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Use for providing access to a donor's blood for apheresis. This device is intended to single use only and is for temporary catheterization less than 30 days. The safety feature (foldable wing and WingEater) aids in prevention of needlestick injuries when removing and discarding needle after blood collection.

JMS Apheresis Needle Set "WingEater" V2 is a device whereby an antineedlestick feature (WingEater guard) is assembled with predicate device under 510(k), K00845.

Needlestick injury can be prevented by pulling the PVC tube to retract the needle and wing into WingEater guard when removing needle so as to encapsulate the whole needle within the WingEater guard.

Modifications to JMS Apheresis Needle Set "WingEater®" V2 in this special 510(k) are:

• Additional new polypropylene (PP) materials used for WingEater a) guard, needle cover, luer lock cover and clamp (non fluid pathway)
  There are other non-significant changes which were made to 510(k) -K010410 in the past. These changes are listed under Attachment 004 List of Past Changes of this special 510(k).

Evaluation of the new packaging configuration was performed accordingly to stimulated conditions experienced during transportation. New design and material used for the WingEater guard was evaluated accordingly with folded wing in order to realize the actual device usage. Reviews of the modifications were documented within this special 510(k) submission.

The provided document is a 510(k) summary for the JMS Apheresis Needle Set "WingEater®" V2. It focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a comprehensive study report with specific performance metrics against those criteria. Clinical trial data or detailed performance studies with human subjects are typically not required for these types of submissions where substantial equivalence is being argued based on technological characteristics and bench testing.

Therefore, the following information cannot be fully extracted or is not applicable to this specific submission type:

• 1. A table of acceptance criteria and the reported device performance: Not explicitly provided in this format for functional acceptance of the device beyond compliance with referenced ISO and USP standards.
• 2. Sample size used for the test set and the data provenance: Not explicitly stated for performance testing; the document refers to "bench testing."
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is not a study assessing diagnostic accuracy or expert consensus.
• 4. Adjudication method for the test set: Not applicable.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used: Not applicable in the context of diagnostic accuracy. The "ground truth" for this device's performance would be successful adherence to the referenced standards during bench testing.
• 8. The sample size for the training set: Not applicable as this is a medical device, not an AI/ML algorithm requiring a training set.
• 9. How the ground truth for the training set was established: Not applicable.

However, based on the provided text, here's what can be gathered regarding the "acceptance criteria" (in the sense of standards compliance) and the "study" (bench testing and standards adherence):

Acceptance Criteria and Device Performance for JMS Apheresis Needle Set "WingEater®" V2

The acceptance criteria for the JMS Apheresis Needle Set "WingEater®" V2 are implicitly defined by its adherence to a series of international and national standards for medical devices, particularly those related to biocompatibility, sterility, packaging, and specific device component performance. The "study" proving the device meets these criteria primarily involved bench testing to verify performance and compliance with these standards, alongside a review of material modifications.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for each bench test performed. It generally states that "Bench testing had been conducted to verify performance." The data provenance is implied to be internal testing conducted by the manufacturer (JMS Singapore Pte Ltd) or contract labs adhering to international standards. No country of origin for specific test data is given beyond the manufacturer's location. The testing would be considered prospective as it evaluates the modified device.

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

Not applicable. This is not a study requiring expert consensus for diagnostic accuracy or clinical judgment. Compliance with engineering and safety standards is determined through objective measurements and test procedures.

4. Adjudication method for the test set

Not applicable. Test results are typically objective measurements against defined standard limits, not subjective assessments requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No. This type of study is for evaluating human performance (e.g., diagnostic accuracy) with or without AI assistance, which is not relevant to this device.

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 algorithm.

7. The type of ground truth used

The "ground truth" implicitly refers to the specific, measurable requirements and limits set forth by each referenced ISO and USP standard for device performance, material safety, sterility, and packaging integrity. For example, specific cytotoxicity levels, luer taper dimensions, or sterility assurance levels would serve as the ground truth for their respective tests. The "safety feature" performance against needlestick injury prevention would be assessed through functional testing and design verification.

8. The sample size for the training set

Not applicable. This is a medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable.

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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 intended to provide access to a patient's blood for Apheresis. Indication for Use : This device is intended to single use only and is for temporary catheterization less than 30 days.

Apheresis Needle

The provided text is related to a 510(k) premarket notification for an "Apheresis Needle." It's an FDA clearance letter and an "Indication for Use" statement. This type of document does not contain the information requested in your prompt regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

The document is a regulatory approval notice, indicating that the FDA has determined the device is substantially equivalent to a legally marketed predicate device. It confirms the device's classification and allows it to be marketed.

Therefore, I cannot extract the requested information from the provided text.

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