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

The EZ™ IV Administration Set is a gravity, single use, disposable, intravenous administration set designed to deliver fluids from a container into a patient's vascular system. The device includes a vented bag spike (air vent 0.1µm) integrated to a drip chamber (not made with DEHP*) featuring a 5-μm particulate filter, a roller clamp, flexible IV tubing (not made with DEHP*), and one (1), two (2) or three (3) needle-free valve (NFV) Y-site connectors. It also features a Luer connector and a priming cap with a 3-μm filter.

The EZ™ IV Administration Set may be used in combination with standard IV therapy devices commonly used throughout the healthcare settings, such as bag spike, Luer lock adaptor, syringe (MLL) (without needle), and IV extension sets. It is configured to achieve the intended use when used with these standard complementary products.

*DEHP – Di (2-ethylhexyl) phthalate (DEHP), a plasticizer to make PVC soft and flexible. It is a substance known to cause cancer or reproductive toxicity.

The provided FDA 510(k) clearance letter and summary for the EZ™ IV Administration Set (K251814) describe the device's acceptance criteria and the studies conducted to demonstrate substantial equivalence to a predicate device. However, this document primarily focuses on demonstrating substantial equivalence rather than proving the device meets specific acceptance criteria for a novel device. It also describes a medical device rather than a software or AI-driven device, so several of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set details) are not applicable.

Here's an analysis based on the provided text, focusing on the available information:

Acceptance Criteria and Device Performance for EZ™ IV Administration Set (K251814)

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the EZ™ IV Administration Set are primarily defined by adherence to recognized international and national standards for intravascular administration sets and specific functional performance metrics derived from these standards. The reported device performance indicates compliance with these standards.

• ISO 8536-4:2019
• ISO 22413:2021
• ISO 10993-1:2018
• ANSI/AAMI CN27:2021
• ISO 80369-7:2021
• ISO 80369-20:2015
• FDA Guidance for Intravascular Administration Sets | Comprehensive performance verification & validation testing performed; met the intended use. |
  | Air-inlet device tests | ISO 8536-4:2019 | Conformed to standard. |
  | Flow rate test | ISO 8536-4:2019 | Conformed to standard. |
  | Piercing device penetration force test | ISO 22413:2021 | Conformed to standard. |
  | Protective cap removal test | ISO 8536-4:2019 | Conformed to standard. |
  | Drip chamber and drip tube tests | ISO 8536-4:2019 | Conformed to standard. |
  | Leak integrity tests | ISO 8536-4:2019 (air leakage under positive pressure, air leakage under negative pressure and fluid leakage) | Conformed to standard. |
  | Tensile strength test | ISO 8536-4:2019 | Conformed to standard. |
  | Particulate contamination level | ISO 8536-4:2019, Annex A, A.2
  USP Particulate Matter in Injections | Met contamination index, N≤90. Conformed to standard. |
  | Drops/mL | 20 gtt/mL (as per Predicate) | 20 gtt/mL |
  | Tubing transparency | Sufficiently clear to observe air/water interface (normal/corrected vision) | Conformed to standard. |
  | Connector type | External Fitting Male Luer Lock (ISO 80369-7:2021) | Conformed to standard. |
  | Sterile barrier packaging | Medical grade paper and plastic film, heat sealed | Conformed to standard. |
  | Sterilization process | Ethylene Oxide (EO), SAL 10⁻⁶ | Ethylene Oxide (EO), SAL 10⁻⁶. Complies with ISO 11135:2014. |
  | Shelf-life validation | 3 years (36 months) via ASTM 1980-21 | 3 years (36 months) validated. |
  | Biocompatibility | ISO 10993-1:2018 (Externally Communicating Device, Blood Path Indirect, Prolonged Contact)
  (Specific ISO 10993 parts for various tests) | Met biological safety specifications. |
  | EO residues limits | ISO 10993-7:2008 & amendments | Conformed to standard. |
  | Shipping | ASTM D 4169-16 | Simulated shipping testing performed on K151650/S004. |
  | Package integrity | ASTM F1980-21, ASTM F88/F88M-21, ASTM F1929-23, EN 868-5:2009 | Testing performed on K151650. |
  | Pyrogen tests | ANSI/AAMI ST72/2019, USP , USP , USP | Testing performed on K151650 and "will be conducted on every lot." |

2. Sample size 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 devices/batches) used for each specific performance test mentioned (e.g., flow rate, leak integrity, tensile strength). The studies are focused on product characteristics and compliance with engineering standards, not clinical patient data.
• Data Provenance: Not explicitly stated for each test. The submitter is "Epic Medical Pte. Ltd." based in Singapore, suggesting the testing data likely originated from or was managed by facilities associated with this company. The testing is for a medical device component, not a diagnostic algorithm, so there is no patient data involved in these performance tests.
• Retrospective or Prospective: Not applicable, as these are engineering and materials performance tests conducted on the physical device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable to this type of device submission. The "ground truth" here is defined by objective engineering specifications and international standards, rather than expert consensus on medical images or diagnoses. Qualification involves expertise in medical device testing, engineering, and regulatory compliance.

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

Not applicable. Adjudication methods are relevant for subjective assessments, typically in clinical readings or evaluations where human interpretation introduces variability. These are objective physical and chemical tests on a medical device.

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

Not applicable. This is a physical medical device (IV administration set), not an AI-powered diagnostic tool, and therefore no MRMC studies were conducted or are relevant.

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

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

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

The "ground truth" for the performance tests conducted on the EZ™ IV Administration Set is based on established international and national standards and their specific test methods and acceptance criteria. This includes standards like ISO 8536-4 for infusion sets, ISO 10993 for biocompatibility, and USP for particulate matter. These standards provide objective, measurable criteria for device performance and safety.

8. The sample size for the training set

Not applicable. This pertains to the training of an algorithm or AI model. This submission is for a physical medical device.

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

Not applicable. As above, this is for a physical medical device and does not involve a training set for an algorithm.

Summary of Study that Proves Device Meets Acceptance Criteria:

The study that proves the EZ™ IV Administration Set meets its acceptance criteria is a comprehensive set of performance verification and validation tests conducted on the subject device and, in some cases, leveraging data from the predicate device (K230343/S001) or an existing device (K151650 and K151650/S004).

These tests address:

• Functional Performance: Evaluated against ISO 8536-4:2019, ISO 22413:2021, and FDA guidance documents, covering aspects like flow rate, leak integrity, piercing device penetration force, protective cap removal, drip chamber performance, and tensile strength.
• Connection Integrity: Evaluated against ANSI/AAMI CN27:2021 (for luer-activated valves) and ISO 80369 series (for small-bore connectors like Luer lock).
• Biocompatibility: Evaluated against ISO 10993 series (e.g., -5, -10, -11, -17, -18, -23) to assess cytotoxicity, sensitization, systemic toxicity, hemolysis, pyrogenicity, and chemical characterization. This classification was for "Externally Communicating Device, Blood Path Indirect, Prolonged Contact (>24 hr to 30 d)."
• Sterility and Shelf-Life: Compliance with ISO 11135:2014 for Ethylene Oxide sterilization, ASTM D 4169-16 for shipping, and ASTM F1980-21 for accelerated aging (shelf-life validation of 3 years). Package integrity, pyrogen, and EO residue tests were also part of this.
• Material Composition: Analysis and risk assessment were conducted given differences in materials between the subject and predicate devices, leveraging biocompatibility and chemical characterization data.

The submitter states that "All performance testing demonstrated and confirmed the safety and effectiveness of the Subject device" and that the results "met the intended use." They explicitly noted for material and dimension differences that "analytical and functional testing were conducted" and "the results...demonstrated that the performance of the Subject devices met the intended use. Therefore, the differences were considered not significant." This body of evidence constitutes the study proving the device meets its acceptance criteria, which are primarily compliance with the listed international and national standards.

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The SteadiSet infusion set is indicated for the subcutaneous infusion of insulin administered by an external pump. The infusion set is indicated for single use.

The subject device, SteadiSet infusion set, is a sterile, non-pyrogenic, intravascular administration set device used to administer insulin from a reservoir cartridge to a patient subcutaneously through a cannula. The infusion set administers insulin by means of a compatible external pump.

The infusion set consists of an inserter, tube set, and disconnect cover. The inserter consists of a housing, insertion buttons, an infusion set hub (with cannula) and adhesive patch with protective liner. The inserter facilitates insertion of the cannula subcutaneously. The cannula is a soft medical-grade polymer extruded over a stainless-steel coil.

The tube set provides the insulin pathway between the hub's indwelling cannula and an external insulin pump cartridge. The tube set consists of infusion set tubing with a reservoir connector (proximal end) and hub connector (distal end).

The disconnect cover can be connected to the hub to provide cover when the infusion set tubing is disconnected from the hub.

The device is sterilized by Ethylene Oxide (ETO) and is a single-patient, single-use device.

This FDA 510(k) clearance letter pertains to a medical device, the SteadiSet infusion set, not an AI or software as a medical device (SaMD). Therefore, many of the requested elements for AI/SaMD studies (such as sample sizes for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable or not found within this type of documentation for a physical infusion set.

However, I can extract the relevant information regarding the clinical trial conducted for the device.

Acceptance Criteria and Study for SteadiSet Infusion Set

Based on the provided FDA 510(k) clearance letter for the SteadiSet infusion set, the "acceptance criteria" are not explicitly defined as specific numerical thresholds for performance metrics (such as sensitivity or specificity) in the way they would be for an AI model. Instead, the "acceptance criteria" are implied by the overall demonstration of safety and effectiveness as required for substantial equivalence to a predicate device.

The study that proves the device meets (these implied) acceptance criteria is a clinical study.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set (Clinical Study)

• Sample Size: A total of 260 subjects were enrolled.
• Data Provenance: The clinical study was conducted in the US at 15 investigational centers. This indicates prospective, real-world data collection in a clinical setting.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable. For a physical medical device like an infusion set, "ground truth" is typically established through direct clinical observation of patient outcomes (safety and effectiveness) rather than expert consensus on diagnostic images or data. The assessment of safety and effectiveness would have been based on clinical endpoints and observed adverse events, which are measured directly.

4. Adjudication Method for Test Set

• Not Applicable. Clinical trial outcomes (adverse events, device function) are typically evaluated by the investigational site staff and potentially reviewed by a clinical events committee, but the concept of "adjudication method" as applied to expert consensus for AI ground truth does not directly apply here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. This type of study is relevant for diagnostic imaging AI, comparing human reader performance with and without AI assistance. It is not applicable to a physical infusion set.

6. Standalone Performance Study

• No, not in the context of an algorithm. The clinical study did evaluate the standalone performance of the device (the infusion set itself) in 260 subjects. However, this definition of standalone performance does not refer to an algorithm without human-in-the-loop, as the device is a physical product directly interacting with the patient.

7. Type of Ground Truth Used

• Clinical Outcomes Data: The ground truth was established by direct observation of clinical outcomes, specifically the absence of device-related serious adverse events and the demonstration of effective insulin infusion over the study period (maximum of 7 days).

8. Sample Size for Training Set

• Not Applicable. This device is a physical product, not an AI model requiring a training set.

9. How Ground Truth for Training Set Was Established

• Not Applicable. As there is no AI model or training set, this question is not relevant.

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The Sparta Infusion Set for Insulin is indicated for the subcutaneous infusion of insulin, administered by an external pump. The infusion set is indicated for use with adult and pediatric users weighing greater than 10 kg. The infusion set is indicated for single-use.

The Sparta Infusion Set is a sterile, single-use, subcutaneous infusion set that establishes a sealed fluid path from an external portable infusion pump to the patient. Fluid is delivered to the patient through a 6 mm, 90°, soft cannula inserted in the subcutaneous tissue. The cannula is inserted using the preloaded, single-use mechanical Inserter. The infusion set has a 23-inch tubing length that terminates in a Luer connecter.

The provided FDA 510(k) summary for the Sparta Infusion Set for Insulin (K243841) does not contain information about acceptance criteria and a study proving a software-driven device meets those criteria. The device described is an infusion set, which is a physical medical device, not an AI/software device. The document explicitly states:

"No clinical testing is required to support the Subject Device's indications for use or a substantial equivalence determination."

And regarding human factors, it says:

"Human Factors validation testing was performed... Testing demonstrated that use of the Sparta Infusion Set is safe and effective for its intended users, uses, and use environments." This is typical for physical devices, not an AI output study.

Therefore, I cannot provide the specific details about acceptance criteria, study design, sample sizes, expert involvement, or MRMC studies that you requested, as these are typically applicable to AI/software-driven diagnostic or imaging devices.

The document primarily focuses on:

• Biocompatibility Testing: To ensure the materials used are safe for contact with the body.
• Bench Performance Testing: To verify physical performance characteristics like leak resistance, insertion performance, needle safety, occlusion performance, etc.
• Sterilization and Shelf Life: To ensure the device remains sterile and functional over time.
• Human Factors: To ensure the device can be used safely and effectively by its intended users.

These are standard types of studies for a physical medical device like an infusion set, not for a software or AI product.

If you have a document describing an AI/software medical device, I would be happy to analyze it against your criteria.

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The Infusomat® Space Volumetric Pump Administration Sets are intended for use on adults, pediatrics, and neonates for the intermittent or continuous delivery of parenteral and enteral fluids through clinically accepted routes of administration. These routes include, but are not limited to intravenous, intra-arterial, subcutaneous, epidural, irrigation/ablation, and enteral. The sets are used for the delivery of medications indicated for infusion therapy including but not limited to drugs like anesthetics, sedatives, analgesics, catecholamines, anticoagulants etc., blood and blood components, Total Parenteral Nutrition (TPN), lipids, and enteral fluids. The Infusomat® Space Volumetric Infusion Pump Administration Sets are intended to be used by trained healthcare professionals in healthcare facilities, home care, outpatient, and medical transport environments.

The Infusomat® Space Volumetric Infusion Pump administration sets are sterile, nonpyrogenic, single-use devices for use with the B. Braun Infusomat® Space Volumetric Infusion Pump for pump and gravity administration of fluids.

Each administration set contains a segment of silicone tubing intended to interface with the linear peristaltic mechanism of the pump. There are two connectors at each end of the pump tube segment and a line loading guide to assist the user in loading the pump segment into the pump. Each set also contains a free flow protection clamp. The clamp is specifically designed to interface with a mating receptacle in the pump and is intended to prevent free flow of fluid when the pump door is opened and the set is removed. There are multiple set configurations including basic sets, burette sets, additive sets, filtered sets, epidural sets, low adsorption sets, add-on sets, and blood sets.

This 510(k) is making limited modifications to the predicate device. The subject changes of this 510(k) were related to updates to the tubing length, diameter, and material, as well as component updates to accommodate the changes to the tubing.

This document is a 510(k) clearance letter for the Infusomat® Space Volumetric Infusion Pump Administration Sets. It focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the safety and effectiveness of a novel device through a comprehensive study meeting specific acceptance criteria.

Therefore, the information requested in your prompt (especially regarding acceptance criteria, study design for proving performance, expert consensus, MRMC studies, etc.) is not applicable to this type of regulatory submission. This 510(k) does not describe a study that "proves the device meets acceptance criteria" in the sense of a clinical trial or performance study against pre-defined thresholds for a new technology. Instead, it relies on demonstrating that the modified device is functionally equivalent and safe compared to an existing, legally marketed device, despite minor changes in materials and specifications.

Here's why each point in your request is not directly extractable or applicable from this 510(k) document:

1. A table of acceptance criteria and the reported device performance: This document lists non-clinical testing (biocompatibility and device performance according to ISO standards, and associated device/pump testing) to demonstrate that the changes implemented do not negatively impact performance compared to the predicate. It does not present specific acceptance criteria in the format of a clinical study endpoint for a novel device. The "performance" is implicitly demonstrated by passing the listed engineering and material tests, showing it functions similarly to the predicate.

2. Sample sized used for the test set and the data provenance: Not specified in detail. The document mentions "non-clinical testing" but does not provide sample sizes for each test or details on data provenance (country of origin, retrospective/prospective). This is typical for 510(k) submissions for accessories or minor modifications where detailed clinical trial data is not required.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not a diagnostic device or an AI/ML algorithm requiring expert interpretation for ground truth. The "ground truth" here is compliance with engineering standards and material specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. There is no expert adjudication process described, as it's not a study where human interpretation is the primary outcome.

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 (infusion set), not an AI/ML diagnostic aid.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this device's safety and performance is based on compliance with established international standards (ISO, USP) for medical devices, material biocompatibility, and functional performance (e.g., flow rates, pressure resistance). This is determined by engineering specifications and laboratory testing, not clinical outcomes or expert consensus on images.

8. The sample size for the training set: Not applicable. There is no "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided FDA 510(k) document is for a medical device (infusion set) and demonstrates substantial equivalence through non-clinical performance and biocompatibility testing against established standards. It does not involve the type of acceptance criteria, study design, or ground truth establishment that would be present for software as a medical device (SaMD) or an AI/ML-driven diagnostic tool.

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Clave Neutral-Displacement Connectors (MicroClave™/ NanoClave™/ Clave™Neutron) are intended for the aspiration, injection, or gravity/pump flow of IV fluids and blood upon insertion of a male luer connector. Clave Connectors may be used with power injectors at a maximum pressure of 400 psi and a maximum flow rate of 10ml/sec. Clave Connectors will prevent microbial ingress for seven (7) days.

Clave Neutral-Displacement Connectors are needlefree, bi-directional connectors that utilize a pre-slit septum which prevents microbial ingress when in the un-activated state and allows access to the fluid path when activated with an ISO 80369-7 compliant male luer. The septum offers neutral displacement of fluid during connection or disconnection of a male luer and self-seals upon disconnection to prevent fluid loss or air ingress. The Neutron incorporates additional technology that will prevent fluid displacement resulting from syringe plunger compression; patient vascular pressure changes, such as coughing or sneezing; and IV solution container run-dry. The Clave Family of Connectors do not require a cap but may be used with disinfecting caps containing 70% isopropyl alcohol.

The provided text is a 510(k) clearance letter and summary for the Clave™ Neutral-Displacement Needlefree Connectors. This document describes a medical device, not an AI/ML algorithm. Therefore, many of the requested fields related to AI/ML device performance (e.g., effect size of human readers with AI vs. without AI, ground truth for training set, number of experts for ground truth) are not applicable.

However, the document does describe the device's acceptance criteria and the studies performed to demonstrate equivalence and support new claims.

Here's the information extracted from the document:

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

The document primarily focuses on demonstrating substantial equivalence to a predicate device and supporting new claims through non-clinical performance data and a retrospective clinical study.

Acceptance Criteria and Device Performance (Based on "Summary of Non-Clinical Testing" and "Performance Data: Non-Clinical Testing Summary")

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

• Non-Clinical Testing: The document does not specify the exact sample sizes for each non-clinical test (e.g., ISO 8536-4, ANSI/AAMI CN27). It states that "The subject device has been evaluated for the prevention of microbial ingress for a worst-case simulated use protocol of seven (7) days" and mentions conformance to various standards, which implicitly include testing of multiple units.
• Clinical Testing (CMS study):
  • Sample Size: Not explicitly stated as a "sample size" in the context of device testing. This was a retrospective study that analyzed 2019 CMS data. The study "analyzed 2019 CMS data" to compare hospitals using Clave connectors to those not using them.
  • Data Provenance:
    • Country of Origin: United States (CMS data).
    • Retrospective or Prospective: Retrospective.
    • Specifics: "analyzed 2019 CMS data," "adjusting for Hospital characteristics," "acute-care Hospitals which utilized the Clave Family of Connectors... had a statistically significant lower relative risk... when compared to acute-care Hospitals that did not utilize Clave Connectors."

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

• Not Applicable. This information is for AI/ML devices. The 510(k) is for a physical medical device (needlefree connector). Ground truth for the clinical study (bloodstream infection rates) would have been established through hospital records and CMS reporting, not by human experts adjudicating images or cases for AI training/testing.

4. Adjudication method for the test set

• Not Applicable. This information is typically for AI/ML devices involving human reviewer consensus. The clinical study used pre-existing CMS data on bloodstream infections.

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/ML device. The clinical study was a comparison of hospital outcomes based on device usage, not human reader performance.

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

• Not Applicable. This is not an AI/ML device.

7. The type of ground truth used

• Non-Clinical Testing: Ground truth is established by the specifications and measurement techniques defined in the referenced industry standards (e.g., ISO, ANSI/AAMI, USP). Performance is measured against these established parameters.
• Clinical Testing: The ground truth for the clinical claim (bloodstream infection reduction) was based on outcomes data from official government reporting (CMS data) regarding bloodstream infection rates (CLABSI) and bloodstream infection-associated mortality in acute-care hospitals.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device. There is no "training set."

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

• Not Applicable. This is not an AI/ML device.

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The SteadiSet Infusion Set is indicated for the subcutaneous infusion of insulin administered by an external pump. The infusion set is indicated for single use.

The subject device, Capillary Biomedical, Inc. SteadiSet Infusion Set, is a sterile, non-pyrogenic, intravascular administration set device used to administer insulin from a reservoir cartridge to a patient subcutaneously through a cannula. The infusion set administers insulin by means of a compatible external pump.

The infusion set consists of an inserter, tube set, and disconnect cover. The inserter consists of a housing, insertion buttons, an infusion set hub (with cannula) and adhesive patch with protective liner. The inserter facilitates insertion of the cannula subcutaneously. The cannula is a soft medical-grade polymer extruded over a stainless-steel coil.

The tube set provides the insulin pathway between the hub's indwelling cannula and an external insulin pump cartridge. The tube set consists of infusion set tubing with a reservoir connector (proximal end) and hub connector (distal end).

The disconnect cover can be connected to the hub to provide cover when the infusion set tubing is disconnected from the hub.

The device is sterilized by Ethylene Oxide (ETO) and is a single-patient, single-use device.

The provided FDA 510(k) Clearance Letter for the SteadiSet Infusion Set does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria. This document primarily focuses on demonstrating substantial equivalence to a predicate device based on similar design, materials, and intended use, rather than presenting detailed performance study results against specific acceptance criteria.

The "Non-Clinical Performance Data" section lists various tests performed (e.g., Insertion Force and Depth, Strength of Materials, Biocompatibility, Sterility), but it does not provide:

• Specific acceptance criteria values for each test (e.g., "Insertion force must be less than X N").
• Reported device performance values (e.g., "Observed insertion force was Y N").
• Details about the study methodology for these performance characteristics (e.g., sample size, ground truth establishment, expert involvement).

Therefore, I cannot fulfill most of the request based solely on the provided text. The questions asking about sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment (especially for training sets) are all related to robust clinical or non-clinical performance studies that are not described in this clearance letter.

This type of FDA letter confirms clearance based on a submission, but the detailed study reports themselves are typically much more extensive and are not usually part of the publicly available clearance letter.

Here's a breakdown of what can be inferred or stated based on the provided document, and what is missing:

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

• Cannot be provided definitively from this document. The document lists types of tests performed (e.g., "Insertion Force and Depth", "Strength of Materials, Joints, and Connectors"), but it does not specify the quantitative acceptance criteria for these tests nor the measured performance values of the SteadiSet Infusion Set against those criteria. For example, it lists "Insertion Force and Depth" as a test, but doesn't say "Acceptance Criteria: Insertion Force

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The JetCan® Pro Safety Huber Needle is indicated for use in the delivery of fluids and drugs, as well as blood sampling through surgically implanted vascular access ports for up to 24 hours. It is compatible with power injection ports and associated power injection procedures up to 325 psi.

The JetCan® Pro Safety Huber Needle incorporates a passive safety mechanism, activated upon the withdrawal from a port catheter to aid in the prevention of accidental needle sticks and minimize exposure to hazardous fluids.

The JetCan® Pro Safety Huber Needle is a non-coring Huber needle used to access the septum of a surgically implanted vascular access port for the delivery of intravenous fluids, blood sampling and power injection of contrast media, up to 5 mL/s at 325 psi.

The JetCan® Pro Safety Huber Needle is a single use, external communicating device, with direct blood contact and a duration of use of less than or equal to 24 hours.

The provided FDA 510(k) clearance letter for the JetCan® Pro Safety Huber Needle primarily focuses on the device's technical characteristics, regulatory compliance, and a comparison to a predicate device. It does not contain information about a study proving the device meets specific acceptance criteria based on AI/ML performance, nor does it refer to human reader studies (MRMC), standalone algorithm performance, or the establishment of ground truth for such studies.

The document describes performance testing related to the physical and functional aspects of the needle, such as burst pressure, flow rate, and safety mechanism activation. These are engineering and performance specifications, not acceptance criteria for an AI/ML model's diagnostic accuracy or similar AI-driven performance.

Therefore, I cannot extract the requested information (points 1-9) about AI/ML performance acceptance criteria or studies from this document. The device is a medical needle, not an AI/ML-powered diagnostic or assistive tool.

To illustrate what a response would look like if the document did contain such information, I will provide a hypothetical example, assuming the JetCan® Pro Safety Huber Needle was an AI-powered device for, e.g., predicting proper needle placement.

Hypothetical Example (if the JetCan® Pro Safety Huber Needle were an AI-powered device):

The JetCan® Pro Safety Huber Needle, if it were an AI-powered device, would require a different set of acceptance criteria and a different type of study to prove it meets those criteria. Based on the provided document, the device is a physical medical instrument (a Huber needle). Therefore, the information requested regarding AI/ML performance, MRMC studies, standalone algorithm performance, and ground truth establishment is not present in the provided 510(k) letter.

However, to demonstrate how such a request would ideally be answered if the document pertained to an AI/ML device, below is a hypothetical example of how a study proving an AI-powered device meets acceptance criteria might be described:

Hypothetical Study Description for an AI-Powered JetCan® Pro Safety Huber Needle (Not present in the provided document):

Let's assume, for the sake of this hypothetical example, that the "JetCan® Pro Safety Huber Needle" was an AI-powered imaging analysis device designed to accurately identify the optimal insertion point for a Huber needle on a vascular access port, thus preventing accidental needle sticks or unsuccessful insertions.

1. Table of Acceptance Criteria and Reported Device Performance (Hypothetical)

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

• Test Set Sample Size: 500 unique patient images (e.g., ultrasound or fluoroscopic images of vascular access ports).
• Data Provenance: Retrospective data collected from five major medical centers across the United States (40%), Europe (30%), and Asia (30%). Data was anonymized and de-identified prior to analysis.

3. Number, Qualifications, and Adjudication Method of Experts for Ground Truth (Hypothetical)

• Number of Experts: A panel of 5 board-certified interventional radiologists and vascular surgeons.
• Qualifications of Experts: Each expert had a minimum of 10-15 years of experience in vascular access procedures, with specific expertise in port placement and troubleshooting. They were blinded to the device's performance during ground truth establishment.
• Adjudication Method: A "3+1" adjudication method was used. Initially, three experts independently reviewed each image and marked the optimal insertion point. If at least two out of three experts agreed on a location, that became the preliminary ground truth. If there was no majority consensus (e.g., 1-1-1 split), a fourth senior expert, blinded to the initial ratings, was brought in as a tie-breaker. All discrepancies were resolved through consensus meetings.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study (Hypothetical)

• Yes, an MRMC study was performed.
• Design: A crossover design was employed where 10 independent vascular access specialists (not involved in ground truth establishment) reviewed the test set images.
  • Phase 1 (Without AI Assistance): Specialists individually identified the optimal insertion point on all 500 images.
  • Phase 2 (With AI Assistance): After a washout period, the same specialists reviewed the same 500 images but with the AI device providing its predicted optimal insertion point. Specialists could accept, reject, or modify the AI's suggestion.
• Effect Size: The study demonstrated a statistically significant improvement in human reader performance with AI assistance.
  • Improvement in Sensitivity: Human readers' average sensitivity for identifying optimal insertion points increased from 82% (without AI) to 94% (with AI assistance), representing a 12% absolute improvement.
  • Reduction in Time to Decision: The average time taken by human readers to identify the optimal point decreased from 15 seconds (without AI) to 8 seconds (with AI assistance), representing a 47% reduction in time.
  • Reduction in Critical Errors: The number of significant misidentification errors (leading to potential adverse events) decreased by 60% when readers used AI assistance.

5. Standalone (Algorithm Only) Performance (Hypothetical)

• Yes, a standalone performance evaluation was conducted.
• Metrics: The algorithm's standalone performance on the test set against the established ground truth showed:
  • Sensitivity: 96.2%
  • Specificity: 91.5%
  • Accuracy: 93.8%
  • Area Under the Receiver Operating Characteristic Curve (AUC): 0.97

6. Type of Ground Truth Used (Hypothetical)

• Expert Consensus: The ground truth was established by the consensus of multiple, highly experienced interventional radiologists and vascular surgeons through a detailed, adjudicated review process of imaging data.

7. Sample Size for the Training Set (Hypothetical)

• Training Set Sample Size: 20,000 unique patient images (e.g., ultrasound and fluoroscopic images) of vascular access ports.

8. How Ground Truth for the Training Set Was Established (Hypothetical)

• Hybrid Approach:
  • Initial Annotation: A team of trained clinical annotators (e.g., medical imaging technicians or nurses with vascular access experience) performed initial annotations of optimal insertion points on all 20,000 images under the supervision of a senior radiologist.
  • Expert Review/Correction: A subset of 2,000 (10%) randomly selected images from the training set, along with all images flagged as challenging or ambiguous by the annotators, underwent expert review by two board-certified interventional radiologists. Discrepancies were resolved through discussion to refine the ground truth.
  • Automated Quality Control: Automated scripts were used to check for consistency in annotations (e.g., size, shape, location of marked areas) and flag outliers for further manual review.

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For the administration of fluids from a container into the patient's vascular system through a vascular access device.

The proposed devices consist of Solution Administration Sets. These devices include Basic, Secondary, CONTINU-FLO solution sets, Stand-Alone devices and Chemotherapy devices (see Table 2 for a list of subject device set names per product family). They are single use disposable, non-pyrogenic, sterile devices intended for the administration of fluids from a container into the patient's vascular system.

This is a 510(k) premarket notification for "Solution Administration Sets" by Baxter Healthcare Corporation. The document states that the devices are substantially equivalent to a predicate device (K203609 cleared on September 30, 2021).

Here's the breakdown of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a specific table of acceptance criteria with corresponding performance values in the format usually seen for AI/ML devices. Instead, it describes general conformance to recognized standards and the positive outcomes of various tests.

Note: This submission is for a traditional medical device (solution administration sets), not an AI/ML device. Therefore, the questions related to AI/ML specific studies (sample size for test set, data provenance, number of experts for ground truth, adjudication, MRMC study, standalone performance, training set sample size, training set ground truth) are not applicable to this document. The "tests" described are standard engineering, biocompatibility, and sterilization validations for physical medical devices.

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, as this is a traditional medical device, not an AI/ML device. The testing described is bench testing and biocompatibility assessments, not a study involving patient data or a specific test set in the AI/ML 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)

Not applicable, as this is a traditional medical device, not an AI/ML device. Ground truth as typically defined for AI/ML models is not relevant here.

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

Not applicable, as this is a traditional medical device, not an AI/ML device.

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

Not applicable, as this is a traditional medical device, not an AI/ML device.

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

Not applicable, as this is a traditional medical device, not an AI/ML device.

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

Not applicable, as this is a traditional medical device, not an AI/ML device. Instead of "ground truth," the device relies on conformance to established international and national standards (ISO, ASTM, USP) and predefined acceptance criteria for various physical, chemical, and biological tests.

8. The sample size for the training set

Not applicable, as this is a traditional medical device, not an AI/ML device.

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

Not applicable, as this is a traditional medical device, not an AI/ML device.

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For the administration of fluids from a container into the patient's vascular system through a vascular access device.

The proposed devices are single use disposable devices intended for the administration of fluids from a container to the patient's vascular system. The extension sets consist of a combination of the following components: PVC or PE lined PVC tubing, a clamp, female Luer with non-vented cap, male Luer with filter vented cap. The accessories consist of an anti-siphon valve, back check valve, and 1.2 µm Filter. The accessories are used in combination with IV sets to administer solutions directly from a container to a patient's vascular system.

This FDA 510(k) summary describes an intravascular extension set and accessories. The filing primarily focuses on demonstrating substantial equivalence to a predicate device (K192366) and the removal of a caution statement related to body weight. Therefore, the information provided does not detail a study involving AI or complex performance metrics as typically seen for AI/ML-enabled devices.

Based on the provided text, the acceptance criteria and study information are as follows:

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

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 a "test set" in the context of performance evaluation with a defined sample size for the device itself. The primary testing mentioned is biocompatibility. For biocompatibility, there is no information about sample size or data provenance provided in this summary.

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 medical device (intravascular extension set and accessories), not an AI/ML-enabled device requiring expert ground truth for performance evaluation of diagnostic accuracy.

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

Not applicable. This device is a physical medical device, not an AI/ML-enabled device requiring adjudication of expert 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

Not applicable. No MRMC study was performed as this is a physical medical device, not an AI-assisted diagnostic tool.

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

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

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

Not applicable. For biocompatibility testing, the "ground truth" would be established by standardized testing methods and international standards (e.g., ISO 10993 series), not expert consensus, pathology, or outcomes data in the context of diagnostic performance.

8. The sample size for the training set

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

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

Not applicable. As there is no training set mentioned, there is no ground truth established for a training set.

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Lyka® PORT needle free access device is intended for use as an accessory to a vascular access device (catheter) used in Hemodialysis or as an accessory to an I.V. Set for the administration or withdraw of fluids to a patient through a cannula or needle placed in the vein or artery. The device may be used for patient populations including very low birth-weight infants, children, and adults for up to 7 days.

Lyka® PORT is a needle free accessory to a vascular access device (catheter) used in Hemodialysis or as an accessory to an IV set. It consists of a housing made from Polycarbonate and a Stem made from Silicone Rubber. The materials used in Lyka® PORT meet the requirements of ISO 10993-1 and have a long history of acceptable use with blood, blood-related products. The device will permit access to a catheter without the used in a closed position, it has a flat, smooth surface. When the male connector of a syringe or secondary line is engaged into the device, the silicone stem opens in the middle creating a straight fluid path. When the male connector is removed from the device, its body forces the stem shut and maintains a sealed fluid path. A cap is not required to seal Lyka® PORT or to maintain sterility. The device will be sold as a sterile, single use for up to seven (7) days.

The provided text describes the Lyka® PORT Needle Free Access Device (4170Y) and its substantial equivalence to a predicate device. However, it does not contain the level of detail requested for acceptance criteria, device performance results, sample sizes, expert qualifications, or ground truth establishment relevant to AI/ML device studies.

The document is a 510(k) summary for a medical device that appears to be a physical product (a needle-free access device), not an Artificial Intelligence/Machine Learning (AI/ML) software device. The acceptance criteria and performance data discussed are typical for a hardware device, focusing on physical properties and biocompatibility, not diagnostic or predictive performance metrics.

Therefore, I cannot fulfill the request to provide information about the acceptance criteria and study proving an AI/ML device meets them. The provided text is not about an AI/ML device.

To directly answer the questions based on the provided text, while acknowledging its irrelevance to AI/ML:

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

   Acceptance Criterion	Reported Device Performance
   Intended Use	Needle-free access to vascular devices for fluid administration/withdrawal. Suitable for very low birth-weight infants, children, and adults for up to 7 days.
   Design and Functionality	Needle-free, swabable, luer-activated, minimizes dead space, ensures sterile access.
   Flow Rate (Subject Device)	Not greater than 600 ml/min.
   Microbial Ingress	Effective barrier for seven days.
   Surface Disinfection	Achieved with 70% isopropyl alcohol in 30 seconds.
   Biocompatibility (ISO 10993-1)	Materials meet ISO 10993-1 requirements.
   Sterilization	Sterilized with ethylene oxide (EO) and packaged in Tyvek pouches.
   Shelf Life	3 years (supported by real-time and accelerated aging studies).
   Priming Volume (Subject Device)	~ 0.1 mL.
   Maximum Pressure (Subject Device)	1550 mmHg (30 psi).
   Valve Mechanism	Silicone valve mechanism with manual flushing (guided by IFU).
   Hemolysis & Biocompatibility (Specific)	Complies with ISO 10993-1 and ASTM F756; non-hemolytic.
   Ethylene Oxide Residuals (ISO 10993-7)	Complies with ISO 10993-7:2008 & AMD1:2019.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   The document does not specify sample sizes for test sets for any of the performance criteria. Data provenance for testing is not mentioned. The studies appear to be bench testing (non-clinical) rather than clinical studies with human subjects.

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 and not provided. The testing described is against engineering specifications and international standards, not against expert human interpretations of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable and not provided.

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. The document explicitly states, "No clinical testing was conducted on this device." This is a physical device, not an AI/ML diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. There is no algorithm mentioned.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   The "ground truth" used for this device's evaluation consists of established engineering specifications, international standards (like ISO 10993-1, ISO 10993-7, ASTM F756), and functional requirements for medical devices of this type (e.g., flow rate, pressure tolerance, microbial ingress prevention).

8. The sample size for the training set:
   Not applicable. There is no AI/ML model, and therefore no training set.

9. How the ground truth for the training set was established:
   Not applicable.

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