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Hospira Primary sets are indicated for the delivery of fluids from a container to a patient's vascular system.

The Hospira Primary Sets with Secure Lock are intended for use as gravity sets. Primary Sets are comprised of a variety of components, at a minimum including a male luer adapter with spin collar, a piercing pin assembly, a cap on each adapter, injection site assembly, dial-a-flo assembly and tubing. In addition to these components, a set may contain one or more of the following components: flow control device, drip chamber assembly and air inlet. Hospira Primary sets are intended for the delivery of fluids from a container to a patient's vascular system. Hospira infusion sets are disposable devices for single patient use.

The provided text describes a 510(k) premarket notification for a medical device, specifically Hospira Primary Sets. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device (Hospira Primary Sets - K142367).

Based on the information provided, it's clear this document is for a physical medical device (intravascular administration sets) and not an AI/ML-driven diagnostic or image analysis software. Therefore, many of the requested criteria (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of device submission.

The "acceptance criteria" for a physical device like this typically revolve around compliance with relevant engineering standards, material biocompatibility, and functional performance tests rather than diagnostic accuracy metrics.

Here's a breakdown of the applicable information:

Acceptance Criteria and Device Performance for Hospira Primary Sets (K143015)

The device in question, Hospira Primary Sets, is an intravascular administration set. The criteria for its acceptance are based on its functional performance, material safety, and compliance with established international standards for such medical devices, demonstrating substantial equivalence to a previously cleared predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not explicitly detailed in the provided document. For physical device performance testing, sample sizes are typically determined by statistical methods to achieve a certain confidence level for the specific tests performed (e.g., tensile strength, leak tests). The data provenance is generally from internal lab testing by the manufacturer.

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

This is not applicable as the device is a physical product, not an AI/ML diagnostic. Ground truth for its performance is established through engineering and laboratory testing against defined standards.

4. Adjudication Method for the Test Set

This is not applicable for a physical device. Performance is objectively measured against engineering specifications.

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

This is not applicable. MRMC studies are relevant for diagnostic devices involving human interpretation, especially with AI assistance. This device is an intravenous fluid delivery set.

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

This is not applicable. This device does not involve an algorithm.

7. The Type of Ground Truth Used

For this physical device, the "ground truth" is defined by:

• Compliance with international standards such as ISO 10993 (biocompatibility), ISO 594-1 (luer fittings), ISO 594-2 (luer fittings), and ISO 8536-4 (infusion sets).
• Demonstrated functional performance through engineering tests that confirm safe and effective fluid delivery.
• Material properties meeting specified requirements.
• Achieving a sterility assurance level of 10-6.

8. The Sample Size for the Training Set

This is not applicable as the device is a physical product and does not involve AI/ML training.

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

This is not applicable for the same reason mentioned above.

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Hospira Primary sets are indicated for the delivery of fluids from a container to a patient's vascular system.

The Hospira Primary Sets with Secure Lock are intended for use as gravity sets. Hospira infusion sets are disposable devices for single patient use.

This document is a 510(k) premarket notification for a medical device called "Hospira Primary Sets." It describes the device, its intended use, and claims substantial equivalence to previously marketed predicate devices.

Based on the provided text, the device is an Intravascular Administration Set, which is a hardware device, not an AI/ML device.

Therefore, I cannot provide information regarding acceptance criteria and studies related to AI/ML device performance, as the requested information is not applicable to this submission. The document discusses performance testing in a general sense to ensure the device performs as intended in accordance with applicable standards, but does not provide specific acceptance criteria or study details that would be relevant to an AI/ML device.

Here's an analysis based on the document if we were to interpret it for a standard medical device, but with the caveat that it doesn't involve AI/ML:

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

The document broadly states: "Performance testing was conducted to ensure the device performs as intended in accordance with applicable standards. All testing is acceptable."

However, it does not provide a table of specific acceptance criteria (e.g., flow rate, burst pressure, leak rate maximums) or their corresponding reported device performance values. It only states that the product Sterility Assurance Level is 10-6, which is a performance characteristic, but not part of a comparative table.

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

The document does not specify the sample size used for performance testing, nor does it mention the data provenance (country of origin, retrospective/prospective). It only refers to "performance testing" generally.

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):

This information is not applicable as the device is a hardware product (intravascular administration set) and does not involve the interpretation of data by experts to establish ground truth in the way an AI/ML device would.

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

This information is not applicable for the same reason as point 3. It's a hardware device, not an AI/ML diagnostic tool.

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:

This information is not applicable as the device is a hardware product 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:

This information is not applicable as the device is a hardware product and does not have an algorithm.

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

For a hardware device like this, "ground truth" would typically refer to established engineering and material standards, or physical measurements that confirm the device meets its specifications (e.g., fluid flow rate, material strength, sterility). The document states: "All materials of construction for Hospira Primary Sets meet the applicable material test requirements for ISO 10993." and "Performance testing was conducted to ensure the device performs as intended in accordance with applicable standards." This implies that industry standards and physical measurements are used as the "ground truth" for evaluating the device's performance.

8. The sample size for the training set:

This information is not applicable as the device is a hardware product and does not involve machine learning or training sets.

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

This information is not applicable as the device is a hardware product and does not involve machine learning or training sets.

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