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510(k) Data Aggregation
(78 days)
The MDP2000 is intended for use in conjunction with patient monitoring equipment. The MDP2000 is not patient connected. It accepts analog and/or digital physiological information from patient monitoring equipment and processes these signals to provide outputs to:
- Color monitors for local and remote display of information
- Chart recorders or printers for hardcopy records
- Media for storage
- Other devices to share information
Examples of areas where the MDP2000 is used include ICU, CCU, PACU, Emergency, Telemetry, Stepdown and other areas where patient's physiological information are to be observed at one or more locations. Typical information displayed includes ECG and blood pressure waveforms and numeric values such as heart rate and systolic, mean, and diastolic pressure.
The MDP2000 is intended for use in conjunction with patient monitoring equipment. The MDP2000 is not patient connected. It accepts analog and/or digital physiological information from patient monitoring equipment and processes these signals to provide outputs to:
- Color monitors for display of information
- Chart recorders or printers for hardcopy records
- Media for storage
- Other devices to share information
Here's a breakdown of the acceptance criteria and study information for the VIDCO MDP2000, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conformance to UL2601 (domestic standard of IEC 601-1) | Tested to and conforms with UL2601 (as a Class I Type B device). ETL listed indicating conformance. |
| Conformance to EN60601-1-2 (IEC 601-1-2) for Electromagnetic Compatibility (EMC) | Tested to and conforms to the requirements of EN60601-1-2. EMC performance exceeds the predicate devices. |
| Bench testing of specifications as called out in the Engineering Instrument Specification (integral part of the Device Master Record) | All tests were completed successfully. MDP2000 meets its specified performance. |
| Conformance to ANSI/AAMI EC13 (1992) Heart Rate Meters & Alarms | Performance includes those related to ANSI/AAMI EC13 (1992) Heart Rate Meters & Alarms. |
| Performance equivalent to or better than predicate devices | MDP2000 performance results are equivalent to or better than the predicate devices. |
| Safety and Effectiveness compared to predicate devices | No new questions of safety or effectiveness as it is performing essentially the same functions as the predicate devices. No new hazards arise. |
2. Sample size used for the test set and the data provenance
The document does not specify a separate "test set" with a specific sample size in the context of clinical data. The primary validation method described is "bench testing of specifications." There is no mention of clinical data, human subjects, or specific data provenance like country of origin or retrospective/prospective study design, as the device is not patient-connected and its approval is based on substantial equivalence and technical performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The validation method described is "bench testing of specifications" and regulatory standard conformance, not expert-adjudicated clinical data.
4. Adjudication method for the test set
Not applicable. The validation method described is "bench testing of specifications" to predefined engineering and regulatory standards.
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. The MDP2000 is a "Medical Data Processor" and not an AI-powered diagnostic tool that assists human readers. Its function is to process and display physiological information from existing patient monitoring equipment.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a "standalone" system in its function. Its performance is evaluated based on its ability to process and output data according to established technical specifications and regulatory standards without human intervention being part of its core performance evaluation in the described tests. However, it's crucial to understand that it is intended for use in conjunction with patient monitoring equipment and for displaying information to human users. Therefore, its ultimate purpose is human-in-the-loop, but the device's individual performance (as described in the validation) is standalone from human judgment.
7. The type of ground truth used
The ground truth for the device's performance is based on:
- Engineering Instrument Specifications: These define the expected technical performance characteristics.
- Regulatory Standards: UL2601 (IEC 601-1), EN60601-1-2 (IEC 601-1-2), and ANSI/AAMI EC13 (1992). Compliance with these standards serves as the ground truth for safety, electrical performance, EMC, and specific physiological parameter processing (like heart rate).
- Predicate Device Performance: The device's performance is also compared against and expected to be equivalent to or better than existing predicate devices, implying their established performance serves as a benchmark and a form of ground truth for substantial equivalence.
8. The sample size for the training set
Not applicable. As a medical data processor, the device's validation is based on engineering specifications and regulatory compliance, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a machine learning model.
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