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The Excelsior XT-27 Microcatheter and Excelsior XT-27 Flex Microcatheter are intended to assist in the delivery of embolization particles, diagnostic agents (such as contrast media), and interventional devices (such as stents) that are indicated for use in the neurovasculature and with a catheter of 0.027 inches in inner diameter.

The Excelsior XT-27 Pre-Shaped Microcatheter and Excelsior XT-27 Flex Pre-Shaped Microcatheter are intended to assist in the delivery of embolization particles, diagnostic agents (such as contrast media), and interventional devices (such as stents) that are indicated for use in the neurovasculature and with a catheter of 0.027 inches in inner diameter.

The subject devices hereafter referred to as Excelsior® XT-27® Microcatheters are sterile, single lumen, 0.027 inch inner diameter (ID) microcatheters with one tip marker designed to aid the physician in accessing distal neurovasculature when used with a guide catheter and steerable guidewire. Graded shaft stiffness ranging from a highly flexible tip to a semi-rigid proximal section aids the physician in tracking over selectively placed guidewires. A luer fitting located on the microcatheter hub is used for the attachment of accessories. One radiopaque tip marker is positioned at the distal tip of the device to facilitate fluoroscopic visualization® XT-27® Microcatheters are coated on the outer surface with Hydrolene™ coating which reduces friction during manipulation in the vessel.

The Excelsior® XT-27® Microcatheters are available in effective lengths of both 135 cm (53.1 inch) and 150 cm (59.1 inch), with two distal shaft configurations achieved through distal shaft lengths of 6 cm (XT-27 model) and 18 cm (XT-27 Flex model). Both straight tip and pre-shaped versions are available.

The provided text is a 510(k) summary for a medical device (Excelsior XT-27 Microcatheters) and details its acceptance criteria and the study performed to demonstrate substantial equivalence, but it does not describe an AI/ML device. Therefore, the questions related to AI/ML specific criteria (such as sample sizes for test and training sets, number of experts for ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, and data provenance) are not applicable to this document.

However, I can provide the acceptance criteria and study information that is available for this mechanical microcatheter from the document.

1. Table of acceptance criteria and the reported device performance:

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 for Test Set: The document does not specify the exact number of samples (e.g., number of microcatheters tested) used for each bench test. It mentions testing with "ancillary devices that represent worst-case sizes" for the Guide Catheter Compatibility test and "worst-case sized ancillary devices and interventional devices" for the Tensile Strength test.
• Data Provenance: The study is described as "Bench testing," indicating it was conducted in a laboratory setting. There is no information regarding country of origin or whether it was retrospective or prospective, as these terms are typically applied to clinical studies involving human or animal subjects.

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 as this is a mechanical device performance study, not an AI/ML diagnostic or prognostic study requiring expert opinion for ground truth. The "ground truth" here is the physical performance of the device against engineering specifications.

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

• Not applicable for the same reason as point 3. Bench testing results are typically adjudicated by meeting predefined engineering specifications and criteria, not by expert consensus in the same way as diagnostic reads.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for AI-assisted diagnostic devices, which is not what this device is.

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

• Not applicable. This is a physical medical device (microcatheter), not an algorithm.

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

• The "ground truth" in this context is based on engineering specifications and performance criteria for the physical device. For example, for tensile strength, the ground truth would be a defined minimum force the joints and marker band must withstand without failure. For compatibility, it would be the ability to successfully deliver and retrieve the microcatheter within the specified guide catheter with acceptable force.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device, so there is no training set.

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

• Not applicable for the same reason as point 8.

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Interferential Stimulation

• Symptomatic relief of chronic intractable pain

• Adjunctive treatment for the management of post-traumatic or post-surgical pain

EMS (Electrical Muscle Stimulation)

• Relaxation of muscle spasm

• Increasing local blood circulation

• Muscle re-education

• Prevention or retardation of disuse atrophy

• Prevention of venous thrombosis of the calf muscles immediately after surgery

• Maintaining or increase range of motion

The Flex-MI is a combination EMS and interferential stimulation device which delivers nerve or muscle stimulation by applying an electrical current to electrodes, which are attached on the patient's skin. The output and waveform is adjustable according to the intended treatment of patient. The stimulator has 2 output channels, accessed through jacks at the top of the housing, so that it may stimulate either 2 or 4 patient electrodes. The device is powered by 4.8V Ni- MH rechargeable battery pack. A patient compliance timer can memorize 60 sets of operation records; the total recordable time is 999 hours. Flex-MI is compatible and recommended for use with Everlife self-adhesive electrodes (K012463).

The provided document is a 510(k) premarket notification for the Flex-MI device, which is a combination EMS and interferential stimulator. It focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance criteria through a standalone study with acceptance criteria.

Therefore, the document does not contain the acceptance criteria and the study details as requested in the prompt. This type of FDA submission (510(k)) primarily aims to show that a new device is as safe and effective as a legally marketed predicate device, often by comparing technical characteristics and indications for use, rather than presenting a full efficacy or performance study against pre-defined acceptance criteria for a novel AI device.

Without specific acceptance criteria and a detailed study report, it's not possible to populate the requested tables and information. The document explicitly states: "Clinical Data: Clinical data is not required to support the substantial equivalence to the predicate devices." This further confirms that a study to prove performance against acceptance criteria was not part of this submission.

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The MAMBA and MAMBA Flex Microcatheters are intended to provide support to facilitate the placement of guidewires in the coronary vasculature, and can be used to exchange one guidewire for another. The microcatheters are also intended to assist in the delivery of contrast media into the coronary vasculature.

The MAMBA™ and MAMBA™ Flex devices (referred to as the "MAMBA Microcatheters") are designed to provide a platform for the user to exchange quidewires without losing their position in the vasculature.

The MAMBA device is available in a 135cm length, while MAMBA Flex is available in 135cm and 150cm lengths.

The MAMBA Flex models have a smaller outer diameter and a more flexible distal portion than the MAMBA device.

Marks on the proximal portion of the catheter shaft and a radiopaque marker at the distal tip facilitate placement of the device.

The device's inner lumen permits the use of 0.014 in./0.36 mm or smaller quidewires. The shaft consists of a coil which allows the device to be torqued to assist in advancement. The distal portion of the shaft is coated hydrophilic coating to assist in advancement.

The proximal end has a single luer hub for flushing or injecting through the inner lumen and is for guide wire lumen access during a guidewire exchange.

The MAMBA Microcatheters are to be used in patients where vessel conditions require additional wire support to reach the lesion and will deliver radiopaque media and therapeutic agents to selected sites in coronary vasculature.

The provided text is a 510(k) Premarket Notification from the FDA regarding the Boston Scientific MAMBA and MAMBA Flex Microcatheters. This document specifically focuses on the substantial equivalence of these microcatheters to a legally marketed predicate device (MAMBA Microcatheters, K171452).

The information provided does not describe a study proving the device meets acceptance criteria in the context of an AI/ML medical device, particularly one involving ground truth derived from expert consensus, pathology, or outcomes data. It also does not involve human readers, multi-reader multi-case (MRMC) studies, or standalone algorithm performance. This document is for a physical medical device (microcatheter), not a software or AI-driven diagnostic tool.

Therefore, many of the requested categories are not applicable to the content provided. I will fill in the relevant information based on the document's content, and specify "Not Applicable" or explain why the information isn't present for the other categories.

Acceptance Criteria and Device Performance for MAMBA and MAMBA Flex Microcatheters

The FDA 510(k) summary for the Boston Scientific MAMBA and MAMBA Flex Microcatheters describes non-clinical performance data to establish substantial equivalence to a predicate device. The "acceptance criteria" here refer to the performance benchmarks that the new device had to meet during bench testing to demonstrate that it is as safe and effective as the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use" and "No new safety or performance issues were raised during the testing." While specific numerical performance values are not provided in this summary, the implication is that the new device met the pre-defined acceptance thresholds for each test.

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

• Sample Size: The document does not specify the exact number of units or tests performed for each bench test. It generically states "Bench testing was performed."
• Data Provenance: The data is from non-clinical bench testing conducted by Boston Scientific Corporation. The country of origin for the testing is not specified, but the company is U.S.-based. This is retrospective data in the sense that it was conducted prior to the 510(k) submission.

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

• Not Applicable. This is a physical medical device. The "ground truth" and "performance" are established through engineering specifications, material science, and mechanical bench testing, not through expert human review of diagnostic images or clinical outcomes in the same way an AI/ML device would be evaluated. The "experts" involved would be engineers, QA personnel, and potentially biomaterials scientists.

4. Adjudication Method for the Test Set

• Not Applicable. As described above, this is about physical device performance rather than interpretation or classification that would require adjudication among multiple human reviewers. Test results are likely objectively measured (e.g., burst pressure, force to kink).

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

• No. This type of study (MRMC) is relevant for diagnostic imaging AI/ML devices where the AI assists human readers. This document describes a physical medical device.

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

• Not Applicable. This is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is established by engineering specifications, material properties, and pre-defined performance thresholds for physical and mechanical characteristics (e.g., dimensional accuracy, burst strength, flexibility, torqueability, guidewire exchange efficiency). It is based on objective, quantifiable measures of the device's physical attributes and functional capabilities as designed and manufactured.

8. The Sample Size for the Training Set

• Not Applicable. This document describes a physical medical device, not an AI/ML algorithm that requires a training set. The "training" for such a device largely refers to its design, material selection, and manufacturing processes, which are informed by engineering principles and previous device experience.

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

• Not Applicable. As per point 8, there is no "training set" in the context of an AI/ML algorithm for this physical device. The design and development of the microcatheters are based on established engineering principles, industry standards for medical devices, and performance requirements derived from extensive experience with similar predicate devices. The "ground truth" in this context would be the successful performance of existing, legally marketed devices that serve as benchmarks.

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The NEUWAVE™ Flex Microwave Ablation System and Accessories are indicated for the ablation (coagulation) of soft tissue.

The NEUWAVE™ Flex Microwave Ablation System is not indicated for use in cardiac procedures.

The system is designed for facility use and should only be used under the orders of a physician.

The design of the NEUWAVE Flex Microwave Ablation System (FLEX) is an evolution of the design of the legally marketed Certus 140 2.45GHz Ablation System (K160936). The FLEX is a fully featured soft tissue ablation system that uses small diameter flexible ablation probes, a single microwave source operating at 2.45 GHz, a CO2-based cooling system, a Power Distribution Module (PDM), and a support arm designed to hold the PDM in a user-selected position. Microwave energy is applied to the target tissue via a single flexible ablation probe, heating the tissue to the point of necrosis.

The FLEX is designed to be used in Target Ablation involves placing a probe into a substantial target and then ablating for up to several minutes until the target tissue is necrotic. The FLEX is designed for ablations in soft tissue in percutaneous (via an introducer) procedures, open surgical procedures, and procedures in which the target tissue is accessed via a lumen or scope such as an endoscope or laparoscopic port.

Two microwave ablation probes are available for use with the NEUWAVE Flex Microwave Ablation System: the FLEX4 and the FLEX6. They are comprised of a conical tip on the end of a flexible cable and a connector assembly. The probe with the sharper tip (FLEX6) is designed for easier tissue penetration while the probe with the less sharp (FLEX4) tip designed for improved navigation. Both FLEX probe models are French gauge 6 (outer diameter of less than 2 mm) and 150 cm long. Both probe models have the same antenna design and ablation performance characteristics.

Each probe contains three (3) temperature measurement sensors that help monitor performance and ensure patient and operator safety.

The FLEX probe antenna was designed to produce an ablation zone substantially equivalent to the predicate Certus® probe but within a flexible probe shaft. Like the predicate Certus® probe, the FLEX probes are designed to produce ablations that encompass the tip of the probe while limiting the overall length of the ablation. Testing in ex-vivo liver, lung and kidney tissue confirm that the FLEX probes produce ablations that are substantially equivalent to the predicate probes.

A PDM and Accessories Support Arm (The Arm) holds the PDM in a user-selected position. The Arm attaches to an imaging/procedure table via a rail mount. This allows the PDM and probe to move with the patient, greatly reducing the potential for patient injury due to accidental probe movement.

The Arm is comprised of three jointed lengths with two tension knobs that allow the user to maneuver and fix the Arm at the user-selected position. The PDM mount on the ARM has a dovetail design with magnetic retention for quick and easy mounting. Additionally, the Arm has a grasping mechanism that can be used to hold a scope such as an endoscope (if used) in a fixed position for an extended period of time.

A CO2 based cooling system ensures the non-active portion of the probe does not exceed temperature requirements.

The system uses two (2) customer supplied E-sized CO2 cylinders. The system monitors the pressure of the tanks and heats the tanks to maintain the desired tank pressure. The FLEX System will select which cylinder to initially use based upon tank pressures.

The provided document is a 510(k) summary for the NEUWAVE Flex Microwave Ablation System and Accessories. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of an AI or algorithmic device. Therefore, many of the requested criteria (e.g., sample size for test set, number of experts for ground truth, MRMC study, sample size for training set, ground truth for training set) are not applicable or cannot be extracted directly from this document.

However, the document does contain information about performance data and acceptance criteria related to its electrosurgical function.

Here's an attempt to answer the questions based on the available information:

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

The document mentions that "The system passed all pre-determined acceptance criteria identified in the test plan." and "Ex-vivo ablation sizes for the FLEX system were deemed to be substantially equivalent to the predicate devices."
While specific numerical acceptance criteria for ablation size are not explicitly stated in a table, the performance is reported in relation to the predicate device.

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

• Sample Size: The document mentions "Testing in ex-vivo liver, lung and kidney tissue" but does not specify the number of samples (e.g., how many livers, lungs, or kidneys were tested, or how many ablation procedures were performed on them).
• Data Provenance: The data is "ex-vivo" (meaning outside a living organism, likely in a lab setting) and was conducted for comparison to predicate devices and for data to be included in the Instructions for Use. The country of origin is not specified but the company is US-based (Madison, Wisconsin). The testing described is prospective in the sense that it was specifically conducted for this submission.

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 a medical device for tissue ablation, not an AI/algorithmic device for diagnosis or image interpretation. The "ground truth" here relates to physical parameters and performance (e.g., ablation size, temperature, power output) which are measured directly, not established by expert consensus.

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

Not applicable. This is not an AI/algorithmic device involving subjective interpretation or expert consensus. Performance is measured against engineering specifications and comparison to a predicate device.

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

Not applicable. This is a medical device for tissue ablation, not an AI/algorithmic device requiring human reader studies.

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. Its "standalone" performance would be its ability to ablate tissue according to specifications, which was tested ex-vivo.

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

The "ground truth" for this device's performance would be:

• Direct physical measurements (e.g., ablation zone dimensions, temperature readings, power output).
• Compliance with pre-determined engineering and safety specifications.
• Substantial equivalence to the performance characteristics of the legally marketed predicate device.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. This is not an AI/machine learning device that requires a training set.

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Stryker Neurovascular's Excelsior XT -17 Microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary and neuro vasculature.

Stryker Neurovascular Excelsior® XT-17™ Microcatheters are single lumen devices designed to aid the physician in accessing distal vasculature when used with a guide catheter and steerable guidewire. Graded shaft stiffness ranging from a highly flexible tip to a semi-rigid proximal section aids the physician in tracking over selectively placed guidewires. A luer fitting located on the microcatheter hub is used for the attachment of accessories. A radiopaque tip facilitates fluoroscopic visualization. Stryker Neurovascular hydrophilically coated Excelsior XT-17 Microcatheters are coated on the outer surface with Hydrolene® Coating that reduces friction during manipulation in the vessel. The Excelsior XT-17 Microcatheter is a single use device made of polymers, stainless steel, and Hydrolene® Coating, sterilized with Ethylene Oxide (EO) gas. Patient contact duration is less than 24 hours, and patient contact materials are polymers and Hydrolene® Coating. The Excelsior XT-17 Microcatheter is used in health care facility/hospital by physicians trained in performing endovascular procedures.

This document is a 510(k) summary for the Stryker Neurovascular Excelsior XT-17 Microcatheter, indicating its substantial equivalence to a predicate device. It is not a study that proves a device meets specific acceptance criteria in the way a clinical trial or a deep learning algorithm validation study would. Instead, it describes a product and compares it to a previously cleared product to show substantial equivalence.

Therefore, many of the requested categories (like sample size for test set, data provenance, ground truth establishment for training, MRMC studies, and standalone algorithm performance) are not applicable or cannot be extracted from this type of regulatory document.

However, I can extract information related to the performance data presented, which essentially serves as the "study" demonstrating the device meets the acceptance criteria of being substantially equivalent to the predicate device.

Here's a breakdown of the information that can be extracted from the provided text:

Acceptance Criteria and Device Performance:

The "acceptance criteria" here is that the modified device, the Excelsior XT-17 Microcatheter, has a safety and effectiveness profile similar to the predicate device (Tracker-17 Microcatheter) and raises no new questions of safety or effectiveness. The device performance is demonstrated through various verification tests.

• Tip Shape Retention
• Tip steam shape shrinkage
• Flexibility of the Distal Shaft
• Softness of the Distal Tip
• Tip shape retention (only applicable to Preshaped catheters)
• Surface defects along effective length
• Surface extraneous matter along effective length
• Static Rupture / Leakage under High Static Pressure
• Dynamic Burst
• Tensile Strength
• Catheter Hub
• Compatibility with DMSO
• Compatibility with Peel-away introducer sheath
• Proximal Fluoro-saver marker visibility |
  | Biological Safety | Biocompatibility testing performed according to EN ISO10993-1:2009 + AC: 2010, comprising:
• Cytotoxicity
• Hemolysis
• Physiochemical Test
• FTIR
• Latex |
  | Shelf Life and Packaging Integrity | Shelf life testing (Product and Packaging) conducted.
  Distribution/shipping Challenge Conditioning and Testing performed.
  Packaging Verification Testing performed. |
  | Risk Assessment | Risk assessment conducted in accordance with EN ISO 14971:2012 (Design and Use FMEAs). Conclusion: Modifications "raise no new questions of safety or effectiveness." |
  | Technological Characteristics | Product feature comparison table shows most characteristics are "Same as predicate" or variations that do not alter safety/effectiveness (e.g., smaller hub, smaller distal OD, material without colorant). |

Here's how the other requested points align with the provided document:

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

   • Sample Size: Not specified in this document. The "test set" here refers to the samples of the device undergoing verification testing. The exact number of microcatheters tested for each functional, biocompatibility, and shelf-life test is not detailed.
   • Data Provenance: Not specified. This is an internal regulatory submission by Stryker Neurovascular (Fremont, CA, USA). The testing would typically be performed internally or by contracted labs.

2. 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 as this is a medical device performance and safety verification, not an AI or diagnostic imaging study requiring expert ground truth consensus. The "ground truth" is established by adherence to established engineering, biocompatibility, and regulatory standards.

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

   • Not applicable. Adjudication methods are typically for clinical outcome or diagnostic performance studies, not for physical device testing.

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:

   • No, an MRMC study was not done. This is a microcatheter, not a diagnostic or AI-assisted device.

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

   • No, this is a physical medical device, not an algorithm.

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

   • The "ground truth" for this type of submission is adherence to established, recognized standards for medical device design, manufacturing, and performance (e.g., ISO standards for biocompatibility, material properties, and functional performance) and comparison to the predicate device's established safety and effectiveness.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that requires a training set.

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

   • Not applicable. This is not an AI/machine learning device.

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