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Fusion Craniofacial Implant (FCI) and Fusion Skull Implant (FSI) are intended to fill a bony void or defect area in a patient's specific cranial and craniofacial skeleton (orbital rim, zygoma, and adjacent bone).

Fusion Craniofacial Implant (FCI) and Fusion Skull Implant (FSI) are individually sized and shaped implantable prosthetic plates intended to fill a bony void or defect area in a specific patient's cranial and craniofacial skeleton, ranging from 2 mm to 10 mm thick (typically 4mm thick based on the patient CT Scan imaging data) x 25mm to 250 mm wide x 25 mm to 250 mm long.

A Fusion Skull Implant (FSI) is intended to fill a bony void or defect area in a specific patient's skull, whereas a Fusion Craniofacial Implant (FCI) is intended to fill a bony void or defect area in a specific patient's facial region of the skull, excluding the Maxilla (upper jaw area surrounding the teeth only) and Mandible, both considered load bearing areas of the facial region of the skull.

The size, asymmetrical shape, thickness, contour, and edge profile are design elements of the non-load bearing patient-specific base implant. These design elements are used to support the base implant in the bony void or defect area to provide a "Precise Fit."

The single-use alterable base implant (1) is fabricated from a billet block of implant grade Polyether ether ketone (PEEK) Thermoplastic Polymer formulated with biphasic calcium phosphate (BCP PEEK), using a patient's CT scan imaging data, (2) is provided clean (non-sterile) for steam sterilization prior to implantation at a hospital or surgical site, and (3) are attached to the native bone using commercially available cranioplasty hardware and fasteners.

The provided FDA 510(k) clearance letter (K250334) addresses the marketing of the Fusion Craniofacial Implant (FCI) and Fusion Skull Implant (FSI). However, this document does not describe a study involving an AI model or a human-in-the-loop system.

The device described is a physical implant (Preformed Alterable Cranioplasty Plate) intended to fill bony voids or defects in the cranial and craniofacial skeleton. The review focuses on the substantial equivalence of this implant to previously cleared predicate devices, primarily based on material composition (a new PEEK formulation: BCP PEEK) and manufacturing processes.

Therefore, the requested information regarding acceptance criteria and studies proving an AI-driven device's performance (including sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment) cannot be extracted from the provided text.

The performance data section in the document describes:

• Biocompatibility testing: Performed on the new material (Evonik Vestakeep iC4800R® BCP PEEK) according to ISO 10993 standards.
• Performance Testing: Refers to raw material certification and acceptance.
• Cleaning Validation: Conducted for previously cleared devices, and the process is identical for the subject devices.
• Steam Sterilization Validation: Conducted according to ANSI/AAMI ST79.
• Mechanical Testing Validation: A protocol developed by Kelyniam was used as there's no industry-accepted standard for non-load-bearing plates. It states that "all samples passed the acceptance criteria" and "performed equivalent to the predicate devices during mechanical testing using a worst-case scenario."
• Ship Testing Validation: Conducted for previously cleared devices, and the process is identical for the subject devices.
• Summary on Clinical Testing: States "Clinical Testing was determined not applicable" for these devices.

In summary, the provided document does not contain any information about an AI/software-based device, nor does it detail acceptance criteria or studies related to AI performance.

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Fusion Core DC Flo is indicated for use as core build up material on vital teeth, sealing root canal openings, cavity floor liner, post cementation, restorative material, and as a dentin replacement material.

Fusion Flo is indicated for direct filling of class V (cervical caries, root erosions, and wedge shaped defects), anterior restorations( Class III and IV), small posterior restorations, repair of composite/ceramic veneers, and blocking out of undercuts.

Fusion Flo SE is indicated for direct filling of class V (cervical caries, root erosion, wedge shaped defects), anterior restorations (Class III and IV), small posterior restorations,

Fusion I-Seal is indicated for Class I and Class II restorations, as a liner under composite restorations, and as a pit and fissure sealant.

Magma NT is indicated for direct restoration in anterior and posterior teeth classes I, III, IV and V, and porcelain/ composite repairs.

Fusion Core DC Flo is dual-curing, radiopaque, flowable restoration for core build-up composite supplied in an auto-mix delivery system.

Fusion Flo is a flowable composite of medium viscosity used for fillings in anterior teeth and small fillings in posterior teeth. Fusion Flo can be used separately or with Magma-NT composites.

Fusion Flo SE is a self-etch, self-adhesive flowable composite. The flowable composite is ready for use and doesn't require the preparatory steps of etching, priming and bonding. Fusion Flo SE can be used separately or with Magma-NT composites.

Fusion I-Seal is a single component, light cured flowable composite.

Magma-NT is a visible light cured, radio opaque highly filled hybrid composite restorative material for anterior and posterior restoration of all teeth.

The provided text describes the acceptance criteria and performance of several dental composite resins from Prevest Denpro Limited (Fusion Core DC Flo, Fusion Flo SE, Fusion I-Seal, and Magna NT) as part of a 510(k) premarket notification to the FDA. The study aims to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally based on meeting the requirements of ISO 4049:2019 and ISO 13116:2014, with specific values mentioned for some parameters. The reported device performance indicates that "All test results met the criteria in standards."

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 sizes used for the test sets for each specific test (e.g., flexural strength, water sorption). It also does not specify the country of origin of the data or whether the studies were retrospective or prospective. The manufacturer, Prevest Denpro Limited, is based in India, so it's possible the testing was conducted there, but this is not confirmed.

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 to this type of device and study. The "ground truth" for dental composite resins is established through objective physical and chemical testing against international standards (ISO standards), rather than expert interpretation of images or clinical outcomes that require human assessment.

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

Not applicable. As noted above, the "truth" is determined by objective laboratory measurements against predefined standards.

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 study concerns the physical and chemical properties of dental composite resins, not an AI-powered diagnostic device requiring evaluation of human reader performance.

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

Not applicable. This is not an algorithm or AI device.

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

The ground truth used for evaluating these dental composite resins is defined by international standard specifications for physical and chemical properties as outlined in ISO 4049:2019 (Dentistry - Polymer-based restorative materials) and ISO 13116:2014 (Dentistry - Dental impression materials - Radiopacity). For Fusion Flo SE, USP 971 was also referenced for pH testing. The "truth" is whether the measured properties of the device meet the quantitative limits set by these standards.

8. The sample size for the training set

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

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

Not applicable. As this is not an AI device, there is no training set or ground truth established in that context.

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The Fusion Robotic Navigation System is indicated for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of a tool holder or guide to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous spinal procedures in reference to rigid patient anatomy and fiducials that can be identified on a 3D imaging scan. The Fusion System is indicated for assisting the surgeon in placing pedicle screws in the posterior lumbar region (L1-S1). The system is designed for lumbar pedicle screw placement with the prone position and is compatible with the ATEC Invictus® Spinal Fixation System.

The Fusion Robotic Navigation System is an image guided system primarily comprised of a computer workstation, software, a trajectory system, including a targeting platform, a camera, and various image guided instruments intended for assisting the surgeon in the pedicles of the lumbar spine.

The provided text describes a 510(k) premarket notification for the Fusion Robotic Navigation System. This submission asserts substantial equivalence to a predicate device (REMI Robotic Navigation System K223070) rather than presenting a performance study with acceptance criteria in the traditional sense of a clinical trial or extensive standalone validation.

The key change described in this submission is the compatibility of the Fusion Robotic Navigation System with the ATEC Invictus® Spinal Fixation System, which includes the introduction of three new instruments: the Invictus Guide Tube, Invictus 8mm Guide Tube Sleeve, and Invictus MIS Screwdriver.

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed within the context of demonstrating substantial equivalence to the predicate device, primarily through an engineering analysis rather than a new clinical performance study.

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

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission based on an engineering analysis of new instruments, the "acceptance criteria" pertain to maintaining the critical features and performance of the predicate device despite the introduction of new compatible instruments. There are no quantitative performance metrics (like sensitivity, specificity, accuracy) provided that would typically arise from a standalone or clinical study.

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

The document does not describe a traditional "test set" with patient data or clinical cases. The "test" involved an engineering analysis comparing designs. There is no mention of a sample size of patients or data provenance in this context.

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

Not applicable. The "ground truth" for this submission is based on the design specifications and performance characteristics of the predicate device and the engineering comparison of the new instruments to those specifications. There were no "experts" in the context of clinical adjudication for a test set mentioned.

4. Adjudication method for the test set

Not applicable. There was no clinical test set requiring adjudication.

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

Not applicable. This device is a robotic navigation system, not an AI imaging analysis tool, and the submission does not describe a comparative effectiveness study involving human readers or AI assistance.

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

This is not an AI algorithm in the traditional sense for diagnostic or prognostic purposes. The performance assessment was based on an engineering analysis of the physical components and their interaction within the system, not a standalone algorithm output.

7. The type of ground truth used

The "ground truth" for this submission is the established design requirements, material specifications, and functional performance characteristics of the predicate device, against which the new compatible instruments were compared via engineering analysis.

8. The sample size for the training set

Not applicable. This submission concerns hardware modifications and compatibility, not a machine learning model requiring a training set.

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

Not applicable, as there was no training set mentioned.

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Fusion Bond 5 is indicated for direct composite or compomer restorations, adhesive cementation, and composite repair.

Fusion Bond 7 is indicated for bonding of composites to tooth structure, core build up, and adhesive cementation of crown & bridges, including inlays and onlays.

Fusion Bond DC is indicated for direct light cure composite or compomer restorations, core build up, and adhesive cementation of crown & bridges, including inlays and onlays.

Renew MDP is indicated for bonding of dual cure, light cure or self cure composite or compomer restorations to tooth structure. treatment of hypersensitive teeth, and intraoral repairs of fractured restorations.

Renew Universal is indicated for direct bonding of light-cured compomers to tooth structure, bonding of dual-cured core build up composites to tooth structure as long as these materials are light-cured. intraoral repair of composite, metal-based and zirconia /alumina-based restorations, intraoral repair of ceramic restorations in combination with a silane coupling agent, treatment of hypersensitive teeth, and cavity sealing as a pretreatment for indirect restorations.

Prevest Denpro Tooth Bonding Agents attach different types of restorations to teeth.

Fusion Bond 5 is a light curing single component bonding agent. It primes and bonds in one step to attach restorations of composites, copomers, amalgams, and porcelains to tooth structures. Tooth structures should have a 37% phosphoric acid etchant application of Fusion Bond 5.

Fusion Bond 7 is a light curing single component bonding agent. It etches, primes, and bonds in one step to attach restorations of composites, copomers, amalgams, and porcelains to tooth structures.

Fusion Bond DC is a dual cure bonding direct and indirect restorations. Enamel and dentin surfaces should be conditioned with 37% phosphoric acid etchant before application of Fusion Bond DC. It is a two component adhesive with bonding agent and activator.

Renew MDP is a light curing single component bondines etching, priming and bonding in one bottle. It is an ethanol-water based dental adhesive containing 10-Methacryloyloxydececyl Dihydrogen Phosphate (10-MDP) a functional monomer which helps in bonding to dentin and cut and un-cut enamel. Renew MDP works with light-cured and dual-cured composite materials.

Renew Universal is a light curing single component bondines etching, priming and bonding. Renew Universal contains a combination of functional monomers such as 10-MDP and 4-META. Renew Universal works with light-cured and dual-cured composite materials.

This document describes a 510(k) premarket notification for a series of dental bonding agents manufactured by Prevest Denpro Limited. The purpose of the 510(k) is to demonstrate substantial equivalence to legally marketed predicate devices, not to prove clinical efficacy through a comparative effectiveness study with human readers and AI assistance. Therefore, many of the requested criteria often associated with AI/ML medical devices are not applicable to this submission.

Based on the provided text, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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

The acceptance criteria are established by the ISO 29022:2013 standard, specifically for "Dentistry - Adhesive - Notched-edge shear bond strength test." The reported device performance is stated as "Complies with ISO 29022" for both shear bond strength and curing time, with specific values provided as well.

Note: The document explicitly states "All test results met the criteria in standard." The specific numeric values (e.g., 10 MPa for Fusion Bond 5) are the reported performance, which is implicitly accepted as meeting the standard's criteria.

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

The document does not specify the exact sample sizes used for each test. It states "Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP and Renew Universal were tested for appearance, shear bond strength and curing time according to protocols based on ISO 29022:2013."

The data provenance is from Prevest Denpro Limited, located in Bari Brahmana, Jammu 181133 India. The tests are presented as part of a regulatory submission, implying they were prospective tests conducted specifically for this 510(k).

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

This is a physical testing submission, not a diagnostic imaging AI/ML device. Therefore, the concept of "experts establishing ground truth for a test set" in the context of medical image interpretation (e.g., radiologists) is not applicable. The ground truth is established by the physical properties measured according to an international standard (ISO 29022:2013).

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 establishing consensus among human readers for image interpretation. This submission involves physical, objective measurements.

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

No, an MRMC comparative effectiveness study was not done. This is not an AI/ML medical device where human reader performance with and without AI assistance is relevant. This is a dental material.

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 in these dental bonding agents. The "performance" is the physical properties of the material.

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

The ground truth for the device's performance is based on objective physical measurements conducted according to the ISO 29022:2013 standard for dental adhesives, specifically for shear bond strength and curing time. In essence, the ground truth is the scientific and engineering standard.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of machine learning for this type of device. The products are dental materials, and their formulation and manufacturing are based on established chemical and material science principles, not on iterative training data.

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

Not applicable. As there is no training set (in the ML sense), there is no ground truth to establish for it. The "ground truth" for the development of these materials would stem from principles of chemistry, material science, and prior knowledge in dental adhesive development.

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Signature Orthopaedics' Fusion Taper System is intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for:

• . Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis
• . Inflammatory joint disease including rheumatoid arthritis
• . Correction of functional deformity including congenital hip dysplasia
• . Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture
• . Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemi-arthroplasty, surface replacement, or total replacement
  Signature Orthopaedics' Fusion Taper System is intended for cementless fixation only.

The Fusion Taper System consists of modular femoral heads and taper sleeves. The Fusion Taper Sleeve is manufactured from Ti6Al4V as per ISO 5832-3. The Fusion Ceramic Head is manufactured from an alumina matrix as per ISO 6474-2. All Fusion Heads are intended for total hip arthroplasty. The Fusion Heads connect to the femoral stem via a Fusion Taper Sleeve which has a 12/14 inner taper and 16/18 outer taper. Signature Orthopaedics Fusion Taper System is indicated for use with Signature Ti6A14V femoral stems: TSI Stem (K102172), Origin Stem (K121297. K161155), Aria Stem (K121297), Remedy Stem (K133370), Spartan Stem (K192883), World Stem (K201278), and acetabular components: Logical Cup (K121297, K153131), Logical Liners (K121297), Logical 20deg Hooded Liners including lateralised variants (K153131), World Cup (K201278), and World Liner (K201278).

This document is a 510(k) summary for the Signature Orthopaedics Fusion Taper System, a hip replacement prosthesis. It primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing. It does not describe an AI/ML device or a study proving that such a device meets acceptance criteria.

Therefore, I cannot extract the requested information regarding acceptance criteria and studies related to an AI/ML device from this document. The document describes a physical medical device (hip implant components) and its non-clinical testing for regulatory clearance.

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The FusionFrame Ring Lock System is indicated for:

• · Stabilization of fractures and osteotomies;
• · Bone deformity correction of lower extremities;
• · Arthrodesis of the rear foot, mid foot and ankle joint; and
• · Limb Lengthening in pediatric and adult patients.

This submission is a line extension to the FusionFrame™ Ring Lock System product line to include fixation pins, pin fixation bolts, pin fixation cubes, threaded sockets, conical washer couples, T-wrench and adapters, hinges, telescoping struts and 5/8 rings to improve the configuration options that the FusionFrame™ Ring Lock System can provide and to be competitively comparable to other circular external fixation predicate devices.

The FusionFrame™ Ring Lock System is an updated version of previously existing circular fixators that is specifically designed for the treatment of pathologies including:

• Stabilization of Fractures and Osteotomies. .
• Bone deformity corrections of lower extremities. .
• Arthrodesis of: .
  • 0 Rear Foot
  • 0 Mid Foot
  • 0 Ankle Joint
• Adult and pediatric limb lengthening

The Fusion Frame was developed to specifically address the extensive requirements of orthopedic surgeons and foot and ankle specialists. Its components have been designed to ensure overall construct stability, versatility, ease of application, functionality and time saving efficiency. Briefly described, the FusionFrame™ provides a weight bearing scaffold that in most cases allows patients to remain mobile throughout the course of treatment.

The numerous variety of constructs afforded by the FusionFrame™ provides a systematic platform for ensuring stability, re-aligning bones, applying compressive forces or controlling the distraction of bone fragments over a period of time. The FusionFrame™ consists of externally mounted Rings and ancillary components that are interconnected with threaded rods and/or telescoping struts. The construct is attached to the bone with a combination of percutaneously applied tensioned Wires and/or Half-Pins. Telescoping struts with compression/distraction nuts may be attached to the frame to systematically control the gaps between bone fragments and distance between Rings to manage a variety of pathologies. Threaded rods or struts may be used to reduce and compress fracture zones, lengthen limbs and even correct deformities.

This document is a 510(k) summary for the FusionFrame Ring Lock System, a medical device used for external fixation. It's a submission to the FDA seeking clearance based on substantial equivalence to previously cleared predicate devices, not an AI/ML device. Therefore, the questions regarding AI/ML device acceptance criteria, performance studies, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information are not applicable to this document.

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This device is used for endoscopic removal of stones in the biliary system and for contrast injection.

The subject device is composed of a latex balloon mounted at the distal end of a nylon triple lumen catheter. The balloon can be inflated to four sizes: 8.5 mm, 10 mm, and 15 mm diameters. Radiopaque bands are placed on the catheter to provide fluoroscopic visualization of the catheter and balloon location. The nylon catheter length is 200 cm with a diameter of 6.6 Fr. There is an injection port on the catheter either above the balloon or below the balloon depending on the device model. The catheter also has black ink markings for direct visualization.

This document describes the regulatory clearance (K200247) of the "Fusion Quattro Extraction Balloon" by Wilson-Cook Medical, Inc. It does NOT contain information about acceptance criteria or a study proving the device meets said criteria in the way typically expected for an AI/ML medical device.

The device described is a physical medical device (a balloon catheter for stone extraction), not an AI/ML algorithm. Therefore, many of the requested categories like sample size for test/training sets, data provenance, expert adjudication, MRMC studies, and standalone algorithm performance are not applicable.

Here's a breakdown based on the provided text, highlighting what is (and isn't) present:

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

The document mentions "performance requirements" but does not detail specific quantitative acceptance criteria or their corresponding reported values in a table. It generally states that the device "met the performance requirements" and "will function as intended."

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

Not applicable. This is a physical device undergoing bench testing, not a clinical study with a patient test set or data provenance in the typical sense for AI/ML. The "testing" refers to non-clinical bench 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):

Not applicable. "Ground truth" in the context of expert consensus or pathology is not relevant for bench testing of a physical device.

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

Not applicable. No expert adjudication process is described for this type of device testing.

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 physical device, not an AI system.

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):

Not applicable. The "truth" for bench testing of this device would be established by engineering specifications and measurement standards, not expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

Not applicable. This is a physical device, not an AI algorithm requiring a training set.

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

Not applicable. This is a physical device, not an AI algorithm.

Summary of available information as it pertains to the request, re-framed for a physical device:

The document describes a 510(k) premarket notification for a medical device called the "Fusion Quattro Extraction Balloon." The clearance is based on substantial equivalence to a predicate device (Fusion Quattro Extraction Balloon XL K063677). The modification involved a change in balloon inflation diameters (8.5 mm, 10 mm, 12 mm, and 15 mm).

Performance Data and Testing:

• Type of Study: Non-clinical bench testing.
• Purpose: To demonstrate the subject device met performance requirements and functions as intended, and does not raise new questions of safety or effectiveness compared to the predicate.
• Tests Conducted:
  • Design Verification Testing
  • Dimensional Verification
  • Functional Testing
  • Fluoroscopic Visibility

The core statement is: "Performance testing consisting of non-clinical bench testing demonstrates the subject device met the performance requirements to fulfill the intended use." However, the document does not provide the specific quantitative "acceptance criteria" or the "reported device performance" values for each test. It simply states that they were met.

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Used for collection of cells in the biliary system.

The subject devices, the Fusion Cytology Brush and CytoMax II Double Lumen Cytology Brush, consist of a nylon brush on a stainless-steel drive wire with a stainless-steel tip, a double lumen catheter with ink markings, radiopaque markers, wire guide access via a wire guide hub or and IDE port, a detachable extension line with a luer lock for optional flushing of the wire guide hub and a pin-vise handle.

The Fusion Cytology Brush and CytoMax II Double Lumen Cytology Brushes are used by passing the device through an endoscope over a prepositioned wire guide to a target location. The cytology brush is located at the distal end (patient contacting) of the device with the pin vise handle located at the proximal end (non-patient contacting). The handle is actuated by pushing the pin vise handle forward to extend the cytology brush and then pulling backward to retract the brush.

The provided text is a 510(k) summary for the Fusion Cytology Brush and CytoMax II Double Lumen Cytology Brush. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices after a design modification. It does not describe an AI medical device, nor does it contain information about acceptance criteria for an AI model, a study proving an AI device meets acceptance criteria, sample sizes for test or training sets for AI, expert involvement for AI ground truth, or MRMC studies.

Therefore, I cannot fulfill your request for information about acceptance criteria and studies related to an AI device based on this input.

The document discusses non-clinical bench testing to ensure the modified devices meet performance requirements and function as intended, specifically:

• Tensile Strength Testing: Assesses the strength of the device.
• Tensile Strength of Handle: Evaluates the handle's ability to withstand pulling forces.

These tests are to ensure the physical integrity and functionality of the cytology brushes themselves, not the performance of an AI algorithm.

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The GAIT Implants are intended for patients presenting with class 3 degeneration of the first metatarsophalangeal joint with narrowing of the joint space, loss of joint cartilage, bony spur ring surrounding the joint space, and a painful range of motion of the first metatarsophalangeal joint both with rotation and with walking. This application is not expected to recreate a normal range of motion of the first metatarsophalangeal joint. The GAIT Implant is a spacer that augments the Keller arthroplasty procedure by stabilizing the hallux to the first metatarsal.
The GAIT Implants w/Grommets are intended for patients presenting with class 3 degeneration of the first metatarsophalangeal joint with narowing of the joint space, loss of joint cartilage, bony spur ring surrounding the joint space, and a painful range of motion of the first metatarsophalangeal joint both with rotation and with walking. This application is not expected to recreate a normal range of motion of the first metatarsophalangeal joint. The GAT Implant is a spacer that augments the Keller arthroplasty procedure by stabilizing the first metatarsal.
The GAIT 2.0 Implants are intents presenting with class 3 degeneration of the first metatarsophalangeal joint with narrowing of the joint space, loss of joint cartilage, bony spur ring surrounding the joint space, and a painful range of motion of the first metatsophalangeal joint both with rotation and with walking. This application is not expected to recreate a normal range of motion of the first metatarsophalangeal joint. The GAIT Implant is a spacer that augments the Keller arthroplasty procedure by stabilizing the hallux to the first metatarsal.
The GAIT 2.0 Implants w/Grommets are intended for patients presenting with class 3 degeneration of the first metatarsophalangeal joint with narowing of the joint space, loss of joint cartilage, bony spur ring surrounding the joint space, and a painful range of motion of the first metatarsophalangeal joint both with rotation and with walking. This application is not expected to recreate a normal range of motion of the first metatarsophalangeal joint. The GAT Implant is a spacer that augments the Keller arthroplasty procedure by stabilizing the first metatarsal.
The SHIP Long Implants, are intents presenting with the following indications commonly found in the interphalangeal joints: Semi-rigid or rigid hammertoe deformity; Impaired function and stability; Pain; Impaired toe length ratio.
The Shaw Rod Implant is intended for patients presenting with the following indications commonly found in the interphalangeal joints: Semi-rigid or rigid hammertoe deformity; Impared function and stability; Pain; Impaired toe length ratio.
The SHIP Short Implants are intents presenting with the following indications commonly found in the interphalangeal joints: Semi-rigid or rigid hammertoe deformity; Impaired function and stability; Pain; Impaired toe length ratio.

The Fusion Silastic System consists of a collection of flexible toe joint prostheses, manufactured from medical grade silicone (ASTM F2042). The product family is offered in five configurations to address varying indications and patient anatomy; the Gait Implant, the Gait 2.0 Implant, the SHIP Long Implant, the SHIP Short Implant and the Shaw Rod. The specialized instruments are made primarily of surgical grade stainless steel (ASTM F899).

This document is a 510(k) premarket notification for the Fusion Silastic System, a toe joint prosthesis. It outlines the company's claim of substantial equivalence to predicate devices.

Based on the provided document, there is NO information about acceptance criteria or a study proving that an AI-driven device meets acceptance criteria.

The document is for a physical medical device (toe joint prosthesis) and does not describe any AI component or a study to evaluate AI performance. The "Non-clinical Test Summary" and "Clinical Test Summary" explicitly state:

• Non-clinical Test Summary: "Validations were performed on the cleaning, packaging and sterilization of the implants and associated surgical instruments. Engineering rational was performed to show performance equivalence. The results of the testing demonstrate that the device is substantially equivalent to the predicate device identified above."
• Clinical Test Summary: "No clinical studies were performed."

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI device meets those criteria because the provided text describes a physical implant and its regulatory clearance process, not an AI-powered device.

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Source of illumination for curing photo-activated dental restorative materials and adhesives.

Fusion Plus Curing Light is a portable dental LED curing light system. It provides a source of illumination for polymerization of photo-activated dental materials. The principle of operation is the same as the predicate devices: illumination for polymerization or curing of photo-activated dental materials. It uses our patented Fusion optical technology in combination with high-power LED to deliver high efficiency and high-power curing light.

The system consists of a curing handpiece, a charging stand, 100 barrier sleeves, light shields, a power adapter, and instructions for use. The handpiece is constructed of aluminum and consists of a main control, a light head, and a rechargeable battery assembly. The main control houses the control circuitry with microprocessor and user interface consisting of LCD display and two control buttons. A mode button selects operation timer and two curing modes: plasma or pulse mode. A ON/OFF button activates and deactivates the light. The handpiece is non-sterile utilizing the barrier sleeves for infection control. Similar to the predicate devices, the light shield and curing cap absorb emitted light and perform the function of eye protection. The charging stand allows for the placement of the handpiece in a holder with electrical connection to the power adapter as the source for charging the rechargeable battery. FUSION Plus has an interchangeable LED light head. Depending on the light head connected with the main control or added later, the kit can be configured in three options:

Trade Name: FUSION Plus, LED Peak Wavelength (nm): 395-480
Trade Name: FUSION Plus Standard, LED Peak Wavelength (nm): 440-480
The instructions for use detail the use of each head in curing of dental materials.

The DentLight FUSION Plus Curing Light is a dental LED curing light system designed for the polymerization of photo-activated dental restorative materials and adhesives. The manufacturer asserts its substantial equivalence to the predicate device Valo (K083647) by Ultradent Products Inc. and the reference device FUSION (K052593) by DentLight Inc., based on similarities in indications for use, technology, and performance test results.

Below is a detailed breakdown of the acceptance criteria and the study proving the device meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The provided document does not specify a separate "test set" in the context of human data or image data for the FUSION Plus Curing Light. The non-clinical performance testing involved evaluating the device's functionality and performance directly, rather than using a dataset of clinical cases. The data provenance is essentially from the internal testing conducted by the manufacturer, DentLight Inc.

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

Not applicable. This device is a dental curing light, a physical device, not an AI or diagnostic tool that requires expert-established ground truth from clinical cases. The testing focused on the physical and electrical properties of the device.

4. Adjudication Method for the Test Set:

Not applicable, as no ground truth requiring adjudication was established from clinical or imaging data.

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:

Not applicable. This device is a dental curing light and does not involve AI assistance for human readers or interpretation of medical images.

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

Not applicable. This device is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

Not applicable in the conventional sense. The "ground truth" for this device's performance is established by direct measurement of its physical and electrical characteristics against established industry standards and the performance of predicate devices. For instance, optical irradiance and spectral irradiance are directly measured and compared.

8. The Sample Size for the Training Set:

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

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

Not applicable. As there is no training set for an AI model, there is no ground truth to establish for it.

Study Proving Device Meets Acceptance Criteria:

The study that proves the FUSION Plus Curing Light meets its acceptance criteria is a series of non-clinical performance tests conducted by DentLight Inc. These tests were performed to evaluate the device's functionality, performance, safety, and substantial equivalence to the predicate devices. The study was guided by the FDA's "Dental Curing Lights – Premarket Notification [510(k)] Submissions" guidance document.

The non-clinical tests included:

• Device performance: This category covered specific technical parameters such as optical irradiance, spectral irradiance, curing time, curing modes and safety controls, and heat management.
• Software and hardware verification and validation: This ensured that the device's internal systems operate correctly and reliably.
• Risks to health and traceability analysis: This involved assessing potential hazards and ensuring the device's components and manufacturing processes are traceable.
• Electrical safety and electromagnetic compatibility (EMC): The device was tested for compliance with relevant electrical and safety standards, specifically IEC 60601-1, IEC 60601-1-2, and ANSI/ADA 48-2.

The conclusion drawn from these tests was that, based on similarities in indications for use and technology, coupled with the results from the performance testing, the FUSION Plus Curing Light is substantially equivalent to the predicate devices. The listed performance values in the table above demonstrate that the FUSION Plus Curing Light performs within acceptable ranges established by the predicate devices, and in some cases, exceeds them (e.g., Pulse/High curing optical intensity). Compliance with relevant IEC and ANSI/ADA standards confirms its safety and electromagnetic compatibility.

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