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A medical examination glove intended to be worn on the hands of healthcare personnel and similar personnel to prevent contamination between such personnel and the patient and for use with chemotherapeutic agents.

The Safeskin PFE-XTRA Examination Glove is a disposable device intended to be worn by healthcare and similar personnel to prevent contamination between such personnel and the patient and for use with chemotherapeutic agents.

The Safeskin PFE-XTRA Latex Examination Glove underwent testing to demonstrate its substantial equivalence to predicate devices and adherence to relevant standards.

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

The document does not specify the exact sample sizes used for each individual test (Dimensions, Physical Properties, Freedom from pinholes, Powder-Free, Biocompatibility). However, the tests are laboratory-based, adhering to predefined ASTM standards.

• Data Provenance: The data is generated from laboratory testing against established ASTM (American Society for Testing and Materials) standards. This indicates a prospective testing methodology. The country of origin of the data is not explicitly stated, but the submission is to the FDA in the USA.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

This device is not an AI/ML powered device, therefore, the concept of establishing ground truth with experts in the typical sense for image interpretation or diagnosis does not apply. The "ground truth" here refers to the objective measurements and pass/fail criteria defined by the ASTM standards themselves. These standards are developed through a consensus process by experts in the field of materials science and medical devices.

4. Adjudication Method for Test Set

Not applicable. The tests are based on objective measurements and adherence to specific ASTM standard specifications, rather than subjective interpretations requiring adjudication.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not an AI/ML powered device, and no MRMC study was performed or required. The device is a physical medical examination glove. Clinical data were explicitly stated as "not needed for examination gloves" [9].

6. Standalone Performance (Algorithm Only)

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

7. Type of Ground Truth Used (Test Set)

The ground truth for the performance claims is derived from established ASTM standards for medical examination gloves. These standards specify objective physical, chemical, and biological properties that the gloves must meet.

8. Sample Size for the Training Set

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

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

Not applicable. As there is no training set for a physical product, the concept of establishing ground truth for a training set does not apply.

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A surgeon's glove is intended to be worn on the hands of operating room personnel to prevent contamination between such personnel and the patient during a surgical procedure.

Safeskin Tactylon® PF powder-free surgical gloves are sterile disposable devices intended to be worn by operating room personnel to prevent contamination between such personnel and the patient during a surgical procedure. Safeskin® Tactylon PF powder-free surgical gloves possess the following technological characteristics (as compared to ASTM or equivalent standards): Dimensions Meets ASTM D 3577, Physical Properties Meets ASTM D 3577, Freedom from pinholes Meets ASTM D 3577 Meets ASTM D 5151, Powder-Free Meets ASTM D 6124 2 mg/glove maximum.

The provided document is a 510(k) Premarket Notification for a medical device, specifically a surgical glove. It does not describe an AI/ML powered device, nor does it detail a clinical study with an AI component. Therefore, much of the requested information regarding AI acceptance criteria, sample sizes for AI training/test sets, expert ground truth, MRMC studies, or standalone algorithm performance is not applicable.

However, I can extract information related to the acceptance criteria and the study (or lack thereof) to prove the device meets these criteria as presented in the document for the physical device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for the individual tests (e.g., how many gloves were tested for pinholes, or how many rabbits/guinea pigs were used). It implicitly refers to compliance with ASTM standards, which would dictate appropriate sampling methods.

The data provenance is not explicitly stated as "country of origin" for testing, but the company is based in San Diego, CA, USA, and the submission is to the US FDA. The testing described is intrinsic to the product's physical and biocompatibility characteristics, not clinical data provenance in the sense of patient records.

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

Not applicable as this is a physical device (surgical glove) meeting manufacturing standards, not a diagnostic or AI device requiring expert-established ground truth from medical images or data. The "ground truth" here is the pass/fail criteria defined by ASTM and biocompatibility standards.

4. Adjudication method for the test set

Not applicable. The tests are based on objective measurements against engineering and biological standards, not subjective expert assessment 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 a physical device submission and does not involve AI or human readers for diagnostic interpretation.

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

Not applicable. This is a physical device submission and does not involve an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is established by:

• ASTM (American Society for Testing and Materials) Standards: These are consensus standards for material properties and testing methods (e.g., D 3577 for rubber surgical gloves, D 5151 for detecting pinholes, D 6124 for powder residue).
• Biocompatibility Standards: These standards (implied by "Passes" for skin irritation and sensitization) ensure the material is safe for contact with human tissue.

8. The sample size for the training set

Not applicable. This is a physical device and the concept of a "training set" for an AI model does not apply. The manufacturing process is analogous to "training" in the sense of quality control and process optimization, but not in the AI context.

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

Not applicable. As noted above, there is no AI training set. The "ground truth" for the device's acceptable quality is defined by adherence to established, external manufacturing and material standards (ASTM, biocompatibility).

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A medical glove intended to be worn on the hands of healthcare and similar personnel to prevent contamination between such personnel and the patient.

The Safeskin Polymer-Coated Nitrile Examination Glove are sterile disposable devices intended to be worn by healthcare and similar personnel to prevent contamination between personnel and the patient. The Safeskin Polymer-Coated Nitrile Examination Glove possesses the following technological characteristics (as compared to ASTM or equivalent standards): Dimensions Meets ASTM D 3578-99, Physical Properties Meets ASTM D 3578-99, Freedom from pinholes Meets ASTM D 5151, Powder-Free Meets ASTM D 6124 2 mg/glove maximum.

The provided text describes the 510(k) premarket notification for the "Safeskin Polymer-Coated Nitrile Examination Glove." This document focuses on demonstrating substantial equivalence to a predicate device by meeting established performance standards for examination gloves.

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

1. Table of Acceptance Criteria and Reported Device Performance

Note: The text explicitly states that the device meets ASTM D 3578-99 with the exception of elongation. It then reiterates that it meets "ASTM D 3578-99 Physical Properties" but implies this exception still applies, as it was mentioned earlier in the same paragraph.

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

The document does not specify the sample size used for the tests to meet the ASTM standards or biocompatibility tests. It also does not mention the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Those Experts

This information is not applicable to this type of device submission. The "ground truth" for examination gloves is defined by adherence to established industry performance standards (ASTM standards) and biocompatibility tests, not by expert consensus on interpretations.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods are typically used in studies involving human interpretation (e.g., medical imaging) to resolve discrepancies in expert opinions. Here, the assessment is against objective physical and chemical standards.

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

No, an MRMC comparative effectiveness study was not performed. This type of study is relevant for AI-powered diagnostic devices where the AI assists human readers. This device is a medical glove.

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

No, a standalone performance assessment is not applicable. This device is a simple physical barrier, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used is based on established industry performance standards (ASTM standards) and biocompatibility testing results. These standards define the acceptable physical properties, freedom from defects, and biological safety of the examination glove.

8. The Sample Size for the Training Set

This information is not applicable as this device does not involve a training set. Machine learning algorithms, which require training sets, are not used in the development or evaluation of this simple medical device.

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.

Summary of the Study:

The study proving the device meets acceptance criteria is a series of standardized laboratory tests. These tests evaluate the physical properties, integrity (freedom from pinholes), powder content, and biocompatibility of the "Safeskin Polymer-Coated Nitrile Examination Glove" against the specified ASTM (American Society for Testing and Materials) standards. The document states that the glove "will meet the current specifications" for ASTM D 3578-99 (with the exception of elongation), ASTM D 5151, and ASTM D 6124, and "Passes" biocompatibility tests. The specific details of these tests (e.g., number of gloves tested for pinholes, the exact methodology for physical property measurement) are not provided in this summary but would be part of the full submission. The document concludes that these performance test data support a determination of substantial equivalence to a predicate device.

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A medical glove intended to be worn on the hands of healthcare and similar personnel to prevent contamination between such personnel and the patient.

ShieldMaster Powdered Purple Nitrile Gloves are disposable devices intended to be worn by healthcare and similar personnel to prevent contamination between such personnel and the patient.

The provided text describes the acceptance criteria and the study conducted for the ShieldMaster Powdered Purple Nitrile Gloves. As this is a medical device (gloves), the "device" in the context of your request refers to these gloves. The study described is a performance test against established industry standards. There is no AI component or software algorithm involved; therefore, many of the requested fields (e.g., sample size for test set, experts, MRMC study, training set) are not applicable.

Here's the information formatted as requested:

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

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

The document does not explicitly state the sample size used for the performance tests against ASTM standards. The data provenance is internal testing conducted by Safeskin Corporation, presumably in a laboratory setting, to demonstrate compliance with the specified ASTM standards. It is a prospective evaluation as the glove was tested to demonstrate it met the standards.

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

Not applicable. The ground truth is established by objective measurements against predefined ASTM standard specifications, not by expert consensus in this context.

4. Adjudication method for the test set

Not applicable. Testing is against objective ASTM standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices involving human interpretation (e.g., imaging software), not for physical medical devices like gloves.

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

Not applicable. There is no algorithm or AI component in this device.

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

The ground truth used is established by objective, quantitative measurements against predefined industry standards (ASTM standards) for physical and performance characteristics, and standardized animal testing for biocompatibility.

8. The sample size for the training set

Not applicable. This is not an AI/ML device requiring a training set.

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

Not applicable. This is not an AI/ML device requiring a training set.

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A medical glove intended to be worn on the hands of healthcare and similar personnel to prevent contamination between such personnel and the patient and for use with chemotherapeutic agents.

Safeskin Purple Nitrile Examination Gloves are disposable devices intended to be worn by healthcare and similar personnel to prevent contamination between such personnel and the patient and for use with chemotherapeutic agents.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Safeskin Purple Nitrile Examination Gloves:

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 specific sample sizes used for the testing, nor does it detail the provenance (e.g., country of origin, retrospective/prospective) of the data for each test. The testing is implied to be for product validation against ASTM standards.

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

The document does not mention the use of experts to establish a "ground truth" for the test set in the way one might for diagnostic algorithm performance. The device's performance is assessed against established ASTM standards, which themselves are developed by expert consensus in their respective fields but not as part of this device-specific submission.

4. Adjudication Method for the Test Set

Not applicable. The "adjudication method" typically refers to how discrepancies in expert opinions are resolved to establish ground truth for a diagnostic study. Here, the device is evaluated against predefined, objective ASTM standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI assistance on human reader performance, which is not applicable to a device like examination gloves. The device is a standalone product.

6. Standalone Performance Study

Yes, a standalone performance study was done. The entire submission details the performance of the Safeskin Purple Nitrile Examination Glove itself against established industry (ASTM) and internal standards without human intervention influencing the device's function. The results indicate that the device "will perform according to the glove performance standards referenced in Section 7 above, thereby meeting ASTM standards, FDA requirements, and the labeling claims for the product."

7. Type of Ground Truth Used

The "ground truth" used for this device's evaluation is primarily based on established industry standards (ASTM) for physical properties, dimensions, freedom from pinholes, powder content, biocompatibility, and chemotherapeutic agent permeation. There is no mention of pathology, expert consensus (in the context of clinical reads), or outcomes data as the primary ground truth for these product characteristics.

8. Sample Size for the Training Set

Not applicable. The concept of a "training set" is relevant for machine learning algorithms. This submission is for a physical medical device (examination gloves) and does not involve AI or machine learning models that require training data. The "training data" here would metaphorically be the experience and research that went into the glove's design, but not in the computational sense.

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

Not applicable, as there is no "training set" in the context of an AI/ML algorithm.

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A medical glove intended to be worn on the hands of healthcare and similar personnel to prevent contamination between such personnel and the patient.

Safeskin Sterile Purple Nitrile Examination Gloves are sterile disposable devices intended to be worn by healthcare and similar personnel to prevent contamination between such personnel and the patient.

Here's an analysis of the provided information, focusing on the acceptance criteria and study details for the Safeskin Sterile Purple Nitrile Examination Gloves:

Acceptance Criteria and Device Performance

Study Details

It's important to note that the provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive clinical study report. Therefore, some of the requested information might not be explicitly detailed, especially concerning aspects typically found in clinical trials for more complex devices.

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

   • The document does not explicitly state specific sample sizes used for testing each characteristic (e.g., number of gloves tested for dimensions, pinholes, etc.). It generally states that the device "meets" the respective ASTM standards.
   • The provenance of the data (country of origin, retrospective/prospective) is not specified. However, the tests are laboratory-based conformance tests to established standards, not human clinical trials.

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

   • This question is not applicable in this context. The "ground truth" for examination gloves is defined by the objective, quantifiable parameters set forth in the ASTM standards (e.g., measurements, tensile strength, pinhole detection methods). Expert opinion is typically not used for these types of performance evaluations.

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

   • This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where there's subjective interpretation (e.g., image reading). For objective performance testing against standards, the results are typically binary (pass/fail) based on direct measurement or observation.

4. 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 is not applicable. An MRMC study with AI assistance is relevant for diagnostic imaging devices where human interpretation is involved. This device is an examination glove, and its performance is assessed via physical and biological safety testing, not human reading of diagnostic output.

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

   • This is not applicable. The device is a physical product (examination glove), not a software algorithm.

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

   • The "ground truth" for the device's performance is established by the specified objective criteria and test methods within the referenced ASTM standards (e.g., ASTM D 6319-99, ASTM D 5151, ASTM D 6124). For biocompatibility, it's based on standard animal model tests (rabbit skin irritation, guinea pig sensitization) designed to detect a biological response.

7. The sample size for the training set:

   • This information is not applicable. Training sets are used for machine learning algorithms. This device is a manufactured product requiring conformance testing to established hardware standards, not algorithmic training.

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

   • This information is not applicable, as there is no training set mentioned or implied for this type of device.

Overall Conclusion from the Provided Document:

The device, Safeskin Sterile Purple Nitrile Examination Gloves, meets the acceptance criteria by demonstrating conformance to established industry standards (ASTM D 6319-99, D 5151, D 6124) for dimensions, physical properties, freedom from pinholes, and powder content. Additionally, it passed biocompatibility tests (primary skin irritation in rabbits and guinea pig sensitization). The study demonstrating this is primarily a series of laboratory-based conformance tests against these published standards. Clinical data was deemed not necessary for this type of disposable medical glove. The FDA's 510(k) clearance signifies that the device is substantially equivalent to a legally marketed predicate device based on these performance characteristics.

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A medical glove intended to be worn on the hands of healthcare and similar personnel to prevent contamination between such personnel and the patient.

Safeskin Synthetic Powder-Free Examination Gloves are disposable medical gloves intended to be worn by healthcare and similar personnel to prevent contamination between such personnel and the patient.

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

The provided document is a 510(k) summary for a medical device, specifically Safeskin Synthetic Powder-Free Examination Gloves. It focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive study proving novel performance. Therefore, many of the requested fields related to clinical studies and AI performance will not be applicable.

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 sample sizes used for testing to demonstrate compliance with ASTM standards. The data provenance is also not specified, only that "The performance test data that support a determination of substantial equivalence are described above." This typically implies testing conducted by the manufacturer. It is a retrospective summary of tests performed.

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. The ground truth for this type of device (examination gloves) is established through adherence to standardized physical and chemical testing methods (ASTM standards), not through expert consensus on images or clinical outcomes.

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

Not applicable. Adjudication methods are typically used in clinical studies or image-based diagnostic evaluations. Compliance with ASTM standards involves objective measurements and defined pass/fail criteria, not subjective 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 device is a medical glove, not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance are irrelevant.

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

Not applicable. This device is a medical glove, not an algorithm.

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

The ground truth is established by objective measurements against established industry standards (ASTM D 5250-99, ASTM D 5151, ASTM D 6124) as well as biocompatibility testing standards (Primary Skin Irritation in Rabbits, Guinea Pig Sensitization).

8. The sample size for the training set

Not applicable. This device is a physical product (medical glove), not a machine learning model, so there is no concept of a "training set."

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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A surgeon's glove is intended to be worn on the hands of operating room personnel to prevent contamination between such personnel and the patient during a surgical procedure.

Safeskin® PFS PLUS powder-free latex surgical gloves are sterile disposable devices intended to be worn by operating room personnel to prevent contamination between such personnel and the patient during a surgical procedure.

I am sorry, but I cannot provide information on the acceptance criteria or study details regarding the performance of the device based on the provided document. The document is a 510(k) summary and FDA clearance letter for a medical device (Safeskin® PFS PLUS powder-free latex surgical gloves), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study data in the format of acceptance criteria and results.

Specifically, the document states:

• "[8] The performance test data that support a determination of substantial equivalence are described above." This refers to a general statement that the device "Meets ASTM D 3577 Dimensions," "Meets ASTM D 3577 Physical Properties," "Meets ASTM D 3577 Freedom from pinholes," "Meets ASTM D 5151 Powder-Free Less than 2 mg/glove," and "Passes Biocompatability Primary Skin Irritation in Rabbits" and "Passes Guinea Pit Sensitization." However, specific numerical acceptance criteria or the reported device performance values (e.g., exact dimensions, specific tensile strength, etc.) are not provided.
• "[9] Clinical data are not needed for surgical gloves." This indicates that no clinical study was conducted for this submission.

Therefore, I cannot extract the requested information like sample size, ground truth details, expert qualifications, or comparative effectiveness study results from this document.

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A glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

This Class I Nitrile patient examination glove (80FMC) is powder-free and meets all the requirements of ASTM Standard D 3578-91 with the exception of pre-aged ultimate elongation. This applicant glove, does however, far exceed the requirements for the only synthetic (non-natural latex) examination glove requirements as described in ASTM D 5250-92. The glove is the same product to which equivalence is claimed, K932404 (Safeskin), except colorant and the Hypoallergenic claim have been added.

Here's a summary of the acceptance criteria and the study details for the Safeskin Hypoallergenic Powder-Free Nitrile Examination Gloves, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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