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Ecomed Disposable Administration sets are used to transfer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.

The Ecomed Disposable Administration Sets are a family of sterile, single use gravity sets composed of common components that are used to administer fluids. Each set is comprised of a subset of common components which are broadly used throughout industry including roller clamp, slide clamp, a flow regulator, a drip chamber, an infusion line filter, fluid delivery tubing, Burette w/ needle-free injection site and vent/cap and drip chamber 60 drop, injection site, connectors between parts of the set, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container. This family of sets and components is broken down into the following main categories: Primary set, Tee set, Flow Controller Set, Filter Set, and Burette Set.

The provided text is a 510(k) premarket notification for a medical device: Ecomed Disposable Administration Sets. This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, not typically for reporting the results of an AI algorithm study or an MRMC study.

Therefore, many of the requested criteria (e.g., acceptance criteria for an AI algorithm's performance, sample size for AI test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone AI performance, training set details) are not applicable to this document, as it describes a non-AI, non-software medical device.

The document primarily focuses on establishing substantial equivalence through performance testing of physical device properties, biocompatibility, and sterilization/packaging, all in conformance with recognized international standards.

However, I can extract information related to the acceptance criteria and proof of adherence for this specific type of device from the provided text.

Analysis of the Provided Document (K234129)

This 510(k) submission is for "Ecomed Disposable Administration Sets," which are physical medical devices (intravenous administration sets). The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the regulatory requirements and performance specifications that the device must meet to demonstrate substantial equivalence to a predicate device, as opposed to performance metrics for an AI/software algorithm.

Here's a breakdown based on the closest applicable information in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a typical "acceptance criteria" table with numerical targets and measured performance, as would be common for an AI algorithm. Instead, it lists the international consensus standards to which the device was tested and found compliant. Compliance with these standards is the acceptance criteria for a device of this type.

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

• Sample Size: The document does not explicitly state the numerical sample sizes for each specific test (e.g., how many infusion sets were tested for flow rate, how many for biocompatibility). It references the standards, implying that the sample sizes were in accordance with the prescribed methodologies of those standards.
• Data Provenance: The document does not specify the country of origin of the data. It is a premarket notification submitted to the U.S. FDA. The studies are prospective in the sense that they were conducted for the purpose of this submission to demonstrate device performance and safety.

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

• This is not applicable. For this type of physical medical device, "ground truth" is not established by human experts interpreting clinical data (like in AI for medical imaging). Instead, the performance is verified against engineering and biological standards using laboratory testing. The "experts" would be the engineers, microbiologists, and other scientific personnel who conducted the testing and verified compliance with the standards, but their number and specific qualifications are not detailed here, as it's not relevant to substantial equivalence in the way an AI study would require.

4. Adjudication Method for the Test Set:

• This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or AI algorithm evaluations where human readers interpret data, and discrepancies need to be resolved. This document pertains to physical device testing against established engineering and biological standards.

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

• This is not applicable. MRMC studies are standard for evaluating diagnostic imaging AI algorithms and their impact on human reader performance. This document concerns a physical administration set.

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

• This is not applicable. This device is not an algorithm or software. Its performance is inherent in its physical properties and design when used by a healthcare professional.

7. The Type of Ground Truth Used:

• The "ground truth" (or basis for evaluation/acceptance) here is compliance with recognized international consensus standards and regulatory requirements. This includes laboratory test results verifying physical parameters (e.g., flow rate, material integrity), biological safety (biocompatibility, sterility), and packaging integrity. It's not a clinical outcome or expert consensus on clinical data.

8. The Sample Size for the Training Set:

• This is not applicable. There is no AI algorithm being trained for this device.

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

• This is not applicable. As there is no AI algorithm, there is no training set or associated "ground truth" establishment in this context.

Summary regarding the device:

The "Ecomed Disposable Administration Sets" gained 510(k) clearance by demonstrating substantial equivalence to existing predicate devices. This was achieved by showing that the device meets well-defined international performance, sterilization, biocompatibility, and packaging standards, applicable to its intended use as an intravascular administration set. The changes from the predicate device (e.g., additional components, different tubing sizes, absence of pre-attached needle) were assessed to ensure they do not raise new questions of safety or effectiveness.

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Disposable TPE Infusion Set is used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.

The applicant device is single-use, sterile disposable infusion device, which is intended to be used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.

The protective cap is intended to protect the needle; The puncturing needle is made of Polyethylene and used to pierce the container; the catheter is made of thermoplastic elastomer (TPE) and used to connect various components, there is no DEHP used in the proposed device; the drip is transparent so that the user can observe the dropping condition of the medical solution, and it has a filtration mesh which can prevent the micro particle with diameter larger than 200 um to from entering human vessel; Flow regulator is used to adjust the flow rate from zero to maximum; Infusion needle is inserted into human vessel for medical solution transfusion, it is made of stainless steel.

The proposed device is provided sterilized.

The provided document is a 510(k) summary for a Disposable TPE Infusion Set. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include detailed information regarding specific acceptance criteria, a comprehensive study report with performance metrics, sample sizes for test and training sets, expert qualifications, or adjudication methods for establishing ground truth, which are typically found in studies relevant to AI/ML software.

The document states: "Laboratory testing was conducted to validate and verify that disposable infusion set met all design specifications and was substantially equivalent to the predicate device." This indicates that physical and functional tests were performed on the device to ensure it met pre-defined engineering and safety standards, rather than a clinical study evaluating an algorithm's performance.

Therefore, many of the requested details about acceptance criteria and study particulars for a software/AI device cannot be extracted from this document.

Here's a breakdown of what can be inferred or what is explicitly missing based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated in terms of specific thresholds for performance metrics (e.g., accuracy, sensitivity, specificity) for a software device. For this hardware device, acceptance criteria would typically relate to physical properties, flow rates, sterility, material biocompatibility, and mechanical integrity. The document only generally states the device "met all design specifications."
• Reported Device Performance: No specific performance metrics (like accuracy, sensitivity, etc.) are reported in the document. The general statement is that it "met all design specifications" and was "substantially equivalent to the predicate device."

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

• Sample Size for Test Set: Not specified. This document pertains to a physical medical device (infusion set), not a software algorithm. Testing would involve a certain number of manufactured units, but the count is not provided.
• Data Provenance: Not applicable in the context of clinical "data provenance" for algorithm training/testing. The testing performed would be laboratory-based validation of the physical device.

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

• Number of Experts: Not applicable. For a physical infusion set, ground truth is established through engineering specifications, validated test methods (e.g., flow rate testing, material testing, sterility testing), and adherence to standards, not expert clinical consensus on images or diagnoses.
• Qualifications of Experts: Not applicable.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

• Adjudication Method: Not applicable for a physical device. Test results are typically compared against pre-defined engineering specifications.

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

• MRMC Study: No. This is a physical medical device, not an AI/ML diagnostic tool requiring human reader comparison.

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

• Standalone Performance: No. This refers to an algorithm's performance, which is not relevant here.

7. The Type of Ground Truth Used

• Type of Ground Truth: For this device, ground truth would be established by validated engineering specifications, international standards (e.g., for sterility, biocompatibility, flow rate), and material properties testing. It's not based on expert consensus, pathology, or outcomes data in the way a diagnostic AI would be.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. There is no software algorithm or "training set" mentioned or implied for this physical device.

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

• Ground Truth for Training Set: Not applicable.

In summary, the provided 510(k) summary for the Disposable TPE Infusion Set is for a conventional physical medical device. It does not contain the type of information related to AI/ML software performance, acceptance criteria, study design (like sample sizes, expert involvement, and ground truth establishment) that your questions are designed to elicit. The "study" referenced is general laboratory testing to confirm the device meets its design specifications and is substantially equivalent to a predicate device.

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