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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 The Mini Guide Wire is then withdrawn from the vessel.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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