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IMM™ Infusion Syringe Set is intended for delivering controlled volume of fluids from reservoirs consistent with the labeled route of administration of fluids by manual operation.

IMM 110 Infusion Syringe Set is single use product which contains disposable parts of one spike infusion set for connecting to fluid reservoir and fluid delivery, and a control syringe for delivery fluid supply from a solution bag to access device for purpose of delivering controlled volume of fluids from reservoirs consistent with the labeled route of administration of fluids by manual operation. The distal end of the set is a dual valve with 6% taper design for connecting to other access device such as needles before use. The IMM Infusion Syringe Set is provided sterile in fluid path, and to be disposed after single patient use.

The provided text describes a 510(k) submission for the IMM™ Infusion Syringe Set. This type of regulatory submission is for medical devices and focuses on demonstrating "substantial equivalence" to a predicate device already legally marketed, rather than proving novel clinical effectiveness through a complex study design like those typically seen for new drugs or high-risk devices.

Therefore, the study presented here is primarily a bench-top performance evaluation to show that the device meets established engineering and safety standards, and functions equivalently to existing devices. It is not a clinical study involving human patients or complex AI algorithms.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the device meets the specific requirements established in voluntary standards ISO8536-4 and ISO7886-1. Unfortunately, the specific acceptance criteria (e.g., minimum tensile strength, flow rate tolerances) within these standards, and the exact measured performance of the device against each criterion, are not detailed within this summary. The summary only provides a general statement of compliance.

However, based on the "Element of Comparison" table, some performance characteristics are implicitly mentioned.

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

The document does not specify the sample size used for the functional and performance tests.
The data provenance is not explicitly stated as "country of origin," but the manufacturing company is located in Miaoli, Taiwan. The studies appear to be retrospective bench-top tests conducted internally to support the 510(k) submission.

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

This information is not applicable in the context of this device and study. The "ground truth" here is compliance with engineering standards and material properties, not clinical diagnoses that would require expert human interpretation. The tests are physical and chemical evaluations.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for resolving discrepancies in clinical image interpretation or diagnostic outcomes. For bench-top engineering tests, the outcome is usually a quantitative measurement or a pass/fail against a standard, not subject to subjective adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially those involving image interpretation by human readers, potentially with AI assistance) to assess improvements in reader performance. The IMM™ Infusion Syringe Set is a manual fluid delivery device, not a diagnostic tool where human reader performance is a primary outcome.

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

No, a standalone (algorithm only) performance study was not done. This concept is only relevant for AI/ML-based algorithms. The IMM™ Infusion Syringe Set is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation primarily relies on:

• Engineering Standards: Compliance with international standards such as ISO8536-4 (Infusion equipment for medical use -- Part 4: Infusion sets for single use, gravity-fed) and ISO7886-1 (Sterile hypodermic syringes for single use -- Part 1: Syringes for manual use). These standards define mechanical properties, dimensional tolerances, flow rates, sterility, etc.
• Material Compatibility/Safety Standards: Compliance with ISO10993 (Biological evaluation of medical devices).
• Predicate Device Equivalence: The performance is also benchmarked for equivalence against the predicate devices (K063851 and K792227) in key areas like construction, transparency, bonding strength, flow regulation, syringe size, interface, material, and sterility.

8. The Sample Size for the Training Set

This information is not applicable. "Training set" refers to data used to train AI/ML algorithms. The IMM™ Infusion Syringe Set is a physical medical device, not an AI model.

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

This information is not applicable as there is no AI/ML algorithm or training set involved.

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The IMM™ Dental Irrigation Tubing Set is intended for providing passage of irrigating fluid from a solution reservoir to a dental handpiece.

The IMM™ Dental Irrigation Tubing Set is to be used for providing passage of irrigating fluid t from a solution reservoir to a dental hand piece. The device consists of one or more inlet spikes, drip chamber, PVC plastic tubes, clamps, silicone tube, consists of only caps.

The document provided is a 510(k) summary for the IMMTM Dental Irrigation Tubing Set. It describes a medical device, its intended use, and its equivalence to a predicate device. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies with specific acceptance criteria in the way an AI/ML device would.

Therefore, the information requested in your prompt regarding acceptance criteria and performance studies, particularly those relevant to AI/ML devices (e.g., sample size for test set, experts for ground truth, MRMC studies, standalone performance, training set details), is not applicable to this traditional medical device submission.

However, I can extract the information that is present concerning performance and testing from the provided text.

Here's a summary based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not Applicable. The document does not describe a "test set" in the context of an AI/ML study. The testing performed was primarily functional, performance, and biocompatibility testing on the device itself, not on a dataset. Data provenance (country of origin, retrospective/prospective) is also not applicable for this type of device testing.

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

• Not Applicable. The concept of "ground truth" established by experts for a test set is specific to AI/ML performance evaluation, not to the functional and biocompatibility testing of a physical medical device like an irrigation tubing set.

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

• Not Applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations within an AI/ML study's ground truth establishment. This is not pertinent to the present 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. An MRMC study is used to evaluate the impact of an AI system on human reader performance. This device is a passive tubing set and does not involve human "readers" or AI assistance.

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

• Not Applicable. Standalone performance refers to the performance of an AI algorithm independent of human interaction. This device is not an algorithm.

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

• Not Applicable. Ground truth, in the context of AI/ML, refers to the verified correct answers for a dataset. For this device, "ground truth" aligns with the objective measurements and adherence to the specified ISO standards for functional performance and biocompatibility.

8. The sample size for the training set:

• Not Applicable. A training set is used for machine learning models. This device does not involve machine learning.

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

• Not Applicable. Not an AI/ML device.

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The IMM Hypodermic Needle Set is to be used for sampling blood from or infusing fluid into body system underneath the skin.

The IMM™ Hypodermic Needle Set consists of a conventional stainless steel needle, needle hub, extension tubing, clamp, and standard female 6% luer conical fitting for connection to a device contains a male luer fitting.

The provided text describes the 510(k) premarket notification for the IMM Hypodermic Needle Set. It details the device, its intended use, and a summary of performance. However, this document does not describe a study involving AI or machine learning.

Instead, it refers to:

• Functional and performance tests demonstrating compliance with voluntary standards (ISO 594, ISO 7864).
• Biocompatibility tests meeting requirements per ISO 10993.

Therefore, many of the requested categories related to AI studies (such as sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance with AI, etc.) cannot be answered from the provided text.

Here's the information that can be extracted:

Acceptance Criteria and Device Performance (Non-AI Study)

Information Not Applicable/Available for an AI Study:

Since this is a submission for a traditional medical device (hypodermic needle set) and not an AI/ML powered device, the following points are not applicable or cannot be answered from the provided document:

1. Sample size used for the test set and the data provenance: Not applicable. Performance was demonstrated against engineering and biological standards, not a clinical test set in the context of AI.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI test set is not relevant here.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is not an AI-assisted device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI study. The "ground truth" here involved physical and chemical properties assessed against established international standards.
7. The sample size for the training set: Not applicable. There is no training set for an AI model.
8. How the ground truth for the training set was established: Not applicable. There is no training set for an AI model.

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