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JMS CAVEO A.V. Fistula Needle Set is intended for temporary cannulation to vascular access for extracorporeal blood treatment for hemodialysis. This device is intended for single use only. The anti-needlestick safety feature aids in prevention of needle stick injuries when removing and discarding the needle after dialysis. The device also has an integrated safety mechanism that is designed to automatically generate a partial occlusion of the internal fluid path and trigger the hemodialysis machine to alarm and shut off if a complete dislodgement of the venous needle from the arm inadvertently occurs. In vitro testing supports that this feature triggers the hemodialysis machine to alarm and shut off.

The subject device is the JMS CAVEO A.V. Fistula Needle Set (CAVEO) with an anti-needlestick safety feature. The Caveo is predicted to protect patients from the risks associated with venous needle dislodgement (VND) based on bench testing results. It contains an integrated stainless steel torsion spring mechanism and bottom footplate that provides an open/fluid path when the AV fistula set is fully cannulated into the access site. When the venous needle becomes completely dislodged from the patient's arm, this mechanism enables the footplate to partially occlude the blood path, generating an increased venous line pressure high enough to trigger automatic alarm and halt further blood pumping of the hemodialysis machine. In vitro testing supports that this feature triggers the hemodialysis machine to alarm and shut off. Based on bench testing results, this may significantly reduce patient blood loss in the event of a complete VND. The Caveo has a pre-attached anti-stick needle guard for prevention of needlestick injury at the time of needle withdraw after completion of a hemodialysis procedure.

In vitro performance testing using dialysis machine Fresenius 2008K supports the function of the Caveo VND feature with a venous pressure limit set to 200mmHg symmetric mode, a maximum dialyzer membrane surface area of 2.5 m2, minimum blood flow rate of 200 mL/min, maximum ultrafiltration rate of 4000 mL/hour, and simulated treatment duration of 8 hours. If different machine and/or setting are used, before introducing the device, refer to Directions for Use.

This document describes the FDA 510(k) clearance for the JMS CAVEO A.V. Fistula Needle Set. This device is a physical medical device, specifically a needle set for hemodialysis, and does not involve Artificial Intelligence (AI). Therefore, many of the requested criteria related to AI/software performance, ground truth establishment, expert adjudication, MRMC studies, and training datasets are not applicable.

The document primarily focuses on bench testing (in vitro performance) and a simulated clinical usability study to demonstrate device safety and effectiveness.

Here's a breakdown based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily demonstrated through various performance tests, with "Passed" as the acceptance. The document doesn't explicitly state numerical acceptance thresholds for all tests (e.g., how much "Force to Depress the Footplate" is acceptable), but it implies successful completion. For some, like needle penetration resistance and retraction lock strength, numerical criteria are provided.

2. Sample Size for Test Set and Data Provenance

• Test Set (Clinical Trial): 15 subjects (2 females, 13 males).
• Data Provenance: The document does not explicitly state the country of origin. It describes the recruitment from "the general hemodialysis population," and mentions racial/ethnic demographics, but not geographic. Given the company is "JMS North America Corporation" (Hayward, CA), it is highly probable the study was conducted in the US. The study appears to be prospective as it involves recruitment and device use to confirm safety, performance, and usability.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This question is largely not applicable as the device is a physical medical device. The "ground truth" for performance is established through bench testing (objective physical measurements) and the success of the device in a simulated clinical setting. There is no mention of human experts establishing a "ground truth" for diagnostic or AI-related interpretations.

For the simulated clinical usability study, the "ground truth" is whether the device performed as intended and was usable, as observed by clinicians/researchers during the study. The qualifications of those assessing the usability are not specified, beyond the implication that they are competent to conduct a clinical trial for hemodialysis devices.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation (e.g., radiology reads) where there might be disagreement in expert opinions needing a tie-breaker. This is not applicable here as:

• The primary "test set" involves objective performance characteristics (bench testing).
• The clinical usability study likely involved observing successful function and user feedback, not a diagnostic interpretation needing adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study is relevant for evaluating the performance of AI systems or diagnostic tools where multiple human readers interpret cases, often with and without AI assistance, to see if the AI improves human performance. This device is a physical hemodialysis needle set, not an AI or diagnostic tool.

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

Not applicable. This refers to the performance of an AI algorithm on its own. The device is a physical product. Its "standalone" performance is assessed through bench testing (e.g., VND Performance, Mechanical Hemolysis Testing, Needle Penetration Resistance). These tests evaluate the device's inherent functional characteristics independent of human interaction during the critical failure modes.

7. The Type of Ground Truth Used

• Bench Testing: The ground truth is based on objective physical measurements and engineering specifications (e.g., force measurements, leak tests, dimensional analyses) and functional success/failure (e.g., did the VND feature trigger the alarm?).
• Simulated Clinical Usability Study: The ground truth is based on observed device performance during simulated use and the successful delivery of hemodialysis without impedance by the device's novel features. This is akin to outcomes data in a controlled simulated environment.

8. The Sample Size for the Training Set

Not applicable. The device is a physical product and does not involve AI or machine learning models that require a "training set."

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

Not applicable. As there is no training set for an AI model.

In summary, the provided document details the non-clinical and limited clinical testing of a physical medical device (hemodialysis needle set). The acceptance criteria are largely met through rigorous bench testing demonstrating physical and functional robustness, and a small simulated clinical study confirming usability and safety in a controlled environment. AI-specific criteria are not relevant to this type of device.

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The DORA Disposable A.V. Fistula Needle Sets (Safety Needle Series) are sterile medical devices intended to be used as vein puncture for hemodialysis treatment. Protective Shield is used for protecting from needlestick imiury.

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 DORA Disposable A.V. Fistula Needle Series) are single-use sterile medical devices intended to be used as vein puncture for hemodialysis treatment. Scab Remover is used for remove the scab at puncture position.

The proposed device, DORA Disposable A.V. Fistula Needle Sets, is a non-implantable blood access device, which mainly consists of flexible tube and sharp needle. It is available in three types, 1) Needle sets with safety feature, 2) Needle sets without safety feature and 3 > Dull Needle sets. Both the three types of proposed device are provided sterile and are for single use only.

The three 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 Ebeam 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.

I am unable to provide a comprehensive answer to your request because the provided text describes a medical device, specifically DORA Disposable A.V. Fistula Needle Sets, which is an in vitro diagnostic (IVD). My capabilities are focused on analyzing documentation related to Artificial Intelligence/Machine Learning (AI/ML) based medical devices, particularly those that involve diagnostic algorithms or image analysis.

The document you provided is a 510(k) summary for a physical medical device and does not contain information about an AI/ML component. Therefore, the details requested in your prompt (e.g., acceptance criteria for an algorithm, sample sizes for test/training sets, ground truth establishment for AI/ML performance, MRMC studies) are not applicable to the content provided.

If you have a document pertaining to an AI/ML-based medical device, I would be happy to analyze it according to the criteria you've outlined.

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The Dimesol Disposable A.V. Fistula Needle Sets are single-use sterile medical devices intended to be used as vein puncture for hemodialysis treatment. This device is for inhospital or hemodialysis center use only.
The Dimesol 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. This device is for inhospital or hemodialysis center use only.
The Dimesol Disposable A.V. Fistula Needle Sets are intended for use as a nonimplantable (i.e., less than 30 days use) vascular/blood access device for temporary cannulation in procedures requiring an extracorporeal circuit, such as hemodialysis.
The Dimesol Disposable A.V. Fistula Needle Sets are intended for use as a nonimplantable (less than 30 days use) vascular access device for temporary cannulation in procedures requiring an extracorporeal circuit, such as hemodialysis.

The Dimesol Disposable A.V. Fistula Needle Sets are intended for use as a nonimplantable (i.e., less than 30 days use) vascular/blood access device for temporary cannulation in procedures requiring an extracorporeal circuit, such as hemodialysis. The cannula (needle) of the device is used to puncture the appropriate area of a patient and the opposite end of the device is attached to a blood tubing set. Typically, two needle sets are used for each treatment. The first set is used to access the patient's artery to transfer blood to the dialyzer and the second set is used to access the patient's vein to transfer filtered blood back to the patient's body. The AV fistula needle sets are available in two main variants: (i) needle sets that do not include a safety feature; and (ii) needle sets that do include a safety feature. The safety feature is a protective shield that covers the cannula after use and requires physical action by the clinician to activate. Both variants are sterile and intended for single use only. Both variants are provided in a fixed-wing design (stationary) and a rotatable wing design (rotatable). The major components of these AV fistula needle sets are manufactured from medical-grade polyvinyl chloride, polypropylene, fire-retardant polyethylene, and other medical-grade macromolecule materials and innocuous stainless steel. These AV fistula needle sets are latex-free and can be inserted into a patient's vein and then connected to a hemodialysis bloodline tubing set. The tubing is soft, transparent, smooth and non-kink. The wings of the needle set are suitably rigid, and the on/off clamps are simple and convenient with regard to use. The wing for 15G is Blue, 16G is Green, and 17G is Red. The tip of the cannula is sharpened to reduce the pain for the patient. The backeye is slender and close to the cannula tip and is slipresistant for smooth puncturing.
The Dimesol Disposable A.V. Fistula Needle Sets without safety shield includes the following structural components: (1) a protective cap for the cannula; (2) a cannula (arterial or venous); (3) a hub; (4) a color-coded fixed or rotatable gripping wing; (5) flexible tubing; (6) a small on/off hemostatic clamp; (7) a connective female luer lock; and (8) a cap for the female luer lock. These AV fistula needle sets are sterilized using gamma radiation. The patient and/or blood contacting components are the cannula, the tubing segment, and the luer lock.
The Dimesol Disposable A.V. Fistula Needle Sets with safety shield includes the following structural components: (1) a protective polypropylene cap for the cannula; (2) a cannula (arterial or venous); (3) a hub; (4) a color-coded fixed or rotatable gripping wing; (5) a safety shield for encapsulating the cannula after use; (6) flexible tubing; (7) a small on/off hemostatic clamp; (8) a connective female luer lock; and (9) a cap for the female leur lock. These AV fistula needle sets are sterilized using gamma radiation. The patient and/or blood contacting components are the cannula, the hub, the tubing segment, and the luer lock.
The protective shield component is generally tubular in shape and includes a locking mechanism that is adapted to secure the hub inside the protective shield when the hub is in its retracted position. The locking mechanism prevents the needle from inadvertently protruding out of the protective shield, thereby ensuring safe disposal of the cannula after use. The oppositely placed axial slots on the protective shield are adapted to receive the wings when the hub moves into the protective shield, thereby ensuring a correct rotational position of the protective shield relative to the hub. The axial length of the slots is long enough to receive both the hub and the cannula, particular the sharp tip of the cannula, thereby preventing accidental exposure to the tip of the needle. The locking mechanism includes two locking aspects. With regard to the first locking aspect, the tubular wall is spread apart when the hub moves into the protective shield. The lower portion of the tubular wall includes a curve that facilitates the insertion of the upper tubular wall includes a locking hoot that maintains the wings in a downward position when the hub moves into the slot. This aspect facilitates the continuous transition of the hub and wings from the minimum width regions of the slots toward the enlarged regions of the slots. With regard to the second locking aspect, two asymmetric locking hooks extend from the tubular walls. These hooks maintain the hub and winds in the enlarged slot. The cannula and hub are thus fully received and locked inside the protective shield and the device may be disposed of in a safe manner. An audible click indicates to the user that the device is in its final locked position.

The provided text is a 510(k) Summary for the Dimesol Disposable AV Fistula Needle Set. This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, not a study proving specific performance metrics against pre-defined acceptance criteria in the context of an AI/ML device.

Therefore, the requested information regarding acceptance criteria, study findings against those criteria, sample sizes, expert involvement, and ground truth establishment, typically associated with performance studies for AI/ML medical devices, is not present in this document.

The document primarily focuses on:

• Device Description: What the device is, its variants (safety and non-safety), and components.
• Indications for Use: What the device is intended for (vein puncture for hemodialysis).
• Substantial Equivalence: A comparison of the Dimesol device's materials, dimensions, intended use, indications for use, configuration, and other factors to legally marketed predicate devices (NIPRO SafeTouch Tulip Safety Fistula Needle, JMS A.V. Fistula Needle Set, EXEL A.V. Fistula Needle Set).
• Performance Testing: A statement that specific performance tests were conducted and found "substantially equivalent" to predicate devices, but without providing the specific acceptance criteria or the reported device performance values for these tests.

However, I can extract the general "performance" aspects that the manufacturer claims are substantially equivalent:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided text, while specific numerical acceptance criteria and reported performance values are not detailed, the document states that the Dimesol Disposable AV Fistula Needle Sets underwent various performance tests and were found to be "substantially equivalent" to the predicate device (K071145). The table below reflects the types of performance criteria assessed, as indicated in Table 7 of the document. The "Acceptance Criteria" here are implicitly "demonstrates substantial equivalence to K071145 for this test," and the "Reported Device Performance" is consistently stated as "substantially equivalent."

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

• The document does not specify the sample sizes used for any of the performance tests.
• The data provenance is for a physical medical device (AV fistula needle set) and the testing would have been conducted by the manufacturer (Bain Medical Equipment (Guangzhou) Co., Ltd.) or a contracted lab. The document does not specify the country of origin of the test data. The product manufacturing is in Guangzhou, China. The application is submitted from the US.
• The document describes premarket testing of a physical device, not an AI/ML model. Therefore, the concepts of "retrospective or prospective" data sets in the context of AI models (which refer to how data was collected for the AI model's training/testing) do not directly apply here in the usual sense. These are engineering performance tests on manufactured product samples.

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

• This document is for a physical medical device. The concept of "ground truth" established by experts (e.g., radiologists for imaging) is not applicable here. The performance tests are engineering and biological validations (e.g., tensile strength, flow rate, biocompatibility) against established standards (e.g., ISO 10993) and comparison to predicate devices, not subjective expert interpretations of data.

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

• As this is a physical device being tested against engineering and biological standards, adjudication methods (common in expert consensus for AI/ML ground truth) are not applicable. The results would be quantitative measurements.

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 question is not applicable. The device is an AV fistula needle set, a physical medical instrument, not an AI/ML diagnostic or assistive tool. Therefore, MRMC studies and "human readers improving with AI assistance" are irrelevant.

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

• This question is not applicable. The device is a physical medical instrument.

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

• For physical devices like this, "ground truth" typically refers to adherence to pre-defined engineering specifications, international standards (e.g., ISO 10993 for biocompatibility), and physical performance measurements rather than a subjective or pathological "truth." The document states conformance to ISO 10993 for biocompatibility.

8. The sample size for the training set:

• This question is not applicable. There is no "training set" as this is not an AI/ML device.

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

• This question is not applicable. There is no "training set."

In summary: The provided text is a regulatory submission for a physical medical device (AV fistula needle set) under the 510(k) pathway, which focuses on demonstrating substantial equivalence to existing devices. It does not contain the specific information typically found in performance studies for AI/ML medical devices, which would detail precise acceptance criteria and quantitative performance results, or involve concepts like ground truth establishment by experts, human-in-the-loop studies, or training/test sets for algorithms. The "acceptance criteria" here are implicitly linked to demonstrating equivalence and meeting relevant device standards.

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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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JMS Harmony® A.V.Fistula Needle Set is intended for temporary cannulation (non-implantable, less than 30 days) to vascular access for extracorporeal blood treatment and for the removal of scabs that have developed over the constant site prior to cannulation. The device is intended for single use only and is used on 'developed constant site' access sites. This device is for use on developed 'constant site' access sites

Not Found

This document is a 510(k) premarket notification for a medical device called the JMS Harmony® A.V. Fistula Needle Set. It aims to demonstrate substantial equivalence to legally marketed predicate devices. The document explicitly states that "Performance Specification: Met established acceptance criteria" for the modified device and both predicates.

However, the document does not provide details about the specific acceptance criteria themselves, nor does it describe the study that proves the device meets these criteria. It only makes a general statement that the criteria were met.

Therefore,Based on the provided text, I cannot extract the detailed information requested in your prompt. The document is a regulatory submission for a medical device, and while it states that "Performance Specification: Met established acceptance criteria" for the modified device and its predicates, it does not elaborate on what those acceptance criteria are or describe the specific study (or studies) used to demonstrate that the device meets them.

The information requested, such as sample sizes, data provenance, number and qualifications of experts, adjudication methods, details of comparative effectiveness studies, standalone performance, type of ground truth, and training set information, is not present in this document. This kind of detailed study information is typically found in a separate section of a 510(k) submission, often within a "Performance Testing" or "Bench Testing" report, which is not provided in this extract.

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The Angel Tip Safety Intravascular Needle Set is indicated to access the peripheral vascular system for hemodialysis. Additionally, after withdrawal of the needle from the patient's vein, the needle can be manually retracted within a safety enclosure to minimize the risk of an accidental needle stick.

The safety needle portion of the Angel Tip Safety Intravascular Needle Set will be available in diameters ranging from 14 to 18 Ga and lengths of 1.0 to 1.5 inches.

The Angel Tip Safety Intravascular Needle Sets are sterile, single use devices designed to access the peripheral vascular system for hemodialysis. Additionally, after withdrawal of the needle from the patient's vein, the needle can be manually retracted within a safety enclosure to minimize the risk of an accidental needle stick. The Angel Tip Safety Intravascular Needle Set consists of a needle attached to a winged hub, microbore or macrobore tubing, adapter and adapter cap and a safety enclosure that attaches to the winged hub.

As the needle is removed from the patient's vessel, the user's finger actively slides the safety enclosure until it latches onto the needle using a one- or two-handed technique. The user will know the needle is engaged based on the tethers being fully extended and hearing an audible click. The safety enclosure is designed to allow the user's fingers to remain behind the needle point so that the risk of needle stick injury is minimized. The enclosure is clear so the user has a visual means of knowing the needle is captured.

This document does not contain the information required to populate all sections of the request. It primarily pertains to a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to existing devices rather than presenting detailed clinical study data with acceptance criteria and reported performance metrics.

Specifically, the document focuses on non-clinical testing for performance aspects like tensile strength, leakage, Luer compatibility, corrosion, force to activate, and force to override, rather than clinical performance for diagnostic or therapeutic accuracy that would require an AI-driven device analysis.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions "performance testing (tensile, leakage, Luer, corrosion, force to activate and force to override)" and states these tests "demonstrate that the Angel Tip Safety Intravascular Needle Set is as safe, as effective and performs comparably to the predicate devices." However, it does not provide specific acceptance criteria values or the reported performance data for these tests. Therefore, a table cannot be fully constructed.

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

This information is not present. The document mentions "nonclinical testing" but does not specify sample sizes for these engineering/material tests, nor does it refer to a "test set" in the context of human or patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not present. The approval is based on substantial equivalence to predicate devices, supported by non-clinical engineering tests, not on an evaluation by experts establishing ground truth for a diagnostic or therapeutic outcome.

4. Adjudication Method:

This information is not present. Adjudication methods are typically relevant for studies involving human interpretation or challenging cases, which is not the nature of the testing described here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This information is not present. This type of study is for evaluating the impact of AI on human reader performance, which is not applicable to a physical medical device (needle set) that does not incorporate AI.

6. Standalone (Algorithm Only) Performance:

This information is not present. This device is a physical medical instrument, not an AI algorithm.

7. Type of Ground Truth Used:

For the non-clinical tests described, the "ground truth" would be the engineering specifications and established test methodologies (e.g., ASTM standards for tensile strength, ISO standards for Luer connections). However, the document does not explicitly state the specific standards or the "ground truth" labels. It implies compliance with predicate device performance.

8. Sample Size for the Training Set:

This information is not present. The device is not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established:

This information is not present as there is no training set for this device.

Summary of Available Information (from the document):

• Device Name: Angel Tip Safety Intravascular Needle Set
• Purpose of Review: 510(k) Premarket Notification for substantial equivalence.
• Tests Performed: Nonclinical tests including tensile, leakage, Luer, corrosion, force to activate, and force to override.
• Conclusion: The device is considered substantially equivalent to predicate devices based on "similar indications for use, intended use, fundamental scientific technology and similar design, materials, and manufacturing processes" and the results of the nonclinical testing, which demonstrated it "does not raise new issues of safety or effectiveness."

Conclusion based on the Request:

The provided document details a 510(k) submission for a physical medical device, not an AI or algorithm-driven device. As such, most of the requested information pertaining to acceptance criteria of an algorithm, studies involving human readers, ground truth establishment for AI, and training/test set sample sizes is not applicable or available in this type of regulatory document. The document focuses on demonstrating that the physical safety needle set is as safe and effective as pre-existing, legally marketed predicate devices through engineering and material performance tests, rather than clinical performance data with specific accuracy metrics.

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Use for temporary cannulation non-implantable, less than 30 days) to vascular access for extra corporeal blood treatment. The device is intended for single use only and has an anti-stick feature integrated as part of the Needle Set which aids in prevention of needle-stick injuries

SysLoc® MINI (V4) is intended as non-implanted blood access device, which consists of flexible tube and needle with integrated sharp safety features as described in 21 CFR 876.5540. SysLoc® MINI (V4) comes with a rotational feature and the needle is retracted with the wing sheath after deliberate release of secured external lock, and final locking is assured by an audible 'click' sound when the hub/tube is pulled rearwards.

The provided text describes a 510(k) premarket notification for a medical device (JMS SysLoc® MINI A.V. Fistula Needle Set (V4) and JMS SysLoc® MINI Apheresis Needle Set (V4)). This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets acceptance criteria through a traditional clinical study with performance metrics in terms of sensitivity, specificity, or similar.

Therefore, the requested information elements related to diagnostic performance (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of regulatory submission and the information provided. The "acceptance criteria" here refer to testing to ensure the device performs as intended and is safe, similar to the predicate, not diagnostic accuracy.

Here's a breakdown of the available information based on your request, with an emphasis on what is not present in this type of document:

1. Table of acceptance criteria and the reported device performance

The document does not specify "acceptance criteria" in terms of diagnostic performance metrics. Instead, it refers to "Performance Specification" and "Bench testing" to demonstrate that the new device (V4) performs as intended and is safe and effective, similar to the predicate (V3).

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

• Not Applicable. This document describes bench testing to demonstrate substantial equivalence, not a clinical study to evaluate diagnostic performance. Therefore, there is no "test set" in the context of diagnostic data. The number of devices tested in bench testing is not specified.

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

• Not Applicable. Ground truth for diagnostic accuracy is not relevant here.

4. Adjudication method 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

• Not Applicable. This is a medical device (fistula needle set), not an AI-powered diagnostic tool.

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

• Not Applicable. This is not an algorithm.

7. The type of ground truth used

• Not Applicable. Ground truth for diagnostic accuracy is not relevant here. The "ground truth" for this device would be its physical and functional specifications meeting design requirements and demonstrating safety and effectiveness through mechanical and material testing, as well as biocompatibility, which are confirmed to be similar to the predicate.

8. The sample size for the training set

• Not Applicable. This is not a machine learning or AI device.

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

• Not Applicable.

Summary of focus (based on the provided document):

This 510(k) submission primarily focuses on demonstrating that the modified device (V4) is substantially equivalent to a legally marketed predicate device (V3). This is achieved by showing that the V4 device has:

• The same intended use as the V3.
• Similar technological characteristics (e.g., anti-stick feature, physical specifications, performance specifications) to the V3.
• Passed bench testing to verify that it performs as intended as a safe and effective medical device.
• Satisfied biocompatibility and sterilization requirements comparable to the V3.

The "study" that proves the device meets (implicit) acceptance criteria is the bench testing and other evaluations (biocompatibility, sterilization) which concluded that the "SysLoc® MINI (V4) device is performing as intended to be a safe and effective medical device" and is "substantially equivalent" to the predicate. Specific details about the methodology and sample sizes of this bench testing are not provided in this summary document.

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The Medisystems Dual Lumen Needle is indicated for use as a vascular access device for dialysis procedures. The Medisystems Dual Lumen Buttonhole Needle is indicated fo use as a vascular access device for dialysis procedures using a constant-site or "buttonhole" method of needle insertion.

The proposed devices are to be used as a vascular access device for dialysis procedures using either a standard needle insertion technique (for Dual Lumen Needle) or a constant-site or "buttonhole" method of insertion (for Dual Lumen Buttonhole Needle).

This document is a 510(k) premarket notification for a medical device -- a dual lumen needle for dialysis. Based on the provided text, this is not an AI/ML medical device. Therefore, the questions related to AI/ML device performance criteria, training sets, expert review, MRMC studies, and ground truth establishment are not applicable to this document.

The document discusses the substantial equivalence of the proposed devices (Medisystems Dual Lumen Needle and Medisystems Dual Lumen Buttonhole Needle) to predicate devices already on the market (Medisystems Buttonhole Needles cleared under K990803 and Cordis Corp. Bionics Bi-Flo double lumen needle cleared under K801355).

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to non-clinical bench testing for a physical medical device, not a software algorithm.

Here's the relevant information that can be extracted from the document:

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

The document broadly states:

Note: The document itself does not provide the specific "predetermined acceptance criteria" or the detailed "results of this testing" for the bench tests. It only states that they were conducted and met.

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

• Sample Size: Not specified in the provided text. The document refers to "Performance, verification and validation testing," which implies a test set, but the size is not mentioned.
• Data Provenance: Not applicable in the context of this type of testing for a physical device. It would involve laboratory bench testing, not patient data.

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)

• Not applicable. This is a physical medical device, not an AI/ML algorithm requiring expert annotation for ground truth.

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

• Not applicable. This relates to expert review of data for AI/ML, not bench testing of a physical device.

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

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

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

• Not applicable. For a physical device, "ground truth" would relate to engineering specifications, material properties, and functional performance metrics established through bench testing, rather than medical "ground truth" like disease presence.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device; there is no "training set" in the AI/ML sense.

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

• Not applicable. Again, this is for AI/ML devices.

Summary based on the document:

The document serves as an FDA 510(k) clearance letter and summary for a physical medical device. It attests that "Performance, verification and validation testing was conducted to characterize performance of the proposed devices and the predetermined acceptance criteria was met." However, it does not provide the specifics of these tests, such as sample sizes, detailed criteria, or specific results, as this information would typically be contained in the full 510(k) submission, not the summary letter itself.

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The A.V. Fistula Needle Set is intended for temporary cannulation (non-implantable, less than 30 days) to vascular access for extracorporeal blood treatment. The device is intended for single use only.

A.V. Fistula Needle Set is a single-use fistula needle which is inserted for temporary cannulation (non-implantable, less than 30 days) to vascular access for extracorporeal blood treatment. The device consists of a needle that is attached to wings, a flexible tube and a luer lock connector.

The provided text is a 510(k) summary for a medical device called the "A.V. Fistula Needle Set for Single Use." This type of document focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical trials with acceptance criteria for a novel AI or diagnostic device.

Therefore, the information required to populate the fields regarding acceptance criteria, study design details, ground truth establishment, sample sizes, and expert qualifications for a diagnostic device is not present in this document.

The document describes performance data for the A.V. Fistula Needle Set, but these are related to biocompatibility and sterilization tests for a physical medical device, not performance metrics for an AI/diagnostic algorithm.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document states these tests were "completed" but does not provide specific quantitative results or defined acceptance thresholds for these tests beyond general compliance with the standards.

Missing Information (Not Applicable to this type of device and submission):

2. Sample sizes used for the test set and the data provenance: Not applicable. This document refers to physical device testing, not a test set for an AI algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is not relevant here.
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: Not applicable. This is not an AI-assisted diagnostic device.
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 (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable. There is no AI training set.
9. How the ground truth for the training set was established: Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" for this device consists of a series of standard performance tests and biocompatibility evaluations required for medical devices. The document implies that the device successfully passed these tests, thereby demonstrating its safety and effectiveness for its intended use and substantial equivalence to the predicate device. The tests, as listed above, cover:

• Biocompatibility: Evaluating the material extracts, system toxicity, cytotoxicity, irritation, sensitization, and residuals from ethylene oxide sterilization. These tests ensure the device materials are safe for contact with the human body during temporary cannulation.
• Sterilization: Validation and routine control of the ethylene oxide sterilization process to ensure the device is sterile for single use.
• Mechanical Performance: A "Tensile Force Test" was conducted, and its results were compared to the predicate device to ensure similar mechanical properties.

The document states that a "claim of substantial equivalence is made to JMS North America Corp. A.V. Fistula Needle Set for Single Use (K990470)" and that "Bench testing was conducted to verify that the APLAN A.V. Fistula Needle Set for Single Use performs as well as the predicate device, thus concluding they are substantially equivalent." This indicates that the predicate device serves as the benchmark for acceptable performance, and the tests performed aimed to demonstrate that the new device performs equivalently.

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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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