Search Results

R2P NaviCross is indicated to guide and support a guidewire during access of the peripheral vasculature through an access site, including but not limited to the radial artery, allow for wire exchanges, and provide a conduit for the delivery of saline or diagnostic contrast agents.

R2P NaviCross is a low-profile, 4.5Fr, 200cm length catheter. It is intended to guide and support a 0.035" or smaller guidewire during access of the vasculature, allow for wire exchanges and provide a conduit for the delivery of saline or diagnostic contrast agents. The catheter is ethylene oxide sterilized for single use only. The catheter features a three-layer construction, consisting of a stainless steel double braid mesh sandwiched between an outer and inner layer of polyester elastomer. The mesh is embedded within the catheter wall the entire length of the catheter with the exception of the distal tip. The distal tip is comprised of a polyester elastomer and is offered in both a straight and an angled tip shape. The catheter features three embedded radiopaque markers, one platinum alloy marker located 2mm from the distal tip, and two gold alloy markers. The first gold alloy marker is located 40mm from the distal edge of the platinum alloy marker, and the second gold marker is located 60mm from the distal edge of the first gold marker. There are also two proximal depth markers (pigment), located at 120cm and 150cm, which are there to help with procedural efficiency and minimize the use of fluoroscopy. The distal 40cm portion of the device has a hydrophilic coating. The catheter body is attached to a polyamide hub and a strain relief that contains a polyether block amide (PEBA with colorant and HLS). The device is offered in an effective length of 200cm.

The document provided does not describe an AI/ML powered medical device. Instead, it is a 510(k) premarket notification for a physical medical device called R2P NaviCross, a support catheter. Therefore, the requested information about acceptance criteria, study details, and impact of AI assistance is not applicable in this context.

The document focuses on demonstrating the substantial equivalence of the R2P NaviCross to a legally marketed predicate device (K110540, NaviCross ™, Terumo Support Catheter) and other reference devices based on non-clinical performance, biocompatibility, and sterilization testing. No clinical tests were performed for this 510(k) submission.

Ask a specific question about this device

The TR Band® is a compression device indicated to apply compression in order to achieve hemostasis while allowing the user to maintain patency of the radial artery after a transradial procedure (patent hemostasis).

The TR BAND® Radial Compression Device is a tourniquet style device consisting of a plastic belt with hook and loop adjustable fastener on each end, two compression balloons, and an injection port. The device also contains a TR Band Inflator.

After a transradial catheterization procedure, the TR Band is placed around the patient's wrist and the hook and loop strap is connected. Once the introducer sheath is removed from the patient's wrist, pressure is applied to the patient's access site by inflating the compression balloons of the TR Band. Both compression balloons are filled at the same time while air is being introduced through the air injection port.

The balloons are inflated when air is injected into the air injection port by the TR Band Inflator. The TR Band inflator is a specially designed syringe for use only with the TR Band. A valve on the air injection port assures that the air remains within the compression balloons. The volume of air can be reduced or increased by use of the TR Band Inflator (20ml syringe). This allows the physician to make fine adjustments to the pressure in the TR Band.

With the two compression balloons (large and small) the pressure is applied for efficient compression for hemostasis. The belt also has a support plate over the two compression balloons to assure that the balloons and belt conform to the contour of the wrist. The belt and compression balloons are made of clear plastic which allows the physician to view the access site during the hemostasis process.

The TR Band is a disposable device intended for single use only. This device is individually packaged and sterilized by ethylene oxide gas.

The provided text is a 510(k) Summary for the TR BAND® Radial Compression Device (K213531). It describes a submission for modifications to the Indications for Use and minor changes to the design of an existing device.

The document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K152525 TR BAND® Radial Compression Device) and a reference device (K173563 ARC Adjustable Radial Cuff Compression Device).

Crucially, this submission explicitly states that it does not include data from clinical tests. Therefore, it does not describe a study that proves the device meets specific performance criteria based on clinical outcomes, nor does it establish ground truth for a test set using expert consensus, pathology, or outcomes data, as would be expected for an AI/ML medical device.

Based on the provided text, the device's acceptance is based on non-clinical performance testing and a comparison to a predicate device, not on a clinical study evaluating its effectiveness with human subjects or AI performance metrics.

Therefore, I cannot fill in most of the requested fields related to a clinical study, AI performance, or ground truth establishment. However, I can extract information regarding the non-clinical acceptance criteria and the testing done to meet them.

Here's the information that can be extracted and a clear explanation of what is not present:

Acceptance Criteria and Device Performance (Based on Non-Clinical Testing for Substantial Equivalence)

The document primarily focuses on demonstrating substantial equivalence to a predicate device by showing that the modified device has the same intended use, technology, materials, and comparable performance through non-clinical testing.

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

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

• Sample Size: Not explicitly stated for specific non-clinical tests. Standard engineering and quality testing typically uses a defined number of units, but this detail is not provided in a summary document like this.
• Data Provenance: The tests were conducted internally by Terumo Medical Corporation or by their contracted sterilization facility (Steris Isomedix Services Inc.). The data is from non-clinical, laboratory-based performance testing of the device prototypes/production samples. It is not patient or clinical data.

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

• N/A. This submission relies on non-clinical engineering and performance testing against established standards and equivalence to a predicate device, not on expert-based clinical ground truth.

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

• N/A. Not applicable, as there is no clinical test set requiring expert adjudication.

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

• No. An MRMC study was not conducted. This device is a mechanical compression device, not an AI/ML-driven diagnostic or assistive tool.

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

• N/A. Not applicable. This is not an algorithm-only device.

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

• Ground truth in this context is based on engineering specifications, adherence to recognized industry standards (e.g., ASTM, ISO), and direct comparison to the performance characteristics of the legally marketed predicate device. There is no "clinical ground truth" established in this submission.

8. The sample size for the training set:

• N/A. Not applicable, as this device does not involve a "training set" in the context of machine learning or AI.

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

• N/A. Not applicable.

Summary of Study Type:

The "study" described in this 510(k) summary is a non-clinical performance and engineering validation study focused on demonstrating substantial equivalence to a predicate device. It involves:

• Bench testing: Evaluating physical and functional characteristics (e.g., tensile strength, leak tests, dimensions).
• Sterilization validation: Ensuring the device can be consistently sterilized to required levels.
• Packaging integrity testing: Verifying the packaging maintains sterility and protects the device.
• Shelf-life testing: Confirming the device retains its properties over its stated shelf life.
• Risk analysis: Identifying and mitigating potential risks associated with the device.

The statement "This 510(k) does not include data from clinical tests" (page 10) explicitly confirms that the acceptance of this medical device (based on this specific submission) is not predicated on human clinical trial data or performance in a patient population to demonstrate its effectiveness or safety. Instead, it relies on the similarity to a device already deemed safe and effective, supported by robust non-clinical testing.

Ask a specific question about this device

R2P™ Destination Slender™ Guiding Sheath is indicated for the introduction of interventional and diagnostic devices into the human vasculature through an access site, including but not limited to the radial artery.

The R2P™ Destination Slender™ Guiding Sheath is a low profile guiding sheath designed to perform as a guiding catheter and an introducer sheath. The sheath is coil reinforced, has a radiopaque tip, is hydrophilically coated, and is available in 6Fr with a length of 75cm, 85cm, 95cm, 105cm, 119cm and 149cm. It comes packaged with a dilator and hemostatic valve.

This document is a 510(k) Premarket Notification for a medical device called the "R2P™ Destination Slender™ Guiding Sheath." It is a submission to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, not a study proving the device meets specific acceptance criteria in the context of an AI/ML-based medical device.

Therefore, the requested information regarding acceptance criteria, study details for AI/ML performance, sample sizes, expert involvement, ground truth establishment, MRMC studies, and standalone performance for an AI/ML device cannot be extracted from this document because this document is about a physical medical device (guiding sheath) and does not involve AI/ML technology or related performance studies.

The document primarily focuses on:

• Device Description: A guiding sheath used for introducing other medical devices into the human vasculature.
• Comparison to Predicate Device: Demonstrating that the new device is substantially equivalent to a previously cleared predicate device (K171491 R2P™ Destination Slender™ Guiding Sheath). This equivalence is based on intended use, technology/principle of operation, materials, and performance.
• Non-Clinical Testing: Performance tests (e.g., Ovalization, Simulated Use and Particulate, Coating Integrity, Torque Strength) conducted to ensure the device meets applicable design and performance requirements and supports substantial equivalence.
• Biocompatibility and Sterilization: Addressing these aspects based on previous testing of the predicate device, as the new device is essentially the same in composition and manufacturing, with only variations in length.
• Absence of Clinical Tests: Explicitly stating that this 510(k) does not include data from clinical tests.

To answer your prompt about acceptance criteria and study data for an AI/ML device, a different type of FDA submission (e.g., a De Novo request or a 510(k) for an AI/ML device) would be required, which would contain performance data derived from clinical or scientific studies involving algorithms and data sets.

Ask a specific question about this device

The Glidesheath Slender Tibial Pedal Kit is indicated to facilitate placing a catheter through the skin into the lower extremity peripheral vasculature below the knee.

The Glidesheath Slender Tibial Pedal Kit is used to facilitate placing a catheter through the skin into the lower extremity peripheral vasculature below the knee. It consists of an introducer (sheath and dilator), which are packaged together with a mini guide wire, an entry needle and a guide inserter.

During a diagnostic or interventional procedure in a cath lab, the stainless steel entry needle (cannula) is used to gain access to the vein or artery for placement of the mini guide wire. The nitinol mini guide wire is inserted through the cannula into the patient's blood vessel. The wire is used for placement of the sheath and dilator into the vein or artery. The Guide Inserter which is attached to the Mini Guide Wire holder is used to assist the placement of the wire into the needle.

Following guide wire insertion, the cannula is removed and the sheath and dilator are then inserted over the mini guide wire and into the blood vessel. The mini guide wire is then withdrawn from the vessel. The dilator maintains the integrity of the sheath and dilates the blood vessel during insertion. Once the sheath is situated in the vessel, the dilator is removed and an appropriate catheter can then be inserted through the sheath.

The sheath incorporates a 1-way valve and a 3-way stopcock connected by a side tube. The sheath is coated with hydrophilic coating to minimize frictional resistance when inserting or removing the sheath from the patient's blood vessel. In addition, the sheath and dilator contain bismuth, making these devices visible under fluoroscopy.

The sheath, dilator, entry needle, mini guide wire and guide inserter are provided in a single package and sterilized together.

The Glidesheath Slender Tibial Pedal Kit is a disposable, ethylene oxide gas sterilized device intended for single use only.

The Glidesheath Slender Tibial Pedal Kit is a medical device, and the provided document is a 510(k) summary for its premarket notification to the FDA. As such, the concept of "acceptance criteria" and "device performance" in this context refers to demonstrating substantial equivalence to a legally marketed predicate device rather than achieving specific quantitative performance metrics typically seen in AI/software medical devices.

The "study" that proves the device meets the acceptance criteria is a combination of non-clinical tests (packaging, cadaver testing) and a comparison to existing PRIME Registry data, rather than a clinical trial directly evaluating the device's efficacy against a predefined standard.

Here's an attempt to extract the requested information, understanding that some categories might not be directly applicable or phrased differently for a medical device clearance like this.

1. Table of Acceptance Criteria and Reported Device Performance

• Identical materials, formulation, geometry, source, processing, and sterilization method for individual components.
• Successful packaging verification testing.
• Demonstrated clinical feasibility in cadaver testing.
• Favorable comparison to PRIME Registry data. |
  | Packaging Durability: Packaging must ensure the durability of the device throughout distribution. | Packaging verification testing was performed, including Visual Inspection (Post Environmental Conditioning and Distribution Simulation), Detecting Seal Leaks by Dye Penetration (ASTM F1929-15), Seal Strength (ASTM F88/F88M-15), and Climatic Stressing (ASTM F2825-10). The packaging was found to be durable. |
  | Clinical Feasibility (Cadaver Testing): Device compatible with insertion angles and acceptable for use in Below-The-Knee (BTK) access; protocols used by physicians in standard practice are equivalent to the test protocol. | Cadaver testing using lower leg models demonstrated that the Glidesheath Slender sheath is compatible with insertion angles for ultrasound-guided BTK access in four BTK vessels. The kit and components were deemed acceptable for BTK access. A follow-up survey confirmed physician protocols align with the study's access protocol. |
  | Biocompatibility: Meet biological safety requirements for an external communicating device, circulating blood with limited contact (up to 24 hours), per EN ISO 10993-1 and FDA Guidance. | No additional biocompatibility testing was performed as all components are identical to predicate/reference devices in materials, formulation, etc. The device is considered to have substantially equivalent biocompatibility. |
  | Sterilization (SAL 10-6): Achieve a Sterility Assurance Level (SAL) of 10-6 in accordance with ISO 11135:2014. | The device was adopted into an existing ethylene oxide sterilization process validated via the overkill half-cycle approach to achieve an SAL of 10-6. |
  | Sterilant Residuals: Ethylene oxide (EO) and ethylene chlorohydrin (ECH) levels must not exceed average daily doses of 4 mg and 9 mg, respectively, after 24 hours of heated aeration, per EN ISO 10993-7:2008. | Sterilant residual testing demonstrated that EO and ECH levels did not exceed the specified limits after 24 hours of heated aeration. |

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

• Test Set for Packaging: The document does not specify the exact sample size for each packaging test (Visual Inspection, Seal Leaks, Seal Strength, Climatic Stressing).
• Test Set for Cadaver Testing: The document mentions "lower leg models" but does not specify the number of cadavers or individual access attempts.
• Test Set for Clinical Comparison (PRIME Registry): "The first 71 patients treated with the Terumo Glidesheath Slender when undergoing an index endovascular procedure using a tibial access point."
  • Data Provenance: The document states this was compared "to a literature based dataset of procedures using radial and femoral access," implying this data might be a mix of prospective collection (for the 71 patients) and retrospective (for the literature comparison). No country of origin is specified for the PRIME Registry data, but generally, medical device registries can be multinational.

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

• Packaging Testing: No external experts are mentioned for ground truth establishment; testing was done against established ASTM/ISO standards.
• Cadaver Testing: The study involved "physicians." A "follow-up survey" was conducted to confirm protocols. The number and specific qualifications of these physicians are not detailed beyond being "physicians" involved in BTK access.
• Clinical Comparison (PRIME Registry): The PRIME Registry data itself is likely based on clinical outcomes and assessments made by healthcare professionals during actual procedures. The document does not specify experts involved in establishing "ground truth" for comparative purposes, rather, it uses existing clinical data.

4. Adjudication Method for the Test Set

• Packaging Testing: Adjudication is inherently built into meeting the criteria of the referenced ASTM/ISO standards. No human adjudication is specified beyond standard quality control procedures.
• Cadaver Testing: The document implies assessment by physicians performing the procedures. No formal adjudication method (e.g., 2+1, 3+1 consensus) for the cadaver test results is described.
• Clinical Comparison (PRIME Registry): The document does not describe any specific adjudication method for the PRIME Registry data or the literature-based dataset. Registry data typically relies on established clinical reporting.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a catheter introducer (hardware), not an AI/software device that would typically involve human readers interpreting output with or without AI assistance. The clinical evaluation focused on comparing the device's performance to predicate devices and existing clinical practices using registry data.

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

No, this question is not applicable. The device is a physical medical instrument (catheter introducer kit), not an algorithm or software. Its performance is tied to its physical characteristics and how it functions during a medical procedure, not an algorithm's output.

7. The Type of Ground Truth Used

• Packaging Testing: Ground truth was based on adherence to established international standards (ASTM and ISO).
• Cadaver Testing: Ground truth was based on direct observation of the device's performance and compatibility with BTK access in simulated use, assessed by physicians. This can be considered a form of "expert assessment" in a simulated environment.
• Clinical Comparison (PRIME Registry): Ground truth was established through real-world clinical outcomes and procedural observations recorded in the PRIME Registry and a literature-based dataset. This could be considered a form of "outcomes data" and "clinical assessment."

8. The Sample Size for the Training Set

This question is not applicable. This is a hardware medical device, not a machine learning or AI model, thus there is no "training set" in the context of algorithm development.

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

This question is not applicable as there is no training set for a hardware device.

Ask a specific question about this device

The Glidesheath Slender is indicated to facilitate placing a catheter through the skin into the radial artery.

The Glidesheath Slender consists of an introducer (sheath and a dilator), which are packaged together with an entry needle, mini guide wire and guide wire inserter. The Glidesheath Slender devices (all sheath sizes) are used to facilitate placing a catheter through the skin into the radial artery. The sheath and dilator contain bismuth, making these devices visible under fluoroscopy. The sheath is coated with hydrophilic coating to minimize frictional resistance when inserting or removing the sheath from the patient's blood vessel.

The entry needle (cannula) is used to gain access to the radial artery for placement of the mini guide wire. The entry needle is offered in either the stainless steel (SS) entry needle version or the Surflo (SR) IV catheter (which includes a needle). There are two different types of stainless-steel entry needles that are available in various gauges and lengths. The two needle types are referenced in the documentation as TPC and TRI. These initials are only used in internal Terumo documents.

The mini guide wire is used for placement of the sheath and dilator into the radial artery. The mini guide wire is offered in three versions made out of three materials, either a stainless-steel spring coil model (stainless steel), a nitinol model with palladium tip (nitinol) or a polyurethane plastic model with a nitinol core (plastic).

During either a diagnostic or interventional catheterization procedure, a physician will perform the following procedure. The mini guide wire is inserted through a cannula placed in the patient's blood vessel. A guide wire inserter is provided to assist in insertion of the mini guide wire into the cannula. Following guide wire insertion, the cannula is removed, and the sheath and dilator are then inserted over the mini guide wire and into the blood vessel. The mini guide wire is then withdrawn from the vessel. The dilator maintains the integrity of the sheath and dilates the blood vessel during insertion. Once the sheath is situated in the vessel, the dilator is removed, and an appropriate catheter can then be inserted through the sheath.

The entry needle, the mini guide wire and the guide wire inserter are all accessories to the Glidesheath Slender sheath/dilator. The accessories for a given product code are provided with the Glidesheat Slender sheath/dilator in an individual package and sterilized together.

The acceptance criteria and study proving the device meets them are detailed for the Glidesheath Slender. The device is a catheter introducer for radial artery access.

Here's a breakdown of the information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a comprehensive list of performance tests conducted on various components of the Glidesheath Slender. The "Reported Device Performance" column implicitly states that the "Glidesheath Slender tested met the predetermined acceptance criteria and results support a determination of substantial equivalence." This means that for each test item listed, the device's performance fell within the acceptable parameters defined by the cited standards (ISO, ASTM, in-house) or internal requirements.

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

The document describes non-clinical performance testing, which typically involves testing of device units according to engineering standards rather than a "test set" of patient data. The specific number of units tested for each performance test item is not provided in this summary. The data provenance is internal to the manufacturer (Terumo Medical Corporation) and follows recognized international and in-house standards. This is not patient data, so "country of origin" and "retrospective/prospective" are not applicable in the usual sense for clinical studies.

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

This information is not applicable as the document explicitly states: "This 510(k) does not include data from clinical tests." The performance testing described is engineering and biocompatibility testing, where "ground truth" is established by adherence to specified physical and chemical properties and compliance with recognized standards.

4. Adjudication Method for the Test Set:

This information is not applicable as clinical data or expert review of cases is not part of this 510(k) summary.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "This 510(k) does not include data from clinical tests." Therefore, there is no information on how much human readers improve with AI vs. without AI assistance.

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

This is not applicable as the device is a physical medical instrument (catheter introducer), not an AI algorithm or software.

7. The Type of Ground Truth Used:

For the performance testing, the "ground truth" is established by:

• International Standards: ISO 11070:2014, ASTM F640-12, ISO 11135:2014, EN ISO 10993-1, EN ISO 10993-7:2008.
• FDA Guidance: FDA PTCA Guidance, FDA Guidance on Use of International Standard ISO 10993-1.
• In-house standards: Internal specifications developed by Terumo Medical Corporation.

These standards and guidances define acceptable physical, mechanical, chemical, and biological properties for device components.

8. The Sample Size for the Training Set:

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

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

This is not applicable for the same reason as above.

Ask a specific question about this device

The Destination® Carotid Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the carotid arteries.

The Destination® Peripheral Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to lower extremity access via a contralateral approach.

The Destination® Renal Guiding Sheath is intended for the introduction of interventional and diagnostic devices into the human vasculature including but not limited to the renal arteries.

The Destination® Guiding Sheath is designed to perform as a guiding catheter and an introducer sheath. The Destination® Guiding Sheath is a 3-layer tubing with a Stainless-Steel coil reinforcement sandwiched between layers of PTFE Teflon and Nylon Pebax, a hemostatic valve at the proximal end, a radiopaque marker near the distal end, and a hydrophilic coating on the distal portion of the tubing of varying lengths based on the product code. The sheath is available in multiple French sizes, useable lengths and distal shape configurations. The Destination® Guiding Sheaths are packaged with the following components: a Sheath, a Dilator, a Hemostatic Valve, and a Dilator Retaining Clip (only available with codes that contain the Tuohy-borst valve).

This is not an AI review. The document is for a medical device called "Destination Guiding Sheath" and pertains to its 510(k) premarket notification to the FDA. The submission seeks to establish substantial equivalence to previously marketed predicate devices, not an AI or algorithm. Therefore, the questions related to AI acceptance criteria, training sets, test sets, and expert adjudication are not applicable to this document.

However, I can provide the available information regarding the device's performance criteria and testing based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "The Destination® Guiding Sheath tested met the predetermined acceptance criteria and results support a determination of substantial equivalence." Specific numerical acceptance criteria are not detailed in the summary, but the types of tests performed and the general outcome are provided.

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

• Sample Size: Not specified in the provided text for non-clinical performance tests.
• Data Provenance: The tests were conducted internally ("In-house standard") or against FDA guidance documents. The document doesn't specify country of origin for the test data, but the manufacturer is Terumo Medical Corporation with locations in Somerset, NJ and Elkton, MD, suggesting U.S.-based testing or oversight. The studies were non-clinical (laboratory/bench testing).

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

This question is not applicable as the document describes a traditional medical device (catheter introducer), not an AI/ML device that requires expert ground truth for image or data interpretation. Performance was evaluated against engineering standards and regulatory guidelines.

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

Not applicable, as this refers to adjudication for expert-labeled ground truth in AI/ML studies.

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, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

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

The "ground truth" for the non-clinical tests was established by predefined engineering specifications, applicable FDA guidance documents, and international standards (e.g., ISO 10993 for biocompatibility, ISO 11135 for sterilization).

8. The sample size for the training set:

Not applicable, as this is not an AI/ML device and thus does not involve a training set.

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

Not applicable, as this is not an AI/ML device and thus does not involve a training set or its ground truth establishment.

Ask a specific question about this device

R2PTM Destination Slender™ Guiding Sheath is indicated to be used for the introduction of interventional and diagnostic devices in the lower extremities of the peripheral vasculature through an access site, including tut not limited to the radial artery.

The R2PTM Destination Slender™ Guiding Sheath is a low profile guiding sheath designed to perform as a guiding catheter and an introducer sheath. The sheath is coil reinforced, has a radiopaque tip, is hydrophilically coated and is available in 6Fr with a length of 119cm and 149cm. It comes packaged with a dilator and hemostatic valve.

The provided FDA 510(k) summary for the Terumo R2P™ Destination Slender™ Guiding Sheath describes non-clinical performance testing to demonstrate substantial equivalence to predicate devices. It does not include clinical study data or information about AI/ML algorithms. Therefore, many of the requested categories related to clinical studies, expert-derived ground truth, and AI performance metrics cannot be populated from the provided text.

Here's a breakdown of the available information:

1. Table of acceptance criteria and the reported device performance

The document states that the R2P™ Destination Slender™ Guiding Sheath "met the predetermined acceptance criteria and results support a determination of substantial equivalence." However, the specific quantitative acceptance criteria for each test item are not explicitly listed in the provided tables, only the test items themselves and the reference standards used.

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: Not specified in the document.
• Data Provenance: The document describes "non-clinical tests" and "performance testing" conducted. This refers to laboratory testing of the physical device, not patient data. Therefore, questions of country of origin or retrospective/prospective do not apply in the typical sense for clinical data. The manufacturer is Terumo Medical Corporation, located in the USA (Somerset, NJ and Elkton, MD).

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)

This question is not applicable. The testing described is non-clinical performance and biocompatibility testing of a physical medical device. "Ground truth" in the context of expert review for diagnostic AI software is not relevant here.

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

This question is not applicable. Adjudication methods are typically for resolving discrepancies in expert interpretations of clinical data, which is not part of this submission.

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 question is not applicable. This submission is for a physical medical device (guiding sheath), not AI software, and no clinical studies, especially MRMC, were conducted or reported.

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

This question is not applicable. This device is not an algorithm or AI software.

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

This question is not applicable in the context of clinical "ground truth." For the non-clinical performance tests, the "ground truth" would be established engineering specifications, industry standards (ISO), and in-house standards against which the device's physical properties are measured.

8. The sample size for the training set

This question is not applicable. This device does not involve a "training set" as it is a physical medical device, not an AI/ML algorithm.

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

This question is not applicable. As explained above, there is no "training set" for this device.

Ask a specific question about this device

The Glidesheath is indicated to facilitate placing a catheter through the skin into a vein or artery including but not limited to the radial artery.

The Glidesheath consists of an introducer (sheath and dilator), which are packaged together with a mini guide wire. Some product configurations also include an entry needle, guide wire inserter and a flushing syringe. The Glidesheath is used to facilitate placing a catheter through the skin into a vein or artery. The sheath is coated with hydrophilic coating to minimize frictional resistance when inserting or removing the sheath from the patient's blood vessel. In addition, the sheath and dilator contain bismuth, making these devices visible under fluoroscopy.

The entry needle (cannula) is used to gain access to the vein or artery for placement of the mini guide wire. The entry needle is offered in either stainless steel (SS) version or the Surflo (SR) IV catheter (which includes a needle) (K891087). There are two different types of stainless steel entry needles that are available in various gauges and lengths.

The mini guide wire is inserted through the cannula into the patient's blood vessel and is used for placement of the sheath and dilator into the vein or artery. A guide wire inserter is provided to assist in insertion of the mini guide wire into the cannula. The mini guide wire is offered in three versions, either a stainless steel spring coil model (stainless steel), a nitinol model with palladium tipped (nitinol) or a polyurethane plastic model with a nitinol core (plastic).

Following guide wire insertion, the cannula is removed and the sheath and dilator are then inserted over the mini guide wire and into the blood vessel. The mini guide wire is then withdrawn from the vessel. The dilator maintains the integrity of the sheath and dilates the blood vessel during insertion. Once the sheath is situated in the vessel, the dilator is removed and an appropriate catheter can then be inserted through the sheath. The flushing syringe is used to prime the dilator with heparinized saline.

The entry needle, the mini guide wire, the guide wire inserter and flushing syringe, are all accessories to the Glidesheath. Depending on the product code, certain accessories may or may not be contained within the kit. All of the accessories for a given product code are provided in an individual package with the Glidesheath and sterilized together.

The provided document is a 510(k) premarket notification for a medical device called Glidesheath™. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets a specific set of acceptance criteria through a clinical study with primary performance endpoints.

For medical devices seeking 510(k) clearance, the primary goal is to show that the new device is as safe and effective as a legally marketed predicate device. This is typically done through non-clinical performance testing and comparison of design, materials, and indications for use. Clinical studies (with human subjects) are often not required for 510(k) submissions if non-clinical data is sufficient to demonstrate substantial equivalence.

Based on the provided text:

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

   The document provides extensive tables (Table 5.4 to 5.9) detailing the non-clinical performance tests conducted on the proposed Glidesheath™. These tables list the component, test description, and the standard (e.g., ISO, ASTM, or Internal) against which the test was performed. The blanket statement "The components tested met the predetermined acceptance criteria and results support a determination of substantial equivalence" (Page 16) serves as the reported device performance, indicating that all listed tests passed their respective internal or external standard requirements.

   Since this is a 510(k) for substantial equivalence, the "acceptance criteria" are generally the standards set forth by the referenced ISO/ASTM documents or internal specifications, with the performance being that the device passed these tests.

   Example Excerpt from Table 5.4 (Sheath Performance Testing):

   Component	Test Description	Standard	Reported Device Performance (Implied)
   Sheath	Visual Inspection – Extraneous

matter | ISO 11070: 1998, Sect. 4.3 | Met acceptance criteria |
| Sheath | Liquid leakage through sheath | ISO 11070:1998, Sect. 7.3 & Annex D | Met acceptance criteria |
| Sheath | External Lubricity | Internal | Met acceptance criteria |

*(This table would be much longer if all tests were listed, but this demonstrates the format.)*

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

The document does **not explicitly state the sample sizes** used for each non-clinical performance test (e.g., number of sheaths, dilators, or needles tested). It refers to the tests being conducted on "the proposed TMC Glidesheath."

The data provenance is from **non-clinical tests** performed by Terumo Medical Corporation (Elkton, MD, USA) as the manufacturing site for the proposed device. The tests are prospective in the sense that they were specifically conducted for this 510(k) submission, testing the new device manufactured at the new site. The country of origin for the data generation would primarily be the USA (Elkton, MD).

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)

This information is **not applicable** to this 510(k) submission. The document describes non-clinical performance and biocompatibility testing of a physical medical device. "Ground truth" and expert adjudication are concepts typically associated with diagnostic AI/imaging studies where human interpretation is being compared against an AI system. For the physical performance tests listed, the "ground truth" is defined by the objective metrics and standards referenced (e.g., a certain force for tensile strength, or a specific leakage rate). The experts involved would be the engineers and technicians performing and verifying these laboratory tests, following the specified standards.

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

This is **not applicable** as the document describes non-clinical performance testing of a physical medical device, not a diagnostic study requiring adjudication of 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

This is **not applicable**. The document does not describe an AI device or a diagnostic imaging study. It pertains to a catheter introducer sheath.

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

This is **not applicable**. The device is a physical catheter introducer sheath, not an algorithm or AI system.

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

For the non-clinical performance tests, the "ground truth" is established by adherence to **predefined, objective metrics and standards** such as:
*   ISO 11070: 1998 (Sterile single-use intravascular introducers, dilators and accessories)
*   ASTM F640-12 (Standard Practice for Radiopacity of Medical Photographic Films)
*   ISO 594-1:1986, ISO 594-2: 1998 (Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment)
*   ISO 7886-1: 1993 (Sterile hypodermic syringes for single use – Part 1: Syringes for manual use)
*   ISO 10993 series (Biological evaluation of medical devices)

These standards define what constitutes acceptable performance for various physical and biological properties of the device components. Visual inspections would also follow internal quality standards based on these principles.

8. The sample size for the training set

This is **not applicable**. The Glidesheath™ is a physical medical device, not an AI or machine learning model that requires a "training set."

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

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

Ask a specific question about this device

The TR BAND® Radial Compression Device is a compression device to assist hemostasis of the radial artery after a transradial procedure.

The TR BAND® Radial Compression Device is a tourniquet style device consisting of a plastic belt with hook and loop adjustable fastener on each end, two compression balloons, and an injection port. The device also contains a TR Band Inflator. After a Transradial catheterization procedure, the TR Band is placed around the patient's wrist and the hook and loop strap is connected. Once the introducer sheath is removed from the patient's wrist, pressure is applied to the patient's access site by inflating the compression balloons of the TR Band. Both compression balloons are filled at the same time while air is being introduced through the air injection port. The balloons are inflated when air is injected into the air injection port by the TR Band Inflator. The TR Band inflator is a specially designed syringe for use only with the TR Band. A valve on the air injection port assures that the air remains within the compression balloons. The volume of air can be reduced or increased by use of the TR Band Inflator (20ml syringe). This allows the physician to make fine adjustments to the pressure in the TR Band. With the two compression balloons (large and small) the pressure is applied for efficient compression for hemostasis. The belt also has a support plate over the two compression balloons to assure that the balloons and belt conform to the contour of the wrist. The belt and compression balloons are made of clear plastic which allows the physician to view the access site during the hemostasis process. The TR Band is a disposable device intended for single use only. This device is individually packaged and sterilized by ethylene oxide gas.

The provided text is a 510(k) summary for the TR BAND® Radial Compression Device. It focuses on demonstrating substantial equivalence to a predicate device rather than conducting a de novo clinical study to establish new acceptance criteria and prove device performance against them.

Therefore, the document does not describe acceptance criteria for clinical performance or a study that proves the device meets such criteria. It explicitly states under section "H. CLINICAL TESTS (807.92(b)(2))": "This 510(k) does not include data from clinical tests."

Instead, it relies on non-clinical tests to demonstrate substantial equivalence to a previously approved predicate device (K070423 – TR BandTM). The acceptance criteria mentioned are related to these non-clinical tests, such as biocompatibility, sterilization, and material performance.

Here's an analysis of the information provided, focusing on what is available:

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

The document lists performance tests and states "All testing met acceptance criteria." However, it does not provide specific quantitative acceptance criteria or detailed reported performance results in a table format for each test. Instead, it refers to compliance with standards.

Here's a summary of the non-clinical tests that were performed and implied acceptance criteria (compliance with standards):

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

• Sample Size for Test Set: Not specified for the non-clinical tests. Non-clinical studies (e.g., sterilization validation, biocompatibility) typically use statistically relevant sample sizes according to the specific test standard, but these are not explicitly stated in the summary.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). Since these are largely lab-based non-clinical tests conducted by Terumo Medical Corporation (Elkton, MD, USA) and Steris Isomedix Services Inc. (South Plainfield, NJ), the data can be considered laboratory testing data. The studies are prospective in the sense that they were designed and executed to test the device's conformance.

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

• This information is not applicable as the submission explicitly states no clinical tests were performed. Ground truth, in the context of clinical studies, refers to a definitive diagnosis or outcome, usually confirmed by experts. The non-clinical tests rely on established scientific methods and standards, not expert consensus on medical diagnoses.

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

• Not applicable as no clinical studies were 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:

• Not applicable. This device is a radial compression device, not an AI-powered diagnostic tool, and no clinical studies were conducted.

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, and no clinical studies were conducted.

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

• Not applicable as no clinical studies were performed. The "ground truth" for the non-clinical tests would be the established scientific principles, test methods defined in ISO/ASTM standards, and the physical properties/performance of the device itself.

8. The sample size for the training set:

• Not applicable, as this is not a machine learning/AI device, and no clinical studies or training sets were mentioned.

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

• Not applicable, as this is not a machine learning/AI device, and no clinical studies or training sets were mentioned.

In summary: The provided FDA 510(k) summary is for a physical medical device (TR BAND® Radial Compression Device) and focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing, rather than establishing new clinical acceptance criteria or conducting clinical performance studies. The document explicitly states that no clinical data was included in this 510(k) submission.

Ask a specific question about this device

The Radifocus Glidewire Endoscopic Wire is intended to be used for selective cannulation of the biliary ducts, including but not limited to, the common bile, cystic, right and left hepatic ducts during endoscopic biliary procedures for catheter introduction and exchanges.

The Radifocus Glidewire Endoscopic Wire is an endoscopic guide wire that is provided sterile and is intended for single use only. It consists of a Nickel Titanium alloy core wire, and a polyurethane containing tungsten and hydrophilic polymer that are applied to the entire wire. There are two shaft configurations: standard and stiff; the stiff shaft has a slightly thicker core wire than that of the standard shaft. The wire distal segment comes in angled or straight configurations and is packaged in a plastic holder that is contained within an individual package. A guide wire inserter is contained within the individual package to assist with the insertion of the wire into an endoscope or catheter.

This document is a 510(k) premarket notification for a medical device called the Radifocus Glidewire Endoscopic Wire. It is a submission to the FDA demonstrating substantial equivalence to a predicate device, not a study describing acceptance criteria and device performance in the context of an AI-based system. Therefore, most of the requested information regarding AI study specifics like sample sizes for test and training sets, expert consensus, MRMC studies, and standalone performance is not applicable to this document.

However, I can extract and describe the acceptance criteria and the studies that prove the device meets these criteria, as presented in the document, which are related to the physical performance and safety of the guidewire.

Acceptance Criteria and Device Performance for the Radifocus Glidewire Endoscopic Wire

The device is a medical guidewire (non-AI), so the acceptance criteria are based on physical performance, biocompatibility, and sterility, rather than diagnostic accuracy or AI performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance:

Regarding the specific questions you asked for an AI study, the following are not applicable to this 510(k) submission for a non-AI medical device (guidewire):

2. Sample sizes used for the test set and the data provenance: Not applicable. Device is a physical guidewire, not an AI system processing data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. "Ground truth" for this device refers to the physical and chemical properties meeting specified standards.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

However, to address the core of "the study that proves the device meets the acceptance criteria" based on the document:

The studies that prove the device meets the acceptance criteria are non-clinical bench tests and material assessments. These include:

• Performance Testing per ISO 11070: 2014: This standard covers "Sterile single-use intravascular introducers, dilators and guidewires." Tests performed included Radiodetectability, Fracture Test, Flexing Test, and Peak Tensile Force of Guidewire. These tests were conducted on both non-aged and accelerated aged samples.
• Performance Testing per Terumo's Internal Standards: These tests included Flexibility Test of Distal Tip, Torque transmission, Sliding Resistance/Coating, Integrity (Product appearance), and Bending Strength. These were based on the predicate device's expected performance.
• Biocompatibility Testing: Assessed in accordance with ISO 10993-1, classifying the device and confirming material compatibility through comparison to the predicate device's established safety record and identical material composition.
• Sterilization Validation: Demonstrated compliance with ISO 11135 for Ethylene Oxide sterilization, ensuring a Sterility Assurance Level (SAL) of 10^-6 (although the document stated 10^-9, which is a higher level of assurance) and meeting residual EO/ECH limits per ISO 10993-7 for limited exposure devices.
• Pyrogen Testing Validation: Conducted using Limulus Amebocyte Lysate (LAL) testing (Photometric Quantitative Method) in accordance with USP and FDA guidance.
• Risk Analysis: Performed according to ISO 14971 to identify and mitigate potential risks.

These non-clinical tests collectively demonstrate that the Radifocus Glidewire Endoscopic Wire is safe and effective and substantially equivalent to the predicate device, fulfilling the regulatory requirements for the 510(k) submission. No clinical trials were conducted or required for this submission.

Ask a specific question about this device