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These Coaxial Dilator Sets are intended to introduce up to a 0.038 in. guidewire or catheter into the vascular system following a small gauge needle stick

The Coaxial Dilator Set (Micro-Introducer) assembly consists of an inner dilator within a slightly shorter outer sheath which is connected to the inner dilator using a spin-lock type connector. The inner and outer dilators are made from radiopaque material so they are visible under fluoroscopy. The design of the subject device, Coaxial Dilator Set (Micro-Introducer) is unchanged from the current line of Coaxial Dilators (K000737). The subject and current marketed predicate devices are identical with the exception of the addition of an optional depth marker, optional outer hub & sheath material and additional lengths.

The provided text is a 510(k) premarket notification for a medical device called the "Coaxial Dilator Set (Micro-Introducer)". This document outlines the manufacturer's claim that their new device is "substantially equivalent" to an existing, legally marketed predicate device.

It is crucial to understand that this document describes a traditional medical device (a physical dilator set) and not an AI/software-based device. Therefore, the concepts of acceptance criteria for AI model performance, sample sizes for test/training sets, expert ground truth, MRMC studies, or standalone algorithm performance are not applicable to this submission.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the bench testing and biocompatibility testing performed to demonstrate that the new physical device performs comparably to the predicate device and is safe for its intended use.

Here's an interpretation based on the provided document, but tailored to the context of a traditional medical device. Many of your requested points are irrelevant for this type of submission.

Acceptance Criteria and Device Performance for the Coaxial Dilator Set (Micro-Introducer)

Since this is a submission for a traditional medical device (Coaxial Dilator Set) and not an AI/software device, the "acceptance criteria" relate to engineering specifications, performance tests, and biocompatibility, rather than algorithmic metrics. The "study" refers to the bench tests and biocompatibility tests conducted.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists the types of tests conducted, implying that the device met internal Galt Medical Corp. requirements and international standards. Specific numerical acceptance criteria and reported results are not provided in this public summary. They would typically be detailed in the full submission.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: Not explicitly stated, as these are engineering and chemical tests, not clinical studies with "test sets" in the AI sense. Samples would have been specimens of the device.
• Data Provenance: The tests were conducted internally by Galt Medical Corp. ("Design testing was conducted according to protocols based on international standards and Galt Medical requirements."). This is laboratory bench testing and biocompatibility testing, not human subject data from specific countries or retrospective/prospective studies.

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

• Not applicable. This relates to human expert review for clinical data, which is not part of this type of submission for a physical device where "ground truth" is established by direct measurement (e.g., tensile strength, dimensions) and laboratory analysis (e.g., biocompatibility assays).

4. Adjudication Method for the Test Set

• Not applicable. This concept typically applies to clinical image or data review by multiple experts for AI ground truth establishment. For physical device testing, results are typically objective measurements against predefined specifications.

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

• No. MRMC studies are for evaluating the performance of diagnostic devices, often AI-assisted. This is a physical interventional device, not a diagnostic one.

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

• Not applicable. This device is a physical instrument, not an algorithm.

7. The Type of Ground Truth Used

• Bench Test Results: Direct physical measurements (e.g., force, dimensions) against engineering specifications.
• Biocompatibility Assay Results: Laboratory test outcomes (e.g., cell viability, chemical analysis) against established international standards (ISO 10993-1).

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" as this is not an AI or machine learning device. The design and manufacturing process for the physical device are based on established engineering principles and prior knowledge.

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

• Not applicable. See point 8.

In summary: The provided document is a 510(k) submission for a conventional medical device. The "acceptance criteria" are implied by the list of tests performed, which confirmed the device's functional integrity, dimensions, material properties, and biocompatibility, demonstrating its substantial equivalence to a predicate device. The "study" refers to the bench and biocompatibility testing conducted in a laboratory setting.

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The coaxial introducer set is indicated for use to introduce up to a 0.038 inch guide wire or catheter into the vascular systems following a small 21 gauge needle stick.

The proposed coaxial introducer set consists of an inner dilator within a slightly shorter outer sheath. The inner dilator is high density polyethylene and has length of approximately 4.5 inches. The outer sheath is also high density polyethylene and is approximately 3.5 inches long. The inner dilator and outer sheath are radiopaque so that they are visible under fluoroscopy. The hub on the inner dilator is high density polyethylene. The hub on the outer sheath is also high density polyethylene. The set may be 4F, 4.5F or 5F.

The kit contains a 21 gauge disposable aspiration and injection needle, a .018 inch diameter guidewire, and a Coaxial Introducer Set consisting of a sheath and dilator.

This document describes the MedAmicus Coaxial Introducer, a device intended to facilitate the introduction of guide wires or catheters into the vascular system. The information provided focuses on demonstrating substantial equivalence to predicate devices rather than proving a novel device's performance through extensive clinical studies and acceptance criteria as might be expected for a new technology with specific performance metrics. Therefore, the questions related to clinical study design, expert ground truth, effect size with AI, etc., are not directly applicable in the context of this 510(k) submission.

Here's an analysis based on the provided text, focusing on the available information regarding performance and equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present a formal table of acceptance criteria with specific quantitative thresholds that the device must meet, nor does it present detailed performance metrics as one might find in a clinical trial. Instead, it focuses on demonstrating equivalence to predicate devices through material similarity, manufacturing processes, and limited functional testing.

2. Sample Size for the Test Set and Data Provenance

• Bonding Strength Test: "All samples met the required specifications." The exact sample size is not stated, but it implies a sufficient number were tested to draw this conclusion. The data provenance is internal testing by MedAmicus.
• Biocompatibility Testing: Conducted on "MedAmicus' peelable sheath and dilator that uses identical material to that used in the Coaxial Introducer." The specific sample size for each biocompatibility test (e.g., number of animals for toxicity, number of cells for cytotoxicity) is not provided. The data provenance is internal testing, likely by a contract lab specializing in medical device biocompatibility.
• Sterilization Validation: Spore strips (one million spores of Bacillus var niger) were used in sample product. This refers to the biological indicator for sterilization validation, not patient data.

This submission is not a clinical study involving human patients, so there is no "test set" in that sense or data provenance related to patient cohorts.

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

Not applicable. This is a 510(k) submission focused on substantial equivalence to existing devices through material and performance comparisons, not a clinical study requiring expert review of patient data for ground truth.

4. Adjudication Method for the Test Set

Not applicable. There is no human-reviewed test set or clinical data requiring adjudication.

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

Not applicable. This is not a study comparing diagnostic accuracy or clinical outcomes of the device with and without AI assistance, nor does it involve multiple readers interpreting medical cases.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical medical instrument, not a software algorithm.

7. Type of Ground Truth Used

The concept of "ground truth" as typically used in medical device AI/diagnostic studies is not directly relevant here. Instead, the "truth" is established through:

• Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate devices (MedAmicus K932323 and Boston Scientific K974640).
• Material Equivalence: Verification that the materials used are identical or highly similar to those in already cleared devices, and pass specified biocompatibility tests.
• Functional Testing: Internal testing demonstrating physical properties (e.g., bonding strength) meet specifications and are comparable to predicate devices.
• Sterilization Validation: Adherence to established standards (AAMI method) for achieving sterility.

8. Sample Size for the Training Set

Not applicable. There is no "training set" as this is not a machine learning or AI-based device.

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

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

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The coaxial dilator is used for percutaneous introduction of 0.035 inch or 0.038 inch guide wires into the vascular system following a small 21 Ga. needle stick.

The coaxial dilator set consists of an inner, tapered dilator with a slightly shorter outer dilator.

This document is a 510(k) premarket notification for a Coaxial Dilator Set. It is not a study demonstrating the performance of an AI/ML device. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, or AI-specific metrics.

The document discusses substantial equivalence to predicate devices, packaging, sterilization, and general safety and effectiveness for a medical device that assists in introducing guidewires into the vascular system. It does not involve any AI/ML components or performance metrics that would require the establishment of ground truth by experts or comparative effectiveness studies.

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