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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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The Jumao JM-P50A Portable Oxygen Concentrator provides a high concentration of supplemental oxygen to adult patients (ages 22 and older) requiring respiratory therapy on a prescriptive basis. It may be used in the home or in professional healthcare facility.

Portable Oxygen Concentrator, model: JM-P50A is a portable oxygen generator that is intended to release oxygen for respiratory therapy by physical means (a molecular sieve). It supplies a pulsed high concentration of oxygen and is used with a nasal cannula (supplied separately) to channel oxygen from the concentrator to the patient. The JM-P50A is small, portable and may be used in the home or in a professional healthcare facility.

Portable Oxygen Concentrator, model: JM-P50A, uses molecular sieve/pressure swing adsorption technology. Ambient air is drawn through particle filters by a compressor and forced through molecular sieve beds, which adsorb nitrogen and allow oxygen to pass. The airflow is then changed, and nitrogen is desorbed from the molecular sieve, allowing it to adsorb again during the next cycle. Oxygen is collected in an air tank. Waste nitrogen is exhausted back into the room. A series of sieve beds, manifolds and precision valves, sensors and embedded software are used to control the cycle to make the system function.

Portable Oxygen Concentrator, model: JM-P50A, can be used in the home or in a professional healthcare facility. Power options include 100 – 240 V (50- 60Hz) AC power supply, rechargeable battery packs.

Oxygen is delivered to the patient on a pulse dose basis in precise amounts during the inhalation part of the breathing cycle. This conserver technology eliminates waste of unused oxygen at other times in the breathing cycle when it is not needed. Portable Oxygen Concentrator, model: JM-P50A, senses the beginning of the inhalation cycle and releases a specified dose of oxygen enriched gas from the accumulator reservoir, through a final filter, into the connected nasal cannula and on to the patient.

The portable oxygen concentrator consists of main unit, battery, power adapter and carry case. The main gas pathway of oxygen concentrator is composed of particle filter, particle filters, air compressor, molecular sieve beds, manifold valve, sensors, air tank.

This is a 510(k) clearance letter for a Portable Oxygen Concentrator (JM-P50A). The document primarily focuses on demonstrating substantial equivalence to a predicate device (Inogen Rove 6 Portable Oxygen Concentrator) through bench testing and compliance with recognized consensus standards. It explicitly states that "There was no clinical testing performed."

Therefore, the provided document does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of clinical performance or human-in-the-loop assessment. The information you're asking for, particularly points 1-7 from your prompt, typically applies to studies proving clinical effectiveness or diagnostic accuracy of AI/software as a medical device (SaMD), which is not the case here.

However, I can extract information related to the device's technical specifications and how its performance was evaluated against standards, which serve as a form of acceptance criteria for this type of device.

Here's an interpretation based on the provided document, addressing what can be extracted and noting what cannot be:

Acceptance Criteria and Device Performance for Portable Oxygen Concentrator (JM-P50A)

Based on the provided 510(k) clearance letter, the acceptance criteria and the "study" (bench testing and standards compliance) focus on demonstrating substantial equivalence to a predicate device and adherence to recognized performance and safety standards. There was no clinical testing performed for this device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from the performance specifications of the predicate device and the requirements of various international standards. The "reported device performance" refers to the JM-P50A's demonstrated capability to meet these criteria through bench testing.

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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 SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.

The SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System is also intended for sacroiliac fusion to augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.

The SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System consists of an X shaped implant designed to assist in the healing of sacroiliac (SI) joints for fusion by providing fixation of the sacroiliac joint. The implant is not intended to replace normal body structures. The implant is offered in five variations with one size per variation. The implant is manufactured from titanium alloy per ASTM F136.

The SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System was designed as a less invasive alternative to traditional open posterior surgical SI joint fusion. The titanium implant consists of a sacrum engaging side and an ilium engaging side connected by a bridge. During the procedure, bone graft material is placed in the window of the implant to facilitate stabilization. The implant is intended for single-use only. Implants are provided clean and non-sterile and designed for routine steam sterilization prior to use.

The provided document is a 510(k) clearance letter for a medical device (SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System), not an AI/ML medical device. As such, it does not contain any information about acceptance criteria, device performance metrics, sample sizes for test or training sets, expert ground truth establishment, adjudication methods, or MRMC studies, which are typical requirements for AI/ML device submissions.

The document is for a mechanical implant system and focuses on demonstrating substantial equivalence to a predicate device through:

• Identical indications for use.
• Identical technological design principles.
• Justifications and adoptions of existing performance testing (e.g., steam sterilization, FEA, pushout testing) from the predicate device (K241813), rather than new performance studies on clinical data or AI model outputs.

Therefore, I cannot extract the requested information to fill in the table or answer the questions related to AI/ML device validation.

Summary of why the requested information cannot be provided from the input:

• No AI/ML Component: The device is a physical implant (sacroiliac joint fusion system), not a software or AI-driven diagnostic/therapeutic device.
• Substantial Equivalence: The clearance is based on demonstrating substantial equivalence to a predicate device, meaning it relies on already established safety and efficacy data for a previous version or similar device, not de novo clinical trials or performance studies specific to an AI algorithm.
• Focus on Physical Properties: The "Performance Testing" section mentions engineering analyses (FEA, pushout testing) and sterilization, which are relevant to the physical characteristics and safety of an implant, not the diagnostic or analytical performance of an AI system.

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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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The Wrinkle Treatment Device is an Over-the-Counter (OTC) light based device intended for the use in treating full-face wrinkles.

The Wrinkle Treatment Device is an Over-the-Counter (OTC), home-use, wearable light based device, and intended for the use in treating full-face wrinkles. Light radiates from the inner surface of the device onto the face. This light is generated by VCSEL (Vertical-cavity surface-emitting laser) with two different spectrum wavelengths: red (660nm) and infrared (850nm).

Model JM1 is controlled directly by the button on the main mask body, which can realize device's power on/off and mode switch. The device will automatically shut down when the treatment time is over or when the pure water is run out.

Model JM2B is controlled by a controller that is connect to the main unit and the device's power-on/off, mode switch and treatment time adjustment can be operated by the controller. The device will automatically shut down when the treatment time is over. Both models are powered by rechargeable Li-battery.

The provided FDA 510(k) clearance letter and summary for the Wrinkle Treatment Device (JM1, JM2B) lack detailed information regarding specific acceptance criteria and the comprehensive study results (particularly clinical performance) that would typically prove a device meets those criteria. The submission focuses heavily on non-clinical performance data and substantial equivalence to a predicate device based on similar technological characteristics.

Therefore, many of the requested details about acceptance criteria, clinical study design (sample size, data provenance, expert adudication, MRMC studies, ground truth establishment), and specific performance metrics are not available in the provided text.

However, I can extract and infer some information based on the typical requirements for a 510(k) submission, especially for a device claiming substantial equivalence to a previously cleared device.

Here's an attempt to describe the acceptance criteria and the study that proves the device meets them, based on the provided document and general FDA 510(k) principles:

Acceptance Criteria and Device Performance (Inferred/General)

Since this is an OTC device intended for treating full-face wrinkles, the acceptance criteria would primarily relate to its safety and efficacy for that stated indication. As per the document, the device (JM1, JM2B) is deemed substantially equivalent to its predicate (JM2), implying that its performance is comparable and acceptable.

Given the nature of the device (light-based for wrinkle treatment), typical acceptance criteria in a clinical study would involve demonstrating a statistically significant reduction in wrinkles or improvement in skin appearance as assessed by objective measures (e.g., standardized photography, wrinkle grading scales) and/or subjective measures (e.g., patient satisfaction, expert assessment). Safety criteria would include the absence of serious adverse events and a low incidence of expected, mild side effects.

Table of Acceptance Criteria and Reported Device Performance

Self-correction: The provided document does not contain a table of explicit acceptance criteria or a detailed report of clinical performance metrics against such criteria. The "Performance Data" section lists non-clinical tests.

However, inferring from the "Substantial Equivalence" claim, the underlying acceptance criteria are that the device is "as safe and as effective as the legally marketed predicate device [K240360 (JM2)] for its intended use".

Study Details (Based on the provided document, many details are not explicit and would typically be found in the full 510(k) submission, not just the summary letter):

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

   • Test Set Sample Size: Not explicitly stated for any clinical performance testing. The document focuses on non-clinical bench and software testing. For the biocompatibility testing, it mentions "the JM1" (implying the device itself), not a sample size of human subjects.
   • Data Provenance: Not specified. If a clinical study was performed for the predicate device, it's highly likely to have been prospective, but the location is not given. For this 510(k) relying on substantial equivalence, the "performance data" listed are primarily non-clinical.

2. Number of Experts Used to Establish Ground Truth and Qualifications:

   • Not applicable as no direct clinical study results requiring such expert assessment are detailed in this summary. If the predicate device had clinical studies assessed by experts (e.g., dermatologists or plastic surgeons grading wrinkles), that information is not present here.

3. Adjudication Method for the Test Set:

   • Not applicable as no direct clinical study results requiring adjudication are detailed in this summary.

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:

   • No evidence of MRMC study: The device described is a light-based wrinkle treatment device, not an AI diagnostic imaging device that typically uses MRMC studies. Therefore, this type of study is not relevant to this device.

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

   • Not applicable. This is a physical treatment device, not a software algorithm for diagnosis that would have a "standalone" performance. Its "performance" refers to its ability to treat wrinkles when used by a human.

6. The Type of Ground Truth Used:

   • For non-clinical performance (safety): The ground truth for biocompatibility was established by recognized international standards (ISO 10993 series). Electrical and laser safety ground truth was established by compliance with IEC standards. Thermal performance ground truth was established through bench testing and ex vivo tissue evaluation against engineering safety limits.
   • For efficacy: The ground truth for efficacy is implicitly established by the predicate device's prior clearance for wrinkle treatment. The applicant argues that their new device is "as safe and as effective" as this predicate. No specific new clinical ground truth data for efficacy is presented in this summary document beyond the claim of substantial equivalence.

7. The Sample Size for the Training Set:

   • Not applicable. This device is not an AI/machine learning algorithm that would typically have a "training set" in the context of data. It's a hardware device.

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

   • Not applicable (as above).

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