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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.

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Obstetrical: This product will be used to detect fetal heart beats as an aid for determining fetal viability. Vascular: This product will also be used to detect blood flow in veins and arteries for assisting in the detection of peripheral vascular disease.

The LifeDop 350 Doppler is a portable, battery-powered ultrasound device used for detecting fetal heart beats and also for blood flow detection in veins and arteries. Primarily intended to be table-top, stand or wall mounted.

The provided document is a 510(k) premarket notification for the Summit Doppler Systems, Inc. LifeDop 350 Doppler. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than explicit acceptance criteria and corresponding performance studies, as would be required for novel devices or higher-risk classifications.

Therefore, the document does not contain the detailed information typically requested for acceptance criteria and study data proving a device meets these criteria. Instead, it asserts substantial equivalence based on comparable technology, materials, and intended use as a previously cleared device (K024197).

Here's a breakdown of the requested information based on the provided text, highlighting what is not available within this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The submission does not specify numerical acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it relies on the device being "substantially equivalent" in technology and intended use to a previously cleared device.

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

No dedicated test set or clinical study for the LifeDop 350 Doppler is described. The submission states "Clinical Testing: None provided," indicating that no new clinical data was generated for this 510(k). The device is cleared based on its similarity to the predicate device.

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

Not applicable. No ground truth was established as no new clinical study was conducted for this submission.

4. Adjudication Method for the Test Set

Not applicable. No clinical study or test set requiring adjudication was performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is a doppler ultrasound system, not an AI-powered diagnostic tool. No MRMC studies or AI involvement are mentioned.

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

Not applicable. This device is not an algorithm, and no standalone performance study was conducted.

7. The Type of Ground Truth Used

Not applicable. As no new clinical testing was performed, no ground truth was established for the LifeDop 350 Doppler in this submission. The substantial equivalence argument relies on the predicate device's existing clearance and the established safety and effectiveness of the underlying Doppler ultrasound technology.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no training set in the context of machine learning.

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

Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth establishment.

Conclusion based on the provided document:

The K090499 submission for the Summit Doppler Systems, Inc. LifeDop 350 Doppler is a Traditional 510(k). For this type of submission, extensive new clinical data or performance studies against predefined acceptance criteria are often not required if the device demonstrates substantial equivalence to a predicate device.

The basis for clearance is that the LifeDop 350 Doppler is "substantially equivalent to the commercially available and legally marketed device indicated above [Summit Doppler Systems Golden, CO LifeDop Doppler Ultrasound System K024197, Cleared 1/3/03]." The document explicitly states "Clinical Testing: None provided" for the LifeDop 350 Doppler. This means the safety and effectiveness are supported by the existing clearance of the predicate device and the recognized principles of Doppler ultrasound technology.

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