(31 days)
CG-7000DX Recorder/Transmitter is a 12 Lead ambulatory electrocardiograph capable of recording and transmitting up to 40 standard ECGs for the purpose of cardiac monitoring and diagnosis, which incorporates a recording and transmitting circuitry, graphic LCD, a package of firmware tools and is intended for use by a medical professional:
a. The ECG is recorded and transmitted to a remote receiving station for consultation with a cardiologist.
b. The ECG is recorded and transferred to a PC for viewing and processing.
CG-7000DX Recorder/Transmitter is a 12 Lead ambulatory electrocardiograph capable of recording and transmitting up to 40 standard ECGs for the purpose of cardiac monitoring and diagnosis, which incorporates a recording and transmitting circuitry, graphic LCD, a package of firmware tools and is intended for use by a medical professional.
The provided text describes the CG-7000DX Recorder/Transmitter, a 12-lead ambulatory electrocardiograph. However, the document is a 510(k) Summary of Safety and Effectiveness for a medical device and does not contain a study that proves the device meets specific acceptance criteria in the typical format of a clinical or performance study report.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (CG-7000D) and lists various verification, validation, and environmental tests conducted as part of design controls. These tests ensure the device's compliance with design specifications and relevant standards, but they are not presented as a study with reported performance against quantitative acceptance criteria in the way a clinical trial or performance study would be.
Therefore, many of the requested fields cannot be directly extracted from the provided text. I will fill in what can be inferred and indicate where information is not present.
Description of Acceptance Criteria and Device Performance
The CG-7000DX Recorder/Transmitter is indicated for recording and transmitting up to 40 standard 12-lead ECGs for cardiac monitoring and diagnosis. The primary "acceptance criterion" for this 510(k) submission is substantial equivalence to its predicate device, the CG-7000D ECG Recorder/Transmitter (K942704). The document attests that the CG-7000DX is as safe, effective, and performs as well as or better than the predicate device.
The acceptance criteria are implicitly defined by compliance with the following standards and successful completion of the listed verification, validation, and environmental tests:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Standards & Tests) | Reported Device Performance (as stated in the document) |
|---|---|
| Standards Compliance: | |
| ANSI/AAMI EC38, "Ambulatory Electrocardiographs" 1994 | Met |
| ANSI/AAMI EC13 Cardiac Monitors, Heart Rate Meters and Alarms, 200 edition 1992 | Met |
| ANSI/AAMI EC11 Diagnostic Electrocardiographic Devices, 2nd edition 1991 | Met |
| IEC-601-1-4 Medical Electrical Equipment 1996 | Met |
| Design Control Tests: | |
| SW Unit/Module Testing (19 tests) | Conducted, device compliant with design specifications |
| User Interface Verification Test | Conducted, device compliant with design specifications |
| Reference Voltage Verification Test | Conducted, device compliant with design specifications |
| Clock Oscillator Verification Test | Conducted, device compliant with design specifications |
| Flash Memory Verification Test | Conducted, device compliant with design specifications |
| LPF Verification Test | Conducted, device compliant with design specifications |
| QRS Detection Test | Conducted, device compliant with design specifications |
| PM Pulse Detection Test | Conducted, device compliant with design specifications |
| Patient Cable Test | Conducted, device compliant with design specifications |
| Common Mode Rejection Test | Conducted, device compliant with design specifications |
| Frequency Response Test | Conducted, device compliant with design specifications |
| Input Dynamic Range Test | Conducted, device compliant with design specifications |
| Overall System Error Test | Conducted, device compliant with design specifications |
| Step Response Test | Conducted, device compliant with design specifications |
| System Noise Test | Conducted, device compliant with design specifications |
| Safe Current Test | Conducted, device compliant with design specifications |
| High and Low Temperature and Humidity Test | Conducted, device compliant with design specifications |
| Surface Temperature Test | Conducted, device compliant with design specifications |
| Leakage Current Test | Conducted, device compliant with design specifications |
| Dielectric Strength Test | Conducted, device compliant with design specifications |
| Mechanical Vibration Shock Test | Conducted, device compliant with design specifications |
| Ingress of Liquids Test | Conducted, device compliant with design specifications |
| EMC Test | Conducted, device compliant with design specifications |
| Biocompatibility Evaluation | Satisfactory |
| System Safety and Risk Analysis | Conducted, rigorous design and structural evaluation |
| Level of Concern | Characterized as a moderate level of concern system |
| Clinical Performance: | "As safe, as effective and performs as well as or better than the legally marketed predicate device, CG-7000D ECG Recorder/Transmitter (K942704)." |
Study Details:
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Sample size used for the test set and the data provenance:
- The document mentions "laboratory testing" and "clinical and laboratory testing" but does not specify sample sizes for any test sets related to performance evaluation (e.g., number of ECGs, number of patients, etc.).
- The provenance of any data (e.g., country of origin, retrospective/prospective) is not mentioned.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not mentioned. The document describes engineering/design control tests and claims substantial equivalence, but it does not detail a study involving expert-established ground truth for diagnostic performance. The intended use includes "consultation with a cardiologist" but this refers to the use of the device, not the validation of its performance in a clinical study as described.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not mentioned. As detailed above, there is no described study requiring an adjudication method.
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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 such study was done or reported. The device is an ECG recorder/transmitter, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable in the context of diagnostic AI. The device itself has internal algorithms (e.g., QRS detection, PM Pulse Detection), which were tested as part of the "SW Unit/Module Testing" and other verification tests. However, these are part of the device's basic functionality, not a "standalone performance" study in the sense of an independent diagnostic algorithm. The device's primary function is data acquisition and transmission, not automated diagnosis.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated for diagnostic accuracy. For the functional tests (e.g., QRS detection, frequency response), the "ground truth" would be the expected technical specifications and performance characteristics, typically established by design requirements and engineering standards. For the overall claim of "safe and effective," the ground truth is established by compliance with recognized standards and successful completion of the described verification and validation tests, implying that the device accurately records and transmits ECG signals as per its design.
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The sample size for the training set:
- Not applicable/Not mentioned. This information would typically be relevant for machine learning-based devices. The CG-7000DX is a hardware device with firmware, not a learning algorithm product.
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How the ground truth for the training set was established:
- Not applicable/Not mentioned. (See point 7).
§ 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).