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The NES Reprocessed Visions PV .018 Digital IVUS Catheter is designed for use in the evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicated for use in cerebral vessels.

The NES Reprocessed Visions PV .018 Digital IVUS Catheter is designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.

The NES Reprocessed Visions PV .018 Digital IVUS Catheter utilizes a cylindrical ultrasound transducer array close to the distal tip to radiate acoustic energy into the surrounding tissue. By using the information gathered from the ultrasonic echoes, the device can generate real-time images of the coronary and peripheral vessels.

The NES Reprocessed Visions PV .018 Digital IVUS Catheter tracks over a 0.018" (0.46mm) guide wire by through an internal lumen. Approximately 31 cm from the catheter tip is a guidewire port for the exiting guidewire. The NES Reprocessed Visions PV .018 Digital IVUS Catheter is introduced into the vascular system percutaneously or via surgical cutdown.

The NES Reprocessed Visions PV .018 Digital IVUS Catheter may only be used with the Volcano s5 Series or CORE Series of Systems Operator's Manual. If connect to another system, the catheter will not operate.

The NES Reprocessed Visions PV .018 Digital IVUS Catheter is intended to be reprocessed one (1x) time.

The provided FDA 510(k) clearance letter and summary for K250592 describes a reprocessed medical device, the NES Reprocessed Visions PV .018 Digital IVUS Catheter. This document does not detail acceptance criteria or the study that proves the device meets AI/Machine Learning performance standards, as it is a traditional medical device (an Intravascular Ultrasound Catheter) and not an AI-enabled device.

Therefore, many of the requested categories regarding AI model performance, ground truth establishment, expert adjudication, MRMC studies, and training/test set sizes are not applicable to this submission.

However, I can extract the relevant information regarding the device's functional and safety testing as described in the 510(k) summary, which serves as the "study" proving the device meets its acceptance criteria for a reprocessed medical device.

Summary of Device Acceptance Criteria and Performance (for a Reprocessed Medical Device, not AI)

The NES Reprocessed Visions PV .018 Digital IVUS Catheter is a reprocessed version of a predicate device. The acceptance criteria and "study" proving the device meets these criteria focus on demonstrating that reprocessing does not compromise the device's safety and effectiveness compared to the original device. The "study" involves various bench and laboratory tests.

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary states that "The test methods, requirements and acceptance criteria used for the .018 IVUS are the same used in cleared K200195 (reprocessed .014 IVUS)." It also indicates that there are "no changes to the claims, clinical applications, patient populations, performance specifications, or method of operation." This implies that the acceptance criteria are met if the reprocessed device performs comparably to a new device (or the predicate reprocessed device K200195) across all specified tests.

Note: The document states that the "NES Reprocessed Visions PV .018 Digital IVUS Catheter is as safe and effective as the predicate devices described herein," which is the overarching conclusion of meeting all acceptance criteria.

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

• Sample Size: Not explicitly stated for each test, but standard for device validations. For a reprocessed device, this would typically involve a statistically significant number of reprocessed units across multiple reprocessing cycles.
• Data Provenance: The tests are described as "Bench and laboratory testing," implying controlled, experimental data generated specifically for this submission. There is no mention of patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• N/A: As this is a traditional medical device (not an AI/ML device), expert establishment of ground truth in the context of image interpretation or diagnostic accuracy is not relevant. The "ground truth" for the device's performance would be established by validated test methods and engineering specifications.

4. Adjudication Method for the Test Set

• N/A: Adjudication is typically relevant for subjective assessments (e.g., in AI or clinical studies). For bench and lab testing of a physical device, performance is measured against objective, predetermined specifications rather than requiring expert consensus or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• N/A: An MRMC study is relevant for evaluating the impact of AI on human reader performance. This device is an IVUS catheter and does not involve AI assistance for image interpretation.

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

• N/A: This question pertains to AI algorithm performance. This device is a physical catheter, not an algorithm.

7. The Type of Ground Truth Used

• Engineering Specifications and Performance Standards: The "ground truth" for this device's performance is compliance with established engineering specifications, safety standards (e.g., sterilization, biocompatibility), and functional performance benchmarks (e.g., image acuity, acoustic output) that are deemed equivalent to the original predicate device. This is determined through objective bench and laboratory testing.

8. The Sample Size for the Training Set

• N/A: No training set is applicable as this is not an AI/ML device.

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

• N/A: Not applicable.

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The NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheters are designed for use in the evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicated for use in cerebral vessels.

The NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter is designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.

The NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter incorporates a cylindrical ultrasound transducer array. The array radiates acoustic energy into the surrounding tissue and detects the subsequent echoes. The information from the echoes is used to generate real-time images of the coronary and peripheral vessels.

The NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter utilizes an internal lumen that allows the catheter to track over the 0.014" (0.36 mm) guide wire exits from the guide wire lumen approximately 24 cm proximal to the catheter is introduced percutaneously or via surgical cutdown into the vascular system.

Three 1 mm-long radiopaque markers are incorporated on the internal lumen positioned 10 mm apart from distal edge to distal edge, starting 10 mm from the proximal edge of the scanner marker tube normally visible under fluoroscopy.

The Eagle Eye catheter may only be used with the Volcano s5 Series or CORE Series of Systems Operator's Manual. This catheter will not operate if connected to any other imaging system.

A hydrophilic coating is applied externally to a distal portion of the catheter.

The provided document describes the FDA 510(k) clearance for the NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter. The document details the device, its intended use, and the testing conducted to demonstrate substantial equivalence to predicate devices.

However, the information provided does not include acceptance criteria or a study directly proving the device meets specific performance metrics in terms of diagnostic accuracy or clinical effectiveness in the way a typical AI/ML medical device would. This is because the device described is an intravascular ultrasound (IVUS) catheter, which is a hardware device used to acquire images, not an algorithm that interprets images or makes diagnoses.

The "studies" mentioned are primarily bench and laboratory testing to demonstrate the functionality, safety, and effectiveness of the reprocessed catheter, ensuring it performs identically to a new, original catheter. These tests focus on aspects like cleaning, sterilization, mechanical characteristics, system compatibility, and biocompatibility, which are typical for reprocessed medical devices.

Therefore, many of the requested categories (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance of an algorithm, and training set details) are not applicable to this type of device and its regulatory submission.

Here's a breakdown based on the available information, with explanations for why certain categories are not present:

Acceptance Criteria and Device Performance (Based on available information)

Study Details and Data Provenance (Not Applicable in the typical sense for an AI/ML device)

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

   • Not applicable for diagnostic performance as an algorithm. The "test set" here refers to the actual reprocessed catheters undergoing quality control. The document does not specify exact numbers of catheters tested for each validation section, but states "bench and laboratory testing was conducted," implying a sufficient sample size for these validation types. Data provenance is internal to Northeast Scientific, Inc.'s reprocessing and testing procedures.

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

   • Not applicable. Ground truth for a diagnostic algorithm is not generally established in this context. The "ground truth" for these tests would be established by validated test methods, reference standards, and specifications (e.g., a specific tensile strength, a certain level of microbial reduction, or successful image acquisition when connected to a compatible system). These are typically verified by qualified engineers and technicians, not clinical experts for diagnostic accuracy.

3. Adjudication method for the test set:

   • Not applicable. Not a diagnostic study requiring expert adjudication. Test results are compared against predetermined specifications and validated methods.

4. 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 an IVUS catheter, not an AI or imaging interpretation algorithm. Therefore, no MRMC study, AI assistance performance, or human reader improvement metric is relevant.

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

   • Not applicable. This is a hardware device; there is no standalone algorithm performance to evaluate.

6. The type of ground truth used:

   • The "ground truth" for the reprocessed catheter's performance is its functional equivalence to the original, new device and compliance with established performance specifications. This is demonstrated through various engineering, mechanical, material, and biological tests (e.g., cleaning efficacy, tensile strength, sterility, biocompatibility standards), not clinical diagnostic ground truth like pathology or outcomes data.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML algorithm that requires a training set.

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

   • Not applicable. No training set is involved.

In summary: The submission for the NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter focuses on demonstrating that the reprocessed device is as safe and effective as the original predicate device through rigorous bench and laboratory testing. The criteria and studies are designed to prove manufacturing and functional equivalence of a reprocessed medical device, rather than the diagnostic interpretive performance of an AI/ML system.

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The NES Reprocessed 0.9mm Turbo-Elite Laser Atherectomy Catheter (0.014" guidewire compatible and over-the-wire configuration) is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions.

The 0.014" Over-the-wire (OTW) Turbo-Elite laser catheters are also indicated for use as an accessory to the use of the Turbo-Tandem System in the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nutinol stents, when used in conjunction with Percutaneous Transluminal Angioplasty (PTA).

The NES Reprocessed Spectranetics Turbo-Elite Laser Catheters are percutaneous intravascular devices constructed of multiple optical fibers arranged around a guidewire lumen. Catheter sizing identification is printed on the catheters.

For NES Reprocessed Spectranetics Turbo-Elite Laser Catheters, Over-The-Wire (OTW) catheters, a Luer adapter located at the proximal end of the usable length facilitates the use of the laser catheter over the appropriately sized guidewire.

This document describes the NES Reprocessed 0.9mm Turbo-Elite Laser Atherectomy Catheter and its substantial equivalence to a predicate device, focusing on functional and safety testing rather than an AI/ML device. Therefore, many standard questions about acceptance criteria and studies for AI/ML devices (e.g., sample sizes for test/training sets, expert consensus, MRMC studies) are not applicable in this context.

However, I can extract the acceptance criteria and the type of studies performed to demonstrate the device's safety and effectiveness.

1. Table of Acceptance Criteria (from the perspective of a reprocessed medical device) and Reported Device Performance:

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

This information is not provided in the given text. For a reprocessed medical device, the "test set" would typically refer to the number of devices subjected to each specific functional and safety test (e.g., how many catheters were used for cleaning validation, how many for tissue ablation testing, etc.) and the number of reprocessing cycles they underwent. The provenance would be the manufacturing facility of Northeast Scientific, Inc., and the studies would be prospective bench and laboratory tests.

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

This is not applicable as the document describes a physical medical device, not an AI/ML algorithm requiring expert interpretation to establish ground truth. The "ground truth" for this device is established through physical and chemical measurements, functional performance, and biological safety testing against established standards.

4. Adjudication Method for the Test Set:

This is not applicable for a physical medical device. Decisions are based on objective measurements and compliance with predetermined specifications and regulatory standards.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI algorithms where human reader performance is being evaluated with and without AI assistance. This document describes a physical laser atherectomy catheter.

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

This is not applicable. The device is a physical catheter, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for this reprocessed device is established through:

• Engineering specifications and design requirements: For dimensional checks, mechanical characteristics, and system compatibility.
• Chemical and microbiological standards: For cleaning, sterilization, and biocompatibility validations.
• Performance metrics: For hydrophilic coating efficacy, solarization, and tissue ablation effectiveness, compared against the original predicate device's performance or established clinical benchmarks.
• Regulatory standards: All testing is performed to meet FDA and international standards for medical devices.

8. The Sample Size for the Training Set:

This is not applicable as the document is for a physical medical device, not an AI/ML algorithm. There is no "training set" in the context of reprocessed medical devices; rather, there are manufacturing and process validation runs.

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

This is not applicable. As mentioned above, there is no "training set" for this type of device. The ground truth for validating the reprocessing process and the final device's performance is based on established engineering principles, scientific standards, and regulatory requirements specific to medical device manufacturing and reprocessing.

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The NES Reprocessed Visions PV .014P RX Digital IVUS Catheter is designed for use in the evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicated for use in cerebral vessels. The NES Reprocessed .014P RX Digital IVUS Catheter is designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.

The NES Reprocessed Visions PV .014P RX Digital IVUS Catheter incorporates a cylindrical ultrasound transducer array. The array radiates acoustic energy into the surrounding tissue and detects the subsequent echoes. The information from the echoes is used to generate real-time images of the coronary and peripheral vessels.

The NES Reprocessed Visions PV .014P RX Digital IVUS Catheter utilizes an internal lumen that allows the catheter to track over the 0.014" (0.36 mm) guide wire exits from the guide wire lumen approximately 24 cm proximal to the catheter tip. The catheter is introduced percutaneously or via surgical cutdown into the vascular system.

Three 1 mm-long radiopaque markers are incorporated on the internal lumen positioned 10 mm apart from distal edge to distal edge, starting 10 mm from the proximal edge of the scanner marker tube normally visible under fluoroscopy.

The VISIONS PV .014P catheter may only be used with the Volcano s5 Series or CORE Series of Systems Operator's Manual. This catheter will not operate if connected to any other imaging system.

A hydrophilic coating is applied externally to a distal portion of the catheter.

This document is a 510(k) premarket notification for a reprocessed medical device, specifically an Intravascular Ultrasound (IVUS) Catheter. The primary objective of this submission is to demonstrate substantial equivalence to a predicate device, not to prove the device meets new acceptance criteria for a novel technology through a clinical study with AI components.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device or a device with new performance claims are not applicable to this specific 510(k) submission.

This submission focuses on demonstrating that the reprocessed device maintains the same safety and effectiveness as the original, new device (predicate device). The "proof" relies on bench and laboratory testing, not on a clinical effectiveness study with human readers or AI.

Here's a breakdown of the requested information and why most of it is not explicitly addressed in this 510(k) summary:

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

   • Acceptance Criteria: Not presented in a tabular format with specific numerical thresholds for clinical performance. The acceptance criteria for this reprocessed device revolve around demonstrating that its functional and safety characteristics are equivalent to the predicate device after reprocessing. This is shown through various tests of physical and functional integrity.
   • Reported Device Performance: The document states that "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the NES Reprocessed Visions PV .014P RX Digital IVUS Catheter." A list of tests is provided (e.g., Cleaning Validation, Sterilization Validation, Visual Inspection, Dimensional Verification, Simulated Use, Mechanical Characteristics, Hydrophilic Coating, System Compatibility, Drying Validation, Packaging Validation, Biocompatibility). However, the specific numerical results of these tests and their direct comparison to pre-defined numerical acceptance criteria are not detailed in this summary. The conclusion is that the reprocessed device is "as safe and effective" as the predicate based on these tests.

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

   • Sample Size: Not explicitly stated for each test. The testing involves reprocessed units of the IVUS catheter.
   • Data Provenance: Not applicable in the context of clinical data for performance evaluation. The data comes from internal lab testing conducted by Northeast Scientific, Inc. It is not clinical patient data, therefore, retrospective/prospective or country of origin of data is not relevant here.

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

   • Not Applicable: This is not a study requiring expert readers to establish ground truth for clinical cases (e.g., image interpretation). The "ground truth" for this submission is established through validated engineering and biological testing methodologies (e.g., confirming sterility, dimensional accuracy, mechanical integrity).

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

   • Not Applicable: As above, this applies to studies with human readers interpreting data, which is not the nature of the testing described in this 510(k) summary.

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 a study assessing the effectiveness of an AI component or the improvement of human readers. This device is an IVUS catheter, an imaging tool; there is no mention of an associated AI component to assist readers.

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

   • Not Applicable: There is no algorithm or AI component discussed for standalone performance.

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

   • Ground Truth: The "ground truth" for this submission is derived from benchmarks and specifications of the original new device and validated test methods (e.g., sterility testing, dimensional measurements, mechanical force testing). The reprocessed device is tested to ensure it meets these established engineering and biological standards, demonstrating equivalence to the predicate.

8. The sample size for the training set:

   • Not Applicable: This is not a machine learning/AI device, so there is no "training set."

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

   • Not Applicable: No training set exists for this device.

In summary, for this particular 510(k) submission for a reprocessed IVUS catheter, the "acceptance criteria" and "proof" primarily revolve around demonstrating that the reprocessed device performs equivalently to the original, new device through a battery of non-clinical, benchtop, and laboratory tests. The summary provided does not contain the detailed numerical results or specific sample sizes for these tests, but merely lists the categories of testing performed to support the claim of substantial equivalence. The questions regarding AI, human readers, and clinical ground truth are not relevant to this type of device submission.

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The NES Reprocessed RF Stylet (RFS) is intended for use in vessel and tissue coagulation including:

• Treatment of incompetent (i.e. refluxing) perforator and tributaiy veins.

The NES Reprocessed RF Stylet (RFS) is a reprocessed VNUS RFS (510(k) # K052003). The device is a high frequency electrosurgical system designed for blood vessel and tissue coagulation in general surgical procedures. This device's energy source comes from a compatible and separately cleared Radiofrequency (RF) Generator. The device has been validated to be reprocessed a maximum of one time. The NES Reprocessed RF Stylet (RFS) is provided sterile (EtO) and is a single use, disposable device. The device is used in a healthcare facility. The device's function is to deliver RF energy to the desired treatment site and relay temperature and other information to the RF Generator. The device consists of one model. The device itself consists of the stylet shaft, handle and cable. A sharp is included with the device for patient insertion. The tip of the stylet serves to deliver the RF energy to the desired treatment site while the cable plugs into the RF generator (for power and relay temperature/other feedback). The tip, inner and outer lumen are the only patient-contacting parts. The patient-contacting material is as follows: AISI 304 SST and polyimide. All patient-contacting material has proven to be biocompatible. The non patient-contacting material is as follows: poly methyl methacrylate and polypropylene. The device is compatible with the separately cleared Radiofrequency (RF) Generator. The NES Reprocessed RF Stylet (RFS) is considered an external communicating device with circulating blood contact for a duration of less than 24 hours.

The provided text describes a 510(k) premarket notification for a reprocessed medical device, the NES Reprocessed RF Stylet (RFS), rather than an AI/ML powered device. As such, the information typically requested for AI/ML device studies (such as sample size for test/training sets, ground truth establishment with expert consensus, adjudication methods, or MRMC studies) is not applicable or provided in the document.

The acceptance criteria and the study proving the device meets these criteria are focused on demonstrating that the reprocessed device is substantially equivalent to its predicate device and maintains its safety and effectiveness.

Here's a breakdown of the provided information, framed within the context of a reprocessed medical device:

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

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 exact sample sizes (e.g., number of devices reprocessed and tested) for each of the performance tests. The testing appears to be conducted on reprocessed devices themselves, rather than clinical patient data. The provenance of the data is implicit in that it comes from testing conducted by Northeast Scientific, Inc. as part of their 510(k) submission. No specific country of origin for the data or whether it was retrospective or prospective is mentioned, but given it's a device reprocessing validation, it would be laboratory-based testing.

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)

For the "Design Validation" section, it is stated that the evaluation was done by "a user and expert of the device." The specific number (one or more) is not definitively stated, nor are their exact qualifications beyond "user and expert." This is not a ground truth establishment in the AI/ML sense, but rather a usability and design review.

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

No adjudication method is relevant or described, as this is laboratory testing of a reprocessed medical device's physical and functional properties, not an interpretative task requiring consensus among experts.

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 is not an AI/ML powered device, so no MRMC study was conducted or is relevant.

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

This is not an AI/ML powered device, so no standalone algorithm performance was assessed.

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

The "ground truth" for this device is its physical and functional performance, as measured against established engineering and biocompatibility standards for medical devices, as well as comparison to the original (predicate) device's specifications. For example, for biocompatibility, the "ground truth" is that the device does not cause adverse biological reactions, confirmed by passing specific biological tests. For functional performance, the "ground truth" is that the device successfully performs its intended function without errors.

8. The sample size for the training set

This is not an AI/ML powered device; therefore, there is no "training set."

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

Not applicable, as this is not an AI/ML powered device and therefore there is no training set or associated ground truth establishment in that context.

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The NES Reprocessed Varicose Vein RF Catheter is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.

NES Reprocessed Varicose Vein RF Catheters are specially designed electrosurgical catheters. RF (radiofrequency) energy is delivered to an intravascular catheter in order to heat a blood vessel to a predetermined heat and coagulate that blood vessel. NES Reprocessed Varicose Vein RF Catheters incorporate a hand piece, a flexible shaft and a distal tip section containing the RF (radiofrequency) electrode.

Here's a breakdown of the acceptance criteria and study information for the Northeast Scientific, Inc. NES Reprocessed Varicose Vein RF Catheter (K090661), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify exact sample sizes for each test (Biocompatibility, Sterilization, Function, Packaging, Animal Testing). It only broadly states that "Bench, laboratory and animal testing was conducted."
• Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given the nature of bench, lab, and animal testing for a reprocessed device, it's highly likely this was prospective testing conducted at Northeast Scientific, Inc. facilities or contracted labs.

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

This information is not provided in the given summary. The "ground truth" for this type of device (reprocessed electrosurgical catheter) is established through objective performance metrics from bench, lab, and animal testing rather than human expert interpretation of data like images.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Adjudication methods are typically used when there's subjective human interpretation involved (e.g., in diagnostic image analysis), which is not the primary method for evaluating the performance of this device.

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 information is not provided and is not applicable to this device. This device is an electrosurgical catheter, not an AI-powered diagnostic tool requiring human reader studies.

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

This information is not provided and is not applicable to this device. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for this device's performance was established through:

• Objective measurements and scientific validations:
  • Biocompatibility tests (e.g., cytotoxicity, sensitization, irritation)
  • Sterilization efficacy tests (e.g., sterility assurance level)
  • Function tests (e.g., RF energy delivery, temperature control, mechanical integrity)
  • Packaging integrity tests
  • Animal studies: Demonstrating the intended physiological effect (coagulation of blood vessels) in a living system.

8. The Sample Size for the Training Set

This information is not provided and is not applicable to this device. As a physical medical device, it does not involve machine learning or "training sets" in the conventional sense. The "training" of the device's design implicitly comes from engineering principles and prior knowledge of electrosurgical catheters.

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

This information is not provided and is not applicable to this device for the reasons stated in point 8.

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Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures.

Trocars are devices inserted into a patient in order to maintain a clear pathway to facilitate the insertion of various surgical tools. Trocars are designed in both bladed and non-bladed configurations, however this submission is for non-bladed B5LTs. Non-bladed trocars require an incision be made before insertion into the patient's cavity. Trocars have a luer stopcock port for insufflation and desufflation of the patient's cavity. NES Reprocessed Endoscopic Trocars are sent from a user facility to be cleaned, sterilized and repackaged by NES. NES Reprocessed Endoscopic Trocars have the same intended use and performance characteristics equivalent to Endoscopic Trocars provided by Original Equipment Manufacturers (OEM).

The provided text describes the regulatory submission for a reprocessed medical device, the "NES Reprocessed Endoscopic Trocar." The focus of the submission is to demonstrate that the reprocessed device is substantially equivalent to legally marketed predicate devices. This type of submission relies on demonstrating that the reprocessed device meets the same performance characteristics as the original, rather than establishing acceptance criteria for a novel algorithm or AI system.

Therefore, the information requested regarding acceptance criteria and a study proving a device meets those criteria in the context of an algorithm's performance is largely not applicable to this document. The document focuses on showing that the reprocessed physical device has equivalent performance, safety, and effectiveness to its original, non-reprocessed counterpart.

Here's an analysis of the provided text in relation to your questions, highlighting why most are not directly addressed:

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

• Not applicable in the typical sense for an algorithm. For a reprocessed physical device like a trocar, the "acceptance criteria" are generally that it functions identically and safely to the original device. This is demonstrated through various physical, chemical, and biological tests, not statistical performance metrics of an algorithm.
• The document states: "NES Reprocessed Endoscopic Trocars have the same intended use and performance characteristics equivalent to Endoscopic Trocars provided by Original Equipment Manufacturers (OEM)." and "NES Reprocessed Endoscopic Trocars operate as originally intended and are safe, effective and sterile as demonstrated by cleaning, packaging, performance, sterilization and biocompatibility testing."
• Implied Acceptance Criteria (based on the text):
  • Functionality: Operates "as originally intended" and has "performance characteristics equivalent" to OEM. This would be assessed through mechanical testing (e.g., insertion force, structural integrity, insufflation seal).
  • Safety: Demonstrated by "biocompatibility testing."
  • Effectiveness: Functions as intended for its "intended use" (establishing a port of entry). This is a broad claim supported by the functionality.
  • Sterility: Demonstrated by "sterilization testing."
  • Cleaning/Reprocessing Efficacy: Demonstrated by "cleaning, packaging" assessments.

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

• Not explicitly mentioned. The document refers to "testing" but does not provide specific sample sizes for each type of test conducted (e.g., how many reprocessed trocars were tested for strength, sterility, or biocompatibility).
• Data Provenance: Not specified. It's implied that the testing was performed by Northeast Scientific, Inc., likely in the USA given their address.

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

• Not applicable. There is no "ground truth" in the algorithmic sense. The "ground truth" for a physical device's performance is typically established by engineering specifications, material science standards, and established medical device performance criteria, often determined by industry standards and regulatory guidance for reprocessed devices. The testing is objective against these standards, not against expert human interpretations.

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

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements in expert interpretations, typically in diagnostic imaging or clinical trials involving subjective assessments. The tests for a medical device like a trocar are objective (e.g., tensile strength, leak rate, sterility tests), so adjudication by human experts 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. This device is a physical medical instrument (trocar), not an AI algorithm. Therefore, an MRMC study or AI assistance is irrelevant.

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)

• Objective testing against predetermined physical, chemical, and biological standards. For a reprocessed device, the "ground truth" for showing substantial equivalence relies on proving that the reprocessed device performs identically to the original OEM device under various conditions (e.g., mechanical strength, sterility, biocompatibility). These are derived from established engineering and biological standards, not from expert consensus or pathology on a specific case.

8. The sample size for the training set

• Not applicable. This device is a reprocessed physical instrument, not an AI algorithm that requires a training set.

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

• Not applicable. As above, no training set for an AI algorithm.

Summary regarding the provided text (K060676):

The document is a 510(k) summary for a reprocessed medical device. The "study" referenced is a series of tests to demonstrate that the reprocessed device meets the performance and safety characteristics of its original, non-reprocessed counterpart. These tests (cleaning, packaging, performance, sterilization, and biocompatibility) are designed to show substantial equivalence, not to prove the statistical performance of an AI algorithm against specific acceptance criteria in the manner you've outlined in your questions. Therefore, most of your specific questions are not directly answerable or applicable from this regulatory submission.

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