(28 days)
The M3810A Philips TeleMonitoring System with M3814A SpO2 unit is intended to be used upon prescription by a licensed physcian or authorized healthcare provider by patients as a means to automatically collect and transmit medical information, such as weight, blood pressure, and non-diagnostic ECG, over normal residential telephone lines, between a patient, typically at home, and a healthcare professional at the authorized provider which is the same intended use as previously cleared for the M3810A Interactive Health System.
The M3810A Philips TeleMonitoring System with M3814A SpO2 unit is indicated for patients at home, who are capable and willing to self administrate this device, upon the prescription of their healthcare provider, to collect and transmit medical information such as weight, blood pressure (including pulse rate) and non-diagnostic ECG rhythm strip to the healthcare provider at another location. The patient takes these measurements, typically once per day, and the information is transmitted automatically via normal telephone lines to the healthcare provider. The device does not send any real time alarms. Clinical judgment and experience are required to check and interpret the information delivered.
The M3810A Philips TeleMonitoring System with M3814A SpO2 Physiological Transmitter and Receiver. The primary modification is a change to add the functionality of pulse oximetry.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the M3810A Philips TeleMonitoring System with M3814A SpO2 unit:
The provided documents, a 510(k) summary and an FDA clearance letter, offer limited but specific information on the acceptance criteria and the nature of the study performed.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Based on the specifications cleared for the predicate device (K992478). | "test results showed substantial equivalence" to the predicate device. |
| Verification and validation testing activities to establish performance and reliability characteristics. | Conducted a range of safety testing, including laboratory studies for biocompatibility, electrical safety, EMC testing, and radio telemetry testing. |
2. Sample Size Used for the Test Set and Data Provenance
The documents do not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of clinical data, if any clinical data was used beyond laboratory testing). The focus of the provided text is on demonstrating substantial equivalence through technical and safety testing rather than a large-scale clinical performance study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
The documents do not describe the use of experts to establish ground truth for a test set in the context of clinical performance. The testing described focuses on engineering and safety specifications.
4. Adjudication Method for the Test Set
No adjudication method is mentioned as the testing described is primarily technical/safety verification against established specifications, not clinical performance requiring expert consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No MRMC comparative effectiveness study is mentioned. The submission focuses on the addition of SpO2 functionality and demonstrating substantial equivalence to a previously cleared device. The device's intended use is for automatic collection and transmission of medical information, with clinical judgment and experience required for interpretation by a healthcare professional; it's not described as an AI-powered diagnostic aid that would typically undergo an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
The concept of "standalone performance" in the context of an algorithm's diagnostic accuracy is not directly applicable to the information provided. The device's primary function is data collection and transmission. The "algorithm" here would pertain to the accuracy of the physiological measurements (like SpO2, blood pressure) and the transmission reliability, which are addressed by the verification and validation (V&V) testing. The document states "test results showed substantial equivalence" for these aspects.
7. The Type of Ground Truth Used
For the SpO2 functionality, the "ground truth" would implicitly be established through reference standards for pulse oximetry accuracy. For other parameters like blood pressure and ECG, established medical device standards and measurement methodologies would serve as the ground truth for the V&V testing. The document highlights "biocompatibility, electrical safety testing, EMC testing and radio telemetry testing," which rely on scientific and engineering standards as their ground truth for compliance.
8. The Sample Size for the Training Set
The concept of a "training set" for an AI algorithm is not applicable here. This device, cleared in 2004, is a medical monitoring system that collects and transmits physiological data. It does not appear to employ machine learning or AI algorithms that would require a training set for model development.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of an AI algorithm or a training set, this question is not relevant to the provided documents.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).