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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 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.

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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 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.

The provided text is a 510(k) summary for the Philips M2376A DeviceLink System. It primarily focuses on the device's function, classification, and substantial equivalence to predicate devices. Crucially, this document does NOT contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) summary describes the device as one that "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." Its intended use is "for electronic data collection and clinical information management." It explicitly states that "DeviceLink is neither patient connected, nor does it remotely control the attached source device."

Because the device's function is data conversion and transmission within a medical information system, and not diagnostics or treatment, the regulatory approval process for such a device typically focuses on aspects like:

• Software Validation: Ensuring the software correctly performs its data conversion and transmission functions.
• Interoperability: Verifying it can correctly interface with various medical devices and clinical information systems.
• Data Integrity and Security: Ensuring data is accurately and securely transferred, without loss or corruption.
• Risk Management: Assessing and mitigating any potential risks associated with data handling.

However, the provided document does not detail any specific performance acceptance criteria or a study that evaluates these criteria. Therefore, I cannot extract the requested information.

If this were a diagnostic or AI-driven device, the information you requested would be critical. However, for a data integration device like this, the nature of "performance" and its "study" would be different and is not described in this 510(k) summary.

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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 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.

The provided text is a 510(k) summary for the M2376A DeviceLink System. It primarily focuses on regulatory information, device description, and indications for use. It does not contain information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a performance study.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document is a regulatory submission for market clearance, not a technical performance study report.

The DeviceLink System is described as a device that "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." Its function is for electronic data collection and clinical information management, and it is explicitly stated that it 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." This suggests its primary function is data transfer and formatting, rather than generating clinical insights or diagnoses that would typically require validation against medical performance metrics.

Ask a specific question about this device

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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