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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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The product is a family of Angiographic Syringes for the injection of contrast media and saline. The syringe is for single use with US legally marketed angiographic injectors.

The Ecomed Disposable Angiographic Syringes are disposable syringes for use with contrast delivery systems that deliver contrast media or saline into the vascular system for the purpose of obtaining enhanced diagnostic images. The syringes are available in several sizes and configurations to ensure compatibility with US legally marketed contrast delivery systems.

The syringes are provided in kits that are configured from the following list of components:

• . Syringe(s)
• . Fill tube
• Vial Spike (small/large)
• . Transfer tubing set (length, y vs straight)

I will provide an answer assuming the request relates to the 'Ecomed Disposable Angiographic Syringes' as described in the provided text.

Based on the provided text, the device in question is the "Ecomed Disposable Angiographic Syringes," which are mechanical devices for injecting contrast media and saline. The text describes non-clinical performance (bench) tests to demonstrate substantial equivalence to predicate devices, rather than a study proving the device meets a specific clinical acceptance criterion with statistical performance metrics. Therefore, many of the requested fields related to diagnostic performance or human reader studies are not applicable.

Here's the information extracted from the document:

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

The document does not explicitly present a table of "acceptance criteria" with numerically reported "device performance" in the context of diagnostic accuracy, sensitivity, or specificity. Instead, the acceptance criteria are implicit in the compliance with various ISO and ASTM standards, which cover aspects like sterility, biocompatibility, packaging, and physical performance. The "reported device performance" is a general statement that the device fulfills these standards and is substantially equivalent.

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

The document does not specify the sample size for each individual test mentioned (e.g., how many syringes were subjected to leak testing). It only states that "Non-clinical performance (bench) tests conducted on the subject devices to support substantial equivalence includes comparison testing and physical performance testing." The data provenance is laboratory bench testing, not patient data, so country of origin or retrospective/prospective status is not applicable in the typical sense.

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

Not applicable. This is a bench study for substantial equivalence of a medical device (angiographic syringes), not a diagnostic device requiring expert interpretation or ground truth establishment in a clinical context.

4. Adjudication method for the test set

Not applicable, as it is a bench testing study, not a study requiring expert adjudication of results.

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

Not applicable. This device is a disposable angiographic syringe, 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 disposable angiographic syringe, not an algorithm.

7. The type of ground truth used

For dimensional compatibility and physical performance tests, the "ground truth" would be the engineering specifications and established performance characteristics of the predicate/reference devices, as well as the requirements set by the various ISO and ASTM standards. For biocompatibility and sterility tests, the "ground truth" would be the chemical, biological, and physical parameters defined by the relevant standards (e.g., absence of cytotoxicity, pyrogens, harmful reactions).

8. The sample size for the training set

Not applicable. This is a medical device, not an AI model.

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

Not applicable. This is a medical device, not an AI model.

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