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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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The JMS Blunt AV Fistula Needle Set is intended for temporary cannulation (nonımplantable, less than 30 days) to vascular access for extracorporeal blood treatment 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 AV Fistula Blunt Needle Set is intended as a non-implanted blood access device, which consists of a needle that is attached to wings, a flexible tube and a luer lock connector

Here's a breakdown of the acceptance criteria and study information based on the provided text, though it's important to note that the document is a 510(k) summary for a medical device (a blunt needle set), not a typical AI/software device. As such, many of the requested categories (like MRMC, training sets, ground truth for AI, etc.) are not applicable in their usual sense. This device relies on "substantial equivalence" to predicate devices rather than a standalone performance study as would be seen for an imaging AI.

Device Name: JMS A V Fistula Blunt Needle Set

1. Acceptance Criteria and Reported Device Performance

For this type of device, "acceptance criteria" and "reported device performance" are primarily demonstrated through equivalence to legally marketed predicate devices, focusing on functional aspects, materials, and intended use. The document doesn't provide specific numerical performance metrics (e.g., sensitivity, specificity, accuracy) typical of AI/software. Instead, the "acceptance" is that it performs as intended and is comparable to predicate devices.

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

For this device, there isn't a "test set" in the sense of a clinical trial dataset for an AI algorithm. The performance is assessed through bench testing for functional performance and a comparison of specifications to predicate devices.

• Sample Size for Test Set: The document mentions "bench testing was conducted," but it does not specify the sample size of devices used in these tests.
• Data Provenance: The document doesn't specify data provenance (country of origin, retrospective/prospective) for any test data. The tests would have been performed by the manufacturer (JMS Singapore Pte Ltd or JMS North America Corporation). The nature of the tests (bench testing) implies a controlled laboratory environment rather than patient data.

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

This question is not applicable to this type of device submission.
Ground truth, in the context of typical AI/imaging studies, refers to the verified correct diagnosis or finding. For a physical medical device like a needle set, performance is evaluated against engineering specifications and functional benchmarks, not by expert consensus on clinical findings from a "test set" of images or patient data.

4. Adjudication Method for the Test Set

This question is not applicable. There is no "test set" or adjudication method in the context of clinical interpretations for this device. Performance is based on bench testing and comparison to predicate devices.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging systems or AI tools where human readers interpret cases. The JMS AV Fistula Blunt Needle Set is a physical access device, not an imaging or interpretive technology.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable. The device is a physical medical device, not an algorithm, and therefore does not have a "standalone" algorithmic performance.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by engineering specifications, material science standards, and the demonstrated performance of the legally marketed predicate devices. The device's functional tests would verify these engineering specifications.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" for a physical medical device. Training sets are used to develop and refine AI algorithms or software.

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

This question is not applicable. As there is no training set, there is no ground truth for it to be established.

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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.

SysLoc® MINI V2 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. Almost identical to the predicate device, SysLoc® MINI V2 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. SysLoc® MINI V2 included in this 510(k) is a modification from the legally marketed device, JMS SysLoc® MINI A.V. Fistula Needle Set & JMS SysLoc® MINI Apheresis Needle Set. SysLoc® MINI V2, is the same version of the predicate device (SysLoc® MUSL ) with modification made to re-position the external lock, so that the device is more user/patient friendly. Modifications are done accordingly to the other components such as wing and huh in order to realize the intended device.

The provided text is a 510(k) summary for a medical device called "JMS SysLoc® MINI V2 A.V. Fistula Needle Set & JMS SysLoc® MINI V2 Apheresis Needle Set." It describes the modifications made to a previously cleared device, the predicate device, and argues for substantial equivalence.

However, the document does not contain information regarding detailed acceptance criteria tests, study designs to prove device performance against those criteria, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. The document focuses on establishing substantial equivalence by stating that the modified device has the "same intended usage, same materials used in the blood-contact components, and adopts identical fundamental scientific technology" as the predicate device. It vaguely mentions that "data and reports are enclosed within this submission document" to demonstrate the device is performing as intended, but these details are not present in the provided text.

Therefore, I cannot fulfill your request for specific details on acceptance criteria and study designs based only on the provided input. The document is essentially a cover letter and summary for a regulatory submission, not a detailed technical report of performance studies.

Here's an explanation of why I cannot complete the table and answer your questions with the given information:

• No detailed acceptance criteria or performance data: The summary states the device performs "as intended" and that "data and reports are enclosed," but it does not list specific acceptance criteria (e.g., "sharps injury rate < X%", "flow rate > Y ml/min") nor does it provide the results of any tests against such criteria.
• No study design information: The document doesn't describe any studies conducted to validate the device's performance, let alone details like sample sizes, data provenance, ground truth establishment, or expert involvement.
• No mention of AI/ML components: The device described is a physical needle set. There is no indication of any AI or machine learning components, which are typically associated with performance metrics like accuracy, sensitivity, specificity, and MRMC studies.

In summary, the provided text does not contain the information needed to answer your questions about acceptance criteria, study details, or AI performance.

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JMS Planecta® Stopcock (PNSC) is indicated for fluid flow directional control and for providing access port(s) for administration of solutions, withdrawal of fluids and pressure monitoring. JMS Planecta® Stopcock can be used by itself, or as component to administration/extension set, and aids in the prevention of needle stick injuries.

The JMS Planecta® Stopcock is a disposable device for one time use. The device consists of a body with integrated female and male connector at extreme ends, a handle (either 1-bar or 3-bar types), pre-slit septum, access port cap and a rotatable lock nut for locking over the female connector of another component. The device contains three channels for fluid flow. The handle/swivel nut contains two independent passageways. A fluid pathway can be achieved by rotating the handle to one of the three channels. There are 'arrow' marks on the handle of 3-bar type and 'OFF' indication on the 1-bar handle to indicate the 'open' and 'closed' position of fluid path, respectively.

JMS Planecta® Stopcock, incorporated with an injection/sampling port accessible with a needleless syringe or regular male connector. JMS Planecta® Stopcock keeps the system closed and the minimal dead space at the access port reduces the chances of bacteremia caused by bacterial proliferation. Contamination by environmental microbes is also reduced by the resealability characteristics of the pre-slit rubber septum.

The provided document is a 510(k) summary for the JMS Planecta® Stopcock. It primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use, materials, biocompatibility, and overall performance characteristics. It does not contain the level of detail typically found in a clinical study report regarding specific acceptance criteria, performance metrics, sample sizes for test/training sets, expert qualifications, or adjudication methods.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions about specific study design elements like sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, or ground truth establishment for either test or training sets from this document.

The document indicates that the device's substantial equivalence was demonstrated through comparisons of its characteristics and performance to legally marketed predicate devices, but it does not detail the specific tests conducted or their results in a quantitative manner that would allow filling in the requested information.

The key takeaway from the document regarding performance is:

• Overall Performance Characteristics: "JMS Planecta® Stopcock demonstrates substantial equivalence to the said predicate devices with regards to intended use, material, biocompatibility, and overall performance characteristics." (Page 2)

This statement implies that performance studies were conducted, but the specifics are not included in this summary. For a medical device like a stopcock, performance characteristics would typically include things like flow rate, connection integrity, leak resistance, pressure limits, and compatibility with various fluids and administration sets. However, the document does not list these as explicit acceptance criteria or provide quantitative results.

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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 JMS Blood Tubing Sets with transducer protector and priming sets are disposable bloodlines intended to provide extracorporeal access to the patient's blood during hemodialysis.

The tubing sets that JMS intended to market include arterial and venous dialysis blood tubing as described in 21 CFR 876.5820. Various models of blood tubing sets are being manufactured for application with different dialysis machines, such as Baxter, Fresenius, Althin, etc. All components of blood tubing set, including drip chambers, infusion tubing, monitoring lines, ports, and segments which are use to pump blood, retain and capture air and blood debris, infuse medications or fluid, sampling blood, pressure monitoring and making connections to other devices, are all included. The materials used are mainly, polyvinylchloride (PVC), polyethylene (PE), polypropylene (PP), acrylonitrite butadiene styrene (ABS), and polycarbonate (PC).

The provided text is a 510(k) summary for a medical device called "JMS Blood Tubing Sets." This document focuses on establishing substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. As such, it does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment relevant to AI/algorithm performance.

The document highlights the following:

• Device Type: Hemodialysis system and accessories (blood tubing sets).
• Intended Use: To transfer blood from patients' vascular access system to the hemodialyzer through an arterial tubing, and from the hemodialyzer to the patient vascular system via a venous tubing.
• Substantial Equivalence: The manufacturer asserts that the JMS Blood Tubing Sets are substantially equivalent to several legally marketed predicate devices in terms of intended use, design, safety, and effectiveness.
• Testing: The document mentions compliance with the AAMI/ANSI RD 17:1994 standard for "Hemodialyzer Tubing set" and biocompatibility testing according to ISO 10993. These are engineering and biocompatibility standards, not clinical performance acceptance criteria or studies involving AI/algorithms.

Therefore, I cannot extract the requested information (table of acceptance criteria, device performance, sample sizes, expert details, adjudication methods, MRMC studies, standalone algorithm performance, ground truth types, or training set details) from the provided text because it is not a clinical study report for an AI/algorithm-based device.

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JMS Bypass Tube is intended to be used to internally shunt blood vessel during anastomosis constructions. The shunt allows blood to be delivered distally past the anastomosis site preventing ischemia while the target coronary artery is opened and surgical grafted to a donor vessel. The bypass shunt is to be removed prior to the final sutures being performed. Select the blood vessel bypass tube which is appropriate for the internal diameter of the blood vessel.

The JMS Bypass Tube is a sterile, single use, consists of a tube shaft made by nylon with bulging bulbs at the distal ends. A guide-wire is inserted within the tube shaft to guide the easy insertion of tube shunt into target vessel. A tab on a thread is attached near to the mid-point of the flexible shaft. Each JMS Bypass Tube is individually packaged sterile and non-pyrogenic in a sealed, peel type pouch.

The provided text describes the 510(k) summary for the JMS Bypass Tube, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive performance studies with specific acceptance criteria as you might find for novel or AI-powered devices.

Therefore, many of the requested elements regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth are not applicable or not provided within this type of regulatory submission for this particular device.

Here's a breakdown of the information that is available and what is not:

Acceptance Criteria and Study Details for JMS Bypass Tube

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. The document refers to "non-clinical performance testing" but does not detail the number of units tested.
• Data Provenance: Not specified, but likely laboratory testing conducted by the manufacturer, JMS North America Corporation.

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

• Not Applicable. This device is a physical medical instrument (a bypass tube), not a diagnostic AI or imaging device that requires expert ground truth for interpretation. The "ground truth" for this device would relate to its physical and material properties, and its ability to function as intended during a surgical procedure, which is evaluated through non-clinical testing and material compliance.

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

• Not Applicable. See point 3.

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 or imaging device that would involve human readers or AI assistance.

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

• Not Applicable. This is not an algorithm or AI device.

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

• Not Applicable / Indirectly Implied: The "ground truth" for this device would be its adherence to established engineering specifications, material standards (e.g., ISO 10993 for biocompatibility), and functional performance in non-clinical models (e.g., fluid flow, mechanical integrity). This is established through standard engineering and laboratory tests, not clinical outcomes data in the usual sense for diagnostic devices.

8. The sample size for the training set:

• Not Applicable. This device does not use machine learning or AI, so there is no "training set."

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

• Not Applicable. See point 8.

Summary of the Study Discussed:

The "study" described in the provided text is a collection of non-clinical performance tests focused on demonstrating the safety and effectiveness of the JMS Bypass Tube and its substantial equivalence to an existing predicate device (T-AnastaFLO, K990396).

• Test Type: Non-clinical (likely bench testing, material compatibility testing).
• Purpose: To confirm the device can perform its intended function (temporary bypass shunt to prevent ischemia during anastomosis) and meets material safety standards (ISO 10993).
• Conclusion: The tests demonstrated the device is "safe and effective for use as intended and the device is substantially equivalent to existing predicate devices."

The 510(k) submission process primarily relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than providing extensive clinical trial data with specific performance metrics and acceptance criteria for novel claims.

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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.

Needle, Fistula

The provided text is a 510(k) clearance letter from the FDA for a medical device called the "Plume Safety AVF Needle." This document grants market clearance based on substantial equivalence to a predicate device, rather than providing details about an acceptance criteria study as typically conducted for novel AI/software devices.

Therefore, most of the information requested in your prompt regarding acceptance criteria, study design, expert involvement, and performance metrics is not available in this type of regulatory document.

Here's what can be extracted and what cannot:

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

• Not Available. This document does not describe specific performance acceptance criteria or report performance data. It is a regulatory clearance letter based on substantial equivalence.

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

• Not Available. No test set or data provenance details are provided as this is not a study report.

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 Available. No experts or ground truth establishment are mentioned as this is not a study report.

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

• Not Available. No adjudication method is mentioned.

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, not an AI/software device. Therefore, an MRMC study or AI assistance is not relevant.

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 (expert consensus, pathology, outcomes data, etc)

• Not Available. Ground truth is not relevant or mentioned for this type of device clearance.

8. The sample size for the training set

• Not Available. No training set is relevant or mentioned.

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

• Not Available. No training set or ground truth establishment is relevant or mentioned.

Information that is available (though not directly addressing your specific questions about study criteria):

• Device Name: Plume Safety AVF Needle
• Indications For Use: "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."
• Regulatory Classification: Class II
• Predicate Device Equivalence: The clearance is based on the device being "substantially equivalent" to legally marketed predicate devices. This means the FDA found that the new device is as safe and effective as a legally marketed device and does not raise different questions of safety and effectiveness. The specifics of the predicate device are not included in this extract, but would have been part of the 510(k) submission.

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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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JMS Extension Set with Planecta™, Planecta™ (stand alone unit) and Planecta™ Lock / Adaptor are accessories and to be used with a primary vascular access device for fluid administration and blood sampling. Planecta™ with a luer slip syringe or male luer connector to allow needle-less access to the vascular path for injection or withdrawal of fluids or blood. Planecta™ Lock / Adaptor will be used as an adaptor for connection with luer lock syringe or other lock-connecting devices. These device accessories are intended for single use only.

JMS Extension Set with Planecta™ (stand alone unit) and Planecta™ Lock / Adaptor will reduce the risk of accidental needle stick injury as a needle will not be used or required throughout the procedure for injection or withdrawal of fluid.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding an intravascular administration set. It discusses regulatory information, classification, and indications for use. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Therefore, I cannot provide the requested information based on the provided text. The document is primarily a regulatory approval letter and does not delve into the specific details of the technical studies underpinning the device's substantial equivalence.

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