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This product will be used to detect blood flow in veins and arteries for assisting in the detection of peripheral vascular disease.

The LifeDop is a hand-held, battery powered, audio Doppler device used for blood flow detection in veins and arteries. The product includes two interchangeable ultrasound transducer probes and user replaceable batteries. The user interface includes an on/off button, volume control, 12 button keypad for entering pressure data and printing, single 2-1/4" speaker, and LCD display for displaying data, battery and waveform information. The product is housed in custom injection molded housings. Patient contact materials are ABS and Ploycarbonate injection molded plastic and hypoallergenic aqueous gel used for ultrasound transmission.

The Summit Doppler Systems, Inc. LifeDop 300ABI is a handheld, battery-powered, audio Doppler device used to detect blood flow in veins and arteries to assist in the detection of peripheral vascular disease.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this submission is a 510(k) for substantial equivalence and there is an explicit statement "Clinical Testing: None provided," there are no specific performance acceptance criteria or reported device performance metrics in the provided document. The basis for clearance is solely on the similarity to a predicate device.

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

No clinical testing was conducted or provided for this 510(k) submission. Therefore, there is no test set sample size or data provenance to report.

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

No clinical testing was conducted or provided for this 510(k) submission. Therefore, there are no experts or ground truth establishment details to report.

4. Adjudication Method for the Test Set:

No clinical testing was conducted or provided for this 510(k) submission. Therefore, no adjudication method was used.

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:

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a diagnostic ultrasound monitor, not an AI-assisted diagnostic tool.

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

A standalone performance study was not done. The device is a diagnostic ultrasound monitor, not an algorithm, and its use inherently involves a human operator to interpret the audio Doppler signal.

7. The Type of Ground Truth Used:

No clinical testing was conducted or provided for this 510(k) submission. Therefore, no ground truth was established by expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set:

No clinical testing was conducted or provided for this 510(k) submission. Therefore, there is no training set sample size to report.

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

No clinical testing was conducted or provided for this 510(k) submission. Therefore, no ground truth for a training set was established.

Summary of the Study:

The provided documentation (K093393) for the Summit Doppler Systems, Inc. LifeDop 300ABI explicitly states "Clinical Testing: None provided." The 510(k) clearance was based on demonstrating substantial equivalence to a previously cleared predicate device, the Summit Doppler Systems LifeDop Doppler Ultrasound System (K024197). The argument for substantial equivalence relies on comparisons of device features, materials, intended use, and performance, asserting that the new device utilizes the same Doppler ultrasound technology and has no change in intended use compared to the predicate. Therefore, no clinical studies were performed to establish performance metrics, acceptance criteria, or ground truth for this specific submission.

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