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510(k) Data Aggregation
(84 days)
MEDISERVE INFORMATION SYSTEMS, INC.
The VentLink system is intended for use with specified or validated ventilator devices to obtain ventilator data and provide the user with the ability to display, store, print and otherwise process that data to other interfaced systems. VentLink is not connected directly to any patient nor does the VentLink device remotely control any connected ventilator device.
The VentLink system is intended for use in any clinical setting while interfaced to any specified or validated ventilator device. The VentLink system is intended to provide a secondary display of data received from an interfaced ventilator device to appropriately configured workstations and wireless laptop computers and to be made available to any interfaced hospital information system (HIS).
The VentLink system is a device composed of MediServe Information Systems' proprietary software and various off-the-shelf hardware, operating system software and third-party proprietary software intended to be interfaced with specified or validated ventilator devices to allow authorized users to move ventilator patient data to wireless laptops and workstations configured with MediServe Information Systems' MediLinks data storage software. Additionally, the VentLink system allows users to move ventilator data to the user's hospital information system (HIS). It is intended to be used in an environmentally controlled hospital and hospital type environment.
The VentLink system software allows users to:
- Enable or disable automatic device data collection.
- Set a default data collection time interval.
- Specify how long unauthenticated data will be retained.
- Alert the user when data collection is paused.
After user review and validation of results received via the Ethernet the results are stored short-term on the VentLink system and transmitted to MediLinks for acceptance and storage.
Specified or validated ventilator devices are interfaced and added to the VentLink system through VentLink's devices' dictionary.
The VentLink system does not alter or change any patient data, but does allow the user to display the received patient data.
VentLink will function within a wide array of connectivity modules which allow VentLink to adapt to the evolving connectivity technology.
VentLink also has advanced device-management functionality.
The provided document is a 510(k) Premarket Notification for the VentLink™ System, submitted to the FDA in 2005. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical performance studies with detailed acceptance criteria and statistical analyses as would be expected for a novel device or a PMA submission.
Therefore, much of the requested information regarding detailed acceptance criteria, specific study designs (like MRMC), sample sizes, and ground truth establishment, which are typical for clinical performance evaluations, is not present in this 510(k) summary.
Here's an attempt to answer the questions based only on the provided text, highlighting where information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" or provide a table of "reported device performance" in a manner typical of a clinical efficacy study. Instead, the "acceptance criteria" for this 510(k) submission are implicitly tied to demonstrating substantial equivalence to the predicate device, the Ventnet system (K963633).
The key "performance" objective stated is:
- The VentLink system is "Safe, and As effective as the predicate device, the Ventnet system, and Performs as well or better than the predicate device, the Ventnet system."
The "reported device performance" is framed as the successful completion of verification and validation testing, confirming it meets its stated intended use and functions similarly to the predicate.
| Acceptance Criteria Category | Specific Criteria (Implicit for 510(k) equivalence) | Reported Device Performance (from text) |
|---|---|---|
| Safety | Device does not introduce new safety concerns compared to predicate. | "The nonclinical testing... documents that the VentLink system is Safe." Implicitly, this is demonstrated through addressing identified hazards, EMI certifications for off-the-shelf components, and functional testing. |
| Effectiveness/Functionality | Functions as intended: collects, displays, stores, and processes ventilator data. | "Alpha validation testing included testing of all functionality and confirmation that all identified hazards have been adequately addressed by software functionality, the user interface or documentation." "Validation testing fully documents that specified ventilator device's data is transmitted from the ventilator through the VentLink system into the submitter's MediLinks device with user control of data review and acceptance." "No changes were made to transmitted ventilator data." |
| Substantial Equivalence | Similar indications for use and technological characteristics to the predicate. | "The VentLink system has the same indications for use as the Ventnet system, K963633." "The VentLink system has the same technological characteristics as the Ventnet system." Differences noted are evolutionary and do not change equivalence. |
| Clinical Performance | (Not applicable, since no clinical claims or studies were required/submitted) | The submitter notes, "The predicate device, Ventnet system, did not provide or reference any clinical tests submitted in compliance with 807.92(b)(2), therefore the submitter believes such clinical testing is not appropriate or required by FDA and has not made or provided any summary of such testing." |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a numerical "sample size" for a test set in a statistical or clinical sense. The testing described is "Alpha validation testing" and "beta testing environments."
- Test Set (Alpha Validation): Refers to testing all functionality and hazard mitigation. The number of test cases or specific data points is not mentioned.
- Test Set (Beta Testing): Involves user validation of each specified ventilator system "PRIOR to implementation." The number of "specified ventilator systems" or "users" is not quantified.
- Data Provenance: The nature of the data (e.g., patient data, simulated data) used during these validation tests is not explicitly stated, nor is the country of origin. Given the function of the device (data management from ventilators), it would likely involve ventilator data, but its source and context are not detailed. These are non-clinical tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided. The document describes "user review and validation of results" and validation by "users in beta testing environments," but it does not specify the number or qualifications of these "users" or "experts" involved in establishing ground truth. For a data management system that does not alter data, the "ground truth" would likely be the original data from the ventilator.
4. Adjudication Method for the Test Set
This information is not provided. The testing described is functional validation rather than a clinical interpretation task requiring adjudication of expert opinions.
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
No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed for image interpretation or diagnostic aid devices. The VentLink system is a data management system for ventilators, not an AI or diagnostic aid that "improves" human readers' performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The VentLink system is primarily an algorithm/software system for data handling. Its performance, as described, is inherently "standalone" in how it processes data. However, it's explicitly designed to integrate with "MediLinks," which "provides the user interface to the VentLink service." So, while the data collection service is algorithmic, the overall system involves human interaction for configuration, review, and authentication. The testing described (alpha and beta validation) evaluates this combined system functionality rather than a purely isolated "algorithm only" performance devoid of its intended human-in-the-loop environment. The device "does not alter or change any patient data, but does allow the user to display the received patient data," indicating its role as a data conduit and display, not an independent decision-making algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the "type of ground truth" in a clinical sense. For this device, which focuses on transmitting ventilator data accurately and without alteration, the "ground truth" for its validation would be the original, unaltered data output directly from the ventilator device. The testing confirmed that this data was correctly transmitted, displayed, and stored.
8. The Sample Size for the Training Set
The document refers to verification and validation testing, but it does not describe any "training set." This is because the VentLink system is a data management interface software, not a machine learning or AI model that requires a training set for model development.
9. How the Ground Truth for the Training Set Was Established
As no "training set" is mentioned or implied for this device, information on how its ground truth was established is not applicable and therefore not provided.
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