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The Nipro SafeTouch Needle is indicated for general purpose injection of fluid from vials, and to and from parts of the body below the surface of the skin. It includes a needle shield to prevent against accidental needlestick injuries. The needle is compatible with standard Luer-lock syringes.

The Nipro Syringe with SafeTouch Needle is indicated for general purpose injection of fluid from vials, and to and from parts of the body below the surface of the skin. It includes a needle shield to prevent against accidental needlestick injuries.

The Nipro SafeTouch Needle is a disposable hypodermic single lumen needle with attached safety device. The safety device is a needle shield that covers the needle post treatment eliminating accidental needlestick injuries. It is provided with and without a piston syringe.

The Nipro SafeTouch Needle is available in gauges of 18-30, lengths of ½". The needles are available individually or attached to a luer lock syringe in volumes of 1, 3, 5 and 10mL.

The device is sterile, single use only, non-toxic, and non-pyrogenic. It is sterilized by Ethylene Oxide gas and has a shelf-life of 5 years.

The provided text describes specific acceptance criteria and study details for the Nipro SafeTouch Needle and Nipro Syringe with SafeTouch Needle, but it does not describe a study proving the device meets acceptance criteria in the context of an AI/ML device. Instead, it outlines a 510(k) premarket notification for a traditional medical device, comparing it to a predicate device.

The document discusses non-clinical tests and a simulated clinical study, but these are for a physical medical device, not an AI/ML diagnostic or therapeutic system. Therefore, I cannot provide information on items such as multi-reader multi-case studies, standalone algorithm performance, ground truth establishment for AI training sets, or sample sizes for AI training sets, as these concepts are not relevant to the provided text.

However, I can extract the acceptance criteria and performance related to the physical medical device and the simulated clinical study.

Here's the information based on the provided text, focusing on the device's physical and functional properties:

Table of Acceptance Criteria and Reported Device Performance

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Indicated for intramuscular administration of Dysport® for the temporary improvement of moderate to severe glabellar lines in adults

The aboNT Syringe is a piston syringe with needle consisting of graduated barrel, plunger rod, and gasket. It is provided with a permanently attached hypodermic needle that is 31G x 5/16″. The syringe barrel is 0.3 mL in volume, with a graduated scale labeled in both volumetric (mL) and corresponding unit dosing for Dysport® (60 units/0.3mL). The syringe is sterile, single use only, non-toxic, non-pyrogenic and sterilized by E-beam radiation. The shelf-life has been determined to be 5 years.

The provided text describes the submission of a medical device (aboNT Syringe) for FDA clearance (K212677) and details its non-clinical testing for substantial equivalence to a predicate device. It explicitly states that no clinical testing was performed or provided, and therefore, a multi-reader multi-case (MRMC) comparative effectiveness study with human readers assisted by AI was not conducted, and a standalone algorithm performance study was not conducted.

Here's an analysis of the provided information regarding acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding "reported device performance" in the format one might expect for a study evaluating an AI algorithm's diagnostic performance. Instead, it compares the subject device (aboNT Syringe) to a predicate device (UniTox® Syringe) across various technological characteristics. The "performance" in this context refers to meeting established standards for syringe manufacturing and function, rather than diagnostic accuracy.

However, we can extract some "acceptance criteria" based on the comparisons and testing outlined. The "reported device performance" is implicitly that the subject device meets these standards and is "within specification."

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

The document does not specify a distinct "test set" in the context of an AI algorithm evaluation with sample sizes. The testing conducted is primarily non-clinical, involving material and performance assessments according to established standards. For these physical and chemical tests, sample sizes would typically be defined by the specific standard, but are not detailed in this summary. The data provenance is internal to the manufacturer's testing processes as required for regulatory submission.

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

Not applicable. This is a non-clinical evaluation of a medical device (syringe), not an AI algorithm requiring expert ground truth for diagnostic accuracy.

4. Adjudication method for the test set

Not applicable. This is a non-clinical evaluation of a medical device (syringe), not an AI algorithm requiring expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not conducted. The document explicitly states: "This submission does not warrant any clinical testing, therefore no clinical testing performed for or provided in this submission." This device is a syringe, not an AI-powered diagnostic tool.

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

No, a standalone algorithm performance study was not done. The device is a syringe, not an AI algorithm.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" is defined by the specifications and acceptable ranges established by recognized international and national standards (e.g., ISO 7886-1, ISO 7864, ASTM F1980-16, USP , etc.). The device's performance is compared against these scientifically established benchmarks.

8. The sample size for the training set

Not applicable. This is a non-clinical evaluation of a syringe; there is no "training set" in the context of machine learning.

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

Not applicable. There is no "training set" or corresponding ground truth establishment for an AI algorithm in this submission.

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The Cronus HP PTA Balloon Catheter is indicated for Percutaneous Transluminal Angioplasty in the following vessel areas:

• Femoral arteries
• Popliteal arteries
• Iliac arteries
• Renal arteries
• For the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
  These catheters are not intended for use in coronary arteries or the neurovasculature.

The Cronus™ HP PTA Balloon Catheter is intended for PTA (Percutaneous Transluminal Angioplasty) procedures. It is an over the wire (OTW) 0.035" dual lumen catheter with a distally mounted semi- compliant inflatable balloon and a flush cut tip. The catheter manifold includes two lumens. A y-connector adaptation is located at the proximal part of the catheter and provides access to the two different lumens. The lumen marked "GW" is the central lumen of the catheter which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire with a maximum outer diameter of 0.035 inches. The lumen, marked "BALLOON" is used to inflate and deflate the dilatation balloon with a solution of contrast medium and saline. The balloon has two radiopaque markers for positioning the balloon relative to the stenosis. The balloon segment expands to a known diameter at a specific inflation pressure.
The Cronus™ HP PTA Balloon Catheter is sterilized using ethylene oxide gas and satisfies a minimum Sterility Assurance Level (S.A.L.) of 10 °. Shelf-life is determined to be 4 years.
The device is available in multiple configurations ranging in sizes of balloon diameter 4-10mm, balloon lengths 20-80mm, and catheter lengths of 45 and 80cm

This document is a 510(k) Premarket Notification from the FDA regarding the Cronus HP PTA Balloon Catheter. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria based on performance study results.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them cannot be extracted from the provided text. The document explicitly states:

• "This submission does not warrant any clinical testing, therefore no clinical testing was performed for or provided in this submission."

This indicates that clinical performance studies to establish specific acceptance criteria and prove the device meets them were not part of this 510(k) submission. The submission relies on non-clinical (bench) testing and comparison of technological characteristics to a legally marketed predicate device to demonstrate substantial equivalence.

Here's what can be inferred from the document regarding the device's evaluation (though it doesn't directly address the acceptance criteria and study proving performance as you've requested):

The 510(k) process for this device, as detailed, focuses on demonstrating substantial equivalence to an existing predicate device (Cronus HP (K151141)). This means the manufacturer is asserting their new device is as safe and effective as the predicate device, not necessarily that it meets a set of isolated performance criteria from a clinical trial.

The "tests" mentioned are primarily bench tests and biocompatibility tests, which establish the basic safety and physical characteristics of the device, and ensure it functions as intended in a laboratory setting. These are not clinical studies designed to show performance against specific clinical acceptance criteria.

To answer your specific questions in the context of this document's limitations:

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

   • Not applicable / Not provided. The document lists various non-clinical tests (e.g., packaging burst, balloon compliance, balloon rated burst pressure) and states they were "conducted successfully." However, it does not provide specific quantitative acceptance criteria or reported performance values for these tests in a table, nor does it present the results of a clinical study proving performance against acceptance criteria.

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

   • Not applicable / Not provided for clinical data. Since no clinical testing was performed, there's no test set for clinical data. For the bench tests, sample sizes are not explicitly stated in this summary. Data provenance would be laboratory testing in an ISO-certified facility likely, but specifics are missing.

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

   • Not applicable. No clinical test set where "ground truth" would be established by experts is mentioned.

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

   • Not applicable. No clinical test set requiring adjudication 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 PTA Balloon Catheter, not an AI-assisted diagnostic tool.

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 applicable. For the bench tests, physical measurements and engineering standards serve as the "truth," but this isn't analogous to clinical ground truth.

8. The sample size for the training set:

   • Not applicable. This device does not involve machine learning or a "training set."

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

   • Not applicable.

In summary, this FDA document is a 510(k) summary for a physical medical device that achieved clearance through demonstrating substantial equivalence to a predicate device, primarily via non-clinical testing. It did not involve or report on a clinical study designed to prove the device met specific acceptance criteria.

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To inject fluids into or withdraw fluids from the body.

The NIPRO Syringe is a piston syringe consisting of graduated barrel, plunger rod, and gasket. It is provided in luer slip, luer lock and eccentric luer slip tips, with and without attached hypodermic needles are available in ranges of 20-27G, and 3/8 to 1 ½" in length. Gauges are color coded for easy differentiation. Its function is mechanical. The syringe is sterile, single use only, non-toxic, non-pyrogenic and sterilized by Ebeam radiation. The shelf-life has been determined to be 5 years.

The provided text is a 510(k) summary for a medical device, specifically a Nipro Syringe. It describes a conventional medical device, not an AI/ML-driven device. Therefore, the information requested in the prompt regarding acceptance criteria, study details, expert involvement, and ground truth for an AI/ML device is not present in the provided document.

The document discusses:

• Device Description: A piston syringe with varied sizes, gauges, and tips.
• Indications for Use: To inject or withdraw fluids from the body.
• Technological Characteristics: Materials, design, sterilization, expiry dating, and dimensions.
• Non-Clinical Performance Testing: A comprehensive list of biocompatibility, visual inspection, dimensional, mechanical, chemical, sterilization, transportation, pyrogen, and shelf-life tests performed to demonstrate substantial equivalence to a predicate device.
• Clinical Study Conclusion: Explicitly states "No clinical Study is included in this submission."

Since the prompt is specifically about the acceptance criteria and study that proves the device meets the acceptance criteria (implying an AI/ML device context), and the document describes a physical medical device (syringe), it does not contain the information necessary to answer the questions about AI/ML device performance, ground truth, expert consensus, or MRMC studies.

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The SURDIAL DX Hemodialysis System is indicated for implementing hemodialysis treatments in patients with acute and chronic kidney (renal) failure. The system can be used in hospitals, healthcare facilities and outpatient dialysis centers when prescribed by a physician and used by qualified operators. The SURDIAL DX accommodates the use of both low flux and high flux hemodialysis.

The SURDIAL DX Hemodialysis System is a single patient dialysis unit that incorporates the mechanism of mixing and producing of dialysate by quantitative mixing method and the mechanism of ultrafiltration control by use of a piston pump. The SURDIAL DX consists of 4 sections: Panel operating section, Blood circuit control section, Liquid circuit control section and Power source control section. CAN communication is used for communication between each section.

This document is a 510(k) Summary for the NIPRO SURDIAL DX Hemodialysis System, demonstrating its substantial equivalence to a predicate device. It details performance specifications, but it does not describe a study involving a test set with ground truth established by experts, MRMC studies, or standalone algorithm performance, as these are typically associated with artificial intelligence/machine learning (AI/ML) device submissions.

The "performance data" section in this document refers to engineering and quality assurance testing (biocompatibility, electrical safety, software verification, environmental testing, human factors) to ensure the device functions as intended and meets established safety standards for a hemodialysis machine. It does not describe a study that would involve a "test set" and "ground truth" derived from expert consensus in the context of diagnostic accuracy, which is what your questions imply.

Therefore, for aspects related to AI/ML device evaluations (e.g., test set sample size, expert consensus, MRMC studies, standalone performance, training set details), the information is not available in the provided text.

Here's a breakdown of the available information based on your request, focusing on the device's engineering and safety performance rather than diagnostic accuracy:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the comparative table against the predicate device, where "Same" or "Similar" indicates meeting equivalence. Specific quantitative acceptance values are embedded within the "Subject Device: SURDIAL DX" column, and its performance is those reported values, as the testing confirmed it met those specifications.

2. Sample Size for Test Set and Data Provenance

This document does not describe a "test set" in the context of an AI/ML diagnostic study with patient data. The "performance data" refers to validation testing of the device itself (e.g., electrical, mechanical, software functionality, biocompatibility). Therefore, there is no sample size of patient data or data provenance (country, retrospective/prospective) relevant to a diagnostic AI model study.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. Ground truth from experts is not established for this type of device performance testing. The "ground truth" here is the engineering specification that the device must meet, tested through controlled experimental conditions in a lab.

4. Adjudication Method for Test Set

Not applicable. There is no expert adjudication for the engineering performance and safety tests described.

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

No. This type of study is for evaluating the impact of AI assistance on human reader performance, typically in diagnostic imaging. The SURDIAL DX Hemodialysis System is a treatment device, not a diagnostic AI system, and this document does not refer to any such studies.

6. Standalone Performance (Algorithm Only)

Not applicable. This device is a hemodialysis machine. While it contains software, its "performance" is its ability to conduct hemodialysis treatments safely and effectively, not to perform a standalone diagnostic algorithm. The software verification and validation section confirms software functions as intended for controlling the machine.

7. Type of Ground Truth Used

The "ground truth" for this device's performance testing is adherence to engineering specifications, recognized international standards (e.g., ISO, IEC), and documented functional requirements. For biocompatibility, it's the results of specific laboratory tests against established biological safety criteria. For software, it's the functionality of the code against its design specifications and requirements.

8. Sample Size for Training Set

Not applicable. This document does not describe an AI/ML model that would have a "training set" of data.

9. How Ground Truth for Training Set was Established

Not applicable, as there is no AI/ML training set.

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to inject fluids into or withdraw fluids from the body

The NIPRO Syringe is a piston syringe consisting of graduated barrel, plunger rod, and gasket. It is provided in luer slip, luer lock and eccentric luer slip tips, with and without attached hypodermic needles are available in ranges of 20-25G, and 3/8 to 1 ½" in length. Gauges are color coded for easy differentiation. Its function is mechanical. The syringe is sterile, single use only, non-toxic, non-pyrogenic and sterilized by Ebeam radiation. The shelf-life has been determined to be 5 years. This device is not intended for patients less than 2 years of age.

The Nipro Syringe is a medical device and thus the provided document is a 510(k) summary, which outlines its substantial equivalence to a predicate device rather than a study proving unmet acceptance criteria in the context of AI/ML performance. Therefore, most of the requested information regarding AI/ML clinical study specifics (such as expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment for training and test sets) is not applicable or cannot be extracted from this document.

However, I can extract the acceptance criteria related to the device's physical and performance characteristics, and how the device's performance was evaluated against these criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes non-clinical tests performed to ensure the Nipro Syringe meets established standards. The acceptance criteria are implicit in the "specifications of the standards listed," and the reported device performance is that these tests were "performed within the specifications" and that the device "performs equivalent to the predicate device."

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

This information is not explicitly provided in the document. The document refers to non-clinical tests performed to specific standards, but it doesn't detail the sample sizes used for each test or the provenance of any data (e.g., country of origin, retrospective/prospective). As this is a physical medical device, not an AI/ML system, "test set" in the context of data for model evaluation is not directly applicable.

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

Not applicable. This device is a physical syringe, not an AI/ML system requiring expert consensus for ground truth establishment. The "ground truth" for this device's performance is determined by meeting the specifications of established engineering and biological standards.

4. Adjudication Method for the Test Set:

Not applicable for a physical device. The compliance with standards and their specifications serves as the evaluation basis, not human adjudication of AI output.

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

Not applicable. This is not an AI-assisted diagnostic or treatment device, so there is no human-in-the-loop performance improvement with or without AI to measure.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

Not applicable. This is a physical medical device, not an algorithm. Its performance is inherent to its design and manufacturing, evaluated through non-clinical testing against established standards.

7. Type of Ground Truth Used:

The "ground truth" for the Nipro Syringe is compliance with internationally recognized and industry-accepted standards (ISO, ASTM, USP) for medical devices, specifically for piston syringes and needles. This includes performance benchmarks for:

• Physical dimensions and integrity
• Mechanical function
• Sterility
• Biocompatibility
• Chemical characteristics
• Shelf-life

8. Sample Size for the Training Set:

Not applicable. This is a physical device, not an AI/ML model, so there is no "training set."

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

Not applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it is irrelevant in this context.

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The Nipro SafeTouch IV Catheter is a passive anti-needle stick intra-vascular catheter that is inserted into the patient's vascular system for short term use for the infusion of fluids, and/or blood components. 16-24 gauge catheters may be used with power injectors for which the maximum pressure setting is 300psi

Nipro SafeTouch IV Catheter consists of an over-the-needle, catheter made of radiopaque polyurethane with a passive safety mechanism that will engage upon removal from the patient in order to prevent accidental needlestick injuries. The device is available in gauges 16-24 and in catheter lengths of ¾" – 2". It is also available with or without wings on the hub. Gauges are color coded for easy differentiation. Nipro SafeTouch IV Catheter is sterilized by Ethylene Oxide gas (EtO). It is packaged in a peel blister that ensures the sterility of the device until package is opened and labeled for single use only. A sleeve of SafeTouch Cath contains 5 units of blister packages. An inner box contains 10 sleeves (50 units). An outer box contains 40 inner boxes (3000 units). Its shelf life period is 5 years.

This document describes a 510(k) premarket notification for the "Nipro SafeTouch IV Catheter". Since it's a 510(k) submission, the primary goal is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove optimal performance against specific clinical acceptance criteria in the same way a new drug or novel high-risk device might.

Based on the provided information, the device is an Intravascular Catheter with a passive anti-needle stick safety mechanism. The acceptance criteria and supporting studies are focused on its non-clinical performance and a simulated clinical study for the safety mechanism.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and the Reported Device Performance

The acceptance criteria are not explicitly stated with quantitative thresholds in the provided document beyond "All of the above tests were performed within the specifications of the standards listed above." The performance is reported as "passed with zero failures" for the simulated clinical study and "performs equivalent to the predicate device" for other tests.

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

• The document does not specify the sample size used for any of the non-clinical tests or for the "simulated clinical study" that evaluated the safety mechanism.
• The provenance of the data (country of origin, retrospective/prospective) is not mentioned. These are likely internal laboratory tests conducted by Nipro Medical Corporation or a contracted testing facility.

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 provided. Since the tests are largely non-clinical engineering and laboratory tests, "experts" in the context of clinical interpretation or diagnostic decision-making are not relevant. The "ground truth" for these tests would be defined by the specifications of the relevant international standards (e.g., ISO, ASTM, USP).

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

• This information is not provided and is generally not applicable to the types of non-clinical, objective tests described here. Adjudication methods are typically used in clinical studies where subjective human interpretation of conditions or outcomes requires consensus.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC comparative effectiveness study was not done.
• This device is an IV catheter, not an AI-assisted diagnostic tool or imaging device. There is no AI component, and therefore no assessment of human reader improvement with AI assistance.

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

• This question is not applicable as the device is an IV catheter, not an algorithm or AI system.

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

• For the non-clinical tests, the "ground truth" is established by the specifications and requirements defined within the referenced international and national standards (e.g., ISO, ASTM, USP). The device performance is compared against these predefined physical, chemical, and biological limits or parameters.
• For the "simulated clinical study" of the safety mechanism, the ground truth would be a binary outcome of successful activation/engagement of the safety mechanism as per its design specifications.

8. The sample size for the training set

• This device is not an AI/machine learning device, so the concept of a "training set" is not applicable.

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

• This question is not applicable as the device does not involve a training set.

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Hemodialysis with the FB-U Hemodialyzer is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs.

The Nipro FB-U hemodialyzer is a medical device intended for use as an artificial kidney system for the treatment of patients with renal failure. During treatment, blood is circulated from the patient, through the extracorporeal system, into the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate.

Device: Nipro FB-U Hemodialyzer

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document states "Non-clinical tests submitted," which include "dimensional and performance to include: positive and negative pressure tests, blood compartment integrity, clearances, Ultrafiltration coefficient, volume of blood compartment, and pressure drop." It also mentions "Other test items include: Transportation tests, biocompatibility, and shelf-life testing."

• Sample Size: The document does not explicitly state the specific sample sizes used for each of these non-clinical tests.
• Data Provenance: The tests are described as "non-clinical tests submitted," implying they were conducted by Nipro Medical Corporation as part of their submission. No information is provided regarding the country of origin of the data or whether it was retrospective or prospective, though non-clinical tests are generally prospective.

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

Not applicable. The study relies on objective physical and chemical measurements (e.g., clearances, pressure tests) rather than expert interpretation of data for establishing ground truth in non-clinical testing.

4. Adjudication Method for the Test Set:

Not applicable. As the study primarily concerns non-clinical, objective measurements, an adjudication method for a "test set" (in the sense of human interpretation) is not relevant.

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. No MRMC study was conducted. This device is a hemodialyzer, not an AI-powered diagnostic or assistive technology for human readers.

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

Not applicable. This device is a physical hemodialyzer, and therefore the concept of a standalone algorithm or human-in-the-loop performance is not relevant. The performance evaluation is of the device's physical and functional characteristics.

7. The Type of Ground Truth Used:

The ground truth for the non-clinical tests was established through objective physical and chemical measurements and engineering standards. For example:

• Clearances were measured against established methods for filtration efficiency.
• Pressure tests confirmed resistance to specified pressures.
• Integrity tests confirmed the physical structural soundness.
• Biocompatibility tests likely adhered to ISO standards (e.g., ISO 10993).
• Shelf-life tests involved stability and performance over time.

The "ground truth" for showing substantial equivalence was the performance characteristics of the legally marketed predicate devices.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI or machine learning algorithm that requires a training set. The performance data is derived from testing of the physical device.

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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The Cronus HP - High Pressure Peripheral Balloon Catheted for Percutaneous Transluminal Angioplasty in the following vessel areas:

• Femoral arteries
• Popliteal arteries
• Iliac arteries
• Renal arteries
• For the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
  These catheters are not intended for use in coronary arteries or the neurovasculature.

The Cronus HP - High Pressure Peripheral Balloon Catheter is intended for PTA (Percutaneous Transluminal Angioplasty) procedures. It is an over the wire (OTW) 0.035" dual lumen catheter with a distally mounted semi- compliant inflatable balloon and a flush cut tip. The catheter manifold includes two lumens. A y-connector adaptation is located at the proximal part of the catheter and provides access to the two different lumens. The lumen marked "GW" is the central lumen of the catheter which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire with a maximum outer diameter of 0.035 inches. The lumen, marked "BALLOON" is used to inflate and deflate the dilatation balloon with a solution of contrast medium and saline. The balloon has two radiopaque markers for positioning the balloon relative to the stenosis. The balloon segment expands to a known diameter at a specific inflation pressure.

The provided text describes a 510(k) premarket notification for a medical device, the Cronus HP - High Pressure Peripheral Balloon Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing full clinical trials to prove efficacy and safety.

Therefore, the document does not contain the kind of information typically found in a study designed to prove a device meets acceptance criteria, especially for a new, innovative device that would require such studies. Specifically:

• No acceptance criteria table and reported performance: The document does not define specific performance metrics (e.g., sensitivity, specificity, accuracy for a diagnostic device; or a clinical outcome measure for a therapeutic device) with corresponding acceptance thresholds. Instead, it relies on demonstrating that the device meets various non-clinical engineering and biocompatibility tests and is similar in function to predicate devices.
• No test set sample size or data provenance: There is no "test set" in the sense of a clinical dataset used for performance evaluation that would require information on sample size, country of origin, or whether it was retrospective/prospective. The non-clinical tests are bench tests or lab-based biocompatibility, not studies on patient data.
• No experts used for ground truth: Since there's no clinical test set requiring ground truth, there are no experts involved in establishing it.
• No adjudication method: Not applicable as there's no clinical test set.
• No multi-reader multi-case (MRMC) comparative effectiveness study: This type of study is typically done for diagnostic imaging devices to assess human reader performance with and without AI assistance. This document describes a balloon catheter, not an imaging device.
• No standalone (algorithm-only) performance: This is a physical medical device, not an algorithm.
• No type of ground truth used: Not applicable as there's no clinical test set.
• No training set sample size: This is not an AI/ML device that requires a training set.
• No ground truth for the training set: Not applicable.

What the document does describe are:

• Non-clinical (bench) tests: A comprehensive list of physical, mechanical, and biological tests (biocompatibility, packaging, guidewire compatibility, dimensional verification, trackability, pushability, balloon inflation/deflation, burst pressure, radiopacity, etc.). The conclusion states these tests were "conducted and passed," demonstrating the device performs equivalently to predicate devices in these aspects.
• Comparison to predicate devices: The "Comparison of technological characteristics" table (Table 4) outlines similarities in physical characteristics, operational mode, basic scientific technology, and intended use between the Cronus HP and its predicate devices (Covidien Evercross and Bard Conquest).
• Conclusion of Substantial Equivalence: The ultimate "acceptance criteria" for a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device. The document explicitly states: "The results of the performance testing and the comparison of technological characteristics with the predicate devices demonstrate that the Cronus HP- High Pressure Peripheral Balloon Catheter has an equivalent performance compared to the predicate devices and it is substantially equivalent for its intended use."
• No clinical tests: The document explicitly states: "This submission does not warrant any clinical testing, therefore no clinical testing performed for or provided in this submission." This reinforces that the "proof" is through non-clinical testing and comparison to predicates, not through clinical trials.

In summary, the provided text is an FDA 510(k) clearance letter and summary for a physical medical device. It proves the device meets regulatory acceptance criteria for substantial equivalence through a series of non-clinical (bench) tests and a direct comparison of technological characteristics to existing, legally marketed predicate devices, rather than through a clinical study with a test set, ground truth, and human expert evaluation as might be seen for a novel diagnostic or AI-powered device.

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Hemodialysis with an ELISIO™-H hemodialyzer is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs.

The device is for prescription use only.

This product is intended for single use only. The performance properties of reused dialyzers have not been established.

The ELISIO-H hemodialyzers are medical devices used as an artificial kidney system for the treatment of patients with renal failure. During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment.

The ELISIO-H dialyzers are composed of polyethersulfone fiber and are available in various sizes, which are differentiated by membrane surface area.

The provided text describes a 510(k) summary for the ELISIO™-H Hemodialyzer, a medical device. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive details about a clinical study with acceptance criteria for device performance in the same way one might for a novel AI/software diagnostic device.

Therefore, many of the requested elements are not applicable or cannot be extracted from this document, as it pertains to a hemodialysis system and not an AI or imaging diagnostic device.

Here's an analysis based on the provided text, addressing the applicable points:

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

The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, or specific physical parameters with defined thresholds) or present a table of reported device performance against such criteria. The "Conclusion" states: "Testing performed on the ELISIO-H dialyzers indicates that they are safe, effective and perform as well as the legally marketed device models, when used in accordance with the instructions for use." This is a qualitative statement of efficacy in the context of substantial equivalence, not a detailed performance report.

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

This information is not provided. The document mentions "testing performed" but does not detail the nature of these tests (e.g., in vitro, animal, or human clinical trials), sample sizes, or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to this type of device and submission. The ground truth for a hemodialyzer's performance would primarily be established through physical and chemical testing (e.g., clearance rates, ultrafiltration rates, biocompatibility) rather than expert interpretation of medical data from a test set.

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

Not applicable. This concept is typically relevant for studies involving human interpretation of data, where multiple experts might be used to resolve discrepancies in diagnoses or interpretations.

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 hemodialysis system, not an AI or imaging device that would typically involve human readers being assisted by AI.

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

Not applicable. The device is a physical medical device (hemodialyzer), not a standalone algorithm.

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

The "ground truth" for a hemodialyzer's performance would be established through engineering and biological testing (e.g., direct measurement of solute clearance, ultrafiltration, pressure drops, blood-material interactions, and possibly in vivo biocompatibility or animal studies to simulate real-world conditions). The document does not detail these specific methods or outcomes. The basis for the substantial equivalence is the ELISIO™-H Hemodialyzer's composition and function being "safe, effective and perform as well as the legally marketed device models," implying that the performance metrics of the predicate devices serve as an implicit benchmark.

8. The sample size for the training set

Not applicable. The ELISIO™-H Hemodialyzer is a physical device, not an algorithm that requires a training set.

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

Not applicable.

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