Search Results

The JMS Blunt AV Fistula Needle Set is intended for temporary cannulation (nonımplantable, less than 30 days) to vascular access for extracorporeal blood treatment The device is intended for single use only The JMS AV Fistula Blunt Needle Set is for use on developed 'constant site' access sites

Device Description

JMS AV Fistula Blunt Needle Set is intended as a non-implanted blood access device, which consists of a needle that is attached to wings, a flexible tube and a luer lock connector

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text, though it's important to note that the document is a 510(k) summary for a medical device (a blunt needle set), not a typical AI/software device. As such, many of the requested categories (like MRMC, training sets, ground truth for AI, etc.) are not applicable in their usual sense. This device relies on "substantial equivalence" to predicate devices rather than a standalone performance study as would be seen for an imaging AI.

Device Name: JMS A V Fistula Blunt Needle Set

1. Acceptance Criteria and Reported Device Performance

For this type of device, "acceptance criteria" and "reported device performance" are primarily demonstrated through equivalence to legally marketed predicate devices, focusing on functional aspects, materials, and intended use. The document doesn't provide specific numerical performance metrics (e.g., sensitivity, specificity, accuracy) typical of AI/software. Instead, the "acceptance" is that it performs as intended and is comparable to predicate devices.

Acceptance Criterion (Implicit)	Reported Device Performance
Intended Use: Temporary cannulation for extracorporeal blood treatment on developed 'constant site' access sites.	Device is intended for temporary cannulation (non-implantable, less than 30 days) to vascular access for extracorporeal blood treatment. Intended for single use only, on developed 'constant site' access sites. This matches the predicate devices.
Functional Performance: Performs as a non-implanted blood access device with a needle, wings, flexible tube, and luer lock connector.	"Functional tests performance data are comparable to predicate device." "Bench testing was conducted to verify that the JMS AV Fistula Blunt Needle Set performs as intended to be a safe and effective medical device, data and reports are enclosed within this submission document." (Specific results of these bench tests are not detailed in this summary).
Materials: Material composition of blood-contact components.	"JMS A V Fistula Blunt Needle Set... adopts identical fundamental scientific technology as the predicate devices." "JMS AV Fistula Blunt Needle Set has the same intended usage, same materials used in the blood-contact components..." (Specific material types are not detailed in this summary, but they are stated to be the same as predicates).
Safety and Effectiveness: Demonstrated through equivalence.	"The information provided in this submission clearly demonstrates the substantial equivalence of JMS AV Fistula Blunt Needle Set to the predicate device..."

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

For this device, there isn't a "test set" in the sense of a clinical trial dataset for an AI algorithm. The performance is assessed through bench testing for functional performance and a comparison of specifications to predicate devices.

Sample Size for Test Set: The document mentions "bench testing was conducted," but it does not specify the sample size of devices used in these tests.
Data Provenance: The document doesn't specify data provenance (country of origin, retrospective/prospective) for any test data. The tests would have been performed by the manufacturer (JMS Singapore Pte Ltd or JMS North America Corporation). The nature of the tests (bench testing) implies a controlled laboratory environment rather than patient data.

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

This question is not applicable to this type of device submission.
Ground truth, in the context of typical AI/imaging studies, refers to the verified correct diagnosis or finding. For a physical medical device like a needle set, performance is evaluated against engineering specifications and functional benchmarks, not by expert consensus on clinical findings from a "test set" of images or patient data.

4. Adjudication Method for the Test Set

This question is not applicable. There is no "test set" or adjudication method in the context of clinical interpretations for this device. Performance is based on bench testing and comparison to predicate devices.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging systems or AI tools where human readers interpret cases. The JMS AV Fistula Blunt Needle Set is a physical access device, not an imaging or interpretive technology.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable. The device is a physical medical device, not an algorithm, and therefore does not have a "standalone" algorithmic performance.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by engineering specifications, material science standards, and the demonstrated performance of the legally marketed predicate devices. The device's functional tests would verify these engineering specifications.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" for a physical medical device. Training sets are used to develop and refine AI algorithms or software.

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

This question is not applicable. As there is no training set, there is no ground truth for it to be established.

Ask a Question

Ask a specific question about this device

Page 1 of 1