(14 days)
Esaote's MyLab90 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Adult Cephalic, Pediatric, Laparoscopic, Intraoperative: Abdominal, and Other: Urologic.
The 6100 MyLab 90 is a mainframe ultrasound system used to perform diagnostic The 0100 MfLad 70 15 a manning modes of operation are: B-Mode, M-Mode, Doppler and Color Flow Mapping and, on lower frequency probes, Tissue Enhancement Imaging (TEI). The 6100 is equipped with a CRT Color Display. The full alphanumeric keyboard allows complete on-screen data entry of patient information and on-screen annotations.
The 6100 can drive phased (PA), convex (CA), linear array (LA) and Doppler probes.
The 6100 is equipped with a DVD-RW disk drive that can be used for image storage. Data can also be stored directly to a Personal Computer via a LAN port. Optional Data can also be berear and of the 6100 include an S-VHS video recorder; a accessory - devices - a rease printer. The 6100 is equipped with an isolation transformer to adequately insulate the system's peripherals.
The provided 510(k) summary for the MyLab90 Ultrasound Imaging System does not contain information on specific acceptance criteria for performance metrics, nor does it detail a study that explicitly proves the device meets such criteria in terms of clinical efficacy or diagnostic accuracy. Instead, the document focuses on demonstrating substantial equivalence to predicate devices based on technical specifications and indications for use.
The data provided primarily outlines:
- The device's technical characteristics and modes of operation.
- Its intended uses across various clinical applications.
- A comparison of the MyLab90 features with several predicate devices.
- A list of compatible transducers.
- Regulatory information, including the FDA's "substantial equivalence" determination.
There is no mention of:
- Specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy).
- A test set size, data provenance, or details on ground truth establishment for performance evaluation.
- The number or qualifications of experts used for ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes for AI assistance.
- Standalone (algorithm-only) performance studies.
- Sample sizes for training sets or how ground truth for training was established.
The "study" implicitly proving the device meets acceptance criteria is the comparison and demonstration of substantial equivalence to already cleared predicate devices, as detailed in the technical specifications comparison table. This is a common method for 510(k) clearance, where a new device is shown to be as safe and effective as an existing legally marketed device without necessarily conducting new clinical trials for efficacy.
Table of Acceptance Criteria and Reported Device Performance:
Based on the provided document, explicit performance acceptance criteria and reported metrics in the traditional sense (e.g., sensitivity, specificity) are not available. The "performance" described relates to functional capabilities and equivalence to predicate devices. The table below summarizes the key comparative information from the document.
| Acceptance Criterion (Implicit) | Reported Device Performance (MyLab90) |
|---|---|
| Modes of Operation (equivalence to predicate devices) | Supported: 2D, M-Mode, PW, CW, CFM, Amplitude Doppler (PD), TEI (Tissue Enhancement Imaging), CnTI (Contrast Media), 3D, VPan, TVM (Tissue Velocity Mapping), Compound Imaging, Bi-Scan. |
| Similar to or exceeding modes offered by predicate devices (Technos, MyLab 50, Megas, iU22). Some modes like Bi-Scan and Intelligent Real-Time Image Processing are new compared to older Esaote predicates. | |
| Clinical Indications for Use (equivalence to predicate devices) | Supported: Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Small organ, Musculoskeletal (conventional and superficial), Abdominal, Fetal, Transvaginal, Transrectal, Adult Cephalic, Pediatric, Laparoscopic, Intraoperative: Abdominal, Urologic. |
| Largely equivalent or expanded compared to predicate devices. Specific 'N' (new indications) are noted for various transducers/applications. | |
| Imaging Frequencies (within established range) | 1 - 16 MHz (comparable to Technos: 1.5 - 16 MHz; broader than MyLab 50 and Megas: 2 - 10 MHz) |
| CFM/Doppler Frequencies (within established range) | 2 - 12 MHz (comparable to Technos: 2 - 12 MHz; broader than MyLab 50: 2 - 8 MHz, and Megas: 2 - 5 MHz) |
| Electrical Safety/Ultrasound Safety | Complies with IEC60601-1 and Track 3 (Acoustic Output Display). This implies meeting relevant safety standards. |
| Probe Technology (supported types) | Phased Array, Convex Array, Linear Array, Doppler probes, compatible with specific listed transducer models. |
| Digital Archival Capabilities | YES (including DVD-RW and LAN for image storage). |
| DICOM Classes | Media Storage, Storage SCU. |
Details of the "Study" (Substantial Equivalence Demonstration):
- Sample size used for the test set and data provenance: Not applicable. The document does not describe a clinical performance study with a test set of patient data. The "study" is a comparison of technical specifications and intended uses against predicate devices.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for performance evaluation was not explicitly established or reported for this submission. The comparison is based on the known features and regulatory clearances of predicate devices.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not described. The document focuses on device features and intended use equivalence, not on human reader performance with or without AI assistance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, a standalone performance study was not described. The device is an ultrasound imaging system, which inherently involves human interpretation.
- The type of ground truth used: Not applicable in the context of a performance study. The "ground truth" for the substantial equivalence claim would be the regulatory clearance and known performance characteristics of the predicate devices.
- The sample size for the training set: Not applicable. This document does not describe the development or training of any AI or algorithmic components that would require a training set.
- How the ground truth for the training set was established: Not applicable.
§ 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.