(14 days)
The Xario XG is intended to be used for the following type 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 Xario XG Ultrasound System is a mobile system is a Track 3 device that employs a wide array of probes including, flat linear array, convex linear array, and sector array with a frequency range of approximately 2 MHz to 12 MHz.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
This document is a 510(k) summary for a Diagnostic Ultrasound System. The purpose of a 510(k) is to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This type of submission usually focuses on technical comparisons and performance metrics against a known, cleared device, rather than extensive clinical studies with specific acceptance criteria in the sense of a new medical claim or algorithmic performance.
Therefore, the "acceptance criteria" here are primarily demonstrating substantial equivalence to the predicate device (Toshiba SSA-790A, Aplio XG Version 2.00 Diagnostic Ultrasound; 510(k) K072000) in terms of technical specifications, intended use, and safety standards. The "study" proving this largely involves comparing the specifications of the new device to the predicate device and certifying compliance with relevant industry standards.
1. Table of Acceptance Criteria and Reported Device Performance
Instead of traditional clinical acceptance criteria (e.g., sensitivity, specificity), the "acceptance criteria" for a 510(k) for an ultrasound system primarily revolves around demonstrating compliance with recognized safety and performance standards, and substantial equivalence to a predicate device for its intended uses.
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Predicate Device Equivalence | Substantial equivalence to Toshiba SSA-790A, Aplio XG Version 2.00 Diagnostic Ultrasound (K072000). | The FDA has determined the device is substantially equivalent to legally marketed predicate devices. (This is the conclusion of the 510(k) review). The transudcers listed are shown to either have "N" (New Indication) or "P" (Previously Cleared by FDA, referencing K072000). |
| Safety and Manufacturing Standards Compliance | Compliance with: |
- Quality System Regulation
- IEC 60601-1 (applicable portions)
- IEC 60601-1-2 (applicable portion)
- IEC60601-2-37 (applicable portions)
- AIUM-NEMA UD2 Output Measurement Standard
- AIUM-NEMA UD3 Output Display Standard | "This device is designed and manufactured in conjunction with the Quality System Regulation, IEC 60601-1 (applicable portions), IEC 60601-1-2 (applicable portion), IEC60601-2-37 (applicable portions), and the AIUM-NEMA UD2 Output Measurement Standard as applied to Track 3 Ultrasound systems and the AIUM-NEMA UD3 Output Display Standard." (Implied compliance is necessary for clearance). |
| Intended Use Claim | Intended for: Fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular and musculo-skeletal (both conventional and superficial) studies. | The device's use for these applications is cleared, based on substantial equivalence claim and the specific transducer modalities ("N" for new, "P" for previously cleared, across various clinical applications). |
| Acoustic Output (Post-Clearance Requirement) | Submission of complete acoustic output measurements based on production line devices, as requested in Appendix G of the "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." (Post-clearance condition). | This is a post-clearance condition; actual measured values are not in this summary but are required to be submitted to the FDA. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not describe a specific "test set" in the context of diagnostic performance evaluation using patient data. For ultrasound systems seeking 510(k) clearance, the "test" typically involves:
- Bench testing: Verifying system specifications, safety features, and performance parameters against established standards.
- Comparison to predicate: Demonstrating that the technical design and performance (e.g., frequency ranges, imaging modes, transducer types) are comparable to a previously cleared device.
- Clinical use claims: Justifying the listed clinical applications based on the device's capabilities and equivalence to the predicate, rather than through a new, independent clinical trial with a specific patient sample size.
Therefore, there is no stated sample size or data provenance (country of origin, retrospective/prospective) related to a clinical test set for evaluating diagnostic accuracy or efficacy.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
As there is no described clinical test set for diagnostic performance, there is no mention of experts used to establish ground truth or their qualifications. The "ground truth" for a 510(k) ultrasound system clearance primarily rests on the device meeting engineering specifications and safety standards, and being technically equivalent to its predicate.
4. Adjudication Method for the Test Set
Again, since there is no described clinical test set for diagnostic performance, there is no adjudication method discussed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Improvement
No MRMC comparative effectiveness study is mentioned. This device is a Diagnostic Ultrasound System, and the 510(k) summary focuses on its technical specifications and equivalence to a predicate, not on human-AI assistive performance or AI capabilities.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
No standalone algorithm performance study is mentioned. This is a medical imaging hardware system, not an AI-driven algorithm, so such a study would not be applicable to this document.
7. The Type of Ground Truth Used
The "ground truth" in this context is the established technical and safety standards (e.g., IEC, AIUM-NEMA) and the specifications and cleared indications of the predicate device (Toshiba SSA-790A, Aplio XG Version 2.00, K072000). There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for a diagnostic performance study in this 510(k) summary.
8. The Sample Size for the Training Set
There is no mention of a training set in this document. This clearance is for an ultrasound hardware system, not an AI or machine learning algorithm that would require a training set.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set, this question is not applicable to the provided document.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.