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The DIOP8 surgical Doppler is indicated for use by qualified healthcare practitioners in a sterile condition in the operating theatre for the assessment of vascular blood flow by direct application to the vessel wall.

The DIOP8 is a sterile, single use, high sensitivity probe that assists in the performance of safe surgery. It is a lightweight, 8MHz ultrasound, handheld pencil probe' that has a small diameter tip that enables the detection of blood flow in vessels. The DIOP8 ultrasound probe operates in pulsed-wave mode. It has one circular piezo-electric crystal that is mounted behind the front faceplate and the crystal is used for both transmit and receive functions. The DIOP8 is manufactured at a frequency of 8MHz. The output ultrasonic parameters are fixed during the manufacturing process and cannot be adjusted by the user. A connector system at the end of the cable allows the DIOP8 to be removed from the hand held Doppler. An interconnection adapter houses the bi-directional electronics, which are specific for the device application, and is required as an interface between the main unit and DIOP8. The connector is similar to a conventional connector, but has no external conductive contacts, and is totally sealed, thus preventing the ingress of fluid and contaminants. Within the connector is a small coil that transfers electrical energy to and from a similar, but larger coil in the corresponding socket at the end of the PA8/PA8XS adapter. Transmitted and received electrical signals are passed through this connector, but there is no direct electrical connection between the probe and the PA8/PA8XS adapter. The connector provides electrical isolation between the probe and the PA8/PA8XS adapter, which optimises system electrical safety by limiting patient leakage currents to very low levels. During use, the adapter is securely held in the probe holder that is an integral part of the Doppler main unit. When connected this way, the hand held Doppler unit operates as if a normal VP8 probe is connected.

The requested information is not available in the provided text. The document is a 510(k) summary for a medical device (Disposable Intraoperative Probe - DIOP8) and details the device's characteristics, comparison to a predicate device, and various performance tests conducted. However, it does not include specific acceptance criteria with reported device performance values in a table, nor does it describe a study proving the device meets those criteria with a breakdown of sample sizes, ground truth establishment, expert involvement, or MRMC study results.

The document primarily focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and general performance testing (biocompatibility, mechanical, functional, electrical safety, EMC, environmental, and software).

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, sample size details for test and training sets, data provenance, number of experts, adjudication methods, MRMC study results, or standalone performance results based on the provided text.

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The Sonicaid Team3 Antepartum and Sonicaid Team3 Intrapartum fetal monitors) are indicated for use by trained healthcare professionals in non-invasive monitoring of physiological parameters in pregnant women and fetuses, during the antepartum and intrapartum periods of pregnancy. The Team3 fetal monitors are intended for pregnant women from the 28th week of gestation, through to term and delivery. The devices are intended for use in clinical and hospital-type facilities.

Sonicaid Team3 Antepartum is suitable for use when there is a need to monitor the following physiological applications:

1. Single or twin fetal heart rates by means of ultrasound
2. Uterine activity externally sensed
3. Fetal movement maternally sensed and externally via ultrasound
4. Maternal heart rate and oxygen saturation via pulse oximetry
5. Maternal non-invasive blood pressure

Sonicaid Team3 Intrapartum is suitable for use when there is a need to monitor the following physiological applications:

1. Single or twin fetal heart rates by means of ultrasound and/or FECG
2. Maternal heart rate via ECG electrodes
3. Uterine activity externally or internally sensed
4. Fetal movement maternally sensed and externally via ultrasound
5. Maternal heart rate and oxygen saturation via pulse oximetry
6. Maternal non-invasive blood pressure

The Sonicaid Team3 is a mains / battery powered multi-function fetal monitor designed for use in clinical and hospital environments during antepartum and intrapartum phases of pregnancy.

The Sonicaid Team3 is designed for use at the bedside; there is a wall mounting bracket available as well as a trolley for fixed or transportable use. The unit may also be used free-standing on a work surface.

The units are powered either from local mains electrical supply or an optional internal rechargeable battery.

The Sonicaid Team3 fetal monitors include the following:

• 8.4" Color LCD Display with LED backlighting.
• Touch screen user interface.
• Monitoring of up to two fetal heart rates via independent ultrasound transducers.
• Monitoring of maternal uterine activity via external tocodynamometer (Toco) or internal intra-uterine pressure (IUP) transducers.
• Monitoring of maternal oxygen saturation (SpO2) and heart rate via pulse oximetry sensor.
• Monitoring of maternal Non-Invasive Blood Pressure . (NIBP).
• Monitoring of fetal heart rate via ECG.
• Maternal heart rate (eMHR).
• Capture of maternally sensed fetal movements via a cabled switch.
• Chart printout via (optional) inbuilt thermal printer
• Data output via RS232.

The provided text describes the acceptance criteria and study for a medical device (Sonicaid Team3 Antepartum and Sonicaid Team3 Intrapartum fetal monitors) in the context of an FDA 510(k) submission. However, it does not contain information about acceptance criteria in terms of numerical performance thresholds (e.g., specific accuracy, sensitivity, or specificity targets for the physiological parameters being monitored). Instead, it primarily focuses on demonstrating substantial equivalence to a predicate device through adherence to recognized standards and various types of engineering and performance testing.

Therefore, the following information is extracted based on the provided text, and where specific details are not present, it will be noted.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of numerical "acceptance criteria" and "reported device performance" in the typical sense of a clinical performance study with specific metrics like sensitivity, specificity, or accuracy targets. Instead, it demonstrates performance through compliance with recognized standards and various engineering and functional tests. The implied acceptance criterion is "demonstrating substantial equivalence to the predicate device" by meeting safety and performance standards and showing that technological differences do not raise new questions of safety or effectiveness.

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The Sonicaid™ Freedom Wireless Fetal Monitoring System ('Freedom') is a wireless transducer system for monitoring fetal heart movement and maternal contractions during intrapartum and antepartum periods of pregnancy.

It is an optional accessory for use with Huntleigh Healthcare Limited's Sonicaid™ FM820 and FM830 Encore Fetal Monitors ('FM800E Monitors') as an alternative to their wired transducers. When connected to an FM800E Monitor, the system monitors:

• Uterine activity by using an external, pressure-sensitive TOCO transducer, and

• Fetal Heart Rate (FHR) by pulsed Doppler ultrasound using an external Ultrasound transducer.

Freedom is suitable for use with pregnant women in clinical and hospital facilities. The transducers are water tight allowing pregnant women to be monitored while they are mobile, stationary or in a bath or shower environment.

This system should only be used by, or under the supervision of, a licensed physician or other health practitioner who is trained in the use of FHR monitors.

The Sonicaid™ Freedom is intended to monitor fetal heart movement and uterine activity by using wireless, non-invasive transducers on pregnant women during antepartum and intrapartum phases of pregnancy. This system is an optional accessory that must be connected to, and used with, a Sonicaid™ FM800E Monitor when a woman wishes to be mobile or in a water environment when being monitored or giving birth.

The Freedom has three major components; the Receiver and Ultrasound ('US') and Tocograph ('TOCO') transducers. The wireless transducers are powered by internal batteries that are recharged when docked on the Receiver.

The Sonicaid ™Freedom operates in the WMTS frequency bandwidth. There are 100 selectable channels available for use. If there is interference when installing the system, then the channel may be changed to achieve clear transmission.

The Huntleigh Healthcare Ltd. Sonicaid™ Freedom Wireless Fetal Monitoring System (K132650) did not report specific acceptance criteria or a dedicated clinical study to demonstrate its performance relative to specific metrics. Instead, the submission relies on demonstrating substantially equivalent performance to a predicate device through bench tests.

Here’s a breakdown of the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy) are not explicitly stated for the device's main function of fetal monitoring. The performance is indirectly demonstrated by showing comparability to the predicate device through bench tests.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not applicable/not reported. The submission did not involve a clinical test set with patient data for performance evaluation. Performance was assessed through simulated bench tests.
• Data Provenance: Not applicable, as there were no clinical test sets or patient data involved. The tests were simulated bench tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not applicable. No expert-established ground truth was reported for a clinical test set, as no clinical tests were performed.

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set or adjudication method was reported.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "No clinical tests were required to determine substantial equivalence between the Freedom and the predicate device."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

• The device itself is a fetal monitoring system that collects data, not an algorithm that interprets data. While the performance of the transducers (the "standalone" components for data acquisition) was assessed through bench tests, it's not a "standalone algorithm" in the typical sense of AI. The system is designed to be used by trained health practitioners.

7. The Type of Ground Truth Used

• For the technical and safety aspects, the "ground truth" was established by compliance with recognized standards (e.g., IEC, ISO, EN, FCC) and by comparison to the established performance of existing Sonicaid™ FM800E transducers (for FHR and UA detection) and the predicate device (Avalon CTS Cordless Fetal Transducer System) for overall system functionality and design. There was no clinical ground truth (e.g., pathology, outcomes data) based on patient results provided.

8. The Sample Size for the Training Set

• Not applicable. This device is a hardware system for signal acquisition, not an AI/machine learning algorithm requiring a "training set" for model development.

9. How the Ground Truth for the Training Set was Established

• Not applicable, as no training set was used.

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