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The PhasTIPP System is indicated for use in ambulatory phlebectomy procedures for the resection and ablation of varicose veins. The Illuminator is also indicated for use without the Resector for visualization of varicose veins and infusion of tumescent solution during an ambulatory phlebectomy procedure.

The PhasTIPP System consists of an Illuminator and a Resector. During the surgical procedure, the illuminator shaft is placed through an incision under the skin with its light-emitting end to provide intense light for a better visualization of the varicose veins. A port that runs along the illuminator shaft is used to infuse tumescence solution to cause the contraction of varicosities, which aids vein visualization by creating a subcutaneous fluid pocket through which the illuminator's light can disperse. A powered resector, positioned through a different incision can then be used to morcellate and aspirate the varicosities.

The PhasTIPP Illuminator consists of two devices: a reusable Illuminator Handpiece and a disposable Illuminator.

The Handpiece provides illumination controls and contains an LED to provide intense light. The Handpiece is powered with new batteries for each new surgical procedure (Duracell CR 123a cell). The handpiece is provided non-sterile and must be covered with the microbial barrier sheath attached to the Disposable Illuminator in the sterile field before the procedure begins.

The Disposable Illuminator includes, in addition to the microbial barrier sheath, a distal stainless steel fiber optic light shaft. When connected to a peristaltic pump, the Disposable Illuminator can also infuse tumescence.

The PhasTIPP Resector consists of two devices: a reusable Resector Handpiece and a Resector Disposable (available in two diameters, 4.5mm and 5.5mm). The Disposable Resector also connects to a peristaltic suction pump to remove the resected varicosities.

The Resector Handpiece provides controls for the operation of the rotation blades on the Disposable Resector and is powered with a set of new batteries (TLM-1550 HPM cell), for each surgical procedure. The Resector Handpiece is provided non-sterile and must be covered with the microbial barrier sheath attached to the Disposable Resector in the sterile field.

The Control Unit that was a large equipment in the predicate device is displaced in the subject device. Instead, the Resector Handpiece and the Illuminator Handpiece control the disposable resector and illuminator in the subject device.

This document describes the PhasTIPP System, an external vein stripper. The FDA's 510(k) summary provides details about the device, its intended use, and the testing conducted to establish its substantial equivalence to a predicate device.

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

The provided document doesn't explicitly state "acceptance criteria" in a tabulated format alongside "reported device performance" in the way one might expect for a clinical study with primary endpoints. Instead, it lists various design validation, system validation, and performance tests that were completed to demonstrate the device meets product performance specifications and for substantial equivalence.

For the purpose of this request, I will infer the "acceptance criteria" from the types of tests performed and the "reported device performance" as the overall statement that the device meets these specifications.

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

The document does not provide specific sample sizes for the individual engineering and performance tests listed. The data provenance is not specified beyond being "product testing" and "verification activities." These are typically conducted in-house by the manufacturer.

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 type of information is not applicable to the tests described in this 510(k) summary. The listed tests are primarily engineering and performance validations, not clinical studies requiring expert interpretation of medical images or patient outcomes.

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

Adjudication methods are typically relevant for clinical studies involving human interpretation or subjective assessments. This 510(k) submission focuses on device engineering and performance validation, so "adjudication method" is not applicable here.

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 such MRMC study was mentioned. The device described is an external vein stripper, not an AI-powered diagnostic or assistive tool for human readers.

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

This question is not applicable as the PhasTIPP System is a physical medical device (an external vein stripper) used in surgery, not a standalone algorithm.

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

For the engineering and performance tests described, the "ground truth" or reference standard would be the established engineering specifications, industry standards (e.g., IEC 60601, ISO 10993-1, EN ISO 11135-1), and the performance of the predicate device. These are objective measures or recognized benchmarks. For example:

• Mechanical properties (tensile strength, torque strength): Established material specifications and engineering design tolerances.
• Flow rate, light output: Measured against design specifications.
• Sterilization: Validated against sterility assurance levels defined by standards.
• Biocompatibility: Assessed against cytotoxicity, sensitization, irritation tests as per ISO 10993.

8. The sample size for the training set

The concept of a "training set" is generally applicable to machine learning or AI models. This 510(k) summary does not concern an AI/ML device, so a training set as such is not relevant. The device undergoes design verification and validation testing.

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

As there is no "training set" in the context of this device, this question is not applicable.

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The DuraSure Biologic Patch is intended for use as a surgical patch material to close dura mater during neurosurgery.

The DuraSure consists of one piece of bovine pericardial tissue that has been selected for minimal tissue blemishes. The tissue is treated with a glutaraldehyde process which crosslinks the collagen fibers and minimizes antigenicity. The DuraSure is liquid chemical sterilized and packaged in a plastic jar containing sterile glutaraldehyde storage solution. The DuraSure is designed to repair the body's natural organs.

Here's a breakdown of the acceptance criteria and the study details for the DuraSure Biologic Patch, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document focuses on "pre-clinical" testing, which includes both in-vitro (bench) testing and an in-vivo animal study.

• Bench Testing (Tensile, Elongation, Burst Strength, Suture Retention, Thickness):

  • Sample Size: Not explicitly stated for each test (e.g., "All DuraSure patches passed the acceptance criteria"). However, results are given as "mean" values, implying multiple samples were tested for each characteristic.
  • Data Provenance: Not specified, but generally refers to laboratory testing conducted by the manufacturer or contracted labs. The country of origin is not mentioned. This is retrospective data collected for the 510(k) submission.

• In-vivo Animal Study:

  • Sample Size: Forty-nine (49) rabbits.
  • Data Provenance: Not explicitly stated, but implies a controlled laboratory setting for animal research. This is prospective data collected during the study.

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

• Bench Testing: No experts are typically used to establish ground truth for this type of quantitative functional testing. The "ground truth" is defined by the physical measurement methods and the device specifications.
• In-vivo Animal Study:
  • Number of Experts: At least one. The document states, "All slides were evaluated by a veterinary pathologist for neuropathological changes in brain tissue, dural integrity, neoduralization and local tissue reaction according to ISO 10993-6 and FDA Guidance."
  • Qualifications: "veterinary pathologist." No further details on years of experience or specific sub-specialties are provided.

4. Adjudication Method for the Test Set

• Bench Testing: Not applicable. These are objective measurements following established test methods.
• In-vivo Animal Study: Not explicitly described. It states "All slides were evaluated by a veterinary pathologist." This implies a single expert assessment. If multiple pathologists were involved, no method for resolving disagreements (e.g., 2+1, 3+1) is mentioned.

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

No, an MRMC comparative effectiveness study was not done. The studies presented are pre-clinical (bench and animal studies) and do not involve human readers evaluating cases.

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

No, this question is not applicable. The DuraSure Biologic Patch is a physical medical device (surgical patch material), not an AI algorithm or software device. Therefore, a standalone performance evaluation of an algorithm is not relevant.

7. The Type of Ground Truth Used

• Bench Testing: The ground truth is based on objective quantitative measurements obtained using standardized test methods (e.g., Instron for tensile/elongation/suture retention, pressure sensors for burst strength, thickness gauges).
• In-vivo Animal Study: The ground truth for the animal study was established through histopathological evaluation by a veterinary pathologist, based on internationally recognized standards (ISO 10993-6) and FDA guidance for dural substitute devices. This includes macroscopic and microscopic evaluations, with scoring.

8. The Sample Size for the Training Set

This question is not applicable. The DuraSure Biologic Patch is a physical medical device, not a machine learning model. Therefore, there is no "training set" in the context of AI.

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

This question is not applicable, as there is no training set for a physical medical device.

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The UnBalloon Non-Occlusive Modeling Catheter is intended to assist in the modeling of selfexpanding endoprostheses in large diameter vessels.

The UnBalloon Non-Occlusive Catheter is a silicone surface coated (medical grade) modeling catheter with an expandable Nitinol mesh in a 14F retractable sheath. The Nitinol mesh design allows for expansion without occluding blood flow. The Nitinol mesh and radiopaque markers are highly visible under fluoroscopy and assist in the positioning of the device. The inner lumen allows for a 0.035 or 0.038 inch guidewire for over-the-wire access. Side ports and clear handle/luer allow the device and guidewire lumen to be flushed. The blue handle allows the device to be sheathed/unsheathed while the clear handle/luer controls the expansion of the Nitinol mesh.

The provided text describes a 510(k) summary for the UnBalloon Non-Occlusive Modeling Catheter, focusing on its substantial equivalence to a predicate device and product testing. It does not present a study proving the device meets specific performance acceptance criteria in terms of clinical or algorithmic performance. The document is a regulatory submission for premarket notification, demonstrating that the device is as safe and effective as a legally marketed predicate device.

Therefore, many of the requested information points, particularly those related to a study proving device performance against acceptance criteria, cannot be extracted from this document, as such a study is not detailed.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

The document mentions "product performance requirements of the device specifications" and lists various tests, but it does not explicitly define specific numerical or qualitative acceptance criteria for each test (e.g., a specific tensile strength value, or a specific duration for fatigue testing without failure). It only states that the device "meets the product performance requirements."

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

Not provided. The document refers to "product characterization and validation" and "verification activities" but does not detail sample sizes, data provenance, or whether the testing was retrospective or prospective.

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/Not provided. This type of information is typically relevant for studies involving human interpretation or clinical outcomes, often in the context of AI/ML device evaluations. The reported testing is primarily in-vitro/bench testing for a physical catheter, not an AI diagnostic device.

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

Not applicable/Not provided. As noted above, this is not relevant for the type of product testing described.

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

Not applicable. This device is a physical catheter, not an AI-assisted diagnostic or treatment system. Therefore, an MRMC study is not relevant.

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

Not applicable. This device is a physical catheter.

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

The "ground truth" for the engineering performance tests (like fatigue, tensile strength, etc.) would be established by engineering specifications, industry standards, and validated testing methodologies against which the device's performance is measured. The document implies compliance with these without detailing them. For biocompatibility, it refers to "ISO 10993 guidelines."

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable. See point 8.

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The UnBalloon Non-Occlusive Modeling Catheter is intended to assist in the modeling of self-expanding endoprostheses in large diameter vessels.

The UnBalloon Non-Occlusive Modeling Catheter consists of an expandable Nitinol mesh in a 14F retractable sheath. The Nitinol mesh design allows for expansion without occluding blood flow. The Nitinol mesh and radiopaque markers are highly visible under fluoroscopy and assist in the positioning of the device. The inner lumen allows for a 0.035 or 0.038 inch guidewire for over-the-wire access. Side ports and clear handle/luer allow the device and guidewire lumen to be flushed. The blue handle allows the device to be sheathed/unsheathed while the clear handle/luer controls the expansion of the Nitinol mesh.

The provided text describes a medical device, the "UnBalloon Non-Occlusive Modeling Catheter," and its premarket notification (510(k) summary). It focuses on demonstrating the device's substantial equivalence to predicate devices rather than providing a detailed study that proves the device meets specific acceptance criteria for performance as an AI/ML product.

Therefore, many of the requested elements are not applicable or cannot be extracted from this document, as they pertain to performance testing of AI/ML devices.

However, I can extract information related to the device's functional performance and safety as described in the "Summary of Product Testing" and "Summary of OUS Post Market Surveillance" sections.

Here's the breakdown of what can be populated based on the provided text:

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

The document does not explicitly state "acceptance criteria" with numerical targets in the same way an AI/ML device would have for metrics like sensitivity, specificity, etc. Instead, it lists various assessments performed and their outcomes, indicating successful performance or minimal issues.

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: 13 cases (OUS Post Market Surveillance).
• Data Provenance: Retrospective collection of data from 13 cases attended by LeMaitre Vascular in Brazil and the European Union. Dates: June 14, 2011 to August 16, 2011.

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. The "Summary of OUS Post Market Surveillance" describes direct observation and recording of outcomes by LeMaitre Vascular staff during cases rather than a formal expert-adjudicated ground truth process. The clinicians performing the procedures are the "evaluative experts" in a practical sense, but their specific qualifications are not detailed.

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

Not applicable. This type of adjudication method is used for establishing ground truth in diagnostic studies, which is not the nature of this device's evaluation. The data seems to be collected directly from the surgical cases by LeMaitre Vascular personnel.

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

Not applicable. This is not an AI/ML device, and no MRMC study was conducted. The evaluation is a direct assessment of the device's performance in clinical use, and a comparison to human readers with/without AI assistance is irrelevant.

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

Not applicable. This is not an AI/ML device.

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

For the "OUS Post Market Surveillance," the "ground truth" is operational and clinical outcomes observed directly during surgical procedures, reported by LeMaitre Vascular personnel attending the cases. This includes observations on technical success, device performance (e.g., resheathing, non-occlusion), and adverse events, as well as subjective assessments like "radiopacity" and "appropriate modeling force."

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set in the context of machine learning.

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

Not applicable. This is not an AI/ML device.

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