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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 The Mini Guide Wire is then withdrawn from the vessel.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® SurGuard2™ SAFETY NEEDLE device is intended for use in the aspiration and injection of fluids for medical purposes. The Terumo Safety Needle is compatible for use with standard luer slip and luer lock syringes.

Additionally, after withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.

The SurGuard2™ Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the connector hub with or without an attached hypodermic syringe. The safety sheath contains a locking mechanism which is activated when the sheath is manually pressed over the needle immediately after use and just prior to disposal to minimize the possibility of sharps injury. The safety sheath is activated with a one-handed operation by pressing the sheath against a firm surface. The locking mechanism is located at a designated position within the body of the short or long sheath appropriate for the needle size it is to contain. The needle gauge sizes fall within the 18 to 30gauge range and the needle lengths are 3/8" to 1 ½". The hinge feature allows the user to set the sheath to the desired position for use. For user convenience, when the needle is in the "bevel up" position the sheath is located to the right. The SurGuard2™ Safety Needle will be individually packaged and sterilized by electron beam as a safety needle only or as a safety needle with attached Terumo syringe. The syringe sizes are 1. 3,5, and 10cc/ml.

The provided document is a 510(k) premarket notification for the TERUMO® SurGuard2™ Safety Needle. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a standalone study with acceptance criteria and performance data for the new device.

Therefore, many of the requested elements (sample sizes for test/training sets, number/qualifications of experts, adjudication methods, MRMC studies, specific ground truth types) are not applicable or extractable from this type of regulatory submission, as it relies on the established performance of predicate devices.

However, I can extract the acceptance criteria as implied by the testing performed and describe how the document implies the device meets these criteria through substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

Description of Acceptance Criteria and Study to Prove Device Meets Criteria (Based on Substantial Equivalence)

The TERUMO® SurGuard2™ Safety Needle, as described in this 510(k) submission (K051865), demonstrates its compliance by proving substantial equivalence to existing legally marketed predicate devices. This means that the acceptance criteria are implicitly met if the new device performs equivalently to the predicates in key areas. The study demonstrating this is essentially a comparison study against the predicates across various specifications and performance tests.

1. Table of Acceptance Criteria and Reported Device Performance:

Study Description:

The study to "prove the device meets the acceptance criteria" is implicitly the 510(k) submission itself, which functions as a comparative effectiveness study against predicate devices to establish substantial equivalence. The manufacturer asserts that the performance of the SurGuard2™ Safety Needle is substantially equivalent to the legally marketed predicate devices (K031453, K040531, K023271, K771205).

The performance tests listed (Activation Force, Deactivation Force, Puncture Resistance, Simulated Use Study, etc.) were conducted, and the document states, "None of the data raises any new issues of safety and effectiveness." This implies that the results of these tests were within acceptable ranges, or comparable to the predicate devices, thereby meeting the unstated acceptance criteria.

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

• Sample Size: Not explicitly stated for each test. The document mentions "The following tests were performed on the SurGuard2™ Safety Needle" and "The following tests were performed on the Terumo Philippines 1cc/ml syringe," but does not provide specific quantities of devices tested for each parameter.
• Data Provenance: The manufacturing entity is Terumo (Philippines) Corporation, and the submission is prepared by Terumo Medical Corporation (USA). The origin of the test data is implied to be from testing performed on devices produced by Terumo (Philippines) Corporation. The data is reported as part of a retrospective comparison to previously cleared predicate devices.

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

• Not Applicable. This is a 510(k) submission for a medical device (hypodermic needle and syringe), not a diagnostic or AI-driven system requiring expert ground truth for image interpretation or similar. The "truth" is established by physical measurement, engineering standards, and biological testing, not expert consensus in a clinical sense.

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

• Not Applicable. As above, this type of adjudication method is generally for clinical endpoints or diagnostic interpretations, which are not relevant to the physical and functional tests described for this 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:

• Not Applicable. This document pertains to a physical medical device (needle/syringe), not a digital health or AI software product.

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 (expert consensus, pathology, outcomes data, etc.):

• The "ground truth" for the performance tests would be defined by established engineering standards, material science properties, and validated test methods for medical devices (e.g., force measurements against specific thresholds, leak rates against defined limits, visual inspections against specifications). For biocompatibility, it's defined by ISO-10993 standards and their associated testing protocols. For sterility, ANSI/AAMI/ISO 11137-1994 provides the ground truth for validation.

8. The sample size for the training set:

• Not Applicable. This refers to a manufactured medical device, not a machine learning model. There is no concept of a "training set" in this context.

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

• Not Applicable. As there is no training set, this question is irrelevant.

In summary, the provided document leverages the substantial equivalence pathway for regulatory clearance. It asserts that the TERUMO® SurGuard2™ Safety Needle meets acceptance criteria because it is identical or critically similar in materials, design, intended use, technology, and performance to previously cleared predicate devices, and any differences raise no new issues of safety or effectiveness. The various tests listed confirm that the device's measured parameters align with expectations for devices of its type and prior clearances.

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The PROGREAT Catheter is intended for the infusion of contrast media into all peripheral vessels up to and including the cervical vessels in the lower and upper extremities and all coronary vessels. The PROGREAT Catheter is also intended for drug infusion in intra-arterial therapy and the infusion of embolic materials for hemostasis. The Catheter should not be used in cerebral vessels.

The PROGREAT catheter is available with or without the following accessories: guide wire, inserter, mandrel (stylet), syringe, wire stopper, and Y-connector. The catheter consists of metal coil reinforced multi-layer polymer tubing. The coil is embedded in the catheter wall the entire length of the catheter. This increases the flexibility, kink resistance, and pressure resistance of the catheter. The inner layer of the catheter is made of PTFE (polytetrafluoroethylene) to ensure smooth movement of devices such as the guide wire. The outer surface of the catheter is coated with a hydrophilic polymer which becomes lubricious when wet with saline solution or blood.

The provided text describes a 510(k) premarket notification for the PROGREAT Catheter, asserting its substantial equivalence to a predicate device, the GT LEGGIERO (K981359). The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the performance tests conducted to demonstrate this substantial equivalence.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table labeled "acceptance criteria." Instead, it lists "verification tests" performed to demonstrate substantial equivalence to the predicate device. For each test, it implicitly states that the performance was satisfactory to deem the device substantially equivalent, meaning it met an internal standard set by the manufacturer to compare to the predicate.

In addition to these performance tests, the device also met biological and sterilization acceptance criteria:

2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the specified verification tests (e.g., Ease of removal, Frictional resistance, etc.). These are likely internal engineering tests, and the exact number of units tested is not typically disclosed in the public summary. The data provenance is internal to the manufacturer, Terumo Medical Corporation, for the "modified device (PROGREAT catheter)." These would be prospective tests performed during the development and verification phase of the PROGREAT catheter.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable in the context of this 510(k) submission. The "ground truth" for the performance tests mentioned (e.g., frictional resistance, kink resistance) would be the physical properties and performance characteristics of the predicate device (GT LEGGIERO K981359) and established engineering standards. There is no mention of human expert consensus being used to establish the "ground truth" for these physical device performance characteristics.

4. Adjudication Method for the Test Set
Not applicable. The verification tests are objective physical and mechanical tests, not subjective evaluations requiring adjudication by experts.

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 device is a physical medical device (angiographic catheter), not an AI imaging or diagnostic algorithm. Therefore, an MRMC study related to AI assistance for human readers is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used
The "ground truth" for demonstrating substantial equivalence for the PROGREAT Catheter primarily relied on:

• Predicate Device Performance: The established performance characteristics of the GT LEGGIERO (K981359) served as the benchmark for comparison.
• Engineering Standards: Standardized tests for mechanical properties (e.g., pressure resistance, kink resistance, joint strength) and material properties were used.
• Regulatory Standards: Biocompatibility was assessed against FDA General Program Memorandum #G95-1 (ISO-10993), and sterilization against AAMI/ANSI/ISO 11135.

8. The Sample Size for the Training Set
Not applicable. This device 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
Not applicable. As noted above, there is no training set for this type of device submission.

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The TERUMO® SurGuard 2™ SAFETY NEEDLE device is intended for use in the aspiration and injection of fluids for medical purposes. The Terumo Safety Needle is compatible for use with standard luer slip and luer lock syringes.

Additionally, after withdraw of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.

The SurGuard 2™ Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the connector hub. The safety sheath contains a locking mechanism which is activated when the sheath is manually pressed over the needle immediately after use and just prior to disposal to minimize the possibility of sharps injury. The safety sheath is activated with a one-handed operation by pressing the sheath against a firm surface. The locking mechanism is located at a designated position within the body of the short or long sheath appropriate for the needle size it is to contain. The needle gauge sizes are 18gauge to 25gauge and the needle lengths are 5/8" to 1 ½". The hinge feature allows the user to set the sheath to the desired position for use. For user convenience, when the needle is in the "bevel up" position the sheath is located to the right. The SurGuard 2™ Safety Needle will be individually packaged and sterilized as a safety needle only or as a safety needle with attached Terumo syringe (as cleared under K771205 and K980181).

Here's a breakdown of the acceptance criteria and the study information for the TERUMO® SurGuard 2™ Safety Needle, based on the provided document.

Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission seeking substantial equivalence, the acceptance criteria are not explicitly defined as pass/fail thresholds in the same way they would be for a de novo or PMA application. Instead, the "acceptance criteria" are implied by the comparison to predicate devices and the demonstration that the new device performs similarly and does not raise new safety or effectiveness issues. The reported device performance is presented as a list of tests conducted, with the overarching conclusion that these tests support substantial equivalence.

Study Details

This 510(k) submission primarily relies on bench testing/performance testing rather than a clinical study involving human subjects or AI algorithms. As such, many of the requested categories (e.g., sample size for test set, experts for ground truth, MRMC study, training set) are not applicable in their typical sense for this type of device.

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

• Sample Size (Test Set): Not explicitly stated in terms of number of devices tested for each performance criterion. The document states "The following tests were performed on the SurGuard 2TM Safety Needle," implying that a sufficient number of devices were tested to draw conclusions.
• Data Provenance: The tests were performed internally by Terumo Medical Corporation (the manufacturer). The country of origin for the data is implied to be the USA, given the submission is to the FDA in the US. The data is prospective as it was generated specifically for this 510(k) submission.

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

• Not Applicable. For a mechanical safety device undergoing bench testing, "ground truth" is established by direct measurement and standardized test methods, not expert consensus on interpretations.

3. Adjudication method for the test set:

• Not Applicable. As per point 2, ground truth is based on direct measurement, not assessment by humans requiring adjudication.

4. 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 medical device (safety hypodermic needle), not an AI-powered diagnostic or interpretive device. Therefore, no MRMC study or AI assistance evaluation was performed.

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

• Not Applicable. This device does not incorporate an AI algorithm.

6. The type of ground truth used:

• For the performance tests (e.g., Activation Force, Puncture Resistance), the "ground truth" is the measured physicochemical and mechanical properties of the device, assessed against pre-defined engineering specifications or comparative data from predicate devices.
• For biocompatibility, the ground truth is established by laboratory testing results compliant with ISO-10993 Part 1.
• For sterility, the ground truth is established by sterilization validation results compliant with ANSI/AAMI/ISO 11137-1994.

7. The sample size for the training set:

• Not Applicable. There is no training set as no AI/machine learning algorithm is involved.

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

• Not Applicable. As there is no training set.

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