Search Results

Transducer Probe Cover placed over diagnostic ultrasound transducer/ probe scan head instruments. The cover allows use of the transducer in scanning and needle guided procedures for body surface, endocavity, and intra-operative diagnostic ultrasound, while helping to prevent transfer of microorganisms, body fluids, and particulate material to the patient and healthcare worker during reuse of the transducer. The cover also provides a means for maintenance of a sterile field. Transducer Probe Cover are furnished sterile; single use patient/procedure, disposable.

The subject device is composed of transparent thin-walled polyurethane sleeve, rubber ring and (or) tape strip. A conventional 0.05mm thin, 49 GSM (Grams per Square Meter), transparent high strength polyurethane film tube shape, in various dimensions with heat sealed distal end to be applied over a transducer probe to provide a Transducer Cover that can be used to minimize contamination between patient and ultrasound probe during ultrasound scanning procedures for body surface, endocavity and intra-operative diagnostic ultrasound. This may help with easier cleaning and disinfection of the probe.

Ultrasound imaging is not impaired by use of the cover as it is intended. Adequate coupling between the cover and the transducer is required. The Transducer Probe Cover is utilized by applying sterile transmission, coupling, or lubricating gel onto the transducer face or into closed end of cover, inserting ultrasound transducer into closed end of cover and unrolling cover over length of the transducer as desired, and securing open end of cover with bands as necessary the removal process is accomplished by pulling the cover off the transducer in a reverse method from the application.

The subject device is furnished in sterile condition, for single use patient/procedure use, disposable.

As the device is single use device, which is individually packaged sterile devices. The packaging is compatible with the product's EO sterilization method. The sterilization validation confirms the packaging is qualified bacterial film to maintain the sterilization condition of the device.

This document is a 510(k) summary for a Transducer Probe Cover. It primarily discusses the equivalence of the subject device to a predicate device, focusing on an expanded indication for use. Therefore, the information provided does not describe a study to prove the device meets acceptance criteria in the typical sense of performance metrics for an AI/algorithm-based device.

Instead, the document asserts substantial equivalence based on the device's characteristics and the performance of its predicate, along with additional biocompatibility testing for the expanded use.

Here's an analysis based on the provided text, addressing your questions where applicable and noting where the information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not detail specific acceptance criteria for performance as would be expected for an AI/algorithm. Instead, it compares the subject device's technological characteristics to predicate devices to establish substantial equivalence. The "performance" here refers to the device's characteristics fulfilling its intended purpose (acting as a barrier and not impairing ultrasound imaging).

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

This information is not applicable and not provided. This submission is for a physical medical device (transducer probe cover), not an AI/algorithm. Therefore, there isn't a "test set" in the context of data for an algorithm. The evaluation is based on non-clinical testing of the physical properties and biological compatibility of the device.

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)

This information is not applicable and not provided. As this is a physical device, not an AI, there is no "ground truth" establishment by experts for a test set of data.

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

This information is not applicable and not provided. As this is a physical device, not an AI, there is no "adjudication method" for a test set of data.

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

This information is not applicable and not provided, as this is a physical device and not an AI or AI-assisted diagnostic tool.

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

This information is not applicable and not provided, as this is a physical device and not an AI/algorithm.

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

This information is not applicable and not provided. For this physical device, "ground truth" would refer to established standards for material properties, sterilization efficacy, biocompatibility, and barrier function, which are evaluated through standardized non-clinical tests (e.g., ASTM F1671-13 for microbial barrier, ISO 10993 for biocompatibility).

8. The sample size for the training set

This information is not applicable and not provided. As this is a physical device, not an AI/algorithm, there is no "training set" in the data science context.

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

This information is not applicable and not provided. As this is a physical device, not an AI/algorithm, there is no "ground truth" establishment for a "training set."

Summary of the Study and Acceptance Criteria (as interpreted for this device type):

The "study" presented here is a pre-market notification (510(k)) submission seeking to demonstrate substantial equivalence to a previously cleared predicate device (K221278), with an expanded indication for use.

The primary "acceptance criterion" for this submission is that the device is as safe, as effective, and performs as well as the legally marketed predicate device and raises no new questions of safety or effectiveness.

The "study" to prove this involves:

• Technological Characteristic Comparison: Detailed comparison of the subject device's design, materials, manufacturing, and performance characteristics (e.g., microbial barrier, acoustic properties, sterilization, shelf life) to the predicate device. The conclusion is that these characteristics are largely identical.
• Non-Clinical Testing Confirmation: Because there were no changes in materials, structure, dimensions, or performance that were deemed to impact the previous clearance, no new performance bench testing was considered necessary, except for additional biocompatibility evaluation related to the expanded indications for use.
• Biocompatibility Testing: For the expanded scope to include endocavity and intra-operative diagnostic ultrasound, additional biocompatibility tests (Thrombogenicity and Complement Activation Testing per ISO 10993-4) were conducted. The results of these tests, along with the previously reviewed biocompatibility data for the predicate, were deemed valid and supportive.

In essence, the "study" is a comparative analysis and targeted supplementary testing demonstrating that the changes (expanded indications) do not introduce new hazards and that the device remains substantially equivalent to market predicates under the new conditions of use.

Ask a specific question about this device

The ExactVu High Resolution Micro-Ultrasound System is intended for use by qualified physicians, physician assistants, sonographers and ultrasound technicians in a healthcare facility for diagnostic ultrasound imaging or fluid flow analysis of the human body in B-Mode (2D), Color Flow Imaging Modes (Color Doppler and Power Doppler) and Combined (B-Mode + CFI Modes). The indications for use are:

• Small Organ
• Transrectal ●
• Abdominal ●

The ExactVu High Resolution Micro-Ultrasound System is intended for use by qualified medical professionals for diagnostic ultrasound imaging, data processing and guidance of puncture and biopsy. The ExactVu System comprises of transducers responsible for ultrasound signal generation and recording, needle guides and a main unit that controls the transducers, processes the acoustic data, and processes and displays images.

The provided document describes the FDA 510(k) summary for the ExactVu™ High Resolution Micro-Ultrasound System (K192303). It outlines the device, its intended use, comparison to a predicate device, and non-clinical performance testing.

However, the document explicitly states:
"This technology is not new; therefore, a clinical study was not considered necessary prior to release. The substantial equivalence of the device is supported by the nonclinical testing."

This means that the provided text does not contain any information about a clinical study involving the device's performance against acceptance criteria in a real-world setting with human subjects, AI assistance, or expert readers. The document focuses solely on non-clinical performance testing (e.g., functional verification, human factors, biocompatibility, electrical safety, acoustic testing) to establish substantial equivalence to a previously cleared predicate device.

Therefore, I cannot provide answers to the requested points that pertain to clinical study data, such as:

• A table of acceptance criteria and reported device performance from a clinical study.
• Sample size used for a test set (clinical).
• Number of experts and qualifications for ground truth establishment.
• Adjudication method for a clinical test set.
• MRMC comparative effectiveness study results.
• Standalone (algorithm only) performance.
• Type of ground truth used (clinical).
• Sample size for the training set (clinical).
• How ground truth for the training set was established (clinical).

Based on the provided text, the device's acceptance was based on non-clinical performance testing demonstrating substantial equivalence to a predicate device, not on a clinical study with a test set, expert readers, or AI performance metrics.

Ask a specific question about this device

The device is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data.

Electromagnetic tracking tool kit works in conjunction with images gathered by OEM imaging devices to provide physicians with a tool for image registration and/or tracking of instruments. This is accomplished by utilizing attachment brackets, needle guides, adhesive skin markers or fiducial markers, needles and other housings that are specially configured to contain an electromagnetic sensor. The electromagnetic sensor in the tracked instrument is used within an EM field introduced by OEM equipment. The position and orientation can be thus detected and combined with the acquired imaging to assist with navigating a tracked instrument. The system also utilizes accessories in conjunction with the system to allow the users additional options for protecting the equipment from contamination, needle guidance, and image registration.

The provided text describes a 510(k) summary for an Electromagnetic Tracking System. However, it does not contain any information regarding specific acceptance criteria, a study that proves the device meets those criteria, or performance data.

The document primarily focuses on:

• Intended Use: Electromagnetic tracking of instruments with respect to image data.
• Device Description: EM sensor within tracked instruments, used with OEM imaging devices, and various accessories (EMT sensor covers, EMT slot guide, skin markers).
• Predicate Devices: A list of previously cleared devices to which the current device claims substantial equivalence.
• Substantial Equivalence Claim: Based on equivalent intended uses, manufacturing materials, operating principles, and physical/operational specifications compared to predicate devices, with the only noted difference being qualification with the GE Logiq E9 system.
• FDA Clearance Letter: Confirming the 510(k) clearance and regulatory details.
• Indications for Use: Reiterating the intended use.

Therefore, I cannot provide the requested table and study details as they are not present in the input text. The document states that "There are no significant differences between the proposed and predicate devices except that they have now been qualified with the GE Logiq E9 system," which implies that the substantial equivalence argument, rather than a new performance study against specific acceptance criteria, was the primary basis for clearance.

Ask a specific question about this device