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A polyethylene cover/drape kit used as an accessory to an ultrasound transducer. The sterile cover/drape acts as a barrier as is placed on the instrument prior to coming in contact with the human bodies internal and external services. The following is an abbreviated list of known uses:

1. General Purpose: Ultrasound scanning
2. Cord cover for an extended sterile field on ultrasound transducer cords.
3. Rectal and vaginal scanning.
4. Drapes on Ultrasound Transducers used as protective coverings to isolate a site of surgical incisions from microbial and other contamination.

Drapes on Ultrasound Transducers used as protective coverings to isolate a site of surgical incisions from microbial and other contaminations.

A variety of kits, ranging in sizes, containing a disposable, single use, sterile instrument cover/drape, gel, bands and tape. The sterile bag is placed over a non-sterile ultrasound transducer probe during a sterile procedure, acting as a barrier between the patient and the ultrasound probe.

Each kit contains one cover/drape, ranging in sizes from 2"x24" to 5"x100", made from extruded Polyethylene film, with a thickness of .001inches-.003inches, Conductivity Gel, Elastic Bands, and Plastic Medical Tape.

The provided document describes a 510(k) premarket notification for a Polyethylene Ultrasound Transducer Surgical Drape Kit. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data as would be found for novel technologies or higher-risk devices.

Therefore, many of the requested categories for acceptance criteria and study details (like sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types beyond basic material testing) are not applicable in the context of this 510(k) submission for a surgical drape kit. The primary 'study' is a comparison to a predicate device and adherence to recognized standards.

Here's a breakdown of the information that is available in the provided text, mapped to your request:

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

The acceptance criteria are implicitly defined by showing substantial equivalence to the predicate device (Civco Medical K844472) and adherence to industry standards for materials and performance. The 'reported device performance' is therefore its equivalence to the predicate and its compliance with specified standards.

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

Not Applicable (N/A) for a 510(k) of this nature. This submission demonstrates substantial equivalence through material and performance specifications rather than a clinical trial-like test set. The 'test' involves demonstrating the device meets specified material and performance standards (e.g., ASTM F1671-95 for resistance to penetration, ISO-10993 for biocompatibility, tensile strength). The data provenance refers to the standards themselves and internal testing results, not patient data.

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)

N/A. The "ground truth" here is compliance with established engineering and safety standards, and the specifications of the predicate device. This doesn't involve expert medical review of images or clinical outcomes in the same way an AI diagnostic device would.

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

N/A. The assessment is against material properties and performance specifications, not subjective clinical adjudication.

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

N/A. This is a medical device (surgical drape), not an AI diagnostic tool.

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

N/A. This is a physical medical device, not an algorithm.

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

The "ground truth" for this 510(k) submission is based on:

• Material specifications: Polyethylene thickness, properties.
• Performance standards: Adherence to ASTM F1671-95 (standard test method for resistance of materials used in protective clothing to penetration by blood-borne pathogens using Phi-X174 bacteriophage penetration as a test system).
• Safety standards: ISO-10993 (biological evaluation of medical devices), 29CFR 1910,1200 (hazard communication standard for chemical safety).
• Predicate device characteristics: Demonstrating that the new device has the same design, materials, performance, sterility, etc., as the legally marketed Civco Medical device (K844472).

8. The sample size for the training set

N/A. As this is a physical medical device applying for 510(k) equivalence, there is no AI model or "training set" in the computational sense. The 'training' would refer to the historical data and manufacturing processes that led to the development and standardization of such surgical drapes, but this is not specified in the document.

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

N/A. See point 8.

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A polyurethane cover/drape kit used as an accessory to an ultrasound transducer. The sterile cover/drape acts as a barrier as it is placed on the instrument prior to coming in contact with the human bodies internal and external services. The following is an abbreviated list of known uses;

1. General Purpose: Ultrasound scanning.
2. Cord cover for an extended sterile field on ultrasound transducer cords.
3. Rectal and vaginal scanning.
4. Drapes on Ultrasound Transducers used as protective coverings to isolate a site of surgical incisions from microbial and other contamination.

A variety of kits, ranging in sizes, containing a disposable, single use, sterile instrument cover/drape, gel, bands and tape. The sterile bag is placed over a non-sterile ultrasound transducer probe during a sterile procedure, acting as a barrier between the patient and the ultrasound probe.

Each kit contains one cover/drape, ranging in sizes from 2"x24" to 5"x100", made from extruded Polyurethane film, with a thickness of .001-. 003 inches, Conductivity Gel, Elastic Bands, and Plastic Medical Tape.

The provided document is a 510(k) premarket notification for a medical device: a Polyurethane Ultrasound Transducer Surgical Drape Kit. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a study with performance metrics in the way an AI/ML device submission would.

Therefore, the document does not contain information typically required to describe acceptance criteria and a study proving device performance for an AI/ML diagnostic or prognostic device. The context is a physical medical device (surgical drape), not a software algorithm.

However, I can extract information related to the "performance" of this physical device in the context of its 510(k) submission, comparing it to its predicate device. This "performance" refers to physical and biological properties, not diagnostic accuracy.

Here's an interpretation based on the provided text, recognizing the different nature of the device:

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

The "acceptance criteria" here are implicitly the characteristics of the predicate device, which the new device must be "substantially equivalent" to (or exceed for safety/effectiveness). The "reported device performance" are the characteristics of the PROTEK device.

Regarding the "study that proves the device meets the acceptance criteria":

The document states: "These new products have the same intended use as legally marketed devices. The same end users. The same material manufactures and the same tests and processes as Civco's legally marketed devices under 510(k) K844472." This indicates that the claim of meeting the "acceptance criteria" (i.e., substantial equivalence) is based on a direct comparison of characteristics and the assertion that similar materials, tests, and processes were used. The document lists "Microbial Challenge," "Biocompatibility (ISO-10993)," "Mechanical Safety (Tensile Strength)," and "Standards Met (Global Test Methods for Resistance to Penetration)" as performance aspects where the new device is equivalent to the predicate. However, it does not provide details of specific studies conducted or their results for the PROTEK device beyond listing these categories. It's a statement of equivalence rather than a report of specific test outcomes.

2. Sample sized 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 to this 510(k) submission for a physical surgical drape. There is no "test set" in the context of an AI/ML algorithm evaluation. The evaluation is based on material and design comparison to a predicate 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. Ground truth is not established in this manner for a physical device like a surgical drape. Equivalence is based on material specifications, manufacturing processes, and adherence to recognized standards.

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

This information is not applicable. There is no "test set" or adjudication method for a physical device in this context.

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. This is a physical medical device, not an 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. This is a physical medical device, not an algorithm.

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

This information is not applicable in the AI/ML sense. For a physical device like this, "ground truth" implicitly refers to established material properties, sterilization efficacy, biocompatibility, and mechanical strength evaluated against recognized standards and the performance of the predicate device. For example, "Microbial Challenge" implies testing against microbial penetration, and "ISO-10993" refers to biocompatibility standards.

8. The sample size for the training set

This information is not applicable. This is a physical medical device, not an AI/ML algorithm that undergoes "training."

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

This information is not applicable. As above, there is no "training set" for this type of device.

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