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The UTC 3 ml Medication Cartridge is intended for use in hospital and outpatient care environments with the CADD-MS® 3 Ambulatory Infusion Pump for subcutaneous infusion of medication in adults.

The UTC 3 mL Cartridge (UTC Cartridge) is a is a sterile, single-use cartridge intended for use with the Smiths Medical MD, Inc. CADD-MS®3 Ambulatory Infusion Pump. The UTC Cartridge is for use in hospitals and outpatient care environments.

The UTC 3 mL Medication Cartridge consists of 3 primary components: a 3mL cartridge that looks like a small syringe, 22G x 0.5 in. needle, and protective cap.

The distal end of the device has a male luer lock used to attach the needle and withdraw medication from a vial. Once filled, the plunger is removed, needle is discarded, and protective cap is place on the luer until the cartridge is inserted into the CADD-MS 3 Infusion Pump and secured into place with the infusion pump's lid. The protective cap can then be discarded and the male luer can then be attached to the female luer of an infusion set.

The provided FDA 510(k) summary for the UTC 3mL Medication Cartridge (K230718) does not describe an AI/ML-driven medical device, nor does it detail acceptance criteria related to algorithmic performance metrics (e.g., accuracy, sensitivity, specificity) for such a device. Instead, it concerns a physical medical device (a medication cartridge) and its substantial equivalence to a predicate device based on material, design, and performance testing for sterility, biocompatibility, and physical properties.

Therefore, many of the requested points regarding AI/ML device testing (e.g., sample size for test set, number of experts, MRMC studies, standalone performance, training set details) are not applicable to this document.

However, I can extract the performance data and acceptance criteria relevant to this specific device, as described in the 510(k) summary, and present them in a structured way that aligns with your request's format, even if the "performance" is mechanical/biological rather than algorithmic.

Here's the information based on the provided document, interpreting "acceptance criteria" and "device performance" in the context of a physical medical device clearance:

Device: UTC 3mL Medication Cartridge (K230718)
Type of Device: Infusion Pump Syringe (Accessory to an Infusion Pump)
Regulatory Class: Class II

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are primarily demonstrated through conformance to recognized international standards and specific performance tests. The summary states that the tests "demonstrated to be in conformance with" or "met the USP acceptance criteria," indicating successful performance against these standards.

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

The document does not explicitly state the specific sample sizes for each of the performance and biocompatibility tests. It only lists the standards followed. For medical device testing, sample sizes are typically defined by the specific test method within the referenced standards (e.g., ISO, ASTM, USP).

The data provenance is implied to be from laboratory testing conducted as part of the device development and regulatory submission process. There is no mention of country of origin for the data or whether it was retrospective or prospective in the sense of clinical study data. These are bench/lab tests.

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

This concept is not applicable here as the "ground truth" for this physical device is established by objective engineering and biological test standards (e.g., whether a Luer taper fits correctly, whether a material is cytotoxic, whether packaging maintains sterility) rather than expert consensus on diagnostic images.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like "2+1" or "3+1" are typical for clinical data review, especially in imaging studies, where expert disagreement needs resolution. For physical device performance tests, the outcome is typically an objective pass/fail against a standard.

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

Not applicable. This type of study assesses how human readers' performance (e.g., diagnostic accuracy) changes with or without AI assistance. The UTC 3mL Medication Cartridge is a physical component, not an AI/ML algorithm used for interpretation.

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

Not applicable, as this is not an AI/ML algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on objective engineering and biological test standards and measurements. This includes:

• Physical dimensions and tolerances (e.g., Luer taper).
• Material properties (e.g., polypropylene).
• Biological responses (e.g., cytotoxicity, irritation, hemocompatibility through ISO 10993 series).
• Sterility assurance (e.g., Bacterial Endotoxin testing, ethylene oxide validation).
• Particulate assessment (USP ).
• Packaging integrity and shelf-life stability.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/ML device that requires a training set.

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

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

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The SmartSite™ Bag is an empty container used for administration of intravenous solutions to the patient using an intravascular administration set. Medication transfer in and out of the container is done using aseptic technique.

The SmartSite™ Bag is a single-use, empty IV container, which will be available in 100mL, 250mL, and 500mL product sizes. The SmartSite™ Bag is labeled as sterile fluid path, and contains both an add port and a spike port. The add port facilitates aseptic transfer of medication(s) into or out of the bag. The spike port contains a twist-off protective seal. Either the add port or the spike port can be connected to an intravenous (IV) administration set for medication delivery to the patient. The add port may be repeatedly accessed in accordance with the Directions for Use (DFU). The SmartSite™ Bag may be used for up to 24 hours after the initial access of the add port, consistent with prescribing information for the medications used.

The provided text describes the 510(k) submission for the SmartSite Bag, an empty IV container. It outlines the device's indications for use, comparison to a predicate device, and non-clinical tests conducted to demonstrate substantial equivalence. However, the document does NOT contain a formal "study" proving the device meets acceptance criteria in the sense of a clinical trial or a structured performance study with defined acceptance criteria and reported numerical performance measures like sensitivity, specificity, or accuracy for a diagnostic device.

Instead, the document details various engineering and biocompatibility tests designed to ensure the SmartSite Bag functions as intended and is safe for its stated use, thereby demonstrating equivalence to the predicate device. The acceptance criteria are implicitly met by passing these tests and standards.

Here's a breakdown of the information that is present, organized as requested where applicable, and noting where the requested information is not available in the given text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present explicit acceptance criteria in a table format with corresponding numerical performance for the device for a specific clinical outcome. Instead, it lists various non-clinical tests and standards the device was evaluated against, implying that meeting these standards constitutes "acceptance."

2. Sample size used for the test set and the data provenance
The document does not provide specific sample sizes for each test in a numerical format (e.g., "n=X bags"). It refers to "testing" performed. The data provenance is internal to Gilero, LLC as it refers to non-clinical laboratory testing. There is no mention of country of origin of data or whether it was retrospective or prospective in a clinical sense, as these are non-clinical engineering tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not available in the document. The tests described are non-clinical, laboratory-based evaluations against established standards (e.g., ISO, USP), not assessments requiring expert "ground truth" establishment in a diagnostic context.

4. Adjudication method for the test set
Not applicable. There is no mention of an adjudication method as the tests are objective, laboratory-based measurements against defined standards.

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 (IV bag), not an AI/diagnostic software.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a medical device (IV bag), not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical tests is based on established industry standards and specifications (e.g., ISO 10993, USP , ISO 15747, and internal performance specifications for factors like leakage, Luer connection, and shelf life).

8. The sample size for the training set
Not applicable. This is a traditional medical device, not an AI/machine learning product that requires a training set.

9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.

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