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The POWDER FREE patient examination gloves is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner.

The subject device is a vinyl examination glove made of synthetic poly vinyl chloride compound. It is sterile, POWDER FREE. The device is ambidextrous. The device meets ASTM D 5250-06: Standard specification for poly vinyl chloride gloves for medical application. The device is for over-the counter single use.

The provided document is a 510(k) premarket notification for Sterile Vinyl Examination Gloves, Powder Free by Primus Gloves, Pvt. Limited (K170612). This document is a regulatory submission for a Class I medical device, which typically does not involve studies for AI performance or clinical efficacy comparison in the way a diagnostic imaging device would. Instead, the "acceptance criteria" and "study" refer to demonstrated conformance with established industrial standards for medical gloves and substantial equivalence to a predicate device.

Let's break down the information based on your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are established by various ASTM and ISO standards for examination gloves. The reported device performance indicates that the "Sterile Vinyl examination gloves, POWDER FREE" meet these specified standards.

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

The document indicates sampling plans based on ISO 2859-1 for various tests (e.g., G1/AQL 2.5 for freedom from holes, S2/AQL 4.0 for dimensions and physical properties). For Powder Free residue, N=5 is stated.

• Sample Size:
  • For physical characteristics (Freedom from Holes, Dimensions, Physical Properties): Specific sample sizes are not explicitly given as absolute numbers, but the reference to ISO 2859-1 with specified Inspection Levels (G1, S2) and AQLs (2.5, 4.0) implies a statistical sampling methodology based on lot size.
  • For Powder Free residue: N=5 gloves.
  • For biocompatibility: The ISO 10993-10 standards would specify animal testing protocols (e.g., rabbits for irritation, guinea pigs for sensitization), but the exact number of animals or repeat tests is not provided in this summary.
• Data Provenance: Not explicitly stated for each test result, but the manufacturing company is PRIMUS GLOVES PRIVATE LIMITED located in Cochin, Kerala, India. It can be inferred that the testing data was generated locally or through contract labs testing products manufactured at this site. The studies are retrospective in the sense that they are tests performed on manufactured batches to confirm compliance with standards.

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

This type of device (examination gloves) does not typically involve human expert consensus for "ground truth" in the way an AI diagnostic algorithm would. The "ground truth" is defined by adherence to objective, measurable physical, chemical, and biological properties as specified in the referenced ASTM and ISO standards.

• Number of Experts: Not applicable in the context of expert consensus for AI ground truth. The "experts" in this scenario are the technical committees and bodies that establish the ASTM and ISO standards, and the qualified laboratory personnel who conduct the standardized tests.
• Qualifications of Experts: N/A for clinical expert consensus. The "experts" are the technicians and engineers performing standardized tests in accredited laboratories.

4. Adjudication Method for the Test Set

Not applicable. This is not an AI diagnostic device requiring adjudication of interpretations. The tests are objective measurements against established thresholds.

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

No, this is not an AI device or a diagnostic device that would typically undergo an MRMC study.

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

No, this is a physical medical device (examination gloves), not an algorithm.

7. The Type of Ground Truth Used

The ground truth used is based on objective, measurable criteria defined by international and national standards and specifications (e.g., ASTM D 5250-06, ASTM D5151-06, ISO 10993-10, ISO 11737-02). These standards define acceptable ranges for physical dimensions, mechanical properties, chemical residue, and biological responses (biocompatibility).

8. The Sample Size for the Training Set

Not applicable. This is a manufactured product, not an AI model that requires a training set. The "training" for such a product would involve process validation and quality control measures during manufacturing, but not a dataset as understood in AI/ML.

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 device. The manufacturing processes are validated to consistently produce gloves that meet the defined standards.

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A Synthetic Vinyl Examination Gloves, Powder-free, Yellow is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Synthetic Vinyl Examination Gloves, Powder-free, Yellow

This document is a 510(k) premarket notification decision letter from the FDA for "Synthetic Vinyl Examination Gloves, Powder-Free, Yellow". It confirms that the device is substantially equivalent to legally marketed predicate devices.

The document does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria. It is a regulatory approval letter, not a performance study report.

Therefore, I cannot provide the requested information:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size
6. If a standalone performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

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Synthetic Vinyl Examination Glove, Powder Free is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Synthetic Vinyl Examination Gloves, Powder-Free

This document is a 510(k) clearance letter from the FDA for "Synthetic Vinyl Examination Gloves, Powder-Free". It does not contain information about acceptance criteria or a study proving that a device meets such criteria in the context of an AI/ML medical device.

The document is a regulatory approval for a medical device (gloves) based on substantial equivalence to a predicate device, not on performance studies against specific acceptance criteria like those used for AI/ML algorithms.

Therefore, I cannot provide the requested information. This document does not describe:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test or training sets, nor data provenance.
• Number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• MRMC comparative effectiveness studies.
• Standalone algorithm performance studies.
• Type of ground truth used.
• Ground truth establishment for a training set.

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A Synthetic Vinyl Examination Gloves, Powder Free (Blue/Green) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent device in between patient and examiner.

Synthetic Vinyl Examination Gloves, Powder Free (Blue/Green)

The provided text is a 510(k) premarket notification letter from the FDA regarding "Synthetic Vinyl Examination Gloves, Powder Free (Blue/Green)". This document primarily deals with regulatory approval based on "substantial equivalence" to a legally marketed predicate device.

It does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving a device meets such criteria.

Therefore, I cannot fulfill your request for the specific details outlined (table of acceptance criteria and performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set size, and ground truth establishment for training). The document is a regulatory approval letter, not a scientific study report.

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Synthetic Vinyl Examination Glove, Powder Free is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Synthetic Vinyl Examination Gloves, Powder-Free

I am sorry, but the provided text is a letter from the FDA regarding the 510(k) premarket notification for "Synthetic Vinyl Examination Gloves, Powder-Free." It primarily discusses the regulatory classification of the device and general compliance requirements.

This document does not contain any information about:

• Acceptance criteria for device performance
• A study proving the device meets acceptance criteria
• Sample sizes for test or training sets
• Data provenance
• Ground truth establishment or type
• Number or qualifications of experts
• Adjudication methods
• Multi-reader multi-case (MRMC) comparative effectiveness studies
• Standalone algorithm performance studies

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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Synthetic Vinyl examination glove, Powder Free is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powder-Free, Synthetic Vinyl Examination Gloves

The provided text is a 510(k) premarket notification letter from the FDA regarding "Powder-Free, Synthetic Vinyl Examination Gloves." This document does not contain information about acceptance criteria or a study proving device performance in the context of an AI/software as a medical device (SaMD).

Instead, it's a regulatory approval document for a Class I medical device (patient examination glove). The "acceptance criteria" discussed in this document refer to regulatory compliance and the demonstration of substantial equivalence to an already legally marketed predicate device, rather than performance metrics from a technical study for a diagnostic or therapeutic device.

Therefore, I cannot extract the requested information (1-9) as it pertains to AI/SaMD performance studies from this document.

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A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Vinyl Examination Gloves, Powder Free, Green Color

This document, a 510(k) premarket notification approval letter, does not contain the detailed information necessary to fully answer all aspects of your request. The letter confirms that Vinyl Examination Gloves, Powder Free, Green Color, manufactured by Arista Latindo Industrial Limited PT, are substantially equivalent to legally marketed predicate devices. However, it does not include a study describing acceptance criteria and device performance in the way you've outlined for an AI/CAD product.

Here's a breakdown of what can and cannot be extracted from the provided text:

Information Available:

• Device Name: Vinyl Examination Gloves, Powder Free, Green Color
• Intended Use/Indications for Use: "A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner."
• Regulatory Class: I
• Product Code: LYZ

Information NOT available in this document:

This document is a marketing clearance for a simple medical device (gloves) and therefore does not include the kind of detailed performance study information typically associated with AI/CAD devices. Specifically, it does not contain:

1. A table of acceptance criteria and reported device performance (in terms of sensitivity, specificity, etc., as would be expected for an AI/CAD system).
2. Sample size used for a test set or data provenance (country, retrospective/prospective).
3. Number of experts, their qualifications, or methods to establish ground truth for a test set.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study results.
6. Standalone (algorithm-only) performance results.
7. Type of ground truth used (pathology, expert consensus, outcomes data).
8. Sample size for a training set.
9. How ground truth for a training set was established.

To answer your request, if this were an AI/CAD device, the 510(k) submission itself (which this letter refers to) would contain the study details you are looking for, not the approval letter. For devices like these gloves, the "performance" is generally assessed against established manufacturing standards (e.g., tensile strength, barrier integrity, dimensions, biocompatibility) rather than diagnostic accuracy metrics.

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A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Vinyl Examination Gloves, Powder Free, Pink Color

This document is a 510(k) premarket notification approval letter for "Vinyl Examination Gloves, Powder Free, Pink Color." It states that the device is substantially equivalent to legally marketed predicate devices.

The information provided in the document does not contain details about acceptance criteria, device performance, study types, sample sizes, expert qualifications, or ground truth establishment relevant to the performance of a medical device in a clinical or diagnostic context.

Instead, the document primarily focuses on the regulatory approval process for a patient examination glove, confirming its substantial equivalence to predicate devices for its intended use (preventing contamination between patient and examiner). The "Indicators For Use" section defines the product, but does not specify performance metrics.

Therefore, I cannot provide the requested information based on the input text. The text is a regulatory approval letter, not a performance study report.

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A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Vinyl Examination Gloves, Powder Free, Violet Color

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, study details, or ground truth for a medical device. The text is a 510(k) premarket notification letter from the FDA to a medical glove manufacturer, confirming the substantial equivalence of their "Vinyl Examination Gloves, Powder Free, Violet Color" to a legally marketed predicate device.

The document discusses regulatory compliance for patient examination gloves but does not contain any scientific study data, performance metrics, or details about how the device's efficacy or safety was evaluated using acceptance criteria.

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A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Vinyl Examination Gloves, Powder Free, with Vitamin E

This document is an FDA 510(k) clearance letter for "Vinyl Examination Gloves, Powder Free with Vitamin E". It indicates that the device has been found substantially equivalent to a legally marketed predicate device.

Therefore, this document does not contain information related to software or AI-powered medical devices. As such, I cannot extract the requested information regarding acceptance criteria, study details, ground truth, or sample sizes related to AI device performance.

The provided text focuses on regulatory approval for examination gloves based on substantial equivalence, not on performance metrics of a diagnostic or therapeutic AI/software device.

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