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GRI single use drapes (both sterile and non-sterile) are made of natural or synthetic material intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.

Non-sterile GRI surgical drapes are sold, in bulk as single use items, to repackager/relabeler establishments for further packaging and ethylene oxide (EtO) sterilization.

GRI single use surgical equipment covers (both sterile and non-sterile) are protective barrier covers intended to be used to cover surgical equipment and provide a protective barrier for that equipment.

Non-sterile GRI surgical equipment covers are sold, in bulk as single use items, to repackager/relabeler establishments for further packaging and ethylene oxide (EtO) sterilization.

GRI's single use drapes and surgical equipment covers with AAMI Liquid Barrier Level 3 claim are constructed with various base sheet fabric and reinforcement fabric types, provided in various sizes and shapes, and may contain fluid collection pouches or clear film panels as components. The base sheet fabric is a three layer laminate comprised of polypropylene spunbond/polypropylene mettblown/polypropylene spunbond. Layers are thermally embossed together producing a single layer with various basis weights. Fabric is topically treated to enhance water repellency and to assure static dissipation. The drape reinforcement fabrics are constructed of various configurations of spunbond, meltblown and film. The reinforcement materials are spunbond/film laminate. The primary component of these materials is polypropylene with surfactant and blue pigment.

Based on the provided text, here's a detailed breakdown of the acceptance criteria and the study for the GRI Sterile and Non-Sterile Surgical Drapes and Surgical Equipment Covers:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document states that "All tests results met acceptance criteria and were substantially equivalent to the predicate devices." While the specific numerical acceptance criteria for each test are not detailed in this summary, the general statement indicates successful compliance.

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

The document does not specify the exact sample sizes used for the performance testing.
The origin of the data is not explicitly mentioned as a country, but GRI Medical & Electronic Technology Co., Ltd. is located in ZheJiang, China. This suggests the testing may have been conducted there or by a contracted lab. The study is retrospective in the sense that it relies on laboratory testing of the device rather than a clinical trial.

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

This information is not applicable to this type of device and study. The "ground truth" for surgical drapes and equipment covers relates to objective performance criteria (e.g., barrier properties, strength, biocompatibility), which are measured in laboratory settings against established standards, not through expert consensus in a clinical diagnostic context.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods like "2+1" are typically used in studies involving human interpretation (e.g., image analysis by radiologists) to resolve discrepancies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human reader performance is being evaluated, especially with and without AI assistance. This document describes the performance testing of physical barriers (surgical drapes and equipment covers).

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

This information is not applicable. The device is a physical product (surgical drapes and equipment covers), not an algorithm or AI system. Therefore, the concept of "standalone performance" in the context of AI does not apply. The device itself is "standalone" in that its physical properties are tested.

7. The Type of Ground Truth Used:

The ground truth used for this device is based on objective performance standards and test methods. Specifically, the document mentions compliance with:

• AAMI Standard PB70 for liquid barrier performance.
• Other unnamed standards for biocompatibility (cytotoxicity, primary skin irritation, sensitization), hydrostatic pressure, impact penetration, tear strength, tensile strength, linting, and flammability.

8. The Sample Size for the Training Set:

This information is not applicable. This is not a machine learning or AI-driven device, so there is no "training set."

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

This information is not applicable as there is no training set for this device.

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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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Kimberly-Clark Corporation intends to market the sterile KC100 Surgical Drapes as devices made of natural or synthetic material intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. Kimberly-Clark intends to market the sterile KC100 Surgical Equipment Covers which are protective barrier covers that are intended to be used to cover surgical equipment and provide a protective barrier for that equipment.

The surgical drapes and equipment covers described in this 510(k) submission are identical in all specifications to the predicate device models identified in K080629 except for minor variations in the widths and lengths of three models.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes used for the test set for each individual criterion. It only states that "All results of testing met acceptance criteria."

The data provenance is not explicitly mentioned. However, since this is a 510(k) submission to the FDA, it is highly likely that the testing was conducted by or on behalf of the manufacturer (Kimberly-Clark Corporation) to demonstrate compliance with US regulations. The nature of the tests (biocompatibility, barrier properties, strength, etc.) suggests these would be laboratory-based studies, likely prospective in nature (i.e., conducted specifically for this submission).

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

This information is not provided in the document. For device performance testing (like material properties), "ground truth" is typically established by standardized testing methods and analytical instruments, not by expert consensus in the same way it would be for diagnostic image interpretation.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Adjudication methods (like 2+1, 3+1) are relevant for studies where human interpretation or judgment is involved, especially in medical image analysis or clinical trials to resolve discrepancies. For material property testing, the results are typically objectively measured against predefined standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This information is not applicable and therefore not provided. The device (surgical drapes and equipment covers) is a medical device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance would not be relevant.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

This information is not applicable and therefore not provided. As mentioned above, the device is a physical sterile barrier product, not a software algorithm.

7. The Type of Ground Truth Used

The ground truth used for this testing would be based on objective measurements and predefined material specifications/standards. For example:

• Biocompatibility: Established by reference to ISO 10993 standards and their associated test methods and acceptable limits (e.g., cell viability percentages, irritation scores).
• Barrier properties: Measured against standardized test methods for fluid penetration, microbial penetration, etc., with defined acceptable levels.
• Tensile and tear strength: Measured using force-testing equipment against specified minimum strength requirements.
• Alcohol repellency & Flammability: Measured according to relevant industry standards and acceptable criteria.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. As the device is a physical product and not an AI/machine learning model, there is no "training set" in the context of algorithm development. The testing conducted is to verify the physical properties of the manufactured product.

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

This information is not applicable and therefore not provided for the same reason as point 8.

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The Sterile Equipment Covers are intended to be used to cover medical equipment in order to maintain the sterile field. These covers are not intended to be used as patient drapes and have no patient contact.

Sterile Equipment Covers

The provided text describes the 510(k) Premarket Notification for Sterile Equipment Covers by Volcano Corp. This device is a Class II surgical drape accessory intended to cover medical equipment to maintain a sterile field, not for patient contact.

The submission focuses on establishing substantial equivalence to predicate devices rather than proving specific performance characteristics through a detailed efficacy study with acceptance criteria and ground truth.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and the Reported Device Performance:

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets its acceptance criteria is a sterilization validation study conducted according to ANSI/AAMI/ISO 11135:1994.

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

• Sterilization Validation Study: The text does not specify the sample size used for the sterilization validation testing. Typical sterilization validation studies involve multiple units per sterilization lot and multiple lots to demonstrate consistency and achieve the required Sterility Assurance Level (SAL).
• Data Provenance: The text does not explicitly state the country of origin for the sterilization validation data, but it is implied to be part of the manufacturer's (Volcano Corp., located in Rancho Cordova, CA, USA) internal testing or a contracted lab. The study is prospective in nature, as it's a validation test performed as part of device development and regulatory submission.

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

• For the sterilization validation study, "ground truth" is established by the accepted standards and protocols defined in ANSI/AAMI/ISO 11135:1994. The "experts" would be the microbiologists and sterilization specialists involved in designing, executing, and interpreting the validation tests. Their qualifications would typically involve degrees in microbiology, biology, or related fields, with experience in medical device sterilization. The specific number or qualifications are not detailed in the provided text.

4. Adjudication method for the test set:

• For sterilization validation, there is no "adjudication method" in the human consensus sense. The results are objectively determined (e.g., presence/absence of microbial growth, chemical analysis for residuals) and compared against the pre-defined criteria of the standard. Deviations or failures would lead to re-testing or process modification.

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, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for diagnostic imaging devices involving human interpretation, often assisted by AI. The Sterile Equipment Covers are a physical barrier device, not an AI-powered diagnostic tool.

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

• No, a standalone algorithm performance study was not done. This device does not involve an algorithm or AI.

7. The type of ground truth used:

• For the sterilization validation study, the ground truth is based on microbiological assay results (e.g., sterility testing, bioburden determination), chemical analysis (e.g., ethylene oxide residual testing), and physical property testing (e.g., package integrity) as defined and accepted by the ANSI/AAMI/ISO 11135:1994 standard.

8. The sample size for the training set:

• There is no training set in the context of AI or machine learning for this device. The product is a physical medical device.

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

• Not applicable as there is no training set for this type of device.

In summary:

The provided information focuses on a 510(k) submission for a physical medical device, not an AI/software-as-a-medical-device. The primary performance evidence presented is a statement of compliance with a recognized sterilization standard (ANSI/AAMI/ISO 11135:1994), which effectively serves as the "study" proving the device meets its key safety and performance acceptance criteria for sterility. The concept of "ground truth," "experts," "AI assistance," and "training/test sets" as applied to AI/ML algorithms is not relevant to this submission.

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proMedical Products Co. Ltd. intends to market Non-sterile surgical equipment covers which are protective barrier covers that are intended to cover equipment and provide a protective barrier for that equipment.

Non-sterile surgical equipment covers which are protective barrier covers that are intended to cover equipment and provide a protective barrier for that equipment.

The provided text is a clearance letter from the FDA for a medical device called "ProMedical Surgical Equipment Covers". It does not contain information about acceptance criteria or a study proving device performance in the way a diagnostic AI/ML device submission would.

The document pertains to a Class II device (Surgical Drape and Drape Accessories) which is a physical product designed to provide a protective barrier for surgical equipment. The FDA clearance is based on "substantial equivalence" to legally marketed predicate devices, not on a performance study against specific acceptance criteria.

Therefore, I cannot provide the requested information from this document. The questions you've asked are typically relevant for AI/ML-driven diagnostic devices that undergo rigorous performance evaluation studies, which is not the case for this type of surgical equipment cover.

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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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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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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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