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These dilators are used for the percutaneous introduction of guidewires into the peripheral vasculature.

The dilator introducer consists of a tipped radiopaque tube with a molded hub that accepts up to a .038-inch guidewire

The provided text is a 510(k) premarket notification for a medical device (Sterile Dilator) and focuses on establishing substantial equivalence to predicate devices based on non-clinical performance testing. It does not contain information about AI/ML algorithm performance, human reader studies, or image-based diagnostic applications. Therefore, I cannot provide details on:

• Acceptance criteria related to algorithm performance (e.g., sensitivity, specificity, AUC).
• Sample sizes for algorithm test sets (image data).
• Data provenance for AI/ML models.
• Number of experts for ground truth establishment in an AI context.
• Adjudication methods for AI ground truth.
• MRMC comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth (e.g., pathology, outcomes data).
• Training set sample size or how ground truth was established for training data.

The document discusses acceptance criteria and studies related to the physical and mechanical performance of the Sterile Dilator itself, ensuring it is equivalent to the predicate devices for its intended use (percutaneous introduction of guidewires).

Here's the information that can be extracted regarding the physical device's performance testing:

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

The document presents performance testing conducted on the Galt sterile dilators.

2. Sample sizes used for the test set and the data provenance

The document does not specify exact sample sizes (N numbers) for each physical/mechanical test. It generally states a qualitative "All sampled dilator sizes" or "Test article."

• Data Provenance: The tests were conducted to evaluate the Galt sterile dilators against pre-defined product specifications, which were based on existing predicate devices (K172487, K153533, K173287). The context implies these are laboratory-based, non-clinical tests. No country of origin for test data is mentioned, but the manufacturer is Galt Medical Corporation, Garland, TX, USA. The study design is implied to be prospective testing for device validation rather than retrospective data analysis.

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

This concept is not applicable to the non-clinical, physical/mechanical testing described. Ground truth for these tests is established by engineering specifications, material properties, and standardized testing protocols (e.g., tensile strength, dimensional measurements, particulate levels). No human expert interpretation of results (like in an AI imaging study) is mentioned or implied beyond standard laboratory personnel conducting and verifying tests.

4. Adjudication method for the test set

Not applicable. The tests are objective quantitative measurements or visual inspections against predetermined engineering specifications, not subjective assessments requiring expert consensus or 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

Not applicable. This is not an AI/ML device or a diagnostic device involving human readers or image interpretation.

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

Not applicable. This is not an AI/ML algorithm.

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

The "ground truth" for the device's performance is based on established engineering specifications, mechanical test standards, and equivalence to the performance of predicate devices as measured through physical and simulated use tests. For example:

• Dimensional: Measured dimensions compared against specified ranges derived from predicate devices.
• Mechanical: Measured tensile strength compared against minimum force requirements.
• Particulate: Measured particulate levels compared against acceptable limits derived from predicate device performance.
• Simulated Use: Measured insertion force compared against a specified percentage (≤ 20%) of the predicate's force.
• Packaging: Visual inspection and performance against established packaging integrity standards (ISTA 2A-2011).

8. The sample size for the training set

Not applicable. This is not an AI/ML model that requires a training set.

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

Not applicable. There is no training set for an AI/ML model.

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The GaltTWS Stylet is a percutaneous catheter stylet placed inside a catheter, lead, or cannula to stiffen the device for placement or extraction.

The GaltTWS stylet is comprised of a stainless steel twisted/braided wire of varying diameters (0.012-0.015 inch), and varying length (30-72cm). The GaltTWS stylet can be configured as a Twisted/Braided wire bonded to a hub, flushable hub, or connected to a flushable adjustable hub using the Galt Gateway Hemostasis Valve (K152528).

This document is a 510(k) premarket notification decision letter for a medical device called the "GaltTWS Stylet." As such, it does not contain the information requested regarding acceptance criteria and the study proving the device meets those criteria in the context of an AI/ML-based medical device.

The requested information (acceptance criteria for AI performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, etc.) is specific to studies proving the performance of AI/ML algorithms. This FDA letter pertains to a non-AI medical device (a catheter stylet) and focuses on demonstrating substantial equivalence to predicate devices through bench testing and biocompatibility.

Therefore, I cannot fulfill the request using the provided text. The document describes:

• Device: GaltTWS Stylet (a percutaneous catheter stylet)
• Purpose: Stiffen a catheter, lead, or cannula for placement or extraction.
• Regulatory Pathway: 510(k) for substantial equivalence.
• Testing: Bench testing (Particulate, Mechanical Properties, Leak, Tortuous Path) and Biocompatibility testing (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Hemolysis, Pyrogen, EO Residuals).
• Conclusion: Device is substantially equivalent to marketed predicate devices.

This information is relevant to traditional medical device clearance, not the evaluation of AI/ML performance.

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The Galt Medical Corp Elite HV Radial is indicated to facilitate placing a catheter through the skin into a vein or artery including but not limited to the radial artery.

The Galt Medical Corp Elite HV product has been on the market since February of 2005, and was cleared under 510(k) K043525. The clearance included sizes from 4-9FR, and lengths from 5-110 cm with the following indication for use: The Sheath Introducer system is indicated for use in percutaneous procedures to introduce catheters and other intravascular devices into the vasculature. The purpose of this 510(k) is to expand that indication for use for the Elite HV products to include radial placement. There were no design changes required as the current Galt offering included sizes which are appropriate for radial placement. The only limitation of the Radial placement claim is that the range of sizes is more limited due to the target anatomy. The Elite HV and Elite HV Radial consists of an introducer (valved sheath with sidearm and stopcock and dilator), which are packaged together with a guide wire. The Elite HV product is configured with a silicone valve or a TPE valve cleared under 510(k) K152528. Some product configurations also include an entry needle, guide wire inserter and a flushing syringe. The Elite HV Radial is used to facilitate placing a catheter through the skin into a vein or artery including but not limited to the radial artery. The sheath is coated with hydrophilic coating to minimize frictional resistance when inserting or removing the sheath from the patient's blood vessel. In addition, the sheath and dilator contain barium sulfate, making these devices visible under fluoroscopy.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Galt Medical Corp. Elite HV Radial device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantitative acceptance criteria for each test. Instead, it describes what types of tests were performed to establish substantial equivalence. It implies that the results of these tests demonstrated substantial equivalence to the predicate device, which is the primary "acceptance criterion" for a 510(k) submission.

Therefore, the table will reflect the types of tests performed and the conclusion reached regarding substantial equivalence.

• Particulate Test
• Mechanical Properties Test
• Lubricity Test
• Durability of coating
• Dimensional comparison test
  Accelerated aging to an equivalent age of 4 years was also performed, and the functional testing was repeated, with the implication that results remained acceptable. The submission concludes: "The technological differences between the subject device and predicate device have been evaluated through bench and biocompatibility tests to provide evidence of substantial equivalence." |
  | Biocompatibility: Device materials are safe for human contact. | Biocompatibility Testing Results: Performed in accordance with ISO 10993-1, including:
• Cytotoxicity (MEM Elution)
• Sensitization (Magnusson - Kligman)
• Irritation (Intracutaneous injection)
• Systemic Toxicity (Systemic injection)
• Hemolysis (Direct Contact)
• Hemocompatibility (Complement Activation)
• In-Vitro Hemocompatibility (Dog Thrombogenicity)
• Systemic Toxicity (Materials Mediated Pyrogen)
• EO Residuals (EO, ECH, & EG)
  This was done "to update the biocompatibility testing to current standards" and the conclusion of substantial equivalence implies these tests were met. |
  | Sterilization Efficacy: Device is effectively sterilized. | Sterilization Efficacy: The subject device was "adopted into the existing ethylene oxide sterilization cycle for the Galt product cleared under K043525 & K152528." This implies the cycle is validated and effective for the new device. |
  | Shelf-Life Stability: Device maintains integrity over shelf life. | Shelf-Life Stability: "Current packaging shelf life testing was provided in the predicate submission." This indicates reliance on previous validation, implying stability for the Elite HV Radial in its unchanged packaging. |
  | Safety and Effectiveness: No new questions regarding safety and effectiveness are raised by the differences to predicate devices. | Conclusion: "It will be shown in this 510(k) submission that the differences between the Galt Elite HV Radial and the predicate devices do not raise any new questions regarding safety and effectiveness. The Galt Elite HV Radial as designed and manufactured is determined to be substantially equivalent to the current marketed predicate device." |

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

The document describes bench testing and biocompatibility testing. It does not specify a "test set" in terms of patient data.

• Sample Size for Functional/Biocompatibility Tests: The document does not provide specific sample sizes (e.g., number of devices tested for particulate, mechanical properties, etc.). It only mentions that testing was conducted "according to protocols based on international standards and Galt Medical requirements."
• Data Provenance: The data provenance is from bench laboratory testing and in vitro biocompatibility studies, not human patient data. There is no mention of country of origin for the data as it's not clinical data. It is inherently retrospective in the sense that the testing was performed, and then the results were compiled for the 510(k) submission.

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

• This question is not applicable to this submission. The "ground truth" for this type of device (a medical introducer) in a 510(k) context is established through compliance with recognized standards (e.g., ISO for biocompatibility, internal engineering specifications for functional tests). There isn't a "ground truth" established by human experts in the same way an AI diagnostic device would have radiologists establishing ground truth for images. The "experts" involved would be the engineers, toxicologists, and quality assurance personnel who designed the tests, conducted them, and interpreted the results against established standards.

4. Adjudication Method for the Test Set

• This question is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies where multiple human readers interpret data (e.g., medical images) and their disagreements need to be resolved. For bench testing and biocompatibility, the results are typically quantitative or qualitative (pass/fail) based on pre-defined criteria in the test protocols and standards.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where the AI assists human readers. The Elite HV Radial is a physical medical device (catheter introducer) and does not involve AI or human interpretation in its function.

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

• No, a standalone performance study was not done. This term also applies to AI algorithms. The Elite HV Radial is a physical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance in the context of the 510(k) submission is derived from:

• Compliance with International Standards: e.g., ISO 10993-1 for biocompatibility.
• Internal Engineering Specifications/Requirements: Derived from design control processes and the intended function of the device, often benchmarked against predicate device performance.
• Predicate Device Performance: The underlying assumption of the 510(k) pathway is that the predicate device is safe and effective when used as labeled. By demonstrating "substantial equivalence," the new device inherits this established "ground truth" of safety and effectiveness.

8. The Sample Size for the Training Set

• This question is not applicable as there is no "training set" in the context of a physical medical device. This term is used for machine learning models.

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

• This question is not applicable as there is no "training set" for this device.

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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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Tearaway introducer sheath: These introducers are used for the percutaneous introduction of diagnostic or therapeutic devices, such as catheters and pacing leads, into the vasculature.

MicroSlide™ Tearaway introducers are used for the procedures to introduce catheters and other intravascular devices into the coronary and peripheral vasculature of adult and pediatric patients of all ages.

The Galt Medical Tearaway Introducer Sheath assembly consists of an outer peelable sheath and a dilator. The tear-away sheath has a winged hub to initiate the tear in the sheath. The design of the tearaway introducer sheath is unchanged from the current line of Tearaway Introducer Sheaths (K000313), and the pediatric version MicroSlide™ Tearaway Introducer (K123430). The subject and current marketed predicate devices are identical with the exception of the material used in the sheath hub.

The provided text is a 510(k) premarket notification for a medical device called the "Tearaway Introducer Sheath and MicroSlide Tearaway Introducer." The purpose of this submission is to demonstrate that the device with a new hub material is substantially equivalent to previously marketed predicate devices.

Acceptance Criteria and Study for the Device:

The core of this submission revolves around demonstrating that changing the hub material of an already cleared device does not negatively impact its safety and effectiveness. Therefore, the "acceptance criteria" are essentially the established performance specifications of the predicate devices. The study conducted is a series of non-clinical tests to show that the new device meets these specifications.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a formal table of "acceptance criteria" with explicit numerical targets, but rather lists the functional tests performed to demonstrate substantial equivalence to the predicate devices. The "reported device performance" is implied to have met these predicate device specifications, as the conclusion states substantial equivalence.

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

The document does not specify the exact sample sizes (e.g., number of units tested) for each non-clinical test. It only states that functional testing was conducted on "aged product."

• Sample Size: Not specified.
• Data Provenance: The tests were conducted internally by Galt Medical Corporation ("Galt Medical requirements") according to protocols "based on international standards." This indicates that the data is from prospective testing performed by the manufacturer to support this specific 510(k) submission. There is no indication of country of origin of the data beyond the manufacturer being in the USA.

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

This is a non-clinical device submission focused on performance and material equivalence. Therefore, there are no "experts" in the clinical sense (e.g., radiologists) used to establish ground truth. The "ground truth" for the test set is established by recognized international standards and the performance specifications of the predicate devices. The expertise involved would be in engineering, materials science, and testing methodology, likely performed by the manufacturer's qualified personnel.

4. Adjudication Method for the Test Set:

Not applicable. This is not a study requiring human interpretation or adjudication for the test set. The tests are objective, measurable physical and chemical properties.

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

No. This is a non-clinical submission for a physical medical device. MRMC studies are typically for diagnostic imaging devices or software.

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 a software algorithm.

7. The Type of Ground Truth Used:

The ground truth used for these non-clinical tests is based on:

• Device specifications: Established performance parameters for the device (e.g., specific force values for hub break, dimensional tolerances).
• International standards: Adherence to relevant ISO or other recognized standards for medical device testing.
• Predicate device performance: The performance of the previously cleared Galt Tearaway Introducer Sheath (K000313) and Galt MicroSlide™ Tearaway Introducer (K123430) serves as the benchmark.

8. The Sample Size for the Training Set:

Not applicable. There is no "training set" as this is not an artificial intelligence/machine learning device. The "training" for the device, in a manufacturing sense, would be the established manufacturing process and quality control, which is addressed by the quality system regulation (21 CFR Part 820).

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

Not applicable. As there is no training set as understood in AI/ML, there's no ground truth established for it in that context.

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The Attachable Cath Lab Hemostasis Valve is indicated to minimize blood loss during the introduction of catheters, guidewires and other intravascular devices into the vasculature.

The Galt Medical Attachable Cath Lab Hemostasis Valve assembly consists of a molded hub with an integrated hemostasis valve, sideport tubing with 3 way stopcock. The design of the Attachable Cath Lab Hemostasis Valve is derived directly from the current line of Galt Medical Cath Lab Introducer Sheath (K043525). The subject and predicate device are both have an integrated hemostasis valve, and side port tubing with stopcock.

The provided text describes a 510(k) submission for a medical device, the "Attachable Cath Lab Hemostasis Valve." However, it does not detail a study that proves the device meets specific acceptance criteria in the manner typically associated with AI/CADe devices, which would involve metrics like sensitivity, specificity, or AUC, established through a rigorous ground truth determination process.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics and functional testing. The "acceptance criteria" here are essentially the performance specifications, and the "study" is the non-clinical functional testing performed.

Here's an analysis based on the information provided:

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

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

   • Sample Size: Not explicitly stated as a number of units tested. The functional testing states it was performed on "4-year aged product," implying a set of devices and potentially new devices.
   • Data Provenance: The functional testing was conducted by Galt Medical Corp. on their own manufactured devices. The text does not specify the country of origin of the data beyond being from the manufacturer's internal testing. It is prospective in the sense that the testing was performed for this submission.

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

   • This question is not applicable in the context of this device and submission type. The "ground truth" for these functional tests is the defined engineering specification (e.g., 7 PSI pressure withstand). The tests themselves are designed to objectively measure whether the device meets these specifications, not to interpret complex medical data requiring expert consensus.

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

   • This is not applicable as the tests are objective functional measurements against engineering specifications, not subjective interpretations requiring 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

   • This is not applicable because the device is a physical medical instrument (hemostasis valve), not an AI/CADe system.

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

   • This is not applicable as the device is not an algorithm or AI system.

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

   • The "ground truth" for the non-clinical functional tests is derived from engineering specifications and established performance standards relevant to the function of such a valve (e.g., ability to withstand a certain pressure, secure insertion of guidewires, pull force thresholds). For biocompatibility and sterilization, the ground truth refers to meeting pre-defined biological safety standards and sterility assurance levels.

8. The sample size for the training set

   • This is not applicable as the device is a physical medical instrument and does not involve AI or machine learning models that require a training set.

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

   • This is not applicable as there is no training set for this type of device.

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The introducer system is intended for use in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature.

The finished device is a valved tear-away introducer for use in percutaneous procedures to introduce or position catheters or other interventional devices into the peripheral vasculature. The unmodified predicate introducers are constructed using identical processes and material with the exception of the subject device was modified to add a new valve design and material. The performance characteristics to the current marketed predicate device are unchanged and are consistent with other legally marketed devices.

The provided text is related to a medical device's 510(k) submission, specifically for the Galt Medical Corp. VTI Valved Tearaway Introducer. This document outlines the regulatory approval process and demonstrates substantial equivalence to a predicate device, focusing on functional testing rather than clinical study results involving human readers or AI.

Therefore, many of the requested categories in the prompt regarding AI, human readers, ground truth, and training data are not applicable to this type of document. The information provided is primarily about the physical and functional performance of the device itself.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document refers to "product specifications" and "protocols based on international standards and Galt Medical requirements" but does not explicitly list the specific quantitative acceptance criteria or detailed numerical results for each test. Instead, it states that the device "met product specifications."

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

• Test Set Sample Size: Not explicitly stated. The document mentions "Functional testing on un-aged and 4 year aged product," implying a set of physical devices were tested.
• Data Provenance: Not specified, but generally, such functional and physical tests are conducted in a controlled laboratory environment by the manufacturer (Galt Medical Corp.) in the US (Garland, TX). The study is retrospective in the sense that the testing has already been completed and the results are being submitted for regulatory review, but it's a prospective test of the device's characteristics against its specifications.

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

• Not Applicable. This is a physical device, and the "ground truth" for its performance is established by standardized functional tests and measurements, not by expert interpretation of data like in an AI or diagnostic study.

4. Adjudication method for the test set:

• Not Applicable. As per point 3, there's no "adjudication" in the sense of resolving discrepancies in expert interpretations. The tests have clear pass/fail criteria based on objective measurements.

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 catheter introducer, not a diagnostic AI system or a system that assists human readers.

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.

7. The type of ground truth used:

• Physical device measurements and established engineering/performance standards. The "ground truth" is whether the physical device can perform its intended functions (e.g., locking, not leaking, ease of use, biocompatibility) according to predefined specifications and regulatory requirements.

8. The sample size for the training set:

• Not Applicable. There is no "training set" in the context of this device's functional testing. This is not an AI/machine learning product.

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

• Not Applicable. Same as point 8.

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The MicroSlide™ Tearaway Introducer System is intended for use in percutaneous procedures to introduce catheters and other intravascular devices into the coronary and peripheral vasculature of adult and pediatric patients of all ages.

The MicroSlide™ Tearaway Introducer is constructed using identical processes and materials as the predicate devices; Tearaway Introducer Sheath, Galt Medical, K000313 with the addition of smaller sizes 2 & 3French, and the Galt VTI™ Valved Tear-away Introducer, K112398 without the hemostasis valve.

The MicroSlide™ Tearaway Introducer device consists of two components; a dilator and an outer sheath. The outer sheath is a one piece, molded hub/sheath "tearaway" design that with minimal force will break and separate at the hub/wing to facilitate the removal of the sheath tube from the patient by peeling/splitting the tub longitudinally down its length. The dilator tube is an open plastic tube with an integral molded luer hub for guidewire insertion. The dilator is longer than the outer sheath with a tapered distal tip. The sheath hub and dilator hub lock together using a rotating motion to add in insertion of the device into the vasculature.

The provided document describes the MicroSlide™ Tearaway Introducer, a medical device for introducing catheters and other intravascular devices. The document outlines substantial equivalence to predicate devices based on functional testing and other characteristics.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the performance specifications of the subject device and compared against predicate devices. The document explicitly lists performance specifications under the "Performance Specifications" row in the comparison table on page 2.

Study Proving Acceptance Criteria:

Functional testing was conducted to verify that the 2F & 3F MicroSlide™ Tearaway Introducer met product specifications. The document states: "Functional testing was conducted to verify that the 2F & 3F MicroSlide™ Tearaway Introducer met product specifications. Testing was conducted according to protocols based on international standards and Galt Medical requirements." (Page 3)

The functional tests included:

• Penetration (Insertion) Force Test Ref. XE-022
• Sheath Peel Force Test - Ref. XE-022
• Sheath Perpendicular Pull Test- Ref. XE-022
• Dilator Pull Test- Ref. XE-022

Additionally, sterilization validation, biocompatibility testing, and packaging/product shelf-life testing were performed to ensure the device's safety and effectiveness.

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

The document does not specify the exact sample sizes used for each functional test (e.g., number of devices tested for insertion force). It broadly states that "Functional testing was conducted to verify that the 2F & 3F MicroSlide™ Tearaway Introducer met product specifications." (Page 3)

The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective. However, since the studies are described as "Functional testing" and "Biocompatibility testing" performed by Galt Medical and its contractors, it implies prospective, in-house testing rather than data from real-world usage or external retrospective studies.

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

This information is not applicable to this type of device and study. The testing described is functional and performance-based, not diagnostic, and therefore does not rely on expert interpretation of results to establish "ground truth" in the way a diagnostic AI device would. The "ground truth" here is the physical measurement of the device's performance against predefined engineering specifications.

4. Adjudication Method for the Test Set

This information is not applicable for the type of device and study. The tests involve objective physical measurements rather than subjective assessments requiring 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

This information is not applicable. The device is a physical medical instrument (catheter introducer), not an AI-powered diagnostic tool, so an MRMC study is not relevant.

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

This information is not applicable. The device is not an algorithm or AI system. Its performance is inherent to its physical design, materials, and manufacturing process.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance specifications is based on engineering specifications and established performance ranges of legally marketed predicate devices. For example, the hub break force acceptance criterion of "2.0 lbs - 5.5 lbs" is derived from the performance of the predicate devices. The functional tests directly measure physical properties, and the results are compared to these pre-defined numerical thresholds.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical instrument and does not involve a "training set" in the context of machine learning or AI.

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

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

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The Galtstick™ Introduce system is indicated for percutaneous introduction and place of catheters and guidewires.

The Galtstick™ device adds a stiffening cannula with an attached hub for ease of insertion into the body.

The provided text is related to a 510(k) premarket notification for a medical device called the "Galtstick™ Introducer System." This document is a letter from the FDA to Galt Medical Corporation, notifying them that their device has been found substantially equivalent to a legally marketed predicate device.

This document does not describe acceptance criteria for device performance or a study proving that the device meets such criteria.

The content relates to regulatory clearance based on substantial equivalence to a predicate device, rather than a performance study with defined acceptance criteria and results. The information provided is primarily administrative and regulatory. Therefore, I cannot extract the requested information about acceptance criteria and a study from this document.

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The Sheath Introducer system is indicated for use in percutaneous introduction of catheters and other intravascular devices into the vasculature.

The materials of construction are consistent with introducers presently in Device Description. The product is available in 4 French to 9 French. The sheath lengths are 5cm to 110cm.

This document describes a 510(k) premarket notification for a Catheter Introducer. The information provided heavily focuses on substantial equivalence to predicate devices rather than a direct performance study with acceptance criteria.

The acceptance criteria described in the document are implicitly based on demonstrating that the Galt Medical Catheter Introducer is "substantially equivalent" to predicate devices. This means that its functionality and performance should be comparable to these existing, legally marketed devices.

Based on the provided text, there is no explicit statement of numerical acceptance criteria (e.g., minimum accuracy, sensitivity, or specificity thresholds) that would typically be seen for a device that relies on a direct performance evaluation against a defined ground truth. Instead, the "acceptance criteria" are met by demonstrating equivalence through non-clinical testing and shared technological characteristics and indications for use.

Here's an attempt to structure the information based on the request, acknowledging the limitations of the provided text for certain categories:

Acceptance Criteria and Device Performance

Study Proving Acceptance Criteria:

The study that proves the device meets the (implicit) acceptance criteria is a non-clinical comparative testing program and a review of technological characteristics against predicate devices.

Detailed Breakdown of Study Information:

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

   • Test Set Sample Size: Not explicitly stated. The tests mentioned are "tensile strength, and valve leakage," which would involve a certain number of manufactured units of the Galt Medical Catheter Introducer. However, the specific quantity is not reported.
   • Data Provenance: The tests were performed on the Galt Medical Catheter Introducer itself. There is no mention of external data or specific countries of origin beyond the company's location (Garland, TX). These were likely prospective tests performed on newly manufactured devices.

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

   • Not Applicable / Not Mentioned. For a device demonstrating substantial equivalence through non-clinical testing (tensile strength, valve leakage), "experts" for ground truth in the traditional sense (e.g., clinical diagnosis) are not required. The "ground truth" would be objective measurements of physical properties compared against established benchmarks or predicate device performance.

3. Adjudication method for the test set:

   • Not Applicable / Not Mentioned. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation (e.g., imaging, pathology). For non-clinical tests measuring physical properties, the results are quantitative and do not require expert adjudication to establish a "ground truth" among differing opinions.

4. 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. This is not an AI/imaging device. No MRMC study was conducted.

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

   • No. This is not an AI/algorithm device.

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

   • The "ground truth" for the non-clinical tests (tensile strength, valve leakage) would be objective physical measurements and engineering specifications for the device, benchmarked against the predicate devices' known performance or industry standards. It's not a clinical "ground truth" in the sense of diagnosis or patient outcomes.

7. The sample size for the training set:

   • Not Applicable. This is a physical medical device, not a machine learning model. There is no "training set."

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

   • Not Applicable. As there is no training set, this question is not relevant.

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