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A medical glove is wom on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.

OmniGrace Nitrile, Blue, Examination Glove, Powder Free, Polymer Coated.

This document is a 510(k) premarket notification decision letter from the FDA to OmniGrace (Thailand) Ltd. regarding their Nitrile, Blue, Powder-Free, Polymer Coated Patient Examination Glove. The letter indicates that the device has been found substantially equivalent to devices marketed prior to May 28, 1976.

Unfortunately, this document does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria. The provided text is a regulatory approval letter and an "Indications for Use Statement," not a study report or a detailed description of performance testing.

Therefore, I cannot provide the requested table or answer the specific questions about sample size, expert involvement, adjudication, MRMC studies, standalone performance, ground truth, or training set details. This information would typically be found in the 510(k) submission itself, or in subsequent test reports, which are not part of this document.

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A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.

OmniGrace Latex Examination Glove, Powder Free, Polymer Coated, with Protein Claim (50 Micrograms or Less)

This document is a 510(k) premarket notification for a medical device: "OmniGrace Latex Examination Glove, Powder Free, Polymer Coated, with Protein Claim (50 Micrograms or Less)."

The document is a clearance letter from the FDA, stating that the device is substantially equivalent to legally marketed predicate devices. It does not contain information about acceptance criteria, device performance tables, study designs, sample sizes, expert qualifications, or ground truth establishment relevant to the device's functional performance metrics.

Therefore, I cannot provide the requested information from the provided text. The document primarily focuses on regulatory approval based on substantial equivalence, rather than detailed performance study results.

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A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.

OmniGrace Nitrile, Green, Examination Glove, Powder Free, Polymer Coated.

The provided document is a 510(k) premarket notification letter from the FDA for a medical device: "Omnigrace Patient Examination Glove, Trade Name: Nitrile, Green, Powder-Free, Polymer Coated." This letter confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a predicate device, rather than requiring extensive clinical efficacy or performance studies with detailed acceptance criteria as one might find for a novel, high-risk device. For devices like examination gloves, the FDA typically assesses factors such as biocompatibility, physical properties (e.g., tensile strength, puncture resistance), and viral barrier claims, often against recognized standards. The letter itself does not detail these specific test results or their acceptance criteria.

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A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.

Not Found

This document is a 510(k) premarket notification for patient examination gloves. It approves the device as substantially equivalent to a predicate device. The information provided does not contain details about specific acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML powered device, which is implied by the detailed questions.

Instead, this document pertains to a physical medical device (examination gloves) and its approval process by the FDA based on substantial equivalence. Therefore, I cannot directly answer your questions about acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies, as they are not applicable to the content of this document.

The document indicates:

• Device Name: Omni Flex Nitrile Examination Glove, Powder Free, Turquoise
• Intended Use: "A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient."
• Regulatory Class: I
• Product Code: LZA
• FDA Action: Substantial Equivalence determination based on comparison to pre-amendment devices, subject to general controls (annual registration, listing, GMP, labeling, prohibitions against misbranding/adulteration).

To answer your specific questions in the context of an AI/ML powered medical device, I would need a different type of document that describes a performance study for such a device.

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A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.

Patient Examination Glove, Nitrile, Powdered, Turquoise

This submission is for a medical device called an "Omni Flex Nitrile Examination Glove, Powdered, Turquoise." The provided documents are a 510(k) clearance letter and an "Indications For Use Statement." These documents do not contain information about acceptance criteria or performance studies as typically required for clinical software or diagnostic devices.

Instead, they address the regulatory clearance of a physical medical device (gloves) based on substantial equivalence to a predicate device already on the market. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth, and expert involvement is not applicable or available in these documents.

Here's an attempt to address the points based only on the provided text, recognizing its limitations for this type of query:

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

This information is not provided in the given documents. The 510(k) clearance process for general-purpose medical gloves typically involves demonstrating substantial equivalence to a legally marketed predicate device through performance criteria such as:

• Physical Properties: Tensile strength, elongation at break, force at break (often specified in ASTM D6319 or similar standards).
• Barrier Integrity: Water leak test (AQL, Acceptable Quality Level, often 2.5 or 4.0 for medical gloves).
• Biocompatibility: Tests for skin irritation and sensitization.
• Powder Residue (if powdered).

However, the specific quantitative acceptance criteria and the Omni Flex Nitrile Examination Glove's performance against these criteria are not detailed in the provided regulatory letter or indications for use. The letter simply states that the FDA has determined the device is "substantially equivalent" to predicate devices.

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

This information is not provided in the given documents. For a 510(k) submission for gloves, the "test set" would refer to the samples of gloves tested for physical and barrier properties. The letter indicates the manufacturer is OmniGrace (Thailand) LTD., located in Thailand, suggesting the testing data would likely originate from Thailand or a designated testing facility. The nature of these tests is usually prospective, as manufactured batches are tested.

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)

This is not applicable to this type of device and submission. "Ground truth" in the context of diagnostic devices often refers to an expert-validated diagnosis or pathology result. For medical gloves, the "ground truth" is typically defined by adherence to established material standards and performance specifications, not expert consensus on an image or diagnosis. Quality control personnel and material science engineers would be involved in testing.

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

This is not applicable to this type of device and submission. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations (e.g., in reading medical images), which is not relevant to testing the physical properties of gloves.

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

This is not applicable to this type of device and submission. MRMC studies are used for evaluating the performance of diagnostic imaging devices or AI algorithms that assist human readers. Medical gloves are barrier devices, not diagnostic or AI-assisted tools.

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

This is not applicable to this type of device and submission. This refers to the evaluation of AI algorithms, which is not relevant to medical gloves.

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

As mentioned in point 3, the concept of "ground truth" in the diagnostic or AI sense does not apply here. For medical gloves, the "truth" is established by measured physical properties (e.g., tensile strength, barrier integrity) meeting predefined standards (e.g., ASTM standards, AQL limits) and biocompatibility test results.

8. The sample size for the training set

This is not applicable to this type of device and submission. Training sets are used in machine learning.

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

This is not applicable to this type of device and submission.

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A medical glove is worn on the hand of healthcare and similar personnel to prevent / moundal you between health care personnel and the patient.

Omni Flex Nitrile Examination Glove, Powder Free, Blue

This document is a 510(k) premarket notification letter from the FDA to OmniGrace (Thailand) Ltd. regarding their Omni Flex Nitrile Examination Glove. It is primarily a regulatory approval document and does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance.

The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its approval. However, it does not provide:

• A table of acceptance criteria and reported device performance.
• Details about specific studies (sample size, data provenance, ground truth, experts, adjudication, MRMC, standalone performance, training set size, or how ground truth was established).

The "Indications For Use Statement" only describes the intended purpose of the glove (to prevent contamination between healthcare personnel and the patient) but does not include any performance metrics or study details.

Therefore, I cannot provide the requested information from this document.

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A medical glove is wom on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.

Omni Touch Nitrile Examination Glove, Powdered, Blue

This document is a 510(k) clearance letter from the FDA for a medical device: "Omni Touch Nitrile Examination Glove, Powdered, Blue." It signifies that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information regarding specific acceptance criteria, device performance data, study details (sample size, provenance, expert qualifications, adjudication, MRMC studies, standalone performance), or ground truth establishment.

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. The document is a regulatory approval, not a scientific study report.

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A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.

Patient Examination Glove - Om Ni. FIT , LATEx TownEzFil EXAMINATION GLOVE.

This is a 510(k) premarket notification for a medical device (OMNI Fit Latex Examination Glove, Powdered). The provided text describes the regulatory approval process and states the intended use of the device. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment—which are typically found in a clinical study report or a more detailed section of a 510(k) submission that discusses performance data.

Therefore, I cannot extract the requested information from the provided text. The document primarily focuses on:

• Regulatory Status: That the FDA has reviewed the 510(k) and determined the device is substantially equivalent to predicate devices.
• Device Classification: Class I.
• General Controls: Mentioning requirements like annual registration, listing, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
• Contact Information: For regulatory advice.
• Indications for Use: Stating that the glove is "worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient."

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