:
- Comparison of technological characteristics: Most characteristics are similar, with improvements in wear time (up to 14 days vs. 7 days) and battery capacity. These differences are argued not to impact safety and effectiveness.
- Compliance with recognized standards: Extensive testing was performed against IEC, ISO, AAMI, and FDA regulations for safety, essential performance, software, biocompatibility, and usability.
- Non-clinical performance data: Mechanical testing, environmental robustness (IP68 rating), and extended battery life were verified.
- No clinical data required: The FDA determined that clinical data was not necessary to support substantial equivalence, implying that the non-clinical data and comparison to the predicate were sufficient to assure safety and effectiveness for its intended use.
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(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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(186 days)
The myPatch is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light headedness, presyncope, syncope, fatigue, chest pain and/or anxiety.
The myPatch ambulatory electrocardiograph(ECG) recorder is a small, lightweight monitor that records ECG continuously. The unit records 2 channel of ECG data up to 3 days. The device is composed of a large ECG electrode and ECG recorder. The ECG recorder clips 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 the USB connection. The ECG recording can be transferred in an available file that can be processed through recording processing software provided by recording processing software manufacturers and analyzed by qualified healthcare providers.
The myPatch records ECG in accordance to the standard IEC 60601-2-47:2012 for ambulatory ECG recorders.
During the recording the patient wears the myPatch connected to an electrode on the sternym. The myPatch consists of a plastic casing containing a battery and electronics consisting of a microprocessor, measuring circult, memory, data storage, light-emitting dlode (transilluminates the plastic casing), and contact to the electrode. In addition to that, myPatch contains firmware to control the collection of the ECG-data and software to transfer to processing software.
The battery is a rechargeable lithium polymer battery with a built-in protection circuit. The charging of the myPatch is by use of a USB cable, which can only be connected to myPatch when it is not connected to the electrode. At the bottom of myPatch is an electrical and click-on connection for the electrode. myPatch must be connected to the electrode to turn on and to acquire data. myPatch has a serial number to secure the traceability of the equipment and the data during and after the investigation. myPatch is reusable.
The electrode ( accessory to myPatch, ) is the passive part. The electrode consists of one layer of onesided adhesive tape that runs the full length of the electrode. This adhesive tape allows the electrode to be placed on the sternum. The electrode gel is placed on the underneath side of the adhesive tape. Through this electrode gel, the ECG of the patient is measured. The top side of the electrode has an electrical and click-on connection to myPatch. The conductor paths are printed on the adhesive tape. These conductor paths make the connection between the electrode gel on the underside and the connection to myPatch on the top side of the electrode.
Release liners are placed on the underside and on the top side of the electrode. These release liners cover the adhesive tape and the electrode gel and are torn off when placing the myPatch on the sternum. The electrode has to be connected to myPatch to have any practical use. The electrode is a single- use device and is disposed of after one single use.
This document is a 510(k) summary for the myPatch Ambulatory ECG Recorder (Model #: Amors1000). It outlines the device's description, indications for use, and a list of standards it meets, which are typically used to demonstrate substantial equivalence to predicate devices. However, this document does not contain a study that proves the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy.
Here's a breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
-
Acceptance Criteria: The document does not explicitly define specific performance-based acceptance criteria (e.g., sensitivity, specificity for arrhythmia detection). Instead, the acceptance criteria are demonstrated by compliance with various international standards for medical electrical equipment.
-
Reported Device Performance: Clinical performance data is not provided in this 510(k) summary. The document states that "All testing demonstrated acceptable results" for various electrical and safety standards, but no quantitative performance metrics for ECG recording accuracy or diagnostic capabilities are presented.
Acceptance Criterion (standard compliance) Reported Device Performance IEC 60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) / IEC 60601-1/A11:2011 (General requirements for basic safety and essential performance) "All testing demonstrated acceptable results" EN 60601-1-11: 2010 (Home healthcare environment requirements) "All testing demonstrated acceptable results" IEC 60601-2-47: 2012 (Particular requirements for ambulatory electrocardiographic systems, equivalent to ANSI/AAMI EC38) "All testing demonstrated acceptable results" and "myPatch has met the design verification testing standards as set forth in IEC 60601-2-47" EN 60601-1-2:2007 (Electromagnetic compatibility) "All testing demonstrated acceptable results" EN 62366:2008 (Application of usability engineering to medical devices) "All testing demonstrated acceptable results" EN 1041:2009 (Information supplied by the manufacturer) "All testing demonstrated acceptable results" EN 980:2008 / EN 980 Bil.1:2008 (Symbols for use in labeling) "All testing demonstrated acceptable results" ISO 15223-1:2012 (Medical devices - Symbols for labels) "All testing demonstrated acceptable results" CE Marking (EU guidelines for medical devices) "The myPatch ECG Recorder has the CE Marking (CE 1008). The CE Mark is a statement that the myPatch ECG Recorder fulfills the guidelines established by the EU for medical devices."
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document refers to "testing" but does not detail sample sizes for any performance evaluation beyond compliance with engineering standards.
- Data Provenance: Not specified. Given the nature of the testing mentioned (compliance with standards), it likely refers to laboratory-based engineering and electrical testing rather than clinical data from human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided. The document focuses on compliance with technical standards, not on clinical performance evaluated against expert-established ground truth.
4. Adjudication method for the test set
- This information is not provided. As clinical performance evaluation is not detailed, adjudication methods are not relevant here.
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 MRMC study was done or reported. The device is an ECG recorder, not an AI-assisted interpretation system. There is no mention of AI in this context.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable in the context of an "algorithm only" performance. The device is a data acquisition tool. Its standalone performance is in recording ECG data, which is confirmed by compliance with relevant standards (e.g., IEC 60601-2-47). The document affirms that the device records "in accordance to the standard IEC 60601-2-47:2012 for ambulatory ECG recorders."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth for the engineering and safety tests would be the specifications and requirements defined within the cited IEC/EN/ISO standards. For example, for "Electromagnetic compatibility," the ground truth would be the permissible emission and immunity levels defined in EN 60601-1-2. There is no clinical ground truth discussed.
8. The sample size for the training set
- Not applicable. This device is an ECG recorder, and the document does not mention any machine learning or AI components that would require a training set.
9. How the ground truth for the training set was established
- Not applicable. As no training set for an algorithm is mentioned, the method for establishing its ground truth is irrelevant.
In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence through compliance with international safety and electrical performance standards for medical devices. It does not present clinical performance data, diagnostic accuracy metrics, or AI algorithm validation studies that would involve a test set, ground truth established by experts, or training sets.
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