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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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The Surgical Drape is intended for external use only and is 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 are intended to provide protection from microbial and other contamination. The Lucas surgical drapes described in this submission are one-piece, single use disposable sheets designed to provide an absorbent sterile barrier during surgical procedures. The drapes cover the patient and are made of an absorbent nonwoven fabric backed with a protective film that stops fluid strike-through. There are various sizes to meet the surgeon's needs. In general, the surgeon delineates with proposed field of surgery and charges the nursing team with the responsibility of draping the patient suing different types of drapes, with & without fenestration.

Lucas surgical drapes are made of nonwoven fabric composes of a three-layer composite comprised of a top layer, middle layer and bottom layer, they passed the industry standard tests that measure fluid and synthetic blood penetration, they are classified as a level 4 device under the AAMI PB 70 for barrier performance.

The document describes the acceptance criteria and the study conducted for the Surgical Drape, models 42526 and 42527, manufactured by GRIFFITH-LUCAS LLC.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document states "bench tests to demonstrate that the proposed device performs within its specifications" and provides a list of standards met for various tests. However, it does not explicitly state the specific sample sizes used for each of these bench tests.

The data provenance is from non-clinical (bench) testing performed by GRIFFITH-LUCAS LLC. There is no information regarding the country of origin of the data beyond the manufacturer being in China, but the tests performed are based on international standards (AAMI, CFR, ASTM). The studies are prospective in the sense that they were conducted specifically for the purpose of demonstrating the device's performance against established standards.

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

This information is not applicable as the ground truth for this device's performance is established through adherence to standardized non-clinical test methods and specified acceptance criteria (e.g., AAMI PB70 Barrier Level 4, ASTM standards) rather than expert consensus on a test set of data.

4. Adjudication Method for the Test Set:

This information is not applicable. The performance is evaluated against defined physical and chemical standards, not through expert adjudication of subjective assessments. The tests have pass/fail criteria based on objective measurements.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "The subject of this premarket submission, SURGICAL DRAPE, did not require clinical studies to support substantial equivalence."

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

This question is not applicable as the device is a physical surgical drape, not an AI algorithm or software. The "standalone performance" refers to the device's functional characteristics (e.g., barrier properties, biocompatibility) when tested independently according to established standards.

7. The Type of Ground Truth Used:

The ground truth used for performance validation is based on established industry standards and regulatory criteria. These include:

• AAMI PB70 (liquid barrier performance and classification)
• CFR Part 1610 (flammability)
• ASTM F 1670-08 (resistance to penetration by synthetic blood)
• ASTM F1929 (seal leaks in porous medical packaging)
• ASTM F1140 (internal pressurization failure resistance)
• Biocompatibility standards (cytotoxicity, irritation, sensitization, pyrogenicity)

8. The Sample Size for the Training Set:

This information is not applicable. This submission is for a physical medical device (surgical drape), not an AI/ML algorithm that requires a training set.

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

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

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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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Cardinal Health Tiburon® surgical drapes are devices made of natural or synthetic materials 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 AAM Standard PB70 liquid barrier performance and classification of protective apparel and drapes intended for use in health-care facilities.

The Cardinal Health Tiburon® surgical drapes described in this submission are single use disposable sheets designed to provide an absorbent sterile barrier during surgical procedures. The drapes cover the patient and are made of absorbent nonwoven fabric backed with a protective film that stops fluid strikethrough. The drapes are provided in various sizes and shapes to meet the surgical procedure. The sterile product will be sold as an individually ethylene oxide sterilized wrapped drape that is placed in a polyolefin - based vented pouch and heat sealed prior to sterilization and are intended for external use only.

These drapes are comprised of a fabric that is an blue absorbent polyolefin spun melt nonwoven fabric adhesively bonded to a polyolefin blue film.

Cardinal Health Tiburon® surgical drapes meet the Level 4 requirements of the AAM Liquid Barrier Classifications.

This submission covers ten different models of Cardinal Health surgical drapes in Table 1. The catalog numbers listed in this submission are representative of all drape models. All models utilize the same material technology.

The information provided describes the Cardinal Health Tiburon® surgical drape, a medical device, and its acceptance criteria as demonstrated through performance testing.

Here's an analysis based on your request:

Acceptance Criteria and Reported Device Performance

Study Information

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

   • Sample Size: The document states that "Extensive performance testing has been completed on the Cardinal Health Tiburon® surgical drape," and "This submission covers ten different models of Cardinal Health surgical drapes in Table 1. The catalog numbers listed in this submission are representative of all drape models. All models utilize the same material technology." However, it does not specify the exact number of drape samples tested for each performance criterion.
   • Data Provenance: The data appears to be prospective as it involves performance testing conducted specifically for this submission. The country of origin is not explicitly stated for the testing, but the manufacturer is Cardinal Health 200, LLC, based in McGaw Park, IL, USA.

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

   • This device is a physical product (surgical drape), not an AI/diagnostic device that relies on expert interpretation of data. Therefore, the concept of "ground truth established by experts" in the context of medical image analysis or disease diagnosis does not directly apply here. The "ground truth" for this device's performance is objective measurements according to established industry standards (AAMI Standard PB70, ISO 10993).

3. Adjudication method for the test set:

   • Not applicable as this is a physical product performance study, not a study involving human interpretation or clinical adjudication.

4. 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 typically performed for diagnostic devices where human readers interpret medical images or data, and its relevance is not applicable to a surgical drape's physical performance evaluation.

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

   • Not applicable. This is a physical medical device submission, not an AI algorithm. The performance evaluation is inherently "standalone" in the sense that the drape's physical properties are tested directly, without human interpretation as part of the core performance metric.

6. The type of ground truth used:

   • The "ground truth" for the performance claims (e.g., Level 4 barrier, biocompatibility) is based on objective measurements and adherence to established industry standards (e.g., AAMI Standard PB70 for liquid barrier performance, ISO 10993 for biocompatibility). These standards define metrics and test methods.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device. There is no "training set" in the context of developing this surgical drape.

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

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

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Exact Medical Manufacturing Surgical Drape AAMI Level 4 are sterile or non-sterile single use devices 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 EMM Surgical Drapes AAMI Level 4 are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and ethylene oxide sterilization according to ISO 11135-1:2007

Exact Medical Manufacturing Surgical Drape AAMI Level 4 are sterile or non-sterile single use devices 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.
Exact Medical Manufacturing Surgical Drape with AAMI Liquid Barrier Level The base sheet fabric is a three layer composite comprised of polypropylene spunbond and a co-extruded PE film. Layers are thermally bonded together producing a single layer with various basis weights. The outer layers are non woven fabric, the inner layer is AAMI PB:70 Level 4 capable PE film.

The provided document K121919 describes a surgical drape, not an AI/ML powered medical device. Therefore, many of the requested categories for AI/ML devices (e.g., sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance) are not applicable.

However, I can extract the acceptance criteria and performance data for this physical medical device based on the information provided.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a "Summary of Testing" described in the 510(k) submission. It states:

"Exact Medical Manufacturing Surgical Drape with AAMI Liquid Barrier Level IV is substantially equivalent and meets the same acceptance criteria as the predicate device/Drape in K102666 Non-clinical performance testing includes: Biocompatibility (cytotoxicity, irritation, sensitization) in compliance with the methods of ISO 10993, Barrier properties- AAMI PB:70 Level 4, tensile, tear strength, flammability, linting and sterility. All results of the testing met acceptance criteria."

Regarding AI/ML Specific Information (Categories 2-9):

As this is a physical surgical drape, the following categories are not applicable and no information is provided in the document:

2. Sample size used for the test set and the data provenance: Not applicable for a physical device undergoing non-clinical performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Material properties and performance are measured against standards, not expert consensus.
4. Adjudication method for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a physical device, the "ground truth" or reference for acceptance is established by recognized international and national standards (e.g., AAMI PB70, ISO 10993, ASTM, 16CFR1610).
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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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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Cobes Sterile Surgical Drape 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.

Not Found

I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) premarket notification letter from the FDA regarding a sterile surgical drape, indicating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory compliance and general information but does not contain any details about performance metrics, study designs, sample sizes, or ground truth establishment.

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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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SurgiPlus Surgical Drapes are single use, disposable patient coverings intended to be used by operating room personnel during surgical and other medical procedures as protective covers to isolate surgical incision sites from microbial and other contaminations.
The SurgiPlus Surgical Drapes are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization.
The drapes are classified as Level 3 or Level 4 per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in health-care facilities.

SurgiPlus Surgical Drapes are single use, disposable patient coverings. They are made of SMS base sheet with SPP with PE reinforcement or SMS base sheet. They are available in sterile and non-sterile forms.

The provided document is a 510(k) premarket notification for surgical drapes. It primarily focuses on demonstrating substantial equivalence to a predicate device based on material composition and adherence to specific AAMI (Association for the Advancement of Medical Instrumentation) standards for liquid barrier performance.

This document does not contain information about studies involving AI/ML devices, human readers, or the establishment of ground truth by experts in a clinical context. It pertains to the physical performance characteristics of a surgical drape.

Therefore, many of the requested categories are not applicable to the provided document.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The device claims to be classified as Level 3 or Level 4 per AAMI Standard PB70 for liquid barrier performance. The document doesn't explicitly list a table of acceptance criteria and reported performance for the device against those criteria in a comparative format. Instead, it states the classification. To fully answer this, one would need to refer to AAMI Standard PB70. However, the FDA's acceptance of the 510(k) implies that the device meets the stated AAMI levels.

The remaining questions are largely not applicable (N/A) to this 510(k) submission because it describes the physical properties and intended use of surgical drapes, not an AI/ML diagnostic or therapeutic device that would involve clinical image analysis or human-in-the-loop performance.

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

• N/A. This is a physical product (surgical drape) and the assessment relates to its material properties and barrier performance according to AAMI standards. There is no "test set" of clinical data to analyze. Testing would involve material samples for physical property assessment.

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. Ground truth from clinical experts is not relevant for the classification of a surgical drape based on AAMI liquid barrier performance standards. The "ground truth" would be the results of standardized physical tests performed by qualified lab personnel.

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

• N/A. No clinical "test set" 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

• N/A. This device is a surgical drape, not an AI system that assists human readers.

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

• N/A. This device is a surgical drape, not an algorithm.

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

• For the AAMI liquid barrier performance, the "ground truth" would be established by standardized laboratory testing protocols as defined by AAMI PB70. This involves objective physical measurements (e.g., hydrostatic pressure, impact penetration) rather than expert consensus on clinical data.

8. The sample size for the training set

• N/A. This is a physical product (surgical drape) and does not involve AI/ML training sets.

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

• N/A. No training set exists for this type of device.

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