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The Midwest Motor Control Module includes a control unit, ports for three motors, an apex location port, and a peristaltic pump port. The motor ports are compatible with the Midwest Power Lux and Midwest Power Lux Implant.

The Midwest Power Lux electric micromotor is intended for use as a drive for rotating and oscillating straight and contra-angle hand pieces for endodontic and general dental purposes.

The Midwest Power Lux Implant motor is intended for use in implant placement and includes a closed system for delivery of sterile solution via peristaltic pump operation.

The apex locator supports the dentist in the determination of the working length during the endodontic treatment.

These motors are to be driven by the control unit. The control unit is an internal component of a dental delivery system.

The use of this product is intended exclusively for duly qualified dental practitioners.

This device is a system that includes a control module (internal component of a dental delivery system) that can operate up to three dental motors, an apex locator, and a peristaltic pump. The motors do not operate concurrently. The motors that can be attached include dental motors and dental implant motors. The motors included with this module in this subject system are the Midwest Power Lux and Midwest Power Lux Implant. Also included is the cable, file, and tip required for the operation of the apex location technology. The programming supports manual use of the apex locator as well as combined use of the locator with a motor. The included peristaltic pump and control allows for sterile solution irrigation when required.

The provided FDA 510(k) Clearance Letter for the "Motor and Apex Module (MaAM)" (K251811) does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria related to the apex locator's accuracy or the motors' performance in a clinical setting.

The document primarily focuses on regulatory approval, substantial equivalence to predicate devices, and general safety and performance testing. While it mentions the device supports "determination of the working length during the endodontic treatment" (for the apex locator) and drives "rotating and oscillating straight and contra-angle hand pieces for endodontic and general dental purposes" (for the motors), it does not provide the specific performance metrics (e.g., accuracy, precision, torque output, speed stability) for these functions, nor the studies that verified them.

The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section explicitly states: "Not applicable (no clinical data necessary)." This indicates that the FDA clearance was based on non-clinical testing, primarily focused on safety, electrical compatibility, and adherence to established industry standards (ISO 14457 for dental motors, IEC 62471 for photobiological safety, and ISO 3964 for dental coupling dimensions).

Therefore, based solely on the provided document, I cannot generate the requested table and study details. The information about performance acceptance criteria, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment for clinical effectiveness is absent.

However, I can extract and present the information that is available in the document regarding testing:

Summary of Device Performance and Testing (Based on Available Information in K251811)

The provided 510(k) clearance letter for the Motor and Apex Module (MaAM) establishes substantial equivalence to predicate devices based on non-clinical testing. The document explicitly states "Not applicable (no clinical data necessary)", indicating that the clearance did not involve clinical studies assessing the device's functional performance in a patient setting, such as the accuracy of the apex locator or the clinical efficacy of the motors.

The testing highlighted in the document focuses on compliance with international standards and mechanical/electrical safety.

1. Table of Acceptance Criteria and Reported Device Performance

Given that clinical performance acceptance criteria and respective reported device performance data are not detailed in the provided document, the table below reflects the types of non-clinical testing mentioned and the general conclusion of meeting specifications.

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

• Sample Size: Not specified in the document. Testing was non-clinical (bench/laboratory).
• Data Provenance: Non-clinical (bench testing in a laboratory). Country of origin is not specified for the test data itself, but the applicant (Dentsply Sirona Inc.) is located in the United States. The testing was retrospective in the sense that it was conducted prior to the submission for clearance.

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

• Not applicable. The clearance was based on non-clinical, standard-driven testing. There was no clinical ground truth established by experts for performance assessment in a patient setting.

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set or subjective assessment requiring adjudication (like image interpretation) was mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC study was done. The document explicitly states "Not applicable (no clinical data necessary)". Therefore, no effect size of human readers improving with AI vs. without AI assistance can be reported. The device is not an AI-assisted diagnostic tool in the sense of image interpretation.

6. Standalone Performance (Algorithm Only)

• Not applicable. The device is a physical medical device (motors, control module, apex locator) and not an algorithm or AI software for standalone performance evaluation in a diagnostic context. Its "performance" refers to its physical and electrical operation within specified limits, not its diagnostic accuracy.

7. Type of Ground Truth Used

• Not applicable, for clinical performance. For the non-clinical tests, the "ground truth" was established by the specifications defined in the referenced ISO and IEC standards (e.g., a motor must achieve a certain speed, a coupling must fit, light emission must be within safety limits). There was no "expert consensus, pathology, or outcomes data" ground truth as would be used for diagnostic accuracy studies.

8. Sample Size for the Training Set

• Not applicable. This device is hardware with embedded control software; it is not a machine learning or AI model that requires a training set in the typical sense of algorithm training on data.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As above, this device does not utilize a "training set" in a machine learning context.

In conclusion, the FDA 510(k) clearance for the MaAM (K251811) was granted based on non-clinical testing demonstrating conformance to relevant safety and performance standards for dental motors, photobiological safety, and dental coupling dimensions. The document explicitly states that no clinical data was necessary for this clearance, meaning functional performance (e.g., apex locator accuracy, motor clinical efficacy) in a patient setting was not assessed as part of this submission.

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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. In the United States, components are intended for cemented use only.

The APEX 3D Total Ankle Replacement System has been cleared under K192994. The purpose of this submission is to introduce a new diffusion bonded talar dome to the 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 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 document is an FDA 510(k) clearance letter for the APEX 3D Total Ankle Replacement System. This document does not describe AI/ML-driven medical devices or related acceptance criteria studies.

The 510(k) summary explains that the submission is to introduce a new diffusion-bonded talar dome to an already cleared total ankle replacement system. The performance testing described is focused on the physical and mechanical properties of the implant materials and manufacturing processes, such as:

• Porous Structure Characterization
• Diffusion Bonded Tensile Strength
• Diffusion Bonded Static Shear Strength
• Diffusion Bonded Fatigue Shear Strength
• Diffusion Bonded Abrasion Resistance
• Metallurgical Analysis
• Accelerated Corrosion Soak

The document explicitly states: "Clinical data are not needed to support the safety and effectiveness of the subject device."

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria and studies for an AI/ML-driven device, as this document pertains to a mechanical orthopedic implant, not an AI/ML product.

To answer your request, I would need a different source document that details the performance study of an AI/ML-driven medical device.

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SprintRay Apex Flex is an alternative to traditional thermoplastic material used for the fabrication and repair of partial dentures. It is intended exclusively for professional dental work.

SprintRay Apex Flex is a photo-polymeric methacrylate/acrylate resin material used in conjunction with a 3D printer and a scanned 3D image in a dental office to fabricate partial dentures by 3D printing layer upon layer of the composite material. The product is available in two shades: Light Pink and Standard Pink.

SprintRay Apex Flex resin is intended exclusively for professional dental work. Fabrication of dental prosthetics with SprintRay Apex Flex resin requires computer-aided design and CAD/CAM manufacturing system that includes the following components not part of the device: Apex Flex file created in an optical impression system, 3D printer, and curing light equipment.

Apex Flex resin is designed to meet appropriate ISO standards for flexibility and sorption, to withstand prolonged use in the oral cavity. It is delivered non-sterile, and instructions on curing, and cleaning the final device prior to providing it to a patient are provided in the device indication for use document.

The provided document is an FDA 510(k) clearance letter and supporting summary for a dental resin product, SprintRay Apex Flex. This document does not describe an AI/ML-enabled medical device or a study involving human readers and AI assistance for diagnostic purposes. Instead, it details the substantial equivalence of a new dental material (resin) to existing predicate devices based on physical, chemical, and biocompatibility properties.

Therefore, many of the requested elements pertaining to AI/ML device studies (e.g., test set data provenance, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, training set details) are not applicable to this document.

However, I can extract the acceptance criteria and performance data for the material properties of the SprintRay Apex Flex device as presented in the document.

Analysis of Acceptance Criteria and Device Performance for SprintRay Apex Flex

The "acceptance criteria" for this device are implicitly derived from the performance of the predicate and reference devices, and conformance to industry consensus standards like ISO 20795-1. The SprintRay Apex Flex is demonstrated to be substantially equivalent to these devices by meeting comparable performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

The document presents a comparison of the SprintRay Apex Flex (Subject Device) against its primary predicate (Flex-Star V), secondary predicate (TCS® Unbreakable), and a reference device (SprintRay NightGuard Flex). The "acceptance criteria" are not explicitly stated as numerical thresholds but are implied by the measured values of the predicate devices, particularly the Flex-Star V as the primary predicate. The subject device must show comparable or improved performance without raising new safety or effectiveness concerns.

Summary of Device Performance: SprintRay Apex Flex demonstrates comparable or in some cases superior physical properties (e.g., flexural modulus, lower water sorption) compared to the predicate and reference devices, while meeting biocompatibility and other standard requirements.

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

The document does not specify a "test set" in the context of an AI/ML model for diagnostic performance. The "testing" refers to bench testing of material properties.

• Sample Size: The exact number of samples tested for each material property (e.g., flexural strength, sorption) is not provided. The results are reported with mean values and standard deviations, implying multiple samples were tested for each property as per ISO standards.
• Data Provenance: The data is generated from bench testing of the manufactured SprintRay Apex Flex resin. The "country of origin" for this data would be the location where these laboratory tests were conducted, which is not specified in the document but is typically part of the manufacturer's internal testing process. The nature of the data is prospective in the sense that the manufacturer specifically produced and tested samples of the Apex Flex resin for this 510(k) submission.

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

This question is not applicable as the document describes a material and its physical properties, not an AI/ML diagnostic device requiring expert interpretation for ground truth. The "ground truth" for material properties is established by standardized test methods (e.g., ISO 20795-1) and measurement equipment, not by human experts.

4. Adjudication Method for the Test Set

Not applicable. As the "test set" refers to material samples undergoing physical and chemical tests, there is no need for adjudicating human interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

Not applicable. This document pertains to a dental material, not an AI-assisted diagnostic device.

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

Not applicable. This question refers to AI algorithm performance.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on standardized laboratory measurements of physical, mechanical, and chemical properties (e.g., flexural strength, water sorption) as defined by ISO consensus standards (specifically ISO 20795-1 and ISO 10993-1/7405 for biocompatibility). There is no "expert consensus" or "pathology" in the context of a diagnostic outcome.

8. The Sample Size for the Training Set

Not applicable. As this is a material, there is no "training set" in the context of machine learning. The device itself is manufactured, and its properties are measured.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no "training set" for this type of device.

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Apex Locator is used to detect the apex of root canal. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.

Apex Locator is an oral equipment used for root canal measurements. It features an LCD color display with functional buttons, enabling users to conveniently view parameters such as battery status, test wire connection status, and apex position etc. Users can easily adjust sound level, brightness, and reference settings using intuitive buttons, and perform functional checks of both the device and cable. The device is intended to be sterilized prior to use.

The provided text is a 510(k) summary for a medical device called "Apex Locator". It details a comparison to a predicate device and states that non-clinical tests were performed. However, it explicitly states that no clinical test data was used to support the decision of substantial equivalence. This means that a study proving the device meets acceptance criteria, as typically understood in the context of clinical trials or performance evaluations with human subjects/data, was not conducted or reported in this submission. The "acceptance criteria" and "device performance" mentioned here refer to specifications confirmed through non-clinical testing and comparison to the predicate.

Given this, I cannot provide information on:

• The study that "proves the device meets the acceptance criteria" in a clinical sense.
• Sample size used for the test set and data provenance (as no clinical test data was used).
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance.
• Type of ground truth (as no clinical data).
• Sample size for the training set (as no clinical data).
• How ground truth for the training set was established (as no clinical data).

I can, however, provide the acceptance criteria based on the non-clinical tests and the device performance as reported in the comparison table and discussion of differences.

Non-Clinical Acceptance Criteria and Reported Device Performance

The provided document describes acceptance criteria and reported "performance" based on non-clinical tests and comparison to a predicate device. The primary method for demonstrating performance and safety was through compliance with recognized standards and verification that design differences do not affect safety and effectiveness.

Key takeaway: This submission focuses on engineering, safety, and functional conformance rather than clinical performance data.

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation of "Study that proves the device meets the acceptance criteria":

The "study" referenced in the document is a series of non-clinical tests and a detailed comparison to a legally marketed predicate device. The conclusion of substantial equivalence is based on demonstrating that the proposed device:

1. Complies with relevant recognized safety and performance standards: These include IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 62366-1 (usability), IEC 62304 (software), ISO 10993-1 and ISO 10993-11 (biocompatibility), and IEC 62133-2 (battery safety).
2. Performs the same intended function as the predicate device.
3. Has fundamental technological characteristics that are substantially equivalent to the predicate device.
4. Any differences in technological characteristics (e.g., dimensions, weight, battery capacity, means of input) do not raise new questions of safety or effectiveness. For each noted difference, the submitter provided a justification that it "would not affect its safety and effectiveness" or "could not effects the performance and safety."
5. Achieves the same specified performance metric as the predicate device where applicable (e.g., Measurement Accuracy: ±0.5mm).

The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence." Therefore, there is no clinical study that "proves the device meets the acceptance criteria" in terms of patient outcomes or comparative clinical performance. The acceptance is based on engineering principles, compliance with standards, and a robust non-clinical comparison to a predicate device.

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The ExamVue Apex flat panel x-ray detector system is indicated for use in general radiology including podiatry, orthopedic, and other specialties, and in mobile x-ray systems. The Exam Vue Apex flat panel x-ray detector system is not indicated for use in mammography.

The ExamVue Apex flat panel x-ray detector system consists of a line of 3 different models of solid state x-ray detectors, of differing size and characteristics, combined with a single controlling software designed for use by radiologists and radiology technicians for the acquisition of digital x-ray images. The ExamVue Apex flat panel x-ray detector system captures digital images of anatomy through the conversion of x-rays to electronic signals, eliminating the need for film or chemical processing to create a hard copy image. ExamVue Apex flat panel x-ray detector system incorporates the ExamVue Duo software, which performs the processing, presentation and storage of the image in DICOM format. All models of the ExamVue Apex flat panel x-ray detector system use a Si TFTD for the collection of light generated by a CsI scintillator, for the purpose of creating a digital x-ray image.

The three available models are:

EVA 14W, with a 14x17in (35x43cm) wireless cassette sized panel
EVA 17W, with a 17x17in (43x43cm) wireless cassette sized panel
EVA 10W, with a 10x12 (24x30cm) wireless cassette sized panel

The provided text describes the regulatory clearance of a digital X-ray detector system, the "ExamVue Apex," and its substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria or an analytical study proving the device meets those criteria, as one would typically find for an AI/ML medical device submission with defined performance metrics (e.g., sensitivity, specificity, AUC).

Instead, the submission focuses on demonstrating substantial equivalence through:

• Bench Testing: Comparing engineering specifications like resolution, sensitivity, and dynamic range to the predicate device.
• Software Validation: Ensuring the software adheres to relevant standards (IEC 62304) and performs expected functions.
• Clinical Testing: An ABR-certified radiologist visually evaluating image quality as equivalent or better than the predicate device.

Therefore, many of the requested fields regarding a detailed statistical study (sample size, ground truth, expert adjudication, MRMC study, standalone performance) cannot be filled from the provided text because such a study, with quantitative acceptance criteria, does not appear to have been performed or reported in this 510(k) summary. The submission relies more on demonstrating equivalence through technical specifications and expert opinion on image quality rather than rigorous statistical performance criteria for an AI algorithm.

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

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

The provided text does not define explicit quantitative acceptance criteria for device performance in the typical AI/ML sense (e.g., a target sensitivity of X% or specificity of Y%). Instead, the "acceptance criteria" are implied by demonstrating "similar or greater imaging characteristics" compared to the predicate device and that the software "performs the same required basic functions."

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

• Sample Size: Not specified. The clinical testing merely states "Clinical data was provided with the submission to demonstrate equivalence with the predicate device. This data includes images of all the relevant ROI." It doesn't quantify the number of images or patients.
• Data Provenance: Not specified (country, retrospective/prospective).

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)

• Number of Experts: "an ABR certified radiologist" (singular, implied to be one).
• Qualifications: "ABR certified radiologist." No mention of years of experience.

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

• Adjudication Method: Not specified. Since only one radiologist is mentioned, it's likely "none" in the sense of a consensus or adjudication process among multiple readers. The single ABR-certified radiologist provided the evaluation.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not explicitly stated or described. This submission is for a general X-ray detector system, not specifically an AI-powered diagnostic algorithm designed to assist human readers. The "AI" mentioned is the software components related to image acquisition, processing, and management, not a diagnostic AI.

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

• Standalone Performance: Not applicable in the context of an AI diagnostic algorithm. This device is a digital X-ray detector system. Its "performance" refers to image quality and functionality, not a diagnostic output from an algorithm that would then require standalone performance metrics (e.g., sensitivity/specificity for disease detection). The software handles image processing, presentation, and storage, not automated diagnosis.

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

• Type of Ground Truth: The "ground truth" for the clinical testing was the visual evaluation of image quality by an ABR-certified radiologist. It's not a diagnostic ground truth (like pathology for cancer detection) but rather an assessment of whether the images produced by the new device are diagnostically acceptable and equivalent/superior to those from the predicate device.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable/not specified. This device is an X-ray detector and associated software for image acquisition and processing, not a deep learning AI model that requires a "training set" to learn features for interpretation. The software's development (as per IEC 62304) involves validation and verification, but not "training" in the machine learning sense.

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

• Ground Truth for Training Set: Not applicable. (See #8).

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The Electronic Apex Locator is used to support the determination of the working length during the endodontic treatment. The use of this product is intended exclusively for duly qualified dental practitioners.

The Electronic Apex Locator is a microprocessor-controlled device used for root canal length determination. The Electronic Apex Locator assesses the electrical resistance of the tooth and surrounding tissues while the file is inserted and moving along the root canal. By detecting the change of the impedance value of the tooth apex to the AC current response of two different frequencies, two signals are output that are proportional to the change of the AC current response of two different frequencies corresponding to the tooth apex, and the two response signals are compared, and the digital quantity of their ratio is output. The digital quantity represents the position of the electrode at the tooth apex.

Advanced user interface implemented in Electronic Apex Locator is based on high resolution TFT (Thin Film Transistor) color graphic display. It provides presentation of endodontic file movement inside the canal. In addition, the interface displays the mute or volume level and power status.

The product is functionally operated by three buttons: 1) On/off button of the main unit: Short press once to hear a beep is to start up the machine, short press once again to shut down, and long press no response. 2) Volume button: Under the startup state, press once to increase one volume. After reaching the maximum volume, press once to enter the mute mode. Press four times as a cycle, and there will be no responds when long press. 3) DEMO button: Under the startup state, long press to enter the DEMO process, and the screen will demonstrate the process of measuring the length.

Here's an analysis of the acceptance criteria and study information for the Electronic Apex Locator (Alpha Apex I), based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the numerical sample size used for the accuracy testing test set (e.g., number of teeth, number of measurements). It only mentions that "Performance testing to verify the apex position measurement accuracy according to internal technical requirements has been conducted."

The data provenance is not specified. It is unclear if the data was collected retrospectively or prospectively, or its country of origin.

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

The document does not provide information on the number of experts used or their qualifications to establish ground truth for the performance testing.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No multi-reader multi-case (MRMC) comparative effectiveness study was mentioned or performed. The device is an electronic apex locator, which is typically used directly by a single dental practitioner, not for multi-reader interpretation of images or data.

6. Standalone Performance Study

Yes, a standalone performance study was conducted. The "Accuracy Testing" section states, "Performance testing to verify the apex position measurement accuracy according to internal technical requirements has been conducted and demonstrated that the subject device meets the requirement of ±0.5mm." This indicates the algorithm's performance was evaluated independently.

7. Type of Ground Truth Used

The document does not explicitly state the specific type of ground truth used for the accuracy measurements (e.g., direct visual measurement through transparent tooth, X-ray confirmation, histological analysis). It only refers to "internal technical requirements" for verifying accuracy.

8. Sample Size for the Training Set

The document does not provide information on the sample size for any training set. This is likely because the Electronic Apex Locator is a hardware device based on electrical impedance principles, and while it contains a microprocessor and software, the core "measurement" algorithm is typically determined through engineering design and calibration rather than machine learning training on a large dataset in the way a diagnostic AI would be. The software validation (Alpha Apex I.1.0.0) focuses on general software development life cycle processes, not necessarily on a training and testing paradigm for an AI model.

9. How Ground Truth for the Training Set Was Established

As no training set is explicitly mentioned or implied for a machine learning model, there is no information on how its ground truth would have been established. The device relies on physical principles and calibrated measurements rather than a trained AI model in the conventional sense.

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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. In the United States, components are intended for cemented use only.

The APEX 3D Total Ankle Replacement System 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 document is a 510(k) summary for a medical device (APEX 3D Total Ankle Replacement System), which focuses on demonstrating substantial equivalence to a predicate device. It addresses the device's indications for use, description, and the performance testing conducted to assure substantial equivalence.

However, the document does NOT contain information related to software or AI device performance, acceptance criteria, or ground truth establishment relevant to the questions asked about AI/software validation.

Therefore, I cannot extract the requested information from the provided text. The document explicitly states:

• "Clinical data are not needed to support the safety and effectiveness of the subject device." This indicates that there was no clinical study, including any involving AI or human readers, performed for this submission.
• The tests listed are all non-clinical performance tests on the physical components of the ankle replacement system (e.g., fatigue, material characterization, micromotion, magnetic resonance compatibility). None of these involve software or AI performance metrics.

To answer your request, if this were an AI/software device submission, the acceptance criteria and study details would typically involve metrics like sensitivity, specificity, AUC, human reader performance studies (MRMC), ground truth assessment by experts, sample sizes for training and testing, and adjudication methods. None of this information is present in the provided document.

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APEX LOCATOR is a device intended for locating the apex of the root canal during endodontic treatments.

APEX LOCATOR is a device used in dentistry to estimate the position of the root apex of teeth during root canal preparation. It is used connected with the Cefla dental units. Its principle of operation relies on measuring the electrical impedance of dental tissue, which varies according to tissue density and composition. The APEX LOCATOR is an accessory device for the Cefla dental units used to estimate the position of the root apex of teeth during root canal preparation. The kit is composed of the following elements: file clip (2 pieces), lip hook (4 piece), external wiring (1 piece).

The provided text is a 510(k) summary for an "Apex Locator" device. It outlines the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include information about AI/ML models, clinical studies for AI device performance, or acceptance criteria and proven performance related to such models.

The document explicitly states: "Clinical performance testing was not conducted." This directly indicates that there is no data to address the points in your request that pertain to acceptance criteria and study proving performance for an AI/ML device.

Therefore, I cannot provide the requested information because the document describes a traditional medical device (an Apex Locator based on electrical impedance measurement) and not an AI/ML-driven device. The review focuses on substantial equivalence based on technological characteristics and non-clinical performance (electrical safety, EMC, usability, biocompatibility, reprocessing validation), not on AI/ML model performance.

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support the dentist in the determination of the working the endodontic treatment. The use of this product is intended exclusively for duly qualified dental practitioners.

Apex locators are equipment used for working length measurement during root canal treatment. The devices are powered by a built-in lithium battery, can be charged by a USB adaptor. The devices employ a LCD screen to display the status of file in the root canal and the relative distance between file tip and reference point.

The devices are reusable medical devices initially supplied as non-sterile to the user and requiring the user to clean and disinfect the surface of device. And their accessory, Dental root canal file clip, Dental lip hook and probe are reusable, initially supplied as non-sterile to the user, and requiring the user to sterile for initial use, as well as to reprocess after each use.

The devices include a main unit, a measurement wire A, a measurement wire B, a dental root canal file clip, a dental lip hook, a probe and an adaptor.

Main unit: measure and display working length.

Measurement wire A: connect file clip and lip hook with main unit.

Measurement wire B: connect lip hook and main unit with EM-Motor root canal preparation device.(The EM-Motor root canal preparation device is not included with the subject device and is sold separately.)

File clip: Connect to file.

Lip hook: hook patient's lip.

Touch Probe: promote to measure molar.

Power Adapter: use for charging.

Tester: use for checking whether the device is normal.

The provided document is a 510(k) summary for the Apex Locator (Model: AL-Pex, AL-Pex+). It outlines why the device is considered substantially equivalent to a predicate device, but it does not contain the specific details of a study with acceptance criteria and reported device performance in the format requested.

The document states:

• "Clinical testing is not required." This means there isn't a clinical study with real patient data to generate the performance metrics typically seen in such tables (sensitivity, specificity, accuracy, etc.) against a human or definitive ground truth.
• The performance data section primarily lists compliance with standards (electrical safety, EMC, biocompatibility) and "Accuracy verification: Internal method." This suggests the accuracy was verified through internal, non-clinical means.

Therefore, I cannot extract the information required for:

1. A table of acceptance criteria and the reported device performance: No such table is in the document for the device's main function (determining working length). The "Accuracy: ±0.5mm" mentioned in the comparison table is likely the design specification and presumed achieved, but no study results are provided to explicitly "prove" it meets this with a test set.
2. Sample size used for the test set and data provenance: No information on a test set (e.g., number of roots/teeth tested) or its provenance (country, retrospective/prospective) is provided, as clinical testing was not required.
3. Number of experts used to establish ground truth and qualifications: Not applicable as no clinical study leveraging human expert ground truth is described.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: Not applicable, as no human reader study is described.
6. Standalone performance: No detailed standalone performance metrics (like accuracy with a confidence interval) are presented from a formal study. The "±0.5mm" is a general specification.
7. Type of ground truth used: Not explicitly stated for accuracy verification beyond "Internal method." For devices like apex locators, the ground truth is typically a known or precisely measured length, often in experimental setups or ex-vivo teeth, rather than clinical outcomes or pathology.
8. Sample size for the training set: Not applicable, as this is a traditional medical device, not an AI/ML-driven software device that would have a "training set" in the context of machine learning.
9. How ground truth for training set was established: Not applicable.

In summary, the provided FDA document focuses on confirming substantial equivalence through device design, intended use, and compliance with general medical device safety and performance standards (electrical safety, EMC, biocompatibility, reprocessing validation), rather than presenting specific quantitative performance data from a clinical or extensive non-clinical study that would fit the requested criteria for acceptance and proof of performance. The "Accuracy: ±0.5mm" found in the comparison table is a functional specification, not a reported result from a study described in the document.

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The Arthrex Univers Apex OptiFit Humeral Stem is indicated in replacement when conditions include severe pain or significant disability resulting from degenerative, theumatic disease, or injury of the glenohumeral joint; nonunion humeral head fractures of long duration; irreducible 2- and 4- part proximal humeral fractures; of the humeral head; or other difficult clinical management problems where arthrodesis or re-sectional arthroplasty is not acceptable.

The glenoid components are designed fixation in the joint and must only be used with an appropriate bone cement.

The proposed Univers Apex OptiFit Humeral Stem is the humeral stem component of a shoulder prosthesis system. It consists of a stem, a trunion, an inclination block, pins, and screws. All the components are comprised of titanium with a titanium plasma spray (TPS) coating.

The provided text describes the regulatory clearance for a medical device called "Arthrex Univers Apex OptiFit Humeral Stem." It focuses on demonstrating substantial equivalence to a predicate device rather than outlining detailed acceptance criteria and performance data for a novel artificial intelligence (AI) or machine learning (ML) device.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving device performance in the context of AI/ML. The performance data mentioned refers to:

• Yield strength testing on samples with and without titanium plasma spray coating, with the acceptance criteria being "met for all samples." This is a material property test, not a performance study for an AI/ML diagnostic or assistive device.
• Computational electromagnetic simulation testing to assess RF heating in bone tissue, demonstrating the device is "MR Conditional." This relates to MRI compatibility, not a diagnostic or therapeutic performance study.

In summary, this document is a 510(k) premarket notification for a traditional medical device (humeral stem), not an AI/ML device. As such, it does not provide the information requested about AI/ML device acceptance criteria, performance studies, sample sizes, expert involvement, or ground truth establishment.

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