Search Results

The SD5 Ultrasonic TableTop Doppler (hereinafter called "SDS") and SD6 Ultrasonic TableTop Doppler (hereinafter called "SD6") are intended to be used by health care professionals including registered nurses, midwives, ultrasound technicians, and physician assistants, by prescription in hospitals, clinics and private offices.

The 2 MHz and/or 3 MHz obstetrical probes are indicated for the detection of fetal heart rate from early gestation thru delivery and as a general indication of fetal heart well being. They can also be used to verify fetal heart viability.

The SD5&SD6 Ultrasonic Tabletop Doppler is a hand-held device for non-invasive measurement and display of fetal heart rate utilizing the principle of Doppler shift of an ultrasound. The ultrasound is transmitted from the probe to patient body (maternal abdominal wall), and moves through biophysical objects. The acoustic ultrasound is reflected by blood and moving objects such as the fetal heart. The reflected ultrasound is received by the probe and is converted into electric signals. The waveform data are applied to the CPU for all the digital processing on LED Display, operation keys. The audio signal is taken off for the routing to the speaker to generate the analogue signals before digital processing. The system is compatible with 2 MHz or 3 MHz for fetal heart rate. The signal acquired can be transferred to SD5 by wired method, and by Bluetooth to SD6.
The main unit can be powered by main supply (100 V-240 V~) or Ni-MH Battery (7.2 V/2000 mAh). And transducers are powered by 3.7 V/800 mAh Lithium Battery only.

The provided document is a 510(k) Premarket Notification from the FDA for the Edan Instruments, Inc. SD5 & SD6 Ultrasonic Tabletop Doppler. This document describes the device, its intended use, and compares it to a predicate device. It also briefly mentions performance testing.

However, the document does not contain the specific acceptance criteria or the detailed study results that prove the device meets these criteria in a quantitative manner, which is typical for a clinical performance study. The primary focus of this document is to demonstrate substantial equivalence to a previously cleared device (K102138, also an SD5/SD6 Ultrasonic Tabletop Doppler from Edan Instruments).

Based on the information available in the document, here's what can be extracted and inferred, along with the information that is not present:

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

Note: The above table is derived directly from the "FHR Specifications" comparison with the predicate device (K102138). The current device (SD5/SD6) actually specifies a better performance for FHR measuring range and accuracy than its predicate, which supports its substantial equivalence claim. However, these are technical specifications and not necessarily acceptance criteria from a specific clinical performance study. The document states that "all testing passed pre-specified criteria," but does not explicitly list these criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not provided. The document states "Clinical test: Not applicable." This indicates that no new clinical study (with a test set of patients) was conducted for this 510(k) submission to assess the device's performance in a clinical setting. The substantial equivalence is based on technical comparisons, safety, and performance bench testing.

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)

• Not applicable. As no clinical test data is provided, there is no mention of experts or ground truth establishment for a patient test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No clinical test data is provided.

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. The device is a fetal ultrasonic monitor (Doppler) for detecting fetal heart rate. It is a standalone measurement device, not an AI-powered image analysis tool that assists human readers. Therefore, an MRMC study and AI assistance effect size are not relevant to this device type.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Yes, effectively. The performance data related to FHR measuring range, accuracy, and resolution (as shown in the table above) represent the standalone technical performance of the device. This performance is assessed through bench testing and compliance with standards (e.g., IEC 60601-2-37). The device, by its nature, provides a direct measurement (fetal heart rate) rather than involving an "algorithm only" in the sense of image interpretation, but its core function is performed independently to provide the output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For the technical specifications (FHR measuring range, accuracy, resolution), the ground truth would typically be established by reference measurement techniques using calibrated equipment and simulated fetal heart rate signals during bench testing. The document states "Bench testing was conducted on the SD5&SD6 Ultrasonic Tabletop Doppler, consisting of all the modules and accessories in the system. The system complies with the IEC 60601-2-37: 2007." This standard specifies requirements for the safety and essential performance of ultrasonic diagnostic and monitoring equipment, including accuracy of measurements.

8. The sample size for the training set

• Not applicable. This device is a hardware-based fetal Doppler. It does not appear to employ machine learning or AI algorithms that would require a "training set" of data in the conventional sense. Its functionality relies on established Doppler physics and signal processing techniques.

9. How the ground truth for the training set was established

• Not applicable. (See point 8).

Summary of what the document focuses on for acceptance:

The primary method for demonstrating acceptance and substantial equivalence in this 510(k) submission relies on:

• Predicate Device Comparison: Showing that the new device has the same intended use, similar product design, and comparable performance and safety characteristics to a legally marketed predicate device.
• Compliance with Recognized Standards: Mentioning compliance with standards such as IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-2-37 (ultrasonic equipment safety/performance), IEC 62304 (software life cycle), ISO 10993-1, -5, -10 (biocompatibility), and NEMA UD-2 (acoustic output). Passing these tests implicitly means meeting the criteria outlined within those standards.
• Bench Testing: Conducted to ensure the system meets specified technical performance.
• Software Verification and Validation: Performed for the "moderate" level of concern software.

The absence of clinical study data is explicitly noted as "Not applicable," suggesting that the FDA deemed the technical and bench testing sufficient to establish substantial equivalence for this type of device based on its intended use and comparison to the predicate.

Ask a specific question about this device

The Ultrasonic Tabletop Doppler is intended to be used by health care professionals including registered nurses, practical nurses, midwives, ultrasound technicians, and physician assistants, by prescription from licensed physicians in hospitals, clinics and private offices.

The 2 MHz and/or 3 MHz probes are indicated for the detection of fetal heart rate from early gestation thru delivery and as a general indication of fetal well being. They can also be used to verify fetal heart viability following patient trauma.

Ultrasonic Tabletop Doppler provides the following primary features:

• Basic parameters: FHR
• 240 seconds fetal heart sound record and playback
• Infrared communication (for TD-6000 only)
• Ni-MU1 battery for 20 hours continuous working of main unit
• Li-ion battery for 2.5 hours continuous working of TD-6000 probe
• Charge the TD-6000 probe battery by main unit
• Continuous wave Doppler transducer for FUR detection

The provided 510(k) summary for the TD-5000 & TD-6000 Ultrasonic Tabletop Doppler explicitly states: "Clinical testing is not required" (Page 2).

Therefore, there is no clinical study that proves the device meets specific acceptance criteria based on human performance or diagnostic accuracy. The substantial equivalence determination is based on non-clinical tests and comparison to a predicate device.

Given this, I cannot provide the requested information regarding acceptance criteria and performance based on a clinical study, as such a study was not performed or reported in this submission.

However, I can extract information about the non-clinical tests that were performed:

Non-Clinical Tests Performed:

The following quality assurance measures were applied to the development of the Ultrasonic Doppler (Page 2):

• Software testing
• Hardware testing
• Safety testing
• Environment test
• Risk analysis
• Final validation

The submission states that "Verification and validation testing was done on the TD-5000 & TD-6000 Ultrasonic Tabletop Doppler" (Page 2), and that the device "has similar technology characteristics and has the same intended use, same design principle, same electrical classification, same measurement mode and same accuracy as the predicate device" (Page 2).

Since no clinical study was conducted, the following requested information points cannot be answered:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
• If a standalone performance (algorithm only) was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

Ask a specific question about this device

The Ultrasonic TableTop Doppler is intended to be used by health care professionals including registered nurses, practical nurses, midwives, ultrasound technicians, and physician assistants, by prescription from licensed physicians in hospitals, clinics and private offices.

The 2 MHz and/or 3 MHz probes are indicated for the detection of fetal heart rate from early gestation thru delivery and as a general indication of fetal well being. They can also be used to verify fetal heart viability following patient trauma.

The 4 MHz, 5 MHz and/or 8 MHz vascular probes are indicated for the detection of blood flow in veins and arteries for assisting in the detection of peripheral vascular disease.

Ultrasonic TableTop Doppler provides the following primary features:

• Basic parameters: FHR, blood flow
• 240 seconds fetal heart sound record and playback
• Infrared communication(for SD6 only)
• Ni-MH battery for 20 hours continuous working of main unit
• Li-ion battery for 2.5 hours continuous working of SD6 probe

The provided text is a 510(k) summary for the Edan Instruments, Inc. Ultrasonic TableTop Doppler (Models SD5 and SD6). It lists device information, predicate devices, and indications for use, but does not contain information about acceptance criteria or a study proving the device meets those criteria.

The document primarily focuses on establishing substantial equivalence to previously cleared devices. It includes forms for "Diagnostic Ultrasound indications for Use" for various probes (5MHz, 4MHz, 8MHz vascular probes, and 5MHz, 4MHz, 8MHz CW wireless vascular probes), indicating their intended use for blood flow detection in peripheral vascular applications. However, these forms do not detail performance metrics, acceptance criteria, or study results.

Therefore, I cannot provide the requested information from the given text.

The following information is NOT present in the provided text:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs without AI assistance.
6. If a standalone (algorithm only without human-in-the-loop performance) study was done.
7. The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

The document is a regulatory submission focused on establishing substantial equivalence for an ultrasonic doppler device, not a performance study report with detailed acceptance criteria and results.

Ask a specific question about this device

The Ultrasonic TableTop Doppler is intended to be used by health care professionals including registered nurses, practical nurses, midwives, ultrasound technicians, and physician assistants, by prescription from licensed physicians in hospitals, clinics and private offices. The 2 MHz and/or 3 MHz probes are indicated for the detection of fetal heart rate from early gestation thru delivery and as a general indication of fetal well being. They can also be used to verify fetal heart viability following patient trauma.

Ultrasonic TableTop Doppler (Models SD5, SD6) provides the following primary features:

• Basic parameters: FHR
• 240 seconds fetal heart sound record and playback
• Infrared communication(for SD6 only)
• Ni-MH battery for 20 hours continuous working of main unit
• Li-ion battery for 2.5 hours continuous working of SD6 probe
• Charge the SD6 probe battery by main unit
• Continuous wave Doppler transducer for FHR detection

Here's a breakdown of the acceptance criteria and the study information for the Edan Instruments, Inc. Ultrasonic TableTop Doppler (Models SD5 and SD6), based on the provided text:

Based on the provided text, the submission is a 510(k) Summary of Safety and Effectiveness, which aims to demonstrate substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a clinical study with detailed performance metrics. Therefore, the "acceptance criteria" here refer to the regulatory standard of substantial equivalence, and the "study" is the overall verification and validation testing, not a traditional clinical trial with a test set, ground truth, and statistical analysis of performance metrics.

Acceptance Criteria and Reported Device Performance

Study Details (Based on the provided 510(k) summary)

The provided document describes a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to previously cleared devices rather than a standalone clinical performance study with explicit acceptance criteria for diagnostic accuracy. Therefore, many of the typical elements of a clinical study, such as specific sample sizes for test sets, expert-established ground truth, adjudication methods, or MRMC studies, are not detailed in this summary.

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified in the provided summary.
   • Data Provenance: Not specified. The document only mentions "Verification and validation testing."

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not specified. The 510(k) summary does not detail the methodology for establishing ground truth for any specific performance metrics.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not specified.

4. 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 comparative effectiveness study was mentioned. This device is a fetal heart rate Doppler, not an AI-assisted diagnostic tool for image interpretation by human readers.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • The document implies general "Hardware testing" and "Software testing," but it does not specify a standalone performance study in the context of an algorithm's diagnostic accuracy. The device itself is a standalone fetal Doppler used by healthcare professionals.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not specified. The "Test Summary" only lists generic quality assurance measures like "Software testing," "Hardware testing," "Safety testing," "Environment test," and "Risk analysis." For a fetal Doppler, ground truth might involve comparisons against other established methods for FHR detection, but the details are not provided.

7. The sample size for the training set:

   • Not applicable as this documentation pertains to a traditional medical device (fetal Doppler) and not an AI/ML algorithm that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable.

Ask a specific question about this device