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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.

Here's an analysis of the provided text regarding acceptance criteria and study details:

The provided document (K033680) is a 510(k) summary for the Philips M2376A DeviceLink System, submitted to the FDA in 2003. This document focuses on establishing substantial equivalence to a predicate device for regulatory clearance, primarily by describing the device's function and intended use.

Critically, the provided text DOES NOT contain specific information about:

• Acceptance Criteria for Device Performance: The document describes the function of the device (receiving, converting, and transmitting data) and its intended use (data collection and clinical information management), but it doesn't define any quantitative or qualitative performance metrics (e.g., data accuracy, latency, error rates) that the device must meet.
• Studies Proving Device Meets Acceptance Criteria: Since no acceptance criteria are explicitly stated for device performance, there are no details of a study designed to prove the device meets such criteria. The 510(k) process primarily assesses substantial equivalence, which often involves comparing the new device's technological characteristics and intended use to a legally marketed predicate, rather than extensive performance studies against pre-defined acceptance criteria for a novel functionality.
• AI/ML Specifics: The device, as described, is a data integration system and does not appear to incorporate artificial intelligence or machine learning components. Therefore, questions related to AI-specific studies (e.g., MRMC, standalone AI performance) are not applicable.

However, based on the information available, we can extract the following:

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

Explanation: The document does not provide quantifiable "acceptance criteria" in the sense of performance thresholds (e.g., "data conversion must achieve 99% accuracy"). Instead, the "acceptance criteria" for K033680 are primarily related to:

• Functional capabilities: What the device does.
• Intended Use: How the device should be used and not used.
• Safety characteristics: Design elements that prevent potential hazards.

The "reported device performance" in the table above consists of descriptive statements from the document itself, outlining the device's capabilities and limitations as stated by the manufacturer for regulatory review. There are no results from specific performance tests against numerical targets.

Additional Information (as requested, but not explicitly present for this device's performance):

2. Sample size used for the test set and the data provenance: Not applicable as no performance study with a test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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. The device is a data integration system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device is a data integration system, not an algorithm with performance evaluated in isolation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary based on the provided K033680 document:

The K033680 document is a regulatory submission for a data integration device. Its primary purpose is to demonstrate substantial equivalence to a predicate device by describing its intended use, technological characteristics, and safety features. It doesn't include details of performance studies against specific, quantifiable acceptance criteria, as might be found for devices with diagnostic or therapeutic functions that require extensive clinical or technical performance validation. The "acceptance" in this context refers to FDA's determination of substantial equivalence, allowing the device to be marketed.

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