(4 days)
The M2376A DeviceLink System is indicated for use in data collection and clinical information management either directly or through networks with independent bedside devices.
The M2376A is not intended for monitoring purposes, nor is the M2376A intended to control any of the clinical devices (independent bedside devices / information systems) it is connected to.
The M2376A DeviceLink System receives digital data produced by external devices through device specific cables, converts that data into the HL7 format and transmits that information to any networked Clinical Information System.
This document describes the Philips M2376A DeviceLink System, a device intended for electronic data collection and clinical information management from external medical devices. However, the provided text does not contain information typically associated with acceptance criteria and studies proving device performance in the context of diagnostic or therapeutic medical devices.
Instead, this is a 510(k) summary filed with the FDA, primarily focusing on proving substantial equivalence to previously marketed devices. The key elements of this filing are:
- Device Description: What the DeviceLink system is and what it does (receives digital data from external devices, converts it to HL7, and transmits it to a Clinical Information System).
- Intended Use: For electronic data collection and clinical information management. Critically, it explicitly states it is not for monitoring purposes and does not control attached source devices. This clarifies its role as a data intermediary, not a diagnostic or treatment device itself.
- Predicate Devices: The 510(k) process relies on demonstrating that a new device is "substantially equivalent" to legally marketed predicate devices. The document lists several types of externally connected devices (e.g., blood pressure computers, cardiac monitors, infusion pumps) that the DeviceLink system can interface with.
Given this context, the questions you've asked about acceptance criteria and performance studies (sample size, ground truth, expert opinions, MRMC studies, standalone performance, training sets) are generally applicable to devices that make a diagnostic claim, provide a therapy, or have a direct impact on patient outcomes based on their own internal performance. The DeviceLink System, as described, is a data integration tool. Its "performance" would likely be evaluated on:
- Data Integrity: Does it accurately transmit the data received from the external devices?
- Data Format Conversion: Does it correctly convert data to HL7?
- Interoperability: Does it successfully connect and communicate with specified external devices and Clinical Information Systems?
- Reliability/Availability: Does it operate consistently without significant downtime or data loss?
The 510(k) summary provided does not detail specific studies or acceptance criteria for these types of performance metrics. The FDA's letter primarily acknowledges the review of the submission and the determination of substantial equivalence, which is a regulatory classification, not an endorsement of detailed performance study results in the common sense of device efficacy or diagnostic accuracy.
Therefore, I cannot populate the table or answer most of your detailed questions because the provided text does not contain that information for this specific type of device (a data integration system).
If this were a diagnostic AI device, for example, the information would be structured very differently, with explicit sensitivity, specificity, accuracy, and ROC curve analyses. For a data integration device, the "acceptance criteria" and "study" would likely refer to internal validation tests for data accuracy, throughput, and interoperability, which are not typically detailed in a publicly available 510(k) summary in the way you've outlined.
In summary, the provided document is a regulatory submission demonstrating substantial equivalence for a data integration device, not a performance study report for a diagnostic or therapeutic medical device.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).