(63 days)
ALOKA LISENDO 880 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Pediatric, Small Organ (Spec.), Intra-operative (Spec.), Neonatal Cephalic, Musculo-skel. (Convent./Superfic.), Peripheral vessel, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card), Adult Cephalic clinical applications.
The Modes of Operation are B mode, PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler, Power Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging.
An ultrasound diagnostic system with the following features:
- Ultrasound transducer(s) to generate the transmitted ultrasound energy and detect the reflected echoes
- Ultrasound transducer accessories (standard and optional) to maximize functional usage of transducer(s) in various modes of operation
- A computer system - to control the transducer and analyze the signals resulting from the reflected echoes
- A video monitor with optional image recorder to display the computed image or derived Doppler data
The provided text is a 510(k) Pre-Market Notification for the ALOKA LISENDO 880 ultrasound system. It outlines the device's indications for use and compares it to a predicate device (ARIETTA 70, K134016) to establish substantial equivalence.
Here's an analysis of the acceptance criteria and supporting studies as presented in the document:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with specific, quantitative acceptance criteria (e.g., minimum sensitivity or specificity values, specific performance metrics) and corresponding reported performance metrics for the ALOKA LISENDO 880. Instead, it relies on a qualitative comparison to a predicate device.
The "Comparison to predicate device" section (Page 20) implicitly defines the acceptance criterion as being "substantially equivalent" to the ARIETTA 70 (K134016) in terms of:
- Indication for Use: The ALOKA LISENDO 880's indications for use are listed and shown to broadly align with those of the ARIETTA 70.
- Modes of Operation: Both devices are stated to have the same core modes of operation (B mode, M mode, PW mode, CW mode, Color Doppler, Power Doppler, TDI, 3D Imaging, 4D Imaging, and combinations).
- Probe Types: Both support Convex, Linear, Sector, and other probe types.
- Applicable Software Features: A long list of software features (e.g., DICOM, Freehand 3D, Real-time Doppler Auto Trace, Spatial Compound) are listed as being present in both the subject and predicate devices with "YES" for both, implying functional equivalence.
The "Conclusions" section (Page 21) summarizes these points, stating that the ALOKA LISENDO 880 is substantially equivalent in safety and effectiveness based on:
- Same indications for diagnostic ultrasound imaging and fluid flow analysis.
- Same gray scale and Doppler capabilities.
- Same essential technology for imaging, Doppler functions, and signal processing.
- Acoustic level below Track 3 FDA limits.
- Manufactured in accordance with FDA 21 CFR 820 Quality System Regulations.
- Designed and manufactured to the same electrical and physical safety standards.
- Materials tested in accordance with ISO 10993-1.
- Reusable probes with instructions for cleaning, disinfection, and sterilization.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document explicitly states under "2. Clinical testing:" that "None required." This indicates that no separate clinical test set was used to establish performance for the ALOKA LISENDO 880 for the purpose of this 510(k) submission. The FDA allows clearance of devices through the 510(k) pathway if they are shown to be substantially equivalent to a legally marketed predicate device, often without new clinical studies if the technological characteristics are similar.
Therefore, there is no information on sample size, data provenance, or whether data was retrospective or prospective, as no new clinical testing was conducted.
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)
Since no clinical testing was performed for the subject device as part of this 510(k) submission, there is no mention of experts being used to establish a ground truth for a test set specifically for the ALOKA LISENDO 880. The substantial equivalence argument relies on the predicate device's established safety and effectiveness.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
As no clinical testing was conducted for the subject device to evaluate its performance against a ground truth, there is no information on adjudication methods for a test set.
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
The document does not mention any multi-reader multi-case (MRMC) comparative effectiveness study, nor does it refer to AI assistance. The ALOKA LISENDO 880 is described as a diagnostic ultrasound system, and the submission focuses on its equivalence to a predicate ultrasound system rather than advanced AI-driven interpretation or assisted diagnostics.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This submission is for a diagnostic ultrasound system, not an algorithm. Therefore, "standalone" algorithm performance is not applicable or discussed. The device is intended for use by "trained personnel (doctor, sonographer, etc.)", indicating human-in-the-loop operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
No new ground truth data was generated or used for the ALOKA LISENDO 880's clearance as "no clinical testing" was required. The "ground truth" for the predicate device would have been established during its own clearance process, but that information is not detailed here.
8. The sample size for the training set
The document does not discuss any training sets, as it's not describing an AI/machine learning device. The clearance is based on the device's technical specifications and substantial equivalence to a predicate, not on a machine learning model's performance.
9. How the ground truth for the training set was established
As there is no mention of a training set or machine learning components, this information is not provided.
§ 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.