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For the administration of fluids from a container into the patient's vascular system through a vascular access device.

The proposed devices consist of Solution Administration Sets. These devices include Basic, Secondary, CONTINU-FLO solution sets, Stand-Alone devices and Chemotherapy devices (see Table 2 for a list of subject device set names per product family). They are single use disposable, non-pyrogenic, sterile devices intended for the administration of fluids from a container into the patient's vascular system.

This is a 510(k) premarket notification for "Solution Administration Sets" by Baxter Healthcare Corporation. The document states that the devices are substantially equivalent to a predicate device (K203609 cleared on September 30, 2021).

Here's the breakdown of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a specific table of acceptance criteria with corresponding performance values in the format usually seen for AI/ML devices. Instead, it describes general conformance to recognized standards and the positive outcomes of various tests.

Note: This submission is for a traditional medical device (solution administration sets), not an AI/ML device. Therefore, the questions related to AI/ML specific studies (sample size for test set, data provenance, number of experts for ground truth, adjudication, MRMC study, standalone performance, training set sample size, training set ground truth) are not applicable to this document. The "tests" described are standard engineering, biocompatibility, and sterilization validations for physical medical devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable, as this is a traditional medical device, not an AI/ML device. The testing described is bench testing and biocompatibility assessments, not a study involving patient data or a specific test set in the AI/ML context.

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, as this is a traditional medical device, not an AI/ML device. Ground truth as typically defined for AI/ML models is not relevant here.

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

Not applicable, as this is a traditional medical device, not an AI/ML 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, as this is a traditional medical device, not an AI/ML device.

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

Not applicable, as this is a traditional medical device, not an AI/ML device.

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

Not applicable, as this is a traditional medical device, not an AI/ML device. Instead of "ground truth," the device relies on conformance to established international and national standards (ISO, ASTM, USP) and predefined acceptance criteria for various physical, chemical, and biological tests.

8. The sample size for the training set

Not applicable, as this is a traditional medical device, not an AI/ML device.

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

Not applicable, as this is a traditional medical device, not an AI/ML device.

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For the administration of fluids from a container into the patient's epidural space with Baxter infusion pumps.

The Solution Set for Epidural Use is a single use disposable device intended for the administration of fluids from a container into the epidural space. The set is used for epidural infusions of fluids (typically analgesic or anesthetic) as an intermittent or continuous infusion to reduce chronic or post-operative pain. The set consists of a nonvented spike, 60 drops per mL drip chamber, minidrip adapter, tubing, fixtured slide clamp, on-off roller clamp, and a male epidural lock connector. The connector is compliant to the provisional AAMI/CN6:2015 Small-bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications.

The provided text describes the Baxter Healthcare Corporation's "Solution Set for Epidural Use" (K161323) and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.

The document is a 510(k) premarket notification for a traditional medical device (an epidural IV administration set), not an AI/ML device. Therefore, the questions regarding AI/ML device performance, sample sizes for training/test sets, ground truth establishment by experts, and MRMC studies are not applicable to this document.

The document focuses on:

• Substantial equivalence to an existing predicate device (Bard Epidural Spike Tubing Set, K925058).
• Nonclinical bench testing to evaluate functional performance (e.g., Drop Volume Test, Cannula Pull Out Test, Pump Tests).
• Biocompatibility testing (e.g., Cytotoxicity, Systemic Toxicity).
• Sterility testing.
• Shelf-life testing.

All these tests are reported to have "met the acceptance criteria," but the specific numerical acceptance criteria and the detailed results are not provided in this summary.

Therefore, I cannot fulfill your request using the provided text because it does not pertain to an AI/ML device and lacks the specific details about acceptance criteria and study results in the format you requested for an AI/ML model.

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For the administration of Nitroglycerin solution from a container into the patient's vascular system through a vascular access device.

The proposed devices, which are the subject of this Traditional 510(k) premarket notification, consist of Nitroglycerin Sets with DUO-VENT Spike. They are single use disposable devices intended for the administration of Nitroglycerin solution from a container into the patient's vascular system through a vascular access device. These devices are the same as the current marketed devices, previously cleared under 510(k) premarket notification K832284 (cleared on December 29, 1983).

Baxter's Nitroglycerin Sets with DUO-VENT Spike are comprised of non-DEHP drip chamber with a vented spike. PVC tubing pump segment, polyethylene (PE) lined trilayer tubing, and a luer lock. On all sets there is a fixture slide clamp and an on-off roller clamp. Configurations of these sets differ in overall length, type of injection site (Interlink, Clearlink, needle-accessed, or none), and type of drip chamber (10 or 60 drops per minute).

Polyethylene lined tubing is used to administer Nitroglycerin due to the compatibility issues between the drug and polyvinyl chloride (PVC). Nitroglycerin concentration can be significantly reduced when infused using standard PVC administration sets, due to absorption into the tubing. For this reason, trilayer tubing with an inner polyethylene layer is used in Baxter's line of Nitroglycerin Sets with DUO-VENT Spike.

The basis for this premarket notification is a modification to the PE lined trilayer tubing used in Baxter's Nitroglycerin Sets with DUO-VENT Spike. The modification consists of a change to the Polyethylene material used in the inner layer of the PE lined trilayer tubing.

Along with this modification, the needle-accessed injection site (y-site) is changing from a latex-containing y-site to one that is not manufactured with latex. This proposed needle-accessed y-site is currently used in Baxter's Intravascular (IV) Administration Sets with y-site(s) and has been previously cleared under 510(k) premarket notification K142011 (cleared on August 18, 2014).

These modifications do not impact the intended use or the fundamental scientific technology of the device. No other materials of construction are being introduced into this device as part of this update. The product labels are also being updated to add the indications for use statement of the device, revise statements regarding latex and references to pump devices, and make any other changes to comply with Baxter's labeling standards.

The provided document is a 510(k) premarket notification for a medical device (Nitroglycerin Sets with DUO-VENT Spike). This type of document is for demonstrating substantial equivalence to a predicate device, not for proving a new device meets specific acceptance criteria through a clinical study in the way an AI/ML device would. Therefore, most of the requested information regarding AI/ML study design, ground truth, experts, and sample sizes is not applicable to this document.

However, I can extract the acceptance criteria and performance related to the bench tests conducted for this device.

Here's the information that can be extracted or stated as not applicable:

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

Note: The document explicitly states "All tests met the acceptance criteria" for the performance tests and "shown to be biocompatible and appropriate for its intended use" for biocompatibility. Specific numerical acceptance criteria are not detailed in this summary, but are implicitly part of the underlying test protocols.

2. Sample size(s) used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not explicitly stated for each test. The document refers to "bench tests" and "biocompatibility assessments" which typically involve a predetermined number of samples per test type according to relevant standards (e.g., ISO, ASTM).
• Data Provenance: This is not relevant for bench testing of a physical device. The tests are conducted in a laboratory setting.

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 a physical medical administration set, not an AI/ML diagnostic or predictive device requiring expert-established ground truth from a dataset. The "ground truth" for these tests is defined by engineering specifications and biocompatibility standards.

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

• Not Applicable. Adjudication methods are typically for resolving discrepancies in expert interpretations of data (e.g., medical images for AI ground truth). This is a physical device being evaluated against objective bench test criteria.

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 physical medical device, not an AI or AI-assisted diagnostic tool.

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

• Not Applicable. This is a physical medical device, not an AI algorithm.

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

• Not Applicable. The "ground truth" for this device's performance is based on established engineering specifications, material properties, and regulatory standards for safety and function of intravascular administration sets and biocompatibility (e.g., ISO-10993, USP).

8. The sample size for the training set

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

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

• Not Applicable. As above, no training set for an AI/ML model is involved.

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