Search Results

These ultrasound probe drape devices are intended for use by or as directed by a licensed medical practitioner during a medical ultrasound imaging procedure involving limited-duration unbroken-skin patient contact, to provide for maintenance of a sterile field (sterile covers only), to help protect the patient and healthcare worker from transfer of contaminants and biological risk agents (sterile and non-sterile covers), and to protect the ultrasound probe from contamination that could adversely affect its functionality or create downtime and require cleaning procedures (sterile and non-sterile covers). These single patient/procedure, disposable devices are furnished sterile, in most cases as an element of a kit-product that also includes a foil packet of ultrasound coupling gel, which always is pre-sterilized.

Contour Fabricators, Inc. Ultrasound Probe Drapes provide an efficient flexible covering to fit various specific ultrasound probes. These ultrasound probe drapes are constructed primarily of polyurethane film, a customary ultrasound probe drape material. Some drape designs additionally utilize an inner layer of polyethylene film to provide an extended cable cover. This extended cable cover has no patient contact and, at most, incidental user contact. Most product versions include a pre-sterilized foil packet of ultrasound coupling gel and two sterile synthetic elastomer (non-latex) bands that are customarily used to control extra "bulk" of drape material in the vicinity of the application procedure. Each Ultrasound Probe Drape is roll- or telescope-folded during its manufacturing to facilitate user application to the ultrasound probe. Each folded Ultrasound Probe Drape then is wrapped with a suitable piece of "CSR-wrap" (medical paper customarily used for this purpose). The wrapped, folded Ultrasound Probe Drape is then placed, along with the pre-sterilized foil packet of ultrasound coupling gel and the synthetic elastomer bands if provided, into a medical device pouch for terminal sterilization and distribution.

The provided 510(k) summary describes the acceptance criteria and the study that indicates the Contour Fabricators, Inc. (CFI) Ultrasound Probe Drape meets these criteria, primarily through demonstrating substantial equivalence to a predicate device and compliance with recognized consensus standards.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

This product is a medical device (ultrasound probe drape) rather than an AI/software device. Hence, the "acceptance criteria" here relate to safety, effectiveness, and substantial equivalence to a predicate device, rather than performance metrics like sensitivity/specificity.

Ask a specific question about this device

The disposable, sterile instrument holder is intended to be an easily positioned sterile support for surgical instruments. Pressure sensitive adhesive strips are included to allow easy application of the holder to a dry operating room surface.

Examples of possible instruments held by this device are lightweight microsurgical instruments, bipolar forceps, or suction tube tips.

The sterile, disposable instrument holder is made of 8 mil vinyl. The overall dimensions of the device are 7.25" x 8.5". The vinyl is heat sealed to create 6 pockets to allow for easy instrument storage and retrieval. Pocket sizes are as follows: (1) pocket at 4"x3.75", (1) pocket at 4"x6", (2) pockets at 2"x3.75", (2) pockets at 2"x6"

I am sorry, but based on the provided text, there is no information available regarding acceptance criteria or a study that proves the device meets specific performance criteria. The document is a 510(k) summary for a medical device (an Instrument Holder) and a letter from the FDA confirming its substantial equivalence to a predicate device.

The 510(k) summary describes the device, its intended use, and identifies a predicate device. The FDA letter confirms that the device is substantially equivalent to a legally marketed predicate and can therefore be marketed. This process primarily focuses on demonstrating equivalence to an existing device rather than on presenting performance data against detailed acceptance criteria in the way a clinical study for a novel or riskier device might.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This is because the provided text does not contain any details about performance testing, clinical studies, or acceptance criteria related to a study.

Ask a specific question about this device

The sterile, disposable cable or tube holder is intended to limit the amount of excess cable or tubing that extends into the surgical field. The holders are offered in 1/2" and 3/4" sizes to allow for a variety of diameters. Pressure sensitive adhesive is attached to the back of both sizes to allow for easy attachment to a clean, dry surface.

The cable or suction tube holder is a sturdy nylon construction available in 1/2" or 3/4" diameter. Pressure sensitive adhesive backing allows for the holders to be positioned on a clean, dry surface. Flexible lock and release loops allow the cable or tube to be retained and held in place.

The provided text is a 510(k) summary for a "Cable Holder / Suction Tube Holder." It describes the device, its intended use, and identifies a predicate device. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot provide the requested information. The 510(k) summary provided pertains to a simple medical device (a cable/suction tube holder) and not a diagnostic or AI-powered device that would typically undergo the kind of performance evaluation described in your request. Such detailed performance studies are usually associated with devices that generate, process, or interpret data, or make diagnostic recommendations.

Ask a specific question about this device

Magnetic Resonance Imaging (MRI) technology requires the use of large magnets for image generation. This technology is now being tested for use in surgical procedures. The sterile, disposable magnet cover is intended to protect the walls of a magnet from gross contamination and also to isolate the sterile field from microbial contamination. This particular cover is specifically intended for use with the General Electric Medical Systems Signa SP MRI system.

The sterile, disposable magnet cover utilizes a Dexter Nonwoven: a soft, strong absorbent pinhole resistant base fabric, which has been coated with .5 mil of linear low density polyethylene extrusion. The material is blue in color, cut to an overall length and width of 114" x 54", and is 5 mils thick. Through the use of pressure sensitive adhesive tape, the cover can be attached to a clean, dry surface to establish a barrier.

This request pertains to the acceptance criteria and study details for a Sterile Disposable Equipment Magnet Cover. However, the provided document is a 510(k) premarket notification summary for this device, and it primarily focuses on detailing the device description, performance standards through internal testing, and its intended use, rather than a clinical study comparing its performance against acceptance criteria in a typical clinical setting or a multi-reader multi-case study.

Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance, sample sizes for test/training sets, experts, adjudication, MRMC studies, or standalone algorithm performance, is not present within the provided text.

The document describes material performance tests, which can be seen as meeting specific internal "acceptance criteria" for the material properties.

Here's a breakdown of the information that can be extracted or inferred from the provided text, and where gaps exist:

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

The document describes performance standards for the material used in the device. These can be considered the acceptance criteria for the material's properties.

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: Not explicitly stated for each test, but implied to be sufficient for material testing. For example, for flammability, a "material was tested" suggests a sample was used, but the number of samples is not given.
• Data Provenance: Not applicable in the sense of patient data. These are laboratory-based material property tests, presumably conducted by or for Contour Fabricators, Inc. The document does not specify a country of origin for the testing data beyond the company's US location.
• Retrospective or Prospective: Not applicable. These are tests on manufactured material.

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. The "ground truth" here is the measured physical property of the material, not an expert-derived clinical diagnosis or assessment. The tests are based on established standards (e.g., 16 CFR 1610) and engineering methods.

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

Not applicable. These are objective material property measurements, not subjective evaluations requiring adjudication among multiple readers.

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

No such study was mentioned or required for this type of device (Sterile Disposable Equipment Magnet Cover). This device is a physical barrier, not an AI-powered diagnostic tool.

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

Not applicable. This device does not involve an algorithm.

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

The "ground truth" for the performance standards described is based on objective physical measurements and adherence to regulatory standards (e.g., flammability standard 16 CFR 1610) or established engineering test methods (fluid penetration test).

8. The sample size for the training set

Not applicable. There is no "training set" as this is not a machine learning or AI device.

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

Not applicable. See point 8.

Ask a specific question about this device

The GE Sterile Disposable Equipment Cover is intended to protect equipment from fluids. Specifically, a coil used in the GE Magnetic Resonance Imaging (MRI) System.

An MRI system requires the use of a remote transmitting coil to generate the localized images. The coil is placed on the area of the patient where the operating incision is made. The coil itself resembles a window frame. These coils are very suspectible to damage caused by various fluids that may be release during an invasive procedure. To protect these coils, a Sterile Disposable Equipment Cover is used to seal the coil inside a wrapper preventing it from fluid contamination. The Sterile Disposable Equipment Cover is made from PVC Film and the strap is polynap of 100% nylon fabric with polyester foam core and nylon tricot backing.

I am sorry, but the provided text does not contain the information required to answer your request. The document is a 510(k) summary for a medical device (Sterile Disposable Equipment Coil Cover) and primarily focuses on its description, intended use, and comparison to a predicate device for regulatory clearance. It does not include acceptance criteria, performance studies, sample sizes, expert involvement, or any details about AI algorithms or ground truth establishment.

Ask a specific question about this device

Ask a specific question about this device