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Surgical Drapes (EO Sterilized) is a single use product used as a protective barrier for patient, such as to isolate a site of surgical incision from microbial and other contamination.

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I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study proving the device meets acceptance criteria. The document is an FDA 510(k) clearance letter for "Plus Surgical Drapes (EO Sterilized), PMDB-XXX," indicating that the device has been deemed substantially equivalent to a legally marketed predicate device.

The document discusses:

• The FDA's review and determination of substantial equivalence.
• Regulatory classifications and requirements.
• Contact information for various FDA divisions.
• The intended use of the surgical drapes.

It does not contain details about:

1. Acceptance criteria and reported device performance (in a table or otherwise).
2. Sample size for test set or data provenance.
3. Number or qualifications of experts for ground truth.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Standalone (algorithm only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

These details are typically found in a 510(k) submission's performance data section, which is not included in this FDA clearance letter.

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HONGYU Disposable Surgical Drapes are devices made of synthetic material intended to be used as a protective patient covering to isolate a site of surgical incision from microbial and other contamination. The drape is sterilized using ethylene oxide and is intended for single external use only.

This drape is classified as Level 4 per AAMI Standard PB70 liquid barrier performance and classification of protective apparel and drapes intended for use in health-care facilities.

Models C-section Drape, Arthroscopy Drape, Bladder Drape, Split (U) Drape, Arm (Wrist) Drape, Miscellaneous Drape, Abdominal Drape, Shoulder Drape, Lithotomy Drape, Neck Drape, Simple Drape, Simple Drape, Extremity Drape, Universal Drape, Head Drape, Craniotomy Drape, Buttock Drape, ENT Drape, ENT Drape, Pediatric Laparotomy Drape, Ophthalmic Drape, Angiography Drape and Articulation Drape.

HONGYU Disposable Surgical Drapes are devices made of synthetic material intended to be used as a protective patient covering to isolate a site of surgical incision from microbial and other contamination. The drape is sterilized using ethylene oxide and is intended for single external use only.

This drape is classified as Level 4 per AAMI Standard PB70 liquid barrier performance and classification of protective apparel and drapes intended for use in health-care facilities.

HONGYU Disposable Surgery Drapes offer a variety of surgery drapes (23 types), including C-section Drape, Arthroscopy Drape, Bladder Drape, Split (U) Drape, Arm (Wrist) Drape, Miscellaneous Drape, Abdominal Drape, Shoulder Drape, Lithotomy Drape, Neck Drape, Fenestrated Drape, Simple Drape, Extremity Drape, Universal Drape, Head Drape, Craniotomy Drape, Buttock Drape, Dental Drape, ENT Drape, Pediatric Laparotomy Drape, Ophthalmic Drape, Angiography Drape and Articulation Drape.

The HONGYU Disposable Surgery Drapes have a basic drape. Additionally, each of the drapes has different drape components according to the intended clinical surgery sites, such as the reinforcement, fenestration, single-coating/ double-coating medical tape. PE film and Velcro-style line holders/ tube holders.

The provided text describes the regulatory clearance of a medical device (HONGYU Disposable Surgical Drapes) and includes a summary of non-clinical testing to demonstrate substantial equivalence to a predicate device. However, it does not contain information about a clinical study involving human subjects or AI performance. Therefore, I cannot fully answer all aspects of your request, particularly those pertaining to AI assistance, human reader performance, training set, or ground truth derived from pathology/outcomes data.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a non-AI, non-diagnostic product, and its performance is evaluated against material properties and sterile barrier standards. The acceptance criteria are typically the standards themselves, and the reported performance is conformity to these standards.

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

The document describes non-clinical tests on the device materials and packaging, not human studies. Therefore, there isn't a "test set" in the context of patient data. The samples would be batches of the surgical drape and its component materials. The document does not specify the number of samples tested for each non-clinical test. The provenance of the data is from Weihai Hongyu Nonwoven Fabric Products Co., Ltd in China, performing tests to demonstrate conformity to international and US standards. These tests are inherently retrospective in the sense that they are performed on manufactured products.

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

Not applicable. This is a non-clinical device that relies on standardized material testing. "Ground truth" in this context refers to the defined parameters of the standards themselves (e.g., a material either passes a certain barrier test or it doesn't). No human experts are involved in establishing "ground truth" for each individual test sample; rather, the tests are performed by technicians/engineers following established protocols.

4. Adjudication method for the test set

Not applicable. As described above, there is no need for adjudication as these are objective material property tests against defined standards.

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 surgical drape, not an AI-powered diagnostic or assistive 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 or AI.

7. The type of ground truth used

The "ground truth" for the performance of this device is established by international and national consensus standards for material properties, barrier performance, biocompatibility, and sterilization. For example, the "ground truth" for liquid barrier performance is a specified level (like Level 4) defined within the AAMI PB70 standard. "Pathology" or "outcomes data" are not relevant for the substantial equivalence demonstration of this type of device.

8. The sample size for the training set

Not applicable. This is a non-AI product, so there is no "training set."

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

Not applicable. There is no training set.

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3M Steri-Drape Fabric Surgical Drapes are used to create a sterile field for surgical procedures. They are provided sterile and intended for external use only.

3M Steri-Drape non-sterile fabric drapes are provided to other manufacturers for further processing using ethylene oxide. 3M provides information on compatibility with ethylene oxide processing.

Non-sterile surgical drapes are sold to repackager or relabeler establishments for EtO sterilization according to ISO 11135-1:2007. Sterile surgical drapes are sold directly to end users after EtO sterilization validation to ISO 11135-1:2007.

The 3M Steri-Drape Fabric Surgical Drapes are one-piece, dual layer, single use disposable drapes with an AAMI Level 4 Liquid Barrier. The drapes are made of a blue absorbent nonwoven fabric thermally bonded to a blue protective barrier film. The drapes are intended to be placed over the patient prior to surgery and are designed to provide an absorbent sterile barrier during surgical procedures and stop fluid strike-through to protect the surgical site and patient from microbial penetration.

Steri-Drape Fabric Surgical Drapes are either provided sterile to end-users or non-sterile to kit manufacturers for further processing including EtO sterilization according to ISO 11135-1:2007

The drapes are provided in multiple sizes and shapes to meet the requirements of various clinical procedures. In general, the surgeon delineates the proposed field of surgery and charges the nursing team with the responsibility of draping the patient using different types of drapes. All models utilize the same material technology.

The document describes the non-clinical performance testing and acceptance criteria for the 3M™ Steri-Drape™ Fabric Surgical Drapes to establish substantial equivalence to a predicate device (3M™ Steri-Drape™ Fabric Surgical, K031287).

Here's the breakdown of the information requested:

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)

The document does not explicitly state the specific sample sizes for each test set. It mentions tests were conducted on the "sterilized, final finished device." The data provenance (country of origin, retrospective/prospective) is also not specified.

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 document details non-clinical performance testing of surgical drapes, which typically relies on laboratory measurements and standardized test methods rather than expert interpretation of data like in medical imaging. Therefore, the concept of "experts establishing ground truth" in the manner of medical professionals is not applicable here. The "ground truth" is defined by the technical specifications and performance characteristics outlined in the relevant ANSI/AAMI, ASTM, ISO, and CFR standards.

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

Not applicable. As this is non-clinical laboratory testing, there is no human adjudication process involved as would be for diagnostic device performance.

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 document pertains to the performance and equivalence of surgical drapes, not a diagnostic device involving human readers or AI.

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

Not applicable. This is not an algorithmic device.

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

The "ground truth" used for these tests is based on established industry standards and regulatory requirements for surgical drapes, such as:

• ANSI/AAMI PB70: 2012 (Liquid barrier performance)
• ASTM F1670-08 (Resistance to synthetic blood penetration)
• ISO 9073-3:1989 (Tensile strength and elongation)
• ISO 13938-1:1999 (Bursting strength)
• ISO 9073-10:2003 (Lint and particle generation)
• 16 CFR Part 1610 (Flammability)
• ISO 10993-5:2009 (Cytotoxicity)
• ISO 10993-10:2010 (Irritation and skin sensitization)

The performance of the device is assessed against the numerical and qualitative criteria specified in these standards, with the predicate device's performance serving as the benchmark for "substantially equivalent" claims.

8. The sample size for the training set

Not applicable. This document describes the testing of a medical device (surgical drapes), not a machine learning model, so there is no training set.

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

Not applicable. There is no training set for this type of device submission.

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HM surgical drapes are intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.
HM surgical drapes are disposable, single use, sterile or nonsterile.
Non-sterile HM surgical drapes are to be sold to repackager/relabeler establishments for EtO sterilization according to ISO 11135-1 and sterile surgical drapes are to be sold directly to users after EtO sterilization validation to ISO 11135-1.
HM Surgical Equipment Covers are intended to be used to cover surgical equipment and provide a protective barrier for that equipment.
HM surgical equipment covers are disposable, single use, sterile or nonsterile.
Non-sterile HM surgical equipment covers are to be sold to repackager/relabeler establishments for E!O sterflization according to ISO 11135-1 and sterile surgical drapes are to be sold directly to users after EtO sterilization validation to ISO 11135-1.

Not Found

This document is a 510(k) premarket notification for "HM Surgical Drapes" and "HM Surgical Equipment Covers." It primarily concerns the regulatory approval of these devices and does not contain information about acceptance criteria for performance, nor a study proving the device meets said criteria, in the context of an AI/ML device.

The document lists:

• Trade/Device Name: HM Surgical Drapes, HM Surgical Equipment Covers
• Regulation Number: 21 CFR 878.4370
• Regulation Name: Surgical Drape and Drape Accessories
• Regulatory Class: II
• Product Code: KKX
• Indications for Use: HM surgical drapes are intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. HM surgical equipment covers are intended to be used to cover surgical equipment and provide a protective barrier for that equipment.
• Sterilization: Products are either sterile or non-sterile. Non-sterile products are to be sterilized by repackager/relabeler establishments using EtO sterilization according to ISO 11135-1. Sterile products are sold directly to users after EtO sterilization validation to ISO 11135-1.
• Materials: Various drapes and covers are made from SMS (Spunbond-Meltblown-Spunbond) base panel, SM (Spunbond-Meltblown) pad, polyethylene film, polyethylene pouch, or polyethylene bags, sometimes with SM reinforcement.

The document does not include any of the following information relevant to the performance acceptance criteria or a study proving device performance:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for the test set.
5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study, its effect size, or human reader improvement with AI assistance.
6. Information on a standalone AI algorithm performance study.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. Sample size for the training set.
9. How the ground truth for the training set was established.

This document is solely a regulatory letter of substantial equivalence for a physical medical device (surgical drapes and equipment covers), not an AI/ML powered device, and thus the requested information concerning AI/ML device performance is not applicable or present in this context.

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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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Kimberly-Clark* Corporation intends to market the sterile Kimberly-Clark* Surgical Drapes with AAMI Liquid Barrier Level 4 claim 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. The Kimberly-Clark* Surgical Drapes with AAMI Liquid Barrier Level 4 claim meet the Level 4 requirements of the AAMI Liquid Barrier classifications.

The Kimberly-Clark* Surgical Drapes with AAMI Liquid Barrier Level 4 claim are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization.

The Kimberly-Clark* Surgical Drapes with AAMI Liquid Barrier Level 4 claim are constructed with various base sheet 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 meltblown/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 either CONTROL PLUS*, a spunbond/meltblown/film laminate or SURROUND*, a spunbond/film laminate. The primary component of these materials is polypropylene with surfactant and blue pigment.

The Kimberly-Clark* Surgical Drapes with AAMI Liquid Barrier Level 4 claim were evaluated through performance testing to ensure compliance with the "Level 4 liquid barrier performance of ANSI/AAMI PB70: 2003 'Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.'"

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample size used for the test set or the country of origin for the data. The testing was described as "performance testing in accordance with industry recognized test methods" and "biocompatibility using cytotoxicity, primary skin irritation tests and sensitization testing." This suggests a prospective testing methodology performed specifically for the device's premarket notification.

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

This information is not applicable to the submitted document. The ground truth for this medical device (surgical drapes) is established through standardized performance tests and material biocompatibility tests, not through expert consensus on medical images or diagnoses.

4. Adjudication method for the test set:

This information is not applicable. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, such as those with medical imaging. For the performance of surgical drapes, the results are determined by objective laboratory tests against predefined standards.

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. The device in question is a surgical drape, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant.

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 drape), not an algorithm.

7. The type of ground truth used:

The ground truth used for this device is based on objective performance standards and material safety requirements. Specifically:

• Performance: Adherence to "Level 4 liquid barrier performance of ANSI/AAMI PB70: 2003".
• Biocompatibility: Results from cytotoxicity, primary skin irritation, and sensitization tests.

8. The sample size for the training set:

This information is not applicable. Surgical drapes are not developed or evaluated using machine learning algorithms that require training sets. The "training" of such a device involves product design, material selection, and manufacturing processes, followed by validation through standardized physical and biological testing.

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

This information is not applicable as there is no "training set" in the context of an AI algorithm for this type of medical device. The "ground truth" for the device's design and manufacturing is established through adherence to recognized industry standards (like ANSI/AAMI PB70: 2003) and regulatory requirements for material biocompatibility and safety.

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Busse Surgical Drape IV is intended to be used as a protective patient covering, such as to isolate a site of surgical incisions from microbial and other contamination. They are provided sterile using Ethylene Oxide.

Surgical drapes described in this submission are one piece, single use, designed to provide an absorbent sterile barrier & protection from microbial and other contamination. There are various sizes, with & without fenestration, and with & without adhesive strip/patch.

The provided document is a 510(k) premarket notification for a medical device, specifically Busse Surgical Drape IV. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through extensive studies with detailed acceptance criteria and performance metrics typically associated with AI/software devices.

Therefore, many of the requested categories related to AI/software performance studies, such as sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable to this document. The document describes a comparison to a predicate device based on material characteristics and safety testing.

Here's an attempt to answer the questions based only on the provided text, indicating when information is not present or not applicable for this type of submission:

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 Test Set: Not specified in the document. The testing refers to "All materials used in the fabrication," implying material-level tests, not a clinical test set with a specific number of patients/cases.
• Data Provenance: Not specified. The tests were performed on the materials of the device.
• Retrospective or Prospective: Not applicable for material testing.

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. Ground truth as typically understood for clinical performance studies (e.g., disease presence) is not established here. The "truth" is whether the materials meet specified safety standards. The document doesn't detail the personnel conducting these material tests.

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

• Not applicable. Adjudication methods are relevant for expert review of images or clinical data, which is not the nature of this submission.

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 a physical medical device (surgical drape), not an AI/software device. No MRMC study was conducted.

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

• Not applicable. 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 device's acceptance is based on adherence to established material safety standards for medical devices (biocompatibility, flammability, lint), which are typically defined by regulatory bodies (e.g., ISO) and demonstrated through standardized laboratory tests.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI/software device that requires a training set.

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

• Not applicable. See #8.

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The Busse Surgical Drape is intended to be used as a protective patient covering, such as to isolate a site of surgical incisions from microbial and other contamination. They are provided sterile using Ethylene Oxide. This is the same intended use as a previously cleared for the Busse Surgical Drape II, K083424.

The Laminated Non-Woven Surgical drapes described in this submission are one piece, single use, designed to provide an absorbent sterile barrier & protection from microbial and other contamination. There are various sizes, with & without fenestration, and with & without adhesive strip/patch.

The provided text describes a 510(k) submission for "Busse Surgical Drapes III." The primary focus of this document is to demonstrate substantial equivalence to a predicate device, "Busse Surgical Drapes II (K083424)," not to provide a detailed study proving the device meets new, objective performance criteria in the way AI/ML medical devices often do.

Therefore, many of the requested categories related to AI/ML device studies (such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable to this 510(k) submission for a traditional medical device (surgical drapes).

However, I can extract the relevant information regarding acceptance criteria and the "study" that demonstrates compliance based on the document's content.

Here's a breakdown:

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

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 specified in the provided document. Biocompatibility tests typically use a small number of animal subjects or cell cultures, but the exact count is not given.
• Data Provenance: Not specified. The tests are standard biological qualification safety tests, generally performed in specialized labs. Whether these were conducted in the US or elsewhere is not stated. The data would be prospective for these specific tests on the device materials.

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 is a traditional medical device (surgical drape), not an AI/ML device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for the material tests would be the established safety thresholds and methodologies for biocompatibility, as defined by international standards (e.g., ISO 10993). The interpretation of these results is done by qualified toxicologists/biocompatibility specialists, but specific numbers and qualifications are not provided in this summary.

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

Not applicable. As this is not an AI/ML device involving human interpretation of results, there is no adjudication method in the context 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 a traditional medical device; therefore, no MRMC study, human readers, or AI assistance is involved.

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

Not applicable. This is a traditional medical device; therefore, no algorithm or "standalone" performance is relevant.

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

The "ground truth" for the reported tests is established through pre-defined scientific methods and acceptance criteria for biocompatibility testing. These criteria are based on established toxicology and material science principles, typically referenced in standards like ISO 10993. The test results (e.g., cell viability, irritation response) are compared against these predetermined thresholds.

8. The sample size for the training set

Not applicable. This is a traditional medical device; there is no "training set" in the context of an AI/ML algorithm.

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

Not applicable. As there is no training set, this question is not relevant.

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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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proMedical Products Co. LTD intends to market sterile surgical drapes identified in 21 CFR 878.4370 as device 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.

proMedical Products Co. LTD intends to market Sterile 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.

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This document is a 510(k) premarket notification approval letter for ProMEDICAL Surgical Drapes and Surgical Equipment Covers. It confirms that the devices are substantially equivalent to legally marketed predicate devices.

This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria related to a specific performance study (like clinical trial results for an AI/ML device).

Instead, it refers to the general requirements for surgical drapes and equipment covers, implying that the acceptance criteria would be related to material properties, sterility, and barrier function as required by the relevant FDA regulations (21 CFR 878.4370). The "study" here is essentially the manufacturer's demonstration that their device meets these general requirements and is substantially equivalent to existing devices, evidenced by the 510(k) submission.

Therefore, I cannot provide the requested information in the format of a table describing acceptance criteria and reported device performance, nor details about sample sizes, experts, adjudication methods, or MRMC studies, as these aspects are not present in the provided text.

The information provided is specific to regulatory approval for a medical device (surgical drapes and equipment covers) based on substantial equivalence, and not a performance study as would be conducted for a diagnostic AI device.

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