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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 correctly 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 Medical Systems M2376A DeviceLink System. This document focuses on demonstrating substantial equivalence to a predicate device and obtaining market clearance, rather than conducting a detailed performance study with acceptance criteria in the manner typically associated with AI/ML-based medical devices or diagnostic tools.

Therefore, many of the requested elements for a performance study (like acceptance criteria, sample sizes for test/training sets, ground truth establishment by experts, MRMC studies, standalone performance, etc.) are not applicable or not present in this type of regulatory submission. The DeviceLink System appears to be an electronic data collection and clinical information management system, not a diagnostic algorithm that produces results needing expert adjudication or performance metrics like sensitivity/specificity.

Here's why each point is largely not applicable or cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance

   • Not applicable / Not Present: The document describes the functionality of the device (receiving digital data, converting to HL7, transmitting to CIS) and its intended use (electronic data collection, clinical information management). It does not present quantitative performance metrics (e.g., accuracy, precision, latency) against specific acceptance criteria because it's not a diagnostic or treatment device with such outputs. The regulatory focus is on its ability to safely and effectively transfer data, and its substantial equivalence to existing devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not applicable / Not Present: There is no mention of a "test set" in the context of evaluating diagnostic performance. The device is a data integration system. Its "testing" would revolve around verifying proper data transmission and conversion, rather than analyzing a dataset for diagnostic accuracy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not applicable / Not Present: "Ground truth" in the context of diagnostic accuracy is not relevant for this device. Its function is data integration.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not applicable / Not Present: Adjudication methods are used to resolve discrepancies in expert readings for diagnostic algorithms. This concept doesn't apply to a data integration system.

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 / Not Present: The DeviceLink System is not an AI-assisted diagnostic tool for human readers. It's a data transfer system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • Not applicable / Not Present: This is not an algorithm-only diagnostic device. Its "performance" would be related to its ability to correctly process and transmit data, which would be verified through system integration testing, but not typically described in terms of "standalone performance" like a diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • Not applicable / Not Present: As discussed, the concept of "ground truth" for diagnostic purposes is not applicable to this data integration device.

8. The sample size for the training set

   • Not applicable / Not Present: Since this is not an AI/ML device that learns from a training set, the concept of a "training set" is irrelevant.

9. How the ground truth for the training set was established

   • Not applicable / Not Present: See point 8.

Summary based on the Provided Text:

The Philips Medical Systems M2376A DeviceLink System is a device intended for electronic data collection and clinical information management by receiving digital data from external devices, converting it to HL7 format, and transmitting it to a networked Clinical Information System. It is explicitly stated that the device is not for monitoring purposes, nor does it control any connected clinical devices.

The 510(k) submission focuses on establishing substantial equivalence to existing predicate devices, as per the FDA's regulatory pathway for such devices. The document lists the types of external medical devices it can connect to and their respective regulatory classifications and product codes. The "Indications for Use" statement defines its intended function: "data collection and clinical information management either correctly or through networks with independent bedside devices."

The regulatory review process, as evidenced by the FDA letter, confirms that the agency "reviewed your Section 510(k) premarket notification of intent to market... and have determined the device is substantially equivalent (for the indications referenced above) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976." This determination allows the device to proceed to market under general controls.

In conclusion, the document does not present a typical performance study with acceptance criteria because the device's nature (data integration) and the regulatory pathway chosen (510(k) for substantial equivalence) do not require such a study for market clearance. The "proof" the device meets acceptance criteria lies in its demonstration of substantial equivalence to already cleared devices performing similar data handling functions, and its adherence to general controls and good manufacturing practices.

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 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.

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 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 Device Link 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 6xemat and transmits that information to any networked Clinical Information System.

This submission does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) summary for the M2376A Device Link System, a device that collects digital data from external medical devices and transmits it to clinical information systems. It primarily describes:

• Device Identification: The name, common name, and classification of the device and connected external devices.
• Intended Use: How the device functions (data conversion and transmission) and its purpose (electronic data collection and clinical information management).
• Limitations: What the device is not intended for (patient connection, remote control, monitoring).
• Regulatory Communication: An FDA letter of substantial equivalence, confirming the device's classification and allowing it to be marketed.

There is no mention of performance metrics, acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement for evaluating the device's efficacy or accuracy. The "study" referenced in the prompt (and relevant for AI/ML devices) is absent in this traditional medical device submission for a data link system.

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 External us noos through anformation to any networked Clinical Information System.

When connected to a bedside device, the M2376A Device Link System is intended for electronic data collection and clinical information management. is intended for olocionis data collected, nor does it remotely control the attached source device.

This is a 510(k) summary for a medical device called the M2376A Device Link System. This document does not describe the acceptance criteria and the study that proves the device meets the acceptance criteria. It focuses on the regulatory submission, classification, and intended use of the device.

Therefore, I cannot provide the requested information from the provided text.

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.

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, convents that data into the HL7 external devices through device specific cables, oblivery and the comments of the System.

The provided text is a 510(k) summary for the M2376A Device Link System, a medical device intended for electronic data collection and clinical information management. The document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It primarily focuses on the regulatory submission details, device description, intended use, and substantial equivalence determination.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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 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