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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 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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Intended for use for lesioning of neural tissue and for pain management. It is indicated for use in the peripheral nervous system. The APEX 6 is to be used with LCCS electrodes and cannulae and Conmed Thermogard Dispersive Electrodes.

The RF Innovations APEX 6 is a desktop RF lesioning generator which is used for the lesioning of neural tissue. The APEX 6 is a multi-lesioning, 6 channel portable generator that can provide continuous or pulsed RF output at 460 kHz, and monopolar or dual electrode modes. The device includes sensory and motor stimulation functions to fine tune electrode placement for procedures. Based on performance testing the device is designed to connect to LCCS FDA cleared lesioning probes which are inserted into patients for lesioning of neural tissue during medical procedures. Device features include a touch screen monitor incorporating microprocessor and graphics display for user interface as well as self-diagnostics, calibration checks, and recordkeeping functions.

This document is a 510(k) summary for the APEX 6 Lesioning Generator. It outlines the device's characteristics, its intended use, and how it compares to a predicate device (NeuroTherm NT 2000 RF Lesioning Generator) to establish substantial equivalence.

Here's an analysis of the acceptance criteria and the supporting study, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details:

The provided document describes bench testing to demonstrate the substantial equivalence of the APEX 6 to its predicate device, primarily focusing on physical performance characteristics and safety standards. There is no clinical study (human-in-the-loop or standalone AI performance) described for this device, as it is a medical device generator and not an AI/Software as a Medical Device (SaMD).

Here's an breakdown of the specific points requested, based on the provided text:

1. A table of acceptance criteria and the reported device performance: (See table above)

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

   • Sample Size: The document does not specify exact sample sizes for the "Lesion size" or "Comparison of treatment times" tests. It refers to "minimal, typical, and maximum energy delivery" for lesion size and "worse case conditions" for treatment times, implying a set of controlled experimental conditions rather than a large clinical "test set" in the common AI/SaMD sense. For "Every unit functional test," the sample size is "Every unit manufactured."
   • Data Provenance: The tests are described as "Bench testing," indicating they were performed in a laboratory or controlled environment. There is no information regarding country of origin or whether it's retrospective or prospective, as it's not a clinical data study.

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

   • This information is not applicable to the type of testing described. The "ground truth" for a device like a radiofrequency lesion generator is based on physical measurements (e.g., lesion dimensions, electrical parameters, time) and established engineering/safety standards. It's not about expert interpretation of medical images or clinical outcomes that would require human expert consensus for ground truth.

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

   • This is not applicable. Adjudication methods are typically used in clinical studies where multiple human readers interpret data, and significant disagreements require a tie-breaking mechanism or consensus. The tests described are bench tests with objective physical measurements.

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

   • No, an MRMC study was not done. This type of study is relevant for AI/SaMD devices where the AI assists human readers in diagnostic or screening tasks. The APEX 6 is a physical medical device generator, not an AI software.

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

   • While the APEX 6 itself performs functions autonomously (e.g., generating RF energy), the "standalone" concept usually applies to AI algorithms whose performance is evaluated independently of human input. No such "algorithm-only" performance study is described here, as the device's function is the generation and control of RF energy, which is evaluated through bench tests against physical parameters and predicate device performance. Software functions were validated, but this is different from a standalone AI performance study.

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

   • The ground truth for the bench tests was based on physical measurements (e.g., linear dimensions in millimeters, time in seconds, electrical parameters like impedance, voltage, current, power) and compliance with established international and national standards (e.g., IEC 60601 series, ANSI/AAMI, CAN/CSA).
   • For "Lesion size" and "Comparison of treatment times," the "ground truth" was derived from the performance of the legally marketed predicate device, used as a benchmark for substantial equivalence.

8. The sample size for the training set:

   • This information is not applicable. The device is not an AI/machine learning model that requires a "training set" in the sense of data used to train a statistical or learning algorithm. Its design and validation rely on engineering principles, product specifications, and comparisons to predicate devices.

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

   • This information is not applicable, as there is no training set for an AI/ML model for this device.

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The Apex Knee™ System is intended for use as a primary or revision total knee replacement. This prosthesis may be used for the following conditions, as appropriate:

• · Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• · Rheumatoid arthritis;
• · Correction of functional deformity:
• · Revision procedures where other treatments or devices have failed;
  The porous coated femoral component may be used cemented (biological fixation).
  The porous coated tibial baseplate is to be used uncemented (biological fixation).
  All other femoral, tibial baseplate, and patellar components are indicated for cemented use only.
  The Apex Knee™ Modular Tibial Augments are intended to the Tibia baseplate and cemented to the prepared tibia.

The proposed devices are intended to be used for primary and revision total knee replacement.
The Pegged Tibial Baseplates offer additional torsional stability by adding pegs to the posterior end of the device. The material of the proposed Pegged Tibial Baseplates are Cobalt Chrome, CoCr (ASTM F75).
The ECiMa tibial inserts are machined from compression molded highly crosslinked polyethylene with Vitamin E (VE-XLPE) and attaches to the cobalt chrome tibial baseplate via dovetails and a retaining

The provided text describes a 510(k) premarket notification for the "Apex Knee™ System," a knee joint prosthesis. However, the document does not include information about acceptance criteria or a study proving the device meets those criteria in the context of an AI-powered medical device.

The document is a submission for a physical medical device (a knee implant), not an AI device. Therefore, the questions related to AI device performance (e.g., number of experts for ground truth, MRMC studies, standalone algorithm performance, training set details) are not applicable to this document.

The document focuses on demonstrating substantial equivalence to a predicate device for a physical implant, primarily through material characterization, mechanical testing, and biocompatibility testing. The "acceptance criteria" discussed are mainly related to the performance standards for the implant materials and design, such as wear testing, strength testing, and sterility assurance levels.

Here's a breakdown of what is and is not in the provided text:

Information NOT Found (as it pertains to an AI device):

• 1. Table of acceptance criteria and reported device performance for an AI device: Not present. The acceptance criteria relate to mechanical and biological properties of the implant.
• 2. Sample size and data provenance for an AI test set: Not applicable. The "test set" refers to mechanical samples and animal models, not patient data for AI evaluation.
• 3. Number of experts and qualifications for AI ground truth: Not applicable. Ground truth for an AI device (e.g., image annotation) is not relevant here.
• 4. Adjudication method for an AI test set: Not applicable.
• 5. Multi-reader multi-case (MRMC) comparative effectiveness study for AI: Not applicable.
• 6. Standalone (algorithm only) performance for AI: Not applicable.
• 7. Type of ground truth for an AI device: Not applicable. Ground truth here refers to engineering specifications and biological response, not diagnostic labels for AI.
• 8. Sample size for an AI training set: Not applicable.
• 9. How ground truth for an AI training set was established: Not applicable.

What the document does provide regarding the physical device's "studies":

The document broadly mentions "non-clinical testing" conducted to demonstrate the safety and effectiveness and substantial equivalence of the modified Apex Knee™ System. These tests are the "study" proving the device meets its acceptance criteria (though not presented in the AI-specific format requested).

• Testing for Pegged Tibial Baseplates:
  • FEA (Finite Element Analysis) simulation
  • Peg location templating study
• Testing for ECiMa Tibial Inserts & Patellae:
  • Material characterization
  • PS (Posterior Stabilized) post strength testing
  • Insert disassembly strength testing
  • Wear testing
• Biocompatibility Testing for ECiMa material:
  • Intramuscular implantation in animal models
  • Implant toxicity and subcutaneous implantation in animal models
• Sterility: Validated sterilization process using ethylene oxide (EO) to a Sterility Assurance Level (SAL) of 10-6. Endotoxin testing via Limulus amebocyte lysate (LAL) on a quarterly rotating basis for product groups.

Conclusion:

This document is a regulatory submission for a physical knee implant and does not contain the specific information requested regarding AI device acceptance criteria and study methodologies. The "studies" mentioned are engineering and biological tests demonstrating the physical device's performance and safety.

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

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

The provided text is a 510(k) summary for the APEX 3D Total Ankle Replacement System. This document focuses on demonstrating substantial equivalence to a previously cleared device, rather than providing detailed acceptance criteria and performance studies for a novel AI/software medical device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a device meets acceptance criteria cannot be extracted from this document.

The document states that the APEX 3D Total Ankle Replacement System is "substantially equivalent" to a predicate device (K192994). This means that the FDA has determined it is as safe and effective as a legally marketed device, but it doesn't involve the kind of rigorous performance testing against specific acceptance criteria that would be conducted for a new, unproven technology, especially software or AI.

The "Performance Data" section mentions "engineering analysis" to show that "the original testing and subsequent performance is not adversely affected by the modifications". This included "talar stability assessment and bacterial endotoxin testing." This is related to the physical device's integrity and biocompatibility, not software performance.

In summary, the provided text does not contain the information requested in your prompt as it pertains to a traditional medical device (total ankle replacement system) demonstrating substantial equivalence, not a software or AI-based device with specific performance metrics and acceptance criteria.

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

The Paragon 28 Laser Alignment Guide is a line extension to the APEX 3D Total Ankle Replacement System instrumentation (K192994). The Paragon 28® APEX 3D™ Total Ankle Replacement System Laser Alignment Guide is designed to provide a visual guide to verify alignment of the instrumentation associated with the APEX 3D™ Total Ankle Replacement System. Once inserted into the proper instrumentation, the Laser projects a line onto the patient to be used by surgeons as a visual reference for alignment. The Laser Alignment Guide is a singleuse electrical device.

This document describes the APEX 3D Total Ankle Replacement System Laser Alignment Guide, a line extension to the APEX 3D Total Ankle Replacement System instrumentation. The information provided is sufficient to answer some, but not all, of your questions regarding acceptance criteria and the study proving device performance, especially concerning clinical study details, as this submission primarily focuses on substantial equivalence based on non-clinical testing.

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

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on the Laser Alignment Guide specifically and its substantial equivalence to predicate devices, rather than establishing new performance criteria or providing a direct table of acceptance criteria and performance for the overall APEX 3D Total Ankle Replacement System itself. The "acceptance criteria" for the Laser Alignment Guide are inferred from the non-clinical tests performed to demonstrate its intended function and safety.

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

• Sample Size: The document mentions "a cadaveric design evaluation" and "stability assessment" but does not specify the sample size (e.g., number of cadavers, number of stability tests).
• Data Provenance: The cadaveric study would imply human anatomical data. The provenance (e.g., country of origin) is not specified.
• Retrospective or Prospective: These non-clinical tests would be considered prospective in nature, as they were conducted specifically for this submission.

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

This information is not provided in the document. The cadaveric design evaluation and stability assessment would likely involve technical and possibly surgical experts, but their numbers and qualifications are not detailed.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the non-clinical tests (cadaveric evaluation, stability, electrical safety), a formal "adjudication method" in the sense of consensus among multiple human readers of medical images is unlikely to apply directly. The "assessment" mentioned suggests an evaluation against pre-defined criteria, but the specific method is not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission for the Laser Alignment Guide is based on substantial equivalence demonstrated through non-clinical testing. It does not involve a study comparing human reader performance with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The Laser Alignment Guide is a physical medical device that provides a visual guide for human surgeons. It is not an algorithm or an AI system, so the concept of "standalone performance" for an algorithm does not apply. Its function is inherently "human-in-the-loop" as it assists a surgeon.

7. The Type of Ground Truth Used

For the non-clinical tests mentioned:

• Cadaveric Design Evaluation: The "ground truth" would be the anatomical landmarks and the intended alignment as determined by surgical principles. The laser's projection would be evaluated against this anatomical reality.
• Stability Assessment: The "ground truth" would be the engineering specifications for stability and secure attachment.
• Electrical Safety Testing: The "ground truth" would be the applicable electrical safety standards and regulations.

8. The Sample Size for the Training Set

The Laser Alignment Guide is a hardware device, not an AI/ML system that utilizes a "training set." Therefore, discussions of a training set sample size are not applicable.

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

As there is no "training set" for this hardware device, this question is not applicable.

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