(13 days)
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 format and transmits that information to any networked Clinical Information System.
This device is a data collection and clinical information management system, and as such, the typical performance metrics like sensitivity, specificity, or AUC as seen with diagnostic AI devices are not applicable. Instead, its "performance" is primarily defined by its ability to accurately receive, convert, and transmit data without loss or corruption, and its compatibility with various external medical devices.
No specific acceptance criteria or a study proving the device meets those criteria are explicitly detailed, but based on the nature of the device (a data link system), the implicit acceptance criteria would revolve around:
Implicit Acceptance Criteria (in the absence of explicit values):
- Data Integrity: The device must accurately transmit all data received from external devices without alteration or loss.
- Data Format Conversion: The device must correctly convert proprietary data formats from external devices into the HL7 standard.
- Connectivity: The device must successfully connect to and receive data from a defined list of external medical devices.
- Interoperability: The device must successfully transmit HL7 formatted data to networked Clinical Information Systems.
- Reliability/Stability: The device should operate consistently without errors or system crashes over extended periods.
Study Information (Based on the Provided Text):
The provided text does not describe a specific clinical study with quantitative performance metrics for the M2376A Device Link System. The document is a 510(k) summary for premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed performance study results with statistical outputs.
The primary "evidence" for this type of device typically comes from:
- Bench Testing/Verification & Validation (V&V): This would involve extensive testing to ensure accurate data parsing, conversion, and transmission with various connected devices under different operating conditions. This V&V would likely cover the "acceptance criteria" outlined above. Such testing is typically performed by the manufacturer's engineers.
- Compatibility Testing: Verifying that the M2376A Device Link System effectively communicates with all the listed external medical devices (e.g., blood pressure monitors, cardiac monitors, infusion pumps) and various Clinical Information Systems.
Since no specific study is detailed to quantify performance, most of the requested information cannot be directly extracted. However, based on the nature of the device and the 510(k) process, we can infer what would have been necessary.
Here's a breakdown of the requested information, acknowledging the limitations of the provided text:
-
A table of acceptance criteria and the reported device performance
Acceptance Criteria (Inferred) Reported Device Performance (Inferred/Implicit) Data Integrity: Accurate transmission of all data. The device "receives digital data produced by external devices... converts that data into the HL7 format and transmits that information..." (K021912, page 2 of 2). This implies accurate and complete processing. Data Format Conversion: Correct conversion to HL7. The device "converts that data into the HL7 format." This function is central to its purpose and would have been verified through V&V testing. Connectivity: Successful connection to specified devices. The device is "connected to a bedside device" and supports a range of external devices listed in the table (e.g., blood pressure, cardiac monitor). Compatibility testing would confirm this. Interoperability: Successful transmission to CIS. The device "transmits that information to any networked Clinical Information System." This suggests successful integration and data transfer. Reliability/Stability Not explicitly stated, but standard for medical devices; would have been assessed during V&V. -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. For a device link system, the "test set" would likely be a combination of various types of data signals/messages from a range of connected devices, and the number of test cases run through the system. This would be part of engineering V&V rather than a clinical trial with patient data.
- Data Provenance: Not applicable in the context of a clinical study. The "data" would be test data generated from medical devices in a lab environment.
-
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 as this is a data integration device, not a diagnostic one requiring expert interpretation of medical images or patient conditions for ground truth. Ground truth for this device would be established by comparing the output of the Device Link System (HL7 data) with the known input data from the external device, which is an engineering verification task. Engineers and IT specialists with expertise in HL7 and medical device communication protocols would verify the system's output.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically used when there's subjective interpretation involved, such as in image reading. For a data transmission device, the "correctness" is objective (did the data transmit accurately, completely, and in the correct format?).
-
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
- No. An MRMC study is completely irrelevant for this type of device. This device does not involve human "readers" interpreting output for diagnostic purposes, nor does it incorporate AI for diagnostic assistance. It is a data conduit.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device is essentially "standalone" in its function as an algorithm-only component that receives, converts, and transmits data. Its performance would inherently be evaluated without human-in-the-loop interaction for its core function. The "human-in-the-loop" would be the clinician interacting with the clinical information system where the data ends up, but not with the Device Link itself for its data transfer function.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Engineering Ground Truth: The ground truth would be the original digital data generated by the connected external medical devices, which would then be compared bit-for-bit or field-for-field with the HL7 output from the M2376A Device Link System. This ensures no data loss or corruption and correct formatting.
-
The sample size for the training set
- Not applicable. This device is not an AI/machine learning device that requires a "training set." It performs deterministic data conversion and transmission based on programmed rules and protocols.
-
How the ground truth for the training set was established
- Not applicable, as there is no training set for this type of device.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).