(15 days)
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)
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Acoustic Output Limits | ISPTA ≤ 720 mW/cm² (Maximum) | 720 mW/cm² (Maximum) |
| TIS/TIB/TIC Range | 0.1 - 4.0 (Range) | |
| Mechanical Index (MI) ≤ 1.9 (Maximum) | 1.9 (Maximum) | |
| ISPPA Range | 0-700 W/cm² (Range) | |
| Standard Compliance | Conformance to AIUM/NEMA 1996 for display of thermal and mechanical acoustic indices | Conforms to AIUM/NEMA 1996 |
| Indications for Use | Intended for listed clinical applications | Meets previously cleared indications, plus Pulsed Wave Doppler for those indications (as per tables provided) |
| Safety | No known adverse effects on human health when used as prescribed | "This device has no known adverse affects on human health when used in the prescribed manner for the intended uses." |
Detailed Study Information (Based on the provided text)
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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.
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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.
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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.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. No diagnostic performance study is detailed.
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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.
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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.
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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.
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The sample size for the training set:
- Not applicable/Not provided. This is not an AI/machine learning device undergoing training.
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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.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.