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The TITANEX® Screw Systems are indicated for fracture fixation, osteotomies, reconstruction procedures and arthrodesis of bones in the foot and ankle.

The TITANEX® Screw Systems contain cannulated bone screws and general instrumentation as a reconstruction solution for foot and ankle applications. The screws are provided in various diameters and lengths with headed, headless, partially, and fully threaded configurations. The implants are composed of titanium alloy. The instrumentation are composed of stainless steels. The devices are provided non-sterile and are intended to be steam sterilized prior to use.

I am sorry, but the provided text from the FDA 510(k) Premarket Notification does NOT contain information about acceptance criteria or a study proving that a device meets acceptance criteria for an AI/ML-based medical device.

The document pertains to the "TITANEX® Screw Systems," which are metallic bone fixation fasteners, and focuses on demonstrating substantial equivalence to already marketed predicate devices. The non-clinical tests performed (e.g., torsional properties, driving torque, axial pullout strength, sterilization, biological evaluation) are typical for mechanical orthopedic implants.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualification of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone AI performance.
7. Type of ground truth used (e.g., pathology, outcomes data).
8. Training set sample size.
9. Ground truth establishment method for the training set.

This information is not present in the provided document because the device in question is a physical orthopedic implant, not an AI/ML-based diagnostic or therapeutic device.

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The Hintermann Series H2 Total Ankle (Hintermann Series H2) system is designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, replacing flexion and extension movement in the ankle joint, and allowing for movement at the replaced joint.

The Hintermann Series H2 is indicated as a total ankle replacement in primary of ankle joints damaged bv:

• Systemic arthritis of the ankle (e.g., rheumatoid arthritis, hemochromatosis)

• Primary arthritis (e.g., degenerative disease)

• Secondary arthritis (e.g., post-traumatic, avascular necrosis, provided enough of the talus is preserved to support the implant)

The Hintermann Series H2 is also indicated for patients with a failed previous ankle surgery and revision surgeries following failed total ankle replacement or non-union of the ankle arthrodesis, provided sufficient bone stock is present.

Note: In the United States, this device is intended for cemented use only.

The Hintermann Series H2 Total Ankle System is a total ankle prosthesis designed to replace the ankle joint. The Hintermann Series H2 Total Ankle System includes the following implantable components.

• H2 Tibial Component
• H2 Tibial Polyethylene (PE) Inlay
• Hintermann Series Talar Component

The tibial and talar components are coated with plasma spray titanium on the cement contacting surfaces. These components are used together to address the indications as outlined.

The provided text is a 510(k) summary for the Hintermann Series H2 Total Ankle System, a medical device. This document focuses on demonstrating the substantial equivalence of the new device to a legally marketed predicate device, rather than providing an acceptance criteria table and detailed study results typical of an AI/ML medical device submission.

As such, the information required to answer your specific questions about acceptance criteria and a study proving the device meets those criteria (especially in the context of AI/ML performance) is not present in the provided text.

The document describes non-clinical testing/performance data for the ankle system, which refers to mechanical and material tests to ensure the physical properties and safety of the implant, not the performance of an AI/ML algorithm.

Here's why the document doesn't contain the requested information:

• Device Type: The Hintermann Series H2 Total Ankle System is a physical orthopedic implant (an ankle joint prosthesis), not an AI/ML-driven diagnostic or therapeutic device.
• Regulatory Pathway: A 510(k) submission for a physical device like this primarily focuses on demonstrating substantial equivalence to a predicate device through engineering analysis, material characterization, and mechanical testing (e.g., wear, fatigue, range of motion). It does not involve AI/ML performance metrics, ground truth establishment, or human reader studies.

Therefore, for each of your points, the answer based solely on the provided text would be:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document lists mechanical tests (e.g., Range of Motion per ASTM F2665-09, Locking Mechanism Testing per ASTM F1814) that were performed, but it does not present a table of specific quantitative acceptance criteria or the numerical results of these tests. It simply states that testing was done to support substantial equivalence.
2. Sample sizes used for the test set and the data provenance: Not applicable in the context of AI/ML. For mechanical testing, sample sizes would refer to the number of prostheses tested, but this information is not detailed in the summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No human experts are establishing ground truth for an AI/ML algorithm in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a mechanical device would be established by standardized testing protocols (e.g., ASTM standards) measuring physical parameters, not by expert consensus on clinical cases.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided FDA 510(k) document is for a physical medical device (an ankle prosthesis) and not an AI/ML-driven device. As such, it does not contain the information related to acceptance criteria, test sets, ground truth, or human reader studies typically associated with AI/ML medical device performance evaluation.

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The TACTIX Vector Syndesmosis System is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.

Specifically, the TACTIX Vector Syndesmosis System is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures.

The TACTIX Vector Syndesmosis System is intended to provide fixation during the healing process following syndesmotic trauma using a TACTIX Vector Suture Loop and Buttons.
The TACTIX Vector System features the following advantageous characteristics: a tensioner to apply suture tension for surgical repair, line lock suture technology without the need to tie a knot, removal of periosteum through a minimal medial skin nick, a larger medial button, and a small thru hole in the bone, only large enough to pass a 2.0 mm suture loop. The TACTIX Vector Syndesmosis System can be used in conjunction with Vilex fibular bone plates and screws, as deemed necessary by the surgeon.

The provided text is a 510(k) premarket notification letter from the FDA regarding the TACTIX Vector Syndesmosis System. It clearly states:

"No clinical data was required in support of the subject device."

Therefore, the information requested for a clinical study proving the device meets acceptance criteria is not applicable in this case. The FDA's substantial equivalence determination for this device was based on non-clinical tests and analyses.

Here's a breakdown of the requested information based on the provided document, clarifying that clinical study details are absent:

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

   • Acceptance Criteria (as implied by the non-clinical tests):
     • Steam sterilization validation successful.
     • Mechanical performance equivalent to predicate device.
     • Biocompatibility (based on biological evaluation) acceptable.
   • Reported Device Performance: "All results met the acceptance criteria."
   • Note: Specific quantitative performance metrics are not provided in this document, only that the criteria were met.

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

   • Not applicable as this was a non-clinical evaluation (e.g., sterilization validation, mechanical testing, biological evaluation). The "test set" would refer to the physical devices/materials tested in these non-clinical studies. Data provenance would be from the studies themselves (e.g., in-house testing, or third-party lab testing). No details on the number of samples for these non-clinical tests are provided.

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

   • Not applicable for non-clinical testing. Ground truth for these tests is established by standardized testing protocols and analytical methods.

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

   • Not applicable for non-clinical testing.

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 MRMC study was done. This device is not an AI/software device that would involve human readers.

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

   • Not applicable. This is a medical device (surgical system) and not an algorithm.

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

   • For the non-clinical tests, the "ground truth" is defined by the established scientific and engineering principles for sterilization, mechanical properties, and biocompatibility.

8. The sample size for the training set:

   • Not applicable. No training set was used as this was not an AI/machine learning device.

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

   • Not applicable. No training set was used.

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The REDEMPTION™ Charcot Plating System bone plates and screws are indicated for use in bone fractures, osteotomies, and fixation of bones and bone fragments in the upper and lower extremities, primarily of the hand, wrist, foot, and digits. Specific examples include: medial column fusion (talus, navicular, cuboid, first metatarsal) for patients with osteopenic bone in neuropathic osteoarthropathy (Charcot).

The REDEMPTION™ Charcot Plating System contains bone plates, screws, and accompanying instruments to aid in the surgical procedures. The system is a multi-indication reconstruction solution providing polyaxial locking technology and low-profile design. The system is optimized for use in osteopenic bone, such as those of neuropathic osteoarthropathy (Charcot) patients.

The system contains poly-axial locking and non-locking 4.0mm and 5.5mm diameter screws with threads optimized for osteopenic bone purchase.

All implant components are manufactured from titanium (Ti-6AI-4V, ASTM F136).

Specific instrumentation including wires, drills, torx drivers, and drill guides are required for use with the system. The REDEMPTION™ instruments are manufactured from stainless steel, with a few Aluminum and Silicone components.

I am sorry, but the provided text from the FDA 510(k) K233816 document for the "REDEMPTION™ Charcot Plating System" does not contain any information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device.

The document describes a traditional 510(k) submission for a metallic bone fixation system (plates and screws), not an AI/ML-driven diagnostic or therapeutic device. The "Performance Data" section details mechanical and material testing for the bone fixation system, such as:

• Static four-point bend testing per ASTM F382-17
• Screw Torsional Properties per ASTM F543-17 A1
• Screw Insertion and Removal Torque per ASTM F543-17 A2
• Screw Pullout Testing per ASTM F543-17 A3
• Cleaning and sterilization validations

These tests are standard for orthopedic implants to demonstrate structural integrity, and biocompatibility, and ensure the device can be properly cleaned and sterilized.

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and reported device performance for an AI/ML device.
2. Sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth types, as these are concepts applicable to AI/ML software validation, not the mechanical testing of orthopedic hardware described in this document.

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The TACTIX Vector Syndesmosis System is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.

Specifically, the TACTIC Vector Syndesmosis System is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures.

The TACTIX Vector Syndesmosis System is intended to provide fixation during the healing process following a syndesmotic trauma using a TACTIX Vector suture loop and buttons.

The TACTIX Vector System features the following advantageous characteristics: a tensioner to apply suture tension for surgical repair, line lock suture technology without the need to tie a knot, removal of periosteum through a minimal medial button, and a small thru hole in the bone, only large enough to pass a 2.0 mm suture loop. The TACTIX Vector Syndesmosis System can be used in conjunction with Vilex fibular bone plates and screws, as deemed necessary by the surgeon.

The TACTIX Vector Syndesmosis System is composed of two titanium alloy buttons and one UHMWPE suture.

The instruments of TACTIX System are composed of stainless steel, UHMWPE, and nylon material.

The TACTIX Vector Syndesmosis System is intended for single use and provided sterile to the end user via ethylene oxide sterilization.

This document is for a medical device called the "TACTIX Vector Syndesmosis System," which is a metallic bone fixation appliance. It is a 510(k) premarket notification to the FDA. The document focuses on establishing substantial equivalence to previously cleared predicate devices.

The information provided does not describe a study that proves the device meets acceptance criteria in the context of clinical performance or diagnostic accuracy, as would be relevant for an AI/ML-driven medical device. Instead, the document describes non-clinical (bench) testing to demonstrate the device's mechanical performance and safety characteristics.

Therefore, for aspects related to "acceptance criteria" for performance metrics like sensitivity, specificity, AUC, human reader improvement with AI, or ground truth establishment relevant to AI/ML, there is no information provided in this document.

However, I can extract the information relevant to the non-clinical testing performed:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: Not explicitly stated for each non-clinical test (e.g., number of devices tested for fatigue, pullout).
• Data Provenance: The tests are non-clinical (bench testing) performed by the manufacturer (Vilex LLC). The document does not specify the country of origin for these tests. The tests are "retrospective" in the sense that they are done in a lab setting to assess the final device design.

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

• Not applicable. This document describes non-clinical engineering bench testing, not clinical studies or AI/ML performance evaluations requiring expert ground truth for interpretation.

4. Adjudication method for the test set:

• Not applicable. This document describes non-clinical engineering bench testing.

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 document describes a medical device (physical implant), not an AI/ML diagnostic or assistive tool. No MRMC study was mentioned or performed.

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

• No, not applicable. This document is for a physical medical device.

7. The type of ground truth used:

• Not applicable in the AI/ML context. For the non-clinical tests, the "ground truth" is established by standard engineering test methods and their defined pass/fail criteria (e.g., meeting a certain force threshold, cycles to failure, absence of toxins). Comparison to a predicate device serves as the benchmark for "truth."

8. The sample size for the training set:

• Not applicable. This document does not describe an AI/ML device that requires a training set.

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

• Not applicable. This document does not describe an AI/ML device that requires a training set.

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The Vilex Redemption Duo Hindfoot Nail System is intended for tibiotalcaneal arthrodesis (fusion)

Specific indications include:

• · Post-traumatic or degenerative arthritis
• · Previously infected arthrosis
• Revision ankle arthrodesis
• Failed total ankle arthroplasty
• · Avascular necrosis of the talus
• · Severe deformity or instability as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease
• Rheumatoid arthritis
• · Osteoarthritis
• Pseudarthrosis
• · Trauma (malunited tibial pilon fracture)
• · Charcot foot
• · Severe endstage degenerative arthritis
• Severe defects after tumor resection
• Pantalar arthrodesis
• · Post-traumatic arthrosis
• · Neuroarthropathy

The Vilex Redemption Duo system consists of implantable intramedullary nails, endcaps, and locking screws manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136 and PEEK per ASTM F2026) that are implanted into the talocrural region to facilitate tibiotalocalcaneal arthrodesis (fusion). A variety of implant sizes are provided to accommodate individual patient anatomy. The Vilex Redemption Duo system includes device specific instrumentation for use in site preparation, implantation, and removal of the implants and instruments are packaged clean and non-sterile in a sterilization tray with instructions for sterilization prior to surgery.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "Vilex Redemption Duo Hindfoot Nail System." This type of document does not typically contain information about AI/ML device performance, acceptance criteria, or a study specifically designed to demonstrate meeting such criteria as it would for an AI/ML diagnostic or prognostic system.

Instead, this clearance letter is for a physical orthopedic implant system (intramedullary nail) that facilitates tibiotalocalcaneal arthrodesis (fusion). The "performance data" referred to in Section VII relates to mechanical testing of the implant's physical properties, not diagnostic accuracy or AI algorithm performance.

Therefore, I cannot provide the requested information about acceptance criteria, AI/ML device performance, sample sizes, ground truth establishment, or expert involvement, as these concepts are not applicable to the type of device described in this FDA clearance.

The document describes the device's technical characteristics and provides references to the following:

Device Name: Vilex Redemption Duo Hindfoot Nail System
Regulation Number: 21 CFR 888.3020
Regulation Name: Intramedullary fixation rod
Regulatory Class: Class II
Product Code: HSB

Performance Data (Mechanical Testing):
The performance data provided supports the mechanical integrity and safety of the implant, not the performance of an AI algorithm. The tests performed are standard for orthopedic implants and include:

• Bending Fatigue per ASTM F1264-16e1
• Static Torsion per ASTM F543-17
• Driving Torque per ASTM F543-17
• Removal Torque per ASTM F543-17
• Axial Pullout Strength per ASTM F543-17
• Static Four-Point Bending per ASTM F1264-16e1
• Static Torsion per ASTM F1264-16e1
• Dynamic Four-Point Bending per ASTM F1264-16e1

The conclusion states that "Although minor differences in the design exist between the subject and predicate devices, the testing supports that these differences do not raise any different questions of safety and effectiveness. Therefore, it is concluded that the Vilex Redemption Duo Hindfoot Nail System is substantially equivalent to the predicate device." This indicates that the mechanical tests demonstrated equivalent performance to predicate devices, satisfying the FDA's requirements for 510(k) clearance for this type of physical implant.

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The TITANEX™ MICROBEAM and TITANEX™ ARTEMIS Screw Systems are indicated for fracture fixation, osteotomies, reconstruction procedures and arthrodesis of bones in the foot and ankle.

The TITANEX™MICROBEAMS and the TITANEX™ ARTEMIS screw systems contain fully threaded screws as a reconstruction solution providing various diameters of cannulated screws.

The TITANEX™ MICROBEAM's are provided in diameters of Ø2.0mm, Ø2.5mm, and the TITANEX™ ARTEMIS screws are Ø3.0mm, and Ø4.0mm. The Screws are a fully threaded design and come in variable lengths from 16mm - 70mm. The Ø2.0mm family: 16mm -50mm, for the Ø2.5mm family: 16mm - 50 mm, for the Ø3.0mm family: 12mm - 50mm, for the Ø4.0mm family: 16mm - 70mm. All screws are provided in 2mm increments.

All implants' components are manufactured from titanium (Ti-6AI-4V, ASTM F136).

Specific instrumentation including wires, drills, depth gages, and torx drivers are required for use with the system. The TITANEX™ Screws instruments are manufactured from stainless steel and aluminum.

This document describes the TITANEX™ MICROBEAM Screw System and TITANEX™ ARTEMIS Screw System, comparing them to a predicate device to establish substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly state numerical acceptance criteria in a table format. Instead, it refers to mechanical testing per a standard (ASTM F543-17) and computational analysis, implying that the performance met the requirements set forth by these methods and their associated thresholds. The discussion section states, "the testing supports that these differences do not raise any new questions of safety and effectiveness," indicating successful performance without providing specific numerical results.

However, based on the provided text, we can infer the tested performance aspects:

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

The document does not specify the sample size for any of the mechanical or computational tests, nor does it provide information on the data provenance (country of origin, 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)

This is a medical device (screw system) that relies on mechanical and computational testing, not diagnostic performance tied to interpretations by experts. Therefore, the concept of "experts establishing ground truth for a test set" with qualifications such as radiologists is not applicable here. The "ground truth" would be established by the engineering standards and validation protocols used in the mechanical and computational analyses.

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

Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in human interpretation studies (e.g., medical image reading). This document describes performance testing of a physical medical device (bone screws) and computational analyses. Therefore, an adjudication method in this context is not applicable.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially AI-powered ones) that involve human interpretation of cases. The TITANEX™ systems are bone fixation screws, and their acceptance is based on mechanical and computational performance, not diagnostic accuracy or human reader performance.

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

This question is not applicable to the TITANEX™ Screw System. The device is a physical implant, not an algorithm. The "standalone performance" here refers to its mechanical integrity and function as a standalone product. The performance data does describe standalone (algorithm-only) performance in the context of the computational analysis, which includes "Cross sectional Analysis" and "Axial Pullout per Chapman et al." These computational models would run independently without human-in-the-loop performance for their execution, although their validation and interpretation would involve human engineers.

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

For the mechanical testing, the "ground truth" would be the physical properties and behavior of the screws measured against established engineering standards and specifications (ASTM F543-17). For computational analysis, the "ground truth" would be the mathematical models and scientific principles (e.g., Chapman et al. for axial pullout) that govern the expected behavior of the device under simulated conditions. It's not expert consensus, pathology, or outcomes data in the traditional medical sense, but rather adherence to validated engineering and scientific principles.

8. The sample size for the training set

The concept of a "training set" is applicable to machine learning or AI models. Since the TITANEX™ Screw System is a physical medical device (bone screws) and not an AI/ML product, there is no "training set."

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

As there is no training set for this device, how its ground truth was established is not applicable.

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The NITINEX Memory Compression Staple is intended for hand and foot bone fragments osteotomy fixation and joint arthrodesis.

The NITINEX Memory Compression Staple is a single-use bone fixation appliance intended to be permanently implanted. The implantation of the NITINEX Memory Compression Staple facilitates hand and foot bone fragment osteotomy fixation and joint arthrodesis. NITINEX Staples are compression staples made of shape memory nickel titanium alloy, nitinol. Vilex LLC will offer NITINEX Staples ranging in width from 8-mm to 30-mm with leg lengths ranging from 8-mm to 30-mm.

The provided text is an FDA 510(k) summary for a medical device called the "NITINEX Memory Compression Staple." It focuses on demonstrating substantial equivalence to a predicate device, as required for 510(k) clearance.

Therefore, the document does not describe acceptance criteria or a study that proves the device meets specific performance criteria in terms of clinical accuracy or diagnostic performance, such as those typically found for AI/ML-based medical devices. The assessments performed are primarily nonclinical (mechanical and corrosion testing) to confirm the device's physical properties are equivalent to the predicate.

Here's why the requested information cannot be extracted from this document:

• This is not an AI/ML device: The NITINEX Memory Compression Staple is a physical implant (a bone fixation device). The acceptance criteria and performance studies described in your prompt (e.g., diagnostic accuracy, human reader improvement with AI, ground truth establishment) are relevant for software as a medical device (SaMD) or AI-powered diagnostic tools, not for physical implants.
• 510(k) for physical devices focuses on substantial equivalence: For devices like the NITINEX staple, the 510(k) pathway primarily requires demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is typically done through comparisons of indications for use, technological characteristics, and non-clinical performance data (like mechanical strength and corrosion resistance). Clinical studies for physical implants are often more involved and specific to the device's function (e.g., healing rates, complication rates), but they are not detailed in a 510(k) summary in the way an AI performance study would be.
• The "performance data" mentioned is nonclinical: The document explicitly states: "The following nonclinical tests were performed to demonstrate the substantial equivalence of the subject device to the predicate device: Static Pullout Testing per ASTM F564-17, Bend Testing per ASTM F564-17, Cyclic Polarization Corrosion Testing per ASTM F2129-19a." These are mechanical and material property tests, not clinical performance studies involving human subjects or expert readers.

Therefore, I cannot fill out the requested table or answer the questions related to AI/ML device performance. The information provided in the document simply does not contain details about:

• Acceptance criteria for diagnostic accuracy (sensitivity, specificity, AUC)
• Sample size for test sets in an AI/ML context
• Data provenance for clinical images or patient data
• Number/qualifications of experts for ground truth establishment
• Adjudication methods for ground truth
• MRMC studies or effect sizes of human reader improvement with AI assistance
• Standalone algorithm performance
• Type of ground truth (pathology, outcomes data, expert consensus for diagnosis)
• Training set sample size or how training set ground truth was established

The document confirms the device passed the specified nonclinical tests and was found to be substantially equivalent to the predicate device in terms of mechanical strength, performance, and corrosion resistance.

If you intended to ask about the acceptance criteria and study for an AI/ML-based medical device, this document is not the correct source of information.

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The OPTIX H2 Patient Specific Instrument System is intended to be used as patient specific surgical planning and instrumentation to assist in the positioning of total ankle replacement components intraoperatively, and in guiding bone cutting. The OPTIX H2 Patient Specific Instrument System is intended for use with Vilex's Hintermann Series H2 Total Ankle System and its cleared indications for use. The OPTIX H2 Patient Specific Instrument System is indicated for single use only and is generated from CT imaging data.

OPTIX H2 Patient Specific Instrument System is patient-specific guides created to fit the contours of the patient's distal tibial and proximal talar anatomy. The guides and models are designed and manufactured from patient imaging data (CT) and are made from biocompatible nylon. The surgical guides in combination with Hintermann reusable instruments, facilitate the positioning of the Hintermann Series H2 Total Ankle implants. Vilex's OPTIX H2 PSI System produces a variety of patient specific outputs including surgical guides, anatomic models, and case reports.

The provided text does not contain specific acceptance criteria, reported device performance metrics, or detailed study information that would typically be required to fill out all aspects of your request for the OPTIX H2 Patient Specific Instrument System. The document is a 510(k) summary for FDA clearance, which focuses on demonstrating substantial equivalence to a predicate device rather than providing granular performance data against predefined acceptance criteria.

However, I can extract the information that is present and indicate where details are missing.

Here's a breakdown based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance

• Missing Details: The document does not specify what the "clinically justified acceptance criteria of the Hintermann Series H2 Total Ankle System" are (e.g., specific angular tolerances, cut depths, etc.), nor does it provide quantitative performance data (e.g., "equivalent implantation within X degrees of rotation" or specific debris generation measurements).

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

• Sample Size: Not explicitly stated. The text refers to "surgical procedures performed during the validation lab," but does not give a number of cases or procedures.
• Data Provenance: The study was a "validation lab" setting, implying a prospective, controlled environment, likely in the US or wherever Vilex, LLC is based. No specific country of origin for patients or data is mentioned, as it appears to be a benchtop/ cadaveric study rather than a clinical trial with patient data.

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

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: The study involved "surgical procedures" and assessed "implantation" equivalence, so it implicitly involved surgeons or trained personnel. However, their specific qualifications (e.g., "orthopedic surgeon with 10 years of experience in total ankle arthroplasty") are not provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. The document states "An analysis of the surgical procedures performed during the validation lab showed...", but doesn't detail how multiple assessments were reconciled (e.g., 2+1, 3+1, or if a single assessor was used).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and 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 conducted according to the provided text. This device is a patient-specific instrument system for surgery, not an AI-assisted diagnostic or imaging interpretation tool that would typically involve "human readers" in an MRMC study context.
• Effect Size of Improvement with AI: Not applicable, as this is not an AI-reader assistance device. "Software-assisted design" is mentioned for the guides, but the performance validation described is on the physical instruments' ability to facilitate implantation, not on human interpretation skills.

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

• Standalone Performance: Not applicable in the sense of an "algorithm only" performance study. The device is a physical instrument system. Its "software-assisted design" is part of its creation process, but the validation focuses on the physical instrument's performance in surgery, which inherently involves human interaction.

7. The Type of Ground Truth Used

• Ground Truth: The "ground truth" implicitly used was the outcome of the surgical procedures performed with both the subject device (OPTIX H2 PSI System) and the predicate device (Hintermann H2 Total Ankle System instrumentation). The comparison aimed to establish "equivalent implantation," suggesting a direct comparison of surgical results (e.g., placement accuracy, bone cuts) facilitated by each system. This is a form of empirical comparison against established surgical practice using the predicate device.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable/not provided. The device relies on patient-specific CT imaging data to create the guides. The "design of the patient specific guides, models, and pre-operative plan is software-assisted," suggesting algorithms or software are used for individual patient customization, but there is no mention of a traditional "training set" in the context of machine learning model development for a generalized diagnostic/predictive task. Each guide is custom-designed based on an individual patient's CT data.

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

• Training Set Ground Truth: Not applicable for the reasons mentioned in point 8. The "ground truth" for the patient-specific design system relies on accurate interpretation of the individual patient's CT imaging data and established surgical principles for total ankle replacement.

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The ALPHALOK™ Plating System bone plates, screws, and washers are intended for use in bone fractures, osteotomies, and fixation of bones and bone fragments in the upper and lower extremities, primarily of the hand, wrist, foot, ankle, and digits. Specific examples include:

• · Forefoot, Midfoot, and Hindfoot Osteotomies
• · Metatarsals and Metacarpals Corrections and Osteotomies
• · Stabilization and Fixation of Metatarsal and Metacarpal Fractures
• Stabilization and Fixation of Ankle Fractures
• Syndesmosis Joint Stabilization
• · Arthrodesis of Metatarsophalangeal (MTP) and Metacarpophalangeal (MCP) joints
• · Flatfoot and Cavus Foot Corrections
• Charcot Fixation

The ALPHALOKTM Ankle Fx Plates are intended for fixation of fractures, and non-unions of the distal tibia and fibula such as:

• · Lateral Malleolar Fractures
• · Syndesmosis Injuries
• · Medial Malleolar Fractures
• Bi-Malleolar Fractures
• Tri-Malleolar Fractures
• · Posterior Malleolar Fractures
• · Distal Anterior Tibia Fractures
• · Vertical Shear Fractures of the Medial Malleolus
• Pilon Fractures
• · Distal Tibia Shaft Fractures
• Distal Fibula Shaft Fractures
• Distal Tibia Periarticular Fractures
• · Medial Malleolar Avulsion Fractures
• Lateral Malleolar Avulsion Fractures

The ALPHALOK™ Plating System is a multi-indication solution providing polyaxial locking technology and low-profile plate designs. The ALPHALOK™ Ankle Fx plates and screws are intended to treat various fracture patterns of the ankle specifically tibia and fibula.

The intent of this submission is to expand indications to include ankle fractures, whereas the previous submissions for the ALPHALOK™ Plating Systems (K221558, K212348) were for forefoot and midfoot respectfully.

All implant components are manufactured from titanium (Ti-6AI-4V, ASTM F136).

Specific instrumentation including wires, drills, torx drivers, and drill guides are required for use with the system. The ALPHALOK™ instruments are manufactured from stainless steel.

The provided text describes a 510(k) premarket notification for the ALPHALOK™ Plating System, which is a medical device for bone fixation. However, the document does not contain information about acceptance criteria, device performance in terms of clinical accuracy or statistical metrics, a study proving the device meets acceptance criteria, sample sizes for test or training sets, data provenance, expert ground truth establishment, or multi-reader multi-case studies, as typically requested for AI/algorithm-based diagnostic devices.

The document is a regulatory submission for a physical medical device (bone plates and screws) and primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and mechanical performance testing.

Therefore, I cannot provide the requested information from the given text alone.

Here's a breakdown of why each point cannot be addressed:

1. A table of acceptance criteria and the reported device performance: Not available. The document mentions "Static four point bend testing per ASTM F382-17" but does not provide specific acceptance criteria values (e.g., minimum load to failure, maximum deflection) or the reported performance data from these tests. These are engineering performance metrics, not clinical performance metrics typically associated with AI devices.
2. Sample sized used for the test set and the data provenance: Not available. The performance data mentioned (static bend testing) would involve physical specimens, not a "test set" of data in the context of an AI study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is not an AI/diagnostic device. Ground truth, in this context, would relate to an objective measurement of mechanical properties rather than expert interpretation of medical images or data.
4. Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating diagnostic accuracy with and without AI assistance, which is irrelevant for a physical bone fixation system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of diagnostic AI. For the mechanical testing, the "ground truth" would be the physically measured values from the tests.
8. The sample size for the training set: Not applicable. No AI model is described.
9. How the ground truth for the training set was established: Not applicable. No AI model is described.

In summary, the provided document is a 510(k) clearance for a physical medical device (bone fixation system) and does not contain the type of information requested regarding acceptance criteria and studies for an AI/algorithm-based device.

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