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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: This transducer is indicated for adjunctive non-quantitative visualization of the target study area.

Device Description

The PVF-375DT volume imaging transducer is a modification of the PVF-375MT convex transducer that was cleared for the SSA-340A, SSA-270A and SSH-140A diagnostic ultrasound imaging systems. It will add volume imaging to conventional diagnostic ultrasound images. Volume imaging is due to the physical characteristics of the device and is intended to assist with patient education during an examination.

AI/ML Overview

The provided text is a 510(k) summary for a diagnostic ultrasound transducer (PVF-375DT). It describes a modification to an existing device, the PVF-375MT, to add "volume imaging" capability.

However, the summary does not contain information about acceptance criteria, detailed device performance studies, sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies (MRMC or standalone AI performance).

Instead, the submission emphasizes that:

The PVF-375DT is a modification of a previously cleared device (PVF-375MT).
It adds "volume imaging" due to its physical characteristics.
This volume imaging is intended to assist with patient education during an examination.
It follows previously cleared software verification and validation procedures.
It employs the same general technology as the predicate device.
It does not affect cleared patient contact materials or acoustic output intensities.
The manufacturer believes it is substantially equivalent because it does not change the cleared safety and effectiveness attributes or indications for use of the predicate device.

The FDA's response confirms substantial equivalence but requests a post-clearance special report containing acoustic output measurements based on production line devices, as per Appendix G of their guidance for diagnostic ultrasound systems and transducers. This indicates that while the device was deemed substantially equivalent based on the provided information, further safety (acoustic output) verification was required post-market.

Therefore, many of the requested details for a comprehensive device study report are not present in this 510(k) summary because the approval relies on substantial equivalence to a predicate device rather than a new de novo approval requiring extensive new clinical performance studies.

Given the limitations of the provided text, I cannot complete all sections of your request. I will fill in what is available and explicitly state where information is not provided.

Acceptance Criteria and Device Performance

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

Acceptance Criteria (Implicit from Substantial Equivalence Basis)	Reported Device Performance
Safety: Acoustic output and patient contact materials are equivalent to the predicate device.	"It does not affect cleared patient contact materials or acoustic output intensities."
Effectiveness: General technology and indications for use are equivalent to the predicate device.	"employs the same general technology as that most lately cleared for the PVF-375MT."
"does not change the cleared safety and effectiveness attributes or the indications for use of the PVF-375MT."
Functionality: Provides volume imaging capability.	"It will add volume imaging to conventional diagnostic ultrasound images."
"intended to assist with patient education during an examination."
Software Validation: Follows established procedures.	"follows previously cleared software verification and validation procedures."
Risk Assessment: No new or increased risk of injury.	"Based on a review of TAMS Complaint and MDR files for similar transducers, any potential failure of this transducer is not expected to result in an injury to the patient."

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 for Test Set: Not specified. The submission relies on engineering principles and comparison to a predicate device, not a new clinical test set for performance.
Data Provenance: Not applicable for a clinical test set as described. The data provenance mentioned refers to TAMS Complaint and MDR files, which would be retrospective internal company data, likely from the US and other countries where the predicate device was marketed.

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)

Not applicable. No new clinical test set requiring expert-established ground truth is mentioned in this 510(k) summary.

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

Not applicable. No new clinical test set requiring adjudication is mentioned.

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 device is an ultrasound transducer, not an AI-assisted diagnostic tool.

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

Not applicable. This device is an ultrasound transducer, not an algorithm.

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

Not applicable in the context of a new clinical performance study. The ground truth for safety implicitly relies on the proven safety and performance history of the predicate device (PVF-375MT) and general ultrasound safety standards. Functionality (volume imaging) is based on the physical design.

8. The sample size for the training set

Not applicable. This 510(k) submission does not describe an AI/algorithm-based device requiring a training set.

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

Not applicable.

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