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

The Arrow Epidural Catheter Kit consists of the epidural catheter packaged with various combinations of accessory components including 0.2 Micron In-Line Flat Anesthesia Conduction Filter necessary for the catheter insertion procedure.

This document is a 510(k) summary for the Arrow Epidural Catheter Kit, which is a medical device. It does not describe an AI/ML device, therefore, the requested information points (1-9) about acceptance criteria and study proving device meets acceptance criteria are not applicable in the context of an AI/ML device.

However, I can provide the available information related to the device and its testing as presented in the document:

Device Type: Medical Device (non-AI/ML). Specifically, an Anesthesia Conduction Kit.

G. Indications for Use:
The Arrow Epidural Catheter kit permits access to the epidural space for the administration of epidural anesthetic. The epidural catheter kit is intended for use up to 72 hours.
Patient Population: Adult

H. Technological Characteristics Comparison to the predicate:
The proposed Arrow Epidural Catheter Kit with 0.2 Micron In-Line Flat Anesthesia Conduction Filter is substantially equivalent to the predicate device (Arrow Epidural Catheter Kit - K143581) with respect to indications for use, technology, and construction. The differences mentioned are minor and related to the filter component:

• Filtration Area: Predicate: 3.8 cm², Proposed: 5.25 cm²
• Housing Material: Predicate: Modified acrylic, Proposed: Modified Acrylic (This appears to be a re-statement, not a difference in material, possibly a clarification from the manufacturer)
• Filter Material: Predicate: Polyethersulfone, Proposed: Supor Polyethersulfone
• Kit Components: Same, except for the 0.2 Micron Anesthesia Conduction Filter.

I. Performance Data:
A summary of tests relied upon to demonstrate substantial equivalence to the predicate is provided. These tests are physical and biological performance tests for the medical device components.

J. Conclusion:
"The Arrow Epidural Catheter kit has the same indications for use and technology of construction as the predicate devices. Performance test results demonstrate that the proposed device meets its intended use. It is for these reasons that the proposed device can be found substantially equivalent."

Since this document pertains to a traditional physical medical device and not an AI/ML powered device, the requested information points (1-9) regarding acceptance criteria and studies for AI/ML performance (e.g., sample sizes for test/training sets, expert qualifications, ground truth methods, MRMC studies, standalone performance) are not applicable to the content provided. The "performance data" provided refers to the physical and biological tests conducted on the device's components to ensure its safety and effectiveness.

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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, lower extremity, abdominal and paravertebral locations for periods not exceeding 72 hours.

The Arrow® FlexBlock® Continuous Peripheral Nerve Block Catheter Kit/Set features a wire reinforced, polyurethane body with centimeter markings to facilitate placement for continuous plexus and peripheral nerve blocks. The catheter includes a SnapLock™ adapter to enable infusion of medications, and a stylet for enhanced maneuverability. Procedural trays also include a stimulating or non-stimulating plexus block needle, and other procedural components.

The provided document is a 510(k) premarket notification for the ARROW® FlexBlock® Continuous Peripheral Nerve Block Kit/Set. This submission focuses on updating the MR (Magnetic Resonance) Conditional statements in the Instructions for Use (IFU) based on new non-clinical testing. It explicitly states that "The device that is the subject of this submission is identical to its predicate in all other respects, including the technological characteristics, materials, indications for use, and FDA classification." Therefore, the study described here is not a clinical study involving human patients or a standalone algorithm performance study, but rather non-clinical testing to assess the device's compatibility with MRI environments.

Here's an analysis of the provided information based on your request:

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

The document does not explicitly state "acceptance criteria" in a quantitative manner for MRI compatibility. Instead, the non-clinical tests aimed to ensure the device could be labeled as "MR Conditional," meaning it can be safely used in a specified MRI environment under certain conditions. The reported device performance is that the tests concluded the FlexBlock Catheter should be labeled as MR Conditional and included labeling guidelines. This implies that the device successfully met the safety thresholds for MRI compatibility during the testing.

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

The document specifies "the test article in both cases was the 19 ga FlexBlock catheter." This implies that the testing was performed on one or more samples of the 19 gauge FlexBlock catheter. The exact number of individual catheter units tested is not provided, but it would have been a sufficient number to represent the product and ensure robust testing according to ASTM guidelines.

The data provenance is from non-clinical laboratory testing conducted by specialized third-party organizations:

• Shellock R&D Services (MRI Testing, 2011)
• Exponent, Inc. (MRI Testing, 2015)

The testing was retrospective in the sense that it was performed on existing device designs to update labeling.

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

This question is not applicable to the provided document. The ground truth for MRI compatibility testing is established by physical measurements and adherence to recognized standards (e.g., ASTM F2182), not by expert consensus on clinical findings. The entities performing the tests (Shellock R&D Services and Exponent, Inc.) are specialized in medical device MRI safety assessments, implying their expertise in the field.

4. Adjudication method for the test set

This question is not applicable. Adjudication methods like 2+1 or 3+1 refer to clinical scenarios where multiple human readers assess a case and a consensus or tie-breaking mechanism is used. Here, the "test set" involves physical measurements against technical standards for MRI safety. The "adjudication" is implicitly the adherence to and interpretation of the results according to the ASTM F2182 standard and other relevant guidelines by the testing facilities.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document describes non-clinical MRI compatibility testing of a medical device, not a comparative effectiveness study involving human readers and clinical cases.

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

No, a standalone (algorithm only) performance study was not done. This document is about the physical properties and MRI compatibility of a medical device, not a software algorithm.

7. The type of ground truth used

The ground truth used for this testing was based on established scientific principles, engineering measurements, and recognized industry standards for MRI compatibility, specifically:

• Physical measurements of magnetic field interactions.
• Measurements of temperature rise due to radiofrequency (RF)-induced heating.
• Evaluation of imaging artifacts.
• Methodologies prescribed in ASTM F2182 ("Standard Test Method for Measurement of Radiofrequency Induced Hearing Near Passive Implants During Magnetic Resonance Imaging") as a guide.

8. The sample size for the training set

This question is not applicable. There is no "training set" as this document describes non-clinical physical testing of a medical device, not the development or evaluation of a machine learning algorithm.

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

This question is not applicable, as there is no training set.

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

The Arrow Epidural Catheter Kit consists of the epidural catheter packaged with various combinations of accessory components including 0.2 Micron In-Line Flat Anesthesia Conduction Filter necessary for the catheter insertion procedure.

This document describes the Teleflex Medical, Inc. Arrow Epidural Catheter Kit (K143581) and its substantial equivalence to predicate devices, not an AI/ML powered device. Therefore, it does not contain the specific information requested in your prompt regarding acceptance criteria and studies for an AI device.

However, I can extract the information provided about the device's performance testing, which serves a similar purpose of demonstrating that the device meets certain criteria for its intended use.

Here's the closest possible interpretation of your request based on the provided document:

Description of Device: The Arrow Epidural Catheter Kit is intended to permit access to the epidural space for the administration of epidural anesthetic for up to 72 hours. It contains an epidural catheter and various accessory components, including a 0.2 Micron In-Line Flat Anesthesia Conduction Filter.

No AI/ML Powered Device: Please note that this document is a 510(k) summary for a medical device (an epidural catheter kit) and does not describe an AI/ML powered device. Therefore, sections related to AI/ML specific criteria (like human reader improvement with AI, standalone performance, training data, etc.) are not applicable and are not present in the document.

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

The document lists various performance tests conducted to demonstrate the device's substantial equivalence to predicate devices. The "reported device performance" is essentially that the device passed these tests and met internal requirements or relevant industry standards. The specific quantitative acceptance criteria are generally "Internal Requirement" or compliance with the specified standard.

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 provide details on the specific sample sizes used for each of the performance tests nor the data provenance (e.g., country of origin, retrospective/prospective). These details are typically found in the full test reports, not in the 510(k) summary. The tests appear to be laboratory-based 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)

This is not applicable as the document describes physical and chemical performance tests of a medical device, not an AI algorithm requiring expert-established ground truth.

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

This is not applicable as the document describes physical and chemical performance tests of a medical device, not an AI algorithm requiring adjudication of interpretations.

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. The device is an epidural catheter kit, not an AI/ML system, and no MRMC study is mentioned.

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

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

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

For the performance tests described, the "ground truth" would be the established scientific principles, engineering specifications, and validated measurement techniques as outlined in the referenced ISO, ASTM, and AAMI standards, or the internal requirements. These are not types of ground truth typically associated with AI/ML systems.

8. The sample size for the training set

This is not applicable as the document describes a physical medical device, not an AI/ML system that requires a training set.

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

This is not applicable as the document describes a physical medical device, not an AI/ML system that requires a training set.

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The Arrow UltraQuik® Peripheral Nerve Block Needle is indicated for the delivery of single-shot peripheral nerve block anesthesia or analgesia using medical imaging devices.

The Arrow UltraQuik Peripheral Nerve Block (PNB) Needle is a single shot needle which is comprised of a cannula, hub, and fluid extension tube with female luer fitting. The single shot needles are available in various gauges, lengths, and point styles. These include:

• Gauge
  • 20 Ga (Touhy only)
  • 21 to 24 Ga
• Lengths
  • 35 mm to 150 mm
• Point style
  • Bevel tip
  • Pencil point
  • Touhy tip
• Cannula echogenicity
  • The cannula is naturally echogenic but the addition of grooves on the cannula enhance the echogenicity

The UltraQuik may be used with medical imaging, i.e., ultrasound to assist in needle tip location.

Here's an analysis of the acceptance criteria and study information for the ARROW UltraQuik Peripheral Nerve Block Needle, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

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The CorrectInject™ Safety System is intended for the injection of local or regional anesthetics, narcotics or other medications indicated for neuraxial injection. The system consists of components that have a unique non-Luer taper that allows connection of compatible CorrectInject™ components that, when used together as a system, help reduce the risk of mis-connection that may result in the injection of medications not intended for neuraxial use.

The CorrectInject™ Catheter Connector is intended for use with an epidural anesthesia catheter and CorrectInject™ compatible components for the injection of local or regional anesthetics, narcotics or other medications indicated for injection into the epidural space.

The CorrectInject™ Syringe is intended for use with CorrectInject™ compatible components for the injection of medications.

The CorrectInject™ anesthesia conduction filter is a microporous filter used while administering to a patient injections of local anesthetics to minimize particulate (foreign material) contamination of the injected fluid when used with CorrectInject™ compatible components.

The CorrectInject™ filter needle is intended to draw up medication when using the CorrectInject™ Syringe.

The CorrectInject™ white transport cap is intended to fit the CorrectInject™ syringe.

The CorrectInject™ yellow cap is intended to fit the female side of the CorrectInject™ catheter connector or CorrectInject™ filter.

The CorrectInject™ System specially designed non-Luer taper aids in preventing a standard Luer taper device from connecting or delivering a medication by the wrong route of administration.

The objective of the CorrectInject™ Taper system is to provide a non-Luer style, safety connection system that will help reduce the risk of misconnection.

The CorrectInject™ Taper system is intended to connect and be used solely with the components of the CorrectInject™ Safety System. The CorrectInject™ Safety System is intended to deliver medication to epidural and neuraxial locations.

CorrectInject™ Safety System components are considered not to be effectively connected if any of the following apply:

• Attachment to Luer components that requires the use of excessive force, torque, time or manipulation
• Physical resistance to attachment to Luer components beyond that defined in ISO 594-1, ISO 594-2 and BS EN 1707
• If an attachment is made to a standard Luer component, this attachment is non-functional as indicated by leakage per ISO 594-2, section 4.2 and BS EN 1707 section 4.2

The term "effectively connected" is defined as the ability to assemble linearly with normal clinical assembly force, or securely assemble together CorrectInject™ Safety System components using equivalent force, torque and technique, and resulting in a physically secure and functional assembly as defined by ISO 594 or BS EN 1707. The term "attachment" means to assemble such components that results in an assembly that may, or may not, be physically secure but is not functional as defined by ISO 594-1, ISO 594-2 and BS EN 1707.

The CorrectInject™ Safety System is designed to function in a similar manner as currently available Luer epidural systems. The locking components are attached together with a twisting motion the same as current Luer lock connectors. The difference in this system is that the interconnection taper is not a standard Luer taper (per ISO 594 Parts 1 &2). This CorrectInject™ Safety System is color-coded yellow for a neuraxial system.

The design consists of several unique pieces:

1. Epidural Catheter Connector
2. CorrectInject™ Syringe
3. Filter
4. Filter Needle Assembly
5. Caps
6. CorrectInject™ non-Luer epidural label

The document describes the CorrectInject™ Safety System, a medical device designed to prevent misconnections during the administration of neuraxial medications by using a non-Luer taper system. The system's components are color-coded yellow.

Here's an analysis of the provided text for acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions "Non-clinical testing" and "Clinical studies."

• Non-clinical testing: No specific sample sizes for components (e.g., number of connectors tested for force, leakage) are provided. The provenance is internal testing by Smiths Medical.
• Clinical studies: No specific sample size is provided for the "clinical studies." The provenance is internal to Smiths Medical. The study is referred to in the past tense ("The clinical studies performed by Smiths Medical show..."). It is not explicitly stated whether the studies were retrospective or prospective, but the phrasing "performed by Smiths Medical" and "participated in the study" suggests prospective data collection for the clinical acceptability assessment. No country of origin is specified for the clinical data beyond "Smiths Medical," which is based in the USA.

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

For the "clinical studies," the document states "Most of the clinicians (85%) that participated in the study felt that the system is clinically acceptable."

• Number of experts: Not explicitly stated, other than "most of the clinicians (85%)". The total number of clinicians is unknown.
• Qualifications of experts: The experts are referred to as "clinicians." No further specific qualifications (e.g., specialty, years of experience) are provided.

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method for the clinical studies. The reported performance is based on a collective sentiment ("85%... felt that the system is clinically acceptable"), rather than independent expert adjudication of specific outcomes.

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

• No, an MRMC comparative effectiveness study was not done.
• This device is a physical medical component, not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.

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

• This question is not applicable as the device is a physical medical system, not an algorithm. However, the non-clinical testing can be considered "standalone" in the sense that the components' performance (e.g., strength of union, leakage) was evaluated without direct human-in-the-loop clinical use.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Non-clinical testing: The ground truth for effectiveness was based on adherence to international standards (e.g., ISO 594-1, ISO 594-2, BS EN 1707) for connection characteristics, and established physical and chemical testing protocols for biocompatibility and drug-device compatibility.
• Clinical studies: The ground truth appears to be based on clinicians' subjective assessment of "clinical acceptability" and the device's ability to "reduce the risk of misconnections that lead to mis-injections of medication not intended for the epidural space." This is a form of expert opinion/consensus regarding clinical utility and risk reduction.

8. The Sample Size for the Training Set

• This information is not provided. As this is a physical medical device and not an AI/machine learning algorithm, the concept of a "training set" in the context of data-driven model development is not directly applicable. If "training set" refers to samples used for initial design, prototyping, or iterative testing, that information is not detailed.

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

• Not applicable for the same reasons as in point 8. The "ground truth" for the device's development would likely stem from engineering specifications, regulatory standards, and clinical needs identified during its design process.

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