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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 sterilizable detachable ultrasound transducer probe and user replaceable batteries. The user interface includes an on/off button, volume control, single 2-1/4" speaker and battery. The product is housed in custom injection molded housings. Patient contact materials are ABS and Ploycarbonate injection molded plastic.

The provided text is a 510(k) summary for the Summit Doppler Systems, Inc. STN Probe. It describes the device, its intended use, and claims substantial equivalence to a previously cleared predicate device (LifeDop Doppler Ultrasound System -- w/ 8.0 MHz CW PV Probe K024197).

Crucially, the document states "None provided" for Clinical Testing. This means no acceptance criteria or study data demonstrating the device meets such criteria are present in this submission. The basis for clearance is solely substantial equivalence to a predicate device, assuming similar features, materials, and intended use.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance or details about a study proving the device meets acceptance criteria, as this information is explicitly stated as not provided in the submitted material.

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This device is intended for detection of blood flow in veins and arteries and as an aid for the diagnosis of peripheral vascular disease.

The Vista AVSTM is a diagnostic ultrasound device used to aid the clinician in obtaining systolic pressure values at the arms, legs and feet. The device will provide a bi-directional Doppler for detecting presence or absence of blood flow, and will control the inflation and deflation of a pressure cuff under direction of the user. Two additional modalities, Pulse Cuff Recording (PCR) and Photoplethysmography (PPG), will provide additional information for the clinician. PCR will be used as a plethysmograph to obtain alternative blood flow waveforms, and the PPG will be used primarily to obtain toe pressures. The unit will calculate Ankle Brachial Index (ABI), Toe Brachial Index (TBI) or segmental values once the clinician has accepted or entered the appropriate pressure values. Waveforms, pressure values, and index results can be printed directly from the device or uploaded using AVS ReportTM report generating software and an external user supplied PC via a USB port. The unit can run from an internal power source or from an external power supply, and mounts to a rolling stand.

The Summit Doppler Systems, Inc. Vista AVS is a diagnostic ultrasound device intended for the detection of blood flow in veins and arteries and as an aid for the diagnosis of peripheral vascular disease. It measures systolic pressure values, provides bi-directional Doppler for blood flow, and controls pressure cuff inflation/deflation. It also incorporates Pulse Cuff Recording (PCR) and Photoplethysmography (PPG) and calculates Ankle Brachial Index (ABI) or Toe Brachial Index (TBI).

Here's an analysis of the provided information regarding its acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (K063600) is a 510(k) premarket notification for substantial equivalence, not a detailed clinical study report with specific acceptance criteria and performance metrics for the device itself. The submission claims substantial equivalence to a predicate device (IMEXLAB 9100 Diagnostic Ultrasound Device, K973562).

Therefore, there are no explicit "acceptance criteria" or "reported device performance" metrics directly stated for the Vista AVS in this document in the typical sense of a clinical trial. Instead, the "acceptance criteria" can be inferred as demonstration of equivalence in:

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

The provided document does not describe a test set or clinical study specific to the Vista AVS for demonstrating performance against defined criteria. The submission is a 510(k) for substantial equivalence, which primarily relies on comparing the new device to a legally marketed predicate device. There is no mention of patient data, sample sizes, or data provenance (country of origin, retrospective/prospective).

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

Since no specific test set or clinical study is described for the Vista AVS in this submission, there is no information about experts used to establish ground truth.

4. Adjudication Method for the Test Set

As there is no described test set, no adjudication method is mentioned.

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

No MRMC comparative effectiveness study is mentioned in the provided document. The submission focuses on demonstrating substantial equivalence to a predicate device, not on directly comparing human reader performance with and without AI assistance.

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

The Vista AVS is described as a diagnostic ultrasound device that aids clinicians. It is not an AI algorithm. Therefore, a standalone performance study in the context of an algorithm's performance without human-in-the-loop is not applicable here, and no such study is mentioned.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically used in AI/diagnostic studies (e.g., pathology, outcomes data) is not applicable to this 510(k) submission. The submission is based on demonstrating substantial equivalence to a predicate device, meaning its "ground truth" for regulatory clearance is that it functions safely and effectively like the predicate device for its intended use.

8. The Sample Size for the Training Set

The Vista AVS is a physical medical device utilizing established Doppler ultrasound technology. It is not an AI system that requires a "training set" in the machine learning sense. Therefore, there is no information about a training set size.

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

Since the Vista AVS is not an AI system developed with a machine learning training set, this question is not applicable.

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This product will be used to detect fetal heartbeats to help determine fetal viability.

OB1 Obstetrical Doppler is a handheld, internally-powered Doppler audio instrument used for detecting fetal heart beats. There are only four user controls; Up and Down audio volume, Freeze Display, and Power On/Off. A three inch loudspeaker provides good Doppler audio. A digital LCD readout shows the fetal heart rate when it is stable for three or four seconds.

The provided text is a 510(k) summary for the OB1 Obstetrical Doppler, a handheld fetal Doppler. However, it does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and a specific study proving the device meets those criteria.

The 510(k) summary focuses on demonstrating substantial equivalence to existing predicate devices. This means the manufacturer is asserting their device is as safe and effective as devices already on the market, rather than conducting a de novo study to establish new performance metrics against specific acceptance criteria.

Here's a breakdown of what can and cannot be answered based on the provided document:

1. Table of acceptance criteria and the reported device performance:

This information is not present in the document. A 510(k) submission for this type of device typically relies on demonstrating that the new device performs similarly to predicate devices, rather than setting and meeting specific, quantifiable acceptance criteria in a dedicated performance study. The "Technology Summary" states, "Recursive filter techniques are used to detect the fetal heart rate displayed on the digital readout. This achieves similar results as the techniques (not published) in the predicate devices." This implies performance is judged by its similarity to existing, cleared devices.

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

This information is not present in the document. Since a specific performance study with a test set is not described, these details are not provided.

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):

This information is not present in the document. As no specific test set or ground truth establishment process is described, this data is unavailable.

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

This information is not present in the document.

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:

This information is not present in the document. An MRMC study is not mentioned. Also, this device is a handheld fetal Doppler, not an AI-assisted diagnostic tool for "human readers." Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply directly to this device.

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

This information is not present in the document. The OB1 Obstetrical Doppler is described as a "handheld, internally-powered Doppler audio instrument used for detecting fetal heart beats." It's a direct-use device, and the concept of an "algorithm only" performance study in the context of AI is not relevant here. Its performance would be assessed through its ability to detect fetal heartbeats and display the rate, likely compared to known standards or predicate devices.

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

This information is not present in the document. For a device like this, the "ground truth" for basic function would typically involve physical measurements (e.g., accuracy of heart rate detection against a known signal generator or a highly accurate reference method) rather than a clinical ground truth like pathology.

8. The sample size for the training set:

This information is not present in the document. This type of device relies on established Doppler ultrasound technology and recursive filter techniques, not machine learning or AI models that require a training set in the conventional sense.

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

This information is not present in the document for the reasons explained in point 8.

Summary regarding the provided text:

The 510(k) summary for the OB1 Obstetrical Doppler demonstrates substantial equivalence to predicate devices (Huntleigh Dopplex II, Medasonics Cadance, Summit LifeDop). The "technology summary" highlights that its Doppler ultrasound technology and recursive filter techniques achieve "similar results" to these predicate devices. The review process involved assessing device features, materials, intended use, and performance characteristics in comparison to these already-cleared devices, as is standard for 510(k) submissions.

The clearance letter also mandates a post-clearance special report containing "complete information, including acoustic output measurements based on production line devices." This indicates that quantifiable performance data (specifically acoustic output) was required, but this is a post-market requirement to ensure the manufactured devices conform to the design, not a pre-market study establishing acceptance criteria in the manner you've described for a diagnostic AI device.

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