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A surgeon glove is a disposable device intended for medical purposes that is worn on the surgeon's hand to prevent contamination between patient and surgeon.

The device in this 510(k) submission is the SensiCare -C Synthetic Polyisoprene Powder-free Surgical Glove (Classification number 79KGO). The SensiCare C Synthetic Polyisoprene Powder-free Surgical Glove is a sterile, synthetic rubber latex surgical glove. These gloves are intended to be used as a barrier by providing protection for surgical personnel and patients against microbial migration and to protect a surgical wound from contamination.

The provided text describes the SensiCare-C Synthetic Polyisoprene Powder-Free Surgical Gloves and their regulatory clearance, but it does not contain information about a study involving an AI/Machine Learning device or its performance criteria, ground truth, or expert review process.

The document is a 510(k) summary for a medical glove, focusing on its substantial equivalence to a predicate device and its compliance with relevant ASTM standards for physical properties, sterility, and freedom from holes.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI device. The input does not contain any of the following:

• A table of acceptance criteria and reported device performance for an AI/ML system.
• Sample sizes for test sets, data provenance, or details about training sets for an AI/ML system.
• Information on experts used to establish ground truth or adjudication methods for an AI/ML system.
• Details about Multi-Reader Multi-Case (MRMC) studies or standalone performance of an AI/ML system.
• The type of ground truth used for an AI/ML system.

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

The product is a powder-free, sterile, polyurethane examination glove that is available in various sizes. It is made with a polyurethane polymer and polyurethane coating on the user side. This coating provides good donning and doffing without the use of donning powder. No release powder or chemical release agents are used. The gloves will be marketed both as medical examination gloves and dental examination gloves.

Here's an analysis of the acceptance criteria and study information for the Sterile SensiCare® Advantix™ Powder Free Polyurethane Medical/Dental Examination Glove based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the specific sample sizes used for each test (e.g., freedom from holes, physical properties, irritation, sensitization). It only indicates that the gloves meet the requirements of the standards or have been tested.

The provenance of the data is not specified (e.g., country of origin). Since it's a 510(k) submission to the FDA, it's generally expected that the testing would be conducted in a manner compliant with US regulatory guidelines or internationally recognized standards. The document does not specify if the testing was retrospective or prospective, but given it's for a new clearance, it would typically involve prospective testing of the device being submitted.

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

This information is not provided in the document. For manufacturing and material strength tests like ASTM D 3578-01a or ASTM-6124-01, "experts" in the sense of human interpretation of complex medical images or conditions are typically not involved. These are objective, quantitative tests performed by trained laboratory technicians following standardized protocols. For ISO 10993-Part 10 (biocompatibility), the "ground truth" (i.e., non-irritating/non-sensitizing) is established through standardized animal or in vitro tests, not expert consensus on human data.

4. Adjudication Method for the Test Set:

Not applicable. The tests performed are objective, standardized laboratory tests. There is no indication of subjective assessment or an adjudication process involved in these performance evaluations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

Not applicable. This is a submission for a sterile medical examination glove, not an AI-powered diagnostic device. Therefore, no MRMC study or AI assistance evaluation was performed.

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

Not applicable. This is a medical device (glove), not an algorithm or AI system.

7. The Type of Ground Truth Used:

The ground truth for the performance claims relies on:

• Standardized Test Results: Compliance with established industry standards like ASTM D 3578-01a, ISO 10993-Part 10, and ASTM-6124-01. These standards define the methods and criteria for evaluating factors like freedom from holes, physical properties, biocompatibility (irritation/sensitization), and powder content.
• Predicate Device Equivalence: The claim of substantial equivalence to the predicate device (K011198) in terms of materials, physical properties, and safety/efficacy. The predicate device's existing clearance serves as a form of "ground truth" for acceptable performance.

8. The Sample Size for the Training Set:

Not applicable. There is no "training set" in the context of a physical medical device like a glove. The device's manufacturing processes and material specifications are developed based on engineering principles and existing knowledge, not through machine learning training.

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

Not applicable, as there is no training set for this type of device. The "ground truth" for the device's design and manufacturing is established through compliance with recognized standards, validated manufacturing processes, and comparison to existing, cleared predicate devices.

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Sniper Elite™ Hydrophilic Guidewires are designed for use in angiographic procedures to introduce/position catheters and interventional devices within the vasculature.

The Sniper Elite™ Hydrophilic Guidewire is constructed from a super elastic, Nitinol core wire. A plastic cladding is applied over the Nitinol core, with a hydrophilic coating covering the plastic cladding. The polymer cladding is impregnated with a radiopacive agent and a platinum/8% tungsten coil is located in the distal tip for enhanced contrast under fluoroscopy.

The provided document describes the Sniper Elite™ Hydrophilic Guide Wire and its substantial equivalence to a predicate device. However, it does not contain information about a study with acceptance criteria to demonstrate device performance in the context of an AI/ML powered device. The document is for a traditional medical device (guidewire) and focuses on engineering and material-based performance tests for substantial equivalence, not AI/ML performance.

Therefore, I cannot provide the requested information for an AI/ML device because the provided text is not about an AI/ML device.

To provide a complete answer regarding an AI/ML device, the input document would need to describe:

• An AI/ML component or function within the device.
• Specific performance metrics related to the AI/ML component (e.g., sensitivity, specificity, AUC).
• Details of a clinical or bench study designed to evaluate the AI/ML performance against defined acceptance criteria.

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The Maxxim Medical angiographic catheters are designed to be used for delivering radiopaque contrast media into the coronary or peripheral vascular systems.

The Pathfinder II Angiographic catheter has a polyurethane body, reinforced with stainless steel braid, containing barium sulfate and a blue colorant. The braiding provides torque-ability. The barium sulfate causes the device to be radio-detectable under a fluoroscope to assist in placing the device in the patient's vasculature. The proximal end of the body is bonded to a polycarbonate hub. The distal end has a polyurethane stem fused to the braided body. All catheters have the distal tip formed either into a pigtail for infusing fluids or into a special "selective" shape that is formed to facilitate rapid placement of the device in the desired location in the circulatory system by the doctor. All selective curves have a soft, atraumatic polyurethane tip fused to the stem. The pigtail catheters have their stems either straight or formed into an angle to allow for user preferences. Pigtail angiographic catheters have a pattern of "side holes" near the distal tip to allow increased infusion flow rate. The catheter is introduced using the Seldinger Technique, Artery Cut-down (Sones method), or the Introducer Technique.

Here's an analysis of the provided text regarding the Pathfinder II Angiographic Catheter:

Please note: This FDA 510(k) summary is for a medical device (angiographic catheter), which is a physical product, not an AI/software device. Therefore, many of the typical acceptance criteria and study components requested (like sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training sets, etc.) are not applicable to this type of submission. The focus for a physical device is on engineering performance metrics, biocompatibility, and substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Study That Proves the Device Meets the Acceptance Criteria:

The study proving the device meets acceptance criteria is a non-clinical performance study and a comparison to a legally marketed predicate device.

• Non-Clinical Performance Study: The device was tested against recognized international consensus standards (ISO 10555-1, ISO 10555-2, ISO 10993-1, ISO 594/1, ISO 594-2). Specific tests mentioned include tensile strength of all bonds, flow rates, and burst strength. These tests demonstrate the physical and mechanical integrity and performance of the catheter.
• Substantial Equivalence Comparison: A detailed comparison table ([1] "Legally marketed device to which equivalence is claimed") directly compares the technological characteristics of the Pathfinder II Angiographic Catheter to the Cordis Corporation Super Torque Plus™. This comparison aims to demonstrate that the new device is as safe and effective as the predicate device by showing similar design features, materials, and performance specifications. Where there are differences (e.g., presence of strain relief, specific range of sizes/lengths, colorants), the submission explicitly states that these differences do not affect the safety or effectiveness of the device.

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

• Sample Size for Test Set: This information is not provided in the 510(k) summary. For device testing to ISO standards, specific numbers of units would have been tested for each criterion, but these are typically found in the full test reports, not the summary.
• Data Provenance: The testing was conducted by Maxxim Medical, Inc. (Argon Division) in Athens, Texas, USA. The studies are prospective in nature, as they involve testing newly manufactured devices against established standards and internal specifications.

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)

• Not Applicable. This is a physical medical device submission, not an AI/software device that relies on expert interpretation of data or images to establish a "ground truth." The "ground truth" for this device's performance is objective measurements against engineering specifications and international standards, and comparison to the predicate device.

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

• Not Applicable. Adjudication methods are typically relevant for human interpretation tasks or clinical endpoints where there might be disagreement, often in the context of an AI/software device. For engineering tests of a physical device, the results are typically quantitative and objective, requiring no 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

• No. An MRMC study is not applicable here. This type of study is used to assess the effectiveness of an AI system to assist human readers (e.g., radiologists interpreting images). This submission is for a physical angiographic catheter, not an AI system.

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

• No. This is not applicable. There is no algorithm; this is a physical medical device.

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

• The "ground truth" in this context is established by:
  • Objective engineering specifications and measurements: The device must meet predefined physical, mechanical, and material properties (e.g., tensile strength, flow rate, burst pressure, dimensions, radio-opacity).
  • International Consensus Standards (ISO): Compliance with these standards serves as a benchmark for safety and performance (e.g., sterility, biocompatibility, luer lock integrity).
  • Predicate Device Characteristics: The characteristics and performance of the legally marketed predicate device (Cordis Super Torque Plus™) serve as a comparative standard for demonstrating substantial equivalence.

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of a physical medical device submission. This term is relevant for machine learning or AI algorithm development.

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

• Not Applicable. As there is no training set, there is no ground truth established for one.

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

This product is a powder free, non-sterile, vinyl examination glove that is available in various sizes. The cuff of the glove has been lengthened and the thickness increased to promote use of the glove for procedures where such features are beneficial. It is made with a poly (vinyl Chloride) polymer and a polyurethane coating on the user side. This coating provides good donning and doffing without the use of donning powder. No release powder or chemical release agents are used. The gloves will be marketed as medical examination gloves. All requirements for physical properties and dimensions have been met for this intended use.

This document describes the safety and effectiveness of the Maxxim Medical SensiCare™ XP Vinyl Powder Free Medical Examination Gloves.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

The document does not explicitly state the specific sample sizes used for each test. The tests were conducted in accordance with ASTM D 5250-99, ASTM D 6124-97, and ISO10993-Part 10. The data provenance is not specified (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is a physical product (medical examination gloves) undergoing testing for compliance with established material and safety standards. The "ground truth" is determined by standardized laboratory testing procedures and criteria outlined in the ASTM and ISO standards, not by expert human interpretation like in diagnostic imaging. Therefore, the concept of "experts establishing ground truth" in the way it applies to image analysis or clinical diagnosis is not applicable here.

4. Adjudication method for the test set:

Not applicable. The "adjudication method" as typically described for clinical or imaging studies (e.g., 2+1, 3+1) is not relevant for laboratory testing of physical product specifications against defined standards.

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 is a medical device (gloves), not an AI diagnostic or assistance tool. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not relevant.

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

Not applicable. This is a physical medical device, not an algorithm or AI system.

7. The type of ground truth used:

The ground truth used for proving the device meets the acceptance criteria is based on objective measurements and assessments against established scientific and industry standards. These standards include:

• ASTM D 5250-99: Standard Specification for Poly(vinyl chloride) Gloves for Medical Application. This standard defines requirements for physical dimensions, tensile strength, elongation, and watertight integrity (freedom from holes).
• ASTM D 6124-97: Standard Test Method for Residual Powder on Medical Gloves. This standard defines the method for determining if gloves can be labeled as "powder-free."
• ISO 10993-Part 10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization. This standard outlines procedures for assessing the potential of medical devices to cause irritation and sensitization.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set" in the context of AI.

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

Not applicable. There is no training set for this type of device.

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