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The Vantage ABI is a non-invasive device used to gauge the lower extremity arterial system using pneumatic volume plethysmography recording (PVR) and oscillometric systolic blood pressure to assist in the diagnosis of vascular disease.

The Vantage ABI performs the ankle-brachial index examination to assist in the diagnosis of peripheral arterial disease. The system will be used to assess peripheral arterial disease using pneumatic volume plethysmography recording (PVR), estimate the systolic blood pressure for each limb and calculate the Ankle Brachial Index. The unit will record a PVR waveform at each ankle and measure pressures in each limb. Four cuffs will be connected. This unit can be powered from its internal battery or from an external line-powered supply.

This document is a 510(k) premarket notification for the Summit Doppler Systems, Inc. Vantage ABI device. It seeks to establish substantial equivalence to previously cleared predicate devices rather than conducting a new clinical study to prove novel efficacy or safety. Therefore, the information typically requested about acceptance criteria, study design, and performance metrics for a de novo device or a device requiring clinical trials is not present in this document.

Here's an analysis based on the provided text, highlighting what is not applicable in this context and what can be inferred:

1. Table of acceptance criteria and reported device performance:

• Not Applicable. This document focuses on establishing substantial equivalence to predicate devices, not on proving new performance against specific clinical acceptance criteria through a dedicated study. The "performance" mentioned is more about equivalence in function and intended use.

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

• Not Applicable. No specific test set data is provided in this 510(k) summary for a clinical study. The submission likely relied on engineering tests and comparisons to the predicate devices.

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

• Not Applicable. No clinical study involving a "test set" and "ground truth" established by experts for performance evaluation is described in this document.

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

• Not Applicable. As no clinical "test set" for performance evaluation is detailed, no adjudication method is relevant.

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 non-invasive instrument for measuring physiological parameters (PVR and ABI), not an AI-assisted diagnostic imaging or interpretation tool. Therefore, an MRMC study and AI-assisted performance improvement are not relevant.

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

• Not Applicable. The Vantage ABI is a hardware device that directly measures and calculates physiological parameters. It is not an algorithm-only software device. Its performance is inherent to its sensors and processing, designed to be used by a human operator.

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

• Not Applicable. For a 510(k) demonstrating substantial equivalence for a device like this, the "ground truth" effectively comes from the performance and established clinical utility of the predicate devices. The new device aims to perform in a similar manner to these already cleared devices.

8. The sample size for the training set:

• Not Applicable. This device does not use machine learning or AI that would require a "training set" in the conventional sense.

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

• Not Applicable. See point 8.

Summary of what can be inferred from the document regarding the device's "performance" and "acceptance":

The acceptance of the Vantage ABI device by the FDA is based on demonstrating substantial equivalence to existing, legally marketed predicate devices, specifically the BioMedix, PADnet (K042616) and Summit Doppler Systems, Vista AVS (K063600).

The "study" in this context is the 510(k) premarket notification process itself, which involved:

• Comparison of device features, materials, intended use, and performance: The document explicitly states: "Based on comparisons of device features, materials, intended use and Conclusion: performance, and user instructions, the Vantage ABI is shown to be substantially equivalent to the commercially available and legally marketed device indicated above."
• Intended Use Equivalence: The Vantage ABI "is a non-invasive device used to gauge the lower extremity arterial system using pneumatic volume plethysmography recording (PVR) and oscillometric systolic blood pressure to assist in the diagnosis of vascular disease," which is the "same manner as the predicate devices."
• Technological Equivalence: The device "uses pneumatic volume plethysmography recording (PVR) and Ankle Brachial Index (ABI) to assist in the diagnosis of vascular disease in the same manner as the predicate devices."

Therefore, the "acceptance criteria" for this 510(k) were to demonstrate that the Vantage ABI is as safe and effective as its predicate devices, based on a direct comparison of its technical specifications and intended use, rather than conducting a de novo clinical trial with novel performance metrics. The FDA's issuance of the 510(k) clearance signifies that this criterion was met.

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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 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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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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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 heart tones transvaginally as an aid for determining fetal viability.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Transvaginal (N= new indication)

The EchoHeart Transvaginal Doppler is an interchangeable transvaginal Doppler probe used with the handheld LifeDop Doppler System. It is designed for more consistent determination of fetal viability in difficult examinations when a standard transabdominal probe is insufficient - such as early gestations. obese patients and retroverted uterine positions.

The provided text is a 510(k) premarket notification for the Summit Doppler Systems, Inc. EchoHeart Transvaginal Doppler. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a detailed study with acceptance criteria and device performance metrics.

Therefore, many of the requested sections (Table of acceptance criteria, sample sizes for test/training sets, number and qualifications of experts, adjudication method, MRMC study, standalone performance, ground truth types, and how ground truth was established) cannot be fully populated as they are not explicitly present in the provided document.

However, I can extract information related to the device's intended use and the basis for its clearance.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for substantial equivalence, formal acceptance criteria in terms of specific performance metrics (like sensitivity, specificity, accuracy) are not provided in the document. The "acceptance criteria" here is implicitly assumed to be "substantial equivalence" to predicate devices, meaning it performs as well as or better than the predicate for its intended use without raising new questions of safety or effectiveness.

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

The provided document does not describe a specific clinical test set (i.e., a study involving human subjects or data collected specifically to test the performance of the EchoHeart Transvaginal Doppler against a defined ground truth). The clearance is based on substantial equivalence, which primarily relies on comparing the new device's features and technological principles to existing, legally marketed devices.

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

Not applicable, as no specific test set requiring expert ground truth establishment is described in the document for the EchoHeart Transvaginal Doppler.

4. Adjudication Method for the Test Set

Not applicable, as no specific test set requiring adjudication is described.

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

Not applicable. The device is a transvaginal Doppler probe, not an AI-powered diagnostic system. No MRMC study is mentioned.

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

Not applicable. The device is a hardware probe used by a human practitioner. It is not an algorithm evaluated for standalone performance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the purpose of this 510(k) submission, the "ground truth" for demonstrating the device's functionality and safety is implicitly tied to the established safety and effectiveness of the predicate devices it is compared against. There is no specific, independent ground truth described as being used for a novel study of the EchoHeart probe itself.

8. The Sample Size for the Training Set

Not applicable, as this is a hardware device (Doppler probe) and not an AI/machine learning algorithm that would require a "training set."

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

Not applicable for the same reason as above.

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Obstetric (2.1 and 3.2 MHz Probes) This product will be used to detect fetal heart beats as an aid for determining fetal viability.

Vascular (4.0 and 8.0 MHz Probes) This product will be used to detect blood flow in veins and arteries for assisting in the detection of peripheral vascular disease.

Diagnostic ultrasound Imaging or fluid flow analysis of the human body as follows: Fetal (Mode of Operation: CWD); Peripheral Vascular (Mode of Operation: CWD)

The LifeDop is a hand-held, battery powered, audio Doppler device used for detecting fetal heart beats and for blood flow detection in veins and arteries. The product includes four interchangeable probes (OB Late Term, OB Early Term, Vascular pencil probe, Vascular flat face probe) and user replaceable batteries. The user interface includes an on/off button, play/record button, volume control, single 2-1/4" speaker, headphone jack and LCD display for heart rate, battery and waveform information.

The provided document is a 510(k) premarket notification for the Summit Doppler Systems LifeDop Doppler Ultrasound System. It asserts substantial equivalence to predicate devices and does NOT contain information about acceptance criteria or a study proving that the device meets those criteria.

Instead, the document focuses on:

• Device Description and Intended Use: The LifeDop is a handheld, battery-powered audio Doppler device for detecting fetal heartbeats (obstetric) and blood flow in veins and arteries (peripheral vascular).
• Predicate Devices: Huntleigh Technologies Manalapan, New Jersey Dopplex II Pocket Doppler (K930200) and Medasonics Incorporated Newark, California Cadance Doppler Ultrasound System (K991441).
• Technology Summary: The core Doppler ultrasound technology is stated to be the same as the substantially equivalent predicate devices. The new technology in the LifeDop is an optional built-in audio recorder.
• Clinical Testing: The document explicitly states "None provided."
• Conclusion: The device is substantially equivalent based on comparisons of device features, materials, intended use, and performance.

Therefore, based on the provided text, there is no information regarding a study demonstrating the device meets specific acceptance criteria.

The request asks for various details related to acceptance criteria and performance studies. Since the document states "Clinical Testing: None provided" and relies on substantial equivalence to predicate devices rather than direct performance metrics against acceptance criteria, most of the requested information cannot be extracted.

Here's a breakdown of why specific points cannot be answered:

1. A table of acceptance criteria and the reported device performance: Not provided. The submission relies on substantial equivalence.
2. Sample sizes used for the test set and the data provenance: Not applicable, as no clinical testing was performed for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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: Not applicable. This device is a basic audio Doppler, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable. This device does not use a training set in the context of an AI/machine learning model.
9. How the ground truth for the training set was established: Not applicable.

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