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The DORA Disposable A.V. Fistula Needle Sets (Safety Needle Series) are single-use sterile medical devices intended to be used as vein puncture for hemodialysis treatment. Protective Shield aids in the prevention of accidental needlesticks.

The DORA Disposable A.V. Fistula Needle Sets are single-use sterile medical devices intended to be used as vein puncture for hemodialysis treatment.

The proposed device, DORA Disposable A.V. Fistula Needle Sets, is a non-implantable blood access device, which mainly consists of an adaptor, flexible tube and sharp needle. It is available in two types, 1) Needle sets with safety feature and 2) Needle sets without safety feature. Both the two types of proposed device are provided sterile and are for single use only.

The two types of proposed devices are offered in difference configurations with options that include needle gauge, needle length, wing types (fixed wing or rotatable wing).

The proposed device and its package are designed to be provided in Gamma sterilization. The package could maintain the sterility of the device for three years.

The Protective Shield for injury prevention requires physical action by the clinician to activate and is designed to cover the cannula after treatment. Correct use of this safety feature will eliminate accidental needlestick injuries.

The proposed device is used in conjunction with following hemodialysis blood tubing sets during clincial use.

The provided document, a 510(k) Summary for the DORA Disposable A.V. Fistula Needle Sets, details the premarket notification of intent to market the device and its substantial equivalence to a legally marketed predicate device. This type of submission focuses on demonstrating that a new device is as safe and effective as an already approved device, rather than proving novel effectiveness through extensive clinical trials.

As such, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria in the context of:

• A table of acceptance criteria and reported device performance for an AI/ML or diagnostic device. This document is for a physical medical device (AV fistula needle sets).
• Sample sizes for a test set (for AI/ML validation). The testing described is for physical characteristics and biocompatibility, not for a 'test set' in the AI/ML sense.
• Data provenance for a test set (for AI/ML validation). Not applicable to a physical medical device.
• Number of experts and their qualifications for establishing ground truth. Not applicable.
• Adjudication method for a test set. Not applicable.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study. Not applicable.
• Standalone (algorithm only) performance. Not applicable.
• Type of ground truth used (expert consensus, pathology, outcomes data). Not applicable.
• Sample size for training set. Not applicable.
• How ground truth for training set was established. Not applicable.

Instead, the document focuses on non-clinical testing and substantial equivalence to a predicate device.

Here's what the document does provide regarding acceptance criteria and performance:

1. Acceptance Criteria (via Standards Compliance and Performance Testing) and Reported Device Performance:

The acceptance criteria for this device are demonstrated through adherence to various international and national standards, as well as the successful completion of specific non-clinical performance tests. The reported performance is that the device "met all design specifications" and "is similar as that of the predicate device" or "acceptable."

2. Sample sizes used for the test set and the data provenance:

• Sample Sizes: Not explicitly stated with specific numbers (e.g., "n=X needles were tested"). The document generally states "Non clinical tests were conducted" and "The test results demonstrated...". For a 510(k) submission for a physical device, detailed sample sizes for each specific test are typically found in the full technical documentation, not summarized in the 510(k) summary as it is here.
• Data Provenance: The tests were conducted internally by Bain Medical Equipment (Guangzhou) Co., Ltd. or by test labs they contracted. The document implicitly indicates the tests originate from China (Guangzhou) as that's the manufacturer's location. The tests are "non-clinical" and likely conducted in laboratory settings, not on patient data or retrospective/prospective human studies.

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 a physical medical device. "Ground truth" in this context refers to compliance with established engineering and biocompatibility standards, not expert human interpretation for a diagnostic or AI device.

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

• Not applicable.

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, a MRMC study was not done. This device is a physical medical instrument, not an AI/ML diagnostic tool.

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

• No, not applicable.

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

• For physical devices, the "ground truth" is adherence to predefined engineering specifications, internationally recognized standards (ISO, ASTM, USP), and established safety and performance benchmarks (e.g., sterilization effectiveness, material strength, biocompatibility profiles). It's a truth based on physical and chemical properties and their interaction, rather than clinical outcomes or diagnostic interpretations.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that uses a "training set."

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

• Not applicable.

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