(35 days)
The PDH&D is indicated for use in non-clinical settings to collect and transmit historical patient data to healthcare professionals to help support effective management of their patients.
The PDH&D includes the Patient Data Handler (PDH) and peripheral biometric devices for the monitoring of chronic diseases. It is intended to be used as a communication tool, enabling Healthcare Providers and Care Managers to receive historical patient data including blood glucose levels, blood pressure, weight, peak flow volume, and oxygen saturation levels. Providers may review patient information over the InterMed Patient Provider Online Tool (IPPOT).
The PDH&D is not intended to provide automated treatment decisions, nor is it to be used as a substitute for a professional healthcare judgment.
The provided K063484 510(k) submission for the Patient Data Handler & Devices (PDH&D) does not contain the detailed acceptance criteria and study information typically found for devices that rely on performance metrics to establish substantial equivalence.
Instead, this submission primarily focuses on establishing substantial equivalence based on technological characteristics and nonclinical tests related to safety and efficacy, without reporting specific performance metrics against pre-defined acceptance criteria.
Here's an analysis based on the information provided, highlighting what is present and what is missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of performance metrics (e.g., accuracy, sensitivity, specificity, data transmission success rate). The submission generally states the device "performs according to requirements and specifications."
- Reported Device Performance: No specific numerical performance figures are provided. The conclusion states "The results of Verification and Validation activities have indicated that the PDH&D performs according to requirements and specifications and represents a residual minor risk to the user."
2. Sample sized 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.
- Data Provenance: Not specified.
3. 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)
- This information is not applicable and therefore not provided, as there is no indication of a study involving expert-established ground truth for performance evaluation of patient data. The device's function is data collection and transmission, not diagnostic interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified, as there's no indication of a study involving human interpretation or adjudication for the device's function.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is not an AI-assisted diagnostic tool; it's a data handler and transmitter.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, the "Nonclinical Tests" section describes activities that would be considered standalone testing of the device's functionality: "Nonclinical tests were performed to ensure the safety and efficacy of the PDH&D. The results of Verification and Validation activities have indicated that the PDH&D performs according to requirements and specifications..."
- However, the specific metrics and results of these standalone tests are not detailed. The focus is on the secure transmission of data via Bluetooth and phone/cable modem.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the nonclinical tests mentioned, the "ground truth" would likely be the expected behavior of the device based on its design specifications. For example, successful data transmission (data sent matches data received), correct display of information on the IPPOT, and adherence to security protocols. It wouldn't involve clinical "ground truth" like pathology or expert consensus on a diagnosis.
8. The sample size for the training set
- Not applicable/Not specified. The PDH&D is a data handling and transmission device, not a machine learning or AI-driven system that requires a "training set" in the conventional sense.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for this type of device.
Summary of what is present in the submission regarding performance:
The submission focuses on nonclinical Verification and Validation (V&V) activities to demonstrate "safety and efficacy" and that the device "performs according to requirements and specifications."
Key aspects highlighted in the "TECHNOLOGICAL CHARACTERISTICS" section, implicitly forming the basis for performance evaluation, include:
- Secure transmission of physiological patient data from biometric devices to InterMed's Data Center.
- Data transfer between peripheral devices and the PDH via Bluetooth Radio (same platform as a predicate device).
- Data transfer between the PDH and the Data Center via phone line or cable modem.
- The Data Center generates session content for PDH units.
- The IPPOT (InterMed Patient Provider Online Tool) is available over a secure website, requiring username and password.
The "CONCLUSION" states that these V&V activities support substantial equivalence and indicate "a residual minor risk to the user."
In essence, this 510(k) submission establishes substantial equivalence primarily through comparison of technological characteristics to a predicate device and general statements about successful nonclinical testing, rather than through a detailed breakdown of clinical performance metrics against specific acceptance criteria.
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).