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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 Dual Lumen Extended Length Catheter (dELC) is indicated for use up to 72 hours in attaining vascular venous access for use with the Aquadex FlexFlow® and Aquadex SmartFlow® systems for ultrafiltration therapy. It is not for pediatric use. The catheter is not intended for the infusion of medications or fluids, for laboratory sampling, or other venous access needs.

The Dual Lumen Extended Length Catheter (dELC) is a 6F reverse-tapered dual lumen venous access device with stainless steel coil reinforcement. It is inserted into peripheral venous circulation by way of a peel away introducer. The catheter is intended for use with the Aquadex FlexFlow® and Aquadex SmartFlow® Systems in attaining vascular venous access for ultrafiltration treatment of patients with fluid overload. It has two models, 320101 and 320102, with identical hub designs but different shaft lengths, 12 cm and 16 cm, to adapt to the patient's body size.

The catheter has a radiopaque polyurethane shaft with two equal-sized inner lumens designed in a "double D" configuration. The shaft has a reverse-tapered design to minimize resistance to flow. Its outside diameter starts at 6F on the distal end and tapers back to 7F on the proximal end. The shaft with the coil reinforcement, designed based on the FDA cleared 5.2F dELC via K041791, provides kinking resistance and ensures consistent flow. Depth markings are provided in 0.5cm increments along the insertable length of the catheter shaft. The proximal end of the catheter shaft and clear polyurethane extension tubes are over-molded into a polyurethane hub, which has suture wings for securement to the skin.

Additionally, the catheter has female ISO 80369-compliant luer connectors to connect with the Aquadex blood tubing set for withdrawal and infusion. When the catheter is not in use, two yellow male locking caps can be placed on the female luer connectors for reducing the risk of infection. Each extension tube has a clamp: blue on the blood withdrawal tube (marked by the withdrawal ID ring) and white on the blood infusion tube (marked by the infusion ID ring). The blood is drawn up through the withdrawal lumen, which is proximal to the infusion lumen. The skived offset tip is designed to minimize blood recirculation.

An attached MRI tag indicates the device is MR unsafe.

The provided FDA 510(k) clearance letter (K252226) describes a medical device, the Dual Lumen Extended Length Catheter (dELC), and details the rationale for its substantial equivalence to a predicate device. This submission focuses on a material change to an existing cleared device, rather than a de novo submission for a novel AI/software device. Therefore, the information typically requested regarding acceptance criteria and study proving performance for an AI/software device (e.g., accuracy, sensitivity, specificity, MRMC studies, ground truth establishment) is not applicable in this context.

The acceptance criteria here pertain to the safety and effectiveness equivalency of the modified medical device (specifically, the change in material for the Female Luer Lock Connector) compared to its predicate. The study conducted is non-clinical performance testing rather than a clinical trial or AI model validation.

Here's a breakdown of the available information relevant to "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of this specific 510(k) submission:

Acceptance Criteria and Reported Device Performance (for a Material Change)

The core acceptance criterion for this 510(k) submission is to demonstrate that the change in material for the Female Luer Lock Connector does not raise new questions of safety and effectiveness and that the modified device remains substantially equivalent to the predicate device.

Information NOT APPLICABLE to this 510(k) (as it's a material change, not an AI/software device):

The following points are standard for AI/software device clearances but are not relevant to this specific 510(k) for a material change in a physical medical device.

2. Sample sizes used for the test set and data provenance: Not applicable. The "test set" here refers to physical samples of the device undergoing non-clinical bench testing, not a dataset for an algorithm. Data provenance (country, retrospective/prospective) is typically for patient data used in AI validation.
3. Number of experts used to establish ground truth for the test set and qualifications: Not applicable. There is no "ground truth" to establish in the context of an algorithmic output. The performance tests are specific to the mechanical and chemical properties of the device.
4. Adjudication method for the test set: Not applicable. No human interpretation or adjudication of an algorithm's output.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. MRMC studies are used to assess the impact of AI on human reader performance, which doesn't apply to this physical device change.
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 typically refers to a verified diagnosis or measurement used to evaluate an AI model's accuracy. For this device, "ground truth" would be established through calibrated instruments measuring physical properties.
8. The sample size for the training set: Not applicable. There is no AI model or training set involved.
9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) demonstrates substantial equivalence through non-clinical bench testing to affirm that a material change to a connector on a physical medical device does not compromise its safety or effectiveness when compared to the previously cleared predicate device. It specifically avoids the need for clinical studies by establishing this equivalence.

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The Duo-Flow® Side X Side double lumen catheter is intended for short-term central venous access for hemodialysis, apheresis and infusion.

The Duo-Flow® Side X Side double lumen catheter is a radiopaque, polyurethane tube with two D-shaped lumina. The lumina can be distinguished by the color-coded luers:

• Red Adaptor = proximal lumen
• Blue Adaptor = distal lumen
  The proximal lumen provides "arterial" outflow from the patient; the distal lumen provides "venous" return.
  The catheter comes in a variety of sizes and is offered with curved or straight extensions.
  The Duo-Flow® Side x Side Catheter removes and returns blood through two segregated lumen passages. Each lumen is connected to an extension line with color-coded female luer connectors. The transition between lumen and extension is housed within a molded hub. Both arterial and venous lumens contain side-holes. The catheter incorporates Barium Sulphate to facilitate visualization under fluoroscopy or Xray. All sizes of the Duo-Flow® Side x Side Catheter are available in a Basic Set intended to be used in an Interventional Radiology or Operating Suite. The Set includes primary insertion componentry for the Modified Seldinger Insertion Technique.

The provided FDA 510(k) clearance letter describes the 14F Duo-Flow® Side X Side Double Lumen Catheter and its substantial equivalence to a predicate device. However, this document does not detail an AI/algorithm-based medical device performance study.

The submission is for a physical medical device (a catheter) and focuses on demonstrating substantial equivalence through non-clinical (bench) testing and comparison of technical specifications with a previously cleared predicate device. Therefore, many of the requested details regarding AI/algorithm performance (e.g., sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance) are not applicable to this particular FDA clearance.

Here's an analysis based on the information provided, highlighting the acceptance criteria and how the device meets them within the context of a physical device submission and not an AI/algorithm study:

Acceptance Criteria and Reported Device Performance (Non-AI/Algorithm Device)

The acceptance criteria for this physical medical device are derived from establishing substantial equivalence to a predicate device (Duo-Flow® Side x Side Double Lumen Catheter, K192807) through a combination of identical intended use, similar technological characteristics, and satisfactory non-clinical performance testing. The "performance" here refers to physical and mechanical attributes, not diagnostic or predictive accuracy.

Table of Acceptance Criteria and Reported Device Performance (Focus on Substantial Equivalence and Bench Testing):

Details Not Applicable to this Submission (as it's not an AI/Algorithm Device):

The following information requested in the prompt is not applicable to this 510(k) submission, as it pertains to AI/algorithm-based medical devices or clinical studies that were explicitly stated as "not required nor performed":

2. Sample size used for the test set and the data provenance: Not applicable. This is a physical device clearance based on bench testing. No "test set" in the context of diagnostic data was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No diagnostic ground truth was established.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No diagnostic test set or adjudication was involved.
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 device. The document explicitly states "Clinical testing was not required nor performed to support the substantial equivalence of these devices."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. "Ground truth" concept does not apply to the physical and mechanical performance testing of a catheter.
8. The sample size for the training set: Not applicable. This is a physical device, not an AI model.
9. How the ground truth for the training set was established: Not applicable. This is a physical device, not an AI model.

In summary, the FDA 510(k) K250836 clearance for the 14F Duo-Flow® Side X Side Double Lumen Catheter is for a physical medical device. The "acceptance criteria" and "study" described in the document are focused on demonstrating substantial equivalence to a predicate device through comparison of intended use, technological characteristics, and comprehensive non-clinical (bench) performance testing. There is no information regarding AI/algorithm performance or clinical studies in this submission.

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• The Hemodialysis Catheter is indicated for use in attaining short-term or long-term vascular access for Hemodialysis therapy and apheresis.

• It may be inserted percutaneously and is primarily placed in the internal jugular vein of an patient.
• Alternate insertion sites include subclavian vein as required.
• Catheters greater than 40 cm are intended for femoral vein insertion.
• The curved Hemodialysis Catheter is intended for internal jugular vein insertion.
• 8-10Fr Hemodialysis Catheters can be used in pediatric patients.

The Hemodialysis Catheter is indicated for use in attaining vascular access for Hemodialysis and Apheresis therapy. The catheter tubing is made of radiopaque polyurethane with a dual D cross-sectional design, providing independent arterial and venous lumens. The proximal end of the catheter features two luer connectors. The luer connectors are connected to extension legs. The extension legs are made of silicone material. Each extension leg has a catheter clamp, which is durable and can effectively ensure timely closure of the extension leg. The lumen with the red catheter clamp, which is called arterial lumen, is used for blood outflow; The lumen with the blue catheter clamp, which is called venous lumen, is used for blood return. The arterial and venous lumen priming volumes are printed directly on the ID ring of the clamp. Catheters range from approximately 13-55 cm long and are offered in straight or curved catheter configurations with cuff for long-term implantation. The Hemodialysis Catheter is packaged in a tray with legally marketed accessories intended for use during catheter placement. The Hemodialysis Catheter Kit is provided sterile, single use.

The provided FDA 510(k) clearance letter and associated documentation for the Hemodialysis Catheter (K241581) primarily detail the regulatory approval process, comparison to predicate devices, and non-clinical performance testing. It does not contain information about acceptance criteria for device performance based on clinical study data, nor does it describe a study that validates the device performance against such criteria in a clinical setting.

The document specifically states: "Clinical test: Clinical testing is not required." This indicates that the clearance was based on non-clinical performance data and substantial equivalence to legally marketed predicate devices, not on direct clinical evidence of the device's performance in patients.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance from a clinical study.
• Sample sizes used for the test set and data provenance from a clinical study.
• Number of experts used to establish ground truth and their qualifications from a clinical study.
• Adjudication method for a clinical study.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm only without human-in-the-loop performance) study.
• Type of ground truth used in a clinical study.
• Sample size for the training set from a clinical study.
• How ground truth for the training set was established in a clinical study.

The provided document focuses on the following types of performance data, which are non-clinical in nature:

1. Acceptance Criteria and Reported Device Performance (Non-Clinical)

While not presented in a table with specific pass/fail metrics, the document implies that the device met the requirements of the following standards and guidance:

• FDA guidance "Implanted Blood Access Devices for Hemodialysis, issued on January 21, 2016"
• ISO 10555-1:2013 (Sterile, single-use intravascular catheters - Part 1: General requirements)

The following non-clinical tests were performed to demonstrate compliance:

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

• Not Applicable for Clinical Data: The document explicitly states "Clinical testing is not required."
• For Non-Clinical Data: Specific sample sizes for each non-clinical test (e.g., tensile testing, leakage testing) are not detailed in this summary document. Data provenance is implied to be from internal lab testing conducted by Haolang Medical USA Corporation, in compliance with the cited ISO standards and FDA guidance.

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

• Not applicable as clinical testing with expert-established ground truth was not performed or required for this 510(k) clearance.

4. Adjudication Method for the Test Set

• Not applicable as clinical testing with an adjudication method was not performed or required.

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

• Not applicable. This type of study is typically for AI/imaging device performance evaluation, not for a physical device like a hemodialysis catheter, and certainly not for a clearance that states "Clinical testing is not required."

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

• Not applicable. This is not a software/AI device.

7. The Type of Ground Truth Used

• For Non-Clinical Testing: The "ground truth" for the non-clinical tests is adherence to the specified performance requirements as outlined in the referenced ISO standards (e.g., ISO 10555-1) and FDA guidance documents for hemodialysis catheters (e.g., "Implanted Blood Access Devices for Hemodialysis"). This involves objective, measurable physical, mechanical, and biological properties.

8. The Sample Size for the Training Set

• Not applicable. This refers to training data for AI/ML algorithms, which is not relevant to this device's clearance.

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

• Not applicable.

In summary, the FDA 510(k) clearance for the Hemodialysis Catheter (K241581) was granted based on a substantial equivalence determination supported by comprehensive non-clinical performance testing (physical, mechanical, biocompatibility, sterilization, and shelf-life) against recognized industry standards and FDA guidance, rather than a clinical study with patient data and expert-derived ground truth.

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The Dual Lumen Extended Length Catheter (dELC) is indicated for use up to 72 hours in attaining vascular venous access for use with the Aquadex FlexFlow® and Aquadex SmartFlow® systems for ultrafiltration therapy. It is not for pediatric use. The catheter is not intended for the infusion of medications or fluids, for laboratory sampling, or other venous access needs.

The Dual Lumen Extended Length Catheter (dELC) is a 6F reverse-tapered dual lumen venous access device with stainless steel coil reinforcement. It is inserted into peripheral venous circulation by way of a peel away introducer. The catheter is intended for short-term use with the Aquadex FlexFlow® and Aquadex SmartFlow® Systems in attaining vascular venous access for ultrafiltration treatment of patients with fluid overload. It has two models, 320101 and 320102, with identical hub designs but different effective (insertable) shaft lengths, 12 cm and 16 cm, to adapt to the patient's body size. The catheter has a radiopaque polyurethane shaft with two equal-sized inner lumens designed in a "double D" configuration. The shaft has a reverse-tapered design to minimize resistance to flow. Its outside diameter starts at 6F on the distal end and tapers back to 7F on the proximal end. The shaft with reinforcement provides kinking resistance and ensures consistent flow. the Catheter has female ISO 80369-compliance Luer connectors to connect with the Aquadex blood tubing set for withdrawal and infusion. Each extension tube has a clamp: blue on the blood withdrawal tube and white on the blood infusion tube. The blood is drawn up through the withdrawal lumen, which is proximal to the infusion lumen. The skived offset tip is designed to minimize blood recirculation.

The provided text is a 510(k) summary for a medical device called the "Dual Lumen Extended Length Catheter (dELC)". It describes the device, its intended use, comparison to predicate devices, and performance data submitted to support substantial equivalence.

However, the provided text DOES NOT contain information about an AI device or a software component that would require an acceptance criteria table, a study proving the device meets that criteria with details about sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance.

The "Performance Data" section (Section VII) lists various bench tests (e.g., Dimensional Analysis, Shaft Stiffness, Flow Rate, Kink Resistance) and biocompatibility tests performed on the physical catheter. These are standard tests for a physical medical device and are not related to an AI/software component.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving an AI device meets the acceptance criteria, as this information is not present in the provided document. The document pertains to a physical catheter, not an AI or software-based medical device.

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The Trio-CT® Triple Lumen Catheter is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis and apheresis. The third internal lumen is intended for infusion, power injection of contrast media and central venous pressure monitoring.
• The catheter is intended to be inserted in the jugular, femoral or subclavian vein as required. The maximum recommended infusion rate is 5ml/sec for power injection of contrast media.

The Trio-CT® Triple Lumen Catheter is a short-term (less than 30 days) dialysis catheter made of thermosensitive polyurethane. The catheter has three separate lumens allowing continuous blood flow. The venous (blue) and arterial (red) lumens may be used for hemodialysis and apheresis treatments. The middle (purple) lumen is independent from the two dialysis lumens, and may be used for intravenous therapy, power injection of contrast media, central venous pressure monitoring, blood draws and infusion of medications. The catheter is available with straight or curved extensions in a variety of lengths to accommodate physician preference and clinical needs. The attachable suture wing can be used to provide additional catheter securement and to minimize movement at the exit site.

The provided text describes the submission of a medical device, the "Trio-CT® Triple Lumen Catheter w/ Curved Extensions," for FDA 510(k) clearance, asserting its substantial equivalence to a predicate device, the "Trio-CT™ Triple Lumen Catheter." The document focuses on regulatory compliance and does not detail a study proving the device meets specific acceptance criteria in the context of an AI/human-in-the-loop performance study.

Therefore, many of the requested elements for an AI evaluation study, such as acceptance criteria based on performance metrics (e.g., sensitivity, specificity, AUC), sample size for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI training sets, are not applicable to this document. This document pertains to the regulatory clearance of a physical medical device, not an AI software component.

However, I can extract information related to the device's technical specifications and the non-clinical testing performed to establish its substantial equivalence.

Here's the relevant information based on the provided text:

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

The document doesn't explicitly state "acceptance criteria" in the format typically used for performance studies (e.g., sensitivity, specificity thresholds). Instead, it compares the technical specifications and performance characteristics of the subject device to its predicate to demonstrate substantial equivalence. The "acceptance criteria" are implied to be that the subject device's performance is comparable to or better than the predicate device across various technical and performance specifications.

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

This information is not applicable. The document describes non-clinical testing for a physical medical device, not a test set for an AI algorithm. The performance testing was "Design validation performance testing... leveraged from the predicate device manufactured by Medical Components, Inc." and "Design verification performance testing was completed to confirm performance criteria of the subject device." No specific sample sizes for these tests are mentioned in the provided text, nor is data provenance in the context of patient data described.

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):

This information is not applicable as this document does not concern an AI/algorithm where human expert ground truth would be established.

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

This information is 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:

This information is not applicable.

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

This information is not applicable.

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

The "ground truth" for this device's performance comes from adherence to established technical specifications and performance characteristics, and the results of various non-clinical tests. These include:

• Biocompatibility Evaluation: This involved specific tests like ISO Muscle Implantation, USP Rabbit Pyrogen, ASTM Hemolysis, SC5b-9 Complement Activation Assay, ISO Guinea Pig Maximization Sensitization, ISO Intracutaneous, Cytotoxicity Study, ISO Acute Systemic Toxicity, ISO Systemic Toxicity in Rat, Bacterial Reverse Mutation, Genotoxicity: Mouse Lymphoma Assay, Infrared Spectroscopy, Mechanical Hemolysis Testing, and In Vivo GLP 30 Day Thromboresistance Study. These tests provide "ground truth" regarding the material's safety and biological interactions.
• Performance Testing: This refers to design verification tests to confirm the device meets its specified technical characteristics (e.g., Catheter French Size, Inner Diameters, Priming Volume, Power Injection Pressure, Flow Rate vs. Pressure). The "ground truth" here is the direct measurement of these physical properties.

8. The sample size for the training set:

This information is not applicable. The document focuses on regulatory clearance of a physical medical device, not an AI algorithm.

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

This information is not applicable.

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The Power Acute Triple Lumen Hemodialysis Catheter is indicated for short term central venous access for hemodialysis, apheresis, infusion, central venous pressure monitoring and pressure injection of contrast media. The maximum recommended infusion rate is 5 mL/sec for power injection of contrast media.

The Power Acute Triple Lumen Hemodialysis Catheter is manufactured from a thermally reactive polyurethane material known for its rigidity at room temperature and softness at body temperature. This reactivity allows bedside insertion, while minimizing the risk of vein perforation and providing an overall improvement of patient comfort after insertion. The catheter cannula is radiopaque and incrementally marked to indicate the effective insertion length of the device in centimeters (cm). This cannula is extruded with three independent, non-communicating inner lumens. The lumens are made accessible within the cannula via luer-fitted silicone extension legs on the proximal end of the device, alongside a rigid polyurethane hub marked with the catheter's size in French (Fr) and effective insertion length that is fitted with a freely rotating suture wing. The clear outer extension legs are fitted with red and blue occlusion clamps, which are marked on either face with the lumen's priming volume in milliliters (mL), and respectively identify arterial and venous lumens. The medial, colored, extension leg is fitted with a purple occlusion clamp that is similarly marked with priming volume on its dorsal face, and marked with the maximum flow rate (in cubic centimeters [cc]) and injection pressure (in pounds per square inch [psi]) recommended for power-injected fluids on its ventral face. The distal end of the device is thermally bonded to a flexible, symmetrically tapered tip, which allows for direct outflow, and is skived on the radial and ulnar sides of the cannula.

The provided text is a 510(k) Premarket Notification Submission for a medical device: the "Power Acute Triple Lumen Hemodialysis Catheter." This document is primarily focused on demonstrating "substantial equivalence" of the new device to existing predicate devices, rather than proving the device meets specific acceptance criteria through a clinical study or a study directly assessing AI performance.

Therefore, many of the specific details requested in your prompt regarding acceptance criteria, AI performance, ground truth establishment, expert adjudication, and MRMC studies are not available in this document because it describes a traditional medical device submission, not an AI/ML-enabled medical device submission.

However, I can extract information related to the device's performance testing and validation as described for a non-AI/ML device.

Here's an analysis based on the provided text, addressing what can be found and noting what is not applicable/present:

Acceptance Criteria and Study for Power Acute Triple Lumen Hemodialysis Catheter

This submission pertains to a traditional medical device (hemodialysis catheter), not an AI/ML-enabled device. As such, the "acceptance criteria" discussed are primarily related to general device performance and safety benchmarks, rather than specific AI performance metrics like sensitivity, specificity, or AUC, or human reader improvement with AI assistance. The "study" refers to bench testing and biocompatibility testing to ensure the device performs as intended and is safe.

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

The document lists various tests performed to ensure the device's safety and performance, demonstrating "substantial equivalence" to a predicate device. The acceptance criteria are implicitly the successful completion of these tests in accordance with recognized standards, showing that the new device performs comparably to or better than the predicate. The "reported device performance" is that it "met the minimum requirements" for these tests.

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

The document describes bench testing and biocompatibility testing. This type of data does not typically involve a "test set" in the context of patient data for AI model validation. The sample sizes for these engineering and biological tests (e.g., number of catheters tested for flow rate, number of samples for chemical tolerance) are not specified in this summary document.

• Data Provenance: Not applicable in the sense of country of origin for clinical data. The tests are laboratory-based and conducted on the manufactured device.
• Retrospective or Prospective: Not applicable for bench/biocompatibility testing.

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

This is not applicable as the document describes a traditional medical device, not an AI/ML device relying on expert-established ground truth from medical images or clinical data. Ground truth for these tests is established by standardized measurements and laboratory methods (e.g., measuring flow rates, observing material reactions).

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

Not applicable. This concept applies to human expert review of medical data, typically for AI model validation, not for the engineering and biocompatibility testing 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

No. This is not applicable. This document describes a traditional hemodialysis catheter, not an AI-assisted device. Therefore, no MRMC study, human reader improvement, or AI effect size would be relevant or performed.

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

No. This is not applicable. There is no algorithm mentioned in this device submission.

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

The "ground truth" for the device's performance is established by physical and chemical measurements conducted according to internationally recognized standards (e.g., ISO standards) and FDA-recognized consensus standards. This includes:

• Measured flow rates
• Measured burst pressures
• Observational results of material integrity (kinking, clamping)
• Biological reactions in biocompatibility tests (e.g., cell culture, animal studies for toxicity, hemolysis)

8. The sample size for the training set

Not applicable. This document describes the testing of a physical medical device, not an AI/ML model that requires a "training set" of data.

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

Not applicable. As there is no training set mentioned, there is no ground truth establishment for it.

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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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Luer lock plug for capping male or female luer tapers for hemodialysis catheters.

The Medcomp® End cap is non-vented plastic cap with a male luer. The end connects directly to the female luer of the catheter.

The provided document is a 510(k) summary for a medical device called "End Cap". It details the device's description, indications for use, comparison to a predicate device, and performance data for demonstrating substantial equivalence.

However, the questions you've asked are specifically about the acceptance criteria and study proving the device meets acceptance criteria for an AI/ML-enabled medical device. The provided document is for a physical medical device (luer lock plug) and does not involve AI or machine learning. Therefore, the questions related to AI/ML device performance (e.g., sample size for test/training sets, experts for ground truth, MRMC study, standalone performance) are not applicable to the content of this document.

The document discusses performance testing (bench testing) to ensure the physical device meets relevant standards, but this is different from the type of performance evaluation required for an AI/ML diagnostic or predictive device.

Here's how I can address the applicable parts of your request based on the provided document, interpreting "acceptance criteria" in the context of a physical device's regulatory submission:

The "acceptance criteria" for this device's submission revolves around demonstrating substantial equivalence to a legally marketed predicate device by meeting recognized consensual standards for physical device performance and biocompatibility.

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

For a physical device like the End Cap, acceptance criteria are typically defined by compliance with recognized international standards (ISO standards in this case) and demonstrating safe and effective performance. The "reported device performance" is essentially that the device passed these tests, confirming its compliance.

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The GlidePath™ Retro Long-Term Hemodialysis Catheters are indicated for use in attaining short-term or long-term vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, subclavian vein, or femoral vein. Catheters longer than 40 cm are intended for femoral vein insertion.

The GlidePath™ Retro Long-Term Hemodialysis Catheter features a dual-lumen polyurethane catheter shaft with optimized double-D cross-sectional design providing separate arterial and venous lumens, an external bifurcation hub with SwiftClick connector assembled by physician upon placement, and arterial and venous extension legs that connect to an external dialysis machine or blood cleansing device. The arterial (red) luer connector secures to the blood intake on the dialysis machine and the venous (blue) luer connector secures to the blood return line on the dialysis machine. Each extension leg has an atraumatic occlusion clamp which closes access to the lumen. The symmetrical catheter tip contains holes that aid in the distribution of blood flow or aid in over-the-guidewire placement. The dialysis catheter is offered in various lengths.

This document describes the GlidePath™ Retro Long-Term Hemodialysis Catheter. It addresses the performance data and comparison to predicate devices, but does not describe a study involving an AI medical device or clinical performance data that would typically include acceptance criteria and reporting on sensitivity, specificity, or other performance metrics for an AI algorithm.

Therefore, I cannot provide the information requested in your prompt regarding AI device acceptance criteria and study details because the provided text is for a traditional medical device (a catheter) and does not contain information about an AI-powered device or its performance study.

The document focuses on demonstrating substantial equivalence of the catheter to a predicate device through non-clinical testing of various physical and functional characteristics.

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