Search Results

The Arthrex 2.4 mm Volar Distal Radius Plate System is internal fixation for fractures and reconstruction of the small bones, primarily including the distal radius and distal ulna. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and extra-articular fractures, displaced fractures, osteotomies, non-unions and mal-unions. This system can be used for palmar, dorsal, or orthogonal application.

The Arthrex Low Profile Screws (2.4 mm solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, and wrist. When used with a plate, the screw may be used with the Arthrex Low Profile, Small Fragment Plates, Distal Extremity Plates, and Distal Radius Plates.

The Arthrex 2.4 mm Volar Distal Radius Plate System consists of a series of plates and screws of varying lengths and orientations. The Arthrex 2.4 mm Volar Distal Radius Plates are 2.26 mm in thickness. Each plate provides locking screw fixation. The proposed plates are manufactured from CP Grade 4 Titanium conforming to ASTM F67. The plates are sold as sterile (Gamma), single-use, and non-sterile, single-use.

The Arthrex Low Profile Screws are a family of fully threaded, solid, non-locking screws. The screw family is offered in 2.4 mm in diameter and range in lengths from 6 mm to 40 mm. The screws are manufactured from Titanium Alloy conforming to ASTM F136. The screws are sold sterile (Gamma) and are single-use.

The provided text describes the Arthrex 2.4 mm Volar Distal Radius Plate System and Arthrex Low Profile Screws. It outlines the device's intended use and performance data as part of a 510(k) premarket notification.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are primarily demonstrated through substantial equivalence to predicate devices and adherence to relevant ASTM and AAMI standards.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "testing" (e.g., 4-Point Bend testing, MRI testing, BET) but does not provide specific sample quantities for each test.
• Data Provenance: Not explicitly stated. Given it's a 510(k) submission for a medical device designed for fracture fixation, the testing would typically be conducted under controlled laboratory conditions rather than involving human patient data at this stage. It's safe to assume the testing is prospective and controlled in nature.

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

• This information is not provided in the given text. The studies described are primarily mechanical, material, and safety tests rather than clinical studies requiring expert interpretation of results to establish ground truth. The "ground truth" for these tests are the objective measurements against established standards.

4. Adjudication Method for the Test Set

• This information is not applicable as the studies described are laboratory-based performance and safety tests, not clinical evaluations requiring adjudication of subjective outcomes.

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

• This is not applicable. The device described is a physical implant (plate and screws) for internal bone fixation, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related effectiveness is discussed.

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

• This is not applicable as the device is a physical implant, not an algorithm or software.

7. The Type of Ground Truth Used

• The ground truth used for the reported studies is based on objective measurements and adherence to established industry standards (ASTM, AAMI, USP, EP) and FDA guidance for device performance, material properties, and safety (e.g., strength, dimensions, pyrogen limits, MRI compatibility).

8. The Sample Size for the Training Set

• This is not applicable as the device is a physical implant, not a machine learning model requiring a training set.

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

• This is not applicable for the same reason as above.

Ask a specific question about this device

GPC Variable Angle Locking Two Column Volar Distal Radius Plating System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones. The system is indicated for use in adult patients only. All implants are for single use only.

GPC Variable Angle Locking Two Column Volar Distal Radius Plates are machined metal plates designed for fixation of various fracture modes of the distal portion of the Variable Angle Locking Two Column Volar Distal Radius Plates allow fragment-specific fracture fixation by providing the flexibility to lock screws in the head or shaft of the plate in trajectories that can diverge from the central axis of the plate hole. The variable angle locking mechanism improves the plate-screw construct stability. GPC Variable Angle Locking Two Column Volar Distal Radius Plates are manufactured using titanium material for surgical implant applications.

Following are the types of the GPC Variable Angle Locking Two Column Volar Distal Radius Plates:

• Variable Angle Locking Two-Column Volar Distal Radius Plate, Width 22 mm, 6 Head Holes (with option of Left and Right Variants)
• Variable Angle Locking Two-Column Volar Distal Radius Plate, Width 25.5 mm, 7 Head Holes (with option of left and right variants)
• Variable Angle Locking Two Column Volar Distal Radius Plate- Narrow, Width 19.5 mm, 6 Head Holes (with option of left and right variants)

Corresponding Screws for fixation:

• Variable Angle Locking Screw 2.4 mm, Star drive Lengths: 6mm to 30mm in 2mm increments
• FixLOCK Self-Tapping Screw 2.4 mm, Star drive Length 6mm to 30mm in 2mm increments
• Self-Tapping Cortex Screw 2.7 mm, Star drive Length: 12mm to 24mm

These implants are supplied non-sterile, the products have to be sterilized prior to use.

The provided document describes a 510(k) premarket notification for the GPC 2.4 mm Variable Angle Locking Two Column Volar Distal Radius Plates. This notification aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than establishing de novo safety and effectiveness. Therefore, the information provided focuses on the comparison to the predicate device and non-clinical testing against established standards, not on a study proving the device meets specific acceptance criteria in a clinical context with human users or AI.

However, based on the provided text, we can extract details related to the "device performance" as demonstrated through non-clinical testing.

Here's an analysis based on the information provided, framed as if the non-clinical tests are the acceptance criteria for substantial equivalence:

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

The document does not explicitly state "acceptance criteria" with numerical targets for the mechanical tests. Instead, it states that the device "Conforms" to the specified ASTM standards, implying successful performance according to the methodology and requirements of those standards.

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

• Sample Size: The document does not specify the sample size (number of plates or screws) used for each mechanical test.
• Data Provenance: The tests are non-clinical, conducted by the manufacturer, GPC Medical Ltd. The country of origin of the data would be India, where the manufacturer is located. The tests are prospective in the sense that they were conducted specifically for this submission.

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

This question is not applicable to the provided context as the "ground truth" here is established by engineering standards and direct physical measurement of mechanical properties, not by human expert interpretation. There were no human readers or expert consensus involved in determining if the device "conforms" to a bending fatigue test.

4. Adjudication method for the test set

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies with expert reviewers establishing ground truth, which is not the case here. The "adjudication" for mechanical tests involves comparing measured values against specified thresholds within the ASTM standards.

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

This question is not applicable. The device is a physical medical implant (bone plate and screws), not an AI software/algorithm. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant.

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

This question is not applicable, as the device is not an algorithm or AI.

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

For the non-clinical performance tests, the "ground truth" is defined by the specifications and methodologies of the applicable ASTM standards (ASTM F382 for plates and ASTM F543 for screws). The device's performance is compared directly against these engineering standards. For the comparison of characteristics, the "ground truth" is the specifications and characteristics of the identified predicate devices.

8. The sample size for the training set

This question is not applicable. This is a medical implant, not a machine learning model, so there is no "training set."

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

This question is not applicable, as the device is not a machine learning model.

Ask a specific question about this device

The Skeletal Dynamics Geminus Volar Distal Radius Plate System is intended for fixation of fractures and osteotomies of the distal radius

The Skeletal Dynamics Geminus Volar Distal Radius Plate System contains bone plates for the repair of distal volar radial fractures. Included in the set are titanium bone screws, fixation pegs, fragment plates, and specialized instrumentation. Also included are a Hook Plate Extension to buttress a volar marginal fragment, and cannulated cobalt chrome polyaxial locking screws for trajectories different than those of the fixed angled bone plates.

The Geminus Volar Distal Radius Plates are available in various sizes and are made of medical grade titanium alloy. Cortical screws affix the plate to the diaphysis and fixed angle pegs are used for distal bone fragments. The system is provided non-sterile and is sterilized in the user facility.

The Geminus Volar Distal Radius Plate System is comprised of:

• Titanium alloy plates, washers and screws
• CoCr Cannulated Polyaxial Locking Screw (PLS)
• Stainless steel K-wires (for provisional fixation; not for implantation)
• System specific instrumentation

The provided text describes the regulatory clearance of a medical device, the "Geminus Volar Distal Radius Plate System," through a 510(k) premarket notification. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than requiring extensive de novo clinical studies to prove safety and efficacy against predefined acceptance criteria.

Therefore, the document does not contain information about:

• Acceptance criteria and reported device performance in the context of a clinical study.
• Sample size used for a test set, data provenance, or the number/qualifications of experts for ground truth establishment.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes for human reader improvement with AI assistance (as this is not an AI/software device).
• Standalone (algorithm only) performance.
• The type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for a training set or how ground truth for a training set was established.

Instead, the performance testing for this device focused on demonstrating equivalence to the predicate device through engineering analysis and testing.

Key information from the text regarding performance:

• Performance Testing: "Engineering analysis and testing demonstrated that the Geminus Volar Distal Radius Plate System is substantially equivalent to predicate devices currently marketed. Therefore, the subject device is as safe and effective as legally marketed predicate devices."
• Technological Characteristics: "The substantial equivalence of the Geminus Volar Distal Radius Plate System to the predicate device is demonstrated by similarities in intended use, indications for use, materials, design (fundamental scientific technology), performance, sterility and packaging, and does not present any new issues of safety or effectiveness."

In summary, the provided text describes a 510(k) clearance based on substantial equivalence, not a study evaluating a device against specific clinical acceptance criteria. The "performance testing" mentioned refers to non-clinical engineering and bench testing to show that the new device performs similarly to predicate devices.

Ask a specific question about this device

The DePuy Synthes 2.4/2.7 mm VA-LCP Two-Column Volar Distal Radius Plate, Extra-Long is intended for intra- and extra-articular fractures, osteotomies, nonunions of the distal radius, with or without extension into the radial diaphysis in adults and adolescents (12-21) where the growth plates have fused or will not be crossed, and the following adolescent distal radius fractures:

• Intra-articular fractures exiting the epiphysis
• Intra-articular fractures exiting the metaphysis
• Physeal crush injuries
• Any injuries which cause growth arrest to the distal radius.

The DePuy Synthes 2.4/2.7mm VA-LCP Two-Column Volar Distal Radius Plate, Extra-Long will be available in stainless steel and titanium. The head of the plate will remain the same as the existing 2.4mm VA-LCP Two-Column Volar Distal Radius Plate (K102694) and will therefore allow the use of the existing guide block for these plates. The DePuy Synthes 2.4/2.7mm VA-LCP Two-Column Volar Distal Radius Plate, Extra-Long will come in 3 different lengths (7 shaft holes, 10 shaft holes and 13 shaft holes). To accommodate different patient anatomy, the plate with 7 shaft holes will be available with three different plate head widths (Standard, Narrow and Wide). The 10 shaft hole and the 13 shaft hole plate will only be released with the Standard plate head width and additionally they feature a curvature in the shaft. All plates will feature left- and right-specific designs and will be offered in sterile packed only.
The DePuy Synthes 2.4/2.7mm VA-LCP Two-Column Volar Distal Radius Plates, Extra-Long are designed to accept existing 2.4mm Variable Angle Locking Screws, 2.4mm Cortex Screws, 2.4mm Locking Screws, 1.8mm VA Buttress Pins and 1.8mm Locking Buttress Pins in the plate head holes. In the plate shaft, existing 2.4mm Cortex Screws, 2.7mm Cortex Screws, 2.4mm Variable Angle Locking Screws, 2.7mm Variable Angle Locking Screws, 2.4mm Locking Screws, and 2.7mm Locking Screws can be inserted.

This 510(k) premarket notification is for a medical device called the "DePuy Synthes 2.4/2.7mm VA-LCP Two-Column Volar Distal Radius Plate, Extra-Long". It is a metallic bone fixation appliance and accessories. This document does not describe the acceptance criteria or studies for an AI/ML device. It focuses on the substantial equivalence of a physical medical implant to existing predicate devices through mechanical and biocompatibility testing. Therefore, I cannot provide the requested information.

Ask a specific question about this device

The Skeletal Dynamics Geminus Volar Distal Radius Plate System is intended for fixation of fractures and osteotomies of the distal radius.

The Skeletal Dynamics Geminus Volar Distal Radius Plate System contains bone plates for the repair of either distal or volar radial fractures. Included in the set are titanium bone screws, fixation pegs, fragment plates, and specialized instrumentation. The Skeletal Dynamics Geminus Volar Distal Radius Plate is available in 6 sizes and is made of medical grade titanium alloy. Cortical locking screws affix the plate to the diaphysis and fixed angle pegs are used for distal bone fragments. The system is provided non-sterile and is sterilized in the user facility. The Skeletal Dynamics Geminus Volar Distal Radius Plate System is comprised of: titanium alloy plates, washers and screws; stainless steel K-wires (for provisional fixation not for implantation); system specific instrumentation.

This is a 510(k) premarket notification for a medical device (Skeletal Dynamics Geminus Volar Distal Radius Plate System), not an AI/ML device. Therefore, the questions related to AI/ML device performance (acceptance criteria, training/test set details, expert ground truth, MRMC studies, standalone performance) are not applicable.

The provided document describes the safety and effectiveness of a bone plate system by demonstrating its substantial equivalence to a predicate device already on the market.

Here's a breakdown of the relevant information provided:

1. Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" in the way one would for an AI/ML model (e.g., specific thresholds for accuracy, sensitivity, specificity). Instead, the "acceptance criteria" for this conventional medical device revolve around demonstrating substantial equivalence to a legally marketed predicate device.

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

• Test Set Sample Size: Not specified in terms of numerical count. The testing involved "preclinical analysis and cadaveric testing."
• Data Provenance: Not explicitly stated (e.g., country of origin). The testing was conducted by Skeletal Dynamics, LLC. It's prospective in the sense that the testing was performed for this 510(k) submission to demonstrate equivalence.

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

This concept is not applicable to a conventional medical device like a bone plate system. The "truth" is established through mechanical and cadaveric testing against established engineering principles and medical device standards, not through expert consensus on interpretations of data.

4. Adjudication method for the test set:

Not applicable. There's no "ground truth" to adjudicate in the context of expert review for this type of device. Performance is determined by objective mechanical testing and cadaveric studies.

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/ML device, and no human reader studies are mentioned or relevant for demonstrating equivalence of a bone plate system.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used:

• For the performance testing (mechanical and cadaveric testing), the "ground truth" is based on:
  • Mechanical properties and performance standards: The device's ability to withstand static, fatigue, and dynamic loads as expected for bone fixation, likely compared against established benchmarks or the predicate device's performance.
  • Cadaveric testing: Demonstrating the surgical implantation characteristics and initial biomechanical stability in a simulated human environment.
  • Comparison to predicate device: The ultimate "ground truth" for substantial equivalence is demonstrating that its performance is comparable to an already approved device.

8. The sample size for the training set:

Not applicable. There is no AI/ML model to train for this device.

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

Not applicable. There is no AI/ML model to train for this device.

Ask a specific question about this device

The Synthes 2.4 mm VA-LCP Two-Column Volar Distal Radius Plates are intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones.

The Synthes 2.4 mm Variable Angle LCP (VA-LCP) Two-Column Volar Distal Radius Plate is a machined metal plate that is designed for fixation of various fracture modes of the distal portion of the radius. The 2.4 mm VA-LCP Two-Column Volar Distal Radius plate allows fragment-specific fracture fixation by providing the flexibility to lock screws in the head or shaft of the plate in trajectories that can diverge from the central axis of the plate hole. Synthes' variable angle locking technology enhances plate-screw construct stability. The plates are manufactured in either titanium or stainless steel.

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving the device meets them. This document appears to be a 510(k) summary for a medical device (Synthes 2.4 mm VA-LCP Two-Column Volar Distal Radius Plate), which focuses on establishing substantial equivalence to a predicate device rather than detailing performance studies and acceptance criteria. The information provided is primarily regulatory in nature.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, nor can I populate the table and other requested sections.

Ask a specific question about this device

Synthes LCP Dia-Meta Volar Distal Radius Plates are indicated for fractures, osteotomies, and non-unions of the radius and other small bones.

The Synthes LCP Dia-Meta Volar Distal Radius Plates provide stable fixation for radius fractures. The plates have threaded locking holes in the head of the plate that accept 2.4 mm locking screws, and dynamic compression holes combined with locking holes in the shaft of the plate which accept 3.5 mm cortex, 3.5 mm locking, or 4.0 mm cancellous screws. The plates are available in various lengths and are available in right and left versions to accommodate varying patient anatomy. The plates are manufactured in either titanium or stainless steel.

This document is a 510(k) summary for the Synthes LCP Dia-Meta Volar Distal Radius Plate. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML device.

The document describes a medical device, which is a metallic bone fixation appliance, and its intended use. It is a traditional medical device (implantable plate and screws) and not an AI/ML powered device.

Therefore, I cannot extract the requested information (acceptance criteria, device performance, study details, sample sizes, ground truth, expert qualifications, etc.) as it pertains to AI/ML performance because this document is not about such a device.

Ask a specific question about this device

Synthes Ti Alloy VDRP is intended for fixation of fractures and osteotomies of the distal radius, applied to the volar aspect.

The plate is T-shaped (with the head 10° from perpendicular to the shaft), pre-contoured, and available in right and left versions. The head can be cut to size, and has up to six threaded holes that accept either 2.4 mm cortex screws or 1.8 mm buttress pins. The shaft can also be cut to size, has up to five compression holes (two being elongated shaft holes to facilitate positioning), and accepts 2.7 mm cortex screws. As is stated in its name, the plate is manufactured from a Ti Alloy. Synthes Ti Alloy will be provided both sterile and non-sterile.

The provided text is a summary of safety and effectiveness information for a medical device (Synthes Ti Alloy VDRP), comparing it to existing Synthes VDRP and Synthes STP products. However, it does not contain information about acceptance criteria or a study proving that a device meets specific performance criteria in the context of AI/ML or diagnostic accuracy. Instead, it describes:

• Device Description: Details about the Synthes Ti Alloy VDRP, its design, materials (Ti Alloy), and intended use (fixation of fractures and osteotomies of the distal radius).
• Comparison to Other Devices: Mentions that it's compared to existing Synthes VDRP (made of CP Titanium) and Synthes STP (made of 316L stainless steel).
• Sterilization Information: Specifies sterile and non-sterile options and recommended sterilization methods.
• Mechanical Testing: States that mechanical testing was performed and, based on its results, the Ti Alloy VDRP and CP Titanium VDRP are at least equivalent to the Synthes STP.

Therefore, I cannot fulfill your request for information regarding acceptance criteria, study design for performance, sample sizes, expert ground truth, MRMC studies, standalone performance, or training set details because this information is not present in the provided text. The text pertains to a traditional medical device (a plate for bone fixation) and its mechanical equivalence to other similar plates, not to a diagnostic or AI/ML device performance study as implied by your detailed list of requested information.

Ask a specific question about this device

Synthes Volar Distal Radius Plate is intended for fixation of fractures and osteotomies of the distal radius, applied to the volar aspect.

Synthes Volar Distal Radius Plate is intended for fixation of fractures and osteotomies of the distal radius, applied to the volar aspect. It is manufactured from commercially pure titanium. The plate is T-shaped, with the head 10° from perpendicular to the shaft, is precontoured, and is available in right and left versions. The head can be cut to size; it has up to six threaded holes, and accepts either 2.4 mm Cortex Screws or 1.8 mm Buttress Pins. The shaft can also be cut to size, and has up to five compression holes, two being elongated shaft holes to facilitate positioning, and accepts 2.7 mm Cortex Screws.

This document describes a medical device, the Synthes Volar Distal Radius Plate, and compares it to an existing device, the Synthes Small T-Plate. However, it does not contain information about acceptance criteria or a study related to device performance in terms of diagnostic accuracy or clinical effectiveness for AI/ML or imaging-based devices.

The document focuses on:

• Intended Use: Fixation of fractures and osteotomies of the distal radius.
• Material: Commercially pure titanium for the new device, 316L stainless steel for the comparator.
• Design Features: T-shaped, precontoured, dimensions, screw types accepted.
• Sterilization: Gamma radiation for sterile versions, steam sterilization guidelines for non-sterile.
• Performance Claim: Based on mechanical testing, the Synthes Volar Distal Radius Plate is at least equivalent to the Synthes Small T-Plate.

Therefore, I cannot fulfill your request for the following information as it is not present in the provided text:

1. A table of acceptance criteria and the reported device performance (in terms of diagnostic accuracy/clinical outcomes).
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
6. If a standalone (algorithm only) performance study was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

This document describes a traditional medical implant, and the "study" mentioned is "mechanical testing" to demonstrate equivalence in physical properties, not clinical or diagnostic performance.

Ask a specific question about this device