Search Results

A powder-free patient examination glove 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.

Model 1: Natural Latex Powder Free Polymer Coated Examination Gloves, with Vanilla Scent
Model 2: Orange Latex Powder Free Polymer Coated Examination Gloves, with Citric Scent
Model 3: Pink Latex Powder Free Polymer Coated Examination Gloves

I am sorry, but the provided text is a 510(k) premarket notification for "ILLUSION Powder Free Latex Examination Gloves." This document does not contain information about acceptance criteria or a study that proves a device meets such criteria for an AI or medical imaging device. It is a regulatory approval document for disposable medical gloves.

Therefore, I cannot extract the specific details you requested regarding acceptance criteria and study information for an AI/imaging device from this text.

Ask a specific question about this device

A patient examination glove is a disposable device intended for medical purposes worn on the hands to prevent contamination and eliminating contagious issue by the wearer. Suitable for use in medical examination, contagious issue by the world. In the dentistry field.

Patient Examination Glove Oleicon Powder free polymer coated berce Cot Bubblegum ssented NR latef

The provided text is a 510(k) premarket notification letter from the FDA regarding "Illusion Powder Free-Polymer Coated Bubble Gum Scented NR Latex Examination Gloves (Blue)". This document is a regulatory approval for a medical device and does not contain any information about a study proving the device meets acceptance criteria.

The FDA letter grants substantial equivalence based on the device's similarity to a legally marketed predicate device, not on specific performance studies detailed in this document. Therefore, I cannot provide the requested information.

The document indicates:

• Device Name: Illusion Powder Free-Polymer Coated Bubble Gum Scented NR Latex Examination Gloves (Blue)
• Regulation Number/Name: 880.6250 / Patient Examination Glove
• Regulatory Class: I
• Product Code: LYY
• Indications for Use: A disposable device intended for medical purposes worn on the hands to prevent contamination and eliminating contagious issue by the wearer. Suitable for use in medical examination and in the dentistry field.

To answer your specific questions, one would need access to the full 510(k) submission documentation, which would include the raw data and study reports if they were required and submitted. The letter itself only confirms the FDA's decision based on that submission.

Ask a specific question about this device

A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner. Suitable for use in medical examination, diagnostic and therapeutic procedures, as well as in the dentistry field.

Illusion Powder Free Polymer Coated Blue Scented (Grape) Latex Examination Glove with Protein Content Labeling Claim (50 Micrograms or Less)

This document is a 510(k) premarket notification letter from the FDA regarding "Illusion Powder Free Polymer Coated Blue Scented (Grape) Latex Examination Glove with Protein Content Labeling Claim (50 Micrograms or Less)."

This document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. It is an approval letter for a medical device (patient examination gloves), confirming that the device is substantially equivalent to legally marketed predicate devices. The letter primarily details the regulatory classification, general controls, and compliance requirements for the manufacturer.

Therefore, I cannot provide a table of acceptance criteria, device performance, or details about a study, as this information is not present in the provided text.

Ask a specific question about this device

ILLUSION, a universal, dual-cured resin cement, is based on an opacity/translucency (value) system, and is intended for the cementation of porcelain and composite inlays, onlays, crowns and veneers. ILLUSION can also be used for conventional cementation of metallic inlays, onlays, crowns and fixed partial dentures.
Intended Use of ILLUSION: dental resin cement

ILLUSION, a universal, dual-cured resin cement, is based on an opacity/translucency (value) system, and is intended for the cementation of porcelain and composite inlays, onlays, crowns and veneers. ILLUSION can also be used for conventional cementation of metallic inlays, onlays, crowns and fixed partial dentures.

The provided text describes a 510(k) summary for a dental resin cement called ILLUSION. It aims to establish substantial equivalence to a predicate device, "Choice™," and lacks detailed information typically found in a study report, particularly regarding acceptance criteria and performance data for a medical device that would involve human subjects or complex algorithms.

However, based on the provided information, I can extrapolate the "acceptance criteria" and "device performance" relating to the physical and mechanical properties of the dental cement as these are explicitly compared to the predicate device.

Here's the breakdown of the information as requested, using the available data:

1. Table of Acceptance Criteria and Reported Device Performance

For this specific device (dental resin cement), the "acceptance criteria" are implied by the performance of the legally marketed predicate device, Choice™. The new device, ILLUSION, is deemed "substantially equivalent" if its performance falls within a comparable range to the predicate device, demonstrating similar safety and effectiveness for its intended use.

Study Proving Device Meets Acceptance Criteria:

The provided document is a 510(k) Summary, which typically references internal testing reports rather than providing them in full detail. The "study" mentioned here refers to the testing conducted by Bisco, Inc. to compare ILLUSION's properties against its predicate. The FDA reviewed these undisclosed test results and determined substantial equivalence.

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

• Sample Size for Test Set: The table indicates numerical values followed by a number in parentheses (e.g., "49 MPa (8)"). This "(8)" or "(6)" likely represents the number of samples or measurements taken for that specific physical property test (e.g., 8 samples for diametrical tensile strength, 6 for compressive strength). This is a very small sample size for a "test set" in the context of clinical studies, but common for material property testing.
• Data Provenance: The data is generated by Bisco, Inc., a company located in Schaumburg, IL, USA. This would be considered experimental/laboratory data rather than clinical data, and it is prospective in the sense that the testing was performed specifically to characterize the new device. There is no information regarding the country of origin of the data beyond the company's location.

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

This information is not applicable to this type of submission. For dental cements, "ground truth" is typically established through standardized material property testing, according to recognized ASTM or ISO standards, rather than expert interpretation or clinical consensus. There are no "experts" in the sense of clinicians establishing ground truth for physical properties like tensile strength or hardness, but rather skilled technicians performing tests according to methods.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving reader interpretations (e.g., radiology images) to resolve discrepancies among experts. For physical property testing, results are quantitative and typically averaged or analyzed statistically; there's no "adjudication" in this sense.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used for diagnostic devices involving human interpretation of clinical data (e.g., radiologists reading images). This 510(k) is for a dental material (cement), and its assessment relies on material properties rather than diagnostic performance or human reader interaction.

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

No, a "standalone algorithm performance" study was not done. This concept applies to AI/software as a medical device. ILLUSION is a physical dental material, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the physical and mechanical properties of the dental cement is established by standardized testing methods (e.g., ISO, ASTM standards for dental materials) that yield quantitative measurements. The predicate device's performance provides the benchmark against which the new device's properties are compared. There is no pathology, outcomes data, or expert consensus used for these specific material properties.

8. The Sample Size for the Training Set

This information is not applicable. The concept of a "training set" is relevant for machine learning algorithms. For a physical medical device like a dental cement, there is no "training set" in this context. The characteristics of the material are inherent to its composition and manufacturing process, optimized through formulation development and testing.

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

This information is not applicable, as there is no "training set" for this type of device.

Ask a specific question about this device