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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 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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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 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 temporary cannulation (non-implantable, less than 30 days) to vascular access for extracorporeal 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.

JMS SysLoc MINI™ A.V. Fistula & JMS SysLoc MINI™ Apheresis Needle Set is intended as non-implanted blood access device, which consists of flexible tube and needle with integrated sharps safety features as described in 21 CFR 876.5540. Just like the predicate device, JMS SysLoc MINI™ A.V. Fistula Needle Set & JMS SysLoc MINIT™ Apheresis Needle Set 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. JMS SysLoc MINI™ A.V. Fistula Needle Set & JMS SysLoc MINI™ Apheresis Needle Set included in this 510(k) is a modification from the legally marketed device. JMS SysLoc® A.V. Fistula Needle Set & JMS SysLoc® Apheresis Needle Set. The SysLoc MINI™, is a 'mini' version of the predicate device (JMS SysLoc®) with modification made to reduce the overall length, so that the device is more user/patient friendly. Modifications are done accordinaly to the other components such as wing and hub in order to realize the intended device.

The provided text is a 510(k) summary and FDA clearance letter for a medical device (JMS SysLoc MINI AVF Needle Set and JMS SysLoc MINI Apheresis Needle Set). This type of document is for regulatory clearance based on substantial equivalence to a predicate device, not typically for reporting on a study demonstrating specific device performance against defined acceptance criteria in the way a clinical trial or a performance study for a diagnostic AI device would.

Therefore, the requested information about acceptance criteria, reported performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for an AI or diagnostic device cannot be extracted from this document because it pertains to a different type of device and regulatory submission.

The document states that "Bench testing was conducted to verify that the SysLoc MINI™ device is performing as intended to be a safe and effective medical device, data and reports are enclosed within this submission document." However, the details of these bench tests, including specific acceptance criteria and detailed performance metrics, are not provided in the publicly available summary (the pages provided). This type of information would typically be in the full submission, not the summary given here.

In summary, the provided document does not contain the information required to populate the table and answer the detailed questions about acceptance criteria and study design for statistical performance metrics.

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The BIOTEQ® Arterial-Venous Fistula (A.V.F) Needle Set with Safety Flex is used for temporary cannulation for vascular access for extracorporeal blood treatment. The device is intended for single use only and is for temporary catheterization of less than 30 days. The Safety Feature(Safety Flex) aids in prevention of needle-sticks injuries when removing and discarding needles after dialysis session.

The BIOTEQ® A. V. FISTULA NEDDLE SET WITH SAFETY FLEX consists of the following major components: ① Protection Cap ② Needle Cannula ③ Butterfly Wing ④ Needle Hub ⑤ Safety Flex ⑥ Small Pinch Clamp ⑦ PVC Tubing ⑧ Female Luer ⑨ Cap for Female Luer These components assembled together as BIOTEQ® Arterial-Venous Fistula (A.V.F) Needle Set with Safety Flex for use during hemodialysis procedures. The Safety Feature(Safety Flex) aids in prevention of needle-sticks injuries when removing and discarding needles after dialysis session. Various models of needle size manufactured such as 14 gauge, 15 gauge, 16 gauge, 17 gauge.

The provided document is a 510(k) summary for a medical device called the BIOTEQ® A. V. FISTULA NEEDLE SET WITH SAFETY FLEX. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a full clinical study with specific acceptance criteria related to device performance in a clinical setting.

Therefore, the document does not contain detailed information about acceptance criteria or a study proving the device meets them in the way clinical performance studies typically do. Instead, it focuses on demonstrating that the device meets safety and effectiveness requirements by conforming to applicable standards and showing equivalence to a legally marketed predicate device.

Here's a breakdown of the information that is and is not available based on your request:

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

• Not Applicable in the traditional sense. This 510(k) summary does not present specific clinical acceptance criteria (e.g., sensitivity, specificity, accuracy for an AI device) or reported performance metrics against such criteria.
• What is reported: The document states, "In terms of Physical specification, Chemical specification, Biological specification & Sterilization Specification, the device conforms to applicable standards included ISO 10993 series, ISO 11607-1, ISO 11135, USP Pyrogenic standards & related standards". This is the closest equivalent to "acceptance criteria" here, indicating that the device meets established industry standards for these categories.

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

• Not Provided. This information is not typically included in a 510(k) summary focused on substantial equivalence through bench testing. The "test set" here refers to "bench testing" rather than a clinical dataset.
• The document mentions "bench testing contained in this submission," but does not specify sample sizes or data provenance.

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. For a device like an A.V. Fistula Needle Set, "ground truth" is not established by human experts in the same way it would be for an AI diagnostic device evaluating images. Device performance is assessed against engineering and biological standards.

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

• Not Applicable. Adjudication methods are relevant for studies where human interpretation or consensus is needed to establish ground truth, which is not the case for the type of testing described (physical, chemical, biological, sterilization specifications).

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices, not for a physical medical device like a needle set.

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

• Not Applicable. This device is a physical medical instrument, not an algorithm, so "standalone performance" in the context of AI is not relevant. The device itself is "standalone" in its function.

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

• Ground truth for this device type is based on established engineering, biological, and sterilization standards. For example, "Physical specification" would refer to tensile strength, needle sharpness, flow rates; "Chemical specification" to material composition and biocompatibility; "Biological specification" to absence of certain toxins, and "Sterilization Specification" to sterility assurance levels.

8. The sample size for the training set

• Not Applicable. There is no "training set" for this type of device. The document describes a manufactured product, not an AI/ML algorithm that requires training.

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

• Not Applicable. As there is no training set for this device type, the establishment of ground truth for it is irrelevant.

Summary of the Study (as described in the 510(k)):

The study described is bench testing to demonstrate substantial equivalence to a predicate device (JMS A.V. FISTULA NEEDLE WingEater, K 010406).

• Purpose: To show that any differences in technological characteristics between the BIOTEQ® A. V. FISTULA NEDDLE SET WITH SAFETY FLEX and the predicate device "do not raise any new questions of safety or effectiveness."
• Methods: The device was tested "in terms of Physical specification, Chemical specification, Biological specification & Sterilization Specification." It "conforms to applicable standards included ISO 10993 series, ISO 11607-1, ISO 11135, USP Pyrogenic standards & related standards."
• Conclusion: Based on this bench testing and comparison of intended use and technological characteristics, the device was deemed "substantially equivalent to the predicate devices."

In essence, this 510(k) summary provides evidence of compliance with established standards and equivalence to a predicate, rather than reporting on a clinical trial with specific performance metrics against defined acceptance criteria.

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Use for temporary cannulation for vascular access for extracorporeal blood treatment. The device is intended for single use only and is for temporary catheterization of less than 30 days. The device has an anti-stick feature integrated as part of the Needle Set which aids in prevention of needle-stick injuries when withdrawing and discarding the needle after treatment.

JMS SysLoc A.V. Fistula Needle Set and JMS SysLoc Apheresis Needle Set

This document is a 510(k) clearance letter from the FDA for the JMS SysLoc A.V. Fistula Needle Set and JMS SysLoc Apheresis Needle Set. It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this letter does NOT contain acceptance criteria for device performance or the results of studies proving the device meets said criteria. The FDA 510(k) clearance process focuses on substantial equivalence to existing devices rather than requiring new clinical trials to establish safety and effectiveness for every submission.

Therefore, I cannot provide the requested information from the provided text. The document is primarily a regulatory approval notice, not a detailed technical report on device performance.

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This device is an A.V. Fistula Needle Set part of extracorporial artificial kidney system This device is an A. V. Fistula Noodle Det part of claims of the patient's blood vessel for Hemodialysis.

SHARghP A.V. Fistula Needle Set

The provided text is a clearance letter from the FDA for a medical device called "SHARghP A.V. Fistula Needle Set." This type of document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

The letter is a regulatory document stating that the device has been determined to be "substantially equivalent" to legally marketed predicate devices, allowing its manufacturer to market it. It focuses on regulatory compliance rather than detailed performance data.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and study details based on the provided input.

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