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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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The blood tubing sets are indicated for use with a medically prescribed hemodialyzer. The suitability of a particular configuration is the responsibility of the physician in charge.

Medisystems/NxStage blood tubing sets consist of a family of products which are used during extracorporeal procedures to provide a means to connect blood access devices to a hemodialysis or hemofiltration machine and a hemodialyzer or hemofilter. To facilitate a hemodialysis procedure, for example, the arterial and/or venous blood tubing sets may contain features such as air trap chambers, filters, injection sites, pump segments, heparin infusion lines, saline administration lines, pressure pillows, priming sets, and pressure monitoring lines with or without transducer protectors. Numerous product codes are produced to accommodate various manufacturer's dialysis machines, as well as differing clinical preferences and clinical procedures.

The provided document (K080807) for the NxStage Medical, Inc. Blood Tubing Sets is a Special 510(k) Device Modification, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive new clinical studies with detailed performance metrics. As such, information regarding acceptance criteria, specific device performance numbers, and detailed study parameters (like sample sizes for test and training sets, expert qualifications, MRMC studies, or standalone performance) are not detailed in this type of submission.

The document indicates "Performance, verification and validation testing was conducted to characterize performance of the subject blood tubing sets to provide a basis of comparison to the predicate device as all features are not identical." However, it does not present the specific acceptance criteria or the reported performance data from these tests.

Based on the provided text, here's what can be inferred or explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly provided. The document states that "Performance, verification and validation testing was conducted to characterize performance of the subject blood tubing sets to provide a basis of comparison to the predicate device as all features are not identical." However, the specific acceptance criteria and the numerical results of these tests are not disclosed in this summary. The goal was to demonstrate substantial equivalence, implying that the modified device met performance expectations similar to the predicate.

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

Not explicitly provided. The document states that "Performance, verification and validation testing was conducted," but it does not specify the sample sizes used for these tests. The nature of this 510(k) being a "Special 510(k) Device Modification" suggests that the testing likely focused on bench testing to confirm the modified device's performance against the predicate, rather than large-scale clinical trials. Data provenance (e.g., country of origin, retrospective/prospective) is also not mentioned.

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

Not applicable. This type of submission relies on bench testing and comparison to a predicate device for substantial equivalence, not typically on expert-established ground truth for a test set in the way a diagnostic AI device would.

4. Adjudication Method for the Test Set

Not applicable. As above, a formal adjudication method for establishing ground truth from experts is not described for this type of device and submission.

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

No. The document does not describe a MRMC comparative effectiveness study. This type of study focuses on human reader performance with and without AI assistance, which is not relevant for a blood tubing set re-submission.

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

Not applicable. This submission pertains to a physical medical device (blood tubing sets), not an algorithm or AI. Therefore, the concept of "standalone performance" for an algorithm is not relevant.

7. The Type of Ground Truth Used

Not applicable in the traditional sense. For a physical device like blood tubing sets, "ground truth" would relate to engineering specifications, material properties, and functional performance benchmarks (e.g., flow rates, pressure resistance, sterility). The document implies that the device's performance was characterized against a "basis of comparison to the predicate device," meaning the predicate's established performance served as a de-facto ground for equivalence.

8. The Sample Size for the Training Set

Not applicable. This submission relates to a physical device, not an AI/ML algorithm that requires a training set.

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

Not applicable. As this is not an AI/ML algorithm, there is no training set or ground truth in that context.

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