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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 The mini guide wire is then withdrawn from the vessel.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. 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 TERUMO® SURFLO® FLEX I.V. Catheters and the TERUMO® SURFLASH™ I.V. Catheters are devices consisting of a slender, flexible, radio-opaque, plastic catheter with a hub that is inserted into the patient's vascular system for short term use to withdraw samples, administer fluid intravenously or through which to place monitoring equipment such as blood pressure monitors. The stainless steel cannula, placed in the catheter to maintain rigidity, is withdrawn after the catheter is placed in the vascular system.

The TERUMO SURFLO FLEX I.V. CATHETER AND THE TERUMO SURFLASH I.V. CATHETER are sterile, single use devices consisting of a slender tube (catheter) made of polyurethane. The devices are inserted into the patient's vascular system for short-term use to withdraw samples, administer fluids intravenously, or through which to place monitoring equipment such as blood pressure monitors.

Each device consists of a catheter assembly-catheter, caulking pin, catheter hub; a needle assembly-cannula, needle hub; and a filter cap with an air filter

The catheters are made of polyurethane, which allows appropriate stiffness for proper insertions into the vein, and flexibility during retention in the vein. Each catheter contains barium sulfate radio-opaque stripes along the length of the catheter to allow radio detectability. A stainless steel caulking pin fastens the catheter to the catheter hub.

Each catheter hub is color coded according to the outside diameter as specified in ISO 10555-5, "Sterile, single-use intravascular catheters - Part 5: Over-needle peripheral catheters".

The needle assembly has the same specifications as the Terumo® Surflo® I.V. Catheter, which is the subject of K891087. The transparent needle hubs permit flashback detection when the cannula enters the vessel.

The filter cap with an air filter is provided as a vent fitting.

The Terumo Surflo Flex I.V. Catheter is available in 14 sizes with different combinations of 6 catheter diameters and 5 catheter lengths (see following specifications table). The Terumo Surflash I.V. Catheter is available in 24G by 19mm currently. Additional sizes will be implemented at a later date.

The cannula of the Surflash I.V. Catheter are grooved from the heel of the cannula tip bevel to the end of the catheter tip, which allows flashback detection at the catheter tip after the catheter tip enters the vessel.

The only difference between the TERUMO SURFLO FLEX and the TERUMO SURFLASH I.V. catheters is the grooved cannula feature of the SURFLASH. All other specifications are the same.

The provided text is a 510(k) summary for a medical device (intravascular catheters) seeking substantial equivalence to already cleared devices. This type of submission does not typically involve the kind of elaborate clinical studies or AI performance metrics that the requested questions imply.

Therefore, many of the requested sections about acceptance criteria, detailed study designs, expert involvement, and AI performance cannot be answered from the provided document. The purpose of this 510(k) is to demonstrate that the new device is as safe and effective as a legally marketed predicate device, primarily through performance testing and material comparisons, rather than a comparative clinical trial with human and AI readers.

Here's an attempt to answer the questions based only on the provided text, and explicitly noting when information is not present:

Description of Acceptance Criteria and Device Performance Study

The TERUMO® SURFLO® FLEX I.V. Catheters and TERUMO® SURFLASH™ I.V. Catheters demonstrated substantial equivalence to predicate devices (Becton Dickinson (B-D®) Insyte® I.V. Catheter, B-D Insyte (N) I.V. Catheter, and Terumo® Surflo® I.V. Catheter) through a series of performance tests. The acceptance criterion for these tests was that the performance of the proposed devices be equivalent to that of the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance tests conducted to demonstrate equivalence. However, it does not provide specific quantitative acceptance criteria or detailed numerical results for the proposed device's performance, nor does it explicitly detail the predicate device's performance for direct comparison in the format below. The "reported device performance" is implicitly stated as meeting the equivalence standard.

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