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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 The mini guide wire is then withdrawn from the vessel.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 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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