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Introcan Salety® 2 IV 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 intravascularly with power injectors at a maximum pressure of 325 psi with a luer lock connection only.

The Introcan Safety® 2 IV Catheter consists of an over-the-needle, peripheral catheter made of radiopaque polyurethane, an integrated septum, and a passive safety needleshielding mechanism. Introcan Safety® 2 is designed to protect clinicians and patients from blood exposure. During needle withdrawal through a septum that seals after the needle has been removed, blood is thus contained within the Introcan Safety® 2 device. The pressure exerted on the needle as it passes through the septum wipes blood from the needle further reducing potential blood exposure. The passive safety needle-shielding mechanism of the Introcan Safety® 2 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 catheters may be used intravascularly with power injectors for which the maximum pressure setting is 325 psi with a luer lock connection only.

This document is a 510(k) Pre-market Notification for the Introcan Safety® 2 IV Catheter. As such, it focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets novel acceptance criteria through a standalone study structured like a diagnostic AI performance evaluation. Therefore, many of the requested elements (like MRMC studies, number of experts, training set details) are not applicable or provided in the context of this regulatory submission for a physical medical device.

However, based on the provided text, I can extract information related to the device's performance and the non-clinical testing conducted to support its substantial equivalence.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established based on international standards (e.g., ISO 10555-1, ISO 10555-5) and internal specifications. The reported performance is presented as the device successfully passing or meeting these criteria, particularly highlighting the changes from the predicate device.

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

The document describes non-clinical bench testing rather than clinical studies with human data. Therefore, the concept of "test set" in the context of diagnostic AI is not directly applicable.

• Sample Size: Not explicitly stated as a single number across all tests. The testing section lists various tests performed (e.g., ISO standards, internal specifications). For each test, an appropriate number of device samples would have been used to demonstrate compliance, but specific counts are not provided in this summary.
• Data Provenance: N/A, as this is bench testing of physical devices, not clinical data provenance (country of origin, retrospective/prospective). The tests were conducted internally by B. Braun Medical Inc.

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

N/A. This is a physical device, and the "ground truth" for its performance is established through adherence to engineering standards and protocols, not through expert human interpretation of clinical data as would be done for a diagnostic AI.

4. Adjudication method for the test set

N/A. Adjudication methods (like 2+1, 3+1) are for resolving discrepancies in expert interpretations of data, typically in diagnostic studies. This is not relevant for bench testing of a physical 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

N/A. This is a physical medical device, not an AI diagnostic tool. No MRMC study was performed, nor would it be relevant for this type of device.

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

N/A. This is a physical medical device. It does not involve an algorithm, so "standalone performance" in the AI sense is not applicable.

7. The type of ground truth used

The "ground truth" for this device's performance is compliance with established international consensus standards (ISO 10555-1, ISO 10555-5) and internal engineering specifications and test protocols. These standards define measurable performance characteristics (e.g., flow rate, burst pressure, air tightness) that the device must meet.

8. The sample size for the training set

N/A. This device is not an AI algorithm and therefore does not have a "training set."

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

N/A. Not applicable, as there is no training set for a physical medical device.

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Introcan Safety® IV Catheter is a passive anti-needle stick device to provide venous or arterial access for the infusion of fluids, drugs, and/or blood components, or to facilitate the placement of Vascular Access devices such as guidewires, indwelling central venous catheters, peripherally inserted central catheters, and midline catheters into the vascular system. The catheters may be used with power injectors at a maximum pressure of 325 psi with a luer lock connection only.

The Introcan Safety® IV Catheter is a passive needle stick prevention device used for arterial and venous access for the infusion of fluids, drugs and/or blood components or to facilitate the placement of Vascular Access devices such as guidewires, indwelling central venous catheters, peripherally inserted central catheters, and midline catheters into the vascular system. The catheters may be used with power injectors for which the maximum pressure setting is 325 psi. The Introcan Safety IV Catheter is available in 14 - 24 gauge sizes, and both winged and non-winged versions and consists of an over-the-needle, peripheral intravascular catheter made of radiopaque polyurethane, and a passive safety needle-shielding mechanism.

The passive safety needle-shielding mechanism of the Introcan Safety® 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 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 catheters may be used with power injectors with a maximum pressure setting is 325 psi with a luer lock connection only.

This document is a 510(k) summary for the Introcan Safety® IV Catheter from B. Braun Medical Inc. It is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission focuses on comparing the new device's characteristics and performance to an existing one, rather than presenting a study of the device's independent performance against predefined acceptance criteria for AI or a detailed clinical study with human readers.

Therefore, the requested information cannot be fully extracted or is not applicable in this context. Here's why and what information can be provided:

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

This document does not refer to "acceptance criteria" in the sense of performance metrics for an AI device (e.g., accuracy, sensitivity, specificity, AUC). Instead, it focuses on demonstrating that the proposed device performs comparably to its predicate device, particularly regarding "power injection capabilities" and "flow rate."

The relevant performance information is for the power injection capabilities and gravity flow rate, presented as a comparison:

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

• Test Set Sample Size: The document refers to "bench testing" but does not specify the sample size (number of catheters tested). It mentions testing for "flowrate and device pressure per ISO 10555-1 Section 4.10 9 AnnexG" and "burst pressure under static conditions per ISO 10555-1 Section 4.10 Annex F." The number of units needed to demonstrate equivalence per these standards would be part of the full submission, but not typically detailed in the public 510(k) summary.
• Data Provenance: This is not applicable in the typical sense of AI algorithm evaluation (country of origin, retrospective/prospective). The data comes from bench testing of the physical medical device.

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

This is not applicable. This is a physical medical device (IV catheter), not an AI/imaging device requiring expert interpretation for ground truth establishment. The performance is assessed via engineering bench tests against industry standards (ISO).

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

This is not applicable. There is no human interpretation of data for ground truth establishment as it's a physical device being tested via engineering methods.

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 is not applicable. This is not an AI-powered diagnostic device; it's an IV catheter. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

This is not applicable. This is not an algorithm, but a physical medical device. Performance is measured through bench testing of the device itself.

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

The "ground truth" for the device's performance here is defined by standard engineering test methods (ISO 10555-1), which dictate how concepts like "flow rate" and "burst pressure" are measured objectively and quantitatively.

8. The sample size for the training set:

This is not applicable. This is a manufactured physical device, not a machine learning model that requires a training set.

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

This is not applicable for the same reason as point 8.

Summary of what the document focuses on:

The document focuses on demonstrating substantial equivalence of the Introcan Safety® IV Catheter to its predicate device (K020785 and K021094). The key "differences" and how they were addressed are:

• Increased Power Injection Pressure: The proposed device is capable of handling a maximum pressure of 325 psi, an increase from the predicate's 300 psi for certain gauges. This extended capability was supported by bench testing (Power Injection test for flowrate and device pressure per ISO 10555-1).
• Combined Indications for Use: The new 510(k) combines indications for use across the product family, which doesn't alter the device's fundamental performance but rather its labeling and marketing scope.
• e-IFU: The Instructions for Use were revised to align with other Introcan products and to utilize an electronic format.

The conclusion states that "Results of the testing conducted on the proposed devices demonstrate that the Introcan Safety® IV Catheters are substantially equivalent to the predicate device and are as safe and effective as the predicate device." This indicates that the bench testing results met the necessary criteria to show comparable safety and effectiveness, allowing for the 510(k) clearance despite the slight change in power injection capability.

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The IV Administration Sets are intravenous administration sets intended for delivery of fluids from a container into a patient's vascular system. These devices 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.

IV Administration Sets are gravity, single use, disposable, intravenous administration sets used to deliver fluids from a container into a patient's vascular system. These sets may be comprised of various components which are broadly used throughout industry including insertion spike, drip chamber, clamp, luer access device, stopcock, manifold, tubing, luer connections (connector, adaptor), filter, and hand pump. IV Administration sets are configured to ensure the intended use of the device is met.

The provided text is a 510(k) summary for an IV Administration Set (K213778). It describes the device, its intended use, comparison to a predicate device, and nonclinical testing performed to demonstrate substantial equivalence.

However, the request primarily asks about acceptance criteria and a study proving a device meets acceptance criteria, specifically in the context of an AI/Software as a Medical Device (SaMD). The document furnished details on a physical medical device (IV Administration Set) and its substantial equivalence to a predicate through bench testing and adherence to ISO standards.

Therefore, the information required to answer the prompt regarding AI/SaMD acceptance criteria and proof of performance (e.g., sample size, expert ground truth, MRMC study, standalone performance) is not present in the provided text. The document clearly states: "No clinical testing was performed as these devices does not require clinical studies to demonstrate substantial equivalence with the predicate device."

To reiterate, the provided document does not contain the information requested in your prompt regarding AI/SaMD performance studies and acceptance criteria. This device is a physical IV administration set, not an AI/SaMD.

If you can provide a document related to an AI/SaMD, I would be happy to help answer your questions.

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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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The IV Administration Sets are intravenous administration sets intended for delivery of fluids from a container into a patient's vascular system. These devices 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.

IV Administration Sets are gravity, single use, disposable, intravenous administration sets used to deliver fluids from a container into a patient's vascular system. These sets may be comprised of various components which are broadly used throughout industry including insertion spike, drip chamber, clamp, needleless luer access device, injection site, check valve, tubing, clamp, and luer connection (connector, adaptor). IV Administration sets are configured to ensure the intended use of the device is met.

The provided document is a 510(k) summary for an IV Administration Set, not an AI-powered medical device. Therefore, the information required to answer your query (acceptance criteria and study details for an AI/algorithm-based device) is not present in the given text.

The document focuses on demonstrating substantial equivalence of a conventional medical device (IV administration set) to a predicate device, based on:

• Similar indications for use and intended use.
• Similar principle of operation and fundamental scientific technology.
• Similar component types and materials (with specific testing for material differences).
• Compliance with recognized performance standards (e.g., ISO 8536-4, ISO 10993-1).
• Successful completion of non-clinical performance and biocompatibility testing.

The concept of "acceptance criteria" in this context refers to meeting the performance specifications outlined in the relevant ISO standards and the functional and performance tests listed. There is no mention of an algorithm, AI, or comparative effectiveness studies involving human readers and AI assistance.

To summarize why I cannot provide the requested information:

1. Nature of the Device: The device is a physical medical administration set, not a software or AI-based diagnostic/assistive tool.
2. Type of Submission: This is a 510(k) premarket notification for substantial equivalence, not a de novo or PMA submission that would typically involve extensive clinical performance data for novel AI devices.
3. No AI/Algorithm Mentioned: The document does not describe any AI component, algorithm, or software functionality.
4. No Human-in-the-Loop Study: Since there's no AI, there's no MRMC study, no human reader improvement data, and no standalone algorithm performance.
5. No Ground Truth Establishment: The concept of "ground truth" for diagnostic accuracy is not applicable to a physical IV administration set.

Therefore, I cannot populate the table or answer the specific questions related to AI device evaluation based on the provided text.

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The Perfusor® Space Syringe Infusion Pump System is intended for use on adults, pediatrics and neonates for the intermittent or continuous delivery of parenteral fluids, medications, blood and blood products through clinically accepted routes of administration. These routes intra-arterial, subcutaneous, epidural and enteral.

The Perfusor® Space Syringe Infusion Pump System is intended to be used by trained healthcare professionals in healthcare facilities and for medical ground and/or air transport situations.

The Perfusor® Space Syringe Infusion Pump System includes an external, transportable, electronic infusion pump and pump accessories.

The Perfusor® Space Syringe Infusion Pump utilizes a swivel drive pumping mechanism and operates on a 12V DC power source that can be provided from a battery or through external sources such as a power supply connected to a 120V AC wall outlet.

The front panel of the Perfusor® Space Pump includes a backlit graphical display, a backlit keypad with 10 push buttons including directional arrows to navigate through menu items and indicator lamps to alert the clinician to critical conditions.

The Perfusor® Space Syringe Infusion Pump is capable of wireless communication both inbound and outbound. Autoprogramming of the pump is possible where the pump receives infusion parameters wirelessly from the electronic health record over the hospital Wireless Local Access Network.

The B. Braun Space Station is a flexible docking and communication system designed to accommodate multiple Perfusor® Space Syringe Infusion Pumps for use in a medical facility.

Space Com is a communication device that has been integrated into the SpaceCom supports different interfaces such as Ethernet, PS2-Keyboard, Serial, USB ports and WLAN network card. Data transfer with the pumps is provided via an internal CAN bus. The pumps are coupled together with connectors on the inner backside of the SpaceStation. These connectors provide the voltage supply, distribute the information in the Space system via a serial interface, transfer data via a bus system (CAN bus) and transmit a staff call, which may be pending. Features like barcoding and wireless data transmission are enabled when a Perfusor® Space Pump is housed within a SpaceStation with Space Com. The outbound data communication through Space Com transfers status data of the infusion pumps to a hospital server.

Space OnlineSuite is a server based software system which provides the following applications:

Space Server Core is the basic server framework for Space application framework provides basic server functions like User Management, License Management, Communication Service, Security and Maintenance Functions. These functions are used by the administrator of the Space OnlineSuite. Drug Library Manager and Upload Manager applications also use the basic functions of SpaceServer Core.

Drug Library Manager is used to create and administer a drug library which can be used in the Perfusor® Space Syringe Infusion Pump. These features are designed to enhance medication safety and reduce medication errors.

Upload Manager can be used to manage the upload of drug libraries to any single B. Braun Space infusion pump, multiple Space pumps within a facility or to all Space pumps on the System. The drug libraries will be uploaded to SpaceCom (within SpaceStation) and then transferred via CAN bus (Controller Area Network) to the pumps or to a single Perfusor® Space Syringe Infusion Pump directly.

The provided text is related to a 510(k) premarket notification for the Perfusor® Space Syringe Infusion Pump System. It describes the device, its intended use, a comparison with predicate devices, and performance testing conducted. However, the text does not contain any information about an AI/algorithm-based medical device study.

Therefore, I cannot fulfill the request to describe acceptance criteria and study proving a device meets acceptance criteria using an AI model. The provided document is about a mechanical-electronic infusion pump, not an AI-driven diagnostic or therapeutic device.

To directly address the prompt, based on the provided text, the following information is not available:

1. Table of acceptance criteria and reported device performance (for an AI model): Not applicable as this is not an AI device.
2. Sample size used for the test set and data provenance (for an AI model): Not applicable.
3. Number of experts used to establish ground truth and qualifications (for an AI model): Not applicable.
4. Adjudication method (for an AI model): Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study (for an AI model): Not applicable.
6. Standalone (algorithm only) performance (for an AI model): Not applicable.
7. Type of ground truth used (for an AI model): Not applicable.
8. Sample size for the training set (for an AI model): Not applicable.
9. How ground truth for the training set was established (for an AI model): Not applicable.

The document details engineering and performance testing for a medical pump, such as:

• Software verification and validation per FDA Guidance for Medical Devices.
• Cybersecurity evaluation per FDA Guidance.
• System verification and validation for pump and Space Station functionality.
• Electrical Safety (IEC 60601-1), EMC Testing (IEC 60601-1-2), and Essential Performance testing (IEC 60601-2-24: 2012). Essential performance attributes include:
  • Infusion of liquids without variation of infusion rate.
  • Pressure limitation as protection from the bursting of the infusion line.
  • Protection against unintended bolus volumes and occlusion.
  • Alarm signal of high priority.
• Electromagnetic Compatibility and Wireless testing per relevant FDA guidance and IEC standards.
• Li-ion and NiMH battery safety per IEC 62133.
• Reprocessing validation per FDA Guidance.
• Human factors studies conducted with intended users, environment, and scenarios to validate device per intended use.

The document explicitly states: "No clinical testing was performed as the Perfusor® Space Syringe Pump System does not require clinical studies to demonstrate substantial equivalence with the predicate device." This further confirms that no studies involving human interpretation of data for AI model evaluation were conducted or are relevant to this submission.

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The B. Braun Perican Ultra needle is intended for use in injecting local anesthetics and/or analgesics into a patient to provide regional anesthesia and/or to facilitate the placement of a catheter.

The B. Braun Perican Ultra needle is a single use, disposable anesthesia needle (18 Ga.) with Tuohy (curved) bevel. The needle is intended for use in injecting local anesthetics and/or analgesics into a patient to provide regional anesthesia and/or to facilitate the placement of a catheter. The proposed needle is composed of a hollow stainless steel cannula with 1 cm depth markings along the length of the cannula. The cannula is also designed with small 'echogenic' etched markings intended to enhance visibility of the needle when using an ultrasound imaging device. The cannula are secured to the winged polycarbonate hub using an epoxy resin and plastic spacer. The Perican Ultra needle is provided with a plastic stylet, which is pre-assembled inside the needle cannula. The hub is designed with a Luer adapter to facilitate attachment of the needle to anesthetic administration devices, such as a syringe.

Here's an analysis of the Perican™ Ultra Needle based on the provided 510(k) Premarket Notification:

The document does not describe a study involving an AI/Machine Learning device. It concerns a medical device, specifically an anesthesia conduction needle. Therefore, many of the requested categories related to AI performance, ground truth, experts, and training/test sets are not applicable.

However, I can extract the acceptance criteria and the methods used to demonstrate the device meets those criteria for this non-AI medical device.

1. Table of Acceptance Criteria and Reported Device Performance

• Inspected for presence of echogenic markings. | "Results of testing demonstrate that the Perican Ultra needle performs similarly to the predicate device and is substantially equivalent to the predicate devices." (Implies visual specifications were met and echogenic markings were present and acceptable). |
  | Dimensional Specifications | The following dimensions are within specification according to the product drawing:
• Cannula outer diameter
• Cannula inner diameter
• Cannula length
• Distance to first depth marking
• Depth marking width
• Tip Gap of Stylet | "Results of testing demonstrate that the Perican Ultra needle performs similarly to the predicate device and is substantially equivalent to the predicate devices." (Implies dimensional specifications were met). |
  | Associated Device Testing | - Needle permits a 20 Ga. catheter to freely pass through the cannula.
• Needle performs adequately with sideport valve assembly (i.e., extension tubing) and threading assist guide attached. | "Results of testing demonstrate that the Perican Ultra needle performs similarly to the predicate device and is substantially equivalent to the predicate devices." (Implies adequate performance with associated devices). |
  | Ultrasound Visibility | - Needle is visible under ultrasound. | The device includes "'echogenic' etched markings intended to enhance visibility of the needle when using an ultrasound imaging device." And "Results of testing demonstrate that the Perican Ultra needle performs similarly to the predicate device and is substantially equivalent to the predicate devices." (Implies ultrasound visibility was enhanced and acceptable). |
  | Functional Testing | - The Luer of the needle meets the requirements of ISO 594-1 and ISO 594-2.
• Needle is free of occlusions and permits flow of fluid.
• Needle assembly withstands a minimum pressure without leaking.
• Needle withstands bending without breaking.
• Needle is sufficiently stiff.
• Cannula to hub joint has sufficient tensile strength.
• Stylet fit in cannula is sufficient.
• Stylet to stylet hub has sufficient tensile strength. | "Results of functional performance and biocompatibility testing demonstrate that the Perican Ultra needle is substantially equivalent to the predicate devices." (Implies all functional tests were successfully passed). |
  | Sterilization | - SAL 10^-6
• EO Residual Levels
• LAL Bacterial Endotoxin Testing | "Results of functional performance and biocompatibility testing demonstrate that the Perican Ultra needle is substantially equivalent to the predicate devices." (Implies all sterilization requirements were met). |
  | Biocompatibility | Cytoxicity, Intracutaneous Reactivity, Sensitization, Rabbit Pyrogenicity, Systemic Toxicity, USP Physicochemical Tests for Plastics, Corrosion, Acidity/Alkalinity according to ISO 10993-1:2009. | "Based on similarities to the predicate device and biocompatibility test results, the Perican Ultra needle materials of construction are considered biocompatible for their clinical application." (Implies all biocompatibility tests were passed successfully). |

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 the exact sample sizes for each performance test. It only states that functional performance testing was "completed" and "results of testing demonstrate that the Perican Ultra needle performs similarly to the predicate device." The data provenance (country of origin, retrospective/prospective) is not mentioned, as these are typically bench-top and lab-based engineering tests rather than clinical studies with patient data.

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)

Not applicable. The "ground truth" for this device's performance is established by engineering and laboratory test standards (e.g., ISO standards, dimensional measurements, functional performance metrics), not expert human interpretation of data for diagnostic purposes.

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

Not applicable. Adjudication methods are relevant for studies where human interpretation or consensus is required to establish a gold standard. For this device, objective measurements and adherence to established engineering standards serve as the "ground truth."

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/Machine Learning device, and therefore no MRMC study, human reader improvement with AI, or effect size is discussed.

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

Not applicable. This is not an AI/Machine Learning device.

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

The "ground truth" for this medical device is based on:

• Adherence to international standards (ISO 9626:1991/Amd. 1:2001, ISO 7864:1993, ISO 594-1:1986, ISO 594-2:1998, ISO 10993-1:2009), which define acceptable performance characteristics.
• Objective measurements of physical and functional properties (e.g., cannula dimensions, Luer taper fit, tensile strength, pressure resistance).
• Visual inspection criteria.

8. The sample size for the training set

Not applicable. This is not an AI/Machine Learning device, so there is no training set in the context of machine learning.

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

Not applicable. There is no training set in the context of machine learning for this device.

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