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The Vilex X-Fix is intended for external fixation with the following indications:

1. Stabilization of Fractures & Osteotomy
2. Rear & Mid-foot Foot Arthrodesis
3. Adult and Pediatric Leg Lengthening
4. Correction of Bone Deformity in Upper & Lower Extremities

This submission includes medical grade stainless steel half pins and wires coated with Hydroxyapatite (HA). They are intended to be used with external fixation systems.

This is a 510(k) summary for a medical device called "Ultima HA Coated Half Pins & Wires". The purpose of this summary is to demonstrate substantial equivalence to existing predicate devices, not to prove performance against specific acceptance criteria in a clinical study. Therefore, the information requested regarding acceptance criteria and study details is not present in this document.

Here's a breakdown of why the requested information cannot be provided from the given text:

• This is a 510(k) submission: 510(k) submissions typically focus on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, rather than requiring extensive new clinical trials with specific performance metrics and acceptance criteria.
• Focus on Substantial Equivalence: The document explicitly states: "The safety and effectiveness of the Ultima HA Coated Half Pins & Wires are adequately supported by the substantial equivalence information, material information and analysis data provided within this Premarket Notification." This means the assessment is based on comparisons with existing devices, not a standalone performance study.
• No mention of a clinical study for acceptance criteria: There is no description of a study designed to measure the device's performance against specific acceptance criteria. The "analysis data" mentioned likely refers to bench testing and material characterization, not patient data.

Therefore, I cannot provide the requested information for the following reasons:

1. A table of acceptance criteria and the reported device performance: Not present. The device is being cleared based on substantial equivalence, not a direct performance test against pre-defined criteria.
2. Sample size used for the test set and the data provenance: Not applicable. No test set from a clinical study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment activity from a clinical study is described.
4. Adjudication method: 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. This device is a bone fixation fastener, not an AI-assisted diagnostic tool.
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.
8. The sample size for the training set: Not applicable. No training set is mentioned as this is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable.

The document concludes that "any differences that may exist do not significantly affect device safety and effectiveness" and that the device is "substantially equivalent to the predicate devices." This is the primary "proof" for a 510(k) submission of this nature.

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The Vilex eZ-Staple (Superelastic Bone Fixation Staple) is indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.
The Vilex memory bone fixation staples (eZ-Staple) are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.

The Vilex eZ-Staple Superelastic Bone Fixation Staple is a single-use bone fixation appliance intended to be permanently implanted. Super Elastic staples are compression staples made of shape memory nickel titanium alloy, Nitinol. Vilex will offer Monocortical Staples ranging in width from 10mm to 20mm with leg lengths ranging from 10mm to 20mm and Biocortical Staples ranging in width from 10mm to 18mm with leg lengths from 15x13 to 19x17.

The provided text describes a 510(k) summary for the Vilex eZ-Staple Superelastic Bone Fixation Staple. This document outlines the device's characteristics, intended use, and the non-clinical tests performed to demonstrate its substantial equivalence to a predicate device. It does not contain information about clinical studies, acceptance criteria for device performance based on human reader studies, or details about ground truth establishment with expert consensus.

Therefore, I cannot provide a table of acceptance criteria and device performance as no such criteria or clinical performance data are presented in the document.

Based on the provided text, here's what can be inferred and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size for Test Set: Not applicable. The provided document details non-clinical laboratory testing, not clinical trials with "test sets" in the context of diagnostic or AI performance.
• Data Provenance: Not applicable for clinical data. The non-clinical tests were performed on "samples of the Vilex eZ-Staple." The country of origin of the data is not specified beyond being part of a U.S. FDA 510(k) submission.

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

• Not applicable. This device is a bone fixation staple, not a diagnostic or AI device requiring expert-established ground truth for performance evaluation in the context of clinical images or data.

4. Adjudication Method for the Test Set:

• Not applicable. There is no mention of a test set requiring adjudication in the context of clinical evaluation.

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

• No. The document describes non-clinical testing of a bone fixation staple, not an AI or diagnostic device that would typically undergo an MRMC study.

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

• Not applicable. This is a medical implant, not an algorithm or AI device.

7. The Type of Ground Truth Used:

• Not applicable in the context of clinical ground truth. For the physical and material properties, the "ground truth" would be established by validated ASTM and ISO standards for material properties and predicate device performance for comparative testing.

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI or machine learning device.

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

• Not applicable. This is not an AI or machine learning device.

In summary, the provided document details a 510(k) submission for a medical implant (bone fixation staple), which primarily relies on non-clinical engineering and material compatibility testing to demonstrate substantial equivalence to a predicate device. It does not involve AI, diagnostic imaging, or human reader studies, and therefore, most of the requested information regarding acceptance criteria and studies in that context is not present.

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Ankle Arthrodesis, Tibio-talo-calacaneal Arthrodesis

The Vilex FUZETM is a single-piece intramedullary nail fixed to the tibia and foot with locking cross screws for fusing the ankle joint(s). The FUZETM is a straight cannulated metallic implant offered in five diameters and various lengths in either 316L VM (ASTM 138) stainless steel or Ti6Al4V titanium alloy (ASTM 136). The FUZETM System is a modular system consisting of the implant, locking screws, and instrumentation for fixation. The screws, (offered in one diameter and various lengths), are manufactured from identical materials (either stainless steel or titanium alloy, matching the implant). The targeting device is radio translucent, designed to lock into the FUZETM for the correct insertion of the locking screws. The system also includes drills, reamers, screwdrivers, guide wires and Steinman pins.

Here's an analysis of the provided 510(k) summary for the FUZE®: Intramedullary Arthrodesis Nail System, focusing on acceptance criteria and the supporting study, based only on the information provided in your input:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific acceptance criteria in terms of numerical performance targets (e.g., tensile strength, fatigue life thresholds). Instead, it relies on demonstrating substantial equivalence to predicate devices. The "reported device performance" is framed in terms of achieving this equivalence and demonstrating mechanical integrity.

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

• Sample Size for Test Set: Not explicitly stated in terms of a numerical count of cadavers, sawbones, or specific test pieces. The summary mentions "cadaver, sawbones, and components tests."
• Data Provenance: The nature of the tests (engineering analysis, cadaver, sawbones, and components tests) suggests the data is likely prospective in the sense that these tests were conducted specifically for this submission to evaluate the device. The geographical origin of the data is not specified but would typically be from the manufacturer's testing facilities or contract labs.

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

This information is not provided in the summary. The "tests" mentioned (engineering, cadaver, sawbones, components) are mechanical and material performance tests, where "ground truth" would be established by scientific measurement and engineering principles rather than expert clinical consensus in the way it applies to diagnostic devices evaluating images/data.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human judgment (e.g., reading medical images) to resolve discrepancies among multiple expert opinions in establishing a ground truth. The tests described are engineering and material performance tests.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret medical cases, and the AI's impact on their performance is evaluated. The FUZE system is an implantable orthopedic device.

6. Standalone (Algorithm Only) Performance Study

No, a standalone performance study (algorithm only) was not done. This concept is also primarily applicable to AI/ML diagnostic algorithms. The FUZE is a physical medical device; its performance is evaluated through mechanical testing, material analysis, and comparison to predicate devices, not through an "algorithm only" study.

7. Type of Ground Truth Used

The "ground truth" in this context is established by:

• Engineering principles and measurements: For mechanical integrity (e.g., strength, stiffness, fatigue).
• Material specifications: Conformance to ASTM standards for Titanium and Stainless Steel.
• Comparison to predicate devices: Establishing that its design features (indications, materials, sizes, hole locations, shape) are substantially equivalent.
• Biomechanical performance: Demonstrated through cadaver and sawbones tests for its ability to compress tibi-talo-calcaneal joints.

8. Sample Size for the Training Set

Not Applicable. The FUZE system is a physical orthopedic implant, not an AI/ML algorithm that requires a "training set."

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

Not Applicable. As there is no training set, there is no corresponding ground truth to establish for it.

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The Vilex cannulated metallic hemi implant, a hemi-arthroplasty implant for the metatarsophalangeal (MTP) joint, is indicated for use in the treatment of patients with degenerative and post-traumatic arthritis in the MTP joint in the presence of good bone stock and integrity of the phalangeal base, along with the following clinical conditions; Hallux Limitus, Hallux Valgus, Hallux Rigidus, and an unstable or painful MTP joint.

The Vilex cannulated metallic hemi implant is intended to be used with bone cement or press fit without bone cement.

The Vilex cannulated metallic hemi implant is intended for single use only.

Vilex Cannulated Metallic Hemi Implant is a one-piece device intended to resurface the base of the proximal phalanx. It is similar in design to the predicate devices (BioPro K023684) and MetaSurg (K083469) in terms of articular surface shape and fixation. Implants will be offered in cobalt chrome or titanium, with or without Hydroxyapatite (HA) coated stem and back as an option.

The provided text is a 510(k) summary for a medical device (Vilex Cannulated Metallic Hemi Implant). It describes the device, its indications for use, and a claim of substantial equivalence to predicate devices. However, it does not include the detailed performance study information requested in the prompt.

Specifically, the document states: "Non-Clinical Test Data: Based on the engineering analysis, the Vilex implants are equivalent to predicates in terms of mechanical integrity and resistance to bending torques." This indicates that the primary evidence for this device's acceptance is based on engineering analysis and comparison to existing predicate devices, rather than a clinical study with detailed performance metrics, ground truth establishment, or human reader involvement.

Therefore, many of the requested fields cannot be filled from the provided text.

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

Acceptance Criteria and Device Performance Study for Vilex Cannulated Metallic Hemi Implant

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not applicable. This device's acceptance is based on an "engineering analysis" and comparison to predicate devices, not a clinical test set with patient data.

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

• Not applicable. No clinical test set requiring expert ground truth establishment is described. The evaluation was an engineering analysis.

4. Adjudication method for the test set:

• Not applicable. No clinical test set requiring adjudication is described.

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. This is a medical implant, not an AI-assisted diagnostic device. Therefore, no MRMC study or AI assistance is relevant.

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

• No. This is a medical implant, not an algorithm.

7. The type of ground truth used:

• Engineering Analysis/Predicate Device Specifications: The "ground truth" for the device's acceptance is based on its engineering properties matching those of previously approved predicate devices, along with comparable indications for use, materials, sizes, and shapes.

8. The sample size for the training set:

• Not applicable. This device's acceptance is based on engineering comparison, not a machine learning model that requires a training set.

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

• Not applicable. No training set for a machine learning model is involved.

Summary:

The provided 510(k) summary for the Vilex Cannulated Metallic Hemi Implant demonstrates substantial equivalence through an engineering analysis and comparison to predicate devices in terms of mechanical integrity, resistance to bending torques, indications for use, materials, sizes, and shapes. This is a common pathway for medical device clearance, especially for devices similar to existing ones. It does not involve clinical studies with patient data, expert ground truth, or AI-related performance metrics.

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Hallux Limitus or Rigidus
Resurfacing of Arthritic /Metatarsal joint
To fixate, use cement or press fit without cement

The implant is a fixation metal device, machined from implant quality cobalt-chrome alloy. The implant is cannulated to allow proper positioning. The stem is threaded and functions as a selfreaming and self-tapping screw for easy insertion. The shaft design is a duplicate of Vilex Cannulated Hemi Implant, K023684. The head is spherical and mirror-polished. The outside appearance resembles the STD Great Toe Resurfacing Hemi-Arthroplasty Implant, K031859. Use Only with Approved Bone Cement
Auxiliary instruments for implanting, aligning, countersinking come with "The Met-head."

The provided text describes the regulatory clearance of a medical device, the Vilex™ Met-Head™, by the FDA. It details information about the device, its indications for use, and a comparison to predicate devices, but it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as this information is not present in the provided document.

To be clear, the document is a 510(k) clearance letter from the FDA, which means the device was found to be "substantially equivalent" to a legally marketed predicate device. This process typically relies on demonstrating equivalence in design, materials, indications for use, and technological characteristics, rather than requiring new clinical studies with defined acceptance criteria for device performance. While the manufacturer would have internal testing to ensure the device meets its own specifications, these details are not part of this specific FDA clearance document.

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The Vilex X-Fix is intended for external fixation with the following indications:

1. Stabilization of Fractures & Osteotomy
2. Rear & Mid-foot Foot Arthrodesis
3. Adult and Pediatric Leg Lengthening
4. Correction of Bone Deformity in Upper & Lower Extremities.

Not Found

The provided text is a 510(k) summary for the Vilex External Fixation System, X-Fix. This document is for a medical device (an external fixation system), not a diagnostic AI software. Therefore, the questions related to the acceptance criteria for AI/ML performance, study design for AI models, ground truth establishment, expert adjudication, and sample sizes for training/test sets are not applicable to this submission.

The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and intended use, rather than on performance derived from a study involving AI or machine learning. The acceptance criteria for such a device would typically relate to mechanical performance (e.g., strength, durability, biocompatibility) and clinical effectiveness for its stated indications, usually supported by a comparison to existing devices and bench testing, not by AI performance metrics.

Therefore, I cannot provide the requested information as it pertains to AI/ML device performance. The document focuses on regulatory approval for a physical medical device.

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Small-Bone Fracture and Osteotomy in Upper & Lower Extremities, primarily hand, foot, and digits.

The material used to manufacture the bone plates is implant-quality 316L Stainless (ASTM Fric material used to manufacture (ASTM F-136). The plates are to be used with accompanying bone screws of the same material.

I am sorry, but the provided text from the FDA letter regarding the Vilex Bone Plate Systems does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) clearance letter, which states that the device is substantially equivalent to a legally marketed predicate device. This type of clearance focuses on equivalence rather than performance against specific acceptance criteria from a clinical study.

Therefore, I cannot provide the requested information, which includes:

1. A table of acceptance criteria and reported device performance.
2. Sample sized used for the test set and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study details.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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The Talus of Vilex, as designed, has the following Indications of Use: Flat foot, pronated subtalar joint.
The material used to manufacture this device is implant-quality titaniumTl6A4V alloy. The device is intended to remain implanted for a finite period of time. The implant is best device is ifitended to remain implanted for a minto for a minto for single use only.
Prescription Use (Per 21 CFR 801.109)

The material used to manufacture this device is implant-quality titaniumTl6A4V alloy. The device is intended to remain implanted for a finite period of time. The implant is best device is ifitended to remain implanted for a minto for a minto for single use only.

This is a 510(k) premarket notification for a medical device called "Talus of Vilex (TOV) Implant". A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. This document does not contain information about the device's acceptance criteria or a study proving its performance against such criteria. It is an FDA clearance letter and an "Indications for Use" statement, outlining the device's intended applications and regulatory classification.

Therefore, I cannot provide the requested information based on the given context.

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The Cannulated Metallic Toe Implant, as designed, has the following Indications for Use: Hallux Limitus or Hallux Rigidus, Hallux Valgus, Joint Arthroplasty, Resurfacing of Arthritic M-P Joints.

The material used to manufacture this prosthesis is implant-quality cobalt-chrome alloy ASTM F75. The implant may be cemented to the phalanx or press-fit without cernent.

This document is a 510(k) clearance letter from the FDA for a medical device called the "Cannulated Metallic Hemi Toe Implant." It does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The letter confirms that the device is substantially equivalent to a legally marketed predicate device and can be marketed subject to general controls.

Therefore, I cannot provide the requested information based on the provided text. The document is primarily a regulatory approval notice, not a performance study report.

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The Multithread Vilex Cannulated Bone Screw, as designed, has the following Indications for Use: Bone Fractures, Osteotomies, Arthrodeses, and Tendon Attachment. It is intended for, but not limited to Hand Surgery, Orthopedic and Podiatric Surgery, The materials used to manufacture this screw are 316L, implant-quality stainless steel and Ti6Al4V, implant quality titanium alloy.

Not Found

I am sorry, but based on the provided document, I cannot answer the request about the acceptance criteria and the study that proves the device meets them. The document is a clearance letter from the FDA for a medical device (Vilex/Duval/Orthex Cannulated Bone Screw Double Thread) and outlines regulatory information and an "Indications for Use" statement. It does not contain details about specific acceptance criteria, study designs, sample sizes, expert qualifications, or comparative effectiveness studies.

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