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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.

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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, 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