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JDEvolution Plus L and JDEvolution Plus LE implant system is intended for surgical placement in the upper jaw.

JDEvolution Plus L and JDEvolution Plus LE implant system provides a means for prosthetic attachment in partially or fully edentulous spans with multiple teeth utilizing delayed, or immediate loading, or as a terminal or intermediary abutment for fixed ore removable bridgework or to retain overdentures. JDEvolution Plus L and JDEvolution Plus LE is intended for immediate function multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function.

JDEvolution Plus L and JDEvolution Plus LE implants with lengths of 18, 20, 22, 24, 26 mm are only indicated for multiple unit restorations in splinted applications with at least two implants when placed in the maxilla.

JDEvolution Plus L and LE, are tissue level implantable devices produced in commercially pure titanium, intended for surgical placement in the upper jaw to support prosthetic devices, such as artificial teeth, in order to restore chewing function.

JDEvolution Plus L and LE are endosseous dental implants intended for surgical placement in the upper jaw. JDEvolution Plus L and LE implants includes dental implant fixtures only.

JDEvolution Plus L and LE provide a means for prosthetic attachment partially or fully edentulous spans with multiple teeth utilizing delayed or immediate loading when good primary stability is achieved in order to restore patient chewing function.

The subject implant bodies are compatible with abutments cleared in K143142 and K233896

Knowledgeable clinicians are in charge for the following of a delayed instead immediate loading, evaluating the stability of the implant sites after the surgical operation.

The device insertion occurs at the end of the surgical procedure which consists in an osteotomy of the upper jaw.

JDEvolution Plus L and LE implants are single use devices, supplied sterile and that cannot be re-cleaned or re-sterilised.

JDEvolution Plus L and LE Implant System is a two-piece implant made of commercially pure titanium.

The body of the implant fixture (Endosseous Dental Implant) is surgically placed in the upper or lower jaw, while the Abutment (several type for several clinical application) is screwed into the fixture to support the prosthesis.

The connection is done through an internal hexagon: abutments and other accessories are exclusively designed for JDEvolution Plus L and LE Implant System.

Endosseous dental implant and abutment will represent the support, for the dentist, for building the artificial replacement tooth.

The artificial replacement tooth component is not part of this submission.

The main features of JDEvolution Plus L and LE Implant System are summarized in the table below:

JDEvolution Plus:
Materials: Titanium grade 4 (diameter 4.0)

Design:
General Features: Endosseous implant with connection with internal hexagon
Shape:
Collar: Machined gingival collar of 1,5mm length for all the lengths
Body: Double thread with 0.6 mm lead: straight cylindrical of 4,0 mm diameter for a total length (including collar) of 20 / 22 / 24 / 26mm. Tapered apex with bone cutting flutes.
Double thread with 1.2 mm lead: tapered body of 4,0 mm for a total length (including collar) of 18 / 20 / 22 / 24 / 26mm
Thread: Double thread with 0.6 mm or 1.2 mm lead
Abutment: To be connected with the Conical abutment cleared under K143142, K233896
Ti gr.5: Straight– angled 15° - angled 17° - angled 25°- angled 30°

Surface:
Collar: Machined, without any surface treatment
Body: Treated through sandblasting followed by acid etching (SLA) for the full length of the endosseous portion for all variants (the surface treatment is the same of the JDentalCare Implant System JDIcon cleared under K 182081)

Thread:
Body: Double thread
outline: trapezoidal
Thread lead: 0.6 mm (for tapered body version)
Thread lead: 1.2 mm (for straight cylindrical body version)
Self-Threading Capacity: Self-threading capacity in both direction

Dimensions:
Mean Diameter: 4.0 mm
Total Length: 18mm (only for JD Evolution Plus LE Implant), 20mm, 22mm, 24mm and 26mm
Implanted Length: 16.5mm (only for JD Evolution Plus LE Implant), 18.5mm, 20.5mm, 22.5mm and 24.5mm

Connection:
Shape: Internal hexagonal connection (Hexagon dimension of 2.425 mm)

Packaging:
Type of package: Blister with internal vial and protective cap for implants
External carton box as commercial packaging
Blister material: Tyvek
Polyester PET MO65
Vial material: Polystyrene Empera 116 vial closed with Eralyte PET cap

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The Jarvis Glenoid Reverse Shoulder Prosthesis is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff.

The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The glenoid baseplate is intended for cementless application with the addition of screws for fixation.

The JARVIS Glenoid Reverse Shoulder Prosthesis is used for reverse shoulder prosthesis, intended for primary, fracture or revision shoulder replacement. The JARVIS Glenoid Reverse Shoulder Prosthesis is made up of three components – glenophere, baseplate, and fixation component (screw or post). All components are offered in varying sizes to accommodate patient anatomy. The baseplate and screw components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) per ASTM F-136/ISO 5832-3, while the glenophere is manufactured from wrought cobalt chromium molybdenum alloy per ASTM F1537/ISO 5832-12. All components are provided sterile via gamma irradiation.

The subject submission seeks to gain clearance for design modifications to the existing device components.

The provided FDA 510(k) clearance letter for the JARVIS Glenoid Reverse Shoulder Prosthesis does not contain any information regarding clinical studies, acceptance criteria for an AI/CADe device, or performance data related to AI assistance.

The document describes a traditional medical device (a shoulder prosthesis), not an artificial intelligence (AI) or computer-assisted detection/diagnosis (CADe/CADx) device. Therefore, it lacks the specific details requested in your prompt, such as:

• Table of acceptance criteria and reported device performance for an AI/CADe system.
• Sample sizes, data provenance, expert qualifications, or adjudication methods for a test set.
• Information on multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Ground truth types and methods for establishing ground truth.
• Training set sample size and ground truth establishment for AI.

The "Performance Testing" section explicitly states: "Engineering analysis was conducted on the modified locking screws and concluded that the compressive force of the subject screws is equivalent to that of the predicate and therefore locking capabilities are equivalent. Therefore, all previous performance testing and validations are still applicable and no additional testing is necessary." This refers to mechanical testing of the physical implant components, not performance of an AI algorithm.

In summary, the provided text is for a physical medical implant, not an AI-based or software-as-a-medical-device (SaMD) product that would require the kind of data and studies you are asking about.

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The JAZZ Spinal System is intended for posterior, non - cervical fixation as an adjunct to fusion for skeletally mature patients for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion. In addition, when used as a pedicle screw fixation system, the JAZZ Spinal System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, L5-S1 vertebra, who are receiving fusion by autogenous bone graft only, who are having the device attached to the lumbar and sacral spine (levels may be from L3 to the sacrum/ilium), who are having the device removed after the attainment of a solid fusion.

The JAZZ Spinal System consists of a variety of shapes and sizes of screws and rods that can be rigidly locked in a variety of configurations, with each construct being tailor-made for the individual case. Fixation is provided via a posterior approach. The components are made from titanium alloy, unalloyed titanium, or cobalt chrome alloy. Implant components of the system include straight and pre-bent rods, monoaxial and polyaxial screws, reduction screws, domino connectors, crosslinks, dual headed screws and connectors, transverse and sagittal uniplanar screws, favored angle screws, modular screws, iliac screws, along with associated set screws.

The provided FDA 510(k) clearance letter for the JAZZ Spinal System does not describe a study related to AI/algorithm performance for a diagnostic or imaging device. Instead, it details a clearance for a medical implant device (Thoracolumbosacral Pedicle Screw System).

Therefore, I cannot extract the information requested about acceptance criteria, study design, ground truth establishment, or human-in-the-loop performance related to an AI/algorithm. The document focuses on the mechanical performance and material safety of the spinal implant.

Specifically:

• Acceptance Criteria & Reported Performance (Table): Not applicable for an AI/algorithm study based on this document. The document mentions "Performance testing" for the spinal implant, including "static compression bending, static torsion, and dynamic compression bending per ASTM F1717-21, as well as static neutral angle dissociation and static maximum angle dissociation per ASTM F1798-13." However, these are mechanical tests for the implant itself, not metrics for an AI's diagnostic performance.
• Sample size and data provenance, number of experts, adjudication, MRMC study, standalone performance, type of ground truth, training set size and ground truth: None of this information is present in the document because it pertains to the validation of a software algorithm or AI, not a spinal implant. The "ground truth" for a spinal implant would be its material properties and mechanical integrity, tested in a lab setting, not clinical annotation by experts.

In summary, the provided document is irrelevant to the prompt's request for details on an AI/algorithm performance study.

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JMS CAVEO A.V. Fistula Needle Set is intended for temporary cannulation to vascular access for extracorporeal blood treatment for hemodialysis. This device is intended for single use only. The anti-needlestick safety feature aids in prevention of needle stick injuries when removing and discarding the needle after dialysis. The device also has an integrated safety mechanism that is designed to automatically generate a partial occlusion of the internal fluid path and trigger the hemodialysis machine to alarm and shut off if a complete dislodgement of the venous needle from the arm inadvertently occurs. In vitro testing supports that this feature triggers the hemodialysis machine to alarm and shut off.

The subject device is the JMS CAVEO A.V. Fistula Needle Set (CAVEO) with an anti-needlestick safety feature. The Caveo is predicted to protect patients from the risks associated with venous needle dislodgement (VND) based on bench testing results. It contains an integrated stainless steel torsion spring mechanism and bottom footplate that provides an open/fluid path when the AV fistula set is fully cannulated into the access site. When the venous needle becomes completely dislodged from the patient's arm, this mechanism enables the footplate to partially occlude the blood path, generating an increased venous line pressure high enough to trigger automatic alarm and halt further blood pumping of the hemodialysis machine. In vitro testing supports that this feature triggers the hemodialysis machine to alarm and shut off. Based on bench testing results, this may significantly reduce patient blood loss in the event of a complete VND. The Caveo has a pre-attached anti-stick needle guard for prevention of needlestick injury at the time of needle withdraw after completion of a hemodialysis procedure.

In vitro performance testing using dialysis machine Fresenius 2008K supports the function of the Caveo VND feature with a venous pressure limit set to 200mmHg symmetric mode, a maximum dialyzer membrane surface area of 2.5 m2, minimum blood flow rate of 200 mL/min, maximum ultrafiltration rate of 4000 mL/hour, and simulated treatment duration of 8 hours. If different machine and/or setting are used, before introducing the device, refer to Directions for Use.

This document describes the FDA 510(k) clearance for the JMS CAVEO A.V. Fistula Needle Set. This device is a physical medical device, specifically a needle set for hemodialysis, and does not involve Artificial Intelligence (AI). Therefore, many of the requested criteria related to AI/software performance, ground truth establishment, expert adjudication, MRMC studies, and training datasets are not applicable.

The document primarily focuses on bench testing (in vitro performance) and a simulated clinical usability study to demonstrate device safety and effectiveness.

Here's a breakdown based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily demonstrated through various performance tests, with "Passed" as the acceptance. The document doesn't explicitly state numerical acceptance thresholds for all tests (e.g., how much "Force to Depress the Footplate" is acceptable), but it implies successful completion. For some, like needle penetration resistance and retraction lock strength, numerical criteria are provided.

2. Sample Size for Test Set and Data Provenance

• Test Set (Clinical Trial): 15 subjects (2 females, 13 males).
• Data Provenance: The document does not explicitly state the country of origin. It describes the recruitment from "the general hemodialysis population," and mentions racial/ethnic demographics, but not geographic. Given the company is "JMS North America Corporation" (Hayward, CA), it is highly probable the study was conducted in the US. The study appears to be prospective as it involves recruitment and device use to confirm safety, performance, and usability.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This question is largely not applicable as the device is a physical medical device. The "ground truth" for performance is established through bench testing (objective physical measurements) and the success of the device in a simulated clinical setting. There is no mention of human experts establishing a "ground truth" for diagnostic or AI-related interpretations.

For the simulated clinical usability study, the "ground truth" is whether the device performed as intended and was usable, as observed by clinicians/researchers during the study. The qualifications of those assessing the usability are not specified, beyond the implication that they are competent to conduct a clinical trial for hemodialysis devices.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation (e.g., radiology reads) where there might be disagreement in expert opinions needing a tie-breaker. This is not applicable here as:

• The primary "test set" involves objective performance characteristics (bench testing).
• The clinical usability study likely involved observing successful function and user feedback, not a diagnostic interpretation needing adjudication.

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

No. An MRMC study is relevant for evaluating the performance of AI systems or diagnostic tools where multiple human readers interpret cases, often with and without AI assistance, to see if the AI improves human performance. This device is a physical hemodialysis needle set, not an AI or diagnostic tool.

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

Not applicable. This refers to the performance of an AI algorithm on its own. The device is a physical product. Its "standalone" performance is assessed through bench testing (e.g., VND Performance, Mechanical Hemolysis Testing, Needle Penetration Resistance). These tests evaluate the device's inherent functional characteristics independent of human interaction during the critical failure modes.

7. The Type of Ground Truth Used

• Bench Testing: The ground truth is based on objective physical measurements and engineering specifications (e.g., force measurements, leak tests, dimensional analyses) and functional success/failure (e.g., did the VND feature trigger the alarm?).
• Simulated Clinical Usability Study: The ground truth is based on observed device performance during simulated use and the successful delivery of hemodialysis without impedance by the device's novel features. This is akin to outcomes data in a controlled simulated environment.

8. The Sample Size for the Training Set

Not applicable. The device is a physical product and does not involve AI or machine learning models that require 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.

In summary, the provided document details the non-clinical and limited clinical testing of a physical medical device (hemodialysis needle set). The acceptance criteria are largely met through rigorous bench testing demonstrating physical and functional robustness, and a small simulated clinical study confirming usability and safety in a controlled environment. AI-specific criteria are not relevant to this type of device.

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The Jewel Soft Tissue Reinforcement Device is a single-use device intended for reinforcement of soft tissues that are undergoing reconstruction surgery, utilizing autograft or allograft soft tissue grafts, or are to be repaired by suture or other fixation devices during ligament repair surgery. This includes reinforcement of extra-articular ligaments such as, but not limited to, medial collateral ligament, lateral collateral ligament, spring ligament, deltoid ligament, and ulnar collateral ligament.

The Jewel Soft Tissue Reinforcement Device is not intended to replace normal body structure or provide the full mechanical strength to support the medial collateral ligament, lateral collateral ligament, spring ligament, deltoid ligament, ulnar collateral ligament or other extra-articular ligaments. Sutures, or other fixation devices, used to attach the tissue to the bone, provide mechanical strength for the reconstruction or repair.

The Jewel Soft Tissue Reinforcement Device is a woven tubular implantable device intended to provide support for soft tissues where weakness exists including soft tissues that have been repaired using suture or other fixation devices during ligament repair surgery. The tubular structure of the implant is designed to allow insertion of an allograft or autograft inside the mesh structure; or alternately for reinforcement of the native tissue. The Jewel Soft Tissue Reinforcement Device is a gamma sterilized, single use, permanent implant manufactured from Polyester (Polyethylene Terephthalate; PET) a nonabsorbable material that has a long history of use in the orthopedic market. The Jewel Soft Tissue Reinforcement Device is treated with an atmospheric gas plasma process to improve surface wettability of the mesh structure. The Jewel Soft Tissue Reinforcement Device is MRI safe.

This document is a 510(k) clearance letter for a medical device called the "Jewel Soft Tissue Reinforcement Device" (K242237). It is not a study proving the device meets acceptance criteria related to an AI algorithm. Instead, it describes a medical device for use in surgery and provides information about its mechanical and biocompatibility testing to demonstrate substantial equivalence to a predicate device.

Therefore, many of the requested elements for describing an AI study's acceptance criteria and performance (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable to this document. This document pertains to a physical surgical mesh device, not an AI software device.

However, I can extract the information that is present about the device's performance testing and acceptance criteria as described in the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the series of tests were "successfully completed" and "The results demonstrate that the Jewel Soft Tissue Reinforcement Device... provides adequate mechanical properties for its intended use." The specific numerical acceptance criteria (e.g., minimum tensile strength in Newtons) are not provided in this summary, nor are the specific numerical results. The fundamental acceptance criterion for 510(k) clearance is "substantial equivalence" to a legally marketed predicate device, implying that the performance must be no worse than the predicate device for safety and effectiveness.

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

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified in the provided text. The testing was conducted by the manufacturer, Xiros Limited.

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

• Not Applicable. This is not an AI device clearance based on clinical image interpretation or diagnosis. The "ground truth" here refers to the physical properties of the device measured in performance tests rather than expert interpretation of data.

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

• Not Applicable. See point 3.

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, Not Applicable. This is not an AI device.

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

• Not Applicable. This is not an AI device.

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

• The "ground truth" for this device's evaluation is based on engineering and material science measurement standards and biocompatibility standards. For example, "Ultimate Tensile Strength" would be measured according to an established test method (e.g., ASTM standards) to determine its actual value, which is then compared to an acceptable range or the predicate device's performance.

8. The sample size for the training set

• Not Applicable. This is not an AI device with a training set.

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

• Not Applicable. This is not an AI device with a training set.

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JET BITE & JET BLUE BITE are intended for the registration of occlusion in cases where relationship between the relative positions of maxilla and mandible is required.

Jet Bite and Jet Blue Bite are two component impression materials based on vinylpolysiloxanes used for the registration of occlusion between the maxilla and mandible. Jet Bite and Jet Blue Bite are mixed during application and applied directly to the teeth, after which the mandible is moved into centric occlusion making an impression.

The provided document (FDA 510(k) Clearance Letter - K250969) is for dental impression materials (Jet Bite; Jet Blue Bite Fast; Jet Blue Bite Superfast). Unfortunately, this document does not describe a study involving an AI/software device that requires intricate ground truth establishment, expert adjudication, or MRMC comparative effectiveness studies.

The "Acceptance Criteria and Study" section in the document refers to performance testing for the physical properties of the impression material based on ISO 4823 standards, not an AI model's performance.

Therefore, I cannot fulfill your request for an AI device's acceptance criteria and study details based on the provided text. The document focuses on the substantial equivalence of a physical dental impression material to a predicate device, as opposed to the validation of a software algorithm.

If you have a document describing the validation of an AI/software device, I would be happy to analyze it against your request.

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The JetCan® Pro Safety Huber Needle is indicated for use in the delivery of fluids and drugs, as well as blood sampling through surgically implanted vascular access ports for up to 24 hours. It is compatible with power injection ports and associated power injection procedures up to 325 psi.

The JetCan® Pro Safety Huber Needle incorporates a passive safety mechanism, activated upon the withdrawal from a port catheter to aid in the prevention of accidental needle sticks and minimize exposure to hazardous fluids.

The JetCan® Pro Safety Huber Needle is a non-coring Huber needle used to access the septum of a surgically implanted vascular access port for the delivery of intravenous fluids, blood sampling and power injection of contrast media, up to 5 mL/s at 325 psi.

The JetCan® Pro Safety Huber Needle is a single use, external communicating device, with direct blood contact and a duration of use of less than or equal to 24 hours.

The provided FDA 510(k) clearance letter for the JetCan® Pro Safety Huber Needle primarily focuses on the device's technical characteristics, regulatory compliance, and a comparison to a predicate device. It does not contain information about a study proving the device meets specific acceptance criteria based on AI/ML performance, nor does it refer to human reader studies (MRMC), standalone algorithm performance, or the establishment of ground truth for such studies.

The document describes performance testing related to the physical and functional aspects of the needle, such as burst pressure, flow rate, and safety mechanism activation. These are engineering and performance specifications, not acceptance criteria for an AI/ML model's diagnostic accuracy or similar AI-driven performance.

Therefore, I cannot extract the requested information (points 1-9) about AI/ML performance acceptance criteria or studies from this document. The device is a medical needle, not an AI/ML-powered diagnostic or assistive tool.

To illustrate what a response would look like if the document did contain such information, I will provide a hypothetical example, assuming the JetCan® Pro Safety Huber Needle was an AI-powered device for, e.g., predicting proper needle placement.

Hypothetical Example (if the JetCan® Pro Safety Huber Needle were an AI-powered device):

The JetCan® Pro Safety Huber Needle, if it were an AI-powered device, would require a different set of acceptance criteria and a different type of study to prove it meets those criteria. Based on the provided document, the device is a physical medical instrument (a Huber needle). Therefore, the information requested regarding AI/ML performance, MRMC studies, standalone algorithm performance, and ground truth establishment is not present in the provided 510(k) letter.

However, to demonstrate how such a request would ideally be answered if the document pertained to an AI/ML device, below is a hypothetical example of how a study proving an AI-powered device meets acceptance criteria might be described:

Hypothetical Study Description for an AI-Powered JetCan® Pro Safety Huber Needle (Not present in the provided document):

Let's assume, for the sake of this hypothetical example, that the "JetCan® Pro Safety Huber Needle" was an AI-powered imaging analysis device designed to accurately identify the optimal insertion point for a Huber needle on a vascular access port, thus preventing accidental needle sticks or unsuccessful insertions.

1. Table of Acceptance Criteria and Reported Device Performance (Hypothetical)

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

• Test Set Sample Size: 500 unique patient images (e.g., ultrasound or fluoroscopic images of vascular access ports).
• Data Provenance: Retrospective data collected from five major medical centers across the United States (40%), Europe (30%), and Asia (30%). Data was anonymized and de-identified prior to analysis.

3. Number, Qualifications, and Adjudication Method of Experts for Ground Truth (Hypothetical)

• Number of Experts: A panel of 5 board-certified interventional radiologists and vascular surgeons.
• Qualifications of Experts: Each expert had a minimum of 10-15 years of experience in vascular access procedures, with specific expertise in port placement and troubleshooting. They were blinded to the device's performance during ground truth establishment.
• Adjudication Method: A "3+1" adjudication method was used. Initially, three experts independently reviewed each image and marked the optimal insertion point. If at least two out of three experts agreed on a location, that became the preliminary ground truth. If there was no majority consensus (e.g., 1-1-1 split), a fourth senior expert, blinded to the initial ratings, was brought in as a tie-breaker. All discrepancies were resolved through consensus meetings.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study (Hypothetical)

• Yes, an MRMC study was performed.
• Design: A crossover design was employed where 10 independent vascular access specialists (not involved in ground truth establishment) reviewed the test set images.
  • Phase 1 (Without AI Assistance): Specialists individually identified the optimal insertion point on all 500 images.
  • Phase 2 (With AI Assistance): After a washout period, the same specialists reviewed the same 500 images but with the AI device providing its predicted optimal insertion point. Specialists could accept, reject, or modify the AI's suggestion.
• Effect Size: The study demonstrated a statistically significant improvement in human reader performance with AI assistance.
  • Improvement in Sensitivity: Human readers' average sensitivity for identifying optimal insertion points increased from 82% (without AI) to 94% (with AI assistance), representing a 12% absolute improvement.
  • Reduction in Time to Decision: The average time taken by human readers to identify the optimal point decreased from 15 seconds (without AI) to 8 seconds (with AI assistance), representing a 47% reduction in time.
  • Reduction in Critical Errors: The number of significant misidentification errors (leading to potential adverse events) decreased by 60% when readers used AI assistance.

5. Standalone (Algorithm Only) Performance (Hypothetical)

• Yes, a standalone performance evaluation was conducted.
• Metrics: The algorithm's standalone performance on the test set against the established ground truth showed:
  • Sensitivity: 96.2%
  • Specificity: 91.5%
  • Accuracy: 93.8%
  • Area Under the Receiver Operating Characteristic Curve (AUC): 0.97

6. Type of Ground Truth Used (Hypothetical)

• Expert Consensus: The ground truth was established by the consensus of multiple, highly experienced interventional radiologists and vascular surgeons through a detailed, adjudicated review process of imaging data.

7. Sample Size for the Training Set (Hypothetical)

• Training Set Sample Size: 20,000 unique patient images (e.g., ultrasound and fluoroscopic images) of vascular access ports.

8. How Ground Truth for the Training Set Was Established (Hypothetical)

• Hybrid Approach:
  • Initial Annotation: A team of trained clinical annotators (e.g., medical imaging technicians or nurses with vascular access experience) performed initial annotations of optimal insertion points on all 20,000 images under the supervision of a senior radiologist.
  • Expert Review/Correction: A subset of 2,000 (10%) randomly selected images from the training set, along with all images flagged as challenging or ambiguous by the annotators, underwent expert review by two board-certified interventional radiologists. Discrepancies were resolved through discussion to refine the ground truth.
  • Automated Quality Control: Automated scripts were used to check for consistency in annotations (e.g., size, shape, location of marked areas) and flag outliers for further manual review.

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Jmoon Conductive Gel is intended to be used with microcurrent devices to improve skin conductivity.

The Jmoon Conductive Gel is a clear, viscous and chloride-free formulation. The gel is to be applied to the area under an electrode to reduce the impedance of the contact interface between the electrode surface and the skin.

The provided FDA 510(k) clearance letter and summary for the Jmoon Conductive Gel do not contain any information regarding clinical studies with human participants or the use of AI/algorithms. The document primarily focuses on the device's substantial equivalence to a predicate device based on its physical, chemical, and biological characteristics, as well as biocompatibility and shelf-life testing.

Therefore, many of the requested categories cannot be populated from the provided text.

Here's a breakdown of the available information:

Acceptance Criteria and Reported Device Performance

Study Details Based on Provided Information:

1. Sample size used for the test set and the data provenance: Not applicable. The studies mentioned (biocompatibility, shelf-life, performance testing) refer to laboratory-based evaluations of the gel's properties, not clinical studies with a test set of human subjects or images.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This information is relevant for studies involving human interpretation or clinical outcomes, which are not present in this document.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No human interpretation requiring adjudication was involved.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The device is a conductive gel, not an AI-based diagnostic or assistive tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device would be established through laboratory standards and validated test methods for chemical, physical, and biological properties, as well as regulatory standards for biocompatibility (e.g., ISO 10993 series).
7. The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.
8. How the ground truth for the training set was established: Not applicable. No training set was used.

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The JETi™ Hydrodynamic Thrombectomy System is intended to remove/aspirate fluid and break-up soft emboli and thrombus from the peripheral vasculature, including deep vein thrombosis (DVT), and to sub-selectively infuse/deliver diagnostics or therapeutics with or without vessel occlusion.

The JETi™ Hydrodynamic Thrombectomy System (JETi HTS) is a hydro-mechanical aspiration system intended for the removal of intravascular thrombus. The system is comprised of the JETi™ Catheter, JETi™ Pump Set, JETi™ Saline Drive Unit (SDU), JETi™ Accessory Cart, JETi™ Suction Tubing, and JETi™ Non-sterile Canister Set. The JETi Hydrodynamic Thrombectomy System is designed to continuously aspirate thrombotic material into the JETi Catheter, where a high-pressure stream of saline within the catheter tip macerates the thrombus as it is aspirated.

Here's an analysis of the provided text, focusing on acceptance criteria and the supporting study, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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