Search Results

The SmartLinx Vitals Plus Patient Monitoring System is intended for monitoring and alarming of physiologic parameters, including non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, functional arterial oxygen saturation (SpO2), and temperature, on adult, pediatric, and neonatal patients in hospital environments when used by clinical physicians or appropriate medical staff under the direction of physicians.

The predicate device, SmartLinx Vitals Plus Patient Monitoring System, was cleared in K180734. The SmartLinx Vitals Plus Patient Monitoring System operates on top of the SmartLinx Medical Device Information System (MDIS) to present patient information to the clinical user for active monitoring purposes at the point of care. The proposed SmartLinx SmartLinx Vitals Plus Patient Monitoring System is similar to the predicate SmartLinx Vitals Plus Patient Monitoring System, cleared in K180734. The change being proposed is to integrate the SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus Alarm Hub and Nellcor SpO2 Pulse Oximetry Module into one module or backpack configuration; and the alternative Masimo SpO2 pulse oximetry cable will continue to be connected to the same place as with the predicate. There is no change to the performance or functionality of the device. There is no change to the indications for use or intended use.

The provided text describes a 510(k) submission for a patient monitoring system, focusing on a configuration change rather than a new AI algorithm for diagnosis or treatment. Therefore, many of the requested elements for AI-based device studies (like sample sizes for test/training sets, expert ground truth, adjudication methods, or MRMC studies) are not applicable or explicitly mentioned in this document.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

Acceptance Criteria and Reported Device Performance

The core "acceptance criteria" in this submission revolve around demonstrating substantial equivalence to a previously cleared predicate device. This is achieved by showing that the proposed device, despite a configuration change, does not raise new questions of safety and effectiveness and performs equivalently to the predicate.

• Electromagnetic Compatibility, Electrical Safety, and Safety Standards (e.g., ANSI AAMI ES 60601-1, IEC 80601-2-30 for NIBP, IEC 60601-1-2 for EMC, IEC 60601-2-49 for multifunction monitoring, ISO 80601-2-61 for pulse oximetry, IEC 60601-1-8 for alarms)
• Usability (IEC 60601-1-6, IEC 62366-1)
• Software (IEC 62304:2006)
• Batteries (IEC 62133:2012) |
  | Equivalence in Design, Features, and Functionality to Predicate | The study concluded that the proposed system results in an equivalent design, features, and functionality with "few exceptions that do not raise new questions of safety or effectiveness." |

Study Information (based on provided text):

1. Sample size used for the test set and the data provenance: This information is not provided in the document. The testing described is primarily focused on demonstrating physical and functional equivalence of hardware and software components through bench testing and adherence to standards, rather than evaluating performance against a clinical test set in the way an AI algorithm would be. The document does not specify the number of devices or scenarios used in the "performance testing."

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable to this submission. The device is a patient monitoring system, not an interpretive AI algorithm that requires expert-established ground truth for performance evaluation in a clinical test set.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: This is not applicable for the reasons mentioned above.

4. 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: This is not applicable. This submission is for a patient monitoring system with a configuration change, not an AI-assisted diagnostic tool.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This is not applicable. The device is a monitoring system intended for use by clinical physicians or appropriate medical staff, inherently involving human interaction. The submission does not describe a standalone algorithm performance.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the performance testing conducted, the "ground truth" would be established by the specifications and expected outputs of the individual physiological parameter modules (NIBP, SpO2, Temperature) as defined by their respective recognized standards (e.g., accuracy requirements for NIBP monitors per IEC 80601-2-30). The document refers to "bench testing," "testing to FDA recognized consensus standards," and "software verification and validation testing," inferring that these standards define the expected "truth" or acceptable performance ranges.

7. The sample size for the training set: This is not applicable. The device is not an AI/ML model that undergoes a training phase.

8. How the ground truth for the training set was established: This is not applicable for the reasons mentioned above.

Summary of the Study:

The "study" in this context is a comprehensive set of performance testing designed to demonstrate that a design configuration change to an existing, cleared patient monitoring system (SmartLinx Vitals Plus Patient Monitoring System, K180734) does not negatively impact its safety, effectiveness, or functionality.

The study involved:

• Bench Testing: To ensure the modified hardware and integrated components perform as expected.
• Software Verification and Validation Testing: To confirm the software (SmartLinx Vitals Plus Application, SmartLinx EWSS) functions correctly with the new configuration.
• Conformance to FDA Recognized Consensus Standards: This involved extensive testing against standards such as those for electrical safety (ANSI AAMI ES 60601-1), NIBP accuracy (IEC 80601-2-30), SpO2 accuracy (ISO 80601-2-61), electromagnetic compatibility (IEC 60601-1-2), usability (IEC 62366-1), alarm systems (IEC 60601-1-8), and software lifecycle processes (IEC 62304).

The document explicitly states: "This Special 510(k) for the proposed SmartLinx Vitals Plus Patient Monitoring System did not require clinical studies to support substantial equivalence." This reinforces that the focus was on technical and functional equivalence through non-clinical testing.

Ask a specific question about this device