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The Paragon 8F Balloon Guide Catheter is in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Paragon 8F Balloon Guide Catheter is also indicated for use as a conduit for retrieval devices.

The Paragon™ 8F Balloon Guide Catheter (BGC) is a multi-lumen, braid-reinforced, variable stiffness catheter with a radiopaque marker on the distal end and a bifurcated luer hub on the proximal end. A compliant balloon is mounted on the distal end. Balloon inflation can be facilitated through the side port of the bifurcated luer hub. The 10 mm long balloon can be inflated up to a maximum volume of 0.6 mL. At this volume, the balloon diameter is 10 mm. The through-lumen extends from the center port of the bifurcated luer hub to the distal tip. The external distal segment of the catheter shaft has hydrophilic coating to reduce friction during use. The coating starts from the proximal balloon bond and extends proximally for 19 cm in length. There are two Paragon 8F BGC configurations which have working lengths of 85 cm. The difference in device length resides in the proximal shaft segment only. The 16 cm distal flexible segment and the balloon are identical for both configurations.

The Paragon 8F Balloon Guide Catheter is compatible with minimum 0.110 inch inner diameter (ID) introducer sheaths, guidewires up to 0.038 inch outer diameter (OD), and 6F catheters up to 0.085 inch OD. The Paragon 8F Balloon Guide Catheter is sterile, non-pyrogenic, and intended for single use only.

The provided text describes the acceptance criteria and the study proving the device meets these criteria for the Wallaby Medical Paragon 8F Balloon Guide Catheter (K232437). However, it focuses on the physical and biological performance of the catheter, not on an AI/ML-based medical device. Therefore, many of the requested fields related to AI/ML device validation (e.g., sample sizes for training/test sets, expert ground truth establishment, MRMC studies, standalone algorithm performance) are not applicable to this submission.

Here's a breakdown of the available information based on the provided text, adapted to the context of a physical medical device.

Acceptance Criteria and Device Performance (for a Physical Medical Device)

Since this is for a physical medical device (catheter) and not an AI/ML software, the following sections are either not applicable ("N/A") or cannot be extracted from the provided text, as they pertain specifically to AI/ML software validation.

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

• Sample Size for Test Set: The exact number of samples for each bench test is not explicitly stated in the summary, other than "all samples" met the criteria. For biocompatibility, it refers to standard GLP (Good Laboratory Practice) animal and in vitro studies, which have their own sample size guidelines.
• Data Provenance: N/A. This applies to clinical data for AI/ML. The "data" here is the physical performance and biocompatibility of the device, typically conducted in a laboratory setting.
• Retrospective or Prospective: N/A. (Applies to AI/ML clinical data).

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

• N/A. Ground truth in this context refers to established standards (e.g., ISO, ASTM), specified design requirements, and GLP guidelines for testing. Expert interpretation of images or other data to establish a "truth" is not relevant here.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:

• N/A. This is relevant for AI/ML where multiple human readers interpret data. For physical device testing, results are objective measurements against predefined criteria.

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:

• N/A. This is a physical device, not an AI/ML algorithm.

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

• N/A. This is a physical device, not an AI/ML algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

• For bench testing: Pre-defined engineering specifications, industry standards (ISO, ASTM), and design requirements.
• For biocompatibility: Standardized biological evaluation methods and acceptance criteria defined in ISO 10993 series. Animal studies (e.g., guinea pig, rabbit) are the "ground truth" for assessing biological responses.

8. The Sample Size for the Training Set:

• N/A. This applies to AI/ML software. This device does not have a "training set."

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

• N/A. This applies to AI/ML software.

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The Monster® Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, ligament fixation, fracture repair and fracture fixation, appropriate for the size of the device. Specific examples include: Fractures and Osteotomies, Hallux Valgus Correction, Arthrodesis/Deformity Correction, Fusion resulting from neuropathic osteoarthropathy (Charcot).

The Baby Gorilla® / Gorilla® Bone Plates and Bone Screws of the Baby Gorilla® and Gorilla® Plating System are indicated for use in stabilization and fixation of fractures or osteotomies; intra and extra articular fractures, joint depression, and multi-fragmentary fractures; revision procedures, joint fusion and reconstruction of small bones of the toes, feet and ankles including the distal tibia, talus, and calcaneus, as well as the fingers, hands, and wrists. The system can be used in both adult and pediatric patients. Specific examples include: Forefoot, Mid/Hindfoot, Ankle, First metatarsal osteotomies for hallux valgus correction, Arthrodesis of the first metatarsophalangeal joint (MTP), Flatfoot, Charcot. In addition, the non-locking titanium screws and washers are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device.

The Phantom® Small Bone Intramedullary Nail System is indicated for use in stabilization and fixation of the small bones of the feet and ankle for the treatment of fractures, osteotomies, nonunions, pseudarthroses and malunions by revision, joint fusion or reconstruction procedures.

The Phantom® Hindfoot TTC/TC Nail System is indicated for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot. Examples of specific indications include: Post-traumatic or degenerative arthritis, Previously infected arthrosis, Revision of failed ankle arthrodesis, Revision of failed total ankle arthroplasty, Talar deficiency conditions such as avascular necrosis of the talus (requiring tibiocalcaneal arthrodesis), Neuromuscular deformity or other neuromuscular disease with severe deformity or instability of the ankle, Rheumatoid arthritis, Osteoarthritis, Nonunions or pseudarthrosis of hindfoot and distal tibia, Trauma (severe or malunited tibial pilon fracture), Charcot foot (neuroarthropathy), Severe end-stage degenerative arthritis, Instability and skeletal defects after tumor resection, Pantalar arthrodesis, Severe foot/ankle deformity.

HammerTube™M System is indicated for fixation of The reconstruction and fusion of toes during correction procedures for hammertoe deformity, claw toe deformity, shortening osteotomies of the phalanges and mallet toe deformity as well as revision hammertoe procedures. The cannulated and solid HammerTube™ implants may be used without any other additional device. The cannulated implants may be used with K-Wires for delivery of implants or for the temporary stabilization of nearby joints, such as the metatarsophalangeal joint. The implantable K-Wires are indicated for use in the stabilization and fixation of small bones for use in bone reconstruction, osteotomy, arthrodesis, fracture repair and fixation, appropriate for the size of the joint. Additionally, the implantable K-Wires are indicated as guide pines for insertion of instruments and implants in the HammerTube™ System.

The APEX 3D™ Total Ankle Replacement System is indicated as a total ankle replacement in primary surgery for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. Revision surgery for these patients is also indicated for patients with sufficient bone stock present. Components are intended for cemented use only.

Monster® Screw System: The Monster® Screw System is comprised of threaded bone screws (Ti Alloy or Stainless Steel) offered in 2.0mm to 9.5mm diameters (in 0.5mm increments). In addition, a 2.7mm diameter is also part of the system. The overall screw length ranges from 8mm (for smaller diameters) thru 200mm (for larger diameters). The screws are available in a variety of designs including fully or partially threaded self-drilling or blunt, cannulated or solid, and headed or headless. Sized-matched washers are also available.

Baby Gorilla® / Gorilla® Plating System: The Baby Gorilla® / Gorilla® Plating System is comprised of bone plates, threaded bone screws, and washers. Gorilla® Plates are offered in "mini" and "standard" set sizes in a variety of shapes based upon the anatomical fixation required. Screws are also offered in "mini" and "standard" sets and, in addition, in locking and non-locking versions. Size-matched washers are available for use with the non0locking screws when the latter are used for fixation without the plates. Size-matched plate washers are also available for use with plate holes when there is no desire to use a screw. The Baby Gorilla® / Gorilla® Plating System implants are manufactured from medical grade titanium (per ASTM F67), stainless steel (per ASTM F138), and titanium alloy (per ASTM F136).

Phantom® Small Bone Intramedullarv Nail System: The Phantom® Small Bone Intramedullary Nail System is comprised of small bone intramedullary nails, locking screws and threaded pegs. The Phantom® nails are offered in a variety of lengths to accommodate variations in patient anatomy. The Phantom® threaded pegs and locking screws insert through the intramedullary nail to secure the construct. These are offered in varving lengths to accommodate the anatomical fixation required. The system includes instruments for implantation.

Phantom® Hindfoot TTC/TC Nail System: The Phantom® Hindfoot TTC/TC Nail System is comprised of intramedullary nails, screws and accessory components. The Phantom® nails are offered in a variety of sizes lengths, and configurations to accommodate variations in patient anatomy. The Phantom® screws insert through the intramedullary nail to secure the construct. These are offered in varying lengths to accommodate the anatomical fixation required.

HammerTube™ System: The HammerTube™ System includes HammerTube™ and K-Wire implants. The HammerTube™ is a commercially pure titanium plasma sprayed PEEK cylinder in varying diameters, lengths, and angles. The K-Wires are stainless steel and double trocar pointed. The implants are sold sterile.

APEX 3D Total Ankle Replacement System: The APEX 3D™ Total Ankle Replacement System is a cemented, fixed bearing device comprised of a tibial component, a talar component and an Ultra-High Molecular Weight Polyethylene (UHMWPE) component used for ankle joint replacement. Components are available in varying sizes and design configurations intended for both primary and revision applications.

This FDA 510(k) summary (K231231) describes the MR Safety and Compatibility Testing and Labeling Updates for several Paragon 28 Orthopedic Fixation Devices. The document states that the purpose of this submission is to obtain clearance for Magnetic Resonance (MR) safety and compatibility testing and Magnetic Resonance Imaging (MRI) Safety Information updates to the labeling of previously cleared devices. It explicitly mentions that there are no other indications for use, design, material, processing, performance, or labeling modifications subject to the submission. This is crucial because it means the study described focuses solely on MR safety, not on clinical effectiveness of the orthopedic fixation devices themselves.

Therefore, the study focuses on ensuring the devices meet MR Conditional labeling requirements based on established standards, rather than evaluating their clinical performance in human patients.

Here's a breakdown of the requested information based on the provided text, with the caveat that the study is not a clinical effectiveness study of the orthopedic devices but rather a safety study for MRI compatibility:

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

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

The document does not explicitly state the specific "sample size" of devices tested for MR safety. The testing was performed on the described orthopedic fixation devices (Monster® Screw System, Baby Gorilla® / Gorilla® Plating System, Phantom® Small Bone Intramedullary Nail System, Phantom® Hindfoot TTC/TC Nail System, HammerTube™ System, APEX 3D™ Total Ankle Replacement System).

Data provenance is not directly about country of origin in this context; it's about the nature of the testing. The testing was prospective in relation to the submission, performed specifically to generate the data for the MR safety labeling update. The tests are in vitro (laboratory-based) rather than in vivo (on human 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)

This question is not applicable to the described study. The "ground truth" here is compliance with established engineering standards for MR safety, not a medical diagnosis or outcome requiring expert medical consensus. The testing involved standardized methods (ASTM standards) and engineering evaluations, not interpretation by medical experts for a test set of patient data.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 typically refer to the process of resolving discrepancies among multiple human readers (e.g., radiologists) in a clinical diagnostic study. This study is an engineering safety performance study of medical devices, not a diagnostic study.

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 done. This study is not about AI assistance or human reader performance. It is a safety study evaluating the compatibility of orthopedic implants with MRI environments.

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

No, this question is not applicable. This study involves the physical testing of orthopedic implants in an MRI environment to determine their safety and compatibility characteristics, not the performance of an algorithm.

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

The "ground truth" for this study is compliance with established, recognized engineering standards for MR safety as defined by ASTM (American Society for Testing and Materials) and the FDA's guidance document "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment." These standards provide quantitative metrics and methodologies for evaluating magnetic force, torque, heating, and image artifact.

8. The sample size for the training set

This question is not applicable. The described study is not a machine learning or AI study, so there is no concept of a "training set."

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

This question is not applicable, as there is no training set in this type of device safety study.

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The Paragon 28 External Ring Fixation System is indicated in pediatric patients and adults for the treatment and fixation of:

• Open and closed fractures
• Post-traumatic joint contracture which has resulted in loss of range of motion
• Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
• Pseudoarthrosis, infected union, non-union, or malunion of long bones
• Limb lengthening by epiphyseal, diaphyseal, or metaphyseal distraction
• Correction of bony or soft tissue deformity (e.g. orthoplastic surgery)
• Correction of segmental bony or soft tissue defects
• Joint arthrodesis
• Management of comminuted intra-articular fractures
• Bone transport

The Paragon 28 External Ring Fixation System is indicated in adults for:

• Osteotomy
• Revision procedure where other treatments or devices have been unsuccessful
• Bone reconstruction procedures
• Fusions and replantations of the foot
• Charcot foot reconstruction
• Offloading and/or immobilization of ulcers and/or wounds of the foot and ankle
• Lisfranc dislocations
• Ankle distraction (arthrodiastasis)
• Septic fusion

The Paragon 28 External Ring Fixation System is a modular, ring-based, external fixation system designed for the treatment and fixation of a variety of conditions in pediatric and adult patients. The Paragon 28 External Ring Fixation System utilizes wires, pins, struts, rods, bolts, fasteners, clamps, and plates that connect to rings statically placed or gradually manipulated in order to fixate or correct the bone. The modular design of the system allows for a customized treatment for the patient.

Components of the Paragon 28 External Ring Fixation System may be used in conjunction with all Paragon 28 legally marketed devices.

The components of the device are offered in a variety of sizes, which allow for a truly customized external fixation device.

This document is a 510(k) Summary for the Paragon 28 External Ring Fixation System, which is a medical device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through a clinical study or for evaluating AI performance. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is not present in the provided text.

The document focuses on:

• Indications for Use: Listing the medical conditions the device is intended to treat.
• Device Description: Describing the components and modular nature of the system.
• Predicate Devices: Identifying legally marketed devices to which the Paragon 28 system claims substantial equivalence.
• Performance Testing Summary: Stating that non-clinical testing was performed according to ASTM F1541, which is a standard for external fixation devices. This is mechanical performance testing, not clinical performance for diagnostic accuracy or effectiveness with human intervention.
• Comparison of Technological Characteristics: Arguing that the subject device shares material, design, and operating principles with the predicate devices.
• Conclusion: Stating that the device is substantially equivalent based on the provided information.

In summary, the provided FDA 510(k) clearance letter and summary are for a traditional medical device (an external ring fixation system) and do not contain information related to AI or a study designed to evaluate its clinical performance against specific acceptance criteria as you've outlined.

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The Paragon Adult Maxi PMP Oxygenator is a hollow fiber membrane oxygenator intended for physiologic gas exchange in adults and small adults undergoing cardiopulmonary bypass surgery. The integrated heat exchanger makes it possible to regulate the blood temperature. The Paragon Adult Maxi PMP Oxygenator is intended for up to 6 hours. The Tubing Pack is intended for use in extracorporeal circulation during cardiopulmonary bypass procedures, lasting 6 hours or less.

The Paragon Adult Maxi PMP oxygenator (Paragon Maxi) with Tubing Pack is a hollow fiber membrane oxygenator with an integrated heat exchanger pre-connected to blood line and gas line tubing. The Paragon Maxi facilitates the gas exchange into and out of the blood, and the requlation of blood temperature during cardiopulmonary bypass. The Paragon Maxi is supplied with a Rheopak surface coating that reduces platelet adhesion to coated surfaces.

The gas exchanger part of the Paragon Maxi is formed of plasma tight hollow fiber membranes. The gas flow takes place through the inner lumen of the fibers. Blood is in contact with the outer side of the membranes, so that oxygen can diffuse into the venous blood, while carbon dioxide diffuses out of the blood. The heat exchanging part of the Paragon Maxi is made of non-porous hollow fiber membranes. Water flows through the inner lumen of the fibers, so that blood temperature flowing outside is regulated.

The Tubing Pack is a component of a cardiopulmonary bypass procedure that facilitates extracorporeal circulatory support for a term of up to 6 hours.

The document provided is a 510(k) summary for a medical device (Paragon Adult Maxi PMP Oxygenator with Tubing Pack) and does not contain information about an AI/ML powered device or study that determines acceptance criteria based on AI/ML performance.

The provided text details the regulatory review of a conventional medical device (oxygenator and tubing pack) and focuses on its substantial equivalence to predicate devices, in vitro and non-clinical test results. There is no mention of acceptance criteria related to a study proving an AI/ML device meets them. Therefore, I cannot extract the requested information from the provided document.

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The APEX 3D Total Ankle Replacement System is indicated as a total ankle replacement in primary surgery for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. Revision surgery for these patients is also indicated for patients with sufficient bone stock present. Components are intended for cemented use only.

The Paragon 28 APEX 3D Total Ankle Replacement device is a cemented, fixed-bearing device comprised of a tibial component, a talar component, and a UHMWPE component used for ankle joint replacement. Based on patient anatomy, a number of component sizes and design configurations can be selected for best fit.

The provided FDA 510(k) summary for the Paragon 28 APEX 3D Total Ankle Replacement System does not contain information related to AI/ML device performance or clinical studies using AI/ML. The document describes a traditional medical device (an ankle replacement system) and focuses on its mechanical performance testing and substantial equivalence to predicate devices based on physical properties, materials, and design.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement, as these elements are specific to the evaluation of AI/ML-driven medical devices, not the type of device described in this document.

The document details:

• Device Type: Total Ankle Replacement System (mechanical implant).
• Performance Testing: Focuses on mechanical characteristics like range of motion, contact stress, fatigue strength, polyethylene wear, etc.
• Substantial Equivalence: Based on intended use, indications, design, materials, and size range compared to predicate mechanical devices.

Thus, all specific questions regarding AI/ML device evaluation (e.g., test set, ground truth, experts, MRMC, standalone performance, training set) are not applicable to the content provided.

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The Paragon Adult Maxi PMP oxygenator is a hollow fiber membrane oxygenator intended for physiologic gas exchange in adults and small adults undergoing cardopulmonary bypass surgery. The integrated heat exchanger makes it possible to regulate the blood temperature. The Paragon Adult Maxi PMP Oxygenator is intended for up to 6 hours.

The Paragon Adult Maxi PMP oxygenator (Paragon Maxi) is a hollow fiber membrane oxygenator with an integrated heat exchanger. The Paragon Maxi facilitates the gas exchange into and out of the blood, and the regulation of blood temperature during cardiopulmonary bypass. The Paragon Maxi is supplied with a Rheopak surface coating that reduces platelet adhesion to coated surfaces. The gas exchanger part of the Paragon Maxi is formed of plasma tight hollow fiber membranes. The gas flow takes place through the inner lumen of the fibers. Blood is in contact with the outer side of the membranes, so that oxygen can diffuse into the venous blood, while carbon dioxide diffuses out of the blood. The heat exchanging part of the Paragon Maxi is made of non-porous hollow fiber membranes. Water flows through the inner lumen of the fibers, so that blood temperature flowing outside is regulated.

The provided text describes information for a K191246 submission regarding a Cardiopulmonary Bypass Oxygenator, not an AI/ML medical device. Therefore, it does not contain the specific details requested for an AI/ML device, such as acceptance criteria based on performance metrics (e.g., sensitivity, specificity), nor does it describe studies involving human readers, training/test sets, or ground truth established by experts.

The document focuses on the Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP), a physical medical device. The "acceptance criteria" and "study that proves the device meets acceptance criteria" are discussed in terms of the device's physical and functional performance, rather than AI model performance.

However, I can extract and present the physical device's performance evaluation in a table format as requested, interpreting "acceptance criteria" in the context of this traditional medical device.

1. Table of Acceptance Criteria and Reported Device Performance

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The Diagnostic Ultrasound System is applicable for adults and pediatric patients. It is intended for use in pediatric, small organ (breast, thyroid, testicles, prostate), musculoskeletal (conventional), musculoskeletal (superficial), peripheral vessel and dermatological exams.

The Paragon XHD Diagnostic Ultrasound System is a mobile software controlled ultrasonic system. Its function is to acquire and display ultrasound data in B-Mode, Color Flow Doppler, Power/Dirpower mode or the combination of these modes. The system can also measure anatomical structures and offer software analysis packages performance to provide information based on which the competent health care professionals can make the diagnosis. The Paragon XHD Diagnostic Ultrasound System consists of the main unit, an ultrasound probe, power adapter, connecting cable.

The provided document is a 510(k) summary for the Shenzhen Wisonic Medical Technology Co., Ltd. Paragon XHD Diagnostic Ultrasound System. This document outlines the device's characteristics and its substantial equivalence to predicate devices, focusing on safety and performance.

However, the document does NOT contain information about acceptance criteria and the study that proves the device meets the acceptance criteria from an AI/algorithm performance perspective. Instead, it discusses the device's compliance with electrical safety, EMC, biocompatibility, and general performance standards for an ultrasound system.

Therefore, I cannot extract the requested information regarding AI/algorithm performance acceptance criteria, test set details, expert consensus, MRMC studies, or standalone algorithm performance, as these are not discussed in the provided text.

The information given pertains to the ultrasound system itself, not an AI component within it. The closest approximation to "performance testing" in the document describes evaluating "clinic measurement accuracy and system sensitivity," which are general ultrasound system performance metrics, not related to an AI algorithm that would have specific acceptance criteria like sensitivity, specificity, or AUC.

Without further information describing an AI component and its validation, I cannot fulfill your request in full detail. If there was an AI component, the provided document does not elaborate on its specific validation.

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The SherpaPak™ Pancreas Transport System is intended to be used for the static hypothermic preservation of pancreas organs during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with this organ. The SherpaPak™ Pancreas Transport System can maintain the donor organ storage temperature between 4º C and 8º C up to 21 hours.

Not Found

This looks like a 510(k) clearance letter for the Paragonix SherpaPak Pancreas Transport System. As such, the information you've requested about acceptance criteria and study details (like sample size, number of experts, ground truth, etc.) is typically not found directly within the clearance letter itself.

A 510(k) clearance is about demonstrating substantial equivalence to a predicate device, not necessarily extensive clinical performance studies like those required for a PMA (Premarket Approval). The FDA reviews the provided data (which might include bench testing, engineering reports, and sometimes limited clinical data or literature reviews) to determine if the new device is as safe and effective as a legally marketed predicate device.

Therefore, based solely on the provided text, I cannot extract the specific details you've asked for. The document primarily outlines the FDA's regulatory decision and standard disclaimers.

However, I can tell you the stated "Indications for Use" which implicitly sets the performance envelope for the device:

• Intended Use: Static hypothermic preservation of pancreas organs during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with this organ.
• Performance Claim: The SherpaPak™ Pancreas Transport System can maintain the donor organ storage temperature between 4º C and 8º C up to 21 hours.

To get the detailed information you're looking for (acceptance criteria, study design, sample sizes, ground truth establishment, etc.), you would typically need to refer to:

• The original 510(k) submission document: This is a comprehensive package submitted by the manufacturer to the FDA. It contains all the bench testing, performance data, and other information used to support the substantial equivalence claim. This is usually not publicly available in full detail.
• Any associated clinical trial publications: If the manufacturer performed any studies (even limited ones for 510(k), or more extensive ones for other regulatory purposes or marketing), they might be published in scientific journals.
• The manufacturer's official documentation: User manuals, technical specifications, and marketing materials might provide some of this performance data.

In summary, the provided FDA letter does not contain the detailed study information you're seeking. It confirms the clearance of the device and its intended use and a key performance parameter (temperature range and duration).

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The SherpaPak Cardiac Transport System is intended to be used for the station of hearts during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the heart. The intended organ storage time for the SherpaPak Cardiac Transport System is up to 4 hours. Donor hearts exceeding clinically accepted static hypothermic preservation times should be evaluated by the transplant surgeon to determine transplantability in accordance with accepted clinical guidelines and in the best medical interest of the intended recipient.

Not Found

The provided text is a 510(k) clearance letter from the FDA for the SherpaPak Cardiac Transport System. It indicates that the device has been found substantially equivalent to predicate devices for its intended use. However, the document does not contain any information about acceptance criteria for device performance, nor does it describe any study demonstrating that the device meets such criteria.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance using the provided input. The document focuses on regulatory clearance based on substantial equivalence, not on detailed performance metrics or clinical trial results.

To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data (which may be part of a 510(k) submission but is not included in this clearance letter), a clinical study report, or a descriptive document of the device's validation.

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FluoroPerm® 92 rigid gas permeable spheric contact lenses with Tangible Hydra-PEG are indicated for daily wear as recommended by the eye care practitioner.

FluoroPerm® 92 rigid gas permeable spheric and bifocal contact lenses with Tangible Hydra-PEG are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 92 toric contact lenses with Tangible Hydra-PEG are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 92 bifocal lenses with Tangible Hydra-PEG are indicated to treat presbyopia up to +4.00 D add power.

In daily wear use only, FluoroPerm® 92 contact lenses with Tangible Hydra-PEG are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise non-diseased eyes.

FluoroPerm® 60 rigid gas permeable spheric contact lenses with Tangible Hydra-PEG are indicated for daily wear as recommended by the eye care practitioner.

FluoroPerm® 60 rigid gas permeable spherical, aspheric and bifocal contact lenses with Tangible Hydra-PEG are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit comeal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 60 toric contact lenses with Tangible Hydra-PEG are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 60 bifocal lenses with Tangible Hydra-PEG are indicated to treat presbyopia up to +4.00 D add power.

In daily wear use only, FluoroPerm® 60 contact lenses with Tangible Hydra-PEG are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes.

Paragon HDS® rigid gas permeable spheric contact lenses with Tangible Hydra-PEG are indicated for daily wear as recommended by the eye care practitioner.

Paragon HDS® rigid gas permeable spheric and bifocal contact lenses with Tangible Hydra-PEG are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. Paragon HDS® toric contact lenses with Tangible Hvdra-PEG are indicated to correct astigmatism of up to 6.00 diopters. Paragon HDS® bifocal lenses with Tangible Hydra-PEG are indicated to treat presbyopia up to +4.00 D add power.

In daily wear use only, Paragon HDS® contact lenses with Tangible Hydra-PEG are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise non-diseased eyes.

FluoroPerm® 30 rigid gas permeable contact lenses with Tangible Hydra-PEG are indicated for daily wear as recommended by the eye care practitioner.

FluoroPerm® 30 rigid gas permeable spheric and bifocal contact lenses with Tanzible™ Hydra-PEG are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 30 toric contact lenses with Tangible Hydra-PEG are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 30 bifocal lenses with Tangible Hydra-PEG are indicated to treat presbyopia up to +4.00 D add power.

In daily wear use only, FluoroPerm® 30 contact lenses with Tangible Hydra-PEG are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration. or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes.

Paragon Thin rigid gas permeable contact lenses with Tangible Hydra-PEG are indicated for daily wear as recommended by the eye care practitioner.

Paragon Thin rigid gas permeable spherical, aspheric and bifocal contact lenses with Tangible Hydra-PEG are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. Paragon Thin'm toric contact lenses with Tangible Hydra-PEG are indicated to correct astigmatism of up to 6.00 diopters. Paragon Thin™ bifocal lenses with Tangible Hydra-PEG are indicated to treat presbyopia up to +4.00 D add power.

In daily wear use only, Paragon Thin™ contact lenses with Tangible Hydra-PEG are indicated for management of iregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise non-diseased eves.

FluoroPerm® 151 rigid gas permeable spheric contact lenses with Tangible Hydra-PEG are indicated for daily wear as recommended by the eye care practitioner.

FluoroPerm® 151 rigid gas permeable spherical, aspheric and bifocal contact lenses with Tangible Hydra-PEG are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 151 toric contact lenses with Tangible Hydra-PEG are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 151 bifocal lenses with Tangible Hydra-PEG are indicated to treat presbyopia up to +4.00 D add power.

In daily wear use only, FluoroPerm® 151 contact lenses with Tangible Hydra-PEG are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration. or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes.

Paragon HDS® 100 rigid gas permeable spherical or aspheric contact lenses with Tangible™ Hydra-PEG are indicated for daily wear as recommended by the eye care practitioner.

Paragon HDS® 100 rigid gas permeable spherical, aspheric and bifocal contact lenses with Tangible™ Hydra-PEG are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. Paragon HDS® 100 toric contact lenses with Tangible™ Hydra-PEG are indicated to correct astigmatism of up to 6.00 diopters. Paragon HDS® 100 bifocal lenses with Tangible™ Hydra-PEG are indicated to treat presbyopia up to +4.00 D add power.

In daily wear use only, Paragon HDS® 100 contact lenses with Tangible™ Hydra-PEG are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes.

FluoroPerm® 30, Paragon Thin™, FluoroPerm® 60, Paragon HDS®, FluoroPerm® 92, FluoroPerm® 151 & Paragon HDS® 100 lenses with Tangible™ Hydra-PEG are available as lathe cut rigid gas permeable contact lenses for daily wear only. The lenses are manufactured from the following currently marketed contact lens materials: paflufocon A (FluoroPerm® 92), paflufocon B (FluoroPerm® 60, Paragon HDS®), paflufocon C (FluoroPerm® 30. Paragon Thin™), paflufocon D (FluoroPerm® 151, Paragon HDS® 100). These materials are thermoset copolymers derived from fluorosilicone acrylate monomers. The lenses may be tinted to offer a handling aid for locating the lenses may be available with an ultraviolet absorber (not in all colors and materials). The lens designs have a posterior surface consisting of a base curve and a series of up to four annular spherical or aspheric curves peripheral to the base curve. The FluoroPerm® 92, FluoroPerm® 60, Paragon HDS®, FluoroPerm ® 30, Paragon Thin™ FluoroPerm®151, and Paragon HDS® 100 lenses are treated to incorporate Tangible™ Hydra-PEG-which is a thin polyethylene glycol (PEG)-based polymer that is covalently bonded to the surface of the contact lens and is designed to enhance the surface properties of the contact lens while retaining the mechanical properties of the underlying material. When treated with Tangible™ Hydra-PEG, the underlying material is encapsulated in a thin layer of polymer that results in measurable improvement of wettability (sessile drop contact angle) compared to untreated lenses.

The provided text describes a 510(k) premarket notification for various rigid gas permeable (RGP) contact lenses treated with Tangible™ Hydra-PEG. It details the device, its intended use, and a comparison to predicate devices, but it does not include a detailed study with specific acceptance criteria and performance metrics (like sensitivity, specificity, AUC) typically found in AI/ML device studies.

The "Acceptance Criteria" provided in the document refers to the general safety and effectiveness of the contact lenses, focusing on material properties, biocompatibility, and stability, rather than diagnostic performance metrics. The "study" mentioned is primarily non-clinical and previous clinical data from predicate devices.

Therefore, I cannot populate the table and answer the study-specific questions as they would apply to an AI/ML diagnostic or prognostic device study. Instead, I will extract the information that is present regarding the device's characteristics and the evaluations conducted.

Here’s a summary based on the provided text, focusing on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for contact lenses with a surface coating, the "acceptance criteria" are related to biocompatibility, material properties, and stability, rather than typical diagnostic performance metrics (e.g., sensitivity, specificity) for AI/ML devices. The key performance metric explicitly reported is wettability.

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