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This device is intended for use to inject fluids into or withdraw fluids from the body. The needle protection device covers the needle after use to help prevent needle sticks.

The Hypodermic Needle-Pro® EDGE™ Safety Device with Syringe is intended for injection or aspiration of fluids using a Luer lock (LL) or Luer slip syringe. The device is provided sterile and is for single use only. The Hypodermic Needle-Pro® EDGE™ Safety Device with Syringe is an extension of Smiths Medical's Hypodermic Needle-Pro® EDGE™ product portfolio. The Low Dead-Space (LD) Syringe new component - is added to form new device combo with the previously cleared Hypodermic Needle-Pro® EDGE™ Safety Device. The device combo is intended to offer an optimization of the volume of fluids injected to patients, and thus reduce the amount of medical product remaining in the needle and the syringe's hub after injection. The Needle-Protection (Needle-Pro) EDGE™ safety device covers the needle after use to help prevent needle sticks. The device features a one-viece design of polypropylene needle hub and protective sheath with a living hinge. The stainless-steel needle cannula is permanently affixed into the hub. After a procedure is completed, the needle is pressed into the sheath using a one-handed technique and the needle is contained within the sheath. The Low Dead-Space (LD) Syringe is a new component to be used along with the Hypodermic Needle-Pro® EDGE™ Safety Device. The LD Syringe is designed with luer lock (LL) connection to provide a secure and leak-free connection between the syringe and the needle and maintain a continuous lumen for fluid flow. The LD Syringe plunger is designed for less product waste without changing the use of the device. The Syringe plunger tip extends into the syringe neck reducing fluid waste. The fluid waste is about 0.010 mL (10 µL), max = 0.015 mL (15 µL) for the LD syringe.

This document is a 510(k) Premarket Notification from the FDA regarding a medical device, specifically a hypodermic needle and syringe. It does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of an Artificial Intelligence (AI) or software-based medical device.

The document primarily focuses on demonstrating "substantial equivalence" of a new physical device (Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe) to a previously cleared predicate device. The performance data mentioned (biocompatibility, sterilization, shelf-life, non-clinical bench testing) refers to the physical properties and safety of the needle and syringe, not the performance of an AI algorithm.

Therefore, I cannot extract the requested information regarding AI device acceptance criteria and study details from this document. The provided text does not describe an AI medical device or its performance studies.

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The Portex® BLUxl™ Extra Length Tracheostomy Inner Cannula is intended to be used with the Portex® BLUxl™ Extra Length Tracheostomy Tube indicated for airway maintenance of tracheostomy patients.

Portex® BLUxI™ Extra Length Tracheostomy Tube is indicated for airway maintenance of tracheostomised patients.

The Portex® BLUxl™ Extra Length Tracheostomy Inner Cannula is intended to be used with the Portex® BLUxl™ Extra Length Tracheostomy Tube indicated for airway maintenance of tracheostomy patients.

Portex® BLUxl™ Extra Length Tracheostomy Tube is for the adult patient category that require an artificial airway due to trauma or medical condition. Maximum recommended period of use is 29 days.
200/710, 720 and 730/xxx are extra proximal length (y measurement) tracheostomy tubes and are indicated for use in patients with excessive skin surface to anterior tracheal wall distance as frequently seen in obesity.
200/715, 725 and 735/xxx are extra distal length (x measurement) tracheostomy tubes and are indicated for use in patients with normal skin surface to anterior tracheal wall distance and require the distal length of the tracheostomy tube to extend more caudally within the trachea.

The Portex® BLUxl™ Extra Length Tracheostomy Inner Cannula is intended to be used with the Portex® BLUxl™ Extra Length Tracheostomy Tube for patients that require an artificial airway due to trauma or medical condition. Maximum recommended period of use is 29 days.

Portex® BLUxl™ Extra Length Tracheostomy Tubes and BLUxl™ Suctionaid® Extra Length Tracheostomy Tubes are designed to aid the adult population who require an artificial airway due to trauma or medical condition. Patients who benefit from this procedure are those who: require prolonged intubation for mechanical ventilator support; cannot manage their airway secretions; or have an upper airway obstruction.
Portex® BLUxl™ Extra Length Tracheostomy Inner Cannula is intended to be used with the Portex® BLUxl™ Extra Length Tracheostomy Tubes and Portex® BLUxl™ Suctionaid® Extra Length Tracheostomy Tubes. The inner cannulas are single use only.

The provided FDA 510(k) summary for the Portex® BLUxl™ Extra Length Tracheostomy Tube, BLUxl™ Suctionaid® Extra Length Tracheostomy Tube, and BLUxl™ Extra Length Tracheostomy Inner Cannula focuses on establishing substantial equivalence to a predicate device rather than demonstrating the device meets a specific set of primary acceptance criteria through a clinical study.

Therefore, many of the typical elements requested in a description of acceptance criteria and a study proving a device meets them (such as MRMC studies, specific expert qualifications for ground truth, or effect sizes for AI assistance) are not applicable to this type of submission. This document describes a non-clinical performance evaluation to show similarity and safety compared to an already cleared device.

Here's a breakdown of the information that can be extracted and how it relates to your request:

Study Overview and Acceptance Criteria (as applicable for a 510(k) of this nature)

The acceptance criteria for this 510(k) submission are implicitly defined by demonstrating that the subject devices are substantially equivalent (SE) to the predicate devices (Smiths Medical BLUselect® Tracheostomy Tube, BLUselect® Suctionaid® Tracheostomy Tube, and BLUselect® Inner Cannula) in terms of:

• Intended Use
• Technological Characteristics (materials, design, performance features)
• Safety and Effectiveness (demonstrated through non-clinical testing)

The study proving the device meets these "acceptance criteria" is a non-clinical performance evaluation comparing the subject device to the predicate device. The conclusion states: "The non-clinical performance data included in this submission supports that any differences in technological characteristics from the predicate device do not raise any new questions of safety and effectiveness. It is concluded that the information provided in this submission supports substantial equivalence."

1. Table of acceptance criteria and reported device performance

Since this is a substantial equivalence submission based on non-clinical testing, the "acceptance criteria" are implied by successful demonstration of performance similar to the predicate and compliance with relevant standards. The "reported device performance" refers to the successful completion of these tests.

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

• Sample Size: Not specified in terms of clinical patient numbers since this was a non-clinical (bench and lab) performance evaluation. The "sample size" would refer to the number of devices or components tested for each mechanical, biocompatibility, sterilization, and packaging validation. These numbers are typically defined by engineering standards and internal quality procedures.
• Data Provenance: The data is from non-clinical laboratory testing and validation conducted by Smiths Medical ASD, Inc. (the manufacturer). The country of origin for the data generation is not explicitly stated but would typically be where the manufacturer's R&D and testing facilities are located (Minneapolis, MN, USA, based on the address). The data is prospective in the sense that the tests were designed and executed to support this submission.

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

• Not applicable in the typical sense of clinical ground truth. For a non-clinical performance evaluation, "ground truth" is established by adherence to recognized international and national standards (e.g., ISO, ASTM) and internal design specifications validated by skilled engineers, microbiologists, and other technical experts within the manufacturer's organization or through certified testing labs. These are not "experts" establishing a clinical diagnosis or interpretation but rather technical professionals verifying physical and biological properties against predefined criteria.

4. Adjudication method for the test set

• Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving human interpretation (e.g., subjective image assessment) to resolve discrepancies. For non-clinical performance testing, the results are typically quantitative and objective (e.g., passing/failing a force test, meeting dimensional specifications, biological assay results). Any discrepancies would be resolved through retesting, root cause analysis, or verification against the defined test 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

• No, not done. This type of study is entirely irrelevant to the submission for a tracheostomy tube. MRMC studies are specific to diagnostic devices, particularly those involving image interpretation by human readers, often comparing AI-assisted performance to unassisted performance.

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

• No, not done. This describes the performance evaluation of an AI algorithm, which is not applicable to a physical medical device like a tracheostomy tube.

7. The type of ground truth used

• The "ground truth" for this device's performance evaluation is based on defined engineering specifications, performance standards (e.g., ISO 11135 for sterilization, ISO 10993 for biocompatibility, ASTM for packaging), and comparison to the predicate device's established safe and effective performance. There is no clinical "ground truth" in terms of disease diagnosis or patient outcomes directly derived for this submission, as clinical testing was not deemed necessary.

8. The sample size for the training set

• Not applicable. "Training set" refers to data used to train machine learning models. This is a physical medical device and does not involve AI or machine learning algorithms.

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

• Not applicable. As above, no training set for an AI model.

In summary: This 510(k) submission is for a physical medical device and establishes substantial equivalence through a comprehensive non-clinical performance evaluation. It does not involve clinical studies with human subjects, AI algorithms, or subjective interpretations that would necessitate the study design elements typically seen in diagnostic AI/imaging device submissions. The "acceptance criteria" are the successful demonstration of equivalence in intended use, technological characteristics, and safety/effectiveness via robust non-clinical testing against established engineering and regulatory standards.

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The device is intended for use to inject fluids or withdraw fluids from the body. The needle protection device covers the needle after use to help prevent needle sticks.

Subject Device: The Hypodermic Needle-Pro® EDGE™ Safety Device with Syringe is intended for injection or aspiration of fluids using a Luer slip syringe. The Needle-Protection device covers the needle after use to help prevent needle sticks. The device features a "one-piece" design of polypropylene needle hub and protective sheath with a living hinge. The stainless-steel needle cannula is permanently affixed into the hub. The sheath has an "arrow" indicating the bevel orientation, i.e. when the sheath is oriented to the right, the bevel is in the "up position." After the procedure is completed, the needle is pressed into the sheath using a one-handed technique. As the needle enters the protective sheath, the lugs on the needle hub snap into the clips of the protective sheath resulting in a "bottom snap" and the needle is contained within the sheath. In addition to the "bottom snap," the Needle-Protection sheath has 2 retaining hooks. The EDGE™ safety device may be removed from the syringe when required by a specific medical procedure.i.e., the EDGE™ safety device may be removed from a blood sampling syringe to process the blood sample. The EDGE™ safety device is then discarded into a sharps container. The Subject device is comprised of a 1mL Luer lock syringe with a 23G x 1.5in needle/cannula. This configuration is not currently offered within the Smiths Medical portfolio of Hypodermic Needle-Pro® EDGE™ with syringe devices.

The provided document is a 510(k) summary for the Hypodermic Needle-Pro® EDGE™ Safety Device. It details the device's characteristics, its comparison to a predicate device, and the performance data supporting its substantial equivalence.

Here's an analysis based on your requested information:

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

The document does not explicitly state "acceptance criteria" for each test in a numerical or pass/fail format. Instead, it indicates that testing was performed in accordance with relevant ISO standards and that "There were no failures identified" for shelf-life, and "Results of the testing conducted, demonstrate the Subject device will perform as intended." This implies that meeting the requirements of these standards constitutes the acceptance criteria.

• Compatibility (Luers): Compliance to ISO 594-2 for Luers on Needle Hub/Safety Sheath and Hypodermic Syringe. |

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

The document does not specify sample sizes for any of the performance tests (biocompatibility, sterilization, shelf-life, or non-clinical bench testing). It also does not mention the country of origin of the data or whether it was retrospective or prospective, beyond stating that it was generated for the 510(k) submission.

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 device is a hypodermic needle product, not an AI or diagnostic imaging device that would require expert-established ground truth for performance evaluation in the described tests. The "ground truth" for these tests would be defined by the physical and chemical properties measured against the standards, not expert interpretations.

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

This information is not applicable for the type of device and tests described. Adjudication methods are typically used in clinical studies or studies involving human readers/interpreters to resolve discrepancies in ground truth establishment, which is not relevant here.

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 such study was performed or mentioned. This device is a physical medical device (hypodermic needle), not an AI or diagnostic tool that would involve human readers or AI assistance.

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

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

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

The concept of "ground truth" as typically used for AI or diagnostic devices (e.g., expert consensus, pathology, outcomes data) does not apply here. For the performance tests conducted:

• Biocompatibility: Likely based on standard chemical and biological assays and expert interpretation of material safety.
• Sterilization: Determined by microbial inactivation assays and compliance with sterilization standards.
• Shelf-Life: Determined by stability testing (physical and functional properties) over time.
• Non-Clinical Bench Testing: Determined by objective measurements against quantitative physical and dimensional requirements specified in the relevant ISO standards (e.g., fluid leakage, force required for activation, dimensions).

8. The sample size for the training set

This information is not applicable. No "training set" is mentioned as this is not an AI/machine learning device. The document mentions "predicate device" which is used for comparison, but not as a "training set" in the computational sense.

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

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

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Intellifuse™ Administration Sets are indicated for the delivery of fluids from a container to a patient's vascular system.

Intellifuse™ Blood Administration Sets are indicated for the delivery of fluids including but not limited to blood and blood products from a container to a patient's vascular system.

Intellifuse™ Administration Sets and Intellifuse™ Blood Administration Sets are single use, disposable, sterile fluid path, intravenous administration sets used to deliver fluids, medications, blood and blood products from a container into a patient's vascular system depending on the configuration selected. These sets are available in multiple configurations and may be comprised of various components which are broadly used throughout industry tubing, spike assemblies, drip chambers, check valves, clamps, needleless access connector, injection sites, in-line filters, luer connectors, and a tube frame assembly. The administration sets are intended to administer fluids with gravity flow. The IV Administration sets are configured to ensure the intended use of the device is met. The devices are intended for the general patient population.

The provided text describes the 510(k) premarket notification for Smiths Medical's Intellifuse™ Administration and Intellifuse™ Blood Administration Sets. This document from the FDA clears medical devices based on substantial equivalence to legally marketed predicate devices, rather than through extensive clinical trials for effectiveness like drugs. As such, the information you're requesting regarding acceptance criteria and performance studies in the context of an "AI/algorithm-only" or "human-in-the-loop" device is not applicable to this submission.

This device is an intravascular administration set, which is a physical medical device for delivering fluids. The "study that proves the device meets the acceptance criteria" in this context refers to non-clinical performance data and testing to ensure the device functions as intended and is safe, not a comparative effectiveness study involving human readers or AI.

Therefore, many of the requested points, such as AI performance, human expert adjudication, MRMC studies, and ground truth for AI model training, are not relevant to this type of device clearance.

Here's the relevant information based on the provided text, focused on the device's technical specifications and non-clinical testing:

Acceptance Criteria and Device Performance for Smiths Medical Intellifuse™ Administration Sets

The "acceptance criteria" for this device are primarily met through demonstrating substantial equivalence to a predicate device (Hospira Administration Sets K160870) and by non-clinical performance data demonstrating compliance with relevant ISO standards and internal test methods.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics in the format typically seen for AI/algorithm performance. Instead, it relies on demonstrating compliance with established standards and the equivalence of functional characteristics.

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

• Sample Size: The document does not specify the exact sample sizes for each non-clinical test conducted (e.g., how many sets were tested for priming volume, sterility, etc.). These sizes would typically be determined by statistical methods for validation but are not explicitly stated in this summary.
• Data Provenance: The data is generated from non-clinical laboratory testing performed by Smiths Medical. There is no information about country of origin or whether it's retrospective/prospective data as these terms are usually applicable to clinical studies.

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

This question is not applicable. This device is a physical medical device, not an AI or imaging diagnostic tool that requires human expert interpretation or "ground truth" establishment in the context of diagnostic accuracy. The "ground truth" for this device's performance is established by objective engineering and biological testing standards.

4. Adjudication Method for the Test Set

This question is not applicable. As there is no human interpretation or diagnostic decision involved that requires expert consensus or adjudication. The non-clinical tests have predefined acceptance criteria based on engineering specifications and international standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. This device is an administration set, and its clearance is based on demonstrating functional equivalence and safety through non-clinical testing.

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

This question is not applicable. This device is a physical, non-AI medical product. Therefore, there is no "algorithm only" or "human-in-the-loop" performance to evaluate in this context.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• Compliance with international standards (e.g., various ISO standards for infusion and transfusion equipment, luer fittings, biocompatibility, sterilization, packaging).
• Compliance with **USP ** for particulate assessment.
• Results from internal test methods for specific functions like Microbial Ingress, Pinch Clamp, and Needleless Access Connector performance, which would be validated against engineering specifications.
• The fundamental physical and chemical properties of the materials used.

8. The Sample Size for the Training Set

This question is not applicable. This device is not an AI/machine learning product, so there is no "training set" in the computational sense. The "development" of the device involves engineering design, prototyping, and testing of physical units.

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

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

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The Level 1® Convective Warmer is intended to prevent and treat hypothermia when temperature therapy is clinically indicated. The warmer can also be used to provide thermal comfort when conditions exist that may cause patients to become too warm or too cold. The Level 1® Convective Warmer can be used with adult or pediatric patients and is intended for use by appropriately trained healthcare professionals in clinical environments.

The Level 1® Convective Warmer, is a forced air thermal regulating systems which includes a connection hose to attach to the Snuggle Warm® Convective Warming Blankets for patients requiring body temperature requlation in clinical environments which are provided non-sterile and intended to be reused. In order to accommodate various clinical environments, the Level 1® Convective Warmer is able to be placed on the floor, placed on a floor cart, or mounted on an I.V. pole to allow flexible portability. The Level 1® Convective Warmer is used with the Snuggle Warm® Convective Warming Blankets.

This document is a 510(k) premarket notification for a medical device, specifically a convective warmer. It is not about an AI/ML medical device. Therefore, the information requested about acceptance criteria, study details, expert involvement, and ground truth for an AI/ML model is not available in this document.

The document focuses on establishing substantial equivalence for a physical medical device (Level 1® Convective Warmer) to a predicate device (Equator® Convective Warmer), particularly noting the introduction of a microprocessor control system in the new device where the predicate used analog circuitry. The "performance testing" described refers to engineering and safety tests for the physical device, not a performance study of an AI model's diagnostic accuracy.

Therefore, I cannot provide a response that directly answers the detailed questions about AI/ML acceptance criteria and study particulars based on the provided text. The prompt's assumptions (e.g., test sets, ground truth establishment, MRMC studies) are applicable to AI/ML device submissions, but not to this specific medical device submission.

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The Portex® Lancet Point Spinal Needles with NRFit™ connectors are indicated for the injection of local anesthetics or narcotics to provide regional anesthesia or withdrawal of cerebrospinal fluid when used with compatible components. The intended target population is pediatrics and adults.

The Portex® Pencil Point Spinal Needles with NRFit™ connectors are indicated for the injection of local anesthetics or narcotics to provide regional anesthesia or withdrawal of cerebrospinal fluid when used with compatible components. The intended target population is pediatrics and adults.

The PORTEX® Lancet Point Spinal Needle with NRFit™ connectors and PORTEX® Pencil Point Spinal Needles with NRFit™ connectors are indicated for the injection of local anesthetics or narcotics to provide regional anesthesia or withdrawal of cerebrospinal fluid when used with compatible components. The intended target population is pediatrics and adults.

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 PORTEX® NRFit™ Spinal Needles are color-coded yellow to indicate medication intended for neuraxial or regional anesthetic delivery.

This Premarket Notification Traditional 510(k) includes various configurations of PORTEX® Lancet Point with NRFit TM connectors and PORTEX® Pencil Point Spinal with NRFit TM connectors.

The provided text details the non-clinical testing performed to demonstrate substantial equivalence for the Portex® Lancet Point Spinal Needles and Portex® Pencil Point Spinal Needles with NRFit™ connectors to their predicate devices. This is a premarket notification (510(k)) to the FDA, which focuses on demonstrating substantial equivalence rather than proving device efficacy from scratch.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for functional performance tests are primarily based on ISO 80369-6: Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications. While specific numerical acceptance criteria are not explicitly detailed in the summary, the document states that "All testing met pre-established specifications," implying adherence to the pass/fail criteria outlined in the referenced ISO standards.

Study Proving Acceptance Criteria:

The study that proves the device meets the acceptance criteria is a series of non-clinical performance tests as summarized in "Table 2: Summary of Non-Clinical Testing" and described in Section 7 of the document. These tests evaluated the functional performance of the NRFit™ connectors, packaging integrity, sterilization effectiveness, and biocompatibility of the materials.

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

The document does not specify the exact sample sizes used for each of the non-clinical tests. It states that "various configurations" of the spinal needles were included. The data provenance is also not explicitly stated in terms of country of origin, nor whether it was retrospective or prospective. Given it's non-clinical testing (bench testing, lab tests), these details are typically less relevant than for clinical trials. The tests were performed in a controlled laboratory environment.

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

This information is not applicable to this type of submission. The ground truth for non-clinical performance and biocompatibility tests is established by adherence to recognized international and national standards (e.g., ISO, ANSI/AAMI, USP). There are no "experts" in the sense of clinicians establishing a "ground truth" on patient data for this kind of engineering and laboratory testing.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation relies on objective measurements against pre-defined engineering and biological standards, not subjective assessments requiring adjudication.

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 type of study is relevant for imaging devices or diagnostic tools where human readers interpret results, and the AI's impact on their performance is being evaluated. This submission concerns spinal needles, which are physical medical devices, not an AI or diagnostic algorithm, so an MRMC study is not relevant here.

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 instrument (spinal needle), not a software algorithm or an AI.

7. The Type of Ground Truth Used

For this submission, the "ground truth" is defined by established international and national standards (e.g., ISO 80369-6, ISO 11607, ISO 11135, ISO 10993 series, ANSI/AAMI ST72, USP 788). The device's performance is compared against the requirements and specifications outlined in these standards.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" in the context of this device and its non-clinical testing. Training sets are used in machine learning and AI development, which is not relevant here.

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

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

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The PORTEX® Tuohy and Hustead Needles with NRFif™ connectors are intended to facilitate the placement of an epidural catheter and for the injection or infusion of regional anesthetics or narcotics.

The sterile, single use Tuohy and Hustead needles with NRFit™ connector are for insertion into the epidural space for either single shot doses of anesthetic or narcotics or as an introducer for epidural catheters or spinal needles. The Tuohy needles are marked at 10 mm graduations to enable the depth of needle insertion to be determined. The Tuohy needles are supplied with a removable wing which allow the needle to be used as a winged or non-winged needle. The stylet hub is color-coded for ease of identification. The intended target population is pediatrics and adults.

The provided text describes the non-clinical testing performed on the PORTEX® NRFit™ Epidural Needles to demonstrate their substantial equivalence to predicate devices. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample sized 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 used for each test. It broadly states that "All testing met pre-established specifications."

The data provenance is from non-clinical performance testing, meaning these are laboratory tests on the device itself, not clinical data from patients. There's no information about country of origin for the data or whether it's retrospective or prospective, as it's not clinical 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 section is not applicable. The "ground truth" in this context refers to established standards (e.g., ISO, ANSI/AAMI, USP) and the physical properties and performance of the device. There were no human experts establishing ground truth for a diagnostic outcome, as this is a device for fluid delivery and catheter placement, not a diagnostic imaging device.

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

This section is not applicable. Adjudication methods are typically used in clinical studies where expert consensus is needed for ambiguous cases. These were non-clinical, objective tests against established standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This section is not applicable. This document describes the testing for an epidural needle, not an AI-powered diagnostic device. Therefore, no MRMC study or AI assistance evaluation was performed.

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

This section is not applicable. This document describes the testing for a physical medical device (epidural needle), not an algorithm or AI system.

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

The "ground truth" for the non-clinical testing was established by recognized international and national standards and test methods. These include:

• ISO 80369-6 (for connectors for neuraxial applications)
• ISO 9626-2016 (for stiffness and bending force of needles)
• PWI-10005073-Test Method for Needle Penetration Force
• ISO 11607 (for packaging)
• ISO 11135 (for sterilization)
• ISO 10993 series (for biocompatibility)
• ANSI/AAMI ST72 (for bacterial endotoxins)
• USP 788 (for particulate matter)

These standards define the acceptable performance parameters and methodologies for testing.

8. The sample size for the training set

This section is not applicable. This document describes the testing of a physical medical device, not a machine learning model, so there is no "training set."

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

This section is not applicable. As there is no training set for a machine learning model, the concept of establishing ground truth for it does not apply here.

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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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CADD® Yellow High Volume Administration Sets with NRFit™ connectors are designed for use only with NRFit™ components for delivery of regional anesthetics or narcotics, excluding subarachnoid/spinal block, and are designed for use with CADD® pumps (see CADD® pump Operator's Manual for compatibility).

The intended population is pediatrics and adults.

The CADD® Yellow High Volume Administration Set with NRFit™ connector device is designed to deliver local or regional anesthetics indicated for regional anesthetic infusion applications. The CADD® Yellow High Volume Administration Set with NRFit™ connector consists of components that have a non-Luer taper that allows connection of compatible components that, when used together as a system, help reduce the risk of misconnection that may result in the infusion of medications not intended for regional anesthetic or narcotic delivery.

The NRFit™ connector of the neuraxial ISO 80369-6 compliant non-Luer system is incompatible with standard Luer tapers; therefore, the two systems cannot mate together effectively. 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 regional anesthetic or narcotic delivery.

The CADD® Yellow High Volume Administration Set with NRFit™ connector devices are colorcoded yellow to indicate medication intended for regional anesthetic delivery.

All CADD® Yellow High Volume Administration Set with NRFit™ connector devices are intended for prescription use only.

The provided text describes a 510(k) premarket notification for a medical device called the "CADD® Yellow High Volume Administration Set with NRFit™ connector." This document is focused on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study in the way one might evaluate a diagnostic or AI-driven device.

Therefore, the requested information points, particularly those pertaining to acceptance criteria and studies specifically designed to prove device performance in a comparative effectiveness or standalone clinical context with human interaction or disease detection, are not directly addressed in this type of regulatory submission. This submission primarily focuses on bench testing and biocompatibility to show that the new device, with its modified connector, is as safe and effective as the previously approved device.

However, I can extract information related to the non-clinical testing performed and the standards met, which serve as the "acceptance criteria" for this type of device modification.

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device (an administration set), the "acceptance criteria" are defined by compliance with recognized international standards for medical device safety, biocompatibility, and connector functionality, as well as pre-established internal specifications for certain tests. The "reported device performance" is that all testing met these pre-established specifications.

The core "acceptance criterion" for the primary modification (the NRFit™ connector) is its compliance with ISO 80369-6:2016 (Small bore connectors for liquids and gases in healthcare Applications - Part 6: Connectors for Neuraxial Applications) and its intentional incompatibility with standard Luer connectors (addressed by adherence to ISO 80369-1:2010 for general requirements). The reported performance is that the device conforms to these standards and the connectors are not compatible with standard luer connectors, achieving the risk mitigation objective.

The remaining information requested is largely not applicable or not explicitly stated for this type of 510(k) submission, which evaluates a physical administration set largely through non-clinical (bench) testing and biocompatibility assessments, rather than clinical studies involving patient outcomes, diagnostic accuracy, or human reader performance.

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

   • Not applicable / Not provided in the document. The testing described is primarily non-clinical (bench and lab testing for physical properties and biocompatibility). Sample sizes for these types of tests are typically determined by relevant ISO standards or internal quality procedures and are not usually detailed in this summary document. Data provenance is not specified for these lab tests.

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. This device is a physical administration set, not a diagnostic tool requiring expert interpretation for ground truth establishment. Engineering and lab technicians perform the non-clinical tests.

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

   • Not applicable. Adjudication methods are relevant for clinical studies, particularly those involving human reviewers of data like medical images. This document describes non-clinical testing.

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 medical administration set, not an AI-driven diagnostic or assistive technology for human readers.

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

   • Not applicable. This device is a physical product, not an algorithm.

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

   • For the non-clinical tests, the "ground truth" is defined by the objective pass/fail criteria established by the international standards (e.g., ISO 80369-6 for connector dimensions and functionality, ISO 10993 series for biocompatibility) and internal engineering specifications. There is no expert consensus or pathology involved in this context.

8. The sample size for the training set

   • Not applicable. This is not a device that utilizes machine learning and therefore does not have a "training set."

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

   • Not applicable. As above, no training set.

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Controlled, elective, subcricoid percutaneous insertion of a tracheostomy tube for airway management using a Seldinger guidewire dilation technique.
Controlled, elective subcricoid percutaneous insertion of a tracheostomy tube for airway management using a Seldinger technique to guide the specially designed Guidewire Dilating Forceps into trachea, which are then used to dilate the trachea.

The BLUperc® and BLUgriggs® Percutaneous Dilation Tracheostomy Tube Kits or Trays aid in the tracheostomy tube surgical procedure for adult patients; designed to aid adult patients requiring an artificial breathing airway due to trauma, medical condition and/or for airway maintenance. The tracheostomy tubes (kits or trays) maximum recommended period of use is 29 days. The kit or tray contains all the proprietary procedural components to support tracheostomy insertion, including the BLUselect tracheostomy tube for physician's ease during the clinical procedure flow.

The provided document is a 510(k) premarket notification summary for medical devices (tracheostomy kits). It focuses on establishing substantial equivalence to previously cleared predicate devices rather than proving a device meets specific acceptance criteria through a clinical study. Therefore, most of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types, training set details) is not applicable or cannot be extracted from this type of document.

The document primarily demonstrates that the BLUperc® and BLUgriggs® Percutaneous Dilation Tracheostomy Procedural Kits or Trays are substantially equivalent to existing predicate devices (UltraPerc Percutaneous Dilation Kit and Portex Percutaneous Tracheostomy Kit).

Here's a breakdown of the available information:

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

This document does not present a table of specific performance acceptance criteria in the way it would for a new AI/software device or a device requiring new clinical performance data to demonstrate effectiveness. Instead, the "acceptance criteria" are implied by establishing substantial equivalence to predicate devices. The performance testing conducted (bench testing, packaging validation, design validation/human factors, sterilization/microbiology validation, biocompatibility assessment) ensures the device meets its own specifications and is safe and performs as intended, thereby being equivalent to the predicates.

The study proves the device meets the "acceptance criteria" of substantial equivalence to the predicate device.

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

• Sample Size: Not specified for individual tests. The document refers to "applicable components" for bench testing and mentions that tests were "conducted" without providing specific sample numbers for each test.
• Data Provenance: The studies are described as "Non-clinical testing" and include bench testing, packaging validation, design validation/human factors, sterilization/microbiology validation, and biocompatibility assessment. These are laboratory/engineering tests rather than clinical studies with patient data. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" do not apply.

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

This information is not provided. The testing described (bench, packaging, sterilization, biocompatibility, and human factors) relies on engineering and scientific principles and product specifications, not on expert consensus for "ground truth" as might be seen in diagnostic imaging studies. Human factors testing involves users, but their qualifications are not detailed beyond "physician (healthcare staff)".

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

Not applicable. Adjudication methods are typically used in clinical studies where multiple reviewers assess outcomes, which is not the type of study described here.

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 premarket notification for a physical medical device (tracheostomy kit), not an AI/software device. No MRMC study was conducted or mentioned.

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

Not applicable. This is not an algorithm or AI device.

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

The "ground truth" for the performance testing is adherence to predefined engineering specifications, performance standards (e.g., fluid flow, material strength), and regulatory standards (e.g., ISO for packaging, sterilization, biocompatibility). It is based on objective measurements and compliance with recognized standards, rather than clinical expert consensus or pathology.

8. The sample size for the training set:

Not applicable. This is not a study involving machine learning or AI models, so there is no "training set."

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

Not applicable (no training set).

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