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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 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 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 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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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 ALPHALOK™ Plating System, consisting of the ALPHALOK™ Met Fx and ALPHALOK™ Recon, is a multi-indication reconstruction solution providing polyaxial locking technology and lowprofile design.

The ALPHALOK™ Met Fx contains various sizes of non-sterile straight plates, T plates, Y plates, Jones plates, mini plates, and locking and non-locking screws.

The ALPHALOK™ Recon contains various sizes of non-sterile fusion plates, Lapidus plates, peanut plates, straight plates, tab plates, T-plates, MTP plates, Cotton & Evans plates, utility plates, and Ankle Fracture plates along with locking and non-locking screws, and washers.

All implant components are manufactured from titanium (Ti-6A1-4V, 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 medical device, the ALPHALOK™ Plating System, and its FDA 510(k) clearance. However, it does not contain any information regarding the acceptance criteria for an AI/ML medical device, nor does it describe a study proving such a device meets those criteria.

The document focuses on the substantial equivalence of the ALPHALOK™ Plating System to predicate devices, which is a regulatory pathway for traditional medical devices (bone plates, screws, and washers). The performance data mentioned (static four-point bend testing, torsional properties testing, axial pullout calculations, driving torque testing, engineering calculations, and cleaning/sterilization validations) are all entirely mechanical and material property tests relevant to the physical components of the plating system, not to an AI/ML algorithm.

Therefore, I cannot fulfill your request to describe the acceptance criteria and a study proving an AI/ML device meets those criteria based on the provided input. The document is about a hardware medical device, not a software/AI one.

To answer your specific questions, the information is not present in the provided text:

1. A table of acceptance criteria and the reported device performance: Not available, as it's a hardware device clearance, not an AI/ML performance study.
2. Sample sized used for the test set and the data provenance: Not applicable in the context of an AI/ML test set. The performance data refers to mechanical bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML device would typically involve expert annotations of medical images or data. This document doesn't discuss AI or image analysis.
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 consensus, pathology, outcomes data, etc.): Not applicable to this type of device clearance.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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ALPHALOK™ Plating System bone plates and screws are indicated for use in bone fractures and osteotomies of small bones or small bone fragments of the hand and wrist.

The ALPHALOK™ Plating System, consisting of the ALPHALOK™ Met Fx Mini Plates, is a multi-indication reconstruction solution providing polyaxial locking technology and low profile design.

All implant components are manufactured from titanium (Ti-6Al-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.

This K212348 FDA 510(k) summary provides information for the ALPHALOK™ Plating System, a bone fixation device. Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document details performance data provided in support of substantial equivalence. The acceptance criteria are implicitly met by demonstrating performance equivalent to the predicate devices through standardized testing. The "reported device performance" is that the device passed these tests, indicating it performs comparably to the predicate.

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

The document does not explicitly state the sample sizes used for each mechanical test. The tests are described as being performed "per ASTM F543-17" and "per ASTM F382-17," which implies that the sample sizes would adhere to the recommendations or requirements within those specific ASTM standards.

The data provenance is not explicitly stated in terms of country of origin. The study appears to be prospective in the sense that the testing was conducted specifically for this 510(k) submission to demonstrate the performance of the ALPHALOK™ Plating System.

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

This section is not applicable as the studies are mechanical performance tests of a physical device (bone plates and screws), not a diagnostic or AI-driven system requiring expert ground truth for interpretation. The "ground truth" here is the physical performance data measured according to established engineering standards.

4. Adjudication Method for the Test Set:

This section is not applicable for the same reason as point 3. Mechanical performance tests typically do not involve human adjudication; the results are quantifiable measurements against established engineering benchmarks.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically conducted for diagnostic or imaging devices that rely on human interpretation, often assisted by AI. The ALPHALOK™ Plating System is a surgical implant.

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

No, a standalone algorithm performance study was not done. This device is a physical surgical implant, not an algorithm or software.

7. The Type of Ground Truth Used:

The "ground truth" for the performance studies of this device is based on standardized engineering specifications and measurements defined by the ASTM (American Society for Testing and Materials) and ANSI/AAMI/ISO standards. This includes:

• Mechanical properties: Measured values for torsional strength, axial pullout force, driving torque, and static four-point bend strength.
• Material properties: Chemical composition and physical properties of the titanium alloy, specified by ASTM F136.
• Cleaning and sterilization efficacy: Measured outcomes of cleaning and sterilization processes against predefined acceptance criteria for microbial reduction and residue levels.

8. The Sample Size for the Training Set:

This question is not applicable. This device is a physical medical implant, not an AI or machine learning model that requires a "training set."

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

This question is not applicable for the same reason as point 8.

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The Correx Software is intended to be used as a component of multilateral external fixation system for the Vilex External Fixation System with the indications listed below:

• Stabilization of Fractures & Osteotomy
• Rear and Mid-foot Arthrodesis
• Adult and Pediatric Leg Lengthening
• Correction of Bone Deformity in Upper & Lower Extremities

The Correx Software, intended for use with the Dynex Ring Fixation System (K202054), is an optional-use computational environment that can be used for determining the orientation of bone segments and external fixator elements attached to a bone to treat fractures and bone deformities.

The software includes user interface, processing, data storage, and display functions. The Correx Software can be used to visualize the position of a moving bone segment and to compute the strut lengths necessary to implement any desired translation or rotation. The Software program does not control the device. The Software program does not control any hardware (such as rings, struts, wires) directly. The goal of the Software program is to provide the Surgeon with a tool for determining the length of the six struts connecting the two circular rings. The Surgeon must decide where a bone segment should line up and the angulation and translation necessary for the treatment. The magnitude and direction of any rotation or translation is ultimately the responsibility of the Surgeon.

The provided text describes the Correx Software (K212552), intended for use with the Vilex External Fixation System. However, it does not contain specific acceptance criteria or reported device performance metrics in the format requested. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing comprehensive performance studies with acceptance criteria and statistical results.

Here's a breakdown of what can be extracted or inferred based on the provided text, and what is missing:

The 510(k) summary states:

"Software verification and validation testing was undertaken to ensure that the product requirements and specifications were met."

This indicates that internal testing was performed, but the details of this testing (acceptance criteria, specific performance metrics, study design, sample sizes, etc.) are not provided in this public document.

Missing Information:

• A table of acceptance criteria and the reported device performance: This is the primary missing piece. The document merely confirms that "Software verification and validation testing was undertaken."
• Sample sizes used for the test set and the data provenance: Not provided.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
• Adjudication method for the test set: Not provided.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not mentioned. The focus is on the software's ability to compute strut lengths, not on human reader performance with or without AI assistance.
• If a standalone study was done: The description implies standalone testing as it focuses on software verification and validation, but specific study details are absent.
• The type of ground truth used: Not specified.
• The sample size for the training set: Not specified, as this appears to be a software tool for calculation/visualization, not an AI/ML model that typically requires a large training set in the conventional sense.
• How the ground truth for the training set was established: Not specified.

What can be inferred from the document:

• Device Function: The Correx Software is an "optional-use computational environment" that helps determine the orientation of bone segments and external fixator elements, and computes strut lengths. It takes "Surgeon Inputs based on X-Ray positioning" as input and outputs a "Daily schedule of strut lengths."
• Intended Use: As a component of a multilateral external fixation system for specific orthopedic indications (fractures, osteotomy, arthrodesis, leg lengthening, deformity correction).
• Comparison to Predicate: The document claims "The subject and predicate device share the same intended use and technological characteristics." This implies that the performance expectations would be similar to the predicate (X-Fix Line Additions, K151881), which is also software for diagnosis/treatment in external fixation.

Conclusion based on the provided text:

The provided 510(k) summary for Correx Software (K212552) indicates that verification and validation testing was performed to meet product requirements. However, it does not include the specific details of acceptance criteria, reported performance, study designs, sample sizes, or ground truth establishment that would typically be found in a detailed study report. The document's purpose is a regulatory submission for substantial equivalence, not a publication of a detailed performance study.

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