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The Bone Screw Line Addition is intended to be used for the following indications:

• · Bone fractures
  • o Jones fractures
  • o Acute fractures
  • o Avulsion fractures
  • o Repetitive stress fractures
  • o Malleolar fractures
  • o Talus fractures
  • o Greater tuberosity fractures
    · Fixation of malunions and non-unions
• · Osteotomies
• · Arthrodesis

The Vilex Bone Screw Line Addition includes an implantable device system intended for fixation of bone fractures and osteotomies of the upper and lower extremities. The Bone Screw Line Addition (BSLA) system consists of cannulated and solid screws. The implants are offered fully or partially threaded and in 4.5, 5.5, and 6.0 mm thread diameters. The BSLA implants are fabricated from either titanium or stainless steel.

Based on the provided text, the device is a medical implant (Bone Screw Line Addition) intended for bone fixation, and the document is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance criteria through clinical or analytical studies as one might find for an AI/Software as a Medical Device (SaMD).

Therefore, the provided document DOES NOT contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria in the context of an AI/SaMD. This document describes a physical medical device and its mechanical equivalence to existing devices.

The sections for AI/SaMD performance (e.g., sample sizes, expert ground truth, MRMC studies, training set details) are not applicable to this type of device and submission.

However, I can extract the information that is present and explain why the other requested information is not available in this document.

Acceptance Criteria and Device Performance (for a physical Bone Screw Line Addition)

Since this is a physical medical device (bone screw) and not AI/SaMD, the "acceptance criteria" are related to its mechanical performance and substantial equivalence to legally marketed predicate devices, as assessed through engineering analyses.

• Acceptance Criteria: The device must demonstrate mechanical equivalence (e.g., torsional strength, shear strength, bending strength, pull-out strength) to the cleared predicate devices and not introduce any new questions of safety or effectiveness due to differences in technological characteristics (e.g., thread form, screw head geometry).
• Reported Device Performance: "Engineering analyses demonstrated that the BSLA does not introduce an added risk when compared to the cleared predicate devices. Analysis was used to demonstrate substantially equivalent mechanical strength (i.e., torsional strength, shear strength, bending strength, and pull out strength)."

Why the requested AI/SaMD information is not in this document:

This document is a 510(k) summary for a physical medical device, not a software or AI-driven diagnostic/therapeutic device. The FDA's requirements for demonstrating substantial equivalence for a physical device like a bone screw typically involve:

• Comparison of technological characteristics: Material, design, mechanical performance, intended use.
• Performance data: Often bench testing (mechanical strength, durability) and sometimes biocompatibility testing.
• No clinical trials are usually required if substantial equivalence can be demonstrated through non-clinical means.

Therefore, the specific quantitative details about "acceptance criteria" and "study that proves the device meets acceptance criteria" as defined for AI/SaMD (e.g., sensitivity, specificity, AUC, human reader improvement) are not relevant to this submission type and are not present in the provided text.

Absence of Requested Information (Specific to AI/SaMD):

1. A table of acceptance criteria and the reported device performance: As explained above, for this physical device, the "acceptance criteria" are related to mechanical equivalence to predicates, not specific numerical diagnostic performance metrics. The performance is stated as "substantially equivalent mechanical strength."
2. Sample sizes used for the test set and the data provenance: Not applicable. No test set of patient data (e.g., images) was used for performance validation in the AI/SaMD sense. This involves mechanical testing or analyses, not patient data.
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 diagnostic accuracy is not relevant for a bone screw.
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. This is not an AI-assisted device.
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 for an AI model.
9. How the ground truth for the training set was established: Not applicable.

In conclusion, the document describes the FDA 510(k) clearance process for a physical medical device (bone screw) based on substantial equivalence principles, which are fundamentally different from the performance evaluation requirements for AI/SaMD.

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

The Vilex CHI System includes one-piece cannulated hemi-arthroplasty implants intended to resurface the metatarsal-phalangeal joint. The CHI system includes an MPJ Base and MPJ Head. These are available in standard and lesser options. These components are used for hemi arthroplasty and are not used together to create a total joint.

It appears you've provided a 510(k) Premarket Notification document for a medical device: the Vilex Cannulated Hemi Implant (CHI).

However, this document describes a joint implant, not an AI/software-as-a-medical-device (SaMD) or diagnostic imaging device. The acceptance criteria and supporting studies described in this document relate to the mechanical performance and biocompatibility of a physical implant, not the performance of an algorithm or the accuracy of a diagnostic reading.

Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI-driven diagnostic or image analysis device (e.g., sample size, expert ground truth, MRMC studies, standalone performance) is not present in this document.

The performance data section (VII. Performance Data) for this implant focuses on:

• Engineering analyses: Bending Stress, Shear Stress, Geometric Analysis, Surface Area Analysis. These are tests to ensure the physical implant is strong enough and fits correctly.

It does not contain information relevant to AI/diagnostic device evaluation, such as:

• A table of acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, AUC).
• Sample sizes for a test set of diagnostic images.
• Data provenance for diagnostic images.
• Number of experts for ground truth of diagnostic images or their qualifications.
• Adjudication methods for diagnostic ground truth.
• MRMC studies to show human reader improvement with AI.
• Standalone performance of an algorithm.
• Type of ground truth (e.g., pathology, outcomes data) for diagnostic purposes.
• Training set sample size for an AI model.
• How ground truth for a training set was established for an AI model.

In summary, this document is about a physical orthopedic implant, not an AI or diagnostic software. Therefore, it does not contain the information you are requesting about AI device evaluation methods.

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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 document is a 510(k) Pre-Market Notification from the FDA regarding the "Ultima HA Coated Half Pins And Wire" manufactured by Vilex in Tennessee, Inc. It details the substantial equivalence review process, but it DOES NOT contain information about specific acceptance criteria, a study that proves the device meets those criteria, or performance metrics.

Instead, this document focuses on demonstrating substantial equivalence to a previously cleared predicate device (Ultima HA Coated Half Pins and Wires by Vilex, K132820). The rationale for substantial equivalence is based on:

• Indications for Use: The current device has the same intended uses as the predicate.
• Technological Characteristics: The device has similar technological characteristics (e.g., material, sizes, design) to the predicate.
• Material of Construction: The materials used are the same.
• Analysis Data: General analysis data is mentioned as supporting safety and effectiveness.

Therefore, I cannot provide the requested information about acceptance criteria and device performance as it is not present in the provided text.

Based on the provided text, I can only provide the following:

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

• Not Available. The document does not specify quantitative acceptance criteria or reported device performance metrics. It establishes substantial equivalence by comparing the device's characteristics and indications for use to a predicate device.

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

• Not Available. No specific test set, sample size, or data provenance is mentioned for performance evaluation in this 510(k) summary. The document relies on similarity to a predicate device and material/analysis data.

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)

• Not Applicable. No ground truth establishment related to a test set for performance evaluation is mentioned.

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

• Not Applicable. No test set or related adjudication method is mentioned.

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 medical implant (bone fixation fastener), not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human readers and AI is irrelevant to this submission.

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

• Not Applicable. This device is a physical medical implant, not an algorithm.

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

• Not Available/Not Applicable. The concept of "ground truth" as it applies to performance evaluation of a diagnostic or AI device is not relevant here. The substantial equivalence relies on demonstrating that the device is as safe and effective as a legally marketed predicate through design, material, and intended use similarities.

8. The sample size for the training set

• 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

• Not Applicable. As above, no training set or ground truth for it is relevant to this device.

Summary of what is available from the document:

• Device Name: Ultima HA Coated Half Pins and Wires
• Predicate Device: Ultima HA Coated Half Pins and Wires by Vilex (K132820)
• Basis for Substantial Equivalence: Similar indications for use, technological characteristics (materials, sizes, design), and general analysis data.
• Indications for Use:
  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
• Material: Medical grade stainless steel coated with Hydroxyapatite (HA).
• Safety Testing: Pyrogen testing was conducted and confirmed the device is non-pyrogenic.

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

1. Stabilization of Fractures & Osteotomy
2. Adult and Pediatric Leg Lengthening
3. Correction of Bone Deformity in Upper & Lower Extremities
   The P&C Software is intended to be used as a component of multilateral external fixation system for the indications listed above.

The X-Fix Line Additions, subject of this 510(k) submission, include External Fixation Rings and Footplates, External Fixation Struts, External Fixation Assembly Accessories, and P&C Software. The line additions are manufactured from stainless steel and aluminum materials in various sizes to accommodate patient needs. The X-Fix Line Additions are used with the X-Fix system.

Here's an analysis of the provided text regarding the acceptance criteria and study for the X-Fix Line Additions device, presented in the requested format.

It's important to note that the document describes a 510(k) submission, which aims to demonstrate substantial equivalence to a predicate device rather than strictly proving effectiveness and safety through extensive clinical trials as would be required for a PMA (Premarket Approval). Therefore, the information provided focuses on mechanical testing and software validation, not on clinical performance criteria like sensitivity, specificity, or reader studies.

Acceptance Criteria and Study for X-Fix Line Additions

1. Table of Acceptance Criteria and Reported Device Performance

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

• Mechanical Testing: The document does not specify the exact sample size for mechanical testing. It mentions general adherence to ASTM F1541-02 (Sections A6 and A7), which would define the sample size requirements for specific tests.
• Software Validation: The document does not specify the exact sample size (e.g., number of test cases) for software V&V.
• Data Provenance: The data is likely retrospective (meaning performed according to established protocols) and generated internally by Vilex in Tennessee, Inc. (the manufacturer). The country of origin for the data generation would be USA. This is not clinical data, so patient data provenance is not applicable.

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

• Not Applicable. This submission relied on mechanical engineering and software testing standards, not clinical ground truth established by medical experts for performance evaluation. The "ground truth" for mechanical testing is defined by the stress and strain limits specified in the ASTM standard. For software, the "ground truth" is established by the functional requirements and specifications.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation by multiple human readers. This submission focused on mechanical and software-based performance.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If So, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. An MRMC comparative effectiveness study was not conducted. This device is a physical external fixation system and associated P&C software, not an AI-assisted diagnostic or therapeutic tool that would involve human reader performance improvement.

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

• Yes (for the P&C Software component). The software verification and validation (V&V) essentially evaluates the algorithm's standalone performance against its intended specifications and functionality. The document states, "The results of software V&V testing indicate that the software performed as intended," implying testing of the algorithm itself. However, it's not "algorithm-only" in an AI sense; it's a piece of software for planning and calculation.

7. The Type of Ground Truth Used

• Mechanical Performance: The ground truth for mechanical testing is based on engineering standards and specifications (e.g., ASTM F1541-02). This means the device must withstand specified forces and conditions without failure.
• Software Performance: The ground truth for software validation is based on predefined software requirements, specifications, and functional tests. The software is verified to perform its intended computational and operational tasks accurately.

8. The Sample Size for the Training Set

• Not Applicable. This device is hardware with associated planning and calculation software, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The software is developed based on engineering principles and validated, not trained on data.

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

• Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant to this submission. The "ground truth" for the software's development is its design specification, derived from clinical and engineering principles.

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The EzFuze Implants have the following Indications for Use:
Fixation of osteotomies and reconstruction of the lesser toes and lesser fingers following correction procedures for hammertoe, claw toe, mallet toe, and other deformities of the feet and hands.

The Vilex EzFuze Implant System includes single-piece devices intended for the fixation of PIP joints in lesser toes and digits. Two styles are offered: EzFuze Implant with barbed prongs on both ends and Hybrid EzFuze Implant with a screw design at one end and the other end includes barbed prongs. The EzFuze and Hybrid EzFuze Implants are offered straight or with a 10° bend.

This document is a 510(k) summary for the EzFuze™ Implant System. It outlines the device's indications for use, technological characteristics, and its substantial equivalence to predicate devices. However, this document does not contain information regarding acceptance criteria, device performance metrics, or any study details that would typically be described in an AI/algorithm-based device submission.

This is a submission for a physical medical device (an implant for bone fixation), not an AI-powered software or diagnostic tool. Therefore, the questions related to AI device performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies are not applicable to the content provided.

Based on the provided text, I cannot provide the requested information because the document describes a physical medical implant, not an AI software/device.

To answer your request, I would need a document related to an AI/algorithm-based medical device.

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The Tapered Small Bone Nail Implant (SBNI) is indicated for use in fractures and osteotomies of the fibula, radius, and ulna.

The Vilex Small Bone Nail Implant System includes Tapered Nails (straight or bowed) and Locking Screws.

This document is a 510(k) premarket notification for a medical device called the "Small Bone Nail Implant System." It is a regulatory submission to the FDA, not a study report. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria and device performance from a clinical study.

Specifically, the document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing acceptance criteria and proving performance through a new clinical or standalone study.

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

1. Acceptance Criteria and Reported Device Performance: This document does not present acceptance criteria for a study or report specific performance metrics of the new device. Instead, it states that the device's "technological characteristics are similar to the characteristics of the predicate devices" and that "comparisons confirmed that the Small Bone Nail Implant is as safe, as effective and should perform as well as or better than the predicate devices." This is a qualitative statement of equivalence, not a quantitative measure against pre-defined acceptance criteria.

2. Sample Size for Test Set and Data Provenance: No test set or associated data provenance is mentioned. The submission relies on comparison to predicate devices.

3. Number of Experts for Ground Truth and Qualifications: Not applicable, as there's no diagnostic performance study involving expert ground truth.

4. Adjudication Method: Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No MRMC study is described. The comparison is against predicate devices in terms of design and intended use, not a human reader performance study.

6. Standalone Performance: No standalone performance study (algorithm only) is described, as this is a physical medical implant, not an AI/software device.

7. Type of Ground Truth Used: Not applicable, as there's no diagnostic performance study requiring ground truth.

8. Sample Size for Training Set: Not applicable, as this is not a machine learning device.

9. How Ground Truth for Training Set was Established: Not applicable.

In summary, this document is a regulatory filing asserting substantial equivalence of a physical medical implant (Small Bone Nail Implant System) to existing products. It does not describe a study involving acceptance criteria, test sets, expert ground truth, or performance metrics in the way your prompt anticipates for a diagnostic or AI-driven device.

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The Trident Fusion Implant has the following Indications for Use: Fixation of osteotomies and reconstruction of the lesser toes and lesser fingers following correction procedures for hammertoe, claw toe, mallet toe, and other deformities of the feet and hands.

The Vilex Trident Fusion Implant is a single-piece cannulated bone screw intended for the fixation of PIP joints in lesser toes and digits. The device is offered straight or with a 10° bend at the joint. It is available in either stainless steel or titanium.

The provided text is a 510(k) Summary for the Vilex Trident™ Fusion Implant. This document is a premarket notification to the FDA, demonstrating that a new device is as safe and effective as a legally marketed predicate device.

It does not contain information about acceptance criteria, device performance, or human study results. The document focuses on establishing substantial equivalence based on indications for use, material, sizes, shapes, and technological characteristics compared to predicate devices.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information regarding studies with human participants, expert ground truth, sample sizes, or MRMC studies, as none of this information is present in the provided text.

The closest information to "device performance" is the statement repeated under "Technological Characteristics" and "Substantial Equivalence" that: "The technological characteristics for the Trident Fusion Implant are the same as the characteristics of the predicate devices." and "The design features of the Trident Fusion Implant are substantially equivalent to the design features of other predicate devices previously cleared for market." This implies that its performance is expected to be similar to legally marketed devices.

The document states that "The safety and effectiveness of the Trident Fusion Implant are adequately supported by the substantial equivalence information, material information and analysis data provided within this Premarket Notification." However, the details of this "analysis data" proving safety and effectiveness are not included in the provided text.

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