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Introcan Safety® 3 Closed Intravascular Catheter is inserted into a patient's vascular system for short term use to sample blood, monitor blood pressure or administer fluids and blood intravascularly. The catheters may be used with power injectors at a maximum pressure of 325 psi with luer lock connection only.

The Introcan Safety® 3 Closed IV Catheter consists of an over-the-needle, peripheral intravascular catheter made of radiopaque polyurethane, an integrated bidirectional septum, a stabilization platform, and a passive safety needle-shielding mechanism. Introcan Safety® 3 design is a closed IV catheter since it protects clinicians and patients from blood exposure. Since the needle is withdrawn through a septum that seals after the needle has been removed, blood is thus contained within the Introcan Safety® 3 device. The pressure exerted on the needle as it passes through the septum wipes blood from the needle further reducing potential blood exposure. The Introcan Safety® 3 catheter has an integrated stabilization is designed to improve catheter stability while minimizing catheter movement within the vessel. The device controls the flow of blood, aiding in the prevention of blood exposure. The passive safety needle-shielding mechanism of the Introcan Safety® 3 is located inside the catheter hub. Upon withdrawal of the needle, the safety shield engages as the needle passes through the catheter hub and deploys automatically to shield the needle tip. The safety shield protects during disposal, aiding in the prevention of needlestick injuries. Once the safety shield engages and shields the needle tip, the user is unable to re-insert the needle which aids in the prevention of catheter shearing.

The document is a 510(k) summary for the Introcan Safety® 3 Closed IV Catheter, indicating that the device has been found substantially equivalent to a previously cleared predicate device (K182870). The primary difference for the new submission is an extension of the power injection capabilities to higher pressure rates for all gauge sizes.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly laid out in a table format with specific pass/fail thresholds for each test in the provided document. However, the document lists "Nonclinical Testing" that was performed and states that the "Results of the testing conducted on the proposed devices demonstrate that the Introcan Safety® 3 Closed IV Catheters are substantially equivalent to the predicate device and are as safe and effective as the predicate devices."

Based on the information provided, we can infer the tested parameters and their implied "acceptance" through comparison to the predicate. The "Comparison" column in the Technological Characteristics table effectively serves as the reported device performance relative to the predicate, with the implied acceptance criteria being "Same" or that the difference does not raise additional safety and effectiveness questions.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes (number of devices) used for each nonclinical test (Power Injection and Burst Pressure). It only states that "Bench testing performed on Introcan Safety® 3 Closed IV Catheters supports substantial equivalence of the proposed device."

• Sample Size: Not explicitly stated for each test.
• Data Provenance: The data is from "bench testing" performed by the manufacturer, B. Braun Medical Inc., located in Allentown, PA, USA. This is retrospective data collected for regulatory submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• This information is not applicable as the study described is nonclinical bench testing of a physical medical device, not a diagnostic AI system requiring expert consensus for ground truth.

4. Adjudication Method for the Test Set

• This information is not applicable as it refers to clinical studies or studies using human interpretation, which is not the case here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

• No, an MRMC comparative effectiveness study was not done. The study was nonclinical bench testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• This is not applicable as the device is a physical medical catheter, not an algorithm or AI system. The "standalone" performance here refers to the device's physical and mechanical properties. The bench tests conducted (Power Injection test, Burst Pressure test) represent the standalone performance of the device under simulated conditions.

7. Type of Ground Truth Used

The "ground truth" for the nonclinical tests is established by:

• Engineering specifications and recognized international standards: The tests were performed "per ISO 10555-1 Section 4.10 Annex G" (Power Injection) and "per ISO 10555-1 Section 4.10 Annex F" (Burst Pressure). These standards define the methodology and expected performance characteristics for intravascular catheters.
• Comparison to the predicate device: The new device's performance is gauged against the established and cleared performance of its predicate counterpart. The objective is to demonstrate that the proposed changes (higher pressure for power injection) do not compromise safety or effectiveness compared to the predicate, and meet the new specified performance.

8. Sample Size for the Training Set

• This is not applicable as there is no mention of a training set. This is a nonclinical bench test of a physical device, not an AI/ML algorithm that requires training.

9. How the Ground Truth for the Training Set Was Established

• This is not applicable as there is no training set.

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Introcan Safety® 3 Closed Intravascular Catheter is inserted into a patient's vascular system for short term use to sample blood, monitor blood pressure or administer fluids and blood intravascularly.

The 18-24-gauge catheters may be used with power injectors at a maximum pressure of 300 psi with luer lock connection only.

The Introcan Safety® 3 Closed IV Catheter consists of an over-the-needle, peripheral intravascular catheter made of radiopaque polyurethane, an integrated bidirectional septum, a stabilization platform, and a passive safety needle-shielding mechanism.

Introcan Safety® 3 design is a closed IV catheter since it protects clinicians and patients from blood exposure. Since the needle is withdrawn through a septum that seals after the needle has been removed, blood is thus contained within the Introcan Safety® 3 device. The pressure exerted on the needle as it passes through the septum wipes blood from the needle further reducing potential blood exposure.

The Introcan Safety® 3 catheter has an integrated stabilization platform is designed to improve catheter stability while minimizing catheter movement within the vessel. The device controls the flow of blood, aiding in the prevention of blood exposure.

The passive safety needle-shielding mechanism of the Introcan Safety® 3 is located inside the catheter hub. Upon withdrawal of the needle, the safety shield engages as the needle passes through the catheter hub and deploys automatically to shield the needle tip. The safety shield protects during disposal, aiding in the prevention of needlestick injuries. Once the safety shield engages and shields the needle tip, the user is unable to re-insert the needle which aids in the prevention of catheter shearing.

This device may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy. The 18-24 gauge catheters may be used with power injectors with a rate of injection based on gauge size and for which the maximum pressure setting is 300 psi with a luer lock connection only.

The provided text describes a 510(k) premarket notification for a medical device, the Introcan Safety® 3 Closed IV Catheter. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive new clinical trials. Therefore, the "acceptance criteria" discussed here are primarily focused on equivalence to existing devices and performance against relevant standards, rather than clinical efficacy targets. Similarly, the "study" is a series of non-clinical tests.

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

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a tabular format with corresponding "reported device performance" in the way one might expect for a novel device's clinical trial results. Instead, it details that bench testing was performed to support substantial equivalence and that the device meets internal specifications and relevant ISO standards.

Here's a synthesized table based on the "NONCLINICAL TESTING" section:

The document concludes that the "Results of the functional and performance testing conducted on the proposed devices demonstrate that the Introcan Safety® 3 Closed IV Catheters is as safe and effective as the predicate devices."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for the non-clinical tests. It states "Bench testing performed on Introcan Safety® 3 Closed IV Catheters supports substantial equivalence of the proposed device."

The data provenance is implied to be from the manufacturer's internal testing ("internal specifications"), likely at their facility or a contracted lab. There's no mention of country of origin of data or whether it's retrospective or prospective as these are non-clinical bench tests, not patient studies.

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)

This information is not applicable to this type of regulatory submission. The "ground truth" for non-clinical testing of a medical device like an IV catheter is typically established by engineering standards, validated testing protocols, and physical measurements, rather than expert consensus on diagnostic interpretations.

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

This information is not applicable. Adjudication methods like 2+1 or 3+1 refer to a process where multiple experts review cases and resolve disagreements, often used in clinical trials or studies involving human judgment (e.g., image interpretation). The tests conducted here are bench tests for physical properties and performance against standards.

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

This information is not applicable. The device is an IV catheter, not an AI-powered diagnostic tool. Therefore, MRMC studies or an analysis of "human readers improve with AI vs without AI assistance" are irrelevant to this submission. The device does not involve AI assistance.

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

This information is not applicable. The device is an IV catheter, not an algorithm, so "standalone algorithm performance" is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical bench testing, the "ground truth" is based on engineering specifications, established international standards (ISO), and documented test methods. For example, for biocompatibility, the ground truth is "toxicity" as defined and measured by ISO 10993-1. For liquid tightness, the ground truth is "no leakage" when tested under specified pressure or conditions.

8. The sample size for the training set

This information is not applicable. This is a non-clinical device submission, not a machine learning or AI algorithm. There is no "training set" in this context.

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

This information is not applicable, as there is no training set for this device.

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Introcan Safety® 3 Closed Intravascular Catheter is inserted into a patient's vascular system for short term use to sample blood, monitor blood pressure or administer fluids and blood intravascularly.

The Introcan Safety® 3 Closed IV Catheter consists of an over-the-needle, peripheral intravascular catheter made of radiopaque polyurethane, an integrated bidirectional septum, a stabilization platform, and a passive safety needle shielding mechanism. Introcan Safety® 3 Closed IV Catheter design is described as a closed IV catheter since it protects clinicians and patients from blood exposure. Since the needle is withdrawn through a septum that seals after the needle has been removed, blood is thus contained within the Introcan Safety 3 device. The pressure exerted on the needle as it passes through the septum wipes blood from the needle further reducing potential blood exposure. The Introcan Safety® 3 Closed IV Catheter has an integrated stabilization platform is designed to improve catheter stability while minimizing catheter movement within the vessel. The passive safety needle-shielding mechanism of the Introcan Safety® 3 Closed IV Catheter is located inside the catheter hub. Upon withdrawal of the needle, the safety shield engages as the needle passes through the catheter hub and deploys automatically to shield the needle tip. The safety shield protects during disposal, aiding in the prevention of needlestick injuries. Once the safety shield engages and shields the needle tip, the user is unable to re-insert the needle, which aids in the prevention of catheter shearing.

This document is a 510(k) premarket notification from the FDA, evaluating a medical device (Introcan Safety® 3 Closed IV Catheter). This type of document is not a study demonstrating the performance of an AI/ML powered device, but rather a regulatory review for a traditional medical device (an intravascular catheter).

Therefore, I cannot extract the information requested as the document does not contain details about:

• Acceptance criteria for an AI/ML model
• Performance of an AI/ML model (e.g., Sensitivity, Specificity, AUC)
• Sample sizes for AI/ML test or training sets
• Ground truth establishment by experts for AI/ML
• MRMC studies for AI/ML
• Standalone AI algorithm performance

The document primarily focuses on demonstrating substantial equivalence to a predicate device through bench testing (functional and performance testing) for mechanical and physical properties of the catheter, not diagnostic or predictive performance of an AI model. The tests listed (Dynamic Tensile, Air Tightness, Flow Rate, etc.) are standard engineering tests for physical devices.

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