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The Ecton Lynx with Pulsed Wave Doppler is intended for the previously cleared clinical indications of adult and pediatric cardiac, intraoperative cardiac, peripheral vascular, abdominal, fetal, pediatric and neonatal cephalic imaging.

The Ecton Lynx Ultrasound System is a general purpose and cardiac diagnostic ultrasound system. It is a highly portable digital system. Its function is to transmit and acquire ultrasound image data and display it on a monitor. The system has been cleared to operate in 2D, M-Mode, Color Flow Doppler, Doppler Tissue Imaging, and Continuous Wave Doppler modes (K982800). The current submission is for the addition of the Pulsed Wave Doppler mode to the device.

The provided text is a 510(k) summary for the Ecton Lynx Ultrasound System with Pulsed Wave Doppler. It focuses on demonstrating substantial equivalence to predicate devices and detailing the device's technological characteristics and intended uses. Crucially, it does not contain a study that proves the device meets specific acceptance criteria in terms of diagnostic performance (e.g., sensitivity, specificity, accuracy).

Instead, the summary focuses on:

• Safety and Effectiveness: Asserts that the device operates identically to previously cleared versions and predicate devices.
• Acoustic Output Limits: Provides a table of acoustic output limits, stating that these are the same as the cleared version and predicate Track 3 devices. This is a key safety criterion for ultrasound devices.
• Compliance with Standards: Notes conformance to the AIUM/NEMA 1996 standard for real-time display of thermal and mechanical acoustic indices.
• Intended Use/Indications for Use: Lists the clinical applications for which the device is intended.

Therefore, I cannot populate most of the requested fields as the information is not present in the provided document. The document describes the acceptance criteria for safety (acoustic output limits) and states the device meets them by being identical to previously cleared and predicate devices, implying previous demonstrations of safety and efficacy.

Here's what can be extracted from the document based on your request, with an emphasis on what is not present:

Acceptance Criteria and Device Performance (Safety-related)

Detailed Study Information (Based on the provided text)

1. A table of acceptance criteria and the reported device performance: See table above. This document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a performance study with specific diagnostic metrics (e.g., sensitivity, specificity) against defined acceptance criteria. The "performance" here refers mostly to safety parameters and functional equivalence.

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. This document does not describe a clinical study for diagnostic performance. The testing described implicitly would be engineering and acoustic output testing, not patient data-driven performance.

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/Not provided. No diagnostic performance study is detailed, thus no ground truth establishment by experts is described.

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

   • Not applicable/Not provided. No diagnostic performance study is detailed.

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. This document describes a diagnostic ultrasound system, not an AI-assisted device. Therefore, no MRMC study or AI-related metrics are present.

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

   • No. This is a diagnostic ultrasound system operated by a human, not an algorithm seeking standalone evaluation.

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

   • Not applicable/Not provided. No diagnostic performance study is detailed. For a device like this seeking 510(k) clearance, the "ground truth" for proving substantial equivalence often relies on demonstrating that its technical characteristics (e.g., imaging modes, acoustic output, safety features) are equivalent to already cleared devices, rather than a clinical trial with patient outcomes.

8. The sample size for the training set:

   • Not applicable/Not provided. This is not an AI/machine learning device undergoing training.

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

   • Not applicable/Not provided. This is not an AI/machine learning device.

In summary, this 510(k) document is for a medical device (ultrasound system) demonstrating substantial equivalence to predicate devices for regulatory clearance. It focuses on technical specifications, safety parameters (like acoustic output), and intended uses, rather than performance metrics from a human-interpretive or AI-driven diagnostic study.

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Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intraoperative-Cardiac, Pediatric, Neonatal Cephalic, Cardiac (Adult), Cardiac (Pediatric), Transesophageal, Peripheral Vascular. The Ecton Lynx is not intended for ophthalmic, intraoperative neuralgic, or adult cephalic imaging. The system may be used with or without legally marketed ultrasound contrast agents. The system makes no claims regarding the use of ultrasonic contrast agents but provides harmonic imaging capability, receiving echoes at a multiple of the transmit signal and providing electrocardiographic gating that may be used in conjunction with contrast agents.

The Ecton Lynx Ultrasound System is a general purpose and cardiac diagnostic ultrasound system. It is a highly portable digital system. Its function is to transmit and acquire ultrasound image data and display it on a monitor. The system operates in 2D, M-Mode, Color Flow Doppler, Doppler Tissue Imaging, and Continuous Wave Doppler modes. The Lynx provides the operator with the ability to perform measurements and calculations on images using established clinical formulae. The Lynx complies with the Track 3 Output Display Standard, providing an automatic display of Mechanical Index and Thermal Index. The Ecton Lynx is designed to operate linear and linear phased array transducers (probes). Four probes are included in the current submission: a 2.5MHz external probe, a 5.0MHz external probe, a 5.0MHz biplane transesophageal probe, and a 5.0MHz monoplane transesophageal probe. The transesophageal probes contain a temperature sensing device that is used to limit the surface temperature to 43 degrees C. The Ecton Lynx includes a stress echocardiography software package that utilizes conventional techniques to capture and format images for stress echocardiography studies. The system provides digital output of images in conformance with the DICOM standard. The Lynx does not utilize lossy compression techniques in image storage or transmission.

The provided document is a 510(k) summary for the Ecton Lynx Ultrasound System, submitted to the FDA in 1998. This type of regulatory submission focuses on demonstrating substantial equivalence to predicate devices already on the market rather than on detailed performance studies of clinical efficacy.

Therefore, the document does not contain the kind of detailed acceptance criteria and study results typically found for devices that involve AI/ML components or require extensive clinical validation studies. The Ecton Lynx Ultrasound System is a general-purpose diagnostic ultrasound system from 1998, predating widespread AI/ML integration in medical imaging devices.

Based on the provided text, I can extract information related to safety standards and acoustic output limits, which serve as a form of acceptance criteria for the device's technical performance and safety. However, typical "device performance" in terms of clinical metrics (e.g., sensitivity, specificity, accuracy) is not mentioned because the 510(k) submission primarily relies on demonstrating equivalence to predicate devices that have established their safety and effectiveness through their prior market clearance.

Here's a breakdown of what can be inferred or confirmed from the text, and what information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The document focuses on technical and safety compliance rather than clinical performance metrics. The "acceptance criteria" can be interpreted as adherence to established safety standards and acoustic output limits, and functional equivalence to predicate devices in modes of operation.

The following information is NOT present in the document provided:

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

• Not Available. The document does not describe a clinical study with a "test set" of patient data for evaluating diagnostic performance. The submission is based on technical specifications and substantial equivalence to existing devices.

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. Since there is no described clinical "test set" or diagnostic performance evaluation, there is no mention of experts establishing ground truth for such a study.

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

• Not Applicable. No clinical test set or adjudication process 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

• No. This document describes a diagnostic ultrasound system from 1998, which predates the common integration of AI. No MRMC study or AI assistance is mentioned.

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

• No. No standalone algorithm performance study is described. The device is an imaging system used by human operators.

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

• Not Applicable. As no clinical performance study is detailed, no ground truth types are mentioned. The ground truth for the submission itself is the technical specifications, compliance with standards, and functional equivalence to predicate devices, rather than clinical diagnostic accuracy.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device, so there is no concept of a "training set."

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

• Not Applicable. No training set is mentioned.

Summary of the Study (or lack thereof) that Proves the Device Meets Acceptance Criteria:

The study that proves the Ecton Lynx Ultrasound System meets its acceptance criteria is primarily an engineering and regulatory compliance assessment, not a clinical efficacy study in the modern sense.

• Study Type: The submission is a 510(k) Premarket Notification, which aims to demonstrate "substantial equivalence" to legally marketed predicate devices. This typically involves comparing technical specifications, safety features, indications for use, and operational modes.
• Methodology: The manufacturer conducted an internal evaluation to ensure the device's design and functionality (including modes like 2D, M-Mode, Color Flow Doppler, DTI, CW Doppler, and Harmonic Imaging) were similar to those of the predicate devices.
• Compliance: Compliance with international and Canadian safety standards (IEC601-1, C22.2 No. 601.1, IEC 601-1-2) and the AIUM/NEMA standard for acoustic output display was demonstrated through design and testing. Acoustic output limits for ISPTA, TIS/TIB/TIC, Mechanical Index, and ISPPA were measured and reported to be within acceptable ranges for Track 3 devices and consistent with predicate devices.
• Temperature Control: For transesophageal probes, a temperature sensing device was incorporated to limit surface temperature to 43°C, ensuring patient safety.
• Image Output: The system's ability to output images in conformance with the DICOM standard without lossy compression was a technical specification.
• "Proof": The "proof" that the device meets its criteria is the successful review by the FDA (specifically, the Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices) leading to a finding of "substantial equivalence" to predicate devices and clearance for market. The FDA's letter mentions a post-clearance special report requirement for acoustic output measurements based on production line devices, indicating an ongoing verification of these key safety parameters.

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