(87 days)
Mac-Lab System: The Mac-Lab System is intended for monitoring, calculating and recording cardiovascular data from patients undergoing invasive cardiac catheterization procedures. The data may be manually entered or acquired via interfaced devices. ECG waveforms, heart rate, pulse oximetry (5p(2), respiration rate, EtCO2, temperature, valve gradients and areas, cardias output, hemodynamic measurements, invasive blood pressure, procedural information, and optional intracardiac electrocardiogram (IECG). The intornation can be displayed, trended, stored, printed, and or transmitted to other neworked hospital information systems. The system does not transmit alarns or arthythmias and does not have arthythmia detection capabilities.
CardioLab System: The Cardiol.ab System is intended to acquire, filler, digitize, amplify, display and record the electrical signals. Signal types acquired include ECG signals, direct cardials, temperature, ElCO2, and pressure recordings. Physiological parancers such as diastolic, systolic, and mean blood pressure, hear rate, and cycle length may be derived from the signal data, displayed and recorded. The system allows the user to montor the acquisition of data, and generate reports on the data. Additionally, the system may acquire, amplify, display and received from other interfaced medical devices typically used during thesy processed to such as imaging devices and ablation generators (i.e. RF and cryogenic).
The Cardiol.ab System does not coutrol the delivery of energy, administer drugs, perform any fife-sustaining functions, or analyze data acquired during the procedure. The Cardiol.ab System does not transmit alarms or arthythmias and does not have arrhythmia detection capabilities.
ComboLab System: The Combol.ab System is the combination of the both the Mac-Lab and CardioLab systems. The ComboLab System is intended for use in either a catheterization laboratory or electrophysiological laboratory and related specialty laboratories under the direct supervision of a ficensed healtheare practitioner. The User to run either the Mac-Lab System or the CardioLab System, although only one may be used at a time.
SpecialsLab System: The SpecialsLab is the same as the Mac-Lab. CardioLab systems. The SpecialsLab System is intended for use in cither a catheterization laboratory or electrophysiological laboratory and related specialty laboratories under the direct supervision of a licensed healtheare practitioner. SpecialsLab executes the same software, and runs on the same hardware. Products designated SpecialsLab will support fewer options than the Mac-Lab. Curdiol ab or ComboLab.
The product will be available in the following configurations: Mac-Lab application only, CardioLab application only, SpecialsLab only, or a combination of both CardioLab and Mac-Lab applications, marketed as Combol.ab. Products designated as SpecialsLab are identical to the Mac-Lab, Cardiol.ab or ComboLab Systems with the exception they will support fewer options. The SpecialsLab System performs the same intended use as the Mac-Lab, CardioLab or ComboLab, executes the same software, and runs on the same hardware. The product "CardioLab" was identified as "CardioLab EP" in the predicate device 510(k) submission K050093.
The Mac-Lab System: The Mac-Lab System is intended for monitoring, calculating and recording cardiovascular data from patients undergoing invasive cardiac catheterization procedures. The data may be manually entered or acquired via interfaced devices. Data includes: ECG waveforms, heart rate, pulse oximetry (SpO), respiration rate, EtCO2, temperature, valve gradients and areas, cardiac output, hemodynamic measurements, invasive and noninvasive blood pressure, procedural information, and optional intracardiac electrocardiogram (IECG). The information can be displayed, trended, stored, printed, and or transmitted to other networked hospital information systems. The system does not transmit alarms or arrhythmias and does not have arrhythmia detection capabilities.
Interfaced devices the system may acquire, amplify, display and record anatomical and physiological data from includes equipment typically used in conjunction with these procedures, such as imaging and data devices (e.g. X-ray, ultrasound, magnetic resonance, computed tomography, positron emission tomography, nuclear medicine. 12 lead ECG and information systems.)
The CardioLab System: The CardioLab System is intended to acquire. filter, digitize, amplify, display and record the electrical signal types acquired include ECG signals, direct cardiac signals. temperature, EtCO2, and pressure recordings. Physiological parameters such as diastolic, systolic, and mean blood pressure, heart rate, and cycle length mav be derived from the signal data, displayed and recorded. The system allows the user to monitor the acquisition of data, review the data, and generate reports on the data. Additionally, the system may acquire, amplify, display and record data received from other interfaced medical devices typically used during these procedures, such as imaging devices and ablation generators (i.e. RF and cryogenic).
The CardioLab System does not control the delivery of energy, administer drugs, perform any lifesupporting or life-sustaining functions. or analyze data acquired during the procedure. The CardioLab System does not transmit alarms or arrhythmias and does not have arrhythmia detection capabilities.
Interfaced devices the system may acquire, amplify, display and record anatomical and physiological data from includes equipment typically used in conjunction with these procedures. such as imaging and data devices (e.g. X-ray, ultrasound, magnetic resonance, computed tomography, positron emission tomography, nuclear medicine. 12 lead ECG and information systems.)
The ComboLab System: The ComboLab contiguration is the combination of both CardioLab and Mac-Lab applications, though only one application may be used at a time (CardioLab for electrophysiological lab cases and Mac-Lab for catheterization lab cases).
The SpecialsLab System: The SpecialsLab is the same as the Mac-Lab. CardioLab or ComboLab systems. The SpecialsLab System is intended for use in either a catheterization laboratory or electrophysiological laboratory and related specialty laboratories under the direct supervision of a ficensed healthcare practitioner. Specialst.ab executes the same software, and runs on the same hardware. Products designated SpecialsLab will support fewer options than the Mac-Lab. CardioLab or ComboLab.
The provided text describes a 510(k) submission for the GE Healthcare Mac-Lab/CardioLab/ComboLab/SpecialsLab System. This submission focuses on demonstrating substantial equivalence to a predicate device (Mac-Lab/CardioLab EP/ComboLab System K050093) rather than proving a device meets specific acceptance criteria through a clinical performance study involving diagnostic accuracy metrics.
Here's a breakdown based on your request, highlighting what is and isn't available in the provided document:
1. A table of acceptance criteria and the reported device performance
Based on the provided text, there are no specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) for a diagnostic AI model's performance stated, nor is there reported device performance against such criteria. The submission is a 510(k) for a medical system, not a diagnostic AI device requiring performance metrics.
The document states:
"The results of these measurements demonstrate that the Mac-I ab/CardioLab/ComboLab/SpecialsLab System is as safe, as effective, and performs as well as the predicate device."
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not applicable. The submission explicitly states, "No clinical performance data has been used to support the substantial equivalence claims."
- Data Provenance: Not applicable. The validation activities mentioned (Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level, Clinical Use Validation, Integration Testing, Final acceptance testing, Performance testing, Safety testing, Environmental Testing) are internal quality assurance and engineering tests, not clinical studies with patient data.
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. No clinical test set with ground truth established by experts was used.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No clinical test set requiring adjudication was used.
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, as the submission explicitly states no clinical performance data was used. This device is a system for monitoring, calculating, and recording cardiovascular data, not an AI for assisting human readers in diagnostic tasks.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm being evaluated for standalone diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No clinical ground truth was established for a diagnostic performance evaluation. The "ground truth" equivalent in this submission relates to the correct functioning of the system against its specifications, evaluated through various engineering and quality assurance tests.
8. The sample size for the training set
Not applicable. This submission concerns a medical device system, not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable for the same reason as above.
Summary of the Study that Proves the Device Meets Acceptance Criteria (as described in the document):
The provided document describes a 510(k) submission where GE Healthcare sought to demonstrate that their new Mac-Lab/CardioLab/ComboLab/SpecialsLab System is substantially equivalent to a legally marketed predicate device (Mac-Lab/CardioLab EP/ComboLab System, K050093). The primary method of proving this equivalence was through:
- Technology Comparison: The system employs the "same functional scientific technology" as the predicate device.
- Compliance with Standards: The device complies with voluntary standards detailed in Section 17.1 of their submission, "Specific Standards and Guidance's."
- Quality Assurance Measures: A comprehensive set of quality assurance measures were applied, including:
- Risk Analysis
- Requirements Reviews
- Design Reviews
- Unit-level testing (Module verification)
- Clinical Use Validation (This likely refers to internal validation of the system's functions in a simulated clinical setting, not a formal clinical trial with patient data as explicitly stated later).
- Integration Testing (System verification)
- Final acceptance testing (Validation)
- Performance testing
- Safety testing
- Environmental Testing
The submission explicitly states: "No clinical performance data has been used to support the substantial equivalence claims."
Therefore, the "acceptance criteria" in this context are not quantitative diagnostic performance metrics but rather the demonstration of substantial equivalence to a predicate device through engineering tests, adherence to standards, and compliance with quality assurance protocols to ensure safety, effectiveness, and performance parity.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).