(43 days)
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.
| Acceptance Criteria (Safety/Technical) | Reported Device Performance (Compliance) |
|---|---|
| Safety Standards Compliance | |
| IEC601-1 (Medical Electrical Equipment) | The Ecton Lynx has been designed to meet or exceed IEC601-1. |
| C22.2 No. 601.1 (Canadian Standards) | The Ecton Lynx has been designed to meet or exceed C22.2 No. 601.1. |
| IEC 601-1-2 (Electromagnetic Compatibility) | The Ecton Lynx has been designed to meet or exceed IEC 601-1-2. |
| Acoustic Output Limits (Track 3 Devices) | |
| ISPTA (Maximum) | 720 mW/cm² |
| TIS/TIB/TIC (Range) | 0.1 - 4.0 |
| Mechanical Index (Maximum) | 1.9 |
| ISPPA (Range) | 0-700 W/cm² |
| Temperature Control (Transesophageal probes) | Transesophageal probes contain a temperature sensing device that is used to limit the surface temperature to 43 degrees C. |
| DICOM Standard Compliance | 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. |
| Acoustic Indices Display | The Lynx conforms to the Standard for Real-Time Display of Thermal and Mechanical Acoustic Indices on Diagnostic Ultrasound Equipment (AIUM/NEMA 1996) for the on-screen display of mechanical and thermal indices, providing information on potential thermal and cavitation bioeffect mechanisms. A user education program provides information instructing users on machine settings and scanning techniques that allow for examinations to be conducted in accordance with the ALARA (as low as reasonably achievable) principle. Additionally, the system provides an automatic display of Mechanical Index and Thermal Index. |
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.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.