(29 days)
The PatientNet™ System is intended to collect and analyze patient data from ECG ambulatory The Pational - Syctorn - Jeading manufacturers' bedside monitors and ventilators anywhere in a healthcare facility and distributes the data to locations throughout the facility.
Monitoring of Recognized Conditions:
-An environmentally controlled clinical setting that has multiple patients using any combination of ECG leads, bedside monitors, or ventilators.
-Hospital areas that have the capability of installing hardwire paths to the Central Monitoring Station from the rooms or areas where bedside monitors or ventilators operate.
-Clinical areas that have the capability of installing 174-216 MHz radio systems (or alternate frequency bands approved by the FCC) to communicate via RF. The information from the ECG leads, bedside monitors or ventilators is transferred via an RF transmitter to the Central Monitoring Station.
Target Population:
Those patients who are connected through PatientNet™ Monitoring System via ambulatory ECG transmitters, bedside monitors, or ventilators.
The modified PatientNet™ Monitoring System performs patient monitoring using PatientNet™ rne moulhou Patient for radio transmitters connected directly to bedside monitors or athbuittory fudio transmitors with similar physiological parameters, and to ventilators that have digital outputs.
The provided documentation does not contain detailed acceptance criteria or a study that specifically proves the device meets such criteria in terms of performance metrics like sensitivity, specificity, accuracy, or any other quantitative measure typically associated with medical device performance studies.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (VitalCom Networked Monitoring System K962473) through "risk analysis and verification and validation testing." The document states that "Test results demonstrated that the functionality and safety characteristics of the modified PatientNet™ Monitoring System are to the predicate device," implying that the acceptance criterion was likely meeting the functional and safety profile of the predicate device.
Here's an breakdown of the information that can be extracted from the provided text, while also explicitly stating what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functionality: Equivalent to predicate device (K962473) | "Test results demonstrated that the functionality... of the modified PatientNet™ Monitoring System are to the predicate device." |
| Safety: Equivalent to predicate device (K962473) | "Test results demonstrated that the... safety characteristics of the modified PatientNet™ Monitoring System are to the predicate device." |
| Risk Profile: Acceptable via risk analysis | "The safety and effectiveness... have been demonstrated through risk analysis..." |
| Verification and Validation: Successful completion | "...and verification and validation testing." |
| Intended Use: Capability to collect and analyze patient data | "The PatientNet™ System is intended to collect and analyze patient data from... bedside monitors and ventilators... and distributes the data..." |
Missing Information:
- Specific numerical performance metrics (e.g., accuracy, reliability, latency, data integrity rates).
- Quantitative thresholds for acceptance (e.g., "data transfer success rate must be >99%").
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The submission mentions "verification and validation testing" but does not specify the sample size of the test set, the type of data used (e.g., simulated, real patient data), or its provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided. The type of testing described (risk analysis, verification and validation) for a network monitoring system typically doesn't involve the establishment of "ground truth" by clinical experts in the same way an AI diagnostic device would. It's more about technical verification of functionality and safety.
4. Adjudication Method for the Test Set
This information is not provided. Since the nature of the "test set" and "ground truth" for a network monitoring system validation is not clinical expert-based, an adjudication method like 2+1 or 3+1 would not apply.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not done and would not be applicable for this type of device. An MRMC study is relevant for devices, especially AI-driven ones, where human readers interpret medical images or data, and the study aims to assess how the AI assistance impacts their diagnostic performance. The PatientNet™ Monitoring System is a data collection and distribution system, not a diagnostic interpretation tool.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study, as typically understood for an AI algorithm (i.e., algorithm only without human-in-the-loop performance), was not done or at least not described in this document. The assessment described ("risk analysis and verification and validation testing") focuses on the system's ability to perform its intended functions and meet safety requirements, rather than an "algorithm-only" performance for diagnostic accuracy.
7. Type of Ground Truth Used
The concept of "ground truth" (expert consensus, pathology, outcomes data) as it applies to diagnostic accuracy studies is not relevant or specified here. For a network monitoring system, "ground truth" would likely relate to the system correctly acquiring, transmitting, and displaying physiological data as intended, which would be verified through technical means against known inputs or reference standards rather than clinical outcomes.
8. Sample Size for the Training Set
This information is not provided. This device is a data collection and distribution system, not an AI/ML device that requires a "training set" in the conventional sense for learning patterns or making predictions.
9. How the Ground Truth for the Training Set Was Established
This information is not provided. As noted above, the concept of a training set and its associated ground truth is not applicable to the description of this 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).