(245 days)
The SA-20 Series recorder combines ambulatory ECG Holter and BP monitor. It is intended to acquire, store and display ambulatory ECG signals from adult and pediatric patient. It is capable of measuring systolic and diastolic blood pressures of adults and pediatrics (> 12 years) over a preprogrammed period of time. These measurements are displayed and stored in the recorder. It is intended to be used by trained personnel under the direction of doctors.
Holter ECG and ABP System (Model: SA-20, SA-19, SA-18, SA-15, SA-16) is composed of the recorder, NIBP cuff, lead wire. The ambulatory blood pressure adopts the principle of the oscillometric method for non-invasive blood pressure measurement. ECG signals are obtained by placing electrodes on the patient's surface to record the potential change signal of the human heart and then processing the data to form an ECG waveform and store it in the Recorder to monitor the ECG signal.
The provided text describes the Holter ECG and ABP System and its performance data to establish substantial equivalence to predicate devices. However, the document does not contain an acceptance criteria table or specific details of a study directly proving the device meets acceptance criteria in the format often associated with AI/ML algorithm validation (e.g., sensitivity, specificity, AUC).
Instead, the document focuses on non-clinical performance testing to demonstrate the device's adherence to relevant industry standards and functional specifications, ensuring its safety and effectiveness are comparable to the predicate devices.
Here's a breakdown of the information that can be extracted or inferred based on common medical device submission practices, acknowledging that explicit details on some points are missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal "acceptance criteria" table in terms of diagnostic performance metrics (e.g., sensitivity, specificity for disease detection). Instead, the performance evaluations are based on compliance with established medical device standards. The "reported device performance" is the successful compliance with these standards.
| Acceptance Criteria (Compliance with Standard) | Reported Device Performance (Status) |
|---|---|
| Electrical Safety and Electromagnetic Compatibility (EMC) | |
| ANSI AAMI ES 60601-1:2005/(R) 2012 and A1:2012, C1:2009(R) 2012 and A2:2010(R) 2012 (Medical electrical equipment - General requirements for basic safety and essential performance) | Complies |
| IEC 60601-1-2:2014 (Fourth Edition) (Medical electrical equipment – Electromagnetic disturbances - Requirements and tests) | Complies |
| Performance Testing - Bench | |
| IEC 60601-2-47 Edition 2.0 2012-02 (Medical electrical equipment - Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems) | Meets accuracy specifications, complies |
| IEC 80601-2-30: Edition 2.0 2018-03 (Medical electrical equipment - Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers) | Meets accuracy specifications, complies |
| ANSI AAMI EC53:2013/(R) 2020 (ECG trunk cables and patient leadwires) | Meets accuracy specifications, complies |
| IEC 60601-1-11 Edition 2.1 2020-07 (Medical electrical equipment - General requirements for basic safety and essential performance - Home healthcare environment) | Meets accuracy specifications, complies |
| Software Verification and Validation | Documentation provided as recommended by FDA guidance. |
2. Sample size used for the test set and the data provenance
The document states, "Clinical data: Not applicable," implying that the assessment for this 510(k) submission did not involve a clinical trial or a test set derived from patient data in the typical sense of evaluating diagnostic accuracy. The testing was primarily bench-based and software verification. Therefore, there's no "sample size for a test set" or "data provenance" related to patient data for diagnostic performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical test set for diagnostic performance was used. The "ground truth" for the non-clinical testing was defined by the specifications and requirements of the referenced industry standards.
4. Adjudication method for the test set
Not applicable, as no clinical test set for diagnostic performance 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
Not applicable. This device is a Holter ECG and ABP system (hardware for acquisition, storage, and display of physiological signals), not an AI/ML diagnostic algorithm designed to assist human readers or perform automated interpretations beyond basic parameter measurements.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm in the context of diagnostic interpretation. It is a device for signal acquisition and measurement. The "algorithm" for NIBP (oscillometric method) and ECG signal processing is inherent to the device's function, but it's not described as a standalone diagnostic algorithm requiring performance evaluation against a specific ground truth like an AI model would be.
7. The type of ground truth used
For the performance testing, the "ground truth" was the specifications and requirements defined by the referenced international and national consensus standards (e.g., IEC 60601 series, ANSI AAMI standards). The device's measurements (ECG signals, blood pressure) are verified against the expected outputs and accuracy tolerances dictated by these standards.
8. The sample size for the training set
Not applicable. This is not an AI/ML algorithm that requires a training set of patient data.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML algorithm that requires a training set.
Summary of the Study that Proves the Device Meets Acceptance Criteria (based on the document):
The "study" proving the device meets its "acceptance criteria" is a series of non-clinical performance tests and software verification and validation activities designed to demonstrate compliance with recognized medical device standards.
- Electrical Safety and EMC Testing: The device was tested against ANSI AAMI ES 60601-1 and IEC 60601-1-2 to ensure it is electrically safe and does not cause or succumb to electromagnetic interference.
- Performance Testing (Bench): Functional and system-level bench testing was conducted to validate the device's performance against the accuracy specifications and requirements outlined in:
- IEC 60601-2-47: For ambulatory electrocardiographic systems (ECG Holter functionality).
- IEC 80601-2-30: For automated non-invasive sphygmomanometers (ABP functionality).
- ANSI AAMI EC53: For ECG trunk cables and patient leadwires.
- IEC 60601-1-11: For devices used in the home healthcare environment.
These tests would involve simulating physiological signals or using calibrated equipment to ensure the device accurately acquires, processes, and displays ECG and ABP data within acceptable error margins defined by these standards.
- Software Verification and Validation: This involved rigorous testing of the device's embedded software to ensure it functions as intended, is free from critical bugs, and meets specified requirements, following FDA guidance for software in medical devices.
The conclusion drawn from these "non-clinical data" is that the "subject devices are as safe and as effective as the predicate device," thus establishing substantial equivalence for market clearance.
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).