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The MedAmicus FlowGuard Peelable Introducer in indicated for indications i or ooc. This modifines pacing leads or catheters in the venous system.

The McdAmicus FlowGuard™ Peelable Introducer is a small diameter tubular shaped device with integrated proximal handles. The FlowGuard 100 Peelable Introducer is designed to provide a relatively atraumatic method for implanting catheters and pacemaker leads into the venous system. The FlowGuard™ Peelable Introducer has a "tear-away" feature common to the predicate devices. This feature allows the user to remove the introducer without removing the inserted catheter or pacing lead. The MedAmicus FlowGuard" Peelable Introducer is packaged in three configurations: 1) a convenience kit containing a MedAmicus FlowGuard11M Peelable Introducer, a thin-wall needle, a disposable syringe, and a flexible guidewire, packaged in a tray and a sealed pouch. 2) individually pouched, sterile MedAmicus FlowGuard™ Peelable Introducer and 3) bulk, nonsterile MedAmicus FlowGuard™ Peclable Introducers.

This document describes a 510(k) premarket notification for the MedAmicus FlowGuard™ Peelable Introducer (K040150). This submission is for a material revision to the sheath handle of an already approved device (K030905). Due to the nature of this submission being for a minor change to an existing device, the studies conducted are primarily focused on verifying that the material change does not negatively impact the device's performance or safety.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission mentions "Design Verification of the device has been completed to verify the changes to the device." This implies various internal tests were conducted against pre-defined acceptance criteria. However, the specific quantitative acceptance criteria and the detailed results of these tests are not provided in the given text.

The text states: "Shelf Life testing, using accelerated aging, has been completed to verify that the new material will yield consistent handle integrity." This indicates an acceptance criterion related to handle integrity over time, but the specific metrics are not given.

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

The text does not specify the sample sizes used for the design verification or shelf-life testing. The data provenance is internal to MedAmicus, and the nature of the studies (design verification, shelf-life testing) suggests a prospective approach to test the modified device. There is no mention of country of origin for the data beyond the manufacturer's location in Minneapolis, MN, USA.

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

This information is not applicable as the studies described are engineering design verification and shelf-life tests, not clinical or diagnostic studies requiring expert-established ground truth. Device performance in these contexts is typically evaluated against engineering specifications and material properties, not subjective expert assessment.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3.

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. This type of study is typically performed for diagnostic or imaging devices to assess the impact of AI on human reader performance, which is not relevant for a catheter introducer with a material change.

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

No, a standalone (algorithm only) performance study was not done. This device is a physical medical instrument, not a software algorithm.

7. The Type of Ground Truth Used

The ground truth for the design verification and shelf-life testing would be engineering specifications, material properties, and established performance benchmarks for the predicate device. These are objectively measurable criteria, not expert consensus, pathology, or outcomes data, which are typically associated with diagnostic or therapeutic efficacy studies.

8. The Sample Size for the Training Set

This information is not applicable. There is no mention of a "training set" as this device is not an AI/ML algorithm requiring training data. The studies performed are for a physical device.

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

This information is not applicable for the same reasons as point 8.

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The MedAmicus FlowGuard™ Peelable Introducer indicated for use in the percutaneous insertion of pacing leads or catheters in the venous system.

The MedAnicus FlowGuard™ Peelable Introducer is a small diameter tubular shaped device with integrated proximal handles. The FlowGuard™ Peelable Introducer is designed to provide a relatively atraumatic method for implanting catheters and pacemaker leads into the venous system. The FlowGuard™ Peelable Introducer has a "teat-away" feature common to the predicate devices. This feature allows the user to remove the introducer without removing the inserted catheter or pacing lead. The MedAmicus FlowGuard™ Peelable Introducer is packaged in three configurations: 1) a convenience kit containing a MedAmicus FlowGuard 100 Peelable Introducer, a thin-wall needle, a disposable syringe, and a flexible guidewire, packaged in a tray and a sealed pouch. 2) individually pouched, sterile MedAmicus FlowGuard™ Peelable Introducer and 3) bulk, nonsterile MedAmicus FlowGuard™ Peelable Introducers.

This document describes the MedAmicus FlowGuard™ Peelable Introducer, a medical device used for the percutaneous insertion of pacing leads or catheters into the venous system. The submission is a 510(k) premarket notification for a modified packaging configuration of an already approved device.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a separate "test set" in the context of clinical performance evaluation for the device itself. The primary study mentioned is a "packaging validation."

• Sample Size: Not explicitly stated for the packaging validation.
• Data Provenance: The study is described as an internal packaging validation based on a risk analysis. No country of origin for data is mentioned, nor is it specified if it's retrospective or prospective, though a validation is typically prospective for new configurations.

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

Not applicable. The study described is a packaging validation and risk analysis, not a clinical study involving experts establishing ground truth for device performance in patients.

4. Adjudication Method for the Test Set

Not applicable, as there is no clinical test set requiring adjudication mentioned in the provided text.

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

No. An MRMC comparative effectiveness study was not done. The document focuses on a packaging change and its validation, not a multi-reader evaluation of clinical performance.

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

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

7. Type of Ground Truth Used

For the packaging validation, the "ground truth" would be the established safety and effectiveness parameters of the original device, against which the new packaging's impact is assessed through risk analysis and testing (e.g., sterility, package integrity, material compatibility).

8. Sample Size for the Training Set

Not applicable. This submission is for a physical medical device, not an AI or machine learning algorithm that requires a "training set."

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

Not applicable, as there is no training set for an algorithm.

Summary of the Study Discussed:

The primary "study" mentioned is a packaging validation. The purpose of this validation is to ensure that changing the device's packaging configurations (individually pouched and bulk non-sterile, in addition to the original convenience kit) does not negatively affect the safety and effectiveness of the MedAmicus FlowGuard™ Peelable Introducer.

• Methodology: The validation will be completed based on a Risk Analysis, following internal procedures compliant with European Standard EN1441:1998 Medical Devices - Risk Analysis. This risk analysis involved comparing the risks associated with the new packaging configurations against the currently approved convenience kit packaging.
• Outcome: The document states that the packaging validation will be completed and summarized in Section X of the submission, confirming that "no effect on the safety and effectiveness of the device" is expected.

The FDA's letter (K030905) indicates that the device was found to be substantially equivalent to legally marketed predicate devices. This determination was based on the information provided, including the intention to complete the packaging validation as described.

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The MedAmicus Axia RSN™ is intended to minimize needle stick injuries when used for percutaneous introduction of guidewires or other devices.

The MedAmicus Axia RSN™ is a single use device for percutaneous introduction of guidewires, or similar devices, up to 0.038 inches in diameter. The device is packaged as either sterile single units or as part of a kit. The device is designed with a shield as part of the safety needle mechanism to aid in the prevention of needle stick injuries. The needle of the device is retracted into the shield by pushing the button prior to removal of the device off the guidewire, or other device, and out of the body. After retraction, the shield covers the needle tip. The device is disposed of according to routine procedure in a sharps container.

The provided text describes a 510(k) premarket notification for a medical device called the MedAmicus Axia RSN™, a catheter introducer designed to minimize needle stick injuries. However, the document does not contain the specific information required to complete the requested table and answer the study-related questions for an AI/device performance evaluation.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (MedAmicus Axia RSN K020563) and highlights a material change in the new device. The "Summary of Studies" section only states that "Design Verification has been completed to ensure that the modified material does not affect the safety and effectiveness of the device." It refers to a Risk Analysis compliant with EN 1441, but does not provide any performance metrics, acceptance criteria, or details about patient data, experts, or ground truth that would be relevant to an AI-powered diagnostic or assistive technology.

Therefore, I cannot generate the requested table and answers based on the provided input. The document is for a traditional medical device (catheter introducer) and not an AI/software as a medical device (SaMD) that would typically have the kind of studies and performance data you are asking for.

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The MedAmicus Valved Peelable Introducer is intended for use in the percutaneous insertion of pacing leads or catheters in the venous system.

The MedAmicus Valved Peelable Introducer package consists of a thin-wall needle, a disposable syringe, and a flexible guidewire, packaged in a tray and a sealed pouch. Percutaneous introducers are small diameter tubular shaped devices with integrated proximal handles. The Valved Peelable Introducer is designed to provide a relatively atraumatic method for implanting catheters and pacemaker leads into the venous system. The Valved Peelable Introducer has a "tear-away" feature common to the predicate devices. This feature allows the user to remove the introducer without removing the inserted catheter or pacing lead. The Valved Peelable Introducer includes a sliding valve. When the valve is slid over the proximal end of the sheath, a device may be passed through the valve into the sheath, providing for reduced blood loss and reduced risk of air intake. The valve may be slid so that it is not covering the opening to the inner diameter of the sheath as well. The valve is constructed of a piece of silicon which snaps into a valve 'body' constructed of molded components.

Here's a breakdown of the acceptance criteria and study information for the MedAmicus Valved Peelable Introducer based on the provided text:

Acceptance Criteria and Device Performance

Study Information

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

• Test set sample sizes:
  • Valve Pressure Flowrate: 30 units
  • Valve Vacuum Flowrate: 29 units
  • Dilator Insertion Force: 29 units
  • Dilator Removal Force: 29 units
  • Catheter Insertion Force: 29 units
  • Valve Peeling Force: 29 units
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It implies internal testing by MedAmicus.

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

• This information is not provided. The study appears to be engineering/performance testing against specifications, rather than a clinical study requiring expert ground truth for interpretation of observational data.

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

• Not applicable. The tests are focused on quantifiable physical properties and performance against predefined engineering specifications, not on 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:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a medical introducer, not an AI diagnostic tool.

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

• Not applicable. This device is a physical medical device, not an algorithm. The testing described is "standalone" in the sense that it evaluates the device's physical performance independently.

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

• The ground truth consists of predefined engineering specifications and performance benchmarks (e.g., maximum force, minimum reduction percentage). These are derived from design requirements and potentially industry standards, not from clinical expert consensus, pathology, or outcomes data in the typical sense.

8. The sample size for the training set:

• Not applicable. This device is a physical medical device, not an AI model requiring a training set.

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

• Not applicable. As there is no AI model or training set, this question is not relevant.

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The MedAmicus Axia RSN™ is intended to minimize needle stick injuries when used for percutaneous introduction of guidewires or other devices.

The MedAmicus Axia RSN™ is a single use device for percutaneous introduction of guidewires, or similar devices, up to 0.038 inches in diameter. The device is packaged as either sterile single units or as part of a kit. The device is designed with a shield as part of the safety needle mechanism to aid in the prevention of needle stick injuries. The needle of the device is retracted into the shield by pushing the button prior to removal of the device off the guidewire, or other device, and out of the body. After retraction, the shield covers the needle tip. The device is disposed of according to routine procedure in a sharps container.

The provided document is a 510(k) summary for the MedAmicus Axia RSN™ catheter introducer. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.

Here's why and what information is missing based on your request:

Key Takeaway: The document explicitly states: "No new testing was performed for the device as the only change being made is to the Indications for Use. All testing previously summarized in K011085 remains applicable." This means the current submission (K020563) relies on studies conducted for a previous device (K011085) for its safety and effectiveness claims.

Therefore, for your specific questions, the answers are largely "Not applicable" or "Not provided in this document."

Here's a breakdown based on your requested information:

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

• Not provided in this document. The document does not define specific acceptance criteria for performance metrics (e.g., probability of needle stick injury, force required for retraction, number of successful retractions). It focuses on the change in "Indications for Use" for an existing device.

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

• Not provided in this document. Since no new testing was performed, this information would have been part of the previous 510(k) submission (K011085), which is not included here.

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/Not provided. The device is a physical medical device, not an AI or diagnostic application that typically relies on expert ground truth for evaluating performance. Its "performance" would likely be based on engineering benchmarks, user studies for safety features, and mechanical reliability.

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

• Not applicable/Not provided. This is relevant for image-based diagnostic AI, not for a physical medical device like a catheter introducer.

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 study type is specific to AI-assisted diagnostic tools. The MedAmicus Axia RSN™ is a physical medical device designed to reduce needle stick injuries, not to assist in interpreting diagnostic images.

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

• Not applicable. This question pertains to AI algorithm performance.

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

• Not applicable directly. For a safety needle, "ground truth" would likely relate to objective measurements of safety features (e.g., successful retraction rate, force to retract, accidental stick rate in simulated use). The document does not detail these.

8. The sample size for the training set

• Not applicable. This refers to AI model training data.

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

• Not applicable. This refers to AI model training data.

In summary: The provided document is a regulatory submission for a change in "Indications for Use" for an already cleared device. It explicitly states that no new testing was performed for this submission. All performance and safety data would be found in the referenced predicate device's 510(k) (K011085). Therefore, the specific details you requested regarding acceptance criteria and performance studies are not present in this document.

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The Percutaneous Introducer Set is intended for percutaneous introduction, manipulation, and removal of stimulation leads.

The Percutaneous Introducer Set is a single use device allowing for introduction, manipulation, and removal of stimulation leads after percutaneous entry is gained with a needle. The sheath is made of HDPE (High Density Polyethylene) with a HDPE hub. It is slightly tapered at the distal end to make a smooth transition to the dilator. The dilator is made of 304 stainless steel tubing tapered at the distal end for smooth insertion. It has a molded HDPE hub. The guidewire directional guide is made of 304 stainless steel wire with radiuses at each end. It has depth markings etched into the surface along the distal end.

This document, K013120, is a 510(k) summary for a Percutaneous Introducer Set. The device is intended for the introduction, manipulation, and removal of stimulation leads.

The document indicates that the device's substantial equivalence is based on its similarity to a predicate device, the MedAmicus Epidural Introducer (K994097), in terms of intended use, basic design, manufacturing methods, and materials.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document
does NOT list specific acceptance criteria with quantifiable metrics, nor does it provide a detailed table of reported device performance against such criteria.

Instead, it offers a general statement: "Performance data indicates that the Percutaneous Introducer Set meets the functional requirements and specifications for this device."

To infer potential "acceptance criteria" based on the provided information, we can consider the aspects of similarity to the predicate device and relevant material properties:

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

The document does not provide information on a specific "test set" with a defined sample size or data provenance (e.g., country of origin, retrospective or prospective). The submission relies on establishing substantial equivalence to a predicate device, and the "performance data" mentioned is a general statement, not a detailed study report.

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

This information is not provided in the document. The submission focuses on device equivalence rather than a study requiring expert-established ground truth for a test set.

4. Adjudication Method

This information is not provided in the document. As no specific test set or expert ground truth establishment is described, neither is an adjudication method.

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

A MRMC comparative effectiveness study was not performed or reported in this 510(k) submission. The document aims for substantial equivalence based on physical and functional characteristics, not on the impact of the device on human readers' performance with or without AI assistance.

6. Standalone Performance Study

A standalone (algorithm-only without human-in-the-loop performance) study was not performed or reported in this 510(k) submission. This is a medical device, not an AI/algorithm-based diagnostic tool. The "performance data" mentioned is a general statement about meeting functional requirements.

7. Type of Ground Truth Used

The concept of "ground truth" as typically used in the context of diagnostic performance studies (e.g., expert consensus, pathology, outcomes data) does not apply directly to this 510(k) submission. The "truth" for this submission is based on the demonstration of substantial equivalence to a legally marketed predicate device and the "identicality" of materials to those previously approved.

8. Sample Size for the Training Set

This information is not applicable and therefore not provided. This is not an AI/machine learning device that requires a training set.

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

This information is not applicable and therefore not provided. As there is no training set for an AI/machine learning model, there is no ground truth establishment for such a set.

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For percutaneous introduction, manipulation, and removal of epidural stimulation leads.

The MedAmicus Epidural Introducer is intended to be used in the same manner as the ANS (Neuromed) Introde INT-8 cleared by the FDA under K930242 and in a similar manner to the Coaxial Dilator manufactured by MedAmicus, Inc. and cleared by the FDA under K990705.

The provided text is a 510(k) submission for a medical device called the "MedAmicus Epidural Introducer." It describes the device, its intended use, and its substantial equivalence to predicate devices, leading to FDA clearance.

Crucially, this document does not include information about acceptance criteria, detailed studies proving device performance, sample sizes for test sets or training sets, ground truth establishment, or expert involvement as described in your request.

The submission focuses on demonstrating substantial equivalence to already cleared predicate devices based on intended use, materials, labeling, method of operation, and manufacturing methods. This type of submission relies on the prior approval of the predicate devices rather than new, extensive performance studies for the new device.

Therefore, I cannot provide the requested information from the given text. The text explicitly states:

"MedAmicus believes the MedAmicus Epidural Introducer is safe and effective based on substantial equivalence to the predicate MedAmicus and ANS Introducer Sheaths. The intended use, materials, labeling, method of operation and manufacturing methods are substantially equivalent."

This indicates that the "proof" for meeting acceptance criteria is the argument of substantial equivalence, not a new clinical or performance study with detailed metrics, sample sizes, or expert panels.

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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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