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A CONDUIT FOR BLOOD REMOVAL FROM A PATIENT TO A VACUUM BOTTLE TO AID IN THE TREATMENT OF A DISEASE OR OTHER CONDITION.

A STERILE, SINGLE USE DEVICE FOR WITHDRAWING BLOOD. BASIC CONCEPT: A CONDUIT USED FOR WITHDRAWING BLOOD FROM THE PATIENT'S VEIN TO A VACUUM BOTTLE RESERVOIR

This document describes a 510(k) submission for a medical device (Kawasumi Laboratories Phlebotomy Set) and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive performance studies with detailed acceptance criteria typically found in AI/ML device submissions.

Therefore, many of the requested elements (e.g., sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or available in this type of regulatory submission. The device is a relatively simple, sterile, single-use blood collection set, and the focus is on its basic function and safety.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and the Reported Device Performance

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

• Not applicable/Available. This submission focuses on demonstrating substantial equivalence through design and material characteristics, along with standard biocompatibility and pyrogenicity testing, rather than a clinical "test set" in the context of AI/ML or diagnostic performance.
• Data Provenance: Not specified, but standard regulatory tests (biocompatibility, pyrogenicity) are typically performed in certified laboratories.

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

• Not applicable/Available. There is no "ground truth" establishment in the sense of expert review of data for a diagnostic or AI/ML algorithm. Safety and performance are assessed via specified tests and comparison to a predicate.

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

• Not applicable/Available. No such adjudication method is mentioned or relevant for this type of device submission.

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

• No. This is a basic medical device (phlebotomy set), not an AI-assisted diagnostic tool.

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

• No. This is a basic medical device, not an algorithm.

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

• Not applicable. The "ground truth" for this device's performance and safety is based on validated laboratory testing methods (e.g., ISO standards for biocompatibility and pyrogenicity) and the established performance of the predicate device.

8. The sample size for the training set

• Not applicable/Available. There is no "training set" in the context of an AI/ML algorithm.

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

• Not applicable/Available. No training set exists for this device.

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INFUSION OF FLUIDS, INCLUDING THOSE CONTAINING MEDICATIONS, FROM A CONTAINER TO A PORT IMPLANTED IN, OR OTHERWISE ATTACHED TO, A PATIENT TO AID IN THE DIAGNOSIS OR TREATMENT OF DISEASE OR OTHER CONDITIONS.

A NON-PVC PORT ACCESS INFUSION SET IS A STERILE, SINGLE USE DEVICE WITH A NEEDLE, WING, NON-PVC I.D. TUBING AND NON-PVC COMPONENTS USED FOR ACCESSING IMPLANTED MEDICATION PORTS.

Here's an analysis of the provided text regarding the acceptance criteria and study for the device K974829:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not contain information regarding the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The document only mentions that Kawasumi Laboratories "conducted biocompatibility tests on the body fluid contacting material portions of the device."

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

The provided text does not contain information regarding the number of experts used to establish ground truth or their qualifications. The studies mentioned are laboratory tests (biocompatibility, LAL) and do not appear to involve expert-driven ground truth establishment in a clinical context.

4. Adjudication Method for the Test Set

The provided text does not contain information regarding an adjudication method. The tests described are objective laboratory tests.

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

No, an MRMC comparative effectiveness study was not conducted. The document focuses on demonstrating substantial equivalence to a predicate device based on material characteristics and basic safety tests, not on improving human reader performance.

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

The device is an "Infusion Set," which is a physical medical device, not an algorithm or AI system. Therefore, a standalone algorithm study is not applicable and was not performed.

7. The Type of Ground Truth Used

The ground truth for the device's performance was established through objective laboratory tests, specifically:

• Biocompatibility tests: These typically involve in-vitro and sometimes in-vivo toxicology assessments against established ISO standards or similar guidelines.
• Pyrogenicity testing: This refers to the LAL test, which is a standardized method to detect bacterial endotoxins.

8. The Sample Size for the Training Set

The provided text does not contain information regarding a training set sample size. As the device is not an AI/ML algorithm, the concept of a "training set" is not applicable in this context.

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

As the device is not an AI/ML algorithm, the concept of a "training set" and establishing ground truth for it is not applicable. The "ground truth" for the device's safety and performance was established through the aforementioned laboratory tests on the device materials.

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ROUTINELY USED TO ACCESS IMPLANTED MEDICATION PORTS FOR THE DELIVERY OF MEDICATIONS.

A NON-PVC PORT ACCESS INFUSION SET IS A STERILE, SINGLE USE DEVICE WITH A NEEDLE, WING, NON-PVC I.D. TUBING AND NON-PVC COMPONENTS USED FOR ACCESSING IMPLANTED MEDICATION PORTS.

The provided text does not contain information about acceptance criteria and a study proving a device meets them in the context of AI/ML performance evaluation. The document describes a medical device (KAWASUMI LABORATORIES NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITE) and its performance data relates to biocompatibility and pyrogenicity tests, not AI/ML model performance.

Therefore, I cannot populate the table or answer the questions related to AI/ML study design, sample sizes, expert ground truth, or adjudication methods based on the provided text.

The only relevant information that can be extracted is about the performance data for the described medical device:

Acceptance Criteria and Device Performance (Biocompatibility/Pyrogenicity)

The text explicitly states: "The device meets all biocompatibility and pyrogenicity test requirements."

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