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510(k) Data Aggregation
(232 days)
Digital Electrocardiograph
The intended use of electrocardiograph is to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However the ECG with measurements and interpretive statements is offered to clinician on an advisory basis only.
The proposed device can acquire ECG signal via twelve leads simultaneously, display or print waveform of ECG signal. The ECG electrical signals from patient body surface are acquired by disposable ECG electrodes; after been amplified, filtered and transferred, the ECG signal waveforms are displayed on the LCD and recorded on the paper via an external printer.
The provided text is a 510(k) Summary for a Digital Electrocardiograph. It contains information about the device's substantial equivalence to a predicate device, focusing on non-clinical tests and technical specifications. However, it does not include any details about clinical studies, acceptance criteria for an algorithm's performance, or the specific information requested about human reader performance, ground truth establishment for a test set or training set, or sample sizes related to clinical efficacy evaluation.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on compliance with electrical safety and performance standards for the hardware, not the diagnostic performance of an interpretive algorithm against specific clinical benchmarks.
- Sample sized used for the test set and the data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size, and ground truth establishment for the training set: None of this information is available in the provided text, as it describes a non-clinical assessment for substantial equivalence, primarily focusing on hardware characteristics and safety standards.
The document mentions "automated analysis" and "interpretive statements offered to clinician on an advisory basis only," but it does not provide any data or studies related to the performance or validation of this interpretive function from a clinical accuracy perspective. It primarily verifies that the proposed device met design specifications and complied with relevant safety standards (IEC 60601-1, IEC 60601-2-25, IEC 60601-1-2) which are non-clinical requirements.
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(28 days)
Digital Electrocardiograph
The intended use of electrocardiograph is to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. The proposed device has analysis feature, however the ECC with measurements and interpretive statements is offered to clinician on an advisory basis only.
The proposed digital electrocardiograph, iE 101 and iE 300, are designed based on the cleared digital electrocardiographs K141946 (iE 3). The proposed device has same intended use, functional modules design, working modes, analysis function and accessories. the proposed devices are different than the predicate device in that they has new printing channel for iE 101); new layout of user-machine interface; three different physical specification, such as screen size, device dimension, device weight; three different specification, such as battery capacity, noise level and CMRR; and a modified software which is modified to applicable to the proposed devices.
The proposed electrocardiographs, iE 101 and iE 300, follow the same design principle, main components, accessories and software; they acquire ECG electrical signals from patient body surface by ECG electrodes. After been amplified, filtered and transferred, the ECG signal waveforms are displayed on the LCD and recorded on the paper through thermal printer.
They consist of four modules, which are power supply module, signal collection module, amplification module, and control module.
They can acquire ECG signal via twelve leads simultaneously, display or print waveform of ECG signal via one channel (iE 101) or three channel (iE 300).
The provided text describes a 510(k) submission for a Digital Electrocardiograph, models iE101 and iE300. The submission argues for substantial equivalence to a predicate device (K141946).
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission focuses on establishing substantial equivalence to a predicate device, rather than defining specific performance acceptance criteria for diagnostic accuracy. The "acceptance criteria" here are essentially the compliance with relevant safety and performance standards and the demonstration that the proposed device performs similarly to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with IEC 60601-1:2005 + A1: 2012 (General safety) | Complies with IEC 60601-1:2005 + A1: 2012 |
| Compliance with IEC 60601-1-2: 2007 (EMC) | Complies with IEC 60601-1-2: 2007 |
| Compliance with IEC 60601-2-25:2011 (Electrocardiographs particular requirements) | Complies with IEC 60601-2-25:2011 |
| Biocompatibility (ISO 10993) | Complies with ISO 10993 |
| Intended Use | Same as predicate device |
| Intended Population | Same as predicate device (Adult and pediatric patients) |
| Intended Environment | Same as predicate device (Hospital, clinics) |
| Configuration | Same as predicate device |
| Lead | Same as predicate device (Standard 12-lead) |
| Acquisition mode | Same as predicate device (Simultaneous 12-lead acquisition) |
| Recording format | Same as predicate device (Automatic / Manual / Rhythm) |
| Analysis mode | Yes (Same as predicate, advisory basis only) |
| Physical/Technical Specifications (e.g., screen size, channels, battery capacity, noise level, CMRR) | Differences noted but deemed not to affect substantial equivalence (e.g., iE101: 5.0" screen, 1 channel; iE300: 5.0" screen, 3 channel vs. predicate's 6.0" screen, 3 channel). Software modified to be applicable to proposed devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "No clinical study is included in this submission."
Therefore, there is no test set in the context of clinical performance evaluation based on patient data. The "tests" conducted were non-clinical, likely bench testing and engineering verification to demonstrate compliance with standards.
- Sample Size for Test Set: Not applicable as no clinical test set was used.
- Data Provenance: Not applicable as no clinical data was used for a test set. The non-clinical tests were conducted by the manufacturer (Shenzhen Biocare Bio-medical Equipment Co., Ltd.) in China.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable, as no clinical study or test set requiring expert-established ground truth was performed for this submission. The device's "analysis feature" is offered on an advisory basis only, meaning its interpretive statements are not intended as definitive diagnoses.
4. Adjudication Method for the Test Set
Not applicable, as no clinical study or test set requiring adjudication was performed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The submission explicitly states "No clinical study is included in this submission." Therefore, no MRMC study was conducted, and no effect size calculation for human readers with or without AI assistance is available.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
While the device has an "analysis feature," the submission does not include any standalone performance study of this algorithm. The analysis feature provides "measurements and interpretive statements" on an "advisory basis only," indicating it's not cleared for diagnostic standalone use.
7. The Type of Ground Truth Used
Not applicable, as no clinical performance study requiring ground truth was conducted. For non-clinical tests (electrical safety, EMC, etc.), the "ground truth" would be the specifications and requirements of the relevant IEC standards.
8. The Sample Size for the Training Set
Not applicable. This device is an electrocardiograph hardware with an accompanying analysis feature. The submission does not describe a machine learning algorithm that underwent training with a specific dataset. The analysis function is likely based on pre-programmed algorithms rather than a trained AI model in the modern sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no described training set or AI model training in the submission.
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(116 days)
Digital Electrocardiograph
Digital Electrocardiograph is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and disease. Digital Electrocardiograph shall be used in healthcare facilities by doctors and/or trained healthcare professionals.
Digital Electrocardiograph, ECG-2000, is intended to acquire ECG signals from adult patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease.
It consists of the acquisition box, optional accessories, installation CD, and USB dongle. The acquisition box is connected with ECG electrodes, and intends to acquire ECG signals from patient. The acquired ECG signal is filtered and amplified, then transferred to the working station. The acquisition box is powered by the working station via a USB line. The working station is a Personal Computer installed with ECG-2000 Software, it intends to receive the processed ECG signal from the acquisition box, and further display and record the signals. Optional accessories include lead wires, limb electrodes and chest electrodes, and general-purpose printer (with USB interface, support PCL language, such as HP1010, P2035, and P2055d series). The CD contains Digital Electrocardiograph installer and dongle installation program module.
The provided document is a 510(k) premarket notification for a Digital Electrocardiograph, Model: ECG-2000. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study to prove the device meets acceptance criteria derived from a novel clinical trial.
Here's an analysis based on the provided text:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly define "acceptance criteria" in the context of a clinical performance study with specific metrics like sensitivity, specificity, accuracy, etc. Instead, it demonstrates compliance with technical specifications and safety standards to establish substantial equivalence. The "performance" reported is primarily in terms of meeting these engineering and safety benchmarks.
| Feature | Predicate Device 1 (K092010)
Description / Value | Proposed Device (ECG-2000)
Reported Performance |
|-----------------------|----------------------------------------------------|---------------------------------------------------|
| Product Code | DPS | DPS (Same) |
| Regulation Number | 21 CFR 870.2340 | 21 CFR 870.2340 (Same) |
| Class | Class II | Class II (Same) |
| Intended Use | Acquire ECG signals from adult patients to help analyze and diagnose heart disease. Used by healthcare professionals. | Acquire ECG signals from adult and pediatric patients to help analyze and diagnose heart disease. Used by healthcare professionals. (Similar: extended to pediatric patients)|
| Configuration | Chest Electrode and Limb Electrode | Chest Electrode and Limb Electrode (Same) |
| ECG Lead | Standard 12-lead | Standard 12-lead (Same) |
| ECG Gain | (Implied range from "Similar" to proposed device) | 1.25, 2.5, 5, 10, 20, 10-5, 20-10 (mm/mV) (More options than Predicate 1, Same as Predicate 2) |
| Sampling rate | 1000Hz | 1000Hz (Same) |
| Input circuit current | (Implied value from "Similar" to proposed device, complies with IEC 60601-1) | $\leq$ 0.1 μA (Complies with IEC 60601-1) |
| Noise level | (Implied value from "Similar" to proposed device, complies with IEC 60601-1) | $
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(211 days)
DIGITAL ELECTROCARDIOGRAPH
The intended use of electrocardiograph is to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However the ECG with measurements and interpretive statements is offered to clinician on an advisory basis only.
Digital Electrocardiograph, iE 3/ iE 6/ iE 12/ iE 12A/ iE 15/ ECG-1210/ ECG-3010/ ECG-6010, are intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However the ECG with measurements and interpretive statements is offered to clinician on an advisory basis only.
All the proposed models, iE 3/ iE 6/ iE 12/ iE 12A/ iE 15/ ECG1210/ ECG3010/ ECG6010, follow the same design principle, main components, accessories and software; they acquire ECG electrical signals from patient body surface by ECG electrodes. After been amplified, filtered and transferred, the ECG signal waveforms are displayed on the LCD and recorded on the paper through thermal printer.
They consist of four modules, which are power supply module, signal collection module, amplification module, and control module.
They can acquire ECG signal via twelve leads simultaneously, display or print waveform of ECG signal via three channel, six channel, twelve channel or fifteen channel.
The CardioPro analysis program is the analysis program used in this proposed device.
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative manner for specific performance metrics like accuracy, sensitivity, or specificity regarding the analysis and diagnosis of heart disease. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices and compliance with international safety and performance standards.
The table below summarizes the technical specifications and standards compliance, which implicitly serve as performance requirements for the device's functionality.
| Feature / Standard | Acceptance Criteria (Implied by Predicate & Standards) | Reported Device Performance |
|---|---|---|
| Product Code | DPS | DPS |
| Regulation Number | 21 CFR 870.2340 | 21 CFR 870.2340 |
| Lead Acquisition | Standard 12-lead (or 15-lead for proposed device) | Standard 12-lead or 15 lead |
| Acquisition mode | Simultaneous 12-lead acquisition | Simultaneous 12-lead or 15 lead acquisition |
| Recording format | Automatic / Manual / Rhythm | Automatic / Manual / Rhythm |
| Analysis mode | Yes (presence of analysis program) | Yes (CardioPro analysis program) |
| CMRR | >60dB | >60dB, >100 with AC filter |
| Paper Speed | Multiple levels (e.g., 6.25, 12.5, 25, 50mm/s) | 4-6 levels (e.g., 6.25, 12.5, 25, 50mm/s) |
| Input CIR current | ≤0.1μA | ≤0.1μA |
| Input impedance | >50MΩ | >50MΩ |
| Patient leak current |
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(392 days)
DIGITAL ELECTROCARDIOGRAPH
Digital Electrocardiograph is intended to acquire ECG signals from adult patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiograph shall be used in healthcare facilities by doctors and/or trained healthcare professionals.
Digital Electrocardiograph, ECG-2000, is intended to acquire ECG signals from adult patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease.
It consists of the acquisition box, optional accessories, installation CD, and USB dongle. The acquisition box is connected with ECG electrodes, and intends to acquire ECG signals from patient. The acquired ECG signal is filtered and amplified, then transferred to the working station. The acquisition box is powered by the working station via a USB line. The working station is a Personal Computer installed with ECG-2000 Software, it intends to receive the processed ECG signal from the acquisition box, and further display and record the signals. Optional accessories include lead wires, limb electrodes and chest electrodes, and general-purpose printer (with USB interface, support PCL language, such as HP1010, P2035, and P2055d series). The CD contains Digital Electrocardiograph installer and dongle installation program module.
The provided text is a 510(k) summary for a Digital Electrocardiograph (ECG-2000) and primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing and comparison of technical specifications. It does not contain information about acceptance criteria for device performance based on clinical studies, nor does it describe such a study.
Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance from a clinical study, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or how ground truth was established for a training set.
The document states that non-clinical tests were conducted to verify that the proposed device met all design specifications and complied with relevant IEC and EN standards for electrical safety, EMC, and particular requirements for electrocardiographs. It also mentions "Software Verification Test was performed to verify the software functions against its intended use." However, these are engineering verification tests, not clinical performance studies for diagnostic accuracy.
The closest to "acceptance criteria" presented in the document are the technical specifications compared with predicate devices, such as:
| Item | Acceptance Criteria (from predicate device comparison) | Reported Device Performance (Proposed Device) |
|---|---|---|
| Product Code | DPS | DPS |
| Regulation Number | 21 CFR 870.2340 | 21 CFR 870.2340 |
| Class | Class II | Class II |
| ECG Lead | Standard 12-lead | Standard 12-lead |
| Sampling rate | 1000Hz (at least for one predicate) | 1000Hz |
| Electrical Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1 |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 |
| Input circuit current | ≤0.1 μA (for one predicate) | ≤0.1 μA |
| Noise level |
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(352 days)
DIGITAL ELECTROCARDIOGRAPH
Digital Electrocardiographs are intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.
Digital Electrocardiographs, E30, E65, E70 and E80, are intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. There is no specific contraindication identified for the proposed devices.
The proposed devices acquire ECG electrical signals from patient body surface by ECG electrodes. After been amplified, filtered and transferred, the ECG signal waveforms are displayed on the LCD and recorded on the paper through thermal printer.
The components of the proposed devices, Digital Electrocardiograph, include: (1) chest electrodes (2) limb electrodes, (3) cable and (4) Batteries;
The provided text is a 510(k) Summary for a Digital Electrocardiograph. It describes the device's intended use, comparison to a predicate device, and non-clinical tests conducted to establish substantial equivalence. However, it does not contain any information regarding specific acceptance criteria for device performance, a study proving the device meets these criteria, or details about sample sizes, ground truth establishment, or expert involvement as requested.
The summary primarily focuses on demonstrating substantial equivalence to a predicate device by comparing intended use, technological characteristics, and compliance with general safety and performance standards (like IEC 60601-1 and AAMI EC11).
Therefore, based only on the provided text, I cannot fulfill most of your request.
Here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
- Information in text: The document states the device complies with certain standards (IEC 60601-1, IEC 60601-1-2, AAMI / ANSI EC11:1991/(R)2007, ISO 10993-5, ISO 10993-10). These standards define performance requirements, but the specific acceptance criteria and reported device performance against these criteria are not detailed in the summary. The text only mentions "Non clinical tests were conducted to verify that the proposed device met all design specifications" and that it "complies with the following standards."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Information in text: Not available.
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)
- Information in text: Not available. The device "can help users to analyze and diagnose heart disease," implying human interpretation, but no details of an expert-adjudicated test set are provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Information in text: Not available.
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
- Information in text: Not available. This device is an electrocardiograph for acquiring ECG signals, not an AI-assisted diagnostic tool discussed in the context of MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Information in text: Not available. The device is described as acquiring signals
and assisting users in analysis and diagnosis, not a standalone automated diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Information in text: Not available.
8. The sample size for the training set
- Information in text: Not available. (No mention of a training set for an algorithm).
9. How the ground truth for the training set was established
- Information in text: Not available. (No mention of a training set for an algorithm).
Summary of available information related to performance/acceptance criteria:
| Acceptance Criteria (Standards Met) | Reported Device Performance |
|---|---|
| IEC 60601-1 (Safety) | Complies w/ standard |
| IEC 60601-1-2 (EMC) | Complies w/ standard |
| AAMI / ANSI EC11 (Diagnostic ECG Devices) | Complies w/ standard |
| ISO 10993-5 (Cytotoxicity) | Non-Cytotoxicity |
| ISO 10993-10 (Irritation/Hypersensitivity) | Non-Irritation, Non-Sensitization |
Further Details:
- Test Set Sample Size & Provenance: Not provided.
- Experts for Ground Truth & Qualifications: Not provided.
- Adjudication Method: Not provided.
- MRMC Comparative Effectiveness Study: Not conducted/reported.
- Standalone Performance Study: Not conducted/reported.
- Type of Ground Truth Used: Not provided.
- Training Set Sample Size: Not applicable/provided (device is for signal acquisition, not an AI diagnostic algorithm with a training set).
- Training Set Ground Truth Establishment: Not applicable/provided.
The document focuses on demonstrating substantial equivalence to an existing legally marketed device (predicate device) by showing similar intended use, technological characteristics, and compliance with recognized performance and safety standards for electrocardiographs. It does not provide the kind of detailed clinical study data often found for AI/CADe devices.
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(148 days)
DIGITAL ELECTROCARDIOGRAPH
Digital Electrocardiographs are intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.
Digital Electrocardiographs, iE 3, iE 6, are intended to acquire, display and record ECG signals from adult and pediatric patients through body surface by ECG electrodes. ECG data result and patient information could be stored in the memory of the device. The obtained ECG records can help users to analyze and diagnose heart disease.
The provided text is a 510(k) summary for Digital Electrocardiographs (models iE 3, iE 6) and a letter from the FDA determining their substantial equivalence to a predicate device (iE 12). This document does not contain information about specific acceptance criteria, device performance metrics, or details of a study demonstrating the device meets such criteria.
The core of this document is a comparison between the proposed devices and a predicate device to establish "substantial equivalence," meaning that the new devices are as safe and effective as a legally marketed device. This is a regulatory pathway, not a clinical study demonstrating performance against specific benchmarks.
Therefore, many of the requested details cannot be extracted from this document.
Here's what can be inferred or directly stated from the provided text, and what is explicitly missing:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated in terms of performance metrics (e.g., sensitivity, specificity, accuracy for disease detection). The acceptance criteria, in the context of this 510(k), are primarily related to meeting design specifications and demonstrating substantial equivalence to the predicate device, especially regarding safety and intended use.
- Reported Device Performance: No specific numerical performance metrics are reported in this document. The document states a "Non-Clinical Test Conclusion" that "Non clinical tests were conducted to verify that the proposed device met all design specifications as vas Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: IEC 60601-1, IEC 60601-1-2." This refers to electrical safety and electromagnetic compatibility standards, not clinical performance for diagnosing heart disease.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not mentioned.
- Data Provenance: Not mentioned.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not mentioned, as a clinical study with ground truth established by experts is not detailed here.
4. Adjudication Method
- Not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- If done: No, an MRMC comparative effectiveness study is not described or referenced in this document. This submission focuses on establishing substantial equivalence to a predicate device based on technical characteristics and intended use, not on demonstrating improved human reader performance with AI assistance.
- Effect size of human readers improvement: Not applicable, as no such study is presented.
6. Standalone (Algorithm Only) Performance Study
- If done: No, a standalone performance study of an algorithm is not described or referenced. The device is a "Digital Electrocardiograph" which acquires, displays, and records ECG signals for users (doctors/trained professionals) to analyze and diagnose. While it "can help users to analyze and diagnose heart disease," the document does not detail an inherent diagnostic algorithm's performance.
7. Type of Ground Truth Used
- Not mentioned, as no clinical study requiring a ground truth is detailed.
8. Sample Size for the Training Set
- Not mentioned, as this document does not describe the development or training of an AI algorithm.
9. How Ground Truth for the Training Set Was Established
- Not mentioned, as this document does not describe the development or training of an AI algorithm.
Summary of what the document does provide:
- Device Models: iE 3, iE 6
- Intended Use: To acquire ECG signals from adult and pediatric patients through body surface ECG electrodes, with obtained records helping users to analyze and diagnose heart disease. To be used in healthcare facilities by doctors and/or trained healthcare professionals.
- Predicate Device: Digital Electrocardiographs, iE 12 (K122712)
- Regulatory Basis for Acceptance: Substantial Equivalence (SE) to the predicate device, demonstrated through non-clinical tests verifying compliance with design specifications and international safety and EMC standards (IEC 60601-1, IEC 60601-1-2).
- Key Comparison Points for SE: Intended use, technological characteristics, principles of operation, patient contact material, sterile/single use status, energy source, safety standards, and accessories are deemed equivalent to the predicate device.
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(195 days)
DIGITAL ELECTROCARDIOGRAPHS
Digital Electrocardiographs, IE3/ IE12/ IE12P/ IE15, are intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.
Digital Electrocardiographs, IE3/ IE12/ IE12/ IE15, are designed to acquire, analyze, display and record ECG signals from patient body surface by ECG electrodes. After been amplified, filtered and analyzed, the ECG signals waveforms and analysis results are displayed in the LCD and recorded in the paper through thermal printer. ECG data, analysis result and patient information could be stored in the memory of the device.
The device consists of three modules, which are power supply module, amplification module, and control module.
The device has three recording mode, AUTO mode, MAN mode and RHY mode,
They are standard twelve leads, including bipolar limb leads, augmented unipolar limb leads and unipolar chest leads.
The provided 510(k) summary for K131262 does not contain information related to a clinical study or performance data against specific acceptance criteria for the device's diagnostic capabilities. Instead, it focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing and technical specifications.
Therefore, many of the requested sections regarding acceptance criteria, study details, and performance metrics cannot be directly addressed from the provided document.
Here's a breakdown of what can be extracted and what is missing:
Description of Acceptance Criteria and Device Performance
The submission focuses on establishing substantial equivalence to predicate devices (K122712 and K123816) based on technical specifications and compliance with international standards, rather than defining specific diagnostic acceptance criteria for the device's analytical function.
The non-clinical tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate devices. The test results demonstrated compliance with the following standards:
- IEC 60601-1:1990+ A1:1993+ A11:1993+ A12:1993+ A13:1996, Medical electrical equipment, Part 1: General requirements for safety.
- IEC 60601-2-25:1993+A1:1999. Medical electrical equipment, Part 2-25: Particular requirements for the safety of electrocardiographs.
- IEC 60601-1-2: 2007, Medical electrical equipment, Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests.
Table of Acceptance Criteria and Reported Device Performance (Based on Technical Specifications and Compliance to Standards):
| Acceptance Criteria (from Predicate/Standard Compliance) | Reported Device Performance (K131262 Device) |
|---|---|
| Intended Use (Similar to predicates) | Acquires ECG signals, helps users analyze/diagnose heart disease |
| Lead (Standard 12-lead) | Standard 12-lead |
| Acquisition mode (Simultaneous 12-lead acquisition) | Simultaneous 12-lead acquisition |
| Recording format (Automatic / Manual / Rhythm) | Automatic / Manual / Rhythm |
| Analysis mode (No integrated analysis) | No (similar to predicates) |
| CMRR (>60dB, >100 with AC filter) | >60dB, >100 with AC filter |
| Paper Speed (4 or 6 levels) | 4 levels (6.25, 12.5, 25, 50mm/s) OR 6 levels (5, 6.25, 10, 12.5, 25, 50mm/s) |
| Input CIR current (50MΩ) | >50MΩ |
| Patient leak current ( |
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(77 days)
DIGITAL ELECTROCARDIOGRAPHS
Digital Electrocardiographs, iE 12A / iE 15S, are intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.
Digital Electrocardiographs, iE 12A / iE 15 / iE 15S, are designed to acquire, display and record ECG signals from patient body surface by ECG electrodes. After been amplified and filtered, the ECG signals waveforms are displayed in the LCD and recorded in the paper through thermal printer. ECG data result and patient information could be stored in the memory of the device.
All the models. iE 12A / iE 15 / iE 15S, of the proposed device. Digital Electrocardiographs, follow · the same design principle and similar technical specifications.
The provided text describes a 510(k) premarket notification for Digital Electrocardiographs (models iE 12A, iE 15, iE 15S). The submission focuses on demonstrating substantial equivalence to a predicate device (iE 12) rather than presenting a study with specific acceptance criteria related to clinical performance metrics like sensitivity, specificity, or reader improvement.
Therefore, many of the requested details, such as specific acceptance criteria for diagnostic performance, sample sizes for test and training sets for an AI algorithm, expert qualifications, adjudication methods, or MRMC study results, are not available in this document. This document primarily details the technical specifications and safety/EMC standards met by the device.
Here's a breakdown of what is available and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the sense of diagnostic performance metrics (e.g., sensitivity, specificity, AUC). Instead, it refers to verifiable technical specifications and compliance with international standards for safety and electrical performance. The "reported device performance" in this context refers to the device meeting these technical specifications and standards.
| ITEM | Acceptance Criteria (Predicate iE 12) | Proposed Device Performance (iE 12A / iE 15 / iE 15S) |
|---|---|---|
| Lead | Standard 12-lead | Standard 12-lead (iE 12A), Standard 12-lead/15-lead (iE 15, iE 15S) |
| Acquisition mode | Simultaneous 12-lead acquisition | Simultaneous 12-lead acquisition (iE 12A), Simultaneous 12-lead/15-lead acquisition (iE 15, iE 15S) |
| Recording format | Automatic / Manual / Rhythm | Automatic / Manual / Rhythm |
| Frequency response | 0.05~150Hz | 0.05 Hz |
| Noise level | 60dB, >100dB with AC filter | >60dB, >100dB with AC filter |
| Recording Speed | Six levels as 5, 6.25, 10, 12.5, 25, 50mm/s | Six levels as 5, 6.25, 10, 12.5, 25, 50mm/s |
| Input CIR current | ≤0.1μΑ | ≤0.1μΑ |
| Input impedance | >50ΜΩ | >50ΜΩ |
| External Input Impedance | ≥100k Ω | ≥100k Ω |
| External Input Sensitivity | 10mm/V±5% | 10mm/V±5% |
| External Output Impedance | ≤100 Ω | ≤100 Ω |
| External Output Sensitivity | 1V/mV±5% (at 10mm/mV) | 1V/mV±5% (at 10mm/mV) |
Study Proving Acceptance Criteria Met:
The document states: "Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: EN 60601-1, EN 60601-2-25, EN 60601-1-2, IEC60601-2-51."
The primary "acceptance criterion" for this 510(k) submission is demonstrating substantial equivalence to the predicate device, which is verified by meeting technical specifications and compliance with relevant safety and performance standards. The differences in frequency response and lead type for the proposed devices compared to the predicate were addressed by conducting relative standard tests to demonstrate compliance.
2. Sample size used for the test set and the data provenance
Not applicable/Not provided within the scope of this document. This submission focuses on technical specifications and substantial equivalence, not a clinical study with a patient test set for diagnostic algorithm performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. No diagnostic algorithm performance study is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not provided. No diagnostic algorithm performance study is described.
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 pertains to the hardware and basic signal acquisition capabilities of an electrocardiograph, not an AI-assisted diagnostic system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This document describes the ECG acquisition device itself, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable/Not provided. The "ground truth" here is compliance with engineering standards and technical specifications shown via bench testing.
8. The sample size for the training set
Not applicable/Not provided. No machine learning algorithm is described.
9. How the ground truth for the training set was established
Not applicable/Not provided. No machine learning algorithm is described.
In summary: This 510(k) submission is for a traditional Digital Electrocardiograph hardware device. The "acceptance criteria" and "study" described are focused on engineering specifications, electrical safety, and electromagnetic compatibility (EMC) through bench testing, to demonstrate substantial equivalence to a predicate device. It does not involve a clinical study to evaluate diagnostic performance of an AI algorithm.
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DIGITAL ELECTROCARDIOGRAPH
Digital Electrocardiographs, ECG-8080/ iE 3S/ iE 12/ iE 12P, are intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.
Digital Electrocardiographs, ECG-8080/ IE 3S/ iE 12/ iE 12P, are designed to acquire, display and record ECG signals from patient body surface by ECG electrodes. After been amplified and filtered, the ECG signals waveforms are displayed in the LCD and recorded in the paperthrough thermal printer. ECG data result and patient information could be stored in the memory of the device.
All the models, ECG-8080/ iE 3S/ iE 12/ iE 12P, of the proposed device, Digital Electrocardiographs, follow the same design principle and similar technical specifications.
The provided document is a 510(k) summary for Digital Electrocardiographs. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes for test and training sets, expert qualifications, or ground truth establishment methods.
The document indicates "Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." However, it does not provide specific performance criteria or results from these bench tests beyond compliance with general safety and EMC standards (IEC 60601-1, IEC 60601-2-25, IEC 60601-1-2).
Therefore, I cannot populate the table or answer the specific questions about the study that proves the device meets acceptance criteria based on the provided text.
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