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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 NEOSHIELD System is an airtight and leak proof closed system drug transfer device (CSTD) that mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols and spills.

The NEOSHIELD system also prevents microbial ingress for 3 days.

NeoShield is a needle free closed system drug transfer device (CSTD). Neoshield prevents transfer of environmental contaminants into the system and also prevents the escape of drug or vapor from the system.

The ability to prevent microbial ingress for up to 3 days should not be interpreted as modifying, extending, or superseding a manufacturer labeling recommendations for the storage and expiration dating. Refer to drug manufacturer's recommendations and USP compounding guidelines for shelf life and sterility information.

The provide text is a 510(k) summary for a medical device called NEOSHIELD, an intravascular administration set. It does not describe a study involving humans or AI, but rather a set of non-clinical (bench) performance tests to demonstrate substantial equivalence to a predicate device.

Here's the information extracted and formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify the exact sample sizes for each non-clinical test. It states that "The following non-clinical tests were conducted," and then lists the tests and their results. The data provenance is from bench testing conducted by the manufacturer, JMS Co., Ltd / JMS Singapore Pte Ltd. This is a retrospective analysis of test results.

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

Not applicable. This was a non-clinical (bench) testing study, not a study involving human interpretation or expert ground truth establishment in the traditional sense of clinical studies. The "ground truth" for these tests is based on objective laboratory measurements against defined standards or pass/fail criteria.

4. Adjudication Method for the Test Set:

Not applicable, as this was non-clinical bench testing. The results are typically objectively measured against pre-defined specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

No, an MRMC comparative effectiveness study was not done. This submission focuses on non-clinical performance and substantial equivalence to a predicate device, not on comparing human reader performance with or without AI assistance.

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

Not applicable. The device, NEOSHIELD, is an intravascular administration set (hardware), not an AI algorithm.

7. The Type of Ground Truth Used:

The ground truth used for these non-clinical tests is based on objective physical and chemical measurements against established engineering and regulatory standards (e.g., "no leak," "sterile," "non-pyrogenic," "biocompatible").

8. The Sample Size for the Training Set:

Not applicable. As a hardware device, there is no "training set" in the context of an AI algorithm. The device's design and manufacturing processes are developed through engineering and testing, but not machine learning training.

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

Not applicable, as there is no training set for this type of device.

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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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JMS Syringe is intended to be used to inject fluids into or withdraw fluids out of the body.

JMS syringe is a single use standard piston syringe without hypodermic needle, which consists of a calibrated hollow barrel and a movable plunger with a male Luer lock or Luer slip connector on the tip of barrel.

The provided document is a 510(k) summary for a medical device (JMS Syringe), not a study report for an AI/ML-based device. Therefore, it does not contain the information required to answer the prompt regarding acceptance criteria and performance studies for an AI/ML device.

The document discusses the "JMS Syringe" and its predicate device, focusing on:

• Acceptance criteria: For the syringe, these are described in terms of physical, chemical, and performance requirements (e.g., cleanliness, limits for extractable metals, tolerance of nominal capacity, freedom from leakage).
• Device performance: The performance data is presented as a "Pass or Fail" for each test category, indicating that the device met the established physical and performance criteria.
• Non-clinical performance data: This section lists various tests conducted, such as cleanliness, limits for acidity/alkalinity, lubrication, tolerance of nominal capacity, piston/plunger assembly design, nozzle lumen, dead space, and freedom from air/liquid leakage. All are marked as "Pass."
• Clinical tests: The document explicitly states "Not applicable as no clinical tests were referenced in this submission," indicating that clinical studies were not required or performed for this specific 510(k) submission for the syringe.
• Ground truth: For a physical device like a syringe, "ground truth" would be established by objective measurements against engineering and material standards, not expert consensus or pathology in the way it's used for AI/ML models.

Therefore, I cannot provide the full requested information about AI/ML device acceptance criteria and study details (sample size, expert qualifications, MRMC study, training set details, etc.) based on the provided text, as it describes a traditional medical device (syringe) and not an AI/ML-driven diagnostic or therapeutic device.

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JMS Safe Wing Cath (SWC) is intended for short-term (less than 30 days) access to patient's vascular system for intravascular fluid administration and to sample blood, and to monitor blood pressure. The device is intended for single use only and has an anti-stick feature integrated which aids in prevention of needle-stick injuries.

JMS Safe Wing Cath (SWC) is a single lumen intravenous catheter device for vascular access incorporating an anti-needle stick safety feature. The anti-needle stick feature is integrated in the Safe Wing Cath (SWC) body and functions during retraction of the needle, after vascular access is accomplished (there is a stopper to prevent unwanted retraction of needle during insertion). During retraction, the needle will slide into the body and will lock at the final locking position. An audible clicking sound is heard or locking force is felt when the needle is fully retracted into the final locking position. The entire needle is encapsulated within the body and prevents needle-stick injuries, while the catheter still has vascular access for intravenous fluid administration.

The JMS Safe Wing Cath (SWC) device is an intravascular catheter with an anti-needle stick safety feature. The study conducted to demonstrate its performance and substantial equivalence to predicate devices involved multiple types of tests.

1. Table of Acceptance Criteria and Reported Device Performance

• Catheter (Elastic Modulus in Tension, Tensile Strength, Tensile Elongation)
• Catheter Flexural Modulus
• Force Break of Tubing and Female Connector
• Force Break of tubing to needle hub
• Force Break needle and needle hub
• Catheter collapse Pressure test |
  | | Determination of: | Pressure determined for maximum positive pressure
  Volumes determined for priming volume |

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

• Simulated Clinical Use Test: "over 500 samples" of the device were tested.
• Predicate Comparison Bench Testing: The specific sample sizes for each mechanical and flow test are not explicitly stated, but the results indicate that a sufficient number were tested to determine statistical significance or lack thereof.
• Data Provenance: The simulated clinical use test involved "43 healthcare workers from the Washington/Baltimore area," suggesting a prospective clinical simulation within the USA. The bench testing data would be internal laboratory data.

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

• Simulated Clinical Use Test: "43 healthcare workers" were involved. Their specific qualifications (e.g., years of experience, specialty) are not detailed in the provided summary, but they are described as "healthcare workers," implying relevant professional experience in using such devices.
• Bench Testing: For the in-house bench testing comparing to the predicate, the "ground truth" is established through standardized laboratory test methods (e.g., ISO 10555-1, JIS T3223:2011). No "experts" in the human assessment sense are required to establish this type of ground truth; rather, the tests are performed by qualified laboratory personnel following validated protocols.

4. Adjudication Method for the Test Set

• Simulated Clinical Use Test: The text states "100% success with no device failures and all devices performing as intended." This implies a binary assessment of success or failure for each device, likely without complex adjudication, as any failure would presumably disqualify it from the "100% success" claim.
• Bench Testing: For the laboratory tests, the "adjudication" is based on meeting the defined parameters of the standard test methods or demonstrating statistical equivalence to the predicate device. This is an objective measurement rather than a consensus-based adjudication.

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

• No MRMC comparative effectiveness study was done. This type of study is typically associated with diagnostic imaging devices where multiple human readers assess cases with and without AI assistance. The JMS Safe Wing Cath is a medical device for vascular access, and its evaluation focuses on physical performance, safety features, and clinical usability rather than diagnostic accuracy.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• This device does not involve an algorithm or AI. Its performance is entirely device-centric (e.g., mechanical properties, flow rates, safety mechanism function), and its evaluation is based on bench testing and simulated clinical use involving human interaction with the physical device. Therefore, a standalone algorithm-only study is not applicable.

7. Type of Ground Truth Used

• Biocompatibility: Ground truth is established by adherence to ISO 10993 standards and passing specified biological tests.
• Sterilization: Ground truth is established by achieving a validated Sterility Assurance Level (SAL) and meeting residual chemical limits.
• ISO 10555-1 Compliance: Ground truth is defined by the passing criteria of the specific ISO 10555-1 test methods.
• Simulated Use: Ground truth is based on functional performance during simulated clinical scenarios, assessed by healthcare workers, with the criterion being "performing as intended" and "no device failures."
• Predicate Comparison Bench Testing: Ground truth is the measured performance of both the JMS Safe Wing Cath and the predicate device, with the acceptance criterion being "no significant difference" between the two.

8. Sample Size for the Training Set

• Not applicable. This device is not an AI/ML algorithm that requires a training set. Its development and testing are based on engineering principles, materials science, and medical device standards.

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

• Not applicable, as there is no training set for this device.

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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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Use for temporary cannulation for vascular access for extracorporeal blood treatment. The device is intended to single use only and is for temporary catheterization less than 30 days. The safety feature (foldable wing and WingEater guard) aids in prevention of needlestick injuries when removing and discarding needle after dialysis session.

JMS A.V. Fistula Needle Set "WingEater®V2 is a device whereby an antineedlestick feature (WingEater guard) is assembled with predicate device under 510(k), K000845. Needlestick injury can be prevented when removing needle so as to encapsulate the whole needle within the WingEater guard. Modifications to JMS A.V. Fistula Needle Set "WingEater®V2 in this special 510(k) are: a) Additional new polypropylene (PP) materials used for WingEater guard, needle cover, luer lock cover and clamp (non fluid pathway)

The provided text describes a 510(k) premarket notification for a medical device (JMS A.V. Fistula Needle Set "WingEater®V2") and does not contain information about acceptance criteria, device performance, or a study explicitly proving the device meets acceptance criteria in the format requested.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (JMS A.V. Fistula Needle Set "WingEater®V1") through bench testing and adherence to various ISO standards and USP guidelines. These standards and guidelines likely contain performance criteria, but the document does not explicitly state them as "acceptance criteria" for the device, nor does it present the results in a comparative table.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance or the details of a study proving the device meets these criteria as the information is not present in the provided text.

Specifically, the following requested information is not available in the provided text:

1. A table of acceptance criteria and the reported device performance: The document lists various ISO standards and USP guidelines that bench testing was conducted against, but it does not detail specific acceptance criteria derived from these standards or the quantitative performance results of the JMS A.V. Fistula Needle Set "WingEater®V2" against those criteria.
2. Sample size used for the test set and the data provenance: No information on sample sizes for any tests is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This type of information is generally not relevant for a 510(k) submission for this type of medical device, which relies heavily on bench testing against established standards rather than clinical outcomes or diagnostic accuracy studies involving expert interpretation.
4. Adjudication method: Not applicable/not provided.
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 device is a fistula needle set, not an AI-assisted diagnostic or imaging 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: Not explicitly stated as "ground truth" in the context of diagnostic accuracy. Performance is assessed against established engineering and biological standards.
8. The sample size for the training set: Not applicable. This is not
9. How the ground truth for the training set was established: Not applicable.

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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.

SysLoo® MINI (V3) 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.

SysLoc® MINI (V3) 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 modifications stated for SysLoc® MINI (V3) included in this 510(k) are to have an additional packaging configuration and an alternative Polycarbonate Grade to component (lupilon EB30001R). The modification of the packaging is done accordingly to the device packing, and the modification of polycarbonate grade is evaluated accordingly with the Safety Hub and other components such as wing in order to realize the intended device. The review of modifications is documented within this submission document.

The provided document describes a 510(k) premarket notification for a medical device, the JMS SysLoc® MINI A.V. Fistula Needle Set / Apheresis Needle Set (V3). This submission aims to demonstrate substantial equivalence to a predicate device, the SysLoc® MINI (V2), for two modifications: a new packaging configuration and an alternative polycarbonate grade for a component.

The document does not describe a study involving device performance, clinical outcomes, or human interaction that would typically involve acceptance criteria and a detailed study report. Instead, it focuses on bench testing to verify that the modified device performs as intended and is safe and effective. The acceptance criteria mentioned are primarily related to compliance with various ISO standards and USP requirements, which are typical for medical device manufacturing and material safety.

Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth for test set, training set details) are not applicable or cannot be extracted from this type of regulatory submission, as it does not detail a clinical or performance study of that nature.

Here's a summary of the available information:

1. Table of Acceptance Criteria and the Reported Device Performance

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

The document only states that "Bench testing was conducted" and "data and reports are enclosed within this submission document." It does not specify the sample size for any test set in the context of a performance study on a specific population or data set. The testing described is primarily laboratory-based (bench testing) and compliance-based (ISO standards). Data provenance is internal to the manufacturer (JMS Singapore Pte Ltd).

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

Not applicable. This type of information is not relevant for the bench and compliance testing described for a 510(k) submission regarding material and packaging changes.

4. Adjudication method for the test set

Not applicable. No expert review or adjudication method for a test set is described.

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 device is a physical medical needle set, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or AI-related effectiveness analysis was performed or is relevant.

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

Not applicable. This refers to an AI algorithm performance, which is not relevant to this device. However, the bench testing conducted can be considered "standalone" in the sense that the device's functional performance was evaluated independent of human use context, but within a laboratory setting.

7. The type of ground truth used

For the bench testing and compliance, the "ground truth" is defined by the requirements and specifications of the referenced international standards (ISO, USP) and the device's own design specifications for its intended function (e.g., proper Luer taper fit, successful sterilization, lack of cytotoxicity, safe sharps retraction).

8. The sample size for the training set

Not applicable. This refers to an AI training set, which is not relevant to this device.

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

Not applicable. This refers to an AI training set, which is not relevant to this device.

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The JMS Blunt AV Fistula Needle Set with Site Preparation Tool 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. The JMS AV Fistula Blunt Needle Set is for use on developed 'constant site' access sites.

JMS A.V. Fistula Blunt Needle Set with Site Preparation Tool is a modification of the previously cleared JMS A.V. Fistula Blunt Needle Set (K082882). The modification is the replacement of the standard needle cover with a site preparation tool "scraper" feature that removes the scabs that have developed over the constant site prior to cannulation.

Here's an analysis of the provided 510(k) summary regarding the JMS Blunt A.V. Fistula Needle Set with Site Preparation Tool, focusing on acceptance criteria and supporting studies.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device (JMS A.V. Fistula Blunt Needle Set, K082882) by showing that the new device shares similar technical and performance characteristics, with the key difference being the addition of a "site preparation tool" (scraper) on the needle cover.

The summary states:

Note: The document does not provide specific numerical or qualitative acceptance criteria (e.g., "tear strength must be X N", "cytotoxicity must be scale Y or less"). Instead, it states that established criteria were met, or refers to adherence to international standards. The 510(k) process often relies on demonstrating compliance with recognized standards or equivalency to a predicate for which such standards were previously deemed met.

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

The document mentions a "Clinical Usability Study" but does not specify the sample size for this study. It also does not explicitly state the data provenance (e.g., country of origin, retrospective/prospective). However, given that it's a medical device for use in dialysis, it's highly probable it would involve prospective data collection in a clinical setting relevant to dialysis treatment.

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

The document does not provide this information. For a "clinical usability study," the "ground truth" might be subjective user feedback or objective observations by trained personnel, but the number and qualifications of evaluators are not detailed.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method for the clinical usability study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This question is not applicable. The device described (JMS Blunt A.V. Fistula Needle Set with Site Preparation Tool) is a physical medical device (a needle set), not an AI-powered diagnostic or assistive tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study involving AI assistance would not be relevant.

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

This question is not applicable. As explained above, the device is a physical medical tool, not an algorithm.

7. The Type of Ground Truth Used

For the "Clinical Usability Study," the "ground truth" would likely be based on:

• User feedback: Direct qualitative and quantitative feedback from healthcare professionals (nurses, technicians) on the device's ease of use, functionality of the scraper, and overall performance in a real or simulated clinical setting.
• Observational data: Assessment by trained observers of how efficiently and effectively users performed tasks with the device, and whether the scraper feature successfully removed scabs as intended.
• Label Comprehension: Verification that users understood instructions and warnings on the device labeling.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical medical product and does not involve a "training set" in the context of machine learning or AI models. The design and testing are based on engineering principles, material science, and clinical evaluation.

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

This question is not applicable for the same reason as point 8.

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