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AMBIDERM Powder Free Latex Examination Gloves are intended for single use for medical purposes and are worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patient.

Ambiderm Powder Free Latex Examination Gloves with Protein Labeling Claim meet the current specifications listed under the ASTM specifications D 3578-99 standard specification for rubber examination gloves. They are Violet, Blue, Green or Pink colored.

The provided text describes a 510(k) summary for AMBIDERM POWDER FREE (COLORED) LATEX EXAMINATION GLOVES. This document is a regulatory filing for a medical device and, as such, focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed study proving the device meets specific performance criteria in the way a diagnostic algorithm or drug might.

Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable or available in this type of document. However, I can extract the relevant information where it exists and state explicitly when certain information is not provided.

Here is an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the device is "substantially equivalent to the Class I patient examination glove 80LYY" and "meets all the current spec listed under the ASTM specification D 3578-99 standard specification for rubber examination gloves." This implies that the acceptance criteria are those defined in the ASTM standard and relevant FDA regulations for patient examination gloves. Specific numerical values for the performance criteria (e.g., tensile strength minimums, AQL levels) are not enumerated in this summary but would be detailed in the full ASTM standard.

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

The document does not explicitly state the sample sizes for the "nonclinical tests."
Similarly, the data provenance (e.g., country of origin, retrospective or prospective) for these nonclinical tests is not specified beyond noting they were performed internally via ASTM D 3578-99 and 21 CFR 800.20 methodologies.

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

This information is not applicable and not provided in the document. The "ground truth" for glove performance is established by standardized testing protocols (e.g., ASTM standards for physical properties, USP tests for chemical properties, animal models for biocompatibility), not by expert consensus on specific cases.

4. Adjudication Method for the Test Set

This concept is not applicable for the type of device and testing described. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving interpretation of medical images or diagnoses, not for performance testing of a physical product like an examination glove.

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 relevant for diagnostic devices that involve human interpretation of outputs (e.g., radiologists reading images) and assessing the impact of AI assistance. This device is a physical examination glove.

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

This question is not applicable. This device is a physical product, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance claims of these gloves is based on:

• Standardized Test Specifications: Adherence to ASTM D 3578-99 for physical properties.
• Biocompatibility Testing: Results from established animal models (rabbit for primary skin irritation, guinea pig for delayed contact sensitization).
• Chemical Tests: USP Iodine test for starch.
• Protein Content Measurement: Specific laboratory methods to quantify protein according to the stated claim (though the specific measurement method isn't detailed, it's implied by the protein claim).

8. The Sample Size for the Training Set

This information is not applicable. "Training set" refers to data used to train machine learning algorithms. This device is a physical product, not an AI/ML algorithm.

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

This information is not applicable for the same reason as above.

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AMBIDERM Powder Free Latex Examination Glove (Black Colored), polymer coated, with a protein labeling claim is a single use device intended for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patient.

Ambiderm Powder Free Latex Examination Gloves with Protein Labeling Claim meet the current specifications listed under the ASTM specifications D 3578-99 standard specification for rubber examination gloves. They are black in color.

The provided text describes the 510(k) summary for "AMBIDERM POWDER FREE (COLORED) LATEX EXAMINATION GLOVES WITH PROTEIN CLAIMS OF 50 MICROGRAMS OR LESS PER GRAMS". This document focuses on the regulatory clearance for general-purpose medical gloves and does not involve AI, image analysis, or complex medical diagnostic performance. Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable in the context of this medical device.

However, I can extract the relevant information regarding acceptance criteria and the methods used to demonstrate compliance for these examination gloves.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify the exact sample sizes used for testing according to ASTM D 3578-99 or 21 CFR 800.20 for the specific device being submitted. These standards typically define sampling plans. The data provenance is not explicitly stated in terms of country of origin, but the testing was conducted to U.S. regulatory standards (ASTM and FDA). The implication is that these were non-clinical, лабораторные испытания directly related to the product being submitted. It's a "prospective" evaluation in the sense that the new device was manufactured and then tested to meet established standards.

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

This concept is not applicable here. "Ground truth" in this context refers to the defined specifications and performance requirements set by the ASTM standard and FDA regulations. The "experts" are the consensus bodies that established these standards, and the testing laboratories or personnel simply verify compliance against these objective metrics. There isn't an "expert adjudication" process like there would be for diagnostic imaging.

4. Adjudication Method for the Test Set:

Not applicable. Compliance is determined by direct measurement against objective criteria defined in the ASTM standards and FDA regulations, not by expert consensus or 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 an examination glove, not an AI or diagnostic imaging device that involves human readers or AI assistance.

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

Not applicable. This device is not an algorithm. Its performance is evaluated through physical and material property testing.

7. The Type of Ground Truth Used:

The ground truth used is based on:

• Standard Specifications: ASTM D 3578-99 (physical properties like dimensions, tensile strength, elongation, freedom from holes).
• Regulatory Requirements: 21 CFR 800.20 (biocompatibility, protein claims).
• Laboratory Tests: Primary skin irritation in rabbits, delayed contact sensitization in guinea pigs, USP iodine test for starch presence.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical product (gloves), not an AI algorithm requiring 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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AMBIDERM Powder Free Latex Examination Gloves are intended for single use for medical purposes and are worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patients.

Ambiderm Powder Free Latex Examination Gloves meet the current specifications listed under the ASTM Specification D 3578 - 99 Standard Specification for Rubber Examination Gloves. They are either Violet, Blue, Green or Pink colour.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the AMBIDERM POWDER FREE LATEX EXAMINATION GLOVES.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the AMBIDERM POWDER FREE LATEX EXAMINATION GLOVES are explicitly stated by referencing industry standards. The device's performance is reported as meeting these standards.

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

The document does not explicitly state the specific sample sizes used for each individual test (e.g., how many gloves were tested for tensile strength, or how many rabbits/guinea pigs were used for biocompatibility). However, it implies that the testing was performed "as per ASTM D 3578-99 and 21 CFR 800.20," meaning the sample sizes and testing methodologies would follow those standards.

• Data Provenance: The tests are non-clinical (laboratory and animal data). The country of origin for the data is not specified, but the submission is to the FDA in the USA. The data is retrospective in the sense that it was generated prior to the 510(k) submission to demonstrate compliance.

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

This type of information is not applicable to the evaluation of this device. The "ground truth" for glove performance is established by standardized testing protocols (ASTM D 3578-99) and regulatory requirements (21 CFR 800.20). Expert interpretation of images or clinical outcomes, which typically requires multiple experts and their qualifications, is not relevant for this product.

4. Adjudication Method for the Test Set

Not applicable. The tests involve quantifiable measurements against established standards, not subjective interpretations requiring adjudication.

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

No. This is a medical device clearance for examination gloves. MRMC studies are typically performed for diagnostic imaging devices to evaluate human reader performance with and without AI assistance. This type of study is not relevant for examination gloves.

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

Not applicable. This is not an AI/algorithm-based device. Performance tests were conducted on the physical product.

7. The Type of Ground Truth Used

The ground truth used is based on established industry standards and regulatory requirements.

• Industry Standards: ASTM Specification D 3578-99 for physical properties (e.g., dimensions, physical integrity, tensile strength) which dictate acceptable ranges for these characteristics.
• Regulatory Standards: 21 CFR 800.20 for biological safety (biocompatibility).
• Specific Claims: The claim of "50 microgram or less of total water extractable protein per gram" is also a specific performance metric.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set. The device's performance is evaluated through direct physical and biological testing.

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 patient examination glove is a disposable device intended for medical purposes, that is worn on It pation oxamination grove is a sevent contamination between patient and examiner.

Colored Ambiderm Powder-Free Examination Gloves with Protein Labeling Claim. (White, Violet, Green, Yellow, Orange, Pink & Blue) .

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Ambiderma Colored Powder-Free Latex Examination Glove). This document confirms the device's substantial equivalence to a predicate device and permits its marketing.

However, it does not contain any information about acceptance criteria for device performance or details of a study conducted to prove the device meets such criteria. The letter focuses on regulatory approval based on equivalence, not on the results of a performance study with specific metrics, sample sizes, or ground truth establishment—which are typically found in a detailed study report or scientific publication.

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

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Ask a specific question about this device

Ask a specific question about this device