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The IV Stands and accessories are intended for hanging IV and other solution bags which are being administered to patients. The IV Stands are also used for hanging or supporting Infusion Pumps and other items that are used during IV administration, surgery, or patient care.

The Clinton Industries, Inc. IV Stands consist of a series of poles that are affixed to a base. The poles can telescope to various heights. The bases come in various sizes, depending on the pole used. The IV Stands are purchased with hooks for holding IV or other solution bags. The are either 2 or 4 hooks that are affixed to the top of the poles. The IV poles are chrome-plated steel. Each IV Stand consists of two poles with one fitting inside the other and telescoping to various heights. The telescoping portion of the poles is held in place by either a twist lock design or a compression knob. The bases are steel or aluminum with various coatings. Casters are affixed to the bases for movement of the stands. The following accessories are marketed with the IV Stands: Guidance Handle, Drainage Bag Hook, Utility Console Tray, Dual Pump Holder, Multi-pump Holder.

This document is a 510(k) premarket notification for IV Stands and Accessories from Clinton Industries, Inc., submitted to the FDA in 1998. The purpose of this submission is to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis based on your request, highlighting that this is a medical device substantial equivalence claim, not a study evaluating AI software or diagnostic performance. Therefore, many of your requested fields related to AI performance, ground truth, and expert adjudication are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (IV Stands), "acceptance criteria" are typically met by demonstrating that the device has the same fundamental technological characteristics and intended use as a predicate device already on the market. The "performance" is implicitly accepted if these characteristics are shown to be equivalent and safe. There are no specific quantitative metrics like sensitivity or specificity for an IV Stand.

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

• Not Applicable. This is not a study assessing diagnostic performance or AI. The "test set" here refers to the comparison of the new device's specifications against those of existing predicate devices.
• The data provenance is from the design specifications of the Clinton Industries IV Stands and the publicly available 510(k) summaries for The Brewer Company's IV Stands (K823270 and K850245).

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

• Not Applicable. Ground truth in the context of IV stands refers to their basic engineering and functional specifications, which are objective. There isn't "ground truth" to be established by experts in the same way there would be for image interpretation. The "experts" involved are the design engineers and regulatory professionals from Clinton Industries and potentially FDA reviewers who evaluate the technical specifications against the predicate devices.

4. Adjudication Method for the Test Set

• Not Applicable. There is no "adjudication" in the sense of resolving disagreements among experts on a diagnostic outcome. The comparison is based on objective, verifiable physical and functional characteristics. The FDA's review process serves as the "adjudication" of substantial equivalence.

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

• Not Applicable. This is not a diagnostic device involving human readers or AI.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

• Not Applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

• For this submission, the "ground truth" is the objective physical and functional specifications of the predicate IV stands as documented in their 510(k) submissions. The new device's specifications are compared directly against these documented characteristics.

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" as this is not an AI or machine learning device. The design of the Clinton Industries IV Stands is based on established engineering principles and the design of existing, legally marketed IV stands.

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

• Not Applicable. As there's no training set, there's no ground truth to be established for it.

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The Medrad Contrast Holders are an accessory device intended to be used in conjunction with Medrad injectors. The device is designed to aid in the transfer of common contrast media or flushing agents such as saline to the syringe. Users of this device are to be medical professionals trained in CT, MR .Angiographic Procedures, and are expected to have a good understanding of the events leading up to and including the use of the device. The Medrad Contrast Holder replaces the need for a separate contrast holder or Medrad Contrast Holder and is designed specifically for use with Medrad injectors.

The Medrad Contrast Holder will be used in conjunction with 510 (k) approved Medrad Injector systems. The Contrast Holder mounts to either a Medrad injector pedestal or the Counterpoise System ( CS) by means of clamps that attach to the pedestal or CS.

The injector pedestal mounted Contrast Holder utilizes a two-section telescoping tube with a hand-turned knob to adjust the height. Two hooks are used to hang containers. One of the pedestal mounts uses two ring clamps to mount to the pedestal shaft. The other mounts to one of the pedestal legs and is supported by a clamp on the handle of the injector control unit.

The Contrast Holder for the CS uses a ring clamp to attach to the articulating counterbalance arm of the CS. A hook hangs vertically from the clamp.

An optional tray for holding accessories or bottles is available. The tray snaps into a clamp on the lower section of the telescoping tube and can be removed for cleaning.

This document describes a medical device, the Medrad Contrast Holder, and its performance testing. However, it does not describe acceptance criteria or a study that proves the device meets those criteria in the way typically associated with AI/ML-driven medical devices.

Instead, this document describes a traditional medical device (a physical holder for IV/Contrast containers) and its performance validation through a series of engineering and functional tests. Therefore, many of the requested fields are not applicable in this context.

Here's an analysis based on the provided text, highlighting where information is available or not applicable:

1. Table of acceptance criteria and the reported device performance

Explanation: The document lists various tests performed, implying that successfully passing these tests constitutes meeting the acceptance criteria for a safe and effective device. The "Reported Device Performance" is consistently stated as having "met all specifications and passed all tests performed."

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: Not specified. For a physical device, this would typically refer to the number of units tested. The document implies testing was done on at least one representative unit.
• Data Provenance: Not specified, but implied to be internal testing by Medrad, Inc. (Indianola, PA, USA). This would be prospective testing as it's part of the device development and clearance process.

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

• Not Applicable. This device is hardware; its "ground truth" is established through engineering specifications, material properties, and functional performance tests conducted by engineers and technicians, not clinical experts for diagnostic accuracy.

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

• Not Applicable. Adjudication methods are relevant for subjective assessments, often in diagnostic imaging. Here, tests are typically objective (e.g., measuring forces, observing physical behavior, material compatibility).

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 hardware device, not an AI/ML diagnostic algorithm. MRMC studies are used for evaluating diagnostic performance with AI.

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

• Not Applicable. This is a hardware device.

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

• Engineering Specifications and Material Properties. The "ground truth" for this device's performance is its adherence to predefined engineering specifications (e.g., weight capacity, dimensions, material compatibility for MR environment, durability standards) and its functional operation as designed.

8. The sample size for the training set

• Not Applicable. This is a physical device, not an AI/ML model that requires a training set.

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

• Not Applicable. This is a physical device.

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