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The SenoSonix Ultrasound Breast Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.

The ultrasound module is intended for use in obstetrics/gynecology and general radiology examinations by a qualified physician, to aid in the diagnosis and evaluation of soft tissues, by generating 2 dimensional images, time motion images and biometric studies.

The specific intended uses of the ultrasound system include: abdominal, small parts, peripheral vascular, musculo-skeletal (conventional), musculo-skeletal (superficial), small organ (breast, thyroid, testicle), pediatric and fetal imaging.

The SenoSonix System is a percutaneous ultrasound-guided, vacuum-assisted biopsy device which is intended for use in providing breast tissue samples for diagnostic sampling of breast abnormalities. The SenoSonix System integrates the functions of the existing SenoRx Control Module (K023923) and Vacuum System (K023923) into a single console. An added feature of the SenoSonix System is the integration of Ultrasonix Medical's Sonix Ultrasound Scanner (K061827). The SenoSonix System has 2 flat panel displays. One displays the ultrasound image and the other is for user operation and control. The biopsy module will be controlled by the small window on the touch screen when the biopsy tab is selected.

The provided document is a 510(k) premarket notification for the SenoSonix Ultrasound Breast Biopsy System. It describes the device, its intended use, and argues for substantial equivalence to predicate devices. However, this document does not contain acceptance criteria or a study that presents performance data for the SenoSonix device itself.

The document discusses the device's indications for use and compares them to predicate devices, stating that the SenoSonix System's indications are a "sub-set of the predicate devices" and that the design changes are limited to integrating existing functionalities into a single console. This suggests that the device's performance is inherently linked to the performance of its predicate components (SenoRx Control Module, Vacuum System, and Sonix Ultrasound Scanner), which were previously cleared.

The information provided outlines the indications for use of the ultrasound module and transducers, which detail the clinical applications and modes of operation for which they are intended. These are descriptive rather than quantitative performance criteria for the biopsy system's accuracy or efficacy.

Therefore, I cannot provide the requested table or detailed study information for the SenoSonix Ultrasound Breast Biopsy System based on the input text. The document focuses on demonstrating substantial equivalence to pre-existing, cleared devices rather than providing new performance studies for the integrated system.

Here's a breakdown of why the requested information cannot be fully extracted and what can be inferred:

1. Table of acceptance criteria and reported device performance:

• Acceptance Criteria: Not explicitly stated as quantitative performance metrics for the overall biopsy system (e.g., biopsy success rate, diagnostic accuracy). The "acceptance criteria" here are implicitly tied to demonstrating substantial equivalence to predicate devices, meaning the device should perform "as well as" or "not worse than" the predicates.
• Reported Device Performance: No quantitative performance data (e.g., sensitivity, specificity, accuracy, number of successful biopsies, etc.) for the SenoSonix system is reported in the provided text.

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

• Test Set Size: Not applicable, as no dedicated performance study for the SenoSonix integrated system is described.
• Data Provenance: Not applicable.

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

• Not applicable, as no dedicated performance study for the SenoSonix integrated system is described.

4. Adjudication method for the test set:

• Not applicable, as no dedicated performance study for the SenoSonix integrated system is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

• No MRMC study is mentioned. The submission is based on demonstrating substantial equivalence to predicate devices, not on a comparative effectiveness study of the integrated system.

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

• Not applicable, as this is a medical device for tissue biopsy and ultrasound imaging, not an AI algorithm.

7. The type of ground truth used:

• Not applicable, as no dedicated performance study for the SenoSonix integrated system is described.

8. The sample size for the training set:

• Not applicable, as no "training set" in the context of an algorithm is discussed.

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

• Not applicable.

In summary: The provided document is a regulatory submission focused on substantial equivalence, not a clinical study report. It states that the SenoSonix System "has the same intended use," "uses the same operating principle," "incorporates the same biopsy and ultrasound probes," and "has the same manufacturing materials and processes" as its predicate devices. This implies that the performance of the integrated system is expected to be equivalent to the known performance of its component predicate devices, rather than being demonstrated through a new, independent performance study with defined acceptance criteria and collected data within this document.

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The Orison Embrace is indicated for use as an adjunct to mammography for B-mode ultrasonic imaging of the patients breast when used with an automatic scanning linear array transducer.

The Embrace™ 3D Ultrasound Tomography System is an easy to use diagnostic ultrasound system to be used as an adjunct to mammography for imaging a patient's breast. Ultrasound images are acquired using a general purpose ultrasound system capable of B-mode imaging in conjunction with an automatic scanning concave transducer. The acquired images are reconstructed using 3-D visualization software at a separate clinical review workstation.

The Orison Embrace System is an ultrasound tomography system intended for use as an adjunct to mammography for B-mode ultrasonic imaging of the patient's breast.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: 1 phantom breast with 12 cystic masses.
• Data Provenance: The 'test set' was a phantom breast, not human data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not applicable, as a phantom breast was used. The 'known number of cystic masses' and their positions serve as the ground truth.
• Qualifications: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The ground truth (number and location of cystic masses) was inherently known due to the nature of the phantom.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study Done? No. The study described is a technical verification using a phantom, not a clinical study involving human readers.

6. Standalone Performance Study (Algorithm Only)

• Standalone Study Done? Yes. The System Verification and Validation Testing seems to be a standalone performance study where the device (Orison Embrace System) was tested on its own to identify known masses in a phantom.

7. Type of Ground Truth Used

• Type of Ground Truth: Known physical characteristics in a phantom model (known number and positions of cystic masses).

8. Sample Size for the Training Set

• Training Set Sample Size: Not explicitly stated or detailed in the provided summary. The submission focuses on verification testing rather than algorithm training.

9. How Ground Truth for the Training Set Was Established

• How Ground Truth Was Established: Not explicitly stated in the provided summary. As this is a 510(k) submission for an ultrasound system, rather than an AI/CADe device, the concept of a separate "training set" with established ground truth in the context of machine learning isn't a primary focus of the non-clinical testing described. The primary "test set" was a phantom.

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