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Ask a specific question about this device

Ask a specific question about this device

JMS Needle is intended to be used for infusion of drug, collecting solution or blood. Insert the Needle to patient's body and use it as a fluid pathway which connects inside and outside of the body. JMS Syringe is intended to be used for infusion of solution or collecting blood connecting JMS Needle. It is also used for continuous drug infusion put in Syringe Pump. JMS Needle and JMS Syringe must be discarded after one time use.

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This document is an FDA 510(k) clearance letter for the JMS Needle and JMS Syringe. It states that the devices are substantially equivalent to previously marketed devices. However, this document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

Therefore, I cannot provide the requested information. The document primarily focuses on regulatory approval based on substantial equivalence, not on performance studies with specific acceptance criteria.

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Use for temporary cannulation for vascular access for extracorporeal blood treatment. This device is intended to single use only and is for temporary catheterization less than 30 days. Regarding to pre-attached Anti-stick device, use for prevention of needlestick injury at the time of needle withdrawal after usage.

Needle, Fistula

The provided documents are a 510(k) clearance letter and an "Indications for Use" statement for the "JMS A.V. Fistula Needle Set." These documents do not contain any information regarding acceptance criteria or a study proving that a device meets such criteria.

The 510(k) clearance process focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily based on design, materials, and intended use, rather than detailed performance study data against specific acceptance criteria as you would find for a novel device or a device requiring clinical trials.

Therefore, I cannot provide the requested information based on the input documents.

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This device is intended to provide access to a patient's blood for Apheresis. This device is intended to single use only and is for temporary catheterization less than 30 days. Regarding to pre-attached Anti-stick Device, use for prevention of needlestick injury a the time of needle withdrawal after usage.

Apheresis Needle

The provided documents (FDA Premarket Notification K990510 for the JMS Apheresis Needle) contain very limited information about performance testing or acceptance criteria. Based on the content, here's what can be extracted and what cannot:

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

No detailed acceptance criteria or specific performance data are provided in these documents. The submission is a 510(k) for an apheresis needle, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than extensive de novo performance testing. The FDA letter implicitly confirms that substantial equivalence was demonstrated, which means general safety and effectiveness were considered adequate based on comparisons to existing devices, but specific performance metrics are not listed.

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

This information is not available in the provided documents. Test sets, if used for performance evaluation (e.g., for needle integrity, flow rates, or anti-stick mechanism function), would typically be part of a more detailed submission and are not summarized here.

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 and not available from the provided documents. Apheresis needles are mechanical devices, and their performance is assessed through engineering and bench testing, not typically through expert-read clinical ground truth establishment as would be done for diagnostic imaging AI.

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

This information is not applicable and not available for the reasons stated above. Adjudication methods are relevant for subjective interpretations, like radiology reads, not for mechanical device performance.

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 and not available. This type of study is relevant for AI-assisted diagnostic tools, not for a medical device like an apheresis needle.

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

This information is not applicable and not available. This concept applies to AI algorithms, not a standalone medical device like an apheresis needle.

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

For a mechanical device like an apheresis needle, "ground truth" would typically refer to objective measurements from engineering tests (e.g., material strength, fluid flow properties, sterilization efficacy, anti-stick mechanism functionality). The documents do not specify the exact types of ground truth or performance data collected for this device. The phrase "ground truth" as typically used in AI/diagnostic evaluation is not applicable here.

8. The sample size for the training set

This information is not applicable and not available. Training sets are used for machine learning models, which are not relevant to the approval of this apheresis needle.

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

This information is not applicable and not available for the same reasons as above.

Summary of what is known from the provided documents:

• Device: JMS Apheresis Needle
• Intended Use: To provide access to a patient's blood for apheresis.
• Specifics: Intended for single use, temporary catheterization (less than 30 days), and includes a pre-attached anti-stick device for needlestick injury prevention.
• Regulatory Clearance: 510(k) clearance (K990510) based on substantial equivalence to a predicate device.
• Regulatory Class: Class II (21 CFR §876.5820/Procode: 78 FIE).

The FDA's 510(k) process primarily relies on demonstrating substantial equivalence to predicate devices, meaning the new device is as safe and effective as a legally marketed device. This typically involves showing that the new device has the same intended use, similar technological characteristics, and does not raise different questions of safety and effectiveness, or if it has different technological characteristics, that those characteristics do not raise different questions of safety and effectiveness and that performance data demonstrate the device is as safe and effective as the predicate device. The provided letters do not include the detailed performance data or test reports that would have been part of the 510(k) submission.

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This device is connected with Blood Tubing Set and used to prime Dialyzer and Blood Tubing Set. JMS Dialyzer Priming Set must be discarded after one time use.

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I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies conducted on the "JMS Dialyzer Priming Set." The document is a 510(k) clearance letter from the FDA, indicating that the device has been found substantially equivalent to a predicate device. It does not include details about pre-market studies, acceptance criteria, or performance metrics. Therefore, I cannot fulfill your request to describe these elements.

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