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SnapLock Catheter/Syringe Adapter is intended to be used in conjunction with 19 and 20 Ga. Arrow Pain Management Catheters to facilitate access to the catheter so that an infusion device may be used. Please refer to applicable Arrow Pain Manager Catheter IFU for complete catheter instructions for use.

The Arrow Epidural Catheter permits access to the administration of epidural anesthetic. The epidural catheter is intended for use up to 72 hours.

The Arrow FlexBlock Continuous Peripheral Nerve Block Kit Set permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques including upper extremity, abdominal and paravertebral locations for periods not exceeding 72 hours.

The Arrow SnapLock Catheter Adapter serves as the connecting link between the anesthesia catheter and an infusion device. The adapters facilitate delivery of the desired substance through the adapter-catheter system, into the patient.

Arrow markets two versions of the SnapLock Adapter. The non-stimulating version is used with epidural and peripheral nerve block catheters and the stimulating version includes an integral electrical connector or tab for use with stimulating Peripheral Nerve Block catheters. Both versions of the adapters are included as accessories in their respective kits. The non-stimulating version is also available separately as a replacement component.

The provided text is a 510(k) summary for the Arrow SnapLock Catheter Adapter. It describes the device, its intended use, and a comparison to predicate devices, focusing on demonstrating substantial equivalence. The document outlines performance testing for the new device to show it meets specific "acceptance criteria." However, it is not a study that proves a device meets acceptance criteria in the context of medical AI/imaging devices, which typically involves clinical studies with human readers, ground truth establishment, and statistical analysis of performance metrics like sensitivity, specificity, AUC, etc.

The acceptance criteria and performance data described here are for mechanical and material properties of a medical device (a catheter adapter), not for an AI/imaging diagnostic device. Therefore, many of the requested points in the prompt (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this document's content.

Here's an interpretation based on the provided document, addressing the applicable points:

Device: Arrow SnapLock Catheter Adapter (a non-AI medical device; specifically, an adapter for pain management and nerve block catheters)
Purpose of the Study (as described in the document): To demonstrate substantial equivalence to predicate devices through performance testing related to mechanical properties, material biocompatibility, and functional aspects.

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

The document provides tables for Biocompatibility Testing and Performance Testing with their respective acceptance criteria and results.

Table 1: Biocompatibility Testing Acceptance Criteria and Results

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BD Epilor™ syringes are intended for use with either air or liquid in conjunction with an epidural needle for identifying the epidural space. These types of syringes facilitate the "loss of resistance" technique for identifying the epidural space by reducing subjectivity when locating this space and the potential for complications when administering epidural anesthesia to patients. Not for spinal applications. These devices are intended for adult and pediatric patients.

The subject BD Epilor™ (Loss of Resistance Syringe) is used in various types of epidural anesthesia procedures. The purpose of this syringe is to help the anesthesiologist locate the epidural space prior to administering either single shot or continuous epidural anesthesia. The syringe assembly consists of a lubricated polypropylene barrel imprinted with a graduated scale, a polypropylene plunger rod, and a silicone rubber stopper which is a double-ribbed to prevent leakage. BD Epilor ™ is used in conjunction with an epidural needle for the purpose of identifying the epidural space. BD Epilor™ syringes are available in 7ml sizes and supplied in plastic configurations and as sterile or Bulk Non-Sterile.

The provided document is a 510(k) Premarket Notification for the BD Epilor™ Syringe, and it is primarily a comparison to a predicate device to demonstrate substantial equivalence. It does not describe the acceptance criteria and a study proving a device meets these criteria in the context of an AI/machine learning-enabled device.

The BD Epilor™ Syringe is a physical medical device (Loss of Resistance Syringe), not an AI-enabled device. Therefore, the questions related to AI/ML device performance (like sample sizes for test/training sets, data provenance, ground truth establishment, expert adjudication, MRMC studies, and standalone algorithm performance) are not applicable to this document.

However, I can extract the acceptance criteria and the (non-AI) studies performed to show equivalence to the predicate device.

Acceptance Criteria and Reported Device Performance (BD Epilor™ Syringe)

The submission focuses on demonstrating substantial equivalence to a predicate device (B-D Loss of Resistance Syringe, K925902) through various performance and material characteristic comparisons, rather than establishing acceptance criteria for a novel AI-driven outcome. The "acceptance criteria" are implied by meeting established ISO standards, internal BD requirements, and biocompatibility standards, and the "reported device performance" is that the device met these requirements.

Since this is not an AI/ML device, the following points regarding AI studies are not applicable and thus cannot be provided from this document:

1. Sample size used for the test set and the data provenance: Not applicable.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

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The Plastic LOR Syringe is intended for use in conjunction with an epidural needle, to verify the needle tip placement in the epidural space by the loss of Resistance technique, it will be filled with air and/or saline during use. The loss of Resistance Syringe is not intended for injection or aspiration. The syringe will be sold sterile individually packaged, and as part of a sterile kit.

The Plastic LOR syringe is a piston syringe of three pieces. It consists of barrel, plunger and piston. The barrel is available with Luer slip, NRFit lock, NRFit Slip male connector. The Plastic LOR syringe is provided in combinations of four connectors and four syringe capacities (5ml, 7ml, 10ml, 20ml). The device is a sterile finished disposable device, supplied sterile to the end user and non-sterile will be supplied to Anesthetic Conduction Kit manufacturers to be sterile and packaged into kit. The Plastic LOR syringe is a single use device which will be supplied as sterile individually packaged and the non-sterile bulk packed. The sterilized by Ethylene Oxide Gas to achieve a SAL of 10° and supplied sterility maintenance package which could maintain the sterility of the device during the s helf life of five years.

This document is a 510(k) Summary for a Plastic LOR Syringe. The purpose of this summary is to demonstrate that the device is substantially equivalent to legally marketed predicate devices.

Here's the breakdown of the acceptance criteria and the study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from various ISO and ASTM standards for syringes, neuraxial, and Luer connectors, as well as biocompatibility and sterilization standards. The reported device performance indicates compliance with these standards.

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The E-Cath STIM acc. Tsui System is indicated for delivery of medication for regional anesthesia and pain management. Route of administration may be intraoperative, percutaneous, or perineural. To assist the physician pinpoint the area of application an electrical stimulus can be applied to the conduction needle removal, to assist the physician pinpoint conduction catheter placement, an electrical stimulus can be applied to the conduction catheter tip via the catheter adapter.

The E-Cath STIM acc. Tsui System is contraindicated for the epidural space.

The Over-the-needle (OTN) Catheter Systems are available in different designs with cannula and catheter in different sizes. The system includes: SonoPlex cannula, permanent cannula, E-Cath catheter, locking cap.

The provided document is a 510(k) premarket notification for a medical device (E-Cath STIM acc. Tsui). It is a special 510(k) for a device modification, intending to combine features from previously cleared devices. The document mainly focuses on demonstrating substantial equivalence to predicate devices through bench testing and compliance with recognized standards, rather than clinical studies with human participants. Therefore, several of the requested categories, such as "multi-reader multi-case (MRMC) comparative effectiveness study," "sample size for the test set," "number of experts," "adjudication method," and "standalone (i.e., algorithm only) performance" are not applicable to this type of submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and the Reported Device Performance:

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

• Sample Size: Not explicitly stated for each test, but implied to be sufficient for demonstrating compliance with the referenced ISO/EN standards for medical device components. The tests refer to "tested cannulas" and "tested catheters."
• Data Provenance: Bench testing, compliance with international standards (ISO, EN, DIN). Results are compared against predicate and reference devices, implying these are internal company data.
• Retrospective/Prospective: Not applicable in the context of bench testing for a device modification. The tests are performed on the device itself.

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

• Not applicable. The ground truth for these tests is defined by international standards (e.g., ISO 9626, ISO 7864, DIN EN 1618, DIN EN 10555-1) and internal protocols for performance criteria where standards are not specific. This does not involve expert medical opinion for "ground truth" in the diagnostic sense.

4. Adjudication Method for the Test Set:

• Not applicable. Performance is measured against predefined, objective, quantifiable acceptance criteria established by international standards or internal engineering/risk assessment protocols.

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 medical device (anesthesia conduction kit), not an AI diagnostic or image analysis system.

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 device's performance is established by compliance with recognized international standards for medical device components (e.g., mechanical properties, sterility, biocompatibility) and internal engineering/risk assessment protocols where standards allow for manufacturer-defined criteria (e.g., leak tightness, tensile strength, flow rate).

8. The Sample Size for the Training Set:

• Not applicable. This is not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set was Established:

• Not applicable. As above, this is not a machine learning model.

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Indication for Use: The VPC (Visual Pressure Control) NRFit™ (ISO80369-6) and LUER (ISO80369-7) Loss of Resistance Syringe is intended for use in conjunction with an epidural needle tip placement in the epidural space by the loss of Resistance technique, it will be filled with air and/or saline during use. The loss of Resistance Syringe is not intended for injection or aspiration.

The Syringe will be sold sterile individually packaged, and as part of a sterile kit.

The VPC (Visual Pressure Control) NRFit™ (ISO80369-6) and LUER (ISO80369-7) is a sterile finished disposable device, supplied sterile to the end user and non-sterile intended to be sterilized prior to use to re-packagers/ medical device manufacturers. It consists of a Barrel and Plunger. It has ISO 80369-6 NRFit™ and ISO 80369-7 LUER connectivity. The markings area is 0ml - 10ml and the priming volume is 10ml.

The provided text is a 510(k) summary for the Pajunk VPC (Visual Pressure Control) NRFit and LUER Loss of Resistance Syringe. It details the device's technical specifications and the testing performed to demonstrate its substantial equivalence to a predicate device.

Key takeaway: This document describes the physical and functional performance testing of a medical device (a syringe), not the performance of an AI/ML algorithm. Therefore, many of the requested fields related to AI/ML model evaluation (e.g., ground truth establishment, reader studies, training set size) are not applicable to this document. The "device" in this context refers to the physical syringe, not a software algorithm.

Here's the breakdown based on the provided document, addressing the relevant points and noting where information is not applicable:

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

The document lists various performance characteristics, standards, and their results. The acceptance criterion is implied by the "Pass" result for each test, indicating compliance with the specified standard or internal protocol.

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

• Sample Size: The document does not specify the exact sample sizes (number of syringes) used for each individual test. It mentions that "tests have been performed" on devices for shelf-life validation.
• Data Provenance: The tests are physical and chemical performance tests of a manufactured device, not data collection from patients or retrospective/prospective studies in the clinical sense. The manufacturer is Pajunk GmbH Medizintechnologie, located in Geisingen, Germany. The tests would have been performed in a laboratory setting.

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

• This is not applicable. The ground truth for this device is the physical and chemical properties and functioning according to established international standards (ISO) and the manufacturer's internal protocols. "Experts" in this context would be test engineers and scientists adhering to the specified test methods, not clinical experts establishing diagnostic ground truth.

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

• This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, typically for establishing ground truth from multiple readers for image interpretation (e.g., in AI/ML studies). For mechanical and chemical device testing, results are typically objective measurements against predefined acceptance limits.

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 document describes the performance of a physical medical device (syringe), not an AI/ML algorithm or a system involving human readers.

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

• This is not applicable. This document is about a physical medical device, not a software algorithm.

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

• The "ground truth" for this device's performance relies on objective measurements and adherence to specified international standards (ISO) and validated internal protocols for physical, chemical, and functional characteristics. Examples include measurable parameters for leakage, axial load, unscrewing torque, and adherence to sterilization parameters and residual limits.

8. The sample size for the training set

• This is not applicable. There is no "training set" as this is not an AI/ML algorithm.

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

• This is not applicable. There is no "training set."

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PORTEX® products and components with the NRFit™ Connector are intended for the injection or infusion of regional anesthetics or narcotics.

The PORTEX® LOR Syringe with NRFit™ Connector is intended for use with NRFit™ compatible components to verify needle tip placement in the epidural space by the Loss of Resistance technique using air or saline. The NRFit™ connector is designed to be used with regional anesthesia systems only.

The PORTEX® EpiFuse Catheter with NRFit™ Connector is intended for use with the catheter and compatible components for the injection or infusion of regional anesthetics or narcotics. The key is a tool for re-opening the catheter connector.

PORTEX® Epidural Flat Filter with NRFit™ Connector is designed for use when administering injections and/or infusions of regional anesthetics or narcotics to a patient via compatible system components. The NRFit™ Connector is designed to be used with regional anesthesia systems only.

The PORTEX® Filter Needle with NRFit™ Connector and PORTEX® Filter Straw with NRFit™ Connector are intended to draw up medication when using the PORTEX® LOR Syringe.

The PORTEX® Regional Anesthesia Portfolio with NRFit™, consisting of five (5) categories of product including PORTEX® LOR Syringe with NRFit™ Connector, PORTEX® EpiFuse Catheter with NRFit™ Connector, PORTEX® Epidural Flat Filter with NRFit™ Connector and the PORTEX® Filter Straw with NRFit™ Connector.

PORTEX® products and components with NRFit™ connector are intended for the injection or infusion of regional anesthetics or narcotics.

The NRFit ™ connector conform to ISO 80369-6. Small bore connector for liquids and gases in healthcare applications -- Part 6: Connectors for neuraxial applications. The connectors are not compatible with standard luer connectors which are intended to reduce the risk of misconnection that may result in the infusion of medications not intended for neuraxial or regional anesthetic use.

The PORTEX® Regional Anesthesia Portfolio with NRFit™ connector are color-coded yellow to indicate medication intended for neuraxial or regional anesthetic delivery.

This looks like a 510(k) summary for a medical device modification, specifically for the PORTEX® LOR Syringe with NRFit™ Connector, PORTEX® EpiFuse Catheter with NRFit™ Connector, PORTEX® Epidural Flat Filter with NRFit™ Connector, PORTEX® Filter Needle with NRFit™ Connector, and PORTEX® Filter Straw with NRFit™ Connector.

This document does not describe a study involving AI/ML performance, human readers, or expert adjudication for image analysis. Instead, it focuses on the non-clinical performance testing of a new medical device connector (NRFit™) to demonstrate its substantial equivalence to a predicate device. The acceptance criteria and the "study" that proves the device meets them are based on these non-clinical, bench-top tests, primarily conforming to existing ISO standards.

Therefore, for aspects related to AI/ML, human readers, expert ground truth, and training data, the response will state that this information is not applicable to this type of device submission.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a set of medical connectors, and the "performance" here relates to physical and biological safety and efficacy as defined by recognized standards.

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

This document does not specify a "test set" in the context of AI/ML or image data. The testing described is non-clinical (bench testing) for device components. The sample size for each specific non-clinical test (e.g., number of connectors tested for axial load) is not explicitly provided in this summary but would be detailed in the full test reports. Data provenance is not applicable here as it refers to physical and biological testing of manufactured products, not patient data.

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 submission for physical medical devices and their connectors, not an AI/ML diagnostic or prognostic device that relies on expert interpretation of data for ground truth.

4. Adjudication Method for the Test Set

Not applicable. The "test set" here refers to physical product testing against international standards, not a diagnostic or classification task requiring expert 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 not an AI-assisted diagnostic or imaging device.

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

Not applicable. This is not an AI/ML algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by objective measurements and assessments against recognized international and national standards (e.g., ISO 80369-6, ISO 11607, ISO 11135, ISO 10993 series, ANSI/AAMI ST72, USP 788) for functional performance, sterility, packaging, and biocompatibility.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML algorithm that requires a training set.

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

Not applicable. This is not an AI/ML algorithm.

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The Arrow StimuOuik Insulated Peripheral Nerve Block Needle permits the stimulation and location of nerves and nerve plexuses for single-shot nerve block anesthesia or analgesia techniques.

The StimuQuik peripheral nerve block needle is used to locate nerves or nerve plexuses and facilitate delivery of regional anesthesia to the desired location. The needles are constructed of a steel needle and insulated by a white, non-conductive siliconized polyester coating. A small area at the distal tip remains exposed to conduct the stimulating current to nerve tissue. The tip features a 30-degree bevel. and black centimeter markings are printed along the shaft of the needle. An electrical wire with a shrouded 2 mm female connector and an extension line with a Luer lock extend from the ergonomic plastic hub of the needle.

The StimuQuik ECHO peripheral nerve block needle is identical to the StimuQuik needle with the addition of 5 echogenic grooves on the needle tip. The five grooves are designed to help clinicians locate the tip of the StimuQuik ECHO needle under ultrasound.

The provided text describes a 510(k) premarket notification for a medical device, the StimuQuik Peripheral Nerve Block Needle, and its substantial equivalence to a predicate device. However, it does not describe a study involving an AI/Machine Learning device or a diagnostic algorithm. Therefore, I cannot extract information related to acceptance criteria or studies proving device performance in the context of an AI/ML device from this document.

The document details the following:

• Device: StimuQuik Peripheral Nerve Block Needle
• Purpose: To permit the stimulation and location of nerves and nerve plexuses for single-shot nerve block anesthesia or analgesia techniques.
• Approval type: 510(k) premarket notification, seeking substantial equivalence to a predicate device (AVID-NIT Nerve Stimulation Needles, K014246).
• Testing: Biocompatibility testing (per ISO 10993-1) and Non-clinical performance testing (e.g., needle markings, ink adherence, continuity, current density, leakage, tensile strength, kink resistance, echogenicity).

The performance testing section shows a table with "Test," "Test Objective," "Acceptance Criteria," and "Results" (all pass). However, these are engineering and material performance tests for a physical medical device, not a diagnostic algorithm or AI/ML product. The "acceptance criteria" listed are for physical properties and safety parameters of the needle itself, not for the accuracy or effectiveness of a diagnostic output.

Therefore, I cannot fulfill the request as it pertains to an AI/ML device's acceptance criteria and study design for proving its performance. The provided document is for a traditional physical medical device.

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IMD's Lumbar Puncture Needle, a single patient use needle; it is intended to gain entry into or puncture the spinal cavity permitting injecting (including anesthesia) / withdrawl of fluids for purpose of diagnostic lumbar puncture, myelography discography procedures.

The device is intended for adult and pediatric patients.

It is to be used only under the direction of a licensed clinician.

The IMD Inc. Lumbar Puncture Needle shares major similarities with the predicate device(s), in as much as the configuration, materials, area of use, and are identical to the IMD reference devices.

It consists of an introducer, stylet, and pencil-point needle, with plastic hubs, and stainless steel cannula. Offered in 18-27 gauges, and 3.5 in. (90 mm) and 5.0 in (124 mm) lengths.

The provided text is a 510(k) summary for a medical device called IMD's Lumbar Puncture Needle. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a study that establishes acceptance criteria and proves the device meets them from scratch.

Therefore, the information typically found in a clinical study report regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not present in this document.

The document primarily relies on the equivalency of its design, materials, manufacturing processes, and sterilization methods to previously cleared devices. The "performance" mentioned refers to the device's functional integrity as a medical instrument, rather than clinical efficacy measured through a traditional study.

Here's an attempt to answer your questions based on the available information, noting where information is not provided:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not define specific clinical acceptance criteria in terms of accuracy, sensitivity, specificity, or other performance metrics typically associated with AI/diagnostic device studies. Instead, it relies on demonstrating that the device is manufactured to established standards and is functionally equivalent to already-cleared devices.

The "performance" referred to here relates to product integrity and manufacturing quality, not clinical outcome or diagnostic accuracy.

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

Not applicable. This is not a study involving a "test set" in the context of diagnostic performance evaluation (e.g., AI algorithms). The document does not describe a clinical study with a patient test set for the device's performance. The "testing" mentioned refers to manufacturing quality control (e.g., sterility, biocompatibility).

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

Not applicable. No "ground truth" establishment in a diagnostic sense is described. The assessment is mechanical and material equivalency.

4. Adjudication method for the test set

Not applicable. There is no test set or adjudication process described.

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 instrument (lumbar puncture needle), not an AI algorithm or an imaging device requiring human reader interpretation, hence an MRMC study is irrelevant for this product.

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

Not applicable. This is not an algorithm, it is a physical medical device.

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

Not applicable. Ground truth for diagnostic accuracy is not relevant here. The ground truth for the "performance" described relates to adherence to manufacturing specifications, material composition, and proven sterilization effectiveness, which are established by standardized laboratory tests and regulatory compliance (e.g., ISO 10993 for biocompatibility, USP/AAMI/ISO standards for sterility).

8. The sample size for the training set

Not applicable. This isn't an AI device requiring a training set.

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

Not applicable. This isn't an AI device requiring a training set.

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CADD Yellow Medication Cassette Reservoirs with NRFit™ connectors are designed for use only with NRFit™ components for delivery of regional anesthetics or narcotics, and are designed for use with CADD pumps (see CADD pump Operator's Manual for compatibility) and CADD Yellow Extension Sets with NRFit™ connectors.

The CADD Filling Adapter with male NRFit™ connector and female Luer is an accessory for use in filling of the CADD Medication Cassette Reservoirs with NRFit™ Connector.

CADD Yellow Extension Sets with NRFit™ connectors are designed for use only with CADD Yellow Medication Cassette Reservoirs with NRFit™ connectors for the delivery of regional anesthetics or narcotics.

CADD Yellow Administration Sets with NRFit™ connectors are designed for use only with NRFit™ components for delivery of regional anesthetics or narcotics and are designed for use with CADD pumps (see CADD pump Operator's Manual for compatibility).

The Male Yellow Cap with NRFit™ connector is intended for use as an accessory with the CADD Yellow Medication Cassette reservoirs.

The Female Yellow Cap with NRFit™ connector is intended for use as an accessory with the CADD Yellow Extension sets with NRFit™ connectors and the CADD Yellow Administration sets with NRFit™ connector.

The CADD Infusion Adapter with male NRFit™ connector and female Luer is intended to be used by clinicians to convert administration sets with Luer connectors into permanently dedicated lines for use only with NRFit connectors. The NRFit™ connector with non-luer taper is intended for the injection of regional anesthetics or narcotics and may help reduce the risk of mis-connection or mis-injection.

The CADD® Infusion devices with NRFit™ connectors are part of the CADD System. The CADD System is defined as a CADD pump with an attached CADD Medication Cassette Reservoir with an integral free-flow protection feature and CADD Extension Set with an Integral Anti-Siphon Valve; or as a CADD pump with an attached CADD Administration Set with an integral free-flow protection feature. The CADD Administration Set will be connected to a medication bag to allow for infusion.

The devices are designed to deliver local or regional anesthetics, narcotics indicated for neuraxial or regional anesthetic infusion applications. The NRFit™ connectors conform to ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications -- Part 6: Connectors for neuraxial applications. The connectors are not compatible with standard luer connectors which is intended to reduce the risk of misconnection that may result in the infusion of medications not intended for neuraxial or regional anesthetic use.

The CADD Infusion devices with NRFit™ connectors are color-coded yellow to indicate medication intended for neuraxial or regional anesthetic delivery.

This 510(k) includes various configurations of CADD Infusion devices with NRFit ™ connectors.

The provided document describes a 510(k) premarket notification for the CADD® Infusion Disposables Portfolio with NRFit™ connectors. This submission aims to demonstrate substantial equivalence to legally marketed predicate devices. The core change in the subject device is the incorporation of NRFit™ connectors, compliant with ISO 80369-6, for neuraxial applications, intended to reduce misconnection risks.

Here's an analysis of the acceptance criteria and the study performed, based on the provided text:

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

The document provides a summary of non-clinical testing categories, the evaluations performed, and the test criteria. The reported device performance is a general statement that "All testing met pre-established specifications, and successfully demonstrated that the CADD Infusion Disposables Portfolio with NRFit™ connectors performed as intended." Specific quantitative results or direct performance values are not provided in this summary.

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 sample sizes used for the non-clinical tests. The tests are purely technical/engineering assessments of physical characteristics, sterility, and biocompatibility, not clinical studies involving patient data. Therefore, data provenance such as country of origin or retrospective/prospective is not applicable in this context.

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. The studies conducted are non-clinical, laboratory-based tests against established international standards (ISO, ANSI/AAMI, USP). "Ground truth" in the sense of expert medical diagnosis or interpretation is not relevant for these types of engineering and biological safety evaluations. The "ground truth" would be the specifications outlined in the referenced standards.

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

This information is not applicable, as the tests are non-clinical and do not involve human judgment or adjudication in the way clinical studies requiring ground truth establishment would.

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

A multi-reader, multi-case comparative effectiveness study was not done. This document pertains to the clearance of medical device disposables based on physical properties, materials, and safety, not on the performance of an AI algorithm or human reader interpretation.

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

A standalone performance study of an algorithm was not done. This submission is for physical medical devices (infusion disposables), not an AI algorithm.

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

The "ground truth" for the non-clinical tests conducted is defined by the specific parameters and acceptance limits set forth in the referenced international standards (e.g., ISO 80369-6, ISO 594-2, ISO 11607, ISO 11135, ISO 10993 series, ANSI/AAMI ST72, USP 788). These are objective, measurable standards for device characteristics such as fluid leakage, separation forces, sterility, and biocompatibility.

8. The sample size for the training set

This information is not applicable. There is no AI component or machine learning model described that would require a training set.

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

This information is not applicable, as no training set for an AI/ML model is mentioned in the document.

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The Arrow UltraCath Continuous Nerve block Catheter is placed next to nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.

Stimulating continuous nerve block catheters consist of a stainless steel spring coil encased in a polyurethane outer jacket. The inner spring coil contributes a kink-resistance nature to the catheter when bent through small radii, and in stimulating catheters provides electrical conductivity. A ribbon wire is welded to both the proximal and distal ends of the inside of the coil to prevent stretching. The coils of the main catheter body are tightly wound axially (small pitch), with zero space between adjacent coils. The catheter tip is visible under ultrasound.

The plastic jacket of the Conductive Resin Tip UltraCath Continuous Nerve Block Catheter is made of transparent resin and the catheter tip is made of black electrically conductive resin that covers the internal stainless steel spring coil and seals the system against undesired fluid or air ingress or egress. Anesthetics are distributed into the patient body through a single end hole located at the catheter distal end. The catheter distal tip is made of electrically conductive resin which provides an electrical contact point. The distal end of the catheter is printed with centimeter markings to aid in depth determination during catheter insertion. There is also printed distance indicator at proximal end in order to indicate proper catheter insertion inside the adaptor. A stylet placed inside the catheter's spring coil provides stiffness during the insertion procedure.

I am sorry, but the provided text does not contain information about the acceptance criteria and study proving a device meets them in the context of an AI/ML-based medical device. The document is a 510(k) summary for a physical medical device called the "UltraCath Continuous Nerve Block Catheter" and focuses on demonstrating substantial equivalence to a predicate device through various performance and biocompatibility tests.

There is no mention of:

• A table of acceptance criteria and reported device performance for an AI/ML device.
• Sample sizes for test sets, data provenance, or use of experts and adjudication for ground truth related to an AI/ML algorithm.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone AI performance.
• Training set details for an AI/ML model.

The document lists various physical and chemical tests for the catheter, such as aspiration, column strength, flow rate, electrical leakage, and biocompatibility, but these are for the hardware itself, not an AI component.

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