(15 days)
The Aplio XG is intended to be used for the following types of studies; fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular and musculo-skeletal (both conventional and superficial).
The Aplio XG Ultrasound System is a mobile system. This system is a Track 3 device that employs a wide array of probes that include flat linear array, convex linear array, and sector array with a frequency range of approximately 2 MHz to 12 MHz.
The provided text is a 510(k) summary for a Toshiba Aplio XG Version 3.0 Diagnostic Ultrasound System. This document is a regulatory submission for medical devices and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results and acceptance criteria in the manner you might find for a novel AI/CADe device.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not present in the provided document. The document primarily lists the intended uses for various transducers and indicates whether these uses were "Previously Cleared by FDA" (P) or are "N= new indication." There is no section detailing performance metrics or studies to prove the device meets specific acceptance criteria.
The acceptance of this device for market clearance is based on its substantial equivalence to previously cleared predicate devices, specifically the Toshiba SSA-790A, Aplio XG Version 2.2, and the Hitachi Medical Systems America Inc. HI VISION 900 Diagnostic Ultrasound Scanner. The "study that proves the device meets the acceptance criteria" in this context is the comparison to these predicate devices as detailed in the 510(k) submission, confirming that the new device does not raise new questions of safety or effectiveness.
Here's an attempt to structure what can be extracted from the provided text, while noting the significant lack of the detailed study information you requested:
Acceptance Criteria and Study for Toshiba SSA-790A, Aplio XG Version 3.0 Diagnostic Ultrasound System
Based on the provided 510(k) Summary, the acceptance criteria and study detailed below are primarily focused on demonstrating substantial equivalence to predicate devices rather than proving a specific performance metric against a defined acceptance threshold for a novel AI/CADe functionality. The document does not contain the detailed clinical study information typically associated with proving performance characteristics of an AI/CADe device (e.g., sensitivity, specificity, reader performance improvements, sample sizes of test sets, expert qualifications, or adjudication methods).
1. Table of Acceptance Criteria and Reported Device Performance:
Since explicit quantitative acceptance criteria for performance metrics (like sensitivity or specificity) are not provided in this 510(k) summary (which is typical for ultrasound systems establishing equivalence rather than new AI/CADe performance), this table represents the intended uses and the status of those indications (new vs. previously cleared), which is the primary "performance" aspect evaluated for this type of submission.
| Clinical Application (Example Transducer PST-30BT) | Acceptance Criteria (Implied: Substantially Equivalent or Previously Cleared) | Reported Device Performance (Status) |
|---|---|---|
| Fetal | Substantially Equivalent / Previously Cleared | P (Previously Cleared by FDA) |
| Abdominal | Substantially Equivalent / Previously Cleared | P |
| Pediatric | Substantially Equivalent / Previously Cleared | P |
| Neonatal Cephalic | Substantially Equivalent / Previously Cleared | P |
| Adult Cephalic | Substantially Equivalent / Previously Cleared | P |
| Cardiac | Substantially Equivalent / Previously Cleared | P |
| Various other applications across transducers | Substantially Equivalent / Previously Cleared / New Indication (but within historical performance) | P or N as indicated in forms |
Note: The "acceptance criteria" here are implied by the 510(k) process itself, which requires demonstrating that the new device is as safe and effective as a legally marketed predicate device. The "reported device performance" is the confirmation that the device's capabilities align with previously cleared indications or new indications that do not raise new questions of safety or effectiveness. For new indications (marked 'N'), the submission would typically provide justification, but this level of detail is not in the provided summary.
2. Sample size used for the test set and the data provenance:
- Not provided. The document does not describe specific test sets, sample sizes, or data provenance (e.g., country of origin, retrospective/prospective) for a performance study. Its focus is on the device's technical specifications and intended uses in comparison to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not provided. There is no mention of ground truth establishment, expert reviews, or qualifications in the context of a performance study.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not provided. This information is not relevant to the type of 510(k) submission presented, which does not detail a clinical performance study with adjudication.
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:
- Not applicable / Not provided. This document precedes common AI/CADe applications in ultrasound systems and does not describe an MRMC study comparing human reader performance with and without AI assistance. The device is a diagnostic ultrasound system, not an AI or CADe device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable / Not provided. The device is an ultrasound system, not an algorithm being evaluated in a standalone capacity.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not provided. As no specific performance study with ground truth is detailed, this information is absent. For an ultrasound system like this, the "ground truth" for demonstrating equivalence would typically involve engineering and bench testing, comparison to predicate device specifications, and possibly clinical validation of image quality and diagnostic capabilities, but not in the sense of a definitive diagnostic ground truth for an AI algorithm.
8. The sample size for the training set:
- Not applicable / Not provided. This device is a diagnostic ultrasound system, not an AI model, so there is no mention of a training set for an algorithm.
9. How the ground truth for the training set was established:
- Not applicable / Not provided. As there is no AI model or training set discussed, this information is not present.
In summary, the provided 510(k) document is a regulatory filing for a diagnostic ultrasound system (Toshiba SSA-790A, Aplio XG Version 3.0), focusing on demonstrating substantial equivalence to predicate devices based on its intended uses and technical specifications. It does not contain the detailed clinical study performance data or AI/CADe-specific information that your questions are designed to elicit.
§ 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.