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The Nemio XG system 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, musculo-skeletal (both conventional and superficial).

The Nemio XG will be offered in one variation which is a mobile system. It 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.

This document is a 510(k) summary for the Toshiba Nemio XG, SSA-580A Ultrasound Imaging System. It declares substantial equivalence to a predicate device (Toshiba SSA-550A/NEMIO, K010631) rather than presenting a study to prove new acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics for a novel device is not applicable or not provided in this 510(k) summary.

The document primarily focuses on establishing equivalence and listing the intended uses and associated transducers.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not present quantitative acceptance criteria or device performance data for the Nemio XG, SSA-580A. Instead, it relies on demonstrating substantial equivalence to a previously cleared device (K010631). The premise of a 510(k) submission is that if a new device is substantially equivalent to a legally marketed predicate device, it meets the same safety and effectiveness standards.

The acceptance criteria implicitly refer to the continued satisfactory performance of the predicate device (SSA-550A/NEMIO) and the new device's ability to maintain that level of performance for its stated intended uses.

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable. This is a 510(k) submission asserting substantial equivalence, not a clinical study with a test set of data. The "test" for this type of submission involves demonstrating that the new device's technological characteristics, intended use, and safety/effectiveness are comparable to the predicate.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

Not applicable for this 510(k) submission. This process does not involve expert adjudication of a test set for a new algorithm's performance. The "ground truth" here is the established safety and effectiveness of the predicate device.

4. Adjudication Method for the Test Set:

Not applicable. No test set was used in the context of comparing a new device's performance against ground truth created by expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This document pertains to an ultrasound imaging system, not an AI-assisted diagnostic tool. No MRMC study is mentioned or implied.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an AI algorithm but an ultrasound imaging system.

7. The Type of Ground Truth Used:

The ground truth implicit in a 510(k) substantial equivalence submission is the established safety and effectiveness of the legally marketed predicate device (Toshiba SSA-550A/NEMIO, K010631). The new device is deemed "substantially equivalent" if it can demonstrate it performs as safely and effectively as this predicate, without raising new questions of safety or effectiveness.

8. The Sample Size for the Training Set:

Not applicable. The Nemio XG is an ultrasound system and does not involve AI/machine learning requiring a training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable. As above, there is no AI component or training set discussed in this 510(k) summary.

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The NEMIO systems are 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, musculo-skeletal (both conventional and superficial), and laparoscopic.

The NEMIO will be offered in three variations all of which are mobile systems. These systems are all Track 3 devices that employ 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 differences in systems will be the availability of various options such as size of monitor, ultrasonic, modes, and post processing display capabilities.

The provided text is a 510(k) Summary for a diagnostic ultrasound imaging system (NEMIO, SSA-550A) and a related transducer. It outlines regulatory information, intended use, and substantial equivalence to predicate devices, but it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement in the context of proving the device meets specific performance criteria.

The "Acceptance Criteria" mentioned in the document relate to general regulatory compliance and manufacturing standards, not specific performance metrics of the ultrasound's diagnostic capabilities. The safety considerations listed (IEC standards, AIUM-NEMA standards) are about the design and manufacturing of the device, and acoustic output measurements are a post-clearance requirement, not pre-market performance validation in the sense of a clinical study.

Therefore, for almost all the requested information, the answer is that the document does not provide it.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

• Quality System Regulation
• IEC 60601-1
• IEC 60601-1-2(2001)
• IEC 60601-2-37(2001)
• IEC 60601-2-37 Amd. 1(2004)
• AIUM-NEMA UD2 Output Measurement Standard
• AIUM-NEMA UD3 Output Display Standard | No specific device performance metrics are reported in the document. The document focuses on regulatory compliance and substantial equivalence to predicate devices (Toshiba NEMIO SSA-550A Diagnostic Ultrasound System, K010631; Siemens G60 Diagnostic Ultrasound System, K040060). It also indicates that acoustic output measurements based on production line devices are a post-clearance requirement. |

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size (Test Set): Not provided. This document is a regulatory submission for substantial equivalence based on technical specifications and comparison to predicate devices, not a clinical performance study.
• Data Provenance: Not provided.

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)

• Number of Experts: Not provided.
• Qualifications of Experts: Not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: Not applicable/Not provided. The document does not describe a test set or a process requiring adjudication for performance evaluation.

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

• MRMC Comparative Effectiveness Study: No. This document is for an ultrasound system, not an AI-assisted diagnostic tool. No such study is mentioned.
• Effect size of AI assistance: Not applicable/Not provided.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance Study: Not applicable/Not provided. This document describes an ultrasound system, which inherently involves human operation and interpretation. It is not an algorithm for standalone diagnosis.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Type of Ground Truth: Not applicable/Not provided. The document does not detail any studies requiring the establishment of ground truth for diagnostic performance assessment.

8. The sample size for the training set

• Sample Size (Training Set): Not applicable/Not provided. The document does not describe any machine learning or algorithm training.

9. How the ground truth for the training set was established

• Ground Truth Establishment (Training Set): Not applicable/Not provided. The document does not describe any machine learning or algorithm training.

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Ask a specific question about this device