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The Dukal 20-001 - Fenestrated Dukal Surgical Drape, Blue, 18" x 26", with 3" Fenestration, and 20-002 - Dukal Surgical Drape, Blue, 18" x 26" is a device 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 Dukal 20-001 - Fenestrated Dukal Surgical Drape, Blue, 18" x 26", with 3" Fenestration, and 20-002 - Dukal Surgical Drape, Blue, 18" x 26" is a device 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.

I am sorry, but since this document is a letter from the FDA regarding the 510(k) premarket notification for a surgical drape, it does not contain the information requested in your prompt. Your prompt asks for details about the acceptance criteria and a study proving a device meets these criteria, typically associated with the performance of AI/Machine Learning medical devices.

This document is a regulatory approval letter for a physical product (a surgical drape), and therefore, the concepts of "test set," "ground truth," "MRMC study," "human readers," or "training set" are not applicable.

Could you please provide a document that describes the performance study of a device, likely an AI/ML-based medical device, if you would like me to answer those specific questions?

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The Dukal medical / surgical masks are indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of microorganism, body fluid and particulate aerosol transfer.

Dukal Surgical Masks are pleated 3 - ply masks. Inner and outer layers are made of either medical grade tissue or 100% spun-bond polypropylene. Middle layer is made of 100% melt blown polypropylene filter. Ear loops are made of soft latex free elastic loops. The nose piece for all Dukal Masks is a malleable aluminum wire. Masks with splash visors have an anti fog treated plastic shield attached to masks. All of the material used in the construction of the Dukal face masks are being used in currently marketed devices (see predicate information)

The provided text describes a 510(k) premarket notification for a non-sterile surgical mask (Dukal Surgical Face Mask, referenced as K070407). However, the information provided focuses primarily on regulatory aspects, device description, and intended use, rather than conducting a detailed study with specific acceptance criteria and performance data in the way a diagnostic AI device would.

Based on the provided text, here's a breakdown regarding acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

For this surgical mask, the "acceptance criteria" are defined by the adherence to a recognized performance standard, specifically ASTM 2100-04. The document states, "Recognized Performance Standard: ASTM 2100-04 Refer to submission for applicable standards."

The document does not explicitly list the quantitative acceptance criteria defined within ASTM 2100-04 or the specific test results showing the device performing against these criteria in a table format within the provided excerpt. It simply refers to the standard as being part of the larger submission.

However, based on general knowledge of ASTM F2100 (which is the standard for Medical Face Mask Materials, often referred to as ASTM 2100-04 in older documents), the acceptance criteria typically cover:

Important Note: The provided text only states that ASTM 2100-04 is the recognized standard and refers to the full submission for applicable standards. It does not provide a table with the specific quantitative results for the Dukal Surgical Mask against the various criteria of ASTM 2100-04. The "device performance" in this context is implicitly stated as meeting the requirements of the standard, rather than providing raw data.

Regarding the other requested information (which is not applicable to a physical surgical mask in the same way it would be for an AI/diagnostic device):

The questions regarding sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types (pathology, outcomes), and training set details are not applicable to the evaluation of a non-sterile surgical mask like the one described in K070407.

These questions are specifically designed for evaluating the performance of diagnostic algorithms or AI-driven medical devices that interpret images, generate diagnoses, or assist human readers. Surgical masks are physical barrier devices whose performance is assessed through standardized laboratory tests (like those in ASTM F2100) that measure physical properties (filtration, breathability, fluid resistance, flammability), not through clinical studies involving expert interpretation of data or AI model training.

Therefore, for this device:

2. Sample size used for the test set and data provenance: Not applicable. Performance is determined by laboratory tests on material samples, not a "test set" of patient data.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts: Not applicable. Ground truth for a surgical mask is established by validated laboratory testing methods.
4. Adjudication method: Not applicable.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) study: Not applicable.
7. Type of ground truth used: For surgical masks, the "ground truth" comes from the results of standardized laboratory tests conducted according to methods specified in ASTM F2100, which define the physical properties and performance characteristics of the mask material.
8. Sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document for K070407 confirms conformity to ASTM 2100-04 as the basis for performance acceptance, but does not provide the detailed results of those tests or involve the types of studies relevant to AI/diagnostic software.

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The Dukal medical / surgical masks are indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of microorganism, body fluid and particulate aerosol transfer.

Dukal Surgical Masks are pleated 3 – ply masks. Inner and outer layers are made of either medical grade tissue or 100% spun-bond polypropylene. Middle layer is made of 100% melt blown polypropylene filter. Ear loops are made of soft latex free elastic loops. The nose piece for all Dukal Masks is a malleable aluminum wire. Masks with splash visors have an anti fog treated plastic shield attached to masks. All of the material used in the construction of the Dukal face masks are being used in currently marketed devices (see predicate information)

Here's a breakdown of the acceptance criteria and study information for the Dukal Surgical Mask, based on the provided 510(k) summary:

This device is a surgical mask, and the study described is a performance characteristic comparison against a predicate device and recognized standards, rather than a clinical study involving human readers or AI. Therefore, several sections of your request (MRMC study, standalone performance, training set details) are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the performance of the predicate device and the specified ASTM standards. The reported device performance is compared directly to these.

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

• Sample Size for Test Set:
  • For the Fluid Resistance Performance test (ASTM F1862-05), the sample size was 32 units tested for both the predicate device and the Dukal mask.
  • For other performance tests like Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, and Flammability, a specific sample size is not explicitly stated in the provided text, but it is implied that sufficient samples were tested to obtain the reported percentages and average values according to the specified ASTM standards.
• Data Provenance: Not specified, but implied to be from laboratory testing conducted by Dukal Corporation for their device and likely from the predicate device's 510(k) submission for its data. This is a retrospective comparison against listed predicate device performance and standards. The country of origin of the testing is not mentioned.

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

Not applicable. This study involves objective performance testing of a physical product (surgical mask) against defined material specifications and ASTM standards, not the interpretation of medical data by experts. The "ground truth" for each parameter is established by the results of the standardized test methods.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this involves objective physical testing, not expert interpretation 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/software device and no MRMC study was performed.

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

Not applicable. This is not an AI/software device. The device's performance is standalone in the sense that its physical properties are measured directly.

7. The Type of Ground Truth Used

The ground truth for the performance characteristics is established by:

• Recognized Performance Standards: Specifically, ASTM F1862-05, ASTM2299, ASTM F2101-01, ASTM F2100-04, and MIL-M-36945C. These standards define the acceptable methodology and often performance benchmarks.
• Predicate Device Performance: The performance data of the legally marketed predicate device (A.R. Medicom K051291) serves as a benchmark for substantial equivalence.
• Raw Material Specifications: For the composition of the mask layers, ear loops, nose piece, and plastic shield.

8. The Sample Size for the Training Set

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

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

Not applicable. No training set was used.

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The Dukal Disposable Vaginal Speculum is used to expose the interior of the vagina.

The Dukal Disposable Vaginal Speculum

The provided text describes a 510(k) summary and FDA clearance letter for the Dukal Vaginal Speculum. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for AI/device performance.

The document is a regulatory filing for a manual medical device (a vaginal speculum), not an AI/software device that would typically involve such studies and performance metrics. Therefore, I cannot extract the requested information from the provided input.

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A vapocoolant intended for topical application in management of myofacial pain, restricted motion, and muscle spasm, and for the control of pain associated with injections, minor surgical procedures and the temporary relief of minor sports injuries.

Dispenser Containing a Vapocoolant

This document does not contain information about the acceptance criteria and the study proving the device meets them. The provided text is a 510(k) summary for an Ethyl Chloride and Dispenser and the FDA's response regarding its substantial equivalence to a predicate device.

It includes:

• Contact information for the submitter.
• Date of the summary.
• Trade name, classification, and predicate device.
• Device description and intended use.
• FDA's letter of substantial equivalence.
• Detailed indications for use.

It does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample size for the test set or data provenance.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication method.
5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Information on a standalone algorithm performance study.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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Absorbent non adherent dressing is used as a topical dressing to cover a wound or operative site while providing absorbency.

Absorbent non adherent dressing

This document is a 510(K) Summary for a medical device called "Dukal Non Adherent Pad," submitted in 1997. It describes the device and compares it to a predicate device, the "Kendell Non Adherent Dressing."

Based on the provided information, a significant portion of the requested details about acceptance criteria, study methodologies, and performance metrics are not available in this specific 510(K) summary. This document primarily focuses on demonstrating substantial equivalence to a predicate device through material and physical property comparisons. It does not contain information typically found in studies evaluating software algorithms or complex diagnostic devices.

Here's an analysis of what can be extracted or inferred, and what is missing:

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

Note: The acceptance criteria are implicitly defined by the "same" column, indicating that the Dukal device's performance is deemed acceptable if it matches or is substantially equivalent to the predicate device (Kendell Non Adherent Dressing) for these physical characteristics. The document doesn't explicitly state numerical acceptance thresholds before presenting the results, but rather compares directly to the predicate.

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

• Not available. The document does not describe a clinical "test set" in the sense of patient data or clinical outcomes. The "tests" mentioned are for physical properties of the dressing material. No sample sizes for these material tests are provided, nor is any data provenance information.

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 document pertains to a medical dressing, not a diagnostic device or a device involving expert interpretation of data (like imaging). Therefore, there is no "ground truth" established by experts in the context of a diagnostic test set.

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

• Not applicable. As there is no clinical test set requiring expert interpretation, no adjudication method is relevant or described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is a non-adherent wound dressing, not an AI or imaging diagnostic tool. Therefore, an MRMC study or AI-assisted human reader improvement is irrelevant.

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

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

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

• Not applicable in the conventional sense. For this device, "ground truth" would relate to the physical and chemical properties of the dressing itself (e.g., its measured thickness, tensile strength, absorptive capacity) as determined by standard laboratory test methods. The document doesn't detail these methods, but the reported values act as the "truth" for demonstrating equivalence to the predicate. There's no clinical "ground truth" like pathology or outcomes data presented here.

8. The sample size for the training set

• Not applicable. This device is a physical medical dressing, not a machine learning model. There is no "training set."

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

• Not applicable. As there is no training set, this question is irrelevant.

Summary of what is present and what is missing:

This 510(K) summary for the Dukal Non Adherent Pad is a device comparison document focused on demonstrating substantial equivalence to a predicate device based on material composition and physical characteristics. It is not a clinical study report for a diagnostic or therapeutic device involving complex performance metrics, patient data, or AI algorithms. As such, most of the detailed questions about acceptance criteria for diagnostic performance, expert review, sample sizes for clinical data, or AI model evaluation are not addressed because they are not relevant to the type of device and regulatory submission presented.

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The Dukal Sterile, ABD Combine pad is used as a topical dressing to cover a wound or operative site while providing absorbency.

The Dukal Sterile, ABD Combine pad is used as a topical dressing to cover a wound or operative site while providing absorbency.

Here's an analysis of the provided text in the context of device acceptance criteria and performance, as requested.

Based on the input document, it is clear that this submission is for a medical device that is a dressing (Dukal ABD Combine pad), not an AI/ML-driven diagnostic or assistive device. Therefore, many of the requested elements for AI/ML performance evaluation (such as multi-reader multi-case studies, ground truth establishment with experts, etc.) are not applicable to this type of traditional medical device.

The document describes a 510(k) submission for a Dukal ABD Combine Pad, which is a topical dressing. The primary method of demonstrating substantial equivalence for such devices is through comparison to a predicate device, showing that it has the same technological characteristics and intended use.

Here's how the provided information fits your request:

1. Table of acceptance criteria and the reported device performance

For this type of device, "acceptance criteria" are typically defined by the characteristics of the predicate device that the new device must match or exceed to demonstrate substantial equivalence. The "reported device performance" is the measured characteristic of the new device.

The document explicitly states "same" for all quantitative characteristics, indicating that the Dukal device met these criteria by matching the predicate.

2. Sample size used for the test set and the data provenance
Not applicable for this type of device submission. This refers to clinical performance testing, which is generally not required for 510(k) clearances of dressing devices demonstrating substantial equivalence through material and physical property comparison. The "test set" here refers to physical samples of the dressing being tested for its material properties. The document does not specify the number of samples tested for each characteristic (e.g., how many pads were tested for thickness or absorptive capacity) nor the origin of these samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. "Ground truth" established by experts is relevant for diagnostic devices interpreting complex data (e.g., medical images). For a wound dressing, the "ground truth" is typically the measured physical properties of the material and its functionality, which are objectively measured, not subject to expert interpretation in the same way.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are used in studies where multiple human readers or experts are interpreting results, and their opinions need to be reconciled. This is not relevant for the physical testing of material properties.

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 entire point refers to AI-assisted diagnostic tools. The Dukal ABD Combine pad is a physical wound dressing and does not involve AI or human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This refers to AI algorithm performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this device, the "ground truth" for its performance is derived from objective physical and material property measurements (e.g., thickness, tensile strength, absorptive capacity) conducted in a laboratory setting. It is not based on expert consensus, pathology, or outcomes data in the way these terms are typically used for diagnostic or treatment efficacy studies.

8. The sample size for the training set
Not applicable. This device is not an AI/ML model, so there is no "training set."

9. How the ground truth for the training set was established
Not applicable. As above, no AI/ML model or training set.

Summary of the Study Proving Acceptance Criteria:

The "study" proving the device meets its acceptance criteria for a 510(k) submission like this is primarily a comparison of the new device's physical and material properties to those of a legally marketed predicate device.

• Methodology: The submission presents a direct comparison table, listing several key physical and performance characteristics of the Dukal ABD Combine pad and comparing them to the "Hermitage Combine II Dressing" (predicate device).
• Proof: For each characteristic listed (Thickness, Delnet Fracture, T-Peel, Absorptive Capacity, MD Tensile, Basis weight), the Dukal device's performance is stated as "same" as the predicate device. This indicates that laboratory testing was performed on the Dukal device, and the results of those tests matched the known or established characteristics of the predicate device.
• Acceptance: The acceptance criteria were met by demonstrating that the Dukal device possessed the same technological characteristics and intended use as the predicate device, thereby establishing substantial equivalence. This type of submission relies on the principle that if a new device is substantially equivalent to a device already cleared for market, it is also safe and effective.

In essence, the "study" is the technical testing and characterization of the Dukal ABD Combine pad's physical properties which showed it was identical or sufficiently similar to the predicate device across all critical parameters. The document itself is a summary of that comparison, rather than a detailed report of the underlying tests.

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