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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 Device Link 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.

The provided text is a 510(k) summary for the M2376A Device Link System, a device intended for electronic data collection and clinical information management by converting data from external medical devices into HL7 format and transmitting it to clinical information systems.

Based on the provided document, a study proving the device meets acceptance criteria is not included. The 510(k) summary describes the device, its intended use, and its classification, but it does not contain information about:

• Acceptance criteria for device performance.
• Results of a study demonstrating performance against any criteria.
• Details about sample sizes, data provenance, ground truth establishment, or expert involvement for such a study.
• Any mention of standalone algorithm performance or multi-reader multi-case studies.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing new clinical performance data in the same way a PMA would require. The document outlines regulatory classification and intent for marketing, but no performance study is detailed within.

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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 Device Link 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.

The provided text describes a 510(k) summary for the M2376A Device Link System. However, it does not contain any information about acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, or expert involvement. The document primarily focuses on:

• Submitter Information: Contact details for Agilent Technologies.
• Device Name and Classification: M2376A Device Link System, common name HP Device Link, and a list of associated device regulations and pro codes.
• Device Description: The system receives digital data from external devices, converts it to HL7 format, and transmits it to a Clinical Information System.
• Intended Use: Electronic data collection and clinical information management; explicitly states it is not patient connected, for monitoring, or for controlling attached devices.
• FDA Clearance Letter: A letter from the FDA confirming substantial equivalence to legally marketed predicate devices and outlining regulatory responsibilities.
• Indications for Use: Reiterates its purpose for data collection and clinical information management, and specifies what it is not intended for.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

The document is a regulatory submission for a device that facilitates data transfer and management, not a diagnostic or therapeutic device whose performance would typically be evaluated with metrics like sensitivity, specificity, or accuracy against a ground truth. Its "performance" would likely be related to data integrity, successful transmission, and compatibility, which are implicitly covered by substantial equivalence in this context but not detailed in the provided summary.

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Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device