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The Sonata® Sonography-Guided Transcervical Fibroid Ablation System is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding.

The Sonata System provides radiofrequency (RF) ablation of uterine fibroids using a transcervical approach that is uterine sparing, without incisions or material uterine distension. The system enables a clinician to deliver radiofrequency energy to fibroid tissue resulting in thermal fixation and coagulative necrosis of the tissue. The system combines two technologies - ultrasound for visualization, and radiofrequency energy for ablative therapy - in a single integrated handpiece. The Sonata System is comprised of medical equipment, software, and various single-use and reusable instruments.

The provided text describes the acceptance criteria and the clinical study results for the Gynesonics Sonata® Sonography-Guided Transcervical Fibroid Ablation System.

1. Table of Acceptance Criteria and Reported Device Performance

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The Teratech Corporation Terason™ uSmart3200T (also known as the BenQ UP200) is a general purpose Ultrasound System intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal, Abdominal, Intra-Operative (abdominal, organs and vascular), Pediatrics, Small Organ (Thyroid, Breast, Testes); Neonatal and Adult Cephalic; Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional and Superficial); Cardiac (Adult & Pediatric); Peripheral Vascular.

The Terason uSmart3200T ultrasound system is a portable tablet style full feature, general purpose, and diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. The Terason uSmart3200T Ultrasound System is equivalent to the previously cleared version of the uSmart3200T Ultrasound Systems. The modification includes the addition of 3 transducers (15L4, 16HL7, and 8EC4A) with the no change to tablet style computer form factor.

The Terason™ uSmart3200T ultrasound system was the previously cleared on the date of May 28, 2013 as described in the 510(k) submission (K131209). This system contains a proprietary ultrasound engine for controlling the acoustic output of the transducer and processing the return echoes in real time. This data are then transferred to the tablet computer over a FireWire (aka IEEE 1394) connection for further processing and generation and display of the ultrasound image.

The Terason™ uSmart3200T ultrasound tablet weighs 4.9 pounds (2.21 Kg) and has an 11.5" backlit touch screen. The tablet dimensions (8.82"(H) x 12.64"(W) x 1.25"(D)) are chosen to allow portability. A Lithium-Polymer battery (integrated into the tablet) provides 2 hours of continuous ultrasound scanning. The tablet includes a docking station (for charging) that uses a medicalgrade power supply. The ultrasound transducer connector is identical to that used in the Terason™ predicate device, the uSmart3200T. Optional accessories include a cart and printer.

The provided document is a 510(k) premarket notification for the Terason uSmart3200T and BenQ UP200 Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, the document does not contain the detailed information requested in terms of acceptance criteria, specific study designs (like MRMC or standalone performance), sample sizes, expert ground truth establishment, or training set details.

The submission primarily lists the device's technical specifications and how they compare to predicate devices. The "Non Clinical Tests" section refers to compliance with various electrical safety, usability, and acoustic output standards, which serve as the "acceptance criteria" for regulatory clearance in this context. However, these are performance standards, not clinical performance metrics.

Here's a summary of the available information based on your request, highlighting what is not present in this type of regulatory document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally compliance with international and national standards for medical devices, particularly regarding safety and technological characteristics. The "reported device performance" is demonstrated through this compliance and the assertion of substantial equivalence to predicate devices which have already met such criteria.

2. Sample size used for the test set and the data provenance

This document does not describe a "test set" in the context of clinical performance evaluation with patient data. The tests performed are non-clinical compliance tests against established safety and electrical standards. Therefore, information on sample size and data provenance (country of origin, retrospective/prospective) for a clinical test set is not applicable or present.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This document does not pertain to a clinical study requiring expert ground truth for interpretation.

4. Adjudication method for the test set

Not applicable, as no clinical test set requiring adjudication is 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

Not applicable. This is a 510(k) submission for a diagnostic ultrasound system and transducers, which does not involve AI or comparative effectiveness studies with human readers.

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

Not applicable, as this device does not involve a standalone algorithm for performance evaluation.

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

Not applicable, as no clinical ground truth is established or used in this submission. The "ground truth" here is compliance with engineering and safety standards.

8. The sample size for the training set

Not applicable, as this document does not describe a machine learning model or training set.

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

Not applicable, for the same reason as above.

Summary of Approach:

This 510(k) submission demonstrates substantial equivalence primarily by:

• Listing the device's technical characteristics and comparing them directly to previously cleared predicate devices (Terason uSmart3200T (K131209), Terason™ t3000 (K112953), Terason™ T3200 (K110020)).
• Highlighting that the modifications (addition of three transducers and software updates) do not alter the fundamental technological characteristics or intended use.
• Providing evidence of compliance with a comprehensive set of non-clinical safety, electrical, usability, and acoustic output standards.

The "study" that proves the device meets the "acceptance criteria" here consists of these non-clinical tests and direct comparisons to predicate devices, rather than clinical performance studies with patient data. The regulatory body (FDA) reviews these submissions to ensure the new device is as safe and effective as existing legally marketed devices, without requiring new clinical efficacy data if substantial equivalence is adequately demonstrated.

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The Teratech Corporation Terason™ uSmart3200T is a general purpose Ultrasound System intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal, Abdominal, Pediatrics, Small Organ (Thyroid, Breast, Testes); Neonatal and Adult Cephalic; Musculo-skeletal (Conventional and Superficial); Cardiac (Adult & Pediatric); Peripheral Vascular.

The Terason™ uSmarl3200T ultrasound system is equivalent to the previously cleared version of the t3200 and t3000 Ultrasound Systems described in the following 510(k) submissions (K110020 and K112953). This system contains a proprietary ultrasound engine for controlling the acoustic output of the transducer and processing the return echoes in real time. These data are then transferred to the tablet (previously laptop computer) over a FireWire (aka IEEE 1394) connection for further processing and generation and display of the ultrasound image.

The Terason™ uSmart3200T ultrasound tablet weighs 4.9 pounds (2.21 Kg) and has an 11,5" backlit touch screen. The tablet dimensions (8,82"(H) x 12,64"(W) x 1,25"(D)) are chosen to allow portability. A Lithium-Polymer battery (integrated into the tablet) provides 2 hours of continuous ultrasound scanning. The tablet includes a docking station (for charging) that uses a medical-grade power supply. The ultrasound transducer connector is identical to that used in the Terason™ predicate device, the t3200. Optional accessories include a cart and printer.

The provided document is a 510(k) Summary for the Terason™ uSmart3200T Ultrasound System, detailing its substantial equivalence to previously cleared devices. It focuses on regulatory compliance, safety, and performance characteristics rather than clinical study results establishing diagnostic accuracy against a ground truth.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and reported device performance (in terms of diagnostic accuracy metrics). The document refers to compliance with safety and performance standards (e.g., IEC 60601-1) but not clinical performance acceptance criteria like sensitivity, specificity, or AUC against a ground truth.
• Sample size used for the test set or its provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Whether a multi-reader, multi-case (MRMC) comparative effectiveness study was done or its effect size.
• Whether a standalone (algorithm only) performance study was done.
• The type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How the ground truth for the training set was established.

However, based on the document, I can provide the following relevant information regarding the device's acceptance criteria and the study that proves its compliance with regulatory standards:

The device's acceptance criteria are primarily defined by compliance with established international and national standards for medical electrical equipment, including safety, usability, electromagnetic compatibility, and acoustic output. The "study" proving the device meets these criteria consists of specific non-clinical tests and reports generated by accredited testing laboratories (Intertek).

1. A table of acceptance criteria and the reported device performance (focused on technical compliance):

Important Note: This document describes a 510(k) submission, which primarily aims to demonstrate substantial equivalence to a previously cleared device. It does not typically involve new clinical efficacy studies with ground truth establishment in the way that, for example, a novel diagnostic AI algorithm would. The "performance" here refers to meeting established safety and performance standards for ultrasound devices, and demonstrating that changes from predicate devices (e.g., changing from laptop to tablet) do not raise new safety or effectiveness concerns.

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