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The PowerPort™ Implantable Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications including anti-cancer medicines (chemotherapy), I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. When used with the PowerLoc™ Safety Infusion Set, the PowerPort™ device is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s.

The PowerPort™ Implantable Port is an implantable access device designed to provide repeated access to the vascular system. Port access is performed by percutaneous needle insertion using a non-coring needle. Power injection is performed using a PowerLoc™ Safety Infusion Set only. The PowerPort™ Implantable Port consists of two primary components: an injection port with a self-sealing silicone septum and a radiopaque catheter. Single lumen PowerPort™ Implantable Ports can be identified subcutaneously by feeling the top of the septum, which may include three palpation bumps arranged in a triangle, and by palpating the sides of the port, which is also triangular. Dual lumen PowerPort™ Implantable Ports can be identified subcutaneously by feeling the top of each septum; each septum may feature three palpation bumps arranged in a triangle.

The provided FDA 510(k) clearance letter and summary discuss the substantial equivalence of the PowerPort™ Implantable Ports to predicate devices. It does not present a study with acceptance criteria and reported device performance in the context of a diagnostic or AI-assisted system performance.

The document is a premarket notification for a medical device (implantable ports) and focuses on demonstrating that the new device is substantially equivalent to existing legally marketed predicate devices. This is a regulatory pathway for devices that do not require clinical trials of the same rigor as novel devices or those with significant changes in technology.

Therefore, many of the requested elements, such as "test set," "ground truth," "MRMC study," "effect size of human readers," and "training set," are not applicable to this type of submission for a physical medical device. The "acceptance criteria" discussed are related to physical performance and material equivalence, not diagnostic accuracy.

However, I can extract the information that is available from the document regarding the device's assessment.

Acceptance Criteria and Device Performance (for physical device modifications)

The study performed is primarily design verification testing to ensure the modifications (dimensional changes, shelf-life extension, alternative locking solutions) do not negatively impact the device's safety and effectiveness compared to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various performance specifications that were verified. The "Reported Device Performance" column essentially states that the device "performed as intended by meeting product performance specifications." The precise numerical acceptance criteria and specific reported values are not fully detailed in this summary but are implied to have been met.

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

The document does not specify a discrete "test set sample size" or "data provenance" in the typical sense of a clinical or image-based AI study. The evaluation consists of design verification testing on manufactured units of the device and its components. This testing is conducted on physical samples of the device undergoing mechanical, material, and functional assessments. The provenance is internal to the manufacturer (Bard Access Systems, Inc.). The testing involved simulating aging, exposure to ethylene oxide sterilization, and simulated shipping.

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

This concept is not applicable to this type of device submission. Ground truth, in the context of diagnostic accuracy, is not directly relevant for the physical performance testing of an implantable port. The "truth" is determined by established engineering standards and test methods.

4. Adjudication method for the test set

This concept is not applicable as it relates to expert review of diagnostic findings, which is not part of this device's evaluation. Performance is assessed against quantitative engineering specifications.

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, an MRMC comparative effectiveness study was not done. This is a physical medical device (implantable port), not a diagnostic imaging or AI assistance system.

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

No, this is not an algorithm-based device. It is a physical implantable medical device.

7. The type of ground truth used

For the aspects of the device that are being verified (physical performance, material compatibility, and fluid dynamics), the "ground truth" is established through:

• Established engineering standards and test methods (e.g., NF S 94-370, ISO 10555-3, ASTM D412).
• Internal test methods developed by Bard Access Systems, Inc.
• Compliance with FDA guidance for implanted infusion ports.
• Referenced industry standards like "Infusion Therapy Standards of Practice, 9th Edition (2024)" for locking solutions.

8. The sample size for the training set

This concept is not applicable as this is a physical medical device submission, not an AI/algorithm-based device that would require training data.

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

This concept is not applicable for the same reasons as above.

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PowerLoc™ Max Power Injectable Infusion Set:

The PowerLoc™ Max Power Injectable Infusion Set is a device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through surgically implanted vasular ports. When used with ports that are indicated for power injection of contrast media into the central venous system, the PowerLoc™ Max Power Injectable Infusion Set is also indicated for power injection of contrast media. These devices may be used in any patient population with an implanted vascular port.

For power injection of contrast media, the maximum recommended infusion rate at 11.8 cPs is 5 mL/s for 19 gauge and 20 gauge needles, and 2 mL/s for 22 gauge needles.

SafeStep™ Huber Needle Set:

The SafeStep™ Huber Needle Set is a device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through surgically implanted vascular ports.

These devices may be used in any patient population with an implanted vascular port.

Note: The SafeStep™ Huber Needle Set is NOT indicated for power injection of contrast media or any other high pressure injection.

PowerLoc™ Max Power Injectable Infusion set is a non-coring Huber needle and infusion set with a manually activated needlestick prevention safety mechanism. These devices access surgically implanted subcutaneous vascular ports by penetrating the port septum to provide a closed fluid pathway for the infusion of fluids and drugs, as well as blood sampling. In addition, it may be used for power injection of contrast media through an implanted vascular port that is also indicated for power injection up to 325 psi (2241 kPa). It is supplied sterile and non-pyrogenic, for single use only.

The PowerLoc™ Max Power Injectable Infusion Set is offered with and without a Y-site.

SafeStep™ Huber Needle Set:

The SafeStep™ Huber Needle Set is a device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through surgically implanted vascular ports.

These devices may be used in any patient population with an implanted vascular port.

Note: The SafeStep™ Huber Needle Set is NOT indicated for power injection of contrast media or any other high pressure injection.

This document describes the premarket notification for the "PowerLoc™ Max Power Injectable Infusion Set" and "SafeStep™ Huber Needle Set". The study presented focuses on demonstrating substantial equivalence to a predicate device (K171735) through performance testing, rather than a standalone clinical study to establish new acceptance criteria. Therefore, much of the requested information regarding clinical studies, expert-established ground truth, and training data is not applicable in this context.

Here's a breakdown of the available and applicable information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for each test are implied by the "All testing passed the predetermined acceptance criteria" statement. Specific quantitative acceptance criteria or detailed performance results are not provided in this summary. Instead, the document lists the type of test conducted and the standard it references, indicating compliance.

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

• Sample Size: The document does not specify the exact sample sizes used for each individual performance test. It broadly states "All testing passed the predetermined acceptance criteria."
• Data Provenance: The studies were conducted "by or for Bard Access Systems (BD)". The data is presumably from laboratory testing, not patient data (retrospective or prospective), given the nature of the device and the tests performed. The country of origin for the data is not specified, but the applicant's address is in Salt Lake City, Utah, USA.

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

This information is not applicable. The device's substantial equivalence was established through engineering and performance testing against recognized standards, not through clinical trials requiring expert-established ground truth on patient data.

4. Adjudication Method for the Test Set

This information is not applicable, as no clinical study with human observers or adjudication committees was performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If So, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This is not applicable. This is a medical device (infusion set and Huber needle set), not an AI-powered diagnostic or assistive tool.

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

This is not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for the performance tests would be the established requirements and limits defined by the referenced ISO standards, USP standards, and internal protocols for a device of this type. For example, for "Assembly Burst," the ground truth is that the device must withstand a certain pressure without bursting, as defined by ISO 10555-1.

8. The Sample Size for the Training Set

This is not applicable. There is no AI component or training set involved in the assessment of this physical medical device.

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

This is not applicable as there is no training set. The "ground truth" for the device's acceptable performance is derived from established international and national standards for medical devices and internal quality control protocols.

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The PowerPort™ Implantable Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications including anti-cancer medicines (chemotherapy), I. V. Iluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.

When used with the PowerLoc™ Safety Infusion Set, the PowerPort™ Implantable Port is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s.

The PowerPort™ Implantable Port is an implantable access device designed to provide repeated access to the vascular system. Port access is performed by percutaneous needle insertion using a non-coring needle. Power injection is performed using a PowerLoc™ Safety Infusion Set only. The PowerPort™ Implantable Port consists of two primary components: an injection port with a self-sealing silicone septum and a radiopaque catheter. Single lumen PowerPort™ Implantable Ports can be identified subcutaneously by feeling the top of the septum, which may include three palpation bumps arranged in a triangle, and by palpating the sides of the port, which is also triangular. Dual lumen PowerPort™ Implantable Ports can be identified subcutaneously by feeling the top of each septum; each septum may feature three palpation bumps arranged in a triangle.

The provided text describes a 510(k) premarket notification for the PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable Ports. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by internal product performance specifications and meeting acceptable risk levels, as demonstrated through verification testing. The document states that "Design verification testing was conducted to evaluate device performance over the proposed 2-year shelf life of the to-be-marketed configurations for all models of the subject device." It also mentions that "Verification testing demonstrated that the device performed as intended by meeting product performance specifications and controlling risks to an acceptable level..."

Specific quantitative acceptance criteria and their corresponding reported device performance are not explicitly detailed in a comparative table format within the provided text. Instead, the document lists various verification/validation methods and standards applied, implying that the device was tested against these methods and passed their respective criteria.

However, based on the narrative and the types of tests listed, a conceptual table can be constructed, acknowledging that specific numerical values for criteria and performance are not given:

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

The document does not explicitly state the numerical sample size used for each specific test in the verification activities. It generally refers to "the to-be-marketed configurations for all models of the subject device."

Regarding data provenance:

• The tests were conducted by Bard Access Systems, Inc. ("BAS Internal Test-Method").
• The data appears to be prospective as it involves "design verification testing... over the proposed 2-year shelf life," implying new testing for this submission.
• The country of origin for the data is implicitly the United States, as the submission is to the U.S. FDA.

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

This information is not provided in the document. The tests performed are engineering and performance-based, not clinical studies requiring expert ground truth for interpretation (e.g., radiology reads). The "ground truth" here is determined by direct measurement against engineering specifications and industry standards. The document does mention "Material experts at BAS have confirmed the proposed locking solutions will not impact BAS catheters," indicating internal expertise in materials science informed certain aspects of the design verification.

4. Adjudication Method for the Test Set

This information is not applicable/not provided as the verification tests described are objective, quantitative engineering tests, not subjective assessments requiring adjudication by multiple readers or experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

This information is not applicable. The device (PowerPort™ ClearVUE™ Slim Implantable Ports) is a physical medical device, specifically an implantable port and catheter system. It is not an AI-enabled diagnostic or therapeutic device. Therefore, an MRMC study related to AI assistance would not be relevant to this submission.

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

This information is not applicable. As stated above, this device is a physical medical product, not an algorithm or software-only device.

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

The ground truth for the verification studies is established by engineering specifications, industry standards (e.g., ISO 10555-3, NF S 94-370, ASTM D412), and FDA guidance documents ("FDA Implanted Infusion Port Guidance"). It is based on objective, measurable performance characteristics rather than clinical "ground truth" derived from patient data or expert interpretation.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical device and does not involve machine learning algorithms that require a "training set."

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

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

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The PowerGlide Pro™ Midline Catheter is inserted into a patient's vascular system for short-term use (

Bard Access Systems, Inc.'s PowerGlide Pro™ Midline Catheter is a sterile, single use device designed to provide access to the patient's vascular system. The device is intended for short term use (

The provided FDA 510(k) clearance letter for the PowerGlide Pro™ Midline Catheter specifies that no new performance tests, including verification and validation activities, were conducted because the modifications were limited to labeling updates (specifically, changes to the Indications for Use and associated Instructions for Use/labeling), with no changes to the device's design, materials, performance, or risk profile.

Therefore, based on the provided document, the typical information requested for acceptance criteria and study details (such as sample size, provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, and training set details) is not available as no new studies were deemed necessary due to the nature of the submission. The acceptance criteria essentially rely on the previously established performance of the legally marketed predicate device (K162377), which the subject device is substantially equivalent to.

However, I can extract the comparison table that highlights the differences between the subject device and the predicate device, which implicitly states that the performance criteria for the subject device are considered to be the same as the predicate device due to the lack of design or performance changes.

Here's a summary based on the provided document, addressing the points where information is available or where the document indicates why it's not applicable:

1. A Table of Acceptance Criteria and the Reported Device Performance

Since no new performance studies were conducted for this 510(k) submission, there are no new specific acceptance criteria or reported device performance metrics beyond those previously established for the predicate device. The document explicitly states:

"The results of the risk analysis determined that no verification or validation activities were required because the subject device modifications to the Indications for use and resulting modifications to the instructions for use and labeling do not include any changes to the design, materials, performance, or risk profile of the cited predicate device. Therefore, it is not necessary to conduct additional performance tests including verification and validation."

The "reported device performance" would therefore implicitly be identical to the predicate device, K162377, for all functional aspects. The acceptance criteria for this submission were that the labeling changes do not introduce new questions of safety or effectiveness and do not introduce any new or significantly modified risks. The document claims this was met for each change.

Summary of Device Comparison (Implicit Acceptance of Predicate Performance)

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The AccuCath Ace™ Intravascular Catheter is inserted into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids intravenously. This device may be used for adult and pediatric patients, including those patients with difficult intravascular access who may have small, fragile, and/or non-palpable vessels, with consideration given to adequacy of vascular anatomy, appropriateness of the solution being infused, and duration of therapy. The AccuCath Ace™ IV Catheter is suitable for use with power injectors.

The AccuCath Ace™ Intravascular Catheter system consists of a radiopaque catheter with a valve mechanism delivered over a guidewire with an atraumatic tip design; a flashback chamber to enhance flashback visualization, and a safety container that prevents sharp injuries. The AccuCath Ace IV Catheter is designed to reduce blood exposure during insertion, for use with ultrasound, and for use with the Cue Needle Tracking System.

The information provided indicates that the AccuCath Ace™ Intravascular Catheter did not undergo a new study to prove it meets acceptance criteria for its current submission. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (AccuCath™ Intravascular Catheter, K162894) based on a modification to its Indications for Use, which now explicitly includes patients with difficult intravascular access (DIVA).

The document states that a risk analysis determined that no verification or validation activities were required because the modifications to the Indications for Use and labeling "do not include any changes to the design, materials, performance, or risk profile of the cited predicate device."

Therefore, the "acceptance criteria" and "device performance" described below are in reference to the previous clearance of the predicate device and the modifications that had been made to it, for which "Verification, sterilization, biocompatibility, and packaging testing was carried out as necessary for each of these changes at the time of the change." The current submission does not detail these specific tests, their criteria, or results, but rather asserts that the changes "were found to be as safe and as effective and introduced no new or modified risks."

The table below summarizes the information provided regarding the comparison between the subject device (AccuCath Ace™ Intravascular Catheter) and its predicate device (AccuCath™ Intravascular Catheter, K162894), highlighting what is considered "met" based on the substantial equivalence argument rather than new primary testing.

1. Table of Acceptance Criteria and Reported Device Performance

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BD Prevue™ II Peripheral Vascular Access System is indicated for Vascular Access Imaging Applications performed by appropriately trained healthcare professionals in a medical setting. Typical examinations performed using the BD Prevue™ II Peripheral Vascular Access System include:

Imaging Applications:

Vascular [Exam Type (Adult and Pediatric)]: Assessment of vessels in the extremities and neck leading to or coming from the heart, superficial veins in the arms and legs, and vessel mapping. Assessment of superficial thoracic vessels. Vascular Access [Exam Type (Adult and Pediatric)]: Guidance for PICC, CVC, dialysis catheter, port, PIV, midline, arterial line placement, access to fistula and general vein and artery access in adult and pediatric patients, including those patients with difficult intravascular access who may have small, fragile, and/or non-palpable vessels.

The BD Prevue™ II Peripheral Vascular Access System is a portable device that features real-time 2D ultrasound imaging, customized vascular access applications, procedure documentation, vessel measurement tools, and electronic connectivity (if enabled).

The BD Prevue™ II Peripheral Vascular Access System is equipped with Cue™ Needle Tracking System which is designed to track and display the location and trajectory of a needle under ultrasound guidance. The technology consists of software installed on an ultrasound system and sensors incorporated into the ultrasound probes. The sensors detect a passive magnetic field emitted from the needle. The software interprets the data from the sensors and creates a virtual image of the needle on the ultrasound display, providing clinicians with a visual representation of the needle during the insertion process.

The Cue™ Needle Tracking System requires the use of either the Cue™ Traditional Probe or Cue™ Vascular Access Probe, the Cue™ Magnetizer and a Cue™ enabled needle. The Cue™ Traditional Probe and Vascular Access Probe contain sensors for tracking Cue™ compatible needles (following magnetization by the Cue™ Magnetizer). The tracked needle's current position, trajectory, and intersection window are displayed over the ultrasound image.

The information provided pertains to the BD Prevue™ II Peripheral Vascular Access System. The device has undergone an administrative change to its 510(k) to include the specification of difficult intravascular access (DIVA) patients in its indications for use.

Based on the provided text, a new study was not conducted to specifically prove the device meets new acceptance criteria for the updated indication. Instead, the manufacturer, Bard Access Systems, Inc. (now BD), states that no new verification or validation activities were required because the modifications to the Indications for Use and the Instructions for Use do not involve changes to the device's design, materials, performance, or risk profile. The performance testing conducted for the predicate device clearance (K211193) is deemed to cover the proposed specified difficult intravascular access patient population.

Therefore, the acceptance criteria and performance data referenced are those from the original submission (K211193) for the predicate device, which is the same device, the BD Prevue™ II Peripheral Vascular Access System, but with a narrower previous indication.

Due to the administrative nature of this submission (K240146) and the reliance on previous predicate device testing, the provided text does NOT contain the specific details required for sections 1-9 as no new study was performed for this 510(k).

However, I can extract the available information regarding the device and the rationale for not requiring a new study for K240146:

1. Table of acceptance criteria and the reported device performance

• Acceptance Criteria for K240146: Not explicitly stated as new criteria in this document. The submission relies on the existing performance data and acceptance criteria established for the predicate device (K211193), which is deemed to cover the expanded indication.
• Reported Device Performance for K240146: Not explicitly stated as no new performance data was generated for this administrative change. The statement is that the original performance testing for K211193 is sufficient.

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

• Not applicable for K240146, as no new test set was used. The submission relies on the performance testing from the predicate device (K211193).

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 for K240146, as no new ground truth establishment was reported. The submission relies on the performance testing from the predicate device (K211193).

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

• Not applicable for K240146, as no new test set was used. The submission relies on the performance testing from the predicate device (K211193).

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

• This device is an Ultrasound System with Needle Tracking, not an AI-assisted diagnostic tool for interpretation of medical images by human readers. Therefore, an MRMC comparative effectiveness study of this nature is not applicable in the context of this device's function.

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

• The BD Prevue™ II Peripheral Vascular Access System is a medical imaging device with needle tracking capability, which is inherently used with human-in-the-loop (healthcare professional). Therefore, a standalone algorithm-only performance study is not applicable for this type of device. The "Cue™ Needle Tracking System" is described as software and sensors that create a virtual image for the clinician.

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

• Not applicable for K240146, as no new ground truth establishment was reported. The submission relies on the performance testing from the predicate device (K211193). For an ultrasound imaging and needle tracking system, ground truth in previous studies would likely involve phantom studies for accuracy, clinical observations for usability and performance in procedures, or comparison to established imaging modalities.

8. The sample size for the training set

• Not applicable for K240146, as no mention of a training set for a new study is made. The device performs real-time 2D ultrasound imaging and needle tracking; while it uses software, the context does not indicate an AI model requiring a "training set" in the common sense for diagnostic interpretations. If machine learning is involved in the needle tracking, details about its training set would reside in the K211193 submission.

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

• Not applicable for K240146 for the same reasons as #8.

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The SiteRite™ 9 Ultrasound System is intended for diagnostic ultrasound imaging of the human body performed by appropriately trained healthcare professionals in a medical setting. Specific clinical applications include:

• · Pediatric
• · Peripheral Vessel and Vascular Access
• · Small Organ (breast, thyroid, parathyroid, testicles)
• · Musculo-skeletal (conventional and superficial)
• · Cardiac (adult and pediatric)

The SiteRite™ 9 Ultrasound System is indicated for Vascular, Vascular Access, Interventional, and Superficial Imaging Applications. Typical examinations performed using the SiteRite™ 9 Ultrasound System include:
Vascular: Assessment of vessels in the extremities and neck leading to or coming from the heart, superficial veins in the arms and legs, and vessel mapping. Assessment of superficial thoracic vessels.
Vascular Access: Guidance for PICC, CVC, dialysis catheter, port, PIV, midline, arterial line placement, access to fistula and grafts, and general vein and artery access.
Interventional: Guidance for biopsy and drainage.
Superficial: Assessment of breast, thyroid, parathyroid, testicle, lymph nodes, musculoskeletal procedures, soft tissue structures, and surrounding anatomical structures.

The subject device, the SiteRite™ 9 Ultrasound System ("SiteRite 9 System") is a portable device that features real-time 2D ultrasound imaging for vascular access device placement, which includes vessel measurement tools, vascular access device selection, procedure documentation and electronic connectivity.

The subject SiteRite 9 System is intended to aid in the placement of peripheral and central line vascular access devices and ultimately increase first stick success. The system is the replacement platform for the Site~Rite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology (i.e., the predicate device) and includes more up-to-date and reliable components aimed at providing improved image quality, while maintaining ease of operation.

The subject SiteRite 9 System can be viewed as the next generation SiteRite™ ultrasound system and is equivalent from a functionality standpoint to its predicate device, to the SiteRite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology (K182281). The SiteRite 9 System is essentially replacing its predicate device, the SiteRite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology ("Site~Rite 8 System"), due to the end-oflife obsolescence of its components.

The subject SiteRite 9 System differs from its predicate device, the Site~Rite 8 System (K182281). in that it includes newer, more "state of the art" hardware components resulting in a more efficient and reliable use of the device. Aside from these technical upgrades, most of the previously cleared features of the predicate device are being brought forward.

The subject SiteRite 9 System includes the following main components:

• Ultrasound System Console
• Ultrasound Beamformer
• System Software
• 9 Ultrasound Probe

Additionally, the subject SiteRite 9 System is compatible with the following accessories:

• SiteRite™ Probe Cover Kits
• Site~Rite® Needle Guide Kits
• Pinpoint TM GT Needle Guide Kits
• MER Roll Stand with Mounting Accessory (optional accessory)
• Kickstand with Mounting Accessory (optional accessory)
• Sony Printer UP-X898MD (off-the-shelf, optional accessory)
• USB Storage Device (off-the-shelf, optional accessory)

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the SiteRite™ 9 Ultrasound System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided FDA 510(k) summary does not include a specific table of quantitative acceptance criteria and corresponding device performance metrics for the SiteRite™ 9 Ultrasound System itself. Instead, it relies on a qualitative comparison to a predicate device and a statement that the device "successfully passed all respective testing" based on applicable standards and guidance documents.

However, based on the text, the overarching acceptance criterion is substantial equivalence to the predicate device (Site~Rite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology, K182281), particularly in terms of:

• Intended Use: Diagnostic ultrasound imaging of the human body.
• Indications for Use: Pediatric, Peripheral Vessel and Vascular Access, Small Organ, Musculo-skeletal, Cardiac imaging applications, and guidance for procedures.
• Technological Characteristics: Same fundamental scientific technology (piezoelectric material, 2D ultrasound imaging), patient-contacting materials, and software features.
• Safety and Performance: Demonstrated through non-clinical testing to meet relevant safety and performance requirements.

Reported Device Performance:
The document primarily states that the device "passed all respective testing" and that its performance "support[s] substantial equivalence to the predicate device." It also highlights that the SiteRite™ 9 includes "newer, more 'state of the art' hardware components resulting in a more efficient and reliable use of the device" and aims for "improved image quality" compared to its predicate.

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

The document does not explicitly state the sample size for any specific individual non-clinical test set. The data provenance is internal to Bard Access Systems, Inc. (C.R. Bard, Inc.) through their conducted "extensive verification and validation testing." As this is a non-clinical submission, the data would be laboratory-based and not related to patient retrospective or prospective data.

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. Given that the testing is non-clinical (primarily bench testing) and relies on compliance with standards rather than expert review of images, the concept of "ground truth" established by experts in the clinical sense is not applicable here.

4. Adjudication method

This information is not provided and is not relevant for the type of non-clinical testing described.

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. The device described is an ultrasound system, not an AI-powered diagnostic tool, and the submission explicitly states: "No clinical testing was conducted in support of the SiteRite™ 9 Ultrasound System, as the intended use, indications and technology are equivalent to those of the predicate device."

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

No, a standalone performance study in the context of an algorithm's performance was not done. This device is a hardware-software integrated ultrasound system, not an independent algorithm.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" would be defined by engineering specifications, established physical properties, and compliance with recognized standards (e.g., acoustic output limits, electrical safety parameters, image quality metrics as defined by test phantoms or calibrated equipment). For example, "Acoustic Safety Testing" would have acceptance criteria based on standard limits for acoustic output, and the "ground truth" is that the device's output should not exceed those limits when measured.

8. The sample size for the training set

This information is not applicable and not provided. The SiteRite™ 9 Ultrasound System is not described as an AI/ML device that requires a training set for model development. It's a traditional medical imaging device.

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

This information is not applicable and not provided, as there is no training set mentioned for an AI/ML model.

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Catheter stylets provide internal reinforcement to aid in catheter placement. When used with the Sherlock 3CG® Tip Confirmation System (TCS), the Sherlock 3CG® TPS Stylet/T-Lock Assembly also provides the placer rapid feedback on catheter tip location and orientation through the use of passive magnets and cardiac electrical signal detection.

Bard Access Systems, Inc.'s Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly is a sterile, single use device 0.49 mm (0.019 in) outer diameter x 78.5 cm, made of specially-formulated materials designed to aid in the placement of specific Bard catheters, as well as any open ended, non-valved, polyurethane, peripherally inserted central catheters (PICCs) that meet the dimensional specifications of the stylet. The Sherlock 3CG® TPS Stylet/T-Lock Assembly is designed to work with catheters containing a minimum lumen diameter of 0.51mm (0.020 in). The stylet provides internal reinforcement to aid in catheter placement. The Sherlock 3CG® TPS Stylet/T-Lock Assembly may be used with the Sherlock 3CG® Tip Confirmation System (TCS) to provide catheter tip placement information during the procedure.

I am sorry, but the provided documentation does not contain details about acceptance criteria, device performance, or specific study results for the Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly.

The document is a 510(k) summary for the device, focusing on demonstrating substantial equivalence to a predicate device (K142267). It lists various performance tests conducted (e.g., Clamp/Flow rate Test, Leak/Pressure Test, Reseal Test, Stylet Removal Force, Joint Tensile, Gauging, Liquid Leakage, Air Leakage, Separation Force, Unscrewing Torque, Ease of Assembly, Resistance to Overriding, Stress Cracking), along with the test methods (BD Internal Test Method or ISO 594-2). However, it does not disclose the specific acceptance criteria for these tests or the reported results that would allow for a comparison.

Therefore, I cannot provide the requested table of acceptance criteria and reported device performance or other details regarding a study that proves the device meets acceptance criteria.

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The PowerPICC Catheter is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, power injection of contrast media, and allows for central venous pressure monitoring. The maximum infusion flow rate is 5mL/second for power injection of contral venous pressure monitoring, it is recommended that a catheter lumen of 20gauge or larger be used.

A family of peripherally inserted central catheters made from specially formulated and processed medical grade materials. Each PowerPICC® catheter has a kink resistant, reverse tapered design. Catheters are packaged in a tray with accessories for reliable long (greater than 30 days) or short (less than 30 days) term vascular access.

The provided document is a 510(k) summary for the PowerPICC Catheter. It focuses on demonstrating substantial equivalence to a predicate device through various performance tests, rather than providing details of a study with acceptance criteria for an AI/ML powered device. Therefore, much of the requested information (sample sizes, ground truth establishment, MRMC studies, standalone performance, training set details) is not applicable or available in this document.

Here's the relevant information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the successful completion of the listed tests, indicating that the device performed as expected under the specified conditions. The document states that the performance tests were conducted "in determining substantial equivalence" and that "the subject PowerPICC Family Catheters have been demonstrated to be substantially equivalent to the cited predicate and reference devices." This implies that the device met the acceptance criteria derived from these tests.

2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for each test. It refers to "testing" in general. The data provenance is not mentioned, as these are in vitro and in vivo performance tests on the device itself, rather than studies involving patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. These are physical and biological performance tests, not clinical studies requiring expert ground truth for interpretation of outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is for physical and biological performance testing, not interpretation of data by experts.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML device, and no MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for these tests are the established scientific and engineering principles, material properties, and regulatory standards (e.g., ISO 10993-1, ISO 10555-1, ASTM F640-12, ISO 10555-3, FDA Guidance on Premarket Notification for Intravascular Catheters, ISO 80369-7, USP 788). The device's performance is measured against these defined benchmarks.

8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no training set.

9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.

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