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The BeneHold™ Surgical Incise Drape with CHG antimicrobial II is indicated for use as an incise drape with continuous antimicrobial activity (in vitro) from 30 minutes through 4 hours of use against the following organisms: S. aureus, S. epidermidis, E. coli, P. aeruginosa, E. aerogenes, and C. albicans. In vitro testing on the subject drape has also shown continuous antimicrobial activity from 30 minutes through 2.5 hours against E. faecalis and F. oxysporum. It is intended for external use only. Correlation between in vitro results and any clinical event has not been tested.

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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a surgical incise drape. It outlines the regulatory clearance of the device, its intended use, and relevant FDA regulations.

This document does not contain any information about acceptance criteria for a study proving the device meets acceptance criteria, nor does it detail any specific study design, sample sizes, expert involvement, or adjudication methods. The letter focuses solely on the regulatory approval process for the medical device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the provided text. The information required (e.g., performance metrics, test set details, ground truth establishment) is not present in this regulatory clearance document.

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3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) is indicated for use as an incise drape with continuous antibacterial activity based on in vitro time kill data out to 90 minutes. It is intended for external use only.

3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) is a sterile adhesive film that is applied pre-operatively to skin. It adheres and conforms to body contours, providing a sterile surface on top of the skin prior to surgery. The surgeon incises through the adhesive film and skin, ensuring a sterile film barrier all the way to the edge of the incision. The Chlorhexidine Gluconate (CHG) contained in the adhesive provides antibacterial activity to help reduce the risk of bacterial contamination in the surgical wound.

The drape consists of a transparent, conformable, barrier film coated with an acrylic adhesive containing 2% w/w CHG. The adhesive drape is delivered on a release liner that is discarded after application.

The provided text describes the acceptance criteria and the results from non-clinical testing performed for the 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape.

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 the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document primarily details non-clinical bench testing and biocompatibility testing. It does not specify sample sizes for each individual test. The data provenance is not explicitly stated beyond being "bench testing" and "biocompatibility testing," implying laboratory-based data rather than patient data from a specific geographical location. The nature of these tests suggests they are prospective, as they were conducted specifically to evaluate the device.

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 as the document discusses non-clinical bench and biocompatibility testing. These types of tests typically rely on standardized methods and laboratory analysis rather than expert human interpretation for ground truth.

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

This information is not applicable as the document discusses non-clinical bench and biocompatibility testing. Adjudication methods are typically used in clinical studies or studies involving subjective human interpretation of outputs, which is not the case here.

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 is an incise drape with antibacterial properties, not an AI-assisted diagnostic or interpretive device that would involve human readers.

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 medical device (incise drape), not a software algorithm.

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

The ground truth for the non-clinical tests is established by objective measurements against predefined scientific and regulatory standards/methods. For example:

• Barrier Performance: Measured against AAMI PB70:2012 using ASTM F1670.
• Antibacterial Activity: Measured by in vitro direct time kill based on ASTM E2315, aiming for a >4 log reduction.
• Biocompatibility: Evaluated against ISO 10993-1 and FDA Guidance for biological evaluation.

8. The sample size for the training set

This information is not applicable. The document describes the testing of a physical medical device, not a machine learning model that would require 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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The BeneHold™ Surgical Incise Drape with CHG is indicated for use as an incise drape with continuous antibacterial activity (in vitro) from 2.5 to 4 hours against the following organisms; S. epidermidis, E. faecalis, E. coli, P. aeruginosa and E. aerogenes.

It is intended for external use only. Correlation between in vitro results and any clinical event has not been tested.

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The provided document is a 510(k) clearance letter from the FDA for a medical device called "BeneHold™ Surgical Drape with CHG". This type of document does not contain the information requested regarding acceptance criteria and a study proving a device meets them in the context of a performance study (e.g., for an AI/ML powered device).

Instead, this document confirms that the device is substantially equivalent to a legally marketed predicate device and outline general regulatory requirements. It does not include performance data, expert qualifications, sample sizes for test/training sets, or details about comparative effectiveness studies.

The "Indications for Use" section mentions "continuous antibacterial activity (in vitro) from 2.5 to 4 hours against the following organisms; S. epidermidis, E. faecalis, E. coli, P. aeruginosa and E. aerogenes." This refers to laboratory testing of the antimicrobial properties of the drape, not a clinical study involving human patients or a performance study for an AI-powered device.

Therefore, I cannot extract the requested information from this document.

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ControlRad Sterile Cover is a single use sterile equipment cover intended for use by professionals in a sterile clinical setting to cover the ControlRad Trace Tablet and create a sterile barrier between the rest of the sterile field to prevent contamination during various procedures.

The ControlRad Sterile Cover is a terminally sterilized device intended to cover the ControlRad tablet in order to operate a ControlRad tablet in a sterile environment.

The provided text describes the regulatory clearance for the "ControlRad Sterile Cover," a surgical drape accessory. It details the device's characteristics, indications for use, and a comparison to predicate devices, along with non-clinical testing results.

Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided text:

Important Note: The provided document is a 510(k) summary for a "Sterile Cover," which is a physical device (a surgical drape accessory). It is not an AI/ML-driven device or a diagnostic device, therefore, many of the typical acceptance criteria and study designs associated with AI/ML or diagnostic performance (like MRMC studies, expert ground truth establishment for diagnostic accuracy, standalone algorithm performance, training set details) are not applicable to this type of medical device. The "performance" here refers to the physical and functional integrity of the sterile cover.

1. Table of Acceptance Criteria and Reported Device Performance

Specifics Not Applicable or Not Provided for This Device Type:

Given that this is a physical medical device (sterile cover) and not an AI/ML diagnostic or treatment planning system, several items in the prompt are not applicable to the type of data and studies required for its clearance.

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

  • The document does not explicitly state the sample sizes for each non-clinical test. These tests are typically conducted on a representative sample of the manufactured device.
  • Data provenance is not specified in terms of country of origin or retrospective/prospective, as this applies more to clinical data or imaging datasets, which are not relevant here.

• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device like a sterile cover is established through objective physical, chemical, and biological testing as per international standards (e.g., ASTM, ISO). There are no human "experts" establishing diagnostic ground truth in this context.

• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are relevant for subjective interpretations of data (e.g., image reads by radiologists), which is not part of the testing for this device.

• 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 type of study is for evaluating the impact of AI on human diagnostic performance, which is irrelevant for a sterile cover.

• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.

• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is derived from the established and validated methodologies of the referenced ASTM and ISO standards for physical properties, barrier integrity, sterility, and biocompatibility.

• 8. The sample size for the training set: Not applicable. This device is not an AI/ML model that requires training data.

• 9. How the ground truth for the training set was established: Not applicable.

In summary, the "study" proving the device meets acceptance criteria is a series of non-clinical laboratory tests performed according to recognized international and national standards (ASTM, ISO). The acceptance criteria are objective, quantifiable thresholds or observations (e.g., no penetration, specific strength values, sterility assurance level) that the device must meet to demonstrate its safety and effectiveness as a sterile barrier.

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MediClear™ PreOp is indicated for use as a pre-operative (incision/insertion) drape that provides continuous antimicrobial activity to reduce the risk of contamination of the skin site by acting as an external barrier to microbial and other contamination.

MediClear™ PreOp can be left on the preoperative incision site for up to 7 days.

MediClear™ PreOp is intended to be used on intact skin and for external use only.

MediClear™ PreOp consists of a clear polyurethane film coated with an antimicrobial silicone adhesive containing 3% w/w chlorhexidine and 0.5% w/w silver salts and is intended to cover and protect skin from the risk of contamination prior to an invasive procedure (i.e. incision or insertion). The chlorhexidine and silver contained in the adhesive provides continuous antimicrobial activity while the polyurethane barrier film acts as a protective patient covering to isolate a procedural site from microbial and other contamination.

MediClear™ PreOp provides an effective physical barrier against external contamination including fluids, bacteria, and yeast. In vitro testing* demonstrates that the chlorhexidine and silver incorporated within the silicone adhesive provides a rapid bactericidal and fungicidal effect against microorganisms including Staphylococcus aureus (MRSA), Staphylococcus epidermidis, Enterococcus faecalis (VRE), Klebsiella pneumoniae, Pseudomonas aeruginosa, Enterobacter cloacae, Candida albicans, and Candida tropicalis averaging a 99.9% reduction at 10 minutes and a 99.99% reduction at 30 minutes, and prevents their re-growth for up to 7 days during wear. * In vitro effectiveness does not predict clinical performance.

MediClear™ PreOp is a breathable, transparent, self-adhesive silicone film that conforms to the contours of the body.

The document describes the acceptance criteria for the MediClear™ PreOp device and the studies performed to demonstrate that it meets these criteria.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance:

*Note: The document explicitly states: "In vitro effectiveness does not predict clinical performance." This is an important disclaimer for the antimicrobial activity results.

2. Sample Size Used for the Test Set and the Data Provenance:
The document does not provide specific sample sizes for any of the non-clinical tests mentioned. All tests listed are in vitro or bench tests conducted in a laboratory setting. There is no indication of human or animal data provenance (e.g., country of origin, retrospective/prospective) for these non-clinical tests.

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 as the studies described are non-clinical bench and in vitro tests. Ground truth in this context would typically refer to the reference standards or control groups used in the laboratory experiments, as well as the expertise of the scientists performing and interpreting the tests according to the cited ISO and ASTM standards. The document does not specify the number or qualifications of these scientific personnel.

4. Adjudication Method for the Test Set:
This information is not applicable as the studies described are non-clinical bench and in vitro tests. Adjudication methods like 2+1 or 3+1 are relevant for clinical studies or studies involving human readers/interpreters where disagreements need to be resolved.

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:
A Multi Reader Multi Case (MRMC) comparative effectiveness study was not performed. The device is a physical surgical drape, not an AI or imaging diagnostic tool that would typically involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
A standalone algorithm-only performance study was not performed. This device is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the antimicrobial activity, the "ground truth" or reference for evaluating reduction would be the initial microbial counts before exposure to the device, as measured by standard microbiological assays. For biocompatibility tests, the ground truth refers to established biological responses to control materials or the absence of adverse effects as defined by the ISO 10993 series. For barrier performance, it's the ability to prevent penetration under defined conditions specified by ASTM/AAMI standards. These are laboratory-based ground truths derived from scientific standards and experimental controls.

8. The sample size for the training set:
This information is not applicable. The device is a physical medical device and does not involve AI or machine learning algorithms that require a 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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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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Whitney Medical Solutions equipment drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting. These drapes are used to protect the equipment from contamination during various procedures.

The Whitney Medical Solutions' eShield consists of polyethylene film (and an adhesive pad in some models) with tear guide tape and a zipper that allows the cover to be torn fairly straight across it. There is also a double sided tape below the zipper that is used as a redundant closure method with the cover being folded twice and sealed against it. The device is provided to the user sterile, is labeled for single use only and not intended for resterilization or reprocessing. The sterile eShield is sterilized using a validated irradiation sterilization method.

Here's an analysis of the acceptance criteria and study information for the Whitney Medical Solutions eShield, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes used for each specific test mentioned (e.g., number of drapes tested for tensile strength, number of samples for biocompatibility). The document describes studies that were performed, but not the specific sample sizes required by those standards.

Regarding data provenance, the document does not specify the country of origin. The studies appear to be laboratory-based standardized tests (e.g., ASTM, ISO standards), which are typically performed in a controlled environment. The studies are retrospective in the sense that they were completed to demonstrate conformity for the 510(k) submission.

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 the type of device and testing described. The "Whitney Medical Solutions eShield" is a surgical drape, and its performance is evaluated against engineering and biological standards (e.g., material strength, sterility, biocompatibility). These properties are determined through standardized laboratory tests, not typically by expert consensus of human interpretation, as would be the case for an imaging diagnostic device. Therefore, there is no "ground truth" in the sense of expert human interpretation of medical images or conditions.

4. Adjudication Method for the Test Set

Not applicable. As described above, the tests are objective, laboratory-based measurements against established standards, not subjective interpretations requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-powered diagnostic device or a device involving human readers for interpretation. It is a physical medical device (surgical drape).

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

Not applicable. This is not an algorithm-based device.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is defined by the objective pass/fail criteria established within the referenced national and international standards (e.g., ISO, ASTM, AAMI, CFR). For example:

• Biocompatibility: Absence of sensitization, irritation, toxicity, and cytotoxicity.
• Seal Integrity: Meeting visual inspection requirements or maintaining pressure for a specified time.
• Sterility Assurance: Achieving a Sterility Assurance Level (SAL) of 10^-6.
• Material Strength (Tensile, Tear, Puncture): Meeting specified force/resistance values or equivalence to a reference.
• Flammability: Achieving a Class 1 rating with a burn time >3.5 seconds.
• Viral Penetration: No viral penetration or plaque formation.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-based device that requires a training set. The performance is based on physical and biological testing of the product itself.

9. 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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