(15 days)
Esaote's Model 7348 is a portable ultrasound system used to perform diagnostic general ultrasound studies including Cardiac (adult and pediatric), Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. The 7348 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.
The 7340 is a compact ultrasound system, used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode, XView, Multi View (MView), Trapezoidal View (TPView), Doppler, Color Flow Mapping, Amplitude Doppler (AD) and Tissue Enhancement Imaging (TEI). The system is equipped with a LCD Color Display, a control panel and is capable of operating Linear, Convex, and Phased array probes. The 7340 system has been cleared by FDA via K081794, K091009 and K110688. The 7340 has been modified from the previously cleared version, in order to add a lowcost configuration, named 7348 (modified 7340). Advanced features (such as Stress, Strain, 3D/4D) are not available in the 7348. The main changes to model 7340 consist of the following: New plastic housing of the system to give a new style. New keyboard (control panel) where the modality to select software keys has been modified and some control keys have been replaced by software keys. New Keyboard PCB lay out to match the new organization of the panel keys. New Processor PCB group to have two configurations: basic-performance group for 7348 and high-performance group for 7340. Software modifications to translate new organization of the panel keys and to manage the two Processor PCB group configurations: all other software characteristics and performances have not been changed. The 7348 is equipped with a sub-set of the 7340 probes: the intended use of the probes remains unchanged as previously cleared. These modifications do not affect the intended use or alter the fundamental scientific technology of the 7340 system cleared via K081794, K091009 and K110688.
The provided text is a 510(k) summary for the Esaote 7348 System, which is an ultrasound imaging system. The submission describes modifications to a previously cleared device (Esaote 7340 system) rather than a novel AI system. Therefore, many of the requested details, such as sample sizes for training/test sets, expert qualifications, and specific performance metrics for AI algorithms, are not applicable to this type of regulatory submission.
The document focuses on demonstrating substantial equivalence to predicate devices for its intended use and technological characteristics. The performance is assessed through its previously cleared versions.
Here's an attempt to answer the questions based on the provided text, acknowledging the limitations for an AI-specific evaluation:
1. A table of acceptance criteria and the reported device performance
Since this is a modification of an existing ultrasound system, the "acceptance criteria" are implicitly that the modified device (7348) maintains the same performance and intended use as the previously cleared predicate device (7340, cleared via K081794, K091009, and K110688). The device performance is deemed equivalent to the predicate.
| Acceptance Criteria (Implicit) | Reported Device Performance (Implicit) |
|---|---|
| Maintain intended use as predicate | Intended use remains unchanged (e.g., Cardiac, Peripheral Vascular, Abdominal, Fetal, etc.). |
| Maintain fundamental scientific technology | Fundamental scientific technology not altered. |
| Maintain established performance characteristics | No changes to software characteristics and performances impacting clinical utility. |
The document extensively lists the clinical applications and modes of operation ("P" for "Previously cleared by FDA") for the various transducers associated with the 7348 system. This signifies that for each indicated application and mode, the performance is considered equivalent to the predicate. For example, for the 7348 system (overall), "Cardiac (adult and pediatric)" is listed with "P" across all modes (B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined, TVM, TEI), indicating its performance in these areas is already cleared and accepted.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable or provided in the 510(k) summary. This submission is for a modification of an existing device, and it relies on the substantial equivalence of its technological characteristics to previously cleared predicate devices. Performance data from new clinical studies (test sets) are not typically required or presented for such modifications unless there's a significant change in intended use or technological principle.
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)
This information is not applicable or provided. Since no new clinical test sets are described, there is no mention of experts establishing ground truth for such sets. The "ground truth" here is the established safety and effectiveness of the predicate device, accepted by the FDA.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable or provided. No new clinical test sets, and therefore no adjudication methods for them, are 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
This information is not applicable. The device is an ultrasound system, not an AI-powered diagnostic tool requiring MRMC studies to evaluate AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is an ultrasound system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" implicitly relies on the established clinical utility and safety of the predicate ultrasound device (Esaote 7340) as accepted by the FDA through previous 510(k) clearances (K081794, K091009 and K110688). This means the prior clearances demonstrated clinical performance generally accepted in the medical community for diagnostic ultrasound.
8. The sample size for the training set
This information is not applicable or provided. The device is an ultrasound system with hardware and software modifications, not an AI algorithm trained on a dataset.
9. How the ground truth for the training set was established
This information is not applicable or provided. As above, this is a hardware/software modification, not an AI system that undergoes "training" in the context of machine learning.
§ 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.