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The device is intended to cover an ultrasound transducer and to act as a microbial barrier between the patient and the transducer during transvaginal procedures within assisted reproductive technology or gynecology, for clinical and hospital use by healthcare professionals in adult patients undergoing these procedures.

The Ultrasound Transducer Cover is an elastic cover made of thermoplastic polyurethane (TPU), which is placed over the ultrasound transducer during ultrasound quided procedures within assisted reproductive technology or gynecology. The Ultrasound Transducer Cover is provided sterile (ethylene oxide), for single use, and used with an ultrasound transducer probe to facilitate ultrasound scans.

The Ultrasound Transducer Cover is available in various sizes with different widths of the cover. This is to allow for use with various sizes of ultrasound transducer probe.

The provided text is a 510(k) summary for the Vitrolife Ultrasound Transducer Cover. It describes the device, its intended use, and a comparison to predicate devices, along with non-clinical testing performed to demonstrate safety and effectiveness.

However, the document does not contain information about:

• Acceptance criteria in the context of a statistical study with specific thresholds for performance metrics.
• A study proving the device meets acceptance criteria related to diagnostic accuracy, especially not for an AI/ML-enabled device as implied by the detailed questions about ground truth, expert consensus, MRMC studies, and standalone performance.
• Sample sizes for test sets or training sets in the context of an AI/ML study.
• Data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth types pertaining to an AI/ML diagnostic system.
• Training set size or how its ground truth was established.

The document is for a physical medical device (an ultrasound transducer cover) and focuses on biocompatiability, functional performance (e.g., leakage, ultrasound visibility), sterilization, and shelf-life testing, demonstrating substantial equivalence to a predicate device. It explicitly states "Clinical Testing: Not applicable."

Therefore, I cannot populate the requested table and provide answers for the specific points related to AI/ML device validation because the provided text does not contain this information.

The existing text is a regulatory submission for a simple medical device, not an AI/Machine Learning diagnostic device.

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Protective cover or sheath placed over diagnostic ultrasound transducer / probe / scanhead instruments. The cover allows use of the transducer in scanning and needle guided procedures for body surface, endocavity, central nervous system, and intra-operative diagnostic ultrasound, while helping to prevent transfer of microorqanisms, 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. The cover is single use patient / procedure, nonpyrogenic, and disposable.

The Non-Pyrogenic Ultrasound Transducer Cover provides a thin, conformal covering to fit a variety of ultrasound transducer geometries. The cover is made of polyurethane, polyethylene, and/or synthetic polyisoprene materials. The cover is manufactured as either a one-or two-piece design that helps prevent the transmission of pathogens as the ultrasound transducer is reused from one patient to another. The Non-Pyrogenic Ultrasound Transducer Cover is provided sterile and is single patient / procedure and disposable.

Ultrasound imaging is not impaired by use of the cover as it is intended. As adequate coupling between the cover and the transducer is required, the Non-Pvrogenic Ultrasound Transducer Cover is utilized by applying sterile saline or other non-pyrogenic coupling media onto the transducer face or into the closed end of cover, inserting the ultrasound transducer into the closed end of cover, and unrolling the cover over the length of the transducer as desired. The open end is secured with elastic bands and nylon clips as necessary. The removal process is accomplished by pulling the cover off the transducer in a reverse method from the application.

It seems there's a misunderstanding about the nature of the provided document. This document is a 510(k) Premarket Notification Summary for a medical device (Non-Pyrogenic Ultrasound Transducer Cover), not a study report demonstrating the performance of an AI algorithm or a diagnostic device that outputs specific measurements.

Therefore, the requested information about acceptance criteria for an AI device, sample sizes for test/training sets, expert ground truth, MRMC studies, or standalone algorithm performance, does not apply to this document.

This document is primarily concerned with demonstrating substantial equivalence of a physical medical device (transducer cover) to previously cleared predicate devices, and justifying an expanded indication for use (central nervous system and non-pyrogenic claim) through specific non-clinical tests.

However, I can extract the information that is relevant to the document concerning the device's safety and effectiveness for its intended use based on the non-pyrogenic and implantation claims.

Here's an interpretation based on the document's content, focusing on what could be considered acceptance criteria and how the device met them, with caveats that this is not an AI device:

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

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

• Sample Size for testing: The document does not specify the exact sample size (number of units tested) for the endotoxin or implant testing. It states "test data" was used.
• Data Provenance: The tests were conducted to support a 510(k) submission to the US FDA, implying the data would adhere to relevant US regulatory standards. However, the country of origin of the actual testing facilities or samples is not specified in this summary. The testing appears to be prospective laboratory testing of the device itself.

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 concept is not applicable as this is a physical medical device undergoing non-clinical laboratory testing, not a diagnostic device requiring expert interpretation of results for ground truth.

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

Not applicable. The testing methods (USP and ISO 10993-06) involve objective laboratory measurements, not subjective interpretation requiring adjudication among experts.

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 is not an AI diagnostic device.

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

Not applicable. This is not an AI algorithm.

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

The "ground truth" here would be the objective measurements obtained from standardized laboratory tests:

• For pyrogenicity: Detection of bacterial endotoxins below a specified limit as defined by USP and USP.
• For biocompatibility: Observation of local tissue reactions after implantation in muscle, evaluated against criteria defined by ISO 10993-06.

8. The sample size for the training set

Not applicable. This device does not have a "training set" as it is not an AI/machine learning model.

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

Not applicable.

In summary: The provided document is a regulatory submission for a physical medical device. It details non-clinical testing to demonstrate the safety and effectiveness of a transducer cover for expanded indications, specifically regarding its non-pyrogenic nature and biocompatibility for central nervous system use. The "acceptance criteria" and "device performance" in this context refer to the successful completion and results of these specific laboratory tests against established standards.

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Synthetic polyisoprene probe covers are indicated for use during diagnostic ultrasound procedures in cases where patient sensitivity to natural rubber latex is speculative.

The Sheathing Technologies, Inc CIS-Isoprene Ultrasound Transducer Cover provides a thin, conformal covering to fit various and specific ultrasound transducer shapes. The cover is made by dipping to form a general cylindrical shape. It is closed at the proximal end and open at the distal end for insertion of the ultrasound transducer. This device is an accessory used on diagnostic probes to help minimize cross contamination. The cover material is a Cis-1,4-polyisoprene, a synthetic version of natural rubber latex made without using natural rubber latex in the formulation. Various sizes and shapes of covers are offered to address the variations in Ultrasound Transducer configurations. Product categories/models include General Purpose SheathesISO Ultrasound Transducer Covers (sterile and non-sterile). Covers are packaged in both sterile and nonsterile, individually wrapped or in bag/box quantities, as well as in "procedure kit" form for single patient/procedure, disposable use. The "procedure kit" may include elastic fasteners, with or without coupling gel packets. Transducer covers are also combined with disposable needle guide devices into kits.

This document is a 510(k) premarket notification for a Synthetic Polyisoprene Ultrasound Transducer Cover. The information provided does not describe a study involving AI or complex statistical analysis for diagnostic accuracy. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing and biocompatibility assessments. Therefore, many of the requested categories related to AI performance, expert ground truth, and comparative effectiveness studies are not applicable.

Here's an analysis of the provided text based on your request:

Acceptance Criteria and Reported Device Performance

The document describes the device's characteristics and the non-clinical tests performed to demonstrate its safety and effectiveness relative to predicate devices. The "acceptance criteria" here are implied by successful completion of these tests in comparison to established standards and the predicate device's performance.

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The FreeeScan® Ultrasound Transducer Covers are protective covers applied to ultrasound transducers. These covers are designed to provide a sterile barrier between the non-sterile TXD's (and instrument guide adapters in some cases) and the patient/healthcare worker. The covers are intended for use during both sterile and non-sterile procedures using sector, linear, intravaginal and rectal transducers.

The cover is latex-free and therefore beneficial in procedures with a patient with known type I hypersensitivity, or for the healthcare worker who has become type I sensitive. The transducer covers are supplied sterile or non-sterile and intended for single-use.

Covers are packed in sterile or non-sterile "convenience" kits form for single patient/procedure, disposable use. Covers kits are supplied with needle guide devices, coupling gel packet, elastic bands, and tape.

The FreeeScan® Ultrasound Transducer Cover provides a thin, conformal covering to fit various ultrasound transducer geometries. The device is manufactured as a one-piece design that provides a covering to prevent the transmission of pathogens, as the ultrasound transducer is reused from one patient to another.

The cover material is Chloroprene (synthetic rubber), which is similar to the non-latex material used in medical examination gloves or surgical gloves. Type I natural latex allergy does not occur in response to Chloroprene since the synthetic rubber does not contain the natural protein allergen which is present in latex.

Various sizes and shapes of covers are offered in order to fit different transducer geometries. The following product models are currently included (other shapes are likely to be added):

• . FreeeScan® 1 - W:3.4 cm, L:45-244 cm (Drawing 5500-000002-1B)
• FreeeScan® 4 W:10 cm, L:45-244 cm (Drawing 5500-000003-1B) .
• FreeeScan® 6 W:9.5/11.5 cm, L:45-244 cm (Drawing 5500-000004-1B) .
• . FreeeScan® 8 - W:7.5 cm, L:45-244 cm (Drawing 5500-000005-1B)
• FreeeScan® 77 Ø:2.6 cm, L:30 cm (Drawing 5500-000016-1A) .
• FreeeScan® 84 Ø:3 cm, L:30 cm (Drawing 5500-000015-1A) .

All of these versions are composed of the same materials, they are made using the same processes and procedures, in the same facilities and on the same equipment.

The provided document is a 510(k) summary for the FreeeScan® Ultrasound Transducer Cover. This document focuses on demonstrating substantial equivalence to a predicate device (CIVCO Medical's NeoFlex™ Ultrasound Transducer Cover) rather than presenting a study with specific acceptance criteria and performance metrics for the device itself in the way one might expect for an AI algorithm or diagnostic tool.

The "acceptance criteria" here are essentially the demonstration that the FreeeScan® device is as safe and effective as the predicate device. The "study" is the comparison made against the predicate device based on various parameters.

Here's an analysis based on the structure provided in your request, but adapted to the nature of this 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) summary, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device. The "reported device performance" is a comparison to the predicate's known characteristics.

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Protective cover or sheath is placed over an ultrasound transducer / probes / scanbead instruments. The cover allows use of the transdacer in Naming and intra-operative uitesound, while helping to proven transfer of microorganisms, body fluids, and and intra-operative uitesound, while helping to proven during rease of the tearile and non-sterile covers). The cover also provides a means for maintenance of a sterile fold (sterile covers only). non-sterile covers). The cover also provides a modis for manished sterile and non-sterile, single use patient / procedure, disposable.

The Synthetic Polyisoprene Ultrasound Transducer Cover provides a thin, conformal covering to fit various and specific ultrasound transducer geometries. The cover is manufactured as either a one-or two-piece design that provides a covering that helps prevent the transmission of pathogens as the ultrasound transducer is reused from one patient to another. The cover material is polyisoprene synthetic rubber similar to that of non-latex medical examination / surgical gloves. Various sizes and shapes of covers are offered in order to customize the fit to specific transducer geometries. Product categories / models include: General Purpose Synthetic Polyisoprene Transducer Covers (sterile and non-sterile) Endocavity Synthetic Polyisoprene Transducer Covers (sterile and non-sterile) Surgi-Tip™ Intraoperative* Synthetic Polyisoprene Transducer Covers (sterile) *Polyethylene cord cover w/ Synthetic Polyisoprene tip Covers are packaged in both sterile and non-sterile "procedure kit" form for single patient / procedure, disposable use. Cover kits are supplied with fasteners, and with or without coupling gel packet. Transducer covers are also combined with disposable needle guide devices into custom kits that CIVCO builds for ultrasound OEMs and end users.

The provided text describes a 510(k) submission for a Synthetic Polyisoprene Ultrasound Transducer Cover, arguing for its substantial equivalence to a legally marketed predicate device, the CIVCO NeoFlex™ Ultrasound Transducer Cover (K991236).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets for performance metrics (e.g., "tear strength > X MPa"). Instead, the criteria are qualitative and comparative, demonstrating that the new device performs "effectively similar" to the predicate device in key areas.

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