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MTP Disposable Equipment Covers, KARL STORZ 15" Touch Screen are intended to cover equipment used in medical settings in order to maintain a sterile field and as an aid in the clean up of equipment after surgery. The covers are not intended to be used as patient drapes and have no patient contact.

MTP Disposable Equipment Covers, KARL STORZ 15" Touch Screen

The provided text is a 510(k) premarket notification letter from the FDA regarding "MTP Disposable Equipment Covers, KARL STORZ 15'' Touch Screen." This document is a regulatory approval letter and does not contain any information about acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment for a medical device's performance.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document is about the regulatory clearance process for a non-active, disposable cover, not the performance evaluation of a diagnostic or therapeutic AI-powered device.

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Light Drapes are designed to cover and enhance the outer appearance of phototherapy light fixtures.

Light Drape (accessory to Neonatal Phototherapy Light)

The provided text is a 510(k) premarket notification letter from the FDA regarding a device called "Light Drape." This document does not contain any information about acceptance criteria, device performance, studies, ground truth establishment, or sample sizes.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... You may, therefore, market the device." This indicates that the FDA has found the device to be substantially equivalent to a predicate device, which means it likely does not require extensive new clinical studies or detailed performance metrics to be established for market approval.

The "Indications for Use" section (Image/page/2) merely states: "Light Drapes are designed to cover and enhance the outer appearance of phototherapy light fixtures." This is a functional description, not a performance claim that would necessitate specific acceptance criteria or a study with the details requested.

Therefore, I cannot populate the requested information from the provided document.

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Guangzhou Fortunique's Drapes, Bags and Covers are intended to cover equipment, to maintain a sterile field and as an aid in the clean up of equipment after surgery or other medical procedures. These drapes, bags and covers are not intended to be used as patient drapes and they have no patient contact.

Fortunique intends to manufacture and market Drapes, Bags and Covers sterile in ready to use form and will also provide them in non-sterile form to other companies for inclusion in convenience packages which they will then sterilize.

Guangzhou Fortunique Drapes, Bags and Covers are made of low density polyethylene film ir various sizes and shapes for use in covering equipment. These drapes, bags and covers are offered non-sterile in bulk quantities and sterile in individual packs.

This submission, K041501, is for Guangzhou Fortunique Drapes, Bags and Covers. This is a 510(k) summary for a Class II medical device, and as such, it does not typically involve the types of studies (like MRMC or standalone performance studies with ground truth established by experts) that are common for AI/ML-driven devices or diagnostic tools. Its clearance is based on substantial equivalence to predicate devices, which focuses on comparing physical characteristics and intended use rather than quantitative performance metrics against a defined acceptance criterion.

Therefore, many of the requested categories are not applicable to this type of device submission.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

Not applicable. Substantial equivalence for this type of device is based on a direct comparison of features and intended use to existing predicate devices, not on a performance study with a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth establishment by experts is not relevant for this type of device comparison.

4. Adjudication method for the test set

Not applicable. There was no test set or adjudication method described.

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/ML-driven device or a diagnostic tool that would involve human readers.

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

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used

Not applicable. The basis for clearance is substantial equivalence to predicate devices, not a ground truth against which a device's diagnostic performance is measured. The "ground truth" implicitly used is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable. This device does not involve a training set as it is not an AI/ML model.

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

Not applicable. There is no training set for this device.

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Incubator Capes are designed to cover and enhance the outer appearance of an incubator.

Incubator Cover (accessory to Incubators)

The provided text is a 510(k) clearance letter from the FDA for an "Incubator Cape." This document does not contain information about acceptance criteria or a study proving device performance as described in your request.

The letter explicitly states: "we have determined the device is substantially equivalent... to legally marketed predicate devices." This means the FDA found the device to be similar enough to existing devices that it does not require a new study to prove its safety or effectiveness. The purpose of a 510(k) notification is to demonstrate substantial equivalence, not to provide new performance data against specific acceptance criteria.

Therefore, I cannot provide the requested information from the given text.

If you have a different document that details performance studies and acceptance criteria for a medical device, please provide it, and I will do my best to extract the information you need.

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Medline Band Bags and Equipment Covers are intended to be used to cover medical equipment in order to maintain the sterile field and as an aid in the clean up of equipment after surgery. These covers are not intended to be used as patient drapes and have no patient contact.

Not Found

The provided text does not contain information about acceptance criteria or a study proving device performance for "Medline Band Bags and Equipment Covers." The document is a 510(k) clearance letter from the FDA, indicating that the device is substantially equivalent to a legally marketed predicate device.

Specifically, the letter from the FDA (Pages 0-1) and the "Indications for Use" section (Page 2) discuss the following:

• Device Name: Medline Band Bags and Equipment Covers
• Regulation Number: 878.4370
• Regulation Name: Surgical Drape and Drape Accessories
• Regulatory Class: II
• Product Code: MMP
• Indications for Use: "Medline Band Bags and Equipment Covers are intended to be used to cover medical equipment in order to maintain the sterile field and as an aid in the clean up of equipment after surgery. These covers are not intended to be used as patient drapes and have no patient contact."

The document focuses on regulatory clearance based on substantial equivalence, not on a detailed performance study with acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth, and expert qualifications is not available in the provided text.

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The various sizes of Polyethylene Equipment Covers are intended to be used to cover medical equipment in order to maintain the sterile field and as an aid in the clean up of equipment after surgery. These covers are not intended to be used as patient drapes and do not have patient contact.

ValuMed's Cover Alls, the Sterile Equipment Covers by Custom Medical Products(K931417), Equipment Covers by United States Surgical(K964699) and the Equipment Snap Covers by Advance Medical Designs(K850959) consist of various sizes and shapes of polvethvlene covers that are positioned on surgical equipment. The covers are used to maintain a sterile field and as an aid in the clean up of equipment after surgery.

The provided documents describe a 510(k) premarket notification for "Cover All Equipment Covers" by ValuMed. This notification does not pertain to an AI/ML device, but rather to a simple medical device (protective covers). Therefore, many of the requested categories related to AI/ML device studies, such as sample sizes for test and training sets, expert ground truth establishment, MRMC studies, standalone performance, and data provenance, are not applicable.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This is a non-clinical evaluation of physical properties of a protective cover, not a study involving a "test set" of data in the context of an AI/ML device. The testing conducted (Seal Peel Test, Tear Resistance Test, Flammability Test) would have involved samples of the product, but the specific sample sizes are not reported. The data provenance is internal testing by ValuMed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. Ground truth, in the context of expert review, is not relevant for this type of device and testing.

4. Adjudication Method for the Test Set

Not applicable, as there is no "test set" in the AI/ML sense requiring 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

Not applicable. This device is a passive equipment cover, not an AI/ML diagnostic or assistive tool.

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

Not applicable. This is not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" here is based on engineering specifications and comparison to predicate devices. For physical properties, standard material testing methods (Seal Peel, Tear Resistance, Flammability) were used to confirm similarity with existing, legally marketed devices. The "truth" is that the material's properties meet certain standards or are comparable to those of the predicate devices.

8. The Sample Size for the Training Set

Not applicable. There is no AI/ML training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. There is no AI/ML training set.

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These equipment covers are equipment drapes or drape accessories made of natural or synthetic materials intended to be used as a protective patient covering such as to isolate a site of surgical incision from microbial and other contamination.

The International Medsurg Connections equipment covers are made of polyethylene. The covers are offered sterile and non-sterile.

The provided text describes a 510(k) premarket notification for "International Medsurg Connections Equipment Covers." This document is for a medical device that falls under the category of protective covers, and not an AI/ML-driven diagnostic or analytical device. Therefore, many of the requested elements of the prompt related to AI/ML device testing (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set size, ground truth for training set) are not applicable to the submitted document.

However, I can still extract the acceptance criteria related information about the device and the study as much as possible from the provided context.

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

The document lists performance tests conducted, implying these methods establish the acceptance criteria for the device based on established standards. The document states that the tests were performed, indicating compliance, but it does not explicitly provide numerical "reported device performance" values or specific "acceptance criteria" values for comparison in most cases.

• Size, configuration, color are similar
• Made of polyethylene
• Physical properties are similar |

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

The document does not specify the sample sizes used for the stated tests (Flammability, Hydrostatic Pressure, Grab Tensile, Tear Resistance). It also does not provide information on data provenance (country of origin, retrospective/prospective). This is typical for submissions for physical barrier devices where the testing refers to material properties rather than clinical 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)

Not applicable. This device is an equipment cover, a physical product, not one requiring expert interpretation or ground truth establishment in a clinical or diagnostic context. The "ground truth" for these tests would be the material's physical properties meeting the specified standard.

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

Not applicable. Adjudication methods are relevant for subjective assessments or discrepancy resolution in diagnostic studies, not for objective material property testing.

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-assisted diagnostic or analytical device.

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

Not applicable. This is not an algorithm or software device.

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

The "ground truth" for this device's performance is compliance with established engineering and material standards (e.g., 16 CFR 1610 for flammability, AATCC Test Method 127-1989 for fluid penetration, ASTM D882-91 for grab tensile, ASTM D1424-96 for tear resistance). These are objective measurements against defined criteria.

8. The sample size for the training set

Not applicable. This is not a machine learning/AI device that requires a training set.

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

Not applicable. This is not a machine learning/AI device.

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Ultrasound System Drape Kit - Polyethylene Drapes for covering Monitors, Keyboards, Floorpedals, and Equipment Arms

Not Found

I apologize, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for an "Ultrasound Systems Drape Kit." This document explains the FDA's decision regarding substantial equivalence and the regulatory classification of the device.

It does not contain any information about acceptance criteria, device performance, clinical studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the given input.

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These products have the same intended use, to act as a physical barrier, augmenting existing infection control techniques and make clean-up and disinfection easier. These are the same as those of the predicate devices. These products also have the same intended uses as similar products currently cleared for marketing by the 510(k) process.

These disposable plastic shields are for use with various small hand-held dental instruments such as handpieces, ultrasonic scalers, jet polishers, contra angle handpieces, and similar hand instruments.

In other forms, they are used to cover various devices such as dental chairs, headpieces, accessory trays, x-ray heads, and others.

They are manufactured from clear polyethylene and formed to provide excellent tactile control combined with simple coverage and removal from the instrument.

These shields act as as physical barriers which augment existing infection control techniques and simplify existing clean-up and disinfection methods. They do not obviate, in any way, existing good dental practices such as sterilizing handpieces, hand instruments, etc between each patient.

The various products are designed to slip over the ends of the respective devices, allowing for attachment and/or protrusion of those parts of the devices that are inserted into the patient's mouth (instruments), or otherwise contact the patient (chair covers).

The products will be sold non-sterile, prepackaged, and are disposable, single use only.

The provided text is a 510(k) summary for unclassified infection control barriers (e.g., dental chair sleeves, instrument covers). It focuses on establishing substantial equivalence to previously cleared devices rather than providing a study with specific acceptance criteria and performance metrics.

Therefore, most of the requested information cannot be extracted from this document, as it describes a different kind of regulatory submission. The document emphasizes that the device has "not been classified" and that "None [performance standards] established under section 514."

Here's what can be stated based on the provided text:

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

   • Acceptance Criteria: Not specified. The submission aims for substantial equivalence based on intended use and technological characteristics to predicate devices.
   • Reported Device Performance: Not specified in quantifiable terms. The device is described as acting "as a physical barrier which augment existing infection control techniques and simplify existing clean-up and disinfection methods."

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. No test set or study data is described. This is a substantial equivalence submission based on comparison to existing products.

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 ground truth or expert review process is described.

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

   • Not applicable. No test set or adjudication process is described.

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 a physical barrier, not an AI-assisted diagnostic tool, and no MRMC study is mentioned.

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

   • Not applicable. This device is a physical barrier, not an algorithm.

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

   • Not applicable. No ground truth is described.

8. The sample size for the training set

   • Not applicable. This device is a physical barrier; there is no training set in the context of an algorithm.

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

   • Not applicable. No training set or ground truth establishment is described.

Summary of the study/submission:

The document describes a 510(k) submission to establish "substantial equivalence" for various disposable plastic infection control barriers (e.g., chair sleeves, instrument covers). The basis for equivalence is that the products have the "same intended use" and "same technological characteristics" as predicate devices already cleared for marketing. The document explicitly states that no performance standards have been established for this type of device under section 514. The submission references existing predicate devices like Hydro-Med Product's "Surgical Microscope Drape," Cottrell's "Protouch Overglove," and Dentsply's "Disposa-Shield" to demonstrate equivalence. Performance is qualitatively described as augmenting infection control and simplifying cleanup. No specific studies with acceptance criteria or quantitative performance data are provided, as the regulatory pathway chosen (510(k) substantial equivalence for an unclassified device without performance standards) does not require them in this context.

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Both the Auto Suture* Equipment Covers™ and the Sterile INTENDED USE: Equipment Covers by Custom Medical Products (K931417) are intended to cover equipment and are not intended to be as patient drapes or have patient contact.

Both the Auto Suture* Equipment Covers™ and the Sterile Equipment Covers by Custom Medical Products (K931417) consist of various sizes and shapes of polyethylene covers which are positioned on surgical equipment. The covers are used to maintain the surgeons sterile field and as an aid in the clean up of equipment after surgery.

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

Acceptance Criteria and Study for the Auto Suture® ABBI® System Equipment Cover

Based on the provided document, the "Auto Suture® ABBI® System Equipment Cover" is a relatively simple device – an equipment cover designed to maintain a sterile field and aid in equipment cleanup after surgery. The performance claims focus on its integrity as a barrier.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Sizes Used for the Test Set and Data Provenance:

The document does not specify the sample size used for the performance testing. It also does not specify the country of origin of the data or whether the study was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This information is not applicable to this type of device and study. The "ground truth" here is objective physical properties (tear strength, puncture resistance, fluid impermeability), not expert interpretation of complex data (like medical images).

4. Adjudication Method for the Test Set:

This information is not applicable. As stated above, the performance is measured by objective physical tests, not subjective expert judgment that would require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or interpretive devices, not for simple equipment covers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:

Yes, in a conceptual sense. The performance testing described (tear resistance, puncture resistance, fluid penetration resistance, material thickness) represents the standalone performance of the physical device itself without human intervention affecting the measurement of those properties. There's no "algorithm" in this context.

7. The Type of Ground Truth Used:

The ground truth used was based on objective, physical measurements of the material properties of the equipment cover. This is derived from standardized testing methods for properties like tear strength, puncture resistance, and fluid barrier performance.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a physical product, not a software algorithm that requires a "training set" in the machine learning sense. The materials are likely engineered and tested based on established quality control processes, not a data-driven training paradigm.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable for the same reasons as #8. The "ground truth" for the material selection and manufacturing process would be based on established engineering standards, material science, and manufacturing specifications to ensure the product meets its intended physical properties.

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