(264 days)
The VSH101 is designed to record, transmit, and store single channel electrocardiogram (ECG) data via Bluetooth communication to compatible Bluetooth enabled devices. The device is intended for use by healthcare professionals, individuals with known or suspected cardiac conditions, and health-conscious users. The ECG data serves as a supplementary source of patient information and is not intended for automated analysis.
VitalSigns 1-Lead Holter is an ambulatory and Bluetooth-based wireless communication ECG measurement solution designed to allow users to record, store, transmit, and display single-channel ECG data.
VitalSigns 1-Lead Holter consists of the following three components:
- VS Electrode Patch "VSP101"
- ECG Recorder Host "VSH101"
- iOS APP "VSHealth"
When the ECG Recorder Host "VSH101" is fully charged and connected wirelessly via Bluetooth to the iOS app "VSHealth", it can instantly obtain the user's ECG data. VSHealth assists in transmitting, displaying, recording, and storing ECG data.
After the "VSH101" is fully charged, the device, through the VSHealth app, allows users to continuously use and record ECG data for 24 hours in their daily routines, whether at home or in a work environment.
The provided FDA 510(k) clearance letter and summary for the VitalSigns 1-Lead Holter (VSH101) primarily focus on demonstrating substantial equivalence to a predicate device through comparison of features and adherence to various safety and performance standards. However, it does not include explicit acceptance criteria tables or detailed study results for specific device performance metrics that would be typically found in a clinical or performance validation report.
The document states that "software validation, performance test and usability test have been completed to demonstrate that the differences between these parameters would not impact the safety and effectiveness of the subject device. The subject device has also undergone all safety and performance tests, and the results complied with the test requirements." It also mentions "Performance testing - IEC 60601-2-47 test" and "Disposable ECG electrode test."
Given the information provided in the 510(k) summary, I will infer the acceptance criteria based on the mentioned compliance standards and the general nature of an ECG Holter device, and then describe what is stated about the testing.
Inferred Acceptance Criteria and Reported Device Performance
The 510(k) summary for the VitalSigns 1-Lead Holter (VSH101) does not provide a specific table of acceptance criteria with corresponding performance metrics. Instead, it relies on demonstrating compliance with relevant international standards and equivalence to a predicate device. Based on the mentioned standards (e.g., IEC 60601-2-47 for ambulatory ECG recorders, ANSI/AAMI EC12 for disposable ECG electrodes), the general acceptance criteria for such a device would relate to the accuracy, signal quality, and reliability of ECG signal acquisition.
Here's a table based on the inferred acceptance criteria from the context of ECG device standards and the information stated in the document:
| Acceptance Criteria Category | Specific Metric (Inferred) | Acceptance Threshold (Inferred from Standards & Equivalence) | Reported Device Performance (as stated in document) |
|---|---|---|---|
| ECG Signal Quality | Artifact/Noise Levels, Baseline Wander, Frequency Response | Compliance with IEC 60601-2-47 (e.g., specific limits for noise, linearity, gain accuracy) | "The patch provides stable conductivity, low impedance" (for electrodes). "Performance is equivalent to IEC 60601-2-47 for all devices." "The results complied with the test requirements." |
| ECG Electrode Performance | Impedance, Biocompatibility, Adhesion | Compliance with ANSI/AAMI EC12 (e.g., biocompatibility (cytotoxicity, irritation, sensitization), acceptable impedance range, adhesion properties over time) | "The VS Electrode Patch has been tested in accordance with ANSI/AAMI EC12, confirming compliance with established safety and performance standards." "The patch provides stable conductivity, low impedance, and biocompatibility." |
| Data Acquisition & Storage | Continuous Recording Duration | At least 24 hours (explicitly stated function) | "Allows users to continuously use and record ECG data for 24 hours." "Data storage: 24 hours." |
| Device Functionality & Reliability | Wireless Communication Reliability, Battery Life, Software Functionality | Reliable Bluetooth communication, adequate battery life for intended use, proper software operation (no critical errors) | "Connected wirelessly via Bluetooth." "Allows users to continuously use and record ECG data for 24 hours." "Software validation... has been completed." |
| Safety | Electrical Safety, Electromagnetic Compatibility (EMC), Biocompatibility | Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, ISO 10993-1 | "Meet all requirements for all design, biocompatibility, electrical, EMC safety and cybersecurity protection." "VSH101 has been tested and complies with the requirements of Clause 8.5.5.2 – Energy reduction test." "Pass all testing." |
Study Proving Device Meets Acceptance Criteria
The provided 510(k) summary describes that comprehensive testing was conducted, primarily focusing on compliance with recognized consensus standards and demonstrating substantial equivalence to a predicate device, rather than a single large-scale clinical/performance study with detailed outcome metrics.
Here's an analysis based on the information provided:
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A table of acceptance criteria and the reported device performance:
- As detailed above, a direct table is not provided in the 510(k) summary. The acceptance criteria are inferred from the listed compliance standards (e.g., IEC 60601-2-47, ANSI/AAMI EC12). The reported performance is generally stated as "complied with the test requirements," "met its pre-defined criteria," or "confirmed compliance."
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Sample sizes used for the test set and the data provenance:
- Sample Size: Not explicitly stated for performance testing. For compliance with standards like IEC 60601-2-47 or ANSI/AAMI EC12, testing typically involves a sufficient number of device units or electrodes to statistically demonstrate compliance with the standard's requirements (e.g., a batch of electrodes, multiple device samples). The document does not specify if patient data was used for performance testing beyond what is implied by the "24 hours" recording capability.
- Data Provenance (Country of Origin, Retrospective/Prospective): Not specified. Standard compliance testing is typically done in a lab setting rather than involving patient data in a "retrospective" or "prospective" clinical study design for 510(k) submissions unless a specific clinical performance claim needs to be proven. The focus here is on engineering verification and validation against standards.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the 510(k) summary. The nature of the testing described (compliance with standards like IEC 60601-2-47 for signal quality, ANSI/AAMI EC12 for electrodes, and general electrical safety) suggests controlled laboratory testing and engineering validation, which typically does not involve human expert adjudication of ECG readings as a "ground truth" for device performance in this context. The device's indication for use explicitly states, "The ECG data serves as a supplementary source of patient information and is not intended for automated analysis," implying that human interpretation remains key. Therefore, ground truth establishment by experts for automated analysis is not applicable.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- None is explicitly described. Based on the content, there was no clinical study described that would require a ground truth panel or adjudication method for ECG event interpretation. The testing focuses on technical performance compliance.
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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 described. The device is a "1-Lead Holter" that records ECG data; it does not perform "automated analysis" or include AI assistance. Its purpose is to provide raw ECG data for supplementation of patient information, not for diagnostic interpretation by an algorithm. Therefore, an MRMC study assessing AI assistance is not relevant to this device's claims or function.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Based on the indication for use, "The ECG data serves as a supplementary source of patient information and is not intended for automated analysis," there is no algorithm for diagnostic interpretation. Therefore, no standalone algorithm performance study was done or described.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- As noted above, for the type of device and the presented summary, complex ground truth derived from expert consensus, pathology, or outcomes data is not applicable for the performance testing described. The "ground truth" for compliance testing is largely defined by the technical specifications and requirements within the IEC/AAMI standards themselves (e.g., known input signals for signal quality, chemical assays for biocompatibility).
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The sample size for the training set:
- Not applicable / Not provided. The device records raw ECG data and does not perform automated analysis using a trained algorithm. Therefore, no "training set" for AI/ML model development is mentioned or required for this type of device based on its intended use.
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How the ground truth for the training set was established:
- Not applicable. As there is no AI/ML model for automated analysis that requires a training set, the establishment of ground truth for such a set is not discussed.
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).