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510(k) Data Aggregation
(28 days)
The Diaqnostic Ultrasound System Xario 100 Model TUS-X100 and Xario 100 Model TUS-X100S are indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diaqnosis in the following clinical applications: fetal, abdominal, intra-operative(abdominal), laparoscopic, pediatric, small orqans, neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional), musculo-skeletal (superficial), cardiac adult, cardiac pediatric, trans-esoph(cardiac) and peripheral vessel.
The Xario100 Model TUS-X100 and Model TUS-X100S are mobile diagnostic ultrasound systems. These systems are Track 3 devices that employ a wide array of probes including flat linear array, convex linear array, and sector array with frequency ranges between approximately 2 MHz to 12 MHz.
The provided text describes modifications to an ultrasound system (Xario 100 TUS-X100 and TUS-X100S V3.0) and the testing conducted to support its substantial equivalence. The information is presented in the context of a 510(k) premarket notification to the FDA.
Here's an analysis of the acceptance criteria and study information, based only on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in a quantitative table within the document. Instead, the document focuses on demonstrating that the modified device functions similarly to the predicate device and meets safety and performance standards. The "reported device performance" is described qualitatively as improving needle visualization.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred/Qualitative) | Reported Device Performance (Qualitative) |
|---|---|---|
| Intended Use Equivalence | Device maintains the same intended use as predicate devices. | The device's intended use (visualization of structures and dynamic processes for diagnosis in various clinical applications) is unchanged. |
| Technological Characteristics | Similar technological characteristics to predicate devices and existing transducers. | The device employs a wide array of probes (flat linear, convex linear, sector array) with frequency ranges of 2 MHz to 12 MHz, similar to its predicate. Additions include a laparoscopic transducer. |
| Safety and Effectiveness | Compliance with relevant safety standards and validated software. | Designed and manufactured under Quality System Regulations (21 CFR § 820, ISO 13485). Conforms to IEC60601-1, IEC 60601-1-2:2007, IEC 60601-2-37 (2007), IEC 62304 (2006), AIUM RTD2-2004, and ISO 10993-1 standards. Software validation successfully completed. Risk management applied. |
| Needle Visualization (BEAM feature) | The "BEAM" feature should improve needle visualization during biopsy procedures. | A study confirmed that the subject device "improves needle visualization." |
| Acoustic Output | Compliance with acoustic output standards. | Acoustic Output testing (UD3, 2004) was conducted. |
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 mentions a "study" for the BEAM feature but does not specify the sample size used for the test set. It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective nature of the data).
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)
The document does not provide any information regarding the number of experts used to establish ground truth or their qualifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not specify any adjudication method used for the 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 describes a study comparing "an existing imaging mode with the needle enhancement feature" but does not indicate if it was a multi-reader multi-case (MRMC) comparative effectiveness study with human readers assessing improvement with AI assistance. The "BEAM" feature is described as improving needle visualization, but no effect size or specific metrics on human reader improvement are provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The "BEAM" feature is integrated into the ultrasound system to assist in needle visualization. While the study confirmed the device's ability to improve needle visualization, it's not explicitly stated if this was a standalone algorithm-only performance evaluation, separate from how a human would then use that improved visualization. The context suggests it’s a feature within the system for human use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document does not specify the type of ground truth used for the performance study of the "BEAM" feature. It only mentions that the study "confirmed that the subject device improves needle visualization," but not how that improvement was objectively measured or validated against a ground truth.
8. The sample size for the training set
The document does not mention a training set or its sample size. This implies that the submission does not detail an AI/machine learning model in the sense of requiring a "training set" in the context of the described modifications. The "BEAM" feature might be a signal processing or image enhancement technique rather than a classic AI model requiring a distinct training phase.
9. How the ground truth for the training set was established
Since no training set is mentioned (see point 8), this information is not applicable/not provided in the document.
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