Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Nitrile Examination Gloves, Powder Free Polymer Coated, Purple Color

The provided text contains information about the FDA's clearance of Nitrile Examination Gloves, Powder Free Polymer Coated, Purple Color. However, it does not contain the detailed acceptance criteria or the specifics of a study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter, which affirms substantial equivalence to a predicate device, but does not typically include the full technical study report.

Therefore, most of the requested information cannot be extracted from this document.

Here's what can be extracted, and what cannot:

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

• Cannot be provided. This information is not present in the FDA clearance letter. Such details would typically be found in the manufacturer's submission or a detailed test report. The letter only states that the device is "substantially equivalent" to a legally marketed predicate device.

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

• Cannot be provided. This information is not present.

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)

• Cannot be provided. This information is not present. The device is a glove, so "ground truth" and "experts" in the context of diagnostic performance are not applicable here. Performance criteria for gloves usually relate to physical properties like tensile strength, elongation, and barrier integrity (e.g., freedom from pinholes).

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

• Cannot be provided. This information is not relevant or present.

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

• Cannot be provided. This type of study (MRMC, AI assistance) is not applicable to an examination glove.

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

• Cannot be provided. This is not applicable to a physical examination glove.

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

• Ground truth for examination gloves typically involves objective physical and chemical testing against recognized standards (e.g., ASTM standards for medical gloves) for properties like dimensions, tensile strength, elongation, and barrier integrity (e.g., AQL for pinholes).
• Cannot be provided in detail from this document. The document does not specify the ground truth methods used in the testing for the glove, only that it met requirements for substantial equivalence.

8. The sample size for the training set

• Cannot be provided. Not applicable in the context of substantial equivalence for a physical device like a glove, which doesn't typically involve "training sets" in the AI/ML sense.

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

• Cannot be provided. Not applicable.

Summary of available information from the document:

• Trade/Device Name: Nitrile Examination Gloves, Powder Free Polymer Coated, Purple Color
• Regulation Number: 880.6250
• Regulation Name: Patient Examination Gloves
• Regulatory Class: I (indicating lower risk and general controls apply)
• Product Code: LZA
• K Number: K030245
• Applicant: PT. ARISTA LATINO Industrial Limited, LTD.
• 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."
• Basis for Clearance: Substantial Equivalence to legally marketed predicate devices.

To obtain the specific acceptance criteria and detailed study data (e.g., AQL levels for pinholes, tensile strength values, elongation at break), one would typically need to review the full 510(k) submission available through FDA's public access, or contact the manufacturer directly, as this information is not typically included in the clearance letter itself.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Powder Free Nitrile Examination Gloves, Purple Color

This document is a 510(k) clearance letter from the FDA for Powder Free Nitrile Examination Gloves. It primarily addresses regulatory approval and does not contain information on acceptance criteria, device performance, or study details as typically found in a clinical or performance validation report. Therefore, I cannot provide the requested information.

Ask a specific question about this device

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.

Latex Examination Gloves, Powdered Contains 180 mcgm or less of Total Water Extractable Protein per gram.

This document is a 510(k) premarket notification letter from the FDA to Arista Latindo Industrial Limited for their Latex Examination Gloves, Powdered. It confirms the device's substantial equivalence to a legally marketed predicate device.

This document does not contain information related to acceptance criteria or a study proving a device meets acceptance criteria for an AI/ML medical device.

The provided text discusses general regulatory compliance for medical devices (registration, labeling, manufacturing practices) and does not include details about performance criteria, sample sizes for testing, ground truth establishment, or any studies involving AI. Therefore, I cannot extract the requested information as it is not present in the input.

Ask a specific question about this device

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.

Latex Examination Gloves, Powder Free, Polymer Coated

This is an FDA 510(k) clearance letter for "Latex Examination Gloves, Powder Free, Polymer Coated". This document is a regulatory approval, not a scientific study report. Therefore, it does not contain the detailed information requested regarding acceptance criteria, device performance, study design, or ground truth establishment.

Here's why the requested information cannot be extracted and what the document does provide:

• No Acceptance Criteria or Device Performance Table: The document states that the device is "substantially equivalent" to legally marketed predicate devices. It does not provide specific performance metrics (e.g., tensile strength, puncture resistance, barrier integrity) or the acceptance criteria for those metrics. This level of detail would typically be found in the 510(k) submission itself, not the clearance letter.
• No Study Details (Sample Size, Data Provenance, Ground Truth, Training Set): As this is a clearance letter and not a study report, it does not describe any specific studies conducted by the manufacturer to demonstrate performance. The "substantial equivalence" determination relies on demonstrating that the new device is as safe and effective as a predicate device already on the market, often through comparison of materials, design, and intended use, and sometimes through performance testing if there are significant differences from the predicate. However, the details of such testing, if performed, are not in this letter.
• No Information on Experts, Adjudication, or MRMC Studies: These concepts are typically relevant for AI/ML-based diagnostic devices or complex imaging analysis, where expert interpretation and consensus are crucial for establishing ground truth and evaluating human-AI interaction. This document is for a physical medical device (examination gloves), so these types of studies are not applicable or mentioned.
• Standalone Performance: The concept of "standalone performance" (algorithm only) is not relevant to a physical medical device like gloves.

What the document does tell us:

• Device Name: Latex Examination Gloves, Powder Free, Polymer Coated
• Regulation Number & Product Code: 880.6250, LYY (Patient Examination Gloves)
• Regulatory Class: I (lowest risk class, subject to general controls)
• Indications For Use: A disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
• Date of Clearance: June 7, 2002
• Type of Clearance: 510(k) Premarket Notification, based on "substantial equivalence" to a predicate device.

To obtain the detailed information requested, one would need to access the original 510(k) submission (K021412), which is usually publicly available through the FDA's databases, although often redacted for proprietary information. That submission would describe the specific tests performed (e.g., physical property testing, biocompatibility, leak testing) and the criteria used to demonstrate that the gloves meet recognized standards and are substantially equivalent to marketed predicate devices.

Ask a specific question about this device

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.

Blue Latex Examination Gloves, Powder Free

The provided text is a 510(k) premarket notification approval letter for "Blue Latex Examination Gloves, Powder Free." This document indicates that the device has been found substantially equivalent to legally marketed predicate devices, meaning it meets the necessary standards for safety and effectiveness.

However, the document does not contain the detailed acceptance criteria and study information typically found in a clinical study report or a more comprehensive summary of safety and effectiveness data. It is a regulatory approval letter that references such data but does not provide it in detail.

Therefore, based on the provided text, I cannot answer the questions regarding specific acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details. This information would normally be found in the 510(k) submission itself or a summary of its data, not in the approval letter.

The primary function of this document is to inform the manufacturer that their device can be legally marketed.

Ask a specific question about this device

Ask a specific question about this device