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PCI Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous coronary intervention (PCI) and percutaneous transluminal angioplasty (PTA).

The PCI Guide Wires are not intended for use in the neurovasculature.

The basic structure of the MINAMO blue / viola consists of a hybrid stainless steel and nitinol (Ni-Ti) core wire, with a stainless steel distal inner rope coil. Surrounding the inner rope coil and the distal core wire is a radiopaque platinum nickel / stainless steel outer coil. The outer and inner coils are soldered to the tapered core wire. A similar coil design is used with other ASAHI guide wires, such as the predicate MINAMO (K190176). In addition, coatings are applied on the surface of the product. The coil portion is coated with a silicone and hydrophilic coating. The proximal side of the core wire is coated with PFA, silicone and PTFE.

The nominal outer diameter of the MINAMO is 0.36 mm. The devices are available in three lengths: 190 cm, 235 cm and 300 cm.

The MINAMO blue / viola radiopaque distal tip enables the user to view the position of the tip under X-ray fluoroscopy.

All sizes are available with a straight, pre-shape, and J-shape design.

The provided text focuses on the 510(k) premarket notification for the MINAMO blue and MINAMO viola guide wires. It describes the device, compares it to predicate and reference devices, and outlines the non-clinical and biocompatibility testing performed to demonstrate substantial equivalence.

However, the text does not contain the specific information requested regarding acceptance criteria and a study proving the device meets these criteria in the context of an AI/ML-enabled medical device.

The document states that the MINAMO blue and MINAMO viola are catheter guide wires, which are physical medical devices, not AI/ML-enabled software devices. Therefore, the questions related to:

• AI/ML performance metrics (e.g., Sensitivity, Specificity, AUC)
• Sample sizes for test sets in an AI/ML context
• Number of experts for ground truth establishment
• Adjudication methods
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies
• Standalone AI performance
• Training set sample sizes and ground truth establishment for training data

are not applicable to the submitted document as it describes a traditional medical device (guide wire) and not an AI/ML product.

The document focuses on demonstrating the substantial equivalence of the guide wires to previously cleared predicate devices through:

• Indications for Use: Same as the predicate.
• Technological Characteristics: Similar materials, design, operating principle, and sterilization.
• Non-Clinical Testing/Performance Data: Bench tests following FDA guidance, demonstrating performance similar to predicate devices and meeting acceptance criteria for physical and mechanical properties (e.g., tensile strength, torque strength, tip flexibility, coating integrity, lubricity, corrosion resistance, kink resistance, radiopacity, dimensional verification, simulated use).
• Biocompatibility: In accordance with ISO 10993.

Based on the provided text, here's what can be extracted and what cannot:

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

The document states: "The in vitro bench tests demonstrated that the MINAMO blue and MINAMO viola met all acceptance criteria and performed similarly to the predicate devices."
However, the specific numerical acceptance criteria and the quantified reported device performance values are NOT provided in the document. It only lists the types of tests performed.

Types of Performance Tests (Implied Acceptance Criteria for these properties):

• Tensile Strength
• Torque Strength
• Torqueability
• Tip Flexibility
• Coating Integrity
• Lubricity
• Visual Inspection
• Corrosion Resistance
• Kink Resistance
• Radiopacity
• Dimensional Verification
• Simulated use in a clinically relevant mode
• Coating Integrity/Particulate Evaluation in a clinically relevant mode

Biocompatibility Tests (Implied Acceptance Criteria: Non-cytotoxic, Non-sensitizer, Non-irritant, Non-toxic, Non-pyrogenic, Non-hemolytic, Not an activator, Thromboresistant):

For all other points (2-9), the information is NOT applicable to this document as it does not describe an AI/ML-enabled device or an AI/ML study.

2. Sample sized used for the test set and the data provenance: Not applicable (not an AI/ML study). The document refers to "bench testing" and "in vitro" tests, implying physical samples of the guide wire.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable (not an AI/ML study requiring expert review of data).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable (not an AI/ML study).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For the physical device, the "ground truth" would be established by standardized testing protocols and measurements of physical properties. For biocompatibility, it's based on ISO 10993 standards and the biological responses observed in the tests (e.g., no cellular reactivity, no delayed dermal contact sensitization).
8. The sample size for the training set: Not applicable (no AI model).
9. How the ground truth for the training set was established: Not applicable (no AI model).

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VIOLA clampless proximal anastomosis sealing system is indicated for use by cardiac surgeons during coronary artery bypass grafting procedures to maintain hemostasis and facilitate the completion of proximal anastomoses to the aorta without application of an aortic clamp.

The VIOLA is a sterile, single-use device designed to maintain hemostasis and facilitate the completion of multiple proximal anastomoses during a coronary artery bypass grafting procedure, without application of an aortic clamp. The VIOLA system can be used to create up to 4 anastomoses within the same patient.

This modified version of VIOLA includes an ergonomic handle with operating button and a straight distal end.

The VIOLA is comprised of:

1. A concentric 4 mm aortic punch with a detachable handle.
2. A sealing assembly comprising of a sealing element (which is available in two diameters), a catheter, fixation strap and a handle.
3. A silicone boundary marker stencil for marking the maximal suture line around the aortic incision.

The steps to create a sealed anastomosis hole that enables the surgeon to perform a clampless anastomosis include (1) the creation of a small "needle hole" (performed in the center of the boundary marker), (2) insertion and deployment of the sealing element, (3) creation of an anastomosis hole using the VIOLA's punch, and (4) performing the anastomosis.

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) summary for a medical device called "VIOLA" and it focuses on demonstrating substantial equivalence to a predicate device. It briefly mentions performance data in the form of "risk analysis," "bond strength testing," and "simulated use testing" that "passed successfully all acceptance criteria," but it does not provide:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or their data provenance.
• Details about experts for ground truth or adjudication methods.
• Information on multi-reader multi-case studies or effect sizes.
• Details on standalone algorithm performance.
• The type of ground truth used.
• Sample size for the training set or its ground truth establishment.

The document primarily states that the modified device's technological characteristics are similar to the predicate and that performance data demonstrates it is as safe and effective.

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VIOLA clampless proximal anastomosis sealing system is indicated for use by cardiac surgeons during coronary artery bypass grafting procedures to maintain hemostasis and facilitate the completion of proximal anastomoses to the aorta without application of an aortic clamp.

The VIOLA is a sterile, single-use device designed to maintain hemostasis and facilitate the completion of multiple proximal anastomoses during a coronary artery bypass grafting procedure, without application of an aortic clamp. The VIOLA system can be used to create up to 4 anastomoses within the same patient.

The VIOLA is comprised of:

• 1. A concentric 4 mm aortic punch with a detachable handle.
• 2. A sealing assembly comprising of a sealing element (which is available in two diameters), a catheter, fixation strap and a handle.
• 3. A silicone boundary marker stencil for marking the maximal suture line around the aortic incision.

The steps to create a sealed anastomosis hole that enables the surgeon to perform a clampless anastomosis include (1) the creation of a small "needle hole" (performed in the center of the boundary marker), (2) insertion and deployment of the sealing element, (3) creation of an anastomosis hole using the VIOLA's punch, and (4) performing the anastomosis.

The provided text is a 510(k) summary for the Vascular Graft Solutions, Ltd.'s VIOLA device. It describes the device, its intended use, and substantial equivalence to a predicate device, but it does not contain information about acceptance criteria or a study proving that the device meets specific acceptance criteria in the way typically expected for a detailed performance study with quantifiable metrics and a test set.

The "Performance Data" section lists several types of validation and testing conducted, but these are general categories of testing (e.g., sterilization validation, biocompatibility, design verification, animal testing) rather than a study designed to evaluate performance against specific, pre-defined acceptance criteria for the device's clinical function in humans.

Therefore, many of the requested fields cannot be filled based on the provided document.

Here's a breakdown of what can and cannot be extracted:

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

This information is not present in the document. The document lists types of performance data (e.g., "Bond Strength Testing," "Sealing Element Crush Resistance Testing"), but it does not provide specific acceptance criterion values (e.g., "Bond strength must be > X N") nor the reported performance values that demonstrate these criteria were met.

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

• Sample Size for Test Set: Not specified in terms of a clinical or ex-vivo performance test set with a defined sample size for statistical analysis against acceptance criteria. The document mentions "Animal testing," but does not detail the number of animals or the specific test set size derived from this.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): The animal study was conducted in compliance with Good Laboratory Practice (GLP) requirements (21 CFR 58), but the country of origin is not specified. It would be considered prospective for the animal study.

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 present. The document does not describe a clinical or ex-vivo human-based study where experts would establish ground truth for a test set.

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

This information is not present.

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

This information is not applicable/present. The device is a "Vascular Clamp" and a "clampless proximal anastomosis sealing system," not an AI-assisted diagnostic or imaging interpretation tool that would involve human readers.

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

This information is not applicable/present. The device is a physical medical device, not an algorithm.

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

For the "Animal testing," the ground truth would likely involve direct assessment of surgical outcomes (e.g., hemostasis, anastomosis integrity, tissue reaction) by veterinary or surgical experts following the procedure, possibly supplemented with histopathology. The document doesn't specify the exact type of ground truth.

8. The sample size for the training set:

This information is not applicable/present. The device is a physical medical device, not an algorithm that requires a training set.

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

This information is not applicable/present.

Summary of available information regarding performance:

The document states that the following performance data was generated:

• Sterilization Validation per ISO 11135-1:2014 and ISO 10993-7:2008.
• Packaging validation for sterile barrier and labeling after transit simulation and accelerated aging.
• Biocompatibility testing (material mediated pyrogenicity, cytotoxicity, intracutaneous reactivity, sensitization, acute systemic toxicity, partial thromboplastin time, SC5b-9 complement activation, hemolysis, and thrombogenicity) in accordance with ISO 10993-1.
• Design verification testing including Bond Strength Testing, Sealing Element Crush Resistance Testing, Punch Performance Testing, Simulated Use Testing, and Corrosion Resistance Testing.
• Animal testing to evaluate the safety, performance, and usability of the device conducted in compliance with Good Laboratory Practice (GLP) requirements (21 CFR 58).

These tests are generally required for medical device clearance to demonstrate functionality, safety, and manufacturing quality, often against internal specifications or industry standards. However, the document does not present them as a study with specific acceptance criteria and detailed quantitative results for clinical or user-related performance, nor does it define a "test set" in the context of clinical evaluation. The conclusion is based on substantial equivalence, which primarily relies on comparing the device's characteristics to a legally marketed predicate device and demonstrating that any differences do not raise new questions of safety or effectiveness.

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VIOLA barbed suture comprised of dyed polydoxanone (PDO) is indicated for use in soft tissue approximation where use of absorbable suture is appropriate

The Viola barbed suture is a sterile, synthetic absorbable device that is intended for use in the approximation of soft tissue. It is comprised of over 99.9% of polydioxanone, and dyed with 0.05-0.075% of D&C Violet No 2. The Viola suture has 85 Cog shaped barbs distributed along the suture with a barb size of 0.567mm. The device is designed with small bi-directional barbs along the long axis of the suture monofilament to prevent sliding back and forth of the suture in tissue. VIOLA suture does not need surgical knots after tissue approximation. It is available in diameter size USP 0 through 4-0 in various lengths, and affixed to stainless steel S.S 304 needle size from 19G to 26G. The VIOLA suture is sterilized by ethylene oxide gas and packed each set in a poly bag.

The provided text describes a 510(k) premarket notification for a medical device called "VIOLA barbed suture". It details the device's characteristics, intended use, and the studies conducted to demonstrate its safety and effectiveness for market clearance.

Here is a breakdown of the requested information based on the provided text:

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

Note: The document states that "All of the testing results met the acceptance criteria" but does not explicitly list the quantitative acceptance criteria for each test. Instead, it refers to conformance with standards and substantial equivalence 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)

The document does not explicitly state the sample size for the test set or the data provenance for the non-clinical or biocompatibility testing. These studies are typically laboratory-based and would not involve human participants in the same way as clinical trials.

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

This information is not applicable and not provided. The studies performed are non-clinical, benchtop, and biocompatibility tests, which do not involve expert interpretation or ground truth establishment by clinical experts in the same way an AI diagnostic device would.

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

This information is not applicable and not provided. Adjudication methods are relevant for studies involving human interpretation or clinical endpoints, which is not the case for the non-clinical and biocompatibility testing described.

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

No MRMC comparative effectiveness study was done. This type of study is typically performed for AI-powered diagnostic or assistive devices involving human readers (e.g., radiologists, pathologists). The VIOLA barbed suture is a physical surgical device, and its evaluation does not involve human readers interpreting images with or without AI assistance.

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

A standalone performance evaluation was done for the device itself through the non-clinical laboratory tests and biocompatibility tests. These tests assess the physical and biological properties of the suture in isolation, without human-in-the-loop performance.

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

For the non-clinical performance tests (tensile strength, barb holding strength, diameter, attachment strength, etc.), the "ground truth" is established by physical measurements and adherence to established industry standards and regulatory guidance (USP monographs, FDA special controls guidance, ISO 10993). In essence, the ground truth is defined by the specified physical and chemical properties and performance characteristics required for absorbable surgical sutures.

8. The sample size for the training set

This information is not applicable and not provided. The VIOLA barbed suture is a physical medical device, not an AI/ML algorithm that requires a "training set" of data.

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

This information is not applicable and not provided. As mentioned above, the device is not an AI/ML algorithm, and therefore there is no "training set" or "ground truth for the training set" in that context.

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The Viola II Dental Camera system is designed for use in the following applications:

1. To allow the clinician to provide the patient with accurate information
2. To allow the clinician to provide educational information to the patient as well as other clinical personnel
3. To provide documentation for patient records
4. To assist the clinician in the diagnosis of oral cancer and gum diseases
5. To provide documentation for insurance companies

Not Found

This document is a 510(k) premarket notification for the "Viola II Dental Camera System" and mainly discusses regulatory approval based on substantial equivalence to a predicate device. It does not contain detailed information about acceptance criteria or a specific study proving the device meets acceptance criteria.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document is a regulatory approval letter and an indications for use statement, not a performance study report.

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