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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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Chemfort® is a single use, sterile Closed System Transfer Device (CSTD) that mechanically prohibits the release of drugs, including antineoplastic and hazardous drugs, in vapor, aerosol or liquid form during administration and preparation, thus minimizing exposure of individuals, healthcare personnel, and the environment to hazardous drugs. Chemfort® prevents the introduction of microbial and airborne contaminants into the drug or fluid path for up to 7 days.

The Chemfort® Closed System Transfer Device (CSTD) is developed by Simplivia Healthcare Ltd. The system is used by pharmacists, nurses or other healthcare professionals to prepare drugs, including cytotoxic drugs, and allow the safe reconstitution of powder and liquid drugs transfer for infusion containers (infusion bags, semi-rigid bottles, and collapsible plastic containers), injection, or administration. It is supplied sterile with a sterility assurance level (SAL) of 10-6.

The Chemfort® Female Luer Lock Adaptor is part of the Chemfort® system of devices. The Chemfort® Female Luer Lock Adaptor is intended for the safe drug transfer from one syringe to another and allows closed access via Chemfort® devices to any standard male Luer connection (see below in more details).

1. Syringe to Syringe connection:
   The Chemfort® Female Luer Lock Adaptor is connected to the Chemfort® Luer Lock Adaptor. The Chemfort® Luer Lock Adaptor port is connected to an empty / saline containing syringe (syringe "A"), equipped with a Chemfort® Syringe Adaptor or Chemfort® Syringe Adaptor Lock. A drug containing syringe (syringe "B"), equipped with a Chemfort® Syringe Adaptor or Chemfort® Syringe Adaptor Lock is connected to the Chemfort® Female Luer Lock Adaptor. This assembly of devices allows drug transfer from one syringe "A" to the other, syringe "B", for drug dilution (if syringe "A" contains saline) or drug dosage (if syringe "A" is empty). This procedure allows safe drug transfer from one syringe to another. The drug in Syringe "A" can then be injected to an intravenous (IV) bag through the Chemfort® spike or in a bolus through another Chemfort® Luer Lock Adaptor connected to a Y-site on an IV set.

Note that this procedure also involves the Chemfort® Vial Adaptor to allow to withdraw the drug from the drug vial to syringe "B".

2. Connection to IV sets:
   The Chemfort® Female Luer Lock Adaptor is connected to an IV set through the luer lock connection (proximal end or infusion line). The Chemfort® port can then connect to one of the Chemfort® Closed Administration (CADM) IV sets. This setup transfers an open IV set connection to a closed connection.

The Chemfort® Female Luer Lock Adaptor can be in contact with concentrated or diluted drugs.

The Chemfort® Female Luer Lock Adaptor is a single-use device intended for use on adults, children and infants.

The provided FDA 510(k) clearance letter and supporting documentation (Chemfort® Female Luer Lock Adaptor 510(k) Summary) describe the performance testing and acceptance criteria for a physical medical device, not a software or AI-driven diagnostic device.

Therefore, many of the requested categories in your prompt (e.g., number of experts for ground truth, adjudication method, MRMC study, sample size for training set, how ground truth for training set was established, standalone performance) are not applicable to this type of device submission. These categories are typically relevant for AI/ML-based diagnostic devices where performance data relies heavily on expert annotations, comparative effectiveness studies involving human readers, and distinct training/test datasets.

However, I can extract the relevant acceptance criteria and performance data for the Chemfort® Female Luer Lock Adaptor based on the provided document.

Acceptance Criteria and Device Performance for Chemfort® Female Luer Lock Adaptor

This document outlines the performance data and acceptance criteria for the Chemfort® Female Luer Lock Adaptor, a physical medical device. The study performed demonstrates the device's adherence to established safety and performance standards for intravascular administration sets.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are primarily based on established international standards and internal validation procedures for medical devices of this type. The "Results" column from the provided Table 2 in the 510(k) summary indicates that all tests met their acceptance criteria, demonstrating the device's compliance.

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

• Sample Size: The document does not explicitly state the numerical sample sizes for each performance test (e.g., number of units tested for particulate analysis, bidirectional flow, etc.). However, it indicates that "Simplivia conducted several performance tests to demonstrate that the Chemfort® Female Luer Lock Adaptor is safe and effective..." implying a sufficient number of samples were tested to meet the requirements of the listed standards and internal procedures.
• Data Provenance: The tests were conducted by Simplivia Healthcare LTD. (an Israeli company) for regulatory submission to the FDA. The data provenance is laboratory testing performed by the manufacturer, rather than clinical data from human subjects. The tests are prospective in nature, as they involve testing newly manufactured devices against predetermined specifications.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

This question is not applicable to the type of device being cleared. The "ground truth" for the performance of a physical device like the Chemfort® Female Luer Lock Adaptor is established by adherence to validated engineering specifications, material properties, and functionality defined by international standards (e.g., ISO, USP) and internal quality control procedures. It does not involve expert interpretations of images or signals for diagnostic purposes.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies in expert annotations or interpretations, typically in studies involving human readers or AI outputs for diagnostic tasks. For a physical device, performance is evaluated against objective, measurable criteria with pass/fail outcomes, not subjective interpretations requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. MRMC studies are specific to evaluating the diagnostic performance of medical imaging devices or AI algorithms, often comparing human reader performance with and without AI assistance across multiple cases. This device is an intravascular administration set, not an imaging or diagnostic AI device.

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

This question is not applicable. There is no "algorithm" to be evaluated in a standalone manner for this physical device. Its function is mechanical and fluidic.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on engineering specifications, material science, and compliance with recognized international standards (e.g., ISO 80369-7, ISO 10993 series, USP monographs). These standards define the acceptable performance characteristics, physical properties, and safety profiles for devices of this type. For example, for "Luer Test," the ground truth is defined by the dimensional and functional requirements of ISO 80369-7:2021. For "Biocompatibility," the ground truth is defined by the specific tests and acceptance criteria within the ISO 10993 series.

8. The Sample Size for the Training Set

This question is not applicable. This device is a physical product, not an AI/ML model that requires a training set.

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

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

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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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HYHUB™ and HYHUB™ Duo vial access devices are indicated for patients 17 years of age or older to allow a drug to be transferred from vials without using a needle, as prescribed, in a home environment or clinical setting.

The HYHUB™ and HYHUB™ DUO vial access devices (VAD) are a stand-alone, single-use, disposable, non-pyrogenic, gamma sterilized device, which are intended to support the infusion of two medicinal liquids, as prescribed, in a home environment or clinical setting. The VAD is designed to accommodate up to two (2) or four (4) dual vial units (DVU) to be docked onto the VAD infusion tray which allows the transfer of medicinal liquids in a sequential, needleless manner using standard connections for syringes, applicable pumps, and infusion sets.

The FDA 510(k) clearance letter for the HyHub™ and HyHub™ Duo Vial Access Devices (K243404) does not contain the level of detail typically found in a clinical study report or a summary of clinical performance for AI/ML-based devices. Instead, it focuses on demonstrating substantial equivalence to a predicate device through bench testing, biocompatibility testing, and a comparison of technological characteristics.

Therefore, many of the requested categories relating to acceptance criteria for AI inference, dedicated test sets, expert adjudication, MRMC studies, standalone algorithm performance, and detailed training data are not applicable or cannot be extracted from this document. The document describes a medical device, not an AI/ML algorithm.

However, I can extract the information relevant to the performance testing that was conducted to demonstrate this device meets its requirements for substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

For a traditional medical device like the HyHub, "acceptance criteria" are generally tied to meeting specific performance standards based on recognized test methods or internal protocols. The document does not explicitly state numerical acceptance criteria for each test alongside performance data in a single table, but it lists the tests performed and implies successful completion for substantial equivalence.

Since the document does not provide specific numerical acceptance criteria and reported performance results for each test (e.g., maximum allowable leak rate vs. measured leak rate), I can only present the categories of tests performed.

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

This information is not provided in the FDA 510(k) letter. The document mentions "bench tests" and "biocompatibility evaluation," implying a set of physical devices were tested rather than a "test set" of data in the AI/ML context. No details on the number of units tested per bench test are given, nor is information on geographical origin or retrospective/prospective nature of data for this type of hardware device.

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

This information is not applicable for this type of device and submission. The "ground truth" for a vial access device is its physical performance against established engineering and biocompatibility standards, not expert interpretation of medical images or data.

4. Adjudication Method

Not applicable for this device type. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or labeling of data, typically for AI/ML device validation.

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

No. An MRMC study is not mentioned because this device is a physical vial access device, not an AI/ML diagnostic or assistive tool for human readers.

6. Standalone Performance Study (Algorithm Only)

No. This is a physical device, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's evaluation is based on established engineering and biocompatibility standards, and physical performance measurements.

• Bench Testing: Objective measurements against documented specifications for leak rates, particulate generation, flow rates, residual volumes, connector compatibility, and package integrity.
• Biocompatibility Testing: Results from established in-vitro and in-vivo tests (e.g., cytotoxicity, sensitization, systemic toxicity, hemolysis) against defined biological safety endpoints as per ISO 10993-1.
• Sterility Validation: Demonstration of a Sterility Assurance Level (SAL) of 10-6 in accordance with ISO 11137 (for gamma radiation) or ISO 11135 (for ethylene oxide).
• Pyrogenicity: Testing to confirm the device is non-pyrogenic.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set" of data.

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

Not applicable, as there is no "training set" for this device.

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The BD Intelliport™ System is an automated record keeping system that incorporates patient safety features that are aligned with hospital patient records and protocols. The system is comprised of an injection port and software that enables the identification, measurement, alerting and documentation of the administration of medications to patients.

The BD Intelliport™ System allows the clinician to record anesthesia-related medication administration events during pre-procedure, intra-procedure and recovery phase. The system is indicated for use by healthcare professionals in a hospital or medical center setting with patients who are receiving manually administered bolus intravenous injections as part of their care to facilitate documentation of the medications.

The BD Intelliport™ System is intended for patients with body weights >20 kg.

Do not use the BD Intelliport™ System with blood, blood products, biologics, or chemotherapeutics.

BD Intelliport™ System integrates into an intravenous line and automatically captures information about the anesthesia medications administered to the patient. It wirelessly transmits anesthesia medication administration information to the patient's Electronic Medical Record (EMR) via hospital server applications (Gateway software). The BD Intelliport™ System provides core technologies that enable key functions of the system:
• Medication Identification: Informs clinician of medication and concentration along with any informational notifications such as patient allergy and expired medication reminders. This occurs when syringes with the correct type of RFID encoded label are attached.
• Dose Measurement: Measures volume of drug administered to the patient through the system, then calculates dose weight.
• Automatic Charting: Wirelessly transmits measured doses to the EMR.

The following are the main system components:
• BD Intelliport™ Injection Site which is comprised of the following two components:

• BD Intelliport™ Sensor
• BD Intelliport™ Reader
  • BD Intelliport™ Mount (optional accessory)
  • BD Intelliport™ 2-Bay Charger (accessory)
  • BD Intelliport™ Gateway

The provided FDA 510(k) clearance letter and summary for the BD Intelliport™ System (K243062) describes the performance testing conducted to demonstrate substantial equivalence to its predicate device (K182092). However, it does not provide specific acceptance criteria or reported device performance values in a quantifiable table format, nor does it detail a standalone study with quantitative results, or a multi-reader multi-case (MRMC) comparative effectiveness study.

The document primarily focuses on demonstrating substantial equivalence through a comparison of technological characteristics and a list of performance tests completed.

Here's an attempt to structure the answer based on the available information, with caveats where data is missing:

Acceptance Criteria and Device Performance

The 510(k) summary states that "The subject device, the BD Intelliport™ System, has met all predetermined acceptance criteria for the non-clinical and human factors testing conducted in accordance with relevant FDA guidance, recognized consensus standards, and internal requirements." However, the specific numerical acceptance criteria and the quantitative reported device performance values for most tests are not explicitly stated in the provided document.

The only quantitative performance criteria and reported values mentioned are for "Volume measurement accuracy" and "Volume Measurement Resolution."

Note: The document states these are "Identical" to the predicate device, implying the reported performance matches the specified criteria.

Study Information

Due to the nature of a 510(k) summary, detailed study reports with specific quantitative results (beyond volume measurement accuracy) are not included. The document generally refers to "performance testing" and "human factors evaluation."

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

   • Test Set Sample Size: Not explicitly stated for each test. For "Volume Measurement Performance Window," the volume range tested was 0.5ml to 30ml, and average push speed 10ml/min to 400 ml/min. This implies tests were conducted across this range, but the number of injections or trials is not provided.
   • Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be non-clinical (laboratory-based) and human factors studies. The human factors testing likely involved simulated clinical environments.

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

   • Not applicable/Not provided within the scope of this 510(k) summary. These types of details are usually found in full study reports, not the summary itself, especially for a device that primarily automates record-keeping and measurement, rather than making diagnostic assessments that require expert ground truth. The human factors testing involved "intended device users," but their specific qualifications or roles in establishing "ground truth" (in a diagnostic sense) are not outlined.

3. Adjudication method for the test set:

   • Not applicable/Not provided. Adjudication methods (like 2+1, 3+1) are typically used in studies where there is disagreement in expert interpretation of diagnostic data. This device automates measurements and record-keeping, so such a method is not relevant.

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

   • No, an MRMC comparative effectiveness study was not explicitly reported or appears not to have been the primary method for demonstrating substantial equivalence. The device's primary function is "automated record keeping" and facilitating "documentation of the medications." It improves efficiency and accuracy of recording medication administration, rather than assisting human readers in interpreting medical images or data. The human factors evaluation assessed "critical tasks completed by intended device users," implying usability and user performance with the system, not a comparison of expert diagnostic accuracy with and without AI.

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

   • The document implies that standalone (algorithm-only) performance testing was conducted for various technical attributes. For example, "Bolus volume measurement accuracy," "Sensor flow rate," "Decoding response time," "Wifi functionality," and "Dose transmission time" are intrinsic functions of the system and its algorithms, which would have been tested independently of a human operator to verify their technical specifications. The "Flow Algorithm" itself was updated and "qualified through verification testing." However, explicit, detailed results from a standalone study with acceptance criteria are not presented in a formal table like format for all algorithm-driven functions.

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

   • For the technical performance tests (e.g., volume measurement), the "ground truth" would have been established using calibrated instruments and reference standards (e.g., known volumes, known flow rates) in a laboratory setting.
   • For the human factors evaluation, the "ground truth" would be defined optimal task performance and safety outcomes as determined by medical device standards and clinical best practices.

7. The sample size for the training set:

   • The document does not provide information on a training set size. The BD Intelliport System involves embedded software and algorithms (e.g., flow algorithm, RFID reading, EMR communication). While such systems often involve development and testing cycles, the summary does not detail a specific "training set" like one would find for a machine learning or AI algorithm that learns from data in a traditional sense. The "Flow Algorithm" was updated and "qualified through verification testing," which implies validation against known physical models or experimental data, rather than a statistical "training set" in the context of deep learning.

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

   • As no "training set" is explicitly mentioned for a machine learning model, this question is not applicable in the context of the provided information. The "ground truth" for verifying the updated flow algorithm would have been established through physical experiments and engineering measurements with known parameters (e.g., precise drug volumes, flow rates) to ensure the algorithm accurately processes the sensor data.

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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 ProSeal™ CSTD mechanically prohibits environmental contaminants from entering the system and the escape of drug or vapor concentrations from the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills. The ProSeal™ system also prevents the introduction of microbial contaminations into the drug or fluid path for up to 7 days when used as intended.

The ProSeal™ Bag Spike with Additive Port (or "and Seal Tab" (suffixed ST model no.)) serves as an adaptor between I.V. bags and ProSeal™ CSTD components, facilitating closed system fluid transfer. The spiking port of this device is compatible with generic I.V. spikes. Additionally, the additive port (injection site) allows medication to be added to the bag using the cleared ProSeal™ Injector or Injector Plus (both Syringe Adaptors).

The injection site of the ProSeal™ Bag Spike with Additive Port (or "and Seal Tab") and all corresponding interface membranes ensure a dry connection during fluid transfer. Utilizing this component and its appropriate ProSeal™ CSTD connecting component reduces the risk of microbial ingress for up to 168 hours (7 days).

This document describes a 510(k) clearance for a medical device called "ProSeal™ Bag Spike with Additive Port." 510(k) clearances are for medical devices that are substantially equivalent to a legally marketed predicate device. This process primarily relies on demonstrating that the new device has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.

Important Note: The provided FDA 510(k) clearance letter and summary do not describe a study involving a medical device with Artificial Intelligence (AI) or machine learning (ML) capabilities. The document pertains to a physical medical device (an intravascular administration set) and its mechanical and material properties. Therefore, the questions related to AI/ML specific criteria (e.g., sample size for training set, number of experts for ground truth, MRMC studies, AI assistance) are not applicable to this specific clearance.

I will focus on the acceptance criteria and performance data provided for this physical medical device.

Acceptance Criteria and Device Performance for ProSeal™ Bag Spike with Additive Port

Since this 510(k) is for a physical medical device and not an AI/ML device, the "acceptance criteria" are based on meeting established national and international standards for medical device safety and performance, as well as demonstrating substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and the Reported Device Performance

The device performance is demonstrated by conformance to various ISO standards and validation testing. The table below summarizes the key performance areas and the general nature of the reported performance, as specific quantitative acceptance criteria or detailed results are not explicitly listed in this type of summary document, but rather conformance to the standards is stated.

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

• Sample Size: The document does not specify the exact sample sizes used for each individual functional, biocompatibility, sterility, shipping, or shelf-life test. This level of detail is typically found in the full test reports, not in the 510(k) summary. For device clearances, compliance is often demonstrated by testing a statistically significant number of units to ensure performance within specifications, but the exact number isn't usually summarized here.
• Data Provenance: The document does not explicitly state the country of origin of the data. However, the submitter is Epic Medical Pte. Ltd. based in Singapore, suggesting the testing could have been conducted there or by affiliated labs. The testing refers to "bench performance verifications and validations" and "existing 510(k) cleared referred-to devices (K222929, K223674, K241988)" for leveraging data. This indicates the data is retrospective, drawing from previous tests on related and cleared devices, as well as specific new tests for the subject device. There is no indication of prospective clinical studies.

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

• Not Applicable: This criterion relates to AI/ML model validation, where human experts (e.g., radiologists) establish ground truth for image interpretation. For a physical medical device like an intravascular administration set, "ground truth" is established through engineering and biological testing against predefined performance standards and specifications, not through expert consensus on qualitative data. The "experts" would be the engineers, microbiologists, and other scientific and quality control personnel conducting the rigorous lab tests and validations.

4. Adjudication Method for the Test Set

• Not Applicable: Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or AI/ML model validation to resolve discrepancies in expert interpretations of data. For a physical device, performance is objectively measured against quantifiable technical specifications and standards (e.g., no leaks observed, flow rate within X range, microbial ingress count below threshold).

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: MRMC studies are specific to evaluating the diagnostic performance of AI-assisted systems where human readers interpret medical images or data. This device is a physical product, not an AI system.

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

• Not Applicable: This criterion is for AI/ML algorithms. The performance of this device is inherently its standalone physical function.

7. The Type of Ground Truth Used

• Objective Test Results / Conformance to Standards: The "ground truth" for this device's performance is established by objective engineering measurements, chemical analyses, and biological assays that demonstrate compliance with recognized industry standards (ISO, ASTM, ANSI, USP) and the device's design specifications. Examples include:
  • Absence of leaks under specified pressure.
  • Maintaining sterility and preventing microbial ingress for 7 days.
  • Meeting pre-defined flow rates.
  • No evidence of cytotoxicity, sensitization, or pyrogenicity in biocompatibility tests.
  • Successful vapor containment.

8. The Sample Size for the Training Set

• Not Applicable: There is no "training set" in the context of a physical medical device. This term applies to machine learning models.

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

• Not Applicable: As there is no training set for a physical device, this question is not relevant.

Summary of Study that Proves the Device Meets Acceptance Criteria for this Physical Device:

The study proving the device meets acceptance criteria is a comprehensive set of bench performance verifications and validations, along with biocompatibility, sterility, shipping, and shelf-life testing.

• Purpose: To demonstrate that the ProSeal™ Bag Spike with Additive Port is safe and effective for its intended use as an intravascular administration set component, and that any differences from its predicate device (ProSeal™ Closed System Bag Access, K241988) do not raise new questions of safety or effectiveness.
• Methodology:
  • Functional Testing: The device was subjected to various mechanical and functional tests based on ISO standards (e.g., ISO 8536-4, ISO 22413, ISO 15747, ANSI AAMI CN27), including leak integrity, tensile strength, flow rate, protective cap strength, IV bag spike penetration force, and impermeability to microorganisms (demonstrated for 7 days). Vapor containment was also assessed using a NIOSH CSTD draft protocol.
  • Biocompatibility Testing: In accordance with ISO 10993-1:2018 for externally communicating devices (blood path indirect, prolonged contact), various biocompatibility tests were performed on the device's materials, leveraging data from previously cleared predicate and similar devices (K222929, K223674, K241988). These included cytotoxicity, sensitization, systemic toxicity, hemolysis, pyrogenicity, chemical characterization, and particulate matter analysis.
  • Sterility Validation: Compliance with ISO 11135:2014 for Ethylene Oxide sterilization (SAL 10⁻⁶) was demonstrated, along with pyrogen testing.
  • Shipping and Shelf-Life Validation: Simulated shipping (ASTM D 4169-16) and package integrity tests (ASTM F1980-21, ASTM F88/F88M-21, ASTM F1929-23, EN 868-5:2009) were conducted. Shelf-life of 3 years was validated using accelerated aging (ASTM 1980-21).
• Data Sourcing: Data was obtained from new tests performed on the subject device and by leveraging data from previously cleared devices (K222929, K223674, K241988) that share similar components or materials, indicating a retrospective data approach for certain aspects.
• Conclusion: The results of these tests and validations confirmed that the subject device meets all relevant performance standards and does not raise new questions of safety or effectiveness compared to the predicate device, thus demonstrating substantial equivalence.

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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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