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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.

Both the predicate Glidesheath Slender Tibial Pedal Kit (7cm needle) and the modified Glidesheath Slender Tibial Pedal Kit (4cm needle) are 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 The mini guide wire is then withdrawn from the vessel.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 provided document is a 510(k) summary for a medical device called the Glidesheath Slender Tibial Pedal Kit. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a comprehensive study involving human readers or algorithm-only performance.

Therefore, many of the requested details such as acceptance criteria, sample sizes for test and training sets, expert qualifications, and adjudication methods are not applicable nor present in this type of submission.

Here's an analysis based on the available information:

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

The document does not provide a table of acceptance criteria or specific performance metrics as typically seen in efficacy studies for AI/imaging devices. Instead, the "performance" section refers to a "Verification by Analysis" that confirms the modified device meets "predetermined criteria (Product Specifications)." These product specifications are general design and material characteristics as detailed in the comparison table on page 6, rather than clinical performance metrics.

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

This information is not applicable. The submission is a Special 510(k) for a modification (different needle length) to an already cleared device. It relies on a "Verification by Analysis" and comparison to the predicate device, not a new clinical study with a test set of data.

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 as no test set requiring ground truth established by experts was used.

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

This information is not applicable as no test set requiring expert adjudication was used.

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 is a catheter introducer kit, not an AI or imaging diagnostic device that would involve human readers or AI assistance.

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

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

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

This information is not applicable, as the evaluation was based on engineering verification and comparison to a predicate device, not clinical ground truth.

8. The sample size for the training set

This information is not applicable as no training set was used.

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

This information is not applicable as no training set was used.

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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.

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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.

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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.

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

Both the predicate Glidesheath Slender 6Fr (GSS 6Fr) and the modified Glidesheath Slender 5Fr & 7Fr (GSS 5Fr & 7Fr) consist of an introducer sheath and a dilator which are packaged together with an entry needle, mini guide wire and guide wire inserter. The GSS 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 two versions, either a stainless steel entry needle or a Surflo IV catheter (K891087).

The mini guide wire is used for placement of the sheath and dilator into the radial artery. The mini guide wire is offered in two versions, either a stainless steel (spring coil) model or a polyurethane (nitinol core) plastic model.

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.

This document describes a 510(k) premarket notification for the Glidesheath Slender (GSS) device, specifically for the 5Fr and 7Fr sizes. The submission claims substantial equivalence to the predicate GSS (6Fr) device (K122980). Therefore, the study is a non-clinical performance study comparing the modified device to the predicate.

Here's an analysis of the provided information concerning acceptance criteria and the study:

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

The document primarily relies on adherence to established international and internal standards as acceptance criteria. The device performance is generally stated as "met the requirements" or "results were within the predetermined acceptance criteria." Quantitative data for specific performance metrics are not provided in this summary.

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

• Sample Size: The document does not explicitly state the sample sizes used for each specific non-clinical test.
• Data Provenance: The tests are "non-clinical tests" and were conducted to "ensure safety and effectiveness of the modified GSS (5Fr & 7Fr) device throughout the shelf-life, verify conformity to applicable ISO and internal standards and acceptance criteria, and demonstrate substantial equivalence to the predicate device." The manufacturer is Terumo Medical Corporation, with production facilities in Japan (Ashitaka Factory of Terumo Corporation). This indicates the data is likely from internal testing by the manufacturer, not from a patient population. It is retrospective in the sense that it evaluates the manufactured device, not prospective in a clinical trial sense. The "country of origin of the data" would be Japan, where the manufacturing and potentially some testing occurs, and potentially the US, where Terumo Medical Corporation is located for regulatory affairs.

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

This is a non-clinical, performance testing study focused on engineering and material properties. There is no human "ground truth" establishment in the traditional sense, as these tests are based on objective physical standards (e.g., ISO, ASTM, USP, internal engineering standards). Therefore, this question is not applicable to the provided study description.

4. Adjudication Method for the Test Set:

Not applicable, as this is objective non-clinical performance testing against defined standards, not subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is a non-clinical performance study of a physical medical device (an introducer sheath), not an AI algorithm or an imaging device involving human readers.

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

Not applicable. This is a physical medical device.

7. The type of ground truth used:

The "ground truth" in this context refers to the defined specifications and requirements set forth by international standards (ISO, ASTM, USP) and the manufacturer's own internal standards. These are objective engineering and material science metrics. It is not an expert consensus, pathology, or outcomes data in the biological sense.

8. The sample size for the training set:

Not applicable. This is not a machine learning or artificial intelligence study, so there is no "training set."

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

Not applicable. There is no training set in this context.

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The Glidesheath Slender is used 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 and mini guide wire. The Glidesheath Slender is 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 two versions, either a stainless steel needle or a Surflo IV catheter (K891087).

The mini guide wire is used for placement of the sheath and dilator into the radial artery. The mini guide wire is offered in two versions, either a stainless steel (spring coil) model or a polyurethane (nitinol core) plastic model.

A guide wire inserter is also provided to assist in insertion of the mini guide wire into the cannula.

The provided 510(k) summary describes the Glidesheath Slender, a catheter introducer. This document focuses on demonstrating substantial equivalence to a predicate device (Terumo Glidesheath K082644) through performance testing, material comparison, and biocompatibility evaluations, rather than reporting on a study measuring a specific clinical outcome with defined acceptance criteria for device performance.

Therefore, many of the requested sections related to acceptance criteria, device performance, expert-established ground truth, MRMC studies, standalone performance, and training/test set details are not applicable as this is a submission for a medical device that relies on bench testing and material equivalency, not an AI/software as a medical device (SaMD).

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria or quantifiable device performance results for clinical outcomes. Instead, it lists various performance tests conducted according to ISO standards and internal standards to verify substantial equivalence to the predicate device. The implied acceptance criterion for each test is that the Glidesheath Slender performs adequately and comparably to the predicate device, thereby ensuring safety and effectiveness.

Table of Performance Tests and General Outcome (as inferred from the document):

The "reported device performance" is implicitly that the device successfully met all these technical and biological safety requirements, thereby demonstrating substantial equivalence to the predicate device.

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

The document refers to "bench tests" and "each lot of production" for LAL tests. It does not specify a distinct "test set" in the context of patient data. The tests are focused on component and assembly performance, material properties, and sterilization, typically involving a representative number of units or material samples from manufacturing lots. No patient data or clinical data is mentioned for these performance tests.

• Test Set Sample Size: Not specified in the context of patient data; applies to manufactured units/samples for bench testing.
• Data Provenance: Not applicable as these are bench tests and laboratory evaluations, not data from a specific country of origin or retrospective/prospective patient studies.

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

Not applicable. This device's evaluation relies on established engineering standards, biocompatibility protocols, and manufacturing quality controls, not an expert consensus on a "ground truth" derived from patient cases.

4. Adjudication method for the test set

Not applicable. No expert adjudication process is described for these types of performance tests.

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/SaMD device, and therefore, an MRMC study is not relevant to its evaluation.

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

Not applicable. This is not an AI/SaMD device.

7. The type of ground truth used

The "ground truth" for this device's evaluation is defined by established engineering specifications, material composition standards, ISO/FDA recognized test methods, and biocompatibility requirements. For instance, the ground truth for "Dimensional verification" is the specified blueprint dimensions, and for "Corrosion resistance," it's the absence of corrosion under specified conditions.

8. The sample size for the training set

Not applicable. This is not an AI/SaMD device; there is no "training set."

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

Not applicable. There is no "training set" or corresponding ground truth.

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

The Entry Needle is an accessory device which is used to gain access to the vein or artery including but not limited to the radial artery, for placement of the Mini Guide Wire.

The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or artery including but not limited to the radial artery.

The Glidesheath is comprised of an introducer sheath and a dilator. The Glidesheath is coated with a hydrophilic coating to reduce the frictional resistance of the sheath when inserting or removing the sheath from the patient's blood vessel. The Sheath and Dilator contain bismuth, making these devices visible under fluoroscopy. The Glidesheath is used to facilitate placing a catheter through the skin into a vein or artery including but not limited to the radial artery.

The Entry Needle is an accessory device which is used to gain access to the vein or artery including but not limited to the radial artery, for placement of the Mini Guide Wire.

The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or artery including but not limited to the radial artery. The Guide Inserter which is attached to the Mini Guide Wire holder is used to straighten out the wire.

Accessories to the Glidesheath are the metal entry needle and the mini guide wire. Both the metal entry needle and the mini guide wire are packaged with the Glidesheath in a pouch prior to sterilization.

The provided text describes the 510(k) summary for the Glidesheath introducer sheath, comparing it to a predicate device (K082644) to demonstrate substantial equivalence. The information focuses on the device's design, materials, specifications, and performance testing, which is largely bench testing and biocompatibility studies.

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

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail threshold manner for each performance test. Instead, it lists the performance tests that were successfully passed. The implication is that passing these tests constitutes meeting the acceptance criteria for a medical device of this type.

Table of Acceptance Criteria and Reported Device Performance:

Study Details for Acceptance Criteria Proof:

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

   • The document does not specify sample sizes for individual performance tests (e.g., how many needles were tested for joint strength).
   • It also does not indicate the data provenance (e.g., country of origin, retrospective or prospective). Given the nature of bench testing, it's typically performed in a laboratory setting by the manufacturer.

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

   • This information is not provided. For mechanical and biocompatibility testing, ground truth is typically established by adhering to recognized international standards and internal quality control specifications, rather than relying on expert consensus in the way clinical studies do. The "experts" would be the engineers and scientists performing and interpreting the standardized tests.

3. Adjudication method for the test set:

   • This information is not applicable or not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving subjective interpretations (e.g., image reading). The listed performance tests are primarily objective, quantitative, or qualitative assessments against defined standards.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:

   • No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for diagnostic imaging devices or devices where human interpretation is a key component, often comparing human performance with and without AI assistance. This document describes a physical medical device (introducer sheath) that does not involve diagnostic interpretation or AI.

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

   • No, a standalone algorithm performance study was not done. This device is a physical mechanical instrument and does not incorporate an AI algorithm.

6. The type of ground truth used:

   • The ground truth for most performance tests (Needle, Guide Wire, Dilator, Sheath, Inserter, System) would be based on engineering specifications, material science standards, and functional requirements for similar medical devices.
   • For Biocompatibility, the ground truth is established by international biological evaluation standards (ISO 10993), which define acceptable thresholds for biological responses (e.g., absence of cytotoxicity, genotoxicity, etc.).
   • For Sterilization, the ground truth is based on sterilization validation standards (ANSI/AAMI/ISO 11135) to achieve a defined Sterility Assurance Level (SAL) of 10^-6.

7. 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."

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

   • This is not applicable for the same reason as point 7.

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

The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or artery including but not limited to the radial artery.

The Radifocus Obturator is also an accessory device which is used by placing it into the sheath to create an occlusion and further provide support to the wall of the indwelling sheath while it remains in place within the vein or artery, including but not limited to the radial artery, after removal of a catheter.

The Glidesheath is comprised of an introducer sheath and a dilator. The Glidesheath is coated with a hydrophilic coating to reduce the frictional resistance of the sheath when inserting or removing the sheath from the patient's blood vessel. The Glidesheath is used to facilitate placing a catheter through the skin into a vein or artery including but not limited to the radial artery.

The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or artery including but not limited to the radial artery. The Mini Guide Wire is inserted through a cannula placed in the patient's blood vessel. The Glidesheath is 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 while the Glidesheath is being placed into the vessel. The Dilator can be removed and an appropriate catheter can then be inserted.

The Obturator is also an accessory device which is used by placing it into the sheath to create an occlusion and further provide support to the wall of the indwelling sheath while it remains in place within the vein or artery, including but not limited to the radial artery, after removal of a catheter. The Obturator is sold separately.

The Sheath, Dilator and Obturator contain bismuth, making these devices visible under fluoroscopy.

Accessories to the Glidesheath are the mini guide wire, Surflo IV catheter, Syringe, and Scalpel, and the RADIFOCUS Obturator. Depending on the product code, these accessories may or may not be contained within the kit. All of the accessories are packaged with the Glidesheath in a pouch prior to sterilization.

The provided text is a 510(k) summary for the Glidesheath, a medical device. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a dedicated study with performance metrics in the way, for example, an AI/ML algorithm would be evaluated for accuracy.

Therefore, many of the requested categories (e.g., sample size for test/training set, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth) are not applicable to this type of device submission based on the provided information.

Here's an analysis based on the information provided, highlighting what is included and what is not:

Acceptance Criteria and Device Performance Summary

Since this is a 510(k) submission for substantial equivalence for a medical device (introducer sheath, dilator, guide wire, obturator), the "acceptance criteria" and "device performance" are primarily focused on meeting regulatory requirements for safety and effectiveness through comparison to already marketed predicate devices, rather than quantitative performance metrics like sensitivity, specificity, or accuracy for a diagnostic or AI device.

The "study" that proves the device meets the "acceptance criteria" is essentially the comparison to predicate devices and adherence to relevant standards/tests.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. This is a 510(k) submission for a physical medical device, not a data-driven device (like an AI/ML algorithm) that typically relies on a "test set" in the conventional sense of machine learning. The "testing" involves biocompatibility tests, sterilization validations, and performance characteristic determinations based on engineering principles and comparisons to predicate devices, not data sets of patient information.
• The provenance of data is not specified in terms of country of origin or retrospective/prospective, as typical for clinical data studies. The testing is laboratory and bench-top oriented.

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

• Not Applicable. Ground truth in the context of diagnostic performance metrics is not established for this type of device. The verification and validation activities are based on engineering standards, material science, and regulatory compliance.

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

• Not Applicable. Adjudication methods are relevant for subjective evaluations, typically in clinical studies or expert consensus for ground truth. This is not the type of evaluation 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

• Not Applicable. An MRMC study is relevant for diagnostic imaging devices, particularly with AI assistance. This device is an introducer sheath for facilitating catheter placement, not an imaging or diagnostic interpretation device.

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

• Not Applicable. This is not an algorithm-based device.

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

• Not Applicable in the sense of clinical ground truth for diagnostic accuracy. For physical device testing, "ground truth" equates to established engineering specifications, validated test methods (e.g., ISO standards for biocompatibility and sterilization), and objective measurements.

8. The sample size for the training set

• Not Applicable. This device does not involve a "training set" like an AI/ML algorithm.

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

• Not Applicable. This device does not involve a "training set" or "ground truth" in the context of data-driven learning.

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The Glidesheath is used to facilitate placing a catheter through the skin into a vein or artery. The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or artery. The RADIFOCUS Obturator is also an accessory device which is used by placing it into the sheath to create an occlusion and further provide support to the wall of the indwelling sheath while it remains in place within the vein or artery after removal of a catheter.

The Glidesheath is comprised of an introducer sheath and a dilator.

The Glidesheath is used to facilitate placement of a catheter through the skin into a vein or artery. A Mini Guide Wire (with Inserter) may be included with the Glidesheath. The mini guide wire is available in a stainless steel or a nickel-titanium alloy polyurethane coated configuration. The Inserter does not contact blood and is used strictly for guiding the Guide Wire into a cannula or Introducer.

The A kit also contains a Surflo IV catheter, 2.5ml syringe, and scalpel for use in priming the system and gaining initial access to the vessel. Once access is obtained, the Mini Guide Wire is inserted through the cannula which was placed in the patient's blood vessel. The Glidesheath is then inserted over the Mini Guide Wire and into the blood vessel. The Mini Guide Wire is then withdrawn from the vessel. The Ditator maintains the integrity of the Sheath and dilates the blood vessel while the Glidesheath is being placed into the vessel. The Dilator can be removed and an appropriate catheter can then be inserted. The RADIFOCUS Obturator is an accessory device which creates an occlusion when inserted into the Sheath. The Obturator also provides support to the indwelling Sheath after the catheter is removed.

The Sheath, Dilator and Obturator contain bismuth, making these devices visible under fluoroscopy.

The provided text describes a 510(k) summary for the Glidesheath, a medical device, and its substantial equivalence to a predicate device. It indicates performance testing was conducted to demonstrate this equivalence. However, the document does not describe acceptance criteria, the specific study design to prove acceptance criteria, or the detailed results of such a study in terms of quantitative performance metrics. Instead, it lists the types of verification tests performed and states that "None of the data raises any new issues of safety and effectiveness."

Therefore, based solely on the provided text, I cannot complete the requested tables and information as it is not present in the document. The general nature of the performance section, which focuses on demonstrating substantial equivalence to a predicate device rather than meeting specific, quantified acceptance criteria for a novel functionality, means this level of detail is absent.

Here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

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.
• Data Provenance: Not specified (since this is a device modification, likely internal laboratory testing, but not explicitly stated).
• Retrospective or Prospective: Not specified.

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):

• Number of Experts: Not applicable. This is a physical medical device, not an AI or diagnostic imaging device that requires expert ground truth establishment in the traditional sense. The "ground truth" would be the engineering specifications and performance of the device itself.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable. This is a physical medical device.

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

• MRMC Study: No, this is not an AI or diagnostic imaging device.

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

• Standalone Performance: Not applicable. This is a physical medical device.

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

• Type of Ground Truth: For the "verification tests" performed (Leakage/clogging, Tensile strength of connections, etc.), the "ground truth" would be established engineering standards, material specifications, and physical measurement against those standards. It's an internal verification process, not clinical "ground truth" in the diagnostic sense.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

• Ground truth for training set: Not applicable.

Summary of available information:

The document focuses on demonstrating substantial equivalence of a modified Glidesheath device to a predicate device (Glidesheath K033681). This is done through a series of "verification tests" on the physical properties of the device components. The tests listed are:

• Leakage/clogging
• Tensile strength of connections
• Separation force of dilator and sheath
• Internal sliding resistance
• External sliding resistance
• Penetration force

The conclusion from these tests and a risk analysis is that "None of the data raises any new issues of safety and effectiveness," thus supporting substantial equivalence. The document does not provide specific numerical acceptance criteria or quantitative results for these tests.

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The Glidesheath is used to facilitate placing a catheter through the skin into a vein or artery. The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or artery. The RADIFOCUS Obturator is also an accessory device which is used by placing it into the sheath to create an occlusion and further provide support to the wall of the indwelling sheath while it remains in place within the vein or artery after removal of a catheter.

The Glidesheath is comprised of an introducer sheath and a dilator.

The Glidesheath is used to facilitate placement of a catheter through the skin into a vein or artery. A Mini Guide Wire (with Inserter) may be included with the Glidesheath. The Inserter docs not contact blood and is used strictly for guiding the Guide Wire into a cannula or Introducer.

The Mini Guide Wire is inserted through a cannula placed in the patient's blood vessel. The Glidesheath is 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 while the Glidesheath is being placed into the vessel. The Dilator can be removed and an appropriate catheter can then be inserted. The RADIFOCUS Obturator is an accessory device which creates an occlusion when inserted into the Sheath. The Obturator also provides support to the indwelling Sheath after the catheter is removed.

The Sheath, Dilator and Obturator contain bismuth, making these devices visible under fluoroscopy.

Here's an analysis of the provided text regarding the Glidesheath device, focusing on acceptance criteria and the study proving its compliance:

The provided text describes a 510(k) premarket notification for a new device, the Glidesheath, and its substantial equivalence to a previously cleared device, the RADIFOCUS® Introducer II (K954234). Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are not focused on a strict performance threshold for the Glidesheath itself, but rather on demonstrating that the Glidesheath performs as well as or is substantially equivalent to the predicate device.

Here's the breakdown of the information requested, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states, "None of the data raises any new issues of safety and effectiveness." This implies that the Glidesheath's performance in these categories met the acceptable levels established by the predicate device and did not introduce new risks or deficiencies. The "acceptance criteria" for each test would have been defined by the performance characteristics of the predicate device, K954234.

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

• Sample Size: The document does not specify the sample sizes used for the verification tests (Leakage/clogging, Tensile strength, etc.).
• Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given these are physical/mechanical property tests, they would be conducted in a laboratory setting.

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

This is not applicable in this context. The "ground truth" for these performance tests is typically established through direct measurement against pre-defined engineering and material specifications, and comparison to the predicate device's performance. It does not involve human experts establishing a subjective "ground truth" in the way a diagnostic imaging study would.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like "2+1" or "3+1" are relevant for subjective assessments, often in clinical studies or image interpretation. For engineering verification tests, results are typically objective measurements.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic accuracy, especially of AI/CAD systems, and involves human readers interpreting cases. The Glidesheath is a physical medical device (introducer sheath, dilator, guide wire) and its performance is assessed via engineering and material properties, not diagnostic interpretation.

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

This is not applicable. The Glidesheath is a physical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the verification tests was based on objective measurements of physical and mechanical properties (e.g., force, resistance, leak rates) compared against the performance characteristics of the predicate device, RADIFOCUS® Introducer II. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for these specific tests.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" as this is not an AI/machine learning device. The "study" here refers to verification testing of a physical device.

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

This is not applicable, as there is no training set for this type of device.

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