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

The Enpath Medical PTFE Peelable Introducer kit consists of a disposable needle, a disposable syringe, a guidewire, and a peelable introducer set consisting of a dilator and sheath with integrated proximal handles. The Introducer is available in various lengths in 3.5F through 7F (micro) and 7F through 16.5F (macro). The dilator is designed to be delivered over a 0.018" guidewire (micro) up to a 0.038" guidewire (macro). The dilator and hub is constructed of high density polyethylene. The outer sheath and handle is constructed of PTFE and TPX. The inner dilator and outer sheath are radiopaque so that they are visible under fluoroscopy. The hub of the dilator has a spin lock design that connects to the luer of the sheath when rotated. The Percutaneous Introducer sheath has a "tear-away" feature which allows the user to remove the sheath without removing the inserted catheter or pacing lead. The kit is packaged in a tray and placed into a poly-Tyvek pouch and sealed.

Here's an analysis of the provided text regarding the acceptance criteria and study for the PTFE Peelable Introducer:

This document is a 510(k) summary for a medical device seeking substantial equivalence to a predicate device. It focuses on non-clinical testing for equivalence rather than establishing new clinical effectiveness or performance criteria for a novel device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. The document states "Performance Testing: The performance testing for this device included testing to verify that the device continues to functions in a safe and effective manner." This implies a physical testing or engineering study, not a clinical trial with human subjects.
• Data Provenance: The testing was "non-clinical." This means it was likely laboratory or bench testing performed by the manufacturer, Enpath Medical, probably in the US where the company is based. It is retrospective in the sense that it's based on internal validation against predefined specifications rather than a prospective trial with patient enrollment.

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

• Not Applicable. As this was non-clinical performance testing, there was no "ground truth" to be established by clinical experts in the traditional sense. The "ground truth" was likely the engineering specifications and performance characteristics of the predicate device.

4. Adjudication Method for the Test Set

• Not Applicable. There was no human reading or interpretation of results that would require an adjudication method. The testing involved objective measurements against specifications.

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

• No. The document explicitly states: "Summary of Clinical Testing: No clinical evaluations of this product have been performed." Therefore, no MRMC study was conducted.

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

• Not Applicable. This is a physical medical device (an introducer kit), not an AI algorithm or software. Therefore, the concept of "standalone performance" for an algorithm does not apply. The performance assessed was the physical device itself.

7. Type of Ground Truth Used

• Engineering Specifications / Predicate Device Characteristics. For the non-clinical testing, the ground truth was the established engineering specifications for the device and the performance characteristics of the predicate device (Enpath Medical, Inc. Percutaneous Introducer K000824). The goal was to show the new device met its own specifications and performed equivalently to the predicate.

8. Sample Size for the Training Set

• Not Applicable. There was no "training set" as this device is not an AI/ML algorithm. The testing involved physical device samples.

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

• Not Applicable. As there was no training set, this question is irrelevant. The "ground truth" for the non-clinical testing (not training) was based on established engineering standards and comparison to a legally marketed predicate device.

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

The ViaPeel Peelable Introducer will be available in 3.5F through 7F (micro), and 7F (macro) in lengths of 5cm or 10cm. The sheath handles are color coded for identification of French size. The locking configuration has been modified on the sheath and dilator to an annular snap fit. The dilator will lock into the hub without the use of a rotating collar allowing the user to lock and secure the dilator to the sheath.

Here's a breakdown of the acceptance criteria and study information for the ViaPeel™ Peelable Introducer, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

The summary does not provide details on the specific sample sizes used for the non-clinical performance testing. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) for any of the non-clinical tests. Since no clinical studies were performed, there is no clinical test set.

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

Since no clinical studies were performed, there was no ground truth established by experts for a clinical test set. The non-clinical performance testing would have relied on engineering and quality assurance standards, not expert medical consensus on patient outcomes.

4. Adjudication Method for the Test Set

As there was no clinical test set involving human judgment, there was no adjudication method described. The non-clinical tests would involve repeatable measurements and objective criteria rather than expert adjudication.

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

No MRMC comparative effectiveness study was performed. The summary explicitly states: "No clinical evaluations of this product have been performed." Therefore, there is no information on how much human readers might improve with or without AI assistance, as AI is not part of this device.

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

No standalone study was performed as this device is a physical medical instrument (introducer) and does not involve an algorithm or AI.

7. Type of Ground Truth Used

For the non-clinical performance testing, the "ground truth" was established by engineering specifications, functional requirements, and material biocompatibility standards. These are objective, measurable criteria rather than expert consensus, pathology, or outcomes data in the typical sense for a diagnostic or AI device.

8. Sample Size for the Training Set

Since no AI or algorithm is involved, there was no training set for this device. The development process would have involved design, prototyping, and testing of physical units.

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

Not applicable, as there was no training set.

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The Stiffer Coaxial Micro-Introducer Kit 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 Coaxial Micro-Introducer Kit contains a 21 gauge disposable aspiration and injection needle, a 0.018 inch diameter guidewire, and a coaxial micro-introducer set consisting of a dilator and sheath available in 4F, 4.5F, or 5F.

The modified device contains the same kit configuration as above except that the dilator and sheath are available in 4F or 5F. The inner dilator includes a stainless steel stiffening hypotube. The inner and outer dimensions of the dilator remain the same as the currently marketed Coaxial Micro-Introducer Kit.

The Enpath Medical, Inc. Stiffer Coaxial Micro-Introducer Set (K071574) did not provide traditional acceptance criteria with quantitative performance metrics in the provided document. This submission is for a medical device that introduces a guidewire/catheter, not an AI/ML powered diagnostic device, so the typical AI/ML powered diagnostic study information is not applicable.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device through performance testing and biocompatibility testing.

Here's an interpretation 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 sample sizes for the performance or biocompatibility testing. These tests are typically conducted on a small number of devices or material samples, as appropriate for non-clinical testing of a physical medical device.
• Data Provenance: The data is generated from non-clinical testing conducted by the manufacturer, Enpath Medical, Inc., presumably at their facilities. There is no mention of country of origin of data in a geographic sense, as it is laboratory testing. It is inherently prospective in the sense that the new device was manufactured and then tested.

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

• This information is not applicable to this type of device submission. Ground truth, in the context of diagnostic devices, usually refers to clinical diagnoses or pathology reports. For this introducer set, the "ground truth" is adherence to engineering specifications and performance standards through physical and material testing. The experts involved would be engineers and material scientists performing the tests and comparing results to established standards or predicate device performance. Their qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

• This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic devices, to resolve disagreements among human readers or expert reviewers. For non-clinical performance and biocompatibility testing of a physical device, results are typically objective measurements or observations against predefined criteria, not subject to subjective adjudication in this manner.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of images or data, often comparing AI-assisted performance against unaided human performance. The Stiffer Coaxial Micro-Introducer Kit is a physical device, and its safety and effectiveness are assessed through non-clinical performance and biocompatibility testing, not through MRMC studies.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• No, a standalone (algorithm only) performance study was not done. This concept is entirely irrelevant for a physical medical device like an introducer set, which does not involve an algorithm or artificial intelligence.

7. The Type of Ground Truth Used

• The "ground truth" for this device's evaluation is primarily:
  • Engineering specifications and design requirements: The device's physical dimensions, materials, and functional characteristics are designed to meet specific criteria.
  • Performance standards: The device is tested to ensure it performs its intended function (e.g., smoothly introducing a guidewire/catheter, maintaining integrity under stress).
  • Biocompatibility standards: Materials are tested to ensure they are safe for contact with the body.
  • Predicate device characteristics: The new device's performance, dimensions, and materials are compared to the legally marketed predicate device (Enpath Medical, Inc. Coaxial Micro-Introducer Set K990705) to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

• This information is not applicable. "Training set" refers to data used to train an AI/ML algorithm. This device is a physical product and does not involve AI/ML.

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

• This information is not applicable, as there is no AI/ML training set for this device.

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The Enpath ViaSeal Valved Peelable Introducer is indicated for use in the percutaneous insertion of pacing leads or catheters in the venous system.

The Enpath ViaSeal Valved Peelable Introducer is a small diameter tubular shaped device with integrated proximal handles. The ViaSeal Valved Peelable Introducer is designed to provide a relatively atraumatic method for implanting catheters and pacemaker leads into the venous system while providing hemostatic sealing to venous pressures. The ViaSeal Valved Peelable Introducer has a "peel-away" feature common to the predicate device. This feature allows the user to remove the introducer without removing the inserted catheter or pacing lead.

The ViaSeal Valved Peelable Introducer is packaged in a sterile 5-pack convenience kit containing a ViaSeal Valved Peelable Introducer, a thin-wall needle, a disposable syringe, and a flexible guidewire. The kit is packaged in a PETG tray with a Tyvek lid, and a sealed Tyvek/LDPE pouch.

Introducer sizes of the sheath and dilator range from 7 French to 10.5 French. The materials and construction are the same for all French sizes. Enpath ViaSeal Valved Peelable Introducer kits will be packaged and ETO sterilized for one time use and sealed in a Tyvek/LDPE pouch.

The provided text is a 510(k) summary for the Enpath Medical ViaSeal Valved Peelable Introducer. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical trial data with specific acceptance criteria in the manner typically seen for novel therapeutic devices or diagnostic AI systems.

Therefore, many of the specific questions about acceptance criteria, detailed study design, and AI model performance metrics cannot be directly answered from this document.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a formal table of specific acceptance criteria with quantifiable metrics such as sensitivity, specificity, accuracy, or a detailed breakdown of device performance against these. Instead, it makes a general statement about performance.

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

• Test set sample size: Not applicable/Not mentioned. The study was primarily non-clinical "performance testing."
• Data provenance: Not applicable/Not mentioned for clinical data. The performance testing would have been conducted internally by the manufacturer.

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

Not applicable. This was not a study requiring expert-established ground truth for diagnostic or interpretative tasks. It was performance testing of a medical device.

4. Adjudication method for the test set

Not applicable. This was not a study requiring adjudication of expert interpretations.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a non-AI medical device (a catheter introducer). No MRMC study was conducted, and no AI component is involved.

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

Not applicable. This is a non-AI medical device.

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

Not applicable in the context of diagnostic performance. For a medical device like this, "ground truth" would relate to engineering specifications, material properties, and functional performance benchmarks (e.g., ability to peel, maintain hemostasis, dimensions). These would be established through engineering and quality control standards.

8. The sample size for the training set

Not applicable. This is a non-AI medical device; no training set for an algorithm was used.

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

Not applicable. No training set for an algorithm was used.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" refers to a series of non-clinical performance tests conducted by Enpath Medical Inc. to demonstrate the device's safety and effectiveness and its substantial equivalence to predicate devices.

• Study Title: "Summary of Studies" (as per the 510(k) document)
• Study Type: Non-clinical (in vitro/bench testing)
• Objective: To verify that the device functions in a safe and effective manner and performs per specification requirements, equivalent to predicate devices, without creating additional risk.
• Tests Performed:
  • Device specifications verification
  • Dimensional testing
  • Functional testing
  • Hemostasis testing to venous pressures
• Results: "Test results verify that the device performs per specification requirements and is equivalent to the predicate device without creating additional risk to the patient or user."
• Key Finding for Approval: The device was deemed "substantially equivalent" to the Enpath Medical FlowGuard Valved Peelable Introducer (K040150) and the Thomas Medical Products Inc. SafeSheath MSP Introducer Kit (K003731) based on these non-clinical tests.
• Clinical Evaluations: Explicitly stated: "No clinical evaluations for this submission have been conducted."

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The Enpath Medical Steerable Sheath is intended to be used to facilitate the placement of interventional devices into the peripheral and coronary systems.

The Enpath Steerable Sheath is a guide catheter (delivery sheath) which has a distal tip that deflects to create a variable curve shape. The deflection is controlled through a handle mechanism with the ability to lock at any point along the catheter tip curve travel. The handle incorporates a luer fitting or a hemostasis valve.

The provided document is a 510(k) Summary for the Enpath Medical Steerable Sheath. It describes a Special 510(k) Submission, meaning it's for a modification to a previously cleared device (K043489). Therefore, the study focuses on demonstrating substantial equivalence to the predicate device, rather than a de novo evaluation of efficacy against acceptance criteria in the same way a novel device might.

Here's an analysis of the acceptance criteria and study information based on the provided text:

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

The document does not provide a formal table of explicit acceptance criteria with numerical targets. Instead, it states that "Test results verify that the device performs per specification requirements." The "specification requirements" are not detailed in this summary.

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

• Sample Size: The document does not specify the sample size for the test set for any of the performance tests (articulation, deflection radius, deflection force, hemostasis, deflection cycle testing, etc.). It only mentions that "The performance testing for this device included testing..."
• Data Provenance: Not explicitly stated, but given this is a U.S. FDA submission for a U.S.-based company (Enpath Medical Inc., Minneapolis, MN), it can be inferred that the testing and data likely originated from the U.S. The testing appears to be prospective as it's described as "performance testing" to "verify that the device functions."

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

Not applicable. This was an engineering performance study for a medical device modification, not a study involving human interpretation of data where expert consensus would establish ground truth.

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

Not applicable. As noted above, this was an engineering performance study.

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 Steerable Sheath, a physical medical device, not an AI or imaging diagnostic tool. Therefore, MRMC studies and AI assistance metrics are not relevant.

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

A standalone performance evaluation of the device itself (not an algorithm) was performed. The document states: "The performance testing for this device included testing to verify that the device functions in a safe and effective manner." This refers to laboratory-based functional and mechanical testing.

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

The "ground truth" for this device's performance testing would be the established engineering and design specifications for the device's functional and mechanical properties. For example, the specified range for deflection radius, the maximum deflection force, and the number of cycles the sheath must withstand. These specifications are determined during the device's design and development phase to ensure it functions as intended and safely.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-based device, so there is no concept of a "training set" in the context of this submission. The training set for the manufacturing process (e.g., quality control samples) is not discussed here.

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

Not applicable, as there is no "training set."

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The Enpath Deflectable Catheter is intended to be used to facilitate the placement of interventional devices into the peripheral and coronary systems.

The Enpath Deflectable Catheter is a guide catheter (delivery sheath) which has a distal tip that deflects to create a variable curve shape. The deflection is controlled through a handle mechanism with the ability to lock at any point along the catheter tip curve travel. The handle incorporates a luer fitting or a hemostasis valve. The deflectable catheter shaft is constructed of Pebax, lined with PTFE and filled with Barium Sulfate as a radiopacifier. The catheter hub is overmolded Nylon 12 (10% glass filled). The catheter hub houses a hemostasis valve which is molded silicone rubber. The deflectable catheter handle is made of machined ABS, and is cyanoacrylate bonded onto the deflectable shaft. The dilator tube is made of MDPE (high density/low density polyethylene blend) and has a hub made of HDPE resin overmolded onto the dilator tube. The dilator assembly is coated with silicone lubricant to reduce insertion force through the sheath hemostasis valve. The deflectable tip sheath size range is from 7 FR (ID) to 14 FR. The materials and construction are the same for all French sizes. The Deflectable Tip Sheath will be packaged and EtO sterilized for single use in a Tyvek pouch. The sterile kit packaging configuration will include the deflectable catheter and the dilator. The product may be provided as a bulk non-sterile device to OEM customers for further processing and packaging.

Here's a breakdown of the acceptance criteria and study information for the Enpath Deflectable Catheter, based on the provided 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

The submission statement indicated that the device performs per specification requirements, however specifics criteria and performance metrics were not provided.

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

The document does not explicitly state the sample size for the test set or the data provenance (country of origin, retrospective/prospective). It refers generally to "performance testing" and "test results" without specific numbers of devices tested.

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

This information is not provided. The ground truth for the performance testing appears to be based on engineering specifications and in-house testing rather than expert clinical assessment.

4. Adjudication Method for the Test Set

This information is not provided. It's likely that the testing involved objective measurements against established specifications rather than a consensus-based adjudication process typical for clinical or image-based studies.

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

No. An MRMC comparative effectiveness study was not conducted or reported. This type of study typically involves human readers analyzing cases with and without AI assistance, and it's not applicable to a device like a catheter where the primary assessment is mechanical and functional performance.

6. Standalone (i.e., algorithm-only without human-in-the-loop performance) Study

Yes, in essence, the described "performance testing" is a standalone evaluation of the device's mechanical and functional properties without human intervention during the measurement process. The "algorithm" in this context refers to the device's design and manufacturing, and its performance was assessed independently of a human operator's influence on the test outcome (beyond initiating the test).

7. Type of Ground Truth Used

The ground truth used for the device's performance testing was based on engineering specifications and established functional requirements derived from the device's intended use and relevant FDA guidance.

8. Sample Size for the Training Set

This information is not applicable and is not provided. The Enpath Deflectable Catheter is a physical medical device, not an AI/software algorithm that requires a "training set" in the machine learning sense. The development and verification of such devices rely on engineering design, material science, and physical testing.

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

This information is not applicable. As stated above, this is a physical device, not an AI/software algorithm, so there is no "training set" or "ground truth for the training set" in the context of machine learning. The design and manufacturing process would involve engineering principles, material selection, and iterative prototyping and testing to meet performance objectives.

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The Enpath Safety Introducer is intended to minimize needle stick injuries when used to introduce catheters, pacemaker leads and similar devices into the venous system

The Enpath Safety Introducer is designed to minimize needle stick injuries when used to introduce catheters, pacemaker leads and similar devices into the venous system. Sheath needles consisting of a peelable sheath over a needle, or peelable micro-introducers using the Seldinger Technique, are common methods for placing such devices. This Safety Introducer device combines various attributes of both the needle and the micro-introducer with the inclusion of a safety feature. The Safety Introducer allows for a one-step process of accessing the body. The Safety Introducer includes a safety shield which is spring-loaded in position during the ready-to-use state. After gaining vessel access, the needle subassembly is undocked from the introducer sheath and removed, leaving the sheath in the vessel for Removing the introducer sheath during standard practice passively catheter placement. advances (activates) the safety shield that locks in place. The safety shield covers the sharp of the needle bevel to protect patients and healthcare workers from accidental needle sticks.

The sheath body is constructed of PTFE and is filled with bismuth trioxide as a radiopacifier. The sheath handles, made of polypropylene resin, are overmolded onto the PTFE sheath tubing. The dilator is made of HDPE (high density polyethylene) and has a hub made of HDPE resin overmolded onto the dilator shaft. The front bub and the luer components are both molded of Polycarbonate resin. The needle and spring are stainless steel. The swivel luer cap and needle cover are both made of Polypropylene. UV cured adhesive is used during the assembly to hold the needle to the luer. The final assembly is coated with silicone lubricant from the tip of the needle to the handles of the sheath to reduce insertion force.

Sizes of the assembly range from 3.5 FR to 7FR. The needle is 21gauge for all French sizes, and the materials and construction are the same for all French sizes. The Safety Introducer will be packaged and EtO sterilized for one time use in a Tyvek pouch. The packaging configuration may include sterile kit containing a stainless steel guidewire or a bulk, nonsterile configuration.

The provided text describes a medical device called the "Enpath Safety Introducer" and outlines its 510(k) summary for FDA approval. However, the document does not contain specific acceptance criteria, detailed study designs, or performance metrics in the way requested by the prompt.

The document states:

• "The performance testing for this device included testing to verify that the device safety function performed effectively. Additional testing verified that the device performed per specification requirements."
• "A Risk Analysis for the Safety Introducer was performed per Enpath Medical, Inc internal procedure, WI42020, Hazard Analysis, FMEA and Risk Analysis. This document is modeled closely after European Standard ISO 14971: 2000 Medical Devices - Application of Management to Medical Devices."

This indicates that studies were done, but the details of those studies, including acceptance criteria, sample sizes, ground truth establishment, or specific performance results (e.g., sensitivity, specificity, accuracy, or quantitative measures of safety function effectiveness), are not present in the provided text.

Therefore, I cannot populate the table or answer most of the questions based on the given information.

Here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance

• Cannot be created. The document mentions "performance testing" and "per specification requirements" but does not define these specifications or report specific performance metrics against them.

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

• Cannot be determined. No sample sizes for any testing (whether "test set" or other performance testing) are provided. Data provenance is also not mentioned.

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

• Cannot be determined. There is no mention of ground truth establishment by experts for any test set.

4. Adjudication method for the test set

• Cannot be determined. No information on adjudication is provided.

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

• Cannot be determined. This device is a physical medical introducer, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reader improvement with AI is not applicable and not mentioned.

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

• Cannot be determined. This device is a physical medical introducer, not an algorithm. This question is not applicable.

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

• Cannot be determined. No details about how ground truth (or verification of safety function effectiveness) was established are given.

8. The sample size for the training set

• Cannot be determined. This device is a physical medical introducer, not a machine learning model. There is no concept of a "training set" in this context.

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

• Cannot be determined. As above, this question is not applicable to the device described.

Summary of available information:

• Device Name: Enpath Safety Introducer
• Intended Use: To minimize needle stick injuries when used to introduce catheters, pacemaker leads, and similar devices into the venous system.
• Performance Testing Mentioned: "performance testing for this device included testing to verify that the device safety function performed effectively. Additional testing verified that the device performed per specification requirements."
• Risk Analysis: Performed according to Enpath Medical, Inc internal procedure, WI42020, Hazard Analysis, FMEA and Risk Analysis, modeled after ISO 14971:2000.

In conclusion, the provided 510(k) summary focuses on general device description, intended use, technological characteristics, and mentions that performance and risk analysis studies were conducted, but it does not provide the detailed results, acceptance criteria, or study methodologies asked for in your prompt.

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