(90 days)
The Philips Avalon CTS Cordless Fetal Transducer System (M2720A) and Accessories is indicated for pregnant women from about 22 weeks of gestation on through delivery. It is intended for continuous cordless fetal monitoring in connection with a fetal monitor for resting or ambulating patients, also usable during hydrotherapy, for antepartum testing and labor and delivery (intrapartum).
The system should only be used by, or under the direct supervision of, a licensed physician or other health care practitioner who is trained in the use of fetal heart rate monitors and in the interpretation of fetal heart rate traces. It is not intended for home use.
The Perinatal Monitoring System operates by measuring, processing, and transmitting standard fetal parameters to any Philips Series 50 fetal monitor using radio transmission technology. A group of three wireless transducers is available to obtain specific fetal data in the antepartum period and during labor and delivery. The transducers are designed to operate while the patient is ambulatory, including activity taking place in a submerged water environment, like bathing and hydrotherapy. The devices are identified by the following model numbers: System and Base Station M2720A; Toco transducer M2725A (measures uterine activity externally); US transducer M2726A (measures fetal heart rate and fetal movement profile); and the optional ECG/auxiliary transducer M2727A (measures DECG or direct fetal scalp ECG and MECG or maternal ECG).
The provided text describes the 510(k) summary for the Philips Avalon CTS Cordless Fetal Transducer System but does not contain specific acceptance criteria or a detailed study proving the device meets said criteria.
The submission focuses on establishing substantial equivalence to predicate devices based on technological characteristics and general verification/validation testing. It states that "Test results showed substantial equivalence," but does not provide the specific performance metrics, sample sizes, or methodologies of these tests in a way that allows for a comprehensive answer to your request.
Therefore, I cannot fill out the requested table or answer most of the questions directly from the provided text. I can only extract general information about the testing performed.
Here's what can be inferred:
1. Table of Acceptance Criteria and Reported Device Performance
- The document does not explicitly state numerical acceptance criteria or specific reported device performance metrics (e.g., accuracy, sensitivity, specificity) for the fetal monitoring parameters. It simply states that "Test results showed substantial equivalence," implying that the performance met internal benchmarks or was comparable to predicate devices.
2. Sample size used for the test set and the data provenance
- Not specified in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable, as there's no mention of a ground truth established by experts for performance evaluation.
4. Adjudication method for the test set
- Not applicable, as there's no mention of an adjudication process.
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 MRMC study was done, nor is AI involved in this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device is a hardware system for continuous fetal monitoring with radio transmission technology. There is no mention of a standalone algorithm or AI performance. The system's output is intended to be interpreted by healthcare practitioners.
7. The type of ground truth used
- Not specified. The testing mentioned (environmental, electrical safety, EMC, radio telemetry, biocompatibility, and user evaluations for consumer accuracy, hardware/software verification, cable interface verification) focuses on the device's functional and safety characteristics rather than its diagnostic accuracy against a clinical ground truth.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
However, the document does mention the following general information about testing:
- Study That Proves the Device Meets Acceptance Criteria:
- "Verification and validation testing activities were conducted to establish the performance and reliability characteristics of the modified device."
- "Testing involved environmental, electrical safety, EMC, radio telemetry, biocompatibility and user evaluations for consumer accuracy. Hardware and software verification testing and cable interface verification testing were also conducted. Test results showed substantial equivalence."
Key Point: This 510(k) summary focuses on demonstrating that the modified device has "the same technological characteristics" as the predicate devices and that general verification and validation testing confirmed "substantial equivalence" for its intended use, rather than presenting a detailed clinical performance study with explicit acceptance criteria.
§ 884.2740 Perinatal monitoring system and accessories.
(a)
Identification. A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include any of the devices subject to §§ 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts.(b)
Classification. Class II (performance standards).