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Medline UNITE® Ankle Fracture Plates and Screws are intended for fixation of fractures, and nonunions of the distal tibia and fibula such as:

• · Lateral Malleolar Fractures
• · Syndesmosis Injuries
• · Medial Malleolar Fractures
• Bi-Malleolar Fractures
• · Tri-Malleolar Fractures
• Posterior Malleolar Fractures
• Distal Anterior Tibia Fractures
• · Vertical Shear Fractures of the Medial Malleolous
• · Pilon Fractures
• Distal Tibia Shaft Fractures
• Distal Fibula Shaft Fractures
• · Distal Tibia Periarticular Fractures
• · Medial Malleolar Avulsion Fractures
• · Lateral Malleolar Avulsion Fractures

The Medline Locking and Non-Locking Cortical and Cancellous Screws are indicated for use with the Medline Ankle Fracture Plates of the same base material. The Non-Locking Cortical Screws are also indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the device.

Medline UNITE® Ankle Fracture Plating System are manufactured from Titanium Alloy. The system includes plates offered in various styles, sizes and options; each contoured for specific anatomy and designed for specific procedures, and 2.7mm and 3.5mm diameter locking cortical screws, 4.0mm Cancellous Screws, 4.0mm Medial Hook plate screws and 4.0mm Headed Cannulated screws to be used with the polyaxial locking holes and compression slots included in the plates. The system also includes reusable instrumentation necessary to implant the plates and screws, e.g. drill guides, tissue protectors, and drill bits.

The document describes the Medline UNITE® Ankle Fracture Plating System and its substantial equivalence to predicate devices, particularly the Synthes LCP One Third Tubular Plate (K011335).

Here's an analysis of the acceptance criteria and supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document describes non-clinical testing involving mechanical tests (single-cycle 4-point bend testing and bending fatigue testing).
• The sample size for these mechanical tests is not explicitly stated in the provided text.
• Data provenance is also not applicable in the context of mechanical testing of physical implants rather than patient data. The tests were performed to compare the Medline device against a predicate device.

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

• This information is not applicable to the type of testing performed. The study involved non-clinical mechanical testing of medical devices, not clinical evaluation requiring expert interpretation of patient data.

4. Adjudication Method for the Test Set

• This information is not applicable as the study was non-clinical mechanical testing, not a clinical study requiring adjudication of expert opinions.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not conducted. The document states "Summary of Clinical Testing: Not applicable." The study was entirely non-clinical, focusing on mechanical properties.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• This question is not applicable as the device is a physical bone plating system, not an AI algorithm.

7. Type of Ground Truth Used

• The "ground truth" for this non-clinical study was the established mechanical performance characteristics of the predicate device, as defined by the ASTM F382-14 standard and the performance of the Synthes LCP One Third Tubular Plate. Equivalence to these established benchmarks was the goal.

8. Sample Size for the Training Set

• This information is not applicable as there was no training set in the context of this mechanical device testing.

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

• This information is not applicable as there was no training set mentioned in the context of this mechanical device testing.

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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. In addition these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

The Medline Powder-Free Blue Nitrile Exam Glove, Extended Cuff (Tested for Use with Chemotherapy Drugs) are single use only, disposable gloves intended for medical purposes to be worn on the hands or fingers of examiners. The gloves are powder-free and are made of nitrile with a blue colorant. The gloves are offered non-sterile and are available in small, medium, large and extra-large sizes.

Permeation testing was conducted to support the addition of the labeling claim: Tested for use with chemotherapy drugs. The subject device was tested according to ASTM D6978, Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. Minimum breakthrough times were determined for a wide range of chemotherapy agents.

This document is a 510(k) premarket notification for Medline Powder-Free Blue Nitrile Exam Gloves, Extended Cuff, which have been tested for use with chemotherapy drugs. It is a submission to the FDA seeking to demonstrate substantial equivalence to a legally marketed predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly refers to acceptance criteria by stating "Complies with ASTM D6319-10" or by providing specific thresholds. The "reported device performance" is implicitly shown by the claim of compliance or the listed breakthrough times.

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

The document does not explicitly state the sample sizes used for each physical, biocompatibility, or permeation test. It only refers to compliance with specific ASTM and ISO standards (e.g., ASTM D6319, ASTM D6978, ISO 10993-10). These standards typically define the sampling plans required for testing.

• Data Provenance: The studies were non-clinical bench testing. The origin of the data is from Medline Industries, Inc. (the submitter). The document does not specify the country of origin for the actual testing or if it was retrospective or prospective, but it implies prospective testing conducted to support the 510(k) submission.

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

N/A. This is a non-clinical device (medical glove) and the testing involves objective measurement against performance standards (ASTM, ISO), not subjective interpretation by human experts to establish ground truth.

4. Adjudication Method for the Test Set

N/A. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving reader agreement on subjective assessments. This device underwent bench testing against objective criteria.

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

No. An MRMC comparative effectiveness study is designed for evaluating diagnostic devices where human readers interpret medical images or data, often with and without AI assistance. This document describes the safety and performance testing of a physical medical device (gloves), not a diagnostic algorithm.

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

No. This concept is not applicable to a physical medical device like an examination glove. "Standalone performance" refers to the accuracy of an algorithm without human intervention, which is pertinent to AI/ML software as a medical device.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation of these gloves is defined by the objective performance specifications outlined in recognized international standards:

• Physical properties: ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application). The "ground truth" is that a glove either meets the specified tensile strength, elongation, dimensions, AQL for pinholes, etc., or it does not.
• Biocompatibility: ISO 10993-10:2010/(R) 2014 (Biological Evaluation of Medical Devices – Part 10: Tests for irritation and skin sensitization). The "ground truth" is whether the device causes irritation or sensitization based on established biological test methods.
• Chemotherapy Drug Permeation: ASTM D6978-05 (Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs). The "ground truth" is the measured breakthrough time of the specific chemotherapy drugs, as determined by the standardized test method.

8. The Sample Size for the Training Set

N/A. The concept of a "training set" applies to machine learning algorithms. This document describes the testing of a physical medical device, not an AI/ML algorithm.

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

N/A. As there is no training set for a physical product like a glove, this question is not applicable.

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The Medline High Pressure Tubing is indicated for use during coronary angiography procedures as a connecting line for the injection of radiopaque dye or saline.

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I am sorry, but the provided text does not contain any information regarding the acceptance criteria, study details, or device performance as requested. The document is an FDA 510(k) clearance letter for a medical device called "Medline High Pressure Tubing," indicating its substantial equivalence to a predicate device and specifying its intended use. It does not include any performance data or study design details.

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The Curad Compression Hosiery is intended for use in helping prevent edema and leg discomfort, and helping prevent deep vein thrombosis (DVT) in individuals subjected to immobility.

15-20mmHg: Helps to prevent edema and leg discomfort, and helps to prevent deep vein thrombosis (DVT) in individuals subjected to immobility. Especially for long distance travelers and those on their feet for extended periods of time.

20-30mmHg: Helps to prevent the pooling of blood in the legs and apply controlled pressure to the legs.

30-40mmHg: Helps to prevent edema and leg discomfort and helps to prevent deep vein thrombosis.

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The provided text is a 510(k) clearance letter for the Curad® Compression Hosiery. It does not contain information about the acceptance criteria or a study proving the device meets those criteria. The letter primarily confirms that the device is substantially equivalent to a legally marketed predicate device based on its indications for use.

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance, not a performance study with detailed acceptance criteria and results.

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The Medline Pneumoperitoneum Needle has applications in gynecologic and abdominal endoscopic procedures for establishment of a pneumoperitoneum.

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The provided text is a 510(k) substantial equivalence letter from the FDA for a medical device called the "Medline Pneumoperitoneum Needle." This document establishes the device's regulatory classification and outlines general controls and regulations. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot provide the requested information. The letter is a regulatory approval document and not a scientific study report.

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Medline Vessel Cannulae are intended for use in conjunction with cardiopulmonary bypass surgery or in vascular surgery to perfuse a vein graft or to help check for leaks in a harvested vein which will be used for a graft.

Medline's Vessel Cannula are to be supplied as sterile, non-pyrogenic, single use, disposable devices. They are visually transparent and consist of a flexible, kink resistant body with a one way valve. This vessel cannula is 2 inches in length and terminates with a female luer and a soft blunt tip.

The provided text describes a 510(k) premarket notification for the Medline Vessel Cannula, focusing on its substantial equivalence to a predicate device and its compliance with non-clinical testing standards. It does not contain information about a study proving the device meets acceptance criteria in the context of typical clinical or diagnostic device performance metrics such as sensitivity, specificity, or reader studies for AI-powered devices.

The document primarily outlines:

• Substantial Equivalence: The Medline Vessel Cannula is deemed substantially equivalent to the DLP Vessel Cannulae (Medtronic, K810820). This means its technological characteristics and performance are comparable, and it's intended for the same use.
• Non-Clinical Testing: The submission includes results from biocompatibility and functional performance testing. These are primarily engineering and safety tests rather than clinical performance studies.

Therefore, many of the requested categories for a diagnostic or AI-driven device's performance study cannot be answered from the provided text.

Here's a breakdown of what can and cannot be answered:

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

2. Sample size used for the test set and the data provenance: Not applicable. These were non-clinical, laboratory/benchtop tests, not a clinical study on a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical performance was not established as no clinical performance study was conducted.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 a physical medical instrument (cannula), not an AI-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for these tests would be the established scientific methods and standards defined in ISO/ASTM guidelines for biocompatibility and functional testing (e.g., passing specific thresholds for toxicity, tensile strength, or leakage).

8. The sample size for the training set: Not applicable. This is not an AI/machine learning device.

9. How the ground truth for the training set was established: Not applicable.

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This anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.

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This document is a 510(k) premarket notification approval letter for the Medline Epidural and Spinal Needles. It does not present any clinical study data or acceptance criteria for device performance.

Therefore, I cannot provide the requested information, such as:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or training sets.
• Data provenance or details about experts.
• Adjudication methods.
• MRMC study information.
• Standalone performance.
• Types of ground truth.

This letter solely indicates that the FDA has reviewed the device and determined it to be substantially equivalent to legally marketed predicate devices, allowing it to be marketed subject to general controls. It does not contain the detailed study results and performance metrics typically found in a clinical study report or a summary of safety and effectiveness data.

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