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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 The mini guide wire is then withdrawn from the vessel.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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