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The Disposable Biopsy Needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate. It is not intended for use in bone.

The disposable biopsy needle is a sterile, spring loaded, disposable percutaneous soft tissue biopsy instrument. The disposable biopsy needle consists of a cannula, an inner stylet, a mechanical power device and a protective cover. It is used to obtain tissue samples for tissue biopsy, suitable for tissue biopsy of various organs such as the kidney, liver, prostate etc. The needle need to be inserted by a qualified physician under ultrasound guidance. The button of the mechanical power unit comply with the color coding requirements of ISO 6009, i.e. 18 gauge = Pink. The disposable biopsy needle includes three models: CMBNA/1810, CMBNA/1815, CMBNA/1820.

The provided text is a 510(k) clearance letter for a "Disposable Biopsy Needle." It primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not include information about acceptance criteria, device performance from a clinical study, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, or MRMC studies.

Therefore, many of the requested elements cannot be extracted from this document. However, I can provide what is available, noting where information is absent.

Acceptance Criteria and Device Performance (Based on Non-Clinical Testing)

The document does not explicitly present a table of "acceptance criteria" against which a clinical device performance study was measured. Instead, it details that non-clinical testing was performed to demonstrate substantial equivalence to the predicate device. The performance data provided is primarily related to the physical and material characteristics of the device, rather than diagnostic accuracy or clinical outcomes.

Summary of Reported Performance (Non-Clinical):

Additional Requested Information:

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

   • Sample Size: Not specified for any "test set" in the context of clinical performance. For non-clinical functional testing, "24 repeated sampling steps" were conducted for functional reliability.
   • Data Provenance: Not specified for any clinical data. Non-clinical bench testing was conducted.

2. 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):

   • Not applicable/Not provided. No clinical test set requiring expert ground truth was described.

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

   • Not applicable/Not provided. No clinical test set requiring adjudication was described.

4. 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:

   • No MRMC study was mentioned. This device is a biopsy needle, not an AI-powered diagnostic tool.

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

   • Not applicable. This is a physical medical device (biopsy needle), not an algorithm.

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

   • Not applicable for clinical ground truth. For non-clinical sampling verification, the "mass and quality" of collected tissue samples were compared.

7. The sample size for the training set:

   • Not applicable/Not provided. This device is a physical instrument, not an AI model requiring a training set.

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

   • Not applicable/Not provided. This device is a physical instrument, not an AI model requiring a training set.

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Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound System is applicable for adults. It is intended for use in abdominal, superficial organs, trans-rectal, musculo-skeletal, peripheral vessel, urology exams.

Modes of operation include: B, B+C, B+C+D(PW), B+M Mode, Image fusion, Needle Line.

This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display of the human body and fluid, which is intended to be used in a hospital or medical clinic.

Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound System is a medical, real-time, high-resolution ultrasound diagnosis system. It has a 24" multi-directional swiveled (non-touch) LCD monitor, a secondary 17" touch-display and cart. The System offers B, C, D, M Mode, as well as FUSION Mode which could synthesis real-time US images and preoperative images, such as CT and MRI. It could be equipped with convex-array, linear-array and intracavitary tracked probes, that supporting a wide range of clinical applications.

The provided FDA 510(k) clearance letter for the Venus Ultimate Diagnostic Ultrasound System does not contain information regarding the acceptance criteria for an AI/CAD (Computer-Aided Diagnosis) component or a study proving that such a component meets acceptance criteria.

The document primarily focuses on demonstrating the substantial equivalence of the Venus Ultimate Diagnostic Ultrasound System to a predicate ultrasound device (Resona R9S) based on:

• Indications for Use: Comparing the intended clinical applications.
• Operating Modes: Comparing the types of imaging modes available (B, C, D, M, etc.).
• Functions: Comparing features like Image Fusion and Needle Line/Biopsy Guidance.
• Non-Clinical Testing: Conformance to various safety, electrical, biological, and acoustic output standards.

Specifically, Section 8, "Clinical Studies," explicitly states: "Not applicable. The subject of this submission, Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence."

This indicates that the clearance was based on similarity to existing ultrasound technology and adherence to performance and safety standards for the generalized ultrasound system itself, not on the performance of a specific AI algorithm or CAD feature that would require a clinical validation study with detailed acceptance criteria.

Therefore, I cannot provide the requested information (table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) because the provided text does not describe a clinical study for an AI/CAD component.

To answer your request, the input document would need to describe a specific AI or CAD feature within the ultrasound system and the clinical study conducted to validate its performance against defined acceptance criteria.

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