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The Vortex® MP Vascular Access System is indicated for central venous placement (either peripheral or chest placement) when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.

The Vortex® MP Vascular Access System is a device comprised of a vascular access port, a catheter, locking mechanism and introduction components. The Vortex MP® Port is available in a titanium configuration with a self sealing silicone septum designed to maintain integrity after repeated punctures with a non-coring needle. The catheter is offered in polyurethane and silicone models. The products are packaged in sterile trays with introduction components.

The provided document is a 510(k) Pre-market Notification for a device modification of the Horizon Medical Products, Inc. Vortex® MP Vascular Access System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the device meets specific performance acceptance criteria through clinical studies as would typically be described for a novel device or AI/ML product.

Therefore, many of the requested categories (such as sample sizes for test sets, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and large-scale training set details) are not applicable to this type of regulatory submission. The submission focuses on design verification testing to ensure the modified device maintains the same performance and safety profile as its predicate.

Here's an analysis based on the information available:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

Summary: The submission states that the Vortex® MP Vascular Access System was evaluated through HMP risk analysis and qualified through design verification testing following established Design Control procedures. The conclusion is that "No new questions of safety or effectiveness were raised for the Vortex MP Vascular Access System."

This indicates that the "acceptance criteria" were met by demonstrating that the modified device's performance aligns with the predicate device (Horizon Medical Products Vortex® MP Peripheral Access System, K032754) through engineering and design verification tests, rather than a clinical trial with specific performance metrics like sensitivity/specificity often seen in AI/ML device evaluations.

1. Table of Acceptance Criteria and Reported Device Performance

Given this is a 510(k) for a modification and an "equivalent device" claim, explicit acceptance criteria with quantitative performance metrics for a clinical study are not provided in this summary. The "acceptance criteria" are implied to be adherence to design specifications and safety/effectiveness equivalence to the predicate device.

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

• Sample Size: Not applicable. The document refers to "design verification testing," which typically involves engineering bench testing, material testing, and functional testing on a sample of devices, rather than a clinical test set with patient data. The quantity of devices tested is not specified in this summary.
• Data Provenance: Not applicable. No patient data or clinical data provenance is mentioned.

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

• Number of Experts: Not applicable. This type of submission does not involve expert adjudication of a test set in the way an AI/ML product would.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No test set requiring adjudication by experts is described.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is not relevant for a 510(k) general device modification.

6. If a Standalone Study was Done

• Standalone Study: Not applicable. The term "standalone" performance typically refers to the algorithmic performance of an AI system without human interaction. This document describes a physical medical device.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the "design verification testing," the ground truth would be defined by engineering specifications, material standards, and performance benchmarks derived from the predicate device and relevant industry standards. It is not based on "expert consensus, pathology, or outcomes data" in a clinical sense.

8. The Sample Size for the Training Set

• Sample Size: Not applicable. There is no concept of a "training set" for this type of physical device modification submission.

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

• How Ground Truth Was Established: Not applicable, as there is no training set.

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The Vortex® MP Peripheral Access System is indicated for peripheral placement in the mid-arm, above the antecubital space and well below the subaxillary area, when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.

The Vortex® MP Peripheral Access System is a device comprised of a vascular access port, a catheter, locking mechanism and introduction components. The Vortex MP® Port is available in a titanium configuration with a self sealing silicone septum designed to maintain integrity after repeated punctures with an non-coring needle. The catheter is offered in polyurethance and silicone models. The products are packaged in sterile trays with introduction components.

This 510(k) summary (K032754) is for a medical device, the Vortex® MP Peripheral Access System, not a software or AI-powered diagnostic device. Therefore, many of the requested criteria, such as "acceptance criteria," "reported device performance," "sample sizes for test and training sets," "ground truth establishment," "MRMC studies," or "standalone performance," are not applicable in the context of AI/software validation.

The document describes a traditional substantial equivalence determination for a physical medical device. The manufacturer is demonstrating that their new device is as safe and effective as a legally marketed predicate device, not validating a new algorithm or diagnostic tool.

Here's a breakdown of what can be extracted from the provided text, and where the information relevant to AI/software validation is missing or not applicable:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not provide explicit quantitative acceptance criteria or reported performance metrics in the way one would expect for an AI diagnostic study (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device through design evaluation and verification testing.

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

• Sample Size for Test Set: Not applicable/not reported in the context of an AI/software validation. The "design verification testing" would involve engineering tests on device prototypes, the specific "sample size" of which is not detailed here.
• Data Provenance: Not applicable. This refers to the testing of a physical device, not patient data in terms of its origin (country, etc.). The testing would have been conducted by the manufacturer (Horizon Medical Products, Inc.).
• Retrospective or Prospective: Not applicable. This refers to experimental design for data collection, not the physical testing of a medical device's components.

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

• Number of Experts: Not applicable. Ground truth in this context would relate to the performance of the physical device components during engineering testing, typically assessed against design specifications and industry standards by engineers, not medical experts establishing a diagnostic "ground truth."
• Qualifications of Experts: Not applicable for establishing ground truth in this type of submission.

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

• Adjudication Method: Not applicable. This pertains to resolving disagreements among multiple human readers for diagnostic image interpretation, which is not relevant here.

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:

• MRMC Study: No, an MRMC study was not done. This is exclusively a physical medical device.
• Effect Size of AI Improvement: Not applicable. The device does not incorporate AI for diagnostic or interpretative tasks.

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

• Standalone Performance: Not applicable. There is no algorithm to evaluate in a standalone manner.

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

• Type of Ground Truth: For a physical device, "ground truth" would refer to established engineering and material science principles, performance specifications (e.g., septum resealability, material biocompatibility, structural integrity), and comparisons against the predicate device's known characteristics. It's not clinical "ground truth" in the diagnostic sense.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable. This device is not an AI/ML model that undergoes a "training" phase.

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

• How Ground Truth for Training Set was Established: Not applicable.

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The Triumph™ VTX® Port with LifeValve® Catheter is a totally implantable vascular access system intended for the delivery of medications, intravenous fluids, parenteral nutrition solutions or blood products. The Triumph™ VTX® Port with LifeValve® Catheter is also indicated for the withdrawal of blood samples.

The Triumph™ VTX® Port with LifeValve® Catheter is a device comprised of a vascular access port and a catheter. The Triumph™ VTX® Port is available in a titanium or polysulfone configuration with a self sealing silicone rubber septum designed to maintain integrity after repeated punctures with an anti-coring needle. The LifeValve® Catheter incorporates a bidirectional valve assembly at the distal tip. The catheter is equipped with a pre-threaded stiffening stylet to facilitate passage of the catheter through the introducer. The positioned LifeValve® Catheter is secured to the Triumph™ VTX® Port reservoir with a locking mechanism. The products are packaged in a sterile tray with an introducer kit and components.

The provided text is a 510(k) summary for a medical device (Triumph™ VTX® Port with LifeValve® Catheter) seeking clearance from the FDA. It does not contain information about a study proving the device meets acceptance criteria.

Instead, the document focuses on demonstrating substantial equivalence to previously cleared predicate devices, which is a different regulatory pathway than proving a novel device meets predefined acceptance criteria through performance studies.

Therefore, I cannot provide the requested information, which includes a table of acceptance criteria and reported performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The document explicitly states:

• "No new questions of safety or effectiveness for implantable ports or central venous catheters were raised by the risk analysis or testing of the Triumph™ VTX® Port with LifeValve® Catheter."
• "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices..."

This indicates that the clearance was based on similarity to existing devices, not on direct performance testing against specific acceptance criteria for a novel functionality.

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The LifeValve Central Venous Catheter is indicated for patient therapy requiring acute or long-term (chronic) central venous access for the infusion of medications, parenteral solutions, parenteral nutrition solutions, or blood products, and for the withdrawal of blood samples.

The LifeValve Central Venous Catheter includes a catheter and introduction components. The catheter is a percutaneous central venous catheter that incorporates a bidirectional valve assembly at the distal tip. The catheter is comprised of radiopaque silicone tubing, a molded radiopaque silicone tip with radiopaque marker band and a polvester implant cuff. It utilizes a luer lock connector and catheter Snap-Lock™ for proximal fittings. The catheter is equipped with a stylet stiffener. Each product is packaged in a sterile tray with 8 French introducer components. The family of LifeValve products includes externally communicating central venous catheters in two overall lengths, 50 and 65 cm.

The provided text describes a medical device, the "LifeValve Central Venous Catheter," and its 510(k) submission for regulatory clearance. However, the text does not contain any information about acceptance criteria or a study proving the device meets specific performance metrics.

The document is a 510(k) summary and the FDA's letter of substantial equivalence. These documents focus on demonstrating that a new device is "substantially equivalent" to an already legally marketed predicate device, rather than providing detailed performance study results against specific acceptance criteria.

Therefore, I cannot fulfill your request for the tables and study details based on the provided input. The document mentions:

• Device Description: It describes the physical characteristics and components of the LifeValve Central Venous Catheter.
• Intended Use: It states the medical applications for which the catheter is designed.
• Substantial Equivalence Comparison: It asserts that the LifeValve catheter is "identical in intended use and fundamental scientific technology" and "substantially similar in configuration, dimensions, and materials" to a predicate device (Strato Medical Single Lumen Valved Catheter, K924851). It also states that "Minor configurational, dimensional, and material changes have improved device performance" and were "evaluated through risk analysis and qualified through design verification testing and biomaterial safety evaluations following established Design Control procedures."

Missing Information:

The critical information you requested, such as specific acceptance criteria, detailed study designs, sample sizes for test/training sets, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC study results, is not present in the provided 510(k) summary and FDA letter. These types of detailed performance data are usually found in the full 510(k) submission or separate technical reports, not typically in the summary made publicly available.

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The LifeJet™ F16 Hemodialysis/Apheresis Chronic Catheter is indicated for use in attaining short and long term vascular access for hemodialysis, hemoperfusion or apheresis therapy via the jugular or subclavian vein. The catheter is intended for implantation dwell time of greater than 30 days.

The LifeJet™ F16 Hemodialysis/Apheresis Chronic Catheter is a radiopaque dual lumen polyurethane catheter intended to remove and return blood. The two lumens are designed in a Circle Crescent (Circle "C") configuration. The distal venous lumen extends beyond the arterial lumen to reduce recirculation.

The lumens are connected to the extensions via a molded hub with suture wing. The arterial and venous extensions are identified by red and blue luer connectors and clamps. Priming volume information is printed on identification rings on the clamps for ease in identification. The fixed retention cuff on the shaft provides an anchoring site for tissue ingrowth during long-term placement.

The LifeJet™ F16 Hemodialysis/Apheresis Chronic Catheter is available in varied implantable lengths, with straight or J-Cannula versions.

This 510(k) summary is for the LifeJet™ F16 Hemodialysis/Apheresis Chronic Catheter.
Here's an analysis of the provided text for acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

Notes:

• The document states that "in-vitro testing was sufficient to demonstrate safety and effectiveness by way of comparison to the legally marketed predicate device." This implies that the predicate device's performance metrics served as the de facto acceptance criteria for these in-vitro tests, and the LifeJet™ F16 met or performed comparably to these.
• Specific numerical acceptance thresholds or performance values are not provided in this document. The FDA's substantial equivalence determination supports that the device met the necessary criteria.

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

• Sample Size for Test Set: Not explicitly stated. The performance data is based on "in-vitro performance data," which refers to laboratory testing, not human subjects. The number of samples/units tested for each in-vitro test (tensile strength, leak testing, flow rate, stiffness) is not provided.
• Data Provenance: The data is in-vitro (laboratory testing). It is not derived from human subjects, so concepts like country of origin or retrospective/prospective do not directly apply in the same way they would for clinical data.

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

• Not Applicable. This study did not involve human expert interpretation of data to establish a ground truth. Performance was determined through physical and mechanical testing comparing the device's characteristics to a predicate device.

4. Adjudication Method for the Test Set

• Not Applicable. There was no human interpretation or adjudication process for the in-vitro tests described.

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

• No. An MRMC study was not conducted as this study focused on in-vitro performance testing of a physical medical device, not on AI or diagnostic imaging interpretation.

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

• Not Applicable. This pertains to a physical medical device (catheter), not an algorithm or AI system.

7. The Type of Ground Truth Used

• For the in-vitro performance tests: The ground truth was based on the established performance characteristics and safety profile of the legally marketed predicate device (Super C™ (LifeJet™) Hemodialysis/Apheresis Chronic Catheter). The new device's performance was compared to this predicate to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

• Not Applicable. This is a physical medical device without a "training set" in the context of machine learning or algorithms.

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

• Not Applicable. As there is no training set for this type of device submission, this question is not relevant.

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The LifeGuard™ Safety Infusion Set is used to access implanted vascular ports to administer fluids and/or to withdraw blood. The LifeGuard™ Safety Infusion Set facilitates safe removal of the needle by encapsulating the needle during vascular port de-accessing to help prevent needlestick injuries.

The LifeGuard™ Infusion Set is a standard 90° non-coring needle intravascular administration set with a sharps injury protection. The LifeGuard™ Infusion Set is designed for use with vascular access devices. The needle is inserted into the vascular access port in a standard manner for fluid infusion or for blood sampling. The components that comprise the LifeGuard™ Safety Infusion Set includes the following: a PVC tubing set; a white clamp to prevent fluid flow; a universal female luer lock connector to connect to infusion/aspiration devices; a white cap to close the female luer; a winged needle holder to secure the infusion set to the patient with a pre-attached 90° non-coring needle to access the implanted port and allow the user to pull the needle up into the safety position; a needle trap encapsulates the needle after de-accessing the needle from the implanted port; and a needle guard shrouds the needle before use. Some models include a Ysite as an alternate female luer injection site with an additional white cap and white clamp to prevent fluid flow. A thermoformed tray with a heat sealed tyvek lid provides a sterile barrier. The LifeGuard™ Safety Infusion Set is fabricated from biocompatible, medical grade materials. The LifeGuard™ Safety Infusion Sets are supplied as sterile, non-latex, nonpyrogenic, intended for single use only and are manufactured out of non-DEHP PVC. De-accessing the needle is done as with any standard non-coring needle, using a one-handed (dominant hand) technique to remove the needle while stabilizing the port with the nondominate hand. As the needle is removed, the passive sharps injury protection feature is actuated by sliding the needle holder upward, · which encapsulates the needle within the needle trap.

The provided text describes a medical device, the LifeGuard™ Safety Infusion Set, and details its performance through a "Simulated Use Study". This study focuses on the effectiveness of the sharps injury protection feature.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details:

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

   • Sample Size: n=500 for the Simulated Use Study.
   • Data Provenance: The document does not specify the country of origin. It is a "Simulated Use Study," implying controlled conditions rather than retrospective or prospective patient data from real-world usage.

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

   • The document does not provide details on the number or qualifications of experts used to establish ground truth for this specific "Simulated Use Study." The study focuses on a measurable mechanical failure rate of the safety feature.

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

   • The document does not describe an adjudication method for the test set. Given the nature of a "failure rate" for a mechanical safety feature, an adjudication process involving human interpretation is unlikely in the same way it would be for diagnostic imaging.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a mechanical infusion set with a safety feature, not an AI-assisted diagnostic tool for human readers.

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

   • This question is not applicable. The device is a physical medical device, not an algorithm. The "Simulated Use Study" evaluates the physical device's performance, which inherently includes human interaction (users pulling the needle up) to actuate the safety feature but measures the device's mechanical success.

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

   • The ground truth for the Simulated Use Study appears to be based on the direct observation and quantification of the mechanical failure of the sharps injury protection feature. There is no indication of expert consensus, pathology, or outcomes data being used to establish this specific ground truth. It's a binary outcome: the safety feature either successfully encapsulates the needle or it fails.

7. The sample size for the training set:

   • The document does not mention a "training set." The study described is a "Simulated Use Study" to test the performance of the final device, not to train a machine learning model.

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

   • Not applicable, as no training set is mentioned in the context of this device's evaluation.

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The Super C™ Hemodialysis/Apheresis Chronic Catheter is indicated for use in attaining short and long term vascular access for hemodialysis. hemoperfusion or apheresis therapy via the jugular or subclavian vein. The catheter is intended for implantation dwell time of greater than 30 days.

The Super C™ Hemodialysis/Apheresis Chronic Catheter is composed of a radiopague polyurethane catheter shaft with two lumens (arterial and venous) in a Crescent (Circle "C") configuration. The lumens are distinguishable by color-coded clamps on clear silicone extensions. The fixed retention cuff on the shaft provides an anchoring site for tissue ingrowth during long-term placement. The Super C™ Hemodialysis/Apheresis Chronic Catheter offered in straight versions are available in 19 cm, 23 cm, and 28 cm cuff to tip insertion lengths. Additionally, the Super C™ Hemodialysis/Apheresis Chronic Catheter is available with a J-Cannula version in 19 cm and 23 cm cuff to tip insertion lengths.

The provided text describes a 510(k) premarket notification for the Super C™ Hemodialysis/Apheresis Chronic Catheter. This type of submission is a regulatory pathway for medical devices that are substantially equivalent to legally marketed predicate devices, not a study designed to prove the device meets specific performance criteria through clinical trials or detailed algorithm performance evaluation.

Therefore, many of the requested categories for device acceptance criteria and studies are not applicable to this submission as it focuses on demonstrating substantial equivalence through comparison of technological characteristics and performance testing data rather than a detailed clinical study with established ground truth, expert adjudication, or MRMC studies.

Here's a breakdown of what can be extracted from the provided text, and where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The text does not specify quantitative acceptance criteria. Instead, it states that "Performance testing was conducted data for Super C™ Hemodialysis/Apheresis Chronic Catheter and compared to the predicate devices identified in this 510(k). Test results demonstrated that the Super C™ Hemodialysis/Apheresis Chronic Catheter is substantially equivalent to these predicate devices commercially in distribution for the same intended use."

This implies the acceptance criterion was "substantial equivalence" to the specified predicate devices, meaning its performance characteristics (material type, intended use, operating principle, number of lumens) were similar enough and its performance test results did not raise new questions of safety or effectiveness.

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

• Sample Size: Not specified. The document states "Performance testing was conducted data," indicating in-vitro or bench testing, but does not specify the number of units or tests performed.
• Data Provenance: The nature of 510(k) submissions generally means this would be internal company testing (Horizon Medical Products, Inc.). The data would be prospective in the sense that the company specifically conducted tests for this submission, but it's not a clinical study involving patients or patient data.

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

• Not Applicable. This device is a physical medical device (catheter), not one that generates diagnostic output requiring expert interpretation for ground truth. The "ground truth" for its performance would be established by direct physical measurements, material properties testing, and functional assessments, not expert consensus on interpretations.

4. Adjudication method for the test set

• Not Applicable. As no expert interpretation or diagnostic output is involved, there is no need for an adjudication method.

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 physical medical device (catheter), not an AI-powered diagnostic tool. Therefore, MRMC studies and assessment of human reader improvement with AI assistance are irrelevant.

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 or software.

7. The type of ground truth used

• Not Applicable in the sense of a diagnostic outcome. The "ground truth" for a physical device like this is its physical and functional performance, verified through engineering tests, material science analysis, and potentially some animal or cadaver studies (though not explicitly mentioned here, implied by performance testing). For example, tensile strength would be measured directly, or flow rates assessed under simulated conditions.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.

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

• Not Applicable. (See point 8)

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The MicroPort 2 System is indicated for peripheral placement in the midarm, above the anticubital space and well below the subaxillary area, when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.

The Horizon Medical Products MicroPort 2 system consist of a low profile ellipsoidal port made of Titanium and an attachable Polyurethane catheter. The catheter is attached to the port body by placing the catheter and strain relief connector over the barbed stem (outlet tube) of the body. The port body is implanted in the mid-arm (above the elbow). Implantation in the mid-arm avoids the bend in the elbow, which could place the catheter under added stress. The catheter reaches the central venous circulation via either the basilic or axillary vein. The veins in the upper arm are larger and offer a less tortuous path to the central venous circulation, making insertion easier. Additionally, this catheter route lessens the danger of pneumothorax, hemopneumothorax, air embolism, as well as catheter shear (Note: Catheter does not pass between the clavicle and the first rib.).

The MicroPort 2 Peripheral Access System is packaged without and with kit introducer components. The kit contains basic components required for percutaneous. The system is sterilized by ethylene oxide gas and is labeled as a sterile as well as a single use only device.

This document is a 510(k) premarket notification for the Horizon Medical Products Microport 2 Peripheral Access System. It asserts substantial equivalence to predicate devices and describes the device, its intended use, and general safety considerations, but does not contain acceptance criteria or a study proving the device meets specific performance criteria.

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to existing devices rather than presenting a performance study with acceptance criteria for a new device.

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